Scientists Simplifying Science

Author

Syam Anand

Syam Anand has 17 articles published.

The Patent Chronicle

in Sci-IP by

(April 25th, 2017) Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

India sees high patent growth

Source: India Innovation Trend Report from Clarivate Analytics, a leader in Patent Analytics reports that India scored the highest growth of 26 percent in terms of published patents amongst the countries analyzed. These include China, Japan, Korea, Indonesia and Malaysia.

Reason: Clarivate identified the following main reasons

  1. Government initiatives;
  2. Increasing number of R&D centers being opened by MNCs as well as Indian corporations; and
  3. Indian companies realizing the importance of patent protection in different geographies.

Impact: Polymers and plastics, computing, pharmaceuticals and telecommunications accounted for two-thirds of the published patents indicative of strength in these areas. Encouraging signs are present that the trend will continue and make India competitive in the global market.

Read more here and here

 

Dow wins huge infringement suit against Nova

Decision: A Canadian court ruled that Nova Chemical Corp. has to pay Dow Chemical Co. all the profits it earned by infringing on Dow’s Canadian patent on garbage bags and packaging materials. The ruling judge also came up with a formula that will guide the accountants at Dow and Nova how to determine the Nova’s profits from selling the infringing products.

Reason: Nova sold products for a long time that was covered by Dow’s patent claiming that their method is based on another polymer and did not infringe Dow’s methods patent. The litigation dragged on for several years, during which Nova made substantial profits.

Impact: This is the first time “springboard” damages have been awarded by a Canadian court on infringement. “Springboard” damages are assessed from actual accounted profits made by the infringer during the period of infringement. Backed by the verdict, Nova will pay Dow a substantial amount, which by some accounts is close to a billion dollars. Nova will stop making and selling packaging materials with their SURPASS polymer.

Read more

 

Snap buys an app patent for $7.7 million

Decision: Snap of Snapchat fame buys a geofilter app from Mobli for the huge sum.

Reason: Snapchat wanted to keep Facebook away from acquiring the patent. $360 million out of Snap’s $400 million profit was made from geofilters. Had FB acquired the patent, it would have wiped out Snap’s profits from geofilters.

Impact: Geofilters are location-speific photofilters that can be used for advertising. Snap did not have a geofilter app in their collection. Therefore, this becomes a sensible acquisition for Snap. This deal also sets a new trend for software app market wars between the giants in social media, $7.7 million being the highest sum paid for an Israeli firm for a software app. Mobli was lagging behind its competitor, Instagram. This comes as a decent win for Mobli.

Read more

 

Sanofi and Regeneron faces infringement over their Atopic Dermatitis drug

Decision: Amgen sued Sanofi and Regeneron for infringement over their Atopic Dermatitis (AD) drug Dupilumab (Dupixent),

Reason: Amgen’s subsidiary Immunex has a patent protecting the development of IL4-receptor antibodies. Amgen believes that Dupilumab, a monoclonal human antibody against IL4 and IL3 receptors, infringes the Immunex patent.

Impact: Dupilumab is a rapidly evolving blockbuster for Sanofi and Regeneron that was approved by FDA recently. It had showed efficacy against AD and holds a lot of promise for asthma and other diseases based on the biological mechanism it targets. If they lose, it will be a big loss for Sanofi and Regeneron, as some of their trials for other indications center around Dupilumab. Sweeping claims covering broad biological mechanisms are however difficult to litigate and win in courts. Therefore, it remains to be seen is Amgen’s contention will find support in the court.

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Bellus Health’s patent for Chronic Cough lead compound

Decision: USPTO grants Bellus Health a patent for their lead compound for treating chronic cough.

Reason: BLU-5937 was deemed novel and useful by the patent office. Compound BLU-5937, related imidazopyridine compounds, and pharmaceutical compositions containing these compounds are covered by the patent. They are potent, and selective antagonists of P2X3 receptors located on airway sensory neurons that are hypersensitized in chronic cough.

Impact: Bellus Health is a company focused on developing treatments for diseases with high unmet medical needs. With this win, Bellus Health could attract the resources needed to develop the lead molecule into a drug. Bellus holds the license to develop BLU-5937 from NEOMED who had it assigned to them from AstraZeneca. The P2X3 antagonist program was initiated by AstraZeneca scientists in Montreal.

Read more

Read more about Bellus

 

 

 

About the author:

Syam

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

Featured Image source: Twitter

Blog design: Abhinav Dey

Creative Commons License
This work by ClubSciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

 

 

The Patent Chronicle

in Sci-IP by

(April 18th, 2017) Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

Medco looses infringement contest on Bivalirudin formulation patents

Decision: District court ruled that Mylan’s proposed Abbreviated New Drug Application (ANDA) on the clotting inhibitor did not infringe the Medco’s patents in question. At the same time, Mylan lost the battle seeking invalidation of the Medco patents.

Reason: “Efficient mixing” was as an essential process in the Medco patents for producing batch consistency in Bivalirudin formulations. Mylan’s method was found not to use “efficient mixing” steps in their process as “efficient mixing” was found to be narrowly construed in the one example in the patent, leaving the patent weak.

Impact: Mylan would produce formulations of Bivalirudin without infringing on the Medco patents. Multiple dependable sources for the formulation could turn out to be good for the patients.

Read more

Novartis loses a major Gilenya patent

Decision: USPTO’s Patent Trial and Appeal Board ruled one Novartis patent on Gilenya used to treat MS invalid for being obvious.

Reason: Torrent Pharma, Apotex, and Mylan had initiated an Inter Partes Review, a post-grant review process, in the USPTO. It sought to invalidate the Novartis patent on grounds of obviousness. The components of the drug were Fingolimod and Mannitol. The former was already known to be useful to treat automimmune disorders such as MS.

Impact: The patent covering the MS oral drug earns billions for Novartis. Novartis has altogether four patents covering the MS drug. This particular one would have shielded the drug from generics till 2026. With this loss, the doors open to generics in 2019.

Read more here and here

UC Berkeley’s CRISPR fight proceeds to the next level

Decision: UC Berkeley files an appeal to the USPTO’s Patent Trial and Appeal Board’s decision in the Federal Circuit.

Reason: USPTO had ruled no interference on UC Berkeley’s CRISPR patent by Broad Institute’s CRISPR patent. Inventors of the UC Berkeley’s patent believe they have a broad patent that Broad’s patent infringes.

Impact: In the absence of cross-licensing agreements, it will end up being a long and expensive battle that will become a head ache for everyone, if Broad or UC Berkeley decide to go after the licensees from the other group.

Read more

Coalition for affordable drugs nears end.

Decision: Bass, the founder of Hayman Capital Management, closed the funding that supported the Coalition.

Reason: Lack of success in getting patents owned by the Big Pharma invalidated at the USPTO. For last one and a half years, the coalition has not filed a new case. It had success in only in 3 out of 14 medicines that it targeted.

Impact: According to some, the Coalition brought increased awareness about high drug prices and what to do about it. It appears that generic manufacturers themselves have taken over this task and have found success in several cases. Therefore, the absence of the Coalition at the forefront of the fight to lower drug prices wont be felt.

Read more

Two Goliaths vs many Davids on Eliquis face off

Decision: Over the last two weeks, Pfizer and BMS filed sixteen lawsuits together against 13 generic drug manufacturers of Eliquis.

Reason: Generic manufacturers have been piling up to grab a share of the drug’s multibillion-dollar deep vein thrombosis and pulmonary embolism market. They have abbreviated new drug applications (ANDAs) with the FDA to make and sell Apixaban, a generic for Eliquis.

Impact: Will depend on the ruling of the Delaware court where the lawsuits have been filed.

Read more here and here

Roxane to foot defendant’s legal fees as lawsuit is ruled exceptionally meritless

Decision: NJ District Court ruled, “Roxane pursued an infringement claim for which it lacked any legal or factual support”. “Roxane has been unable to point to any colorable factual or legal support for its position. It is indeed an exceptional case.”

Reason: A motion was brought by the defendants Camber Pharmaceuticals Inc. and InvaGen Pharmaceuticals Inc. in the District Court to declare the case “exceptional”.  Precedent allows the recovery of legal fees by prevailing party in exceptional cases. The case centered on capsule size. According to the plaintiff, the size of capsules of Calcium acetate made by the defendants were within the definition of the size of capsules claimed. The court ruled it was not.

Impact: Probably good for the patients as multiple sources for the end-stage kidney failure drug could keep prices down.

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About the author:

Syam

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

Featured Image source: Pixabay

Blog design: Abhinav Dey

Creative Commons License
This work by ClubSciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

 

The Patent Chronicle

in Sci-IP by

(April 11th, 2017) Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

Organizations request to free USPTO of Federal hiring freeze

Decision: Around twenty organizations directly requested the president to exempt USPTO from the federal hiring freeze. The letter ended by reminding him of the “America first” slogan.

Reason: The 45th president and his administration had instituted a federal hiring freeze that prevents USPTO also from filling several hundred vacancies including support staff. This is in spite of the fact that the government continues to divert hundreds of millions of dollars from fees earned by USPTO. Many including the signatories of the letter consider this a tax on innovation as their fees are diverted to general government funding. The US is now ranked #10 along with Hungary in patent system strength.

Impact: Left unaddressed, the challenges faced by US inventors in the domestic and more importantly in the international arena, will increase. Inadequate staffing will cause further backlog on patent prosecution and post-grant procedures. It will directly affect US innovation.

Read more here

Read the letter here

UK court steps in to guide fair, reasonable and non-discriminatory terms (FRAND)

Decision: UK High Court ruled that it would decide how much should be paid to use an essential patented technology (in this case mobile phone technology).

Reason: The FRAND commitment serves to harmonize the private interests of patent holders and the public interests of standard-setting organizations while attempting to meet industry standards. Those who own patents and those who want to use the patented technology interpret FRAND differently. Often times licensing prices choke off future development of the technology and its use.

Impact: The British High Court had not intervened to decide licensing prices before. Could end up becoming a trendsetter in UK. Licensing royalties that appear exorbitant may start getting litigated in UK courts. Technology adoption, research and development could benefit from favorable outcomes on this and future FRAND rulings. FRAND (RAND in the US) is an outlier like compulsory licensing as far as licensing practices go.

Read more here

RNA-based ProQR Cystic Fibrosis drug gets EU, US patents

Decision: ProQR therapeutics gets EU and US patents on Fast Track for restoring dysfunctional CFTR using RNA oligonucleotides.

Reason: The application enjoyed the Orphan drug designation in both Europe and the US.

Impact: The methods of treatment using the oligos are in clinical trials. If successful, patients will be able to self-administer the oligos with a nebulizer. Earlier trials have successfully restored CFTR function in patients containing two deletions in CFTR.

Read more here

20% workforce hit in Acorda as MS patents lose protection

Decision: Delaware court invalidated 4 (out of 5) patents covering Acorda’s MS drug Ampyra.

Reason: The patents were found to be obvious. The active ingredient in Ampyra is an old organic compound, 4-Aminopyridine that had limited patent protection. It appears that Acorda management were taking undue risks knowing that the protection was weak and very likely to be contested.

Impact: Restructuring of Acorda as it axes the workforce on MS and turns its focus to Parkinson’s disease where it holds IP and encouraging clinical trial data.

Read more here and here

 

PAX, a new alliance to protect Android systems from trolls

Decision: Google, Samsung Electronics, LG Electronics, HTC, Foxconn Technology Group, Coolpad, BQ, HMD Global, and Allview forms the Android-networked cross-license abbreviated “PAX”.

Reason: Open-source software faces legal challenges from trolls and real patent owners. There have been attempts to forms alliances in the hopes of putting resources together to meet these challenges.

Impact: The alliance is free and open to join. Thus, the alliance’s success will depend on who all joins. PAX follows similar efforts such as Open Innovation Network (OIN) that was formed to protect Linux from legal challenges. OIN was successful. PAX could translate into lower costs for Android users. PAX owns more than 230,000 global patents.

Read more here

LOT, a mutual defense alliance against PAEs grows in membership

Decision: Cisco, Slack, Daimler and Udemy joins LOT (License on Transfer)

Reason: Uptick in Patent Assertion Entity (PAE; Troll) activity and lack of attention from Washington D. C. According to LOT, there is a 500% uptick in troll activity in the last 10 years.

Impact: Initiated by Google in 2014, with mostly tech companies, LOT is now more diverse with members such as GM, Honda and JP Morgan. It works on a simple principle- if any member were to sell a patent to a troll, they cannot use the same against another member in LOT. According to LOT 80, billion dollars (80,000,000,000 $) are lost in needless patent troll litigation. Alliances such as OIN, PAX and LOT will reduce risk, and resources spend on troll-initiated litigations. LOT has 600,000 plus patents in their shelf.

Read more here

About the author:

Syam

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

Featured Image source: Pixabay

Blog design: Abhinav Dey

Creative Commons License
This work by ClubSciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The Patent Chronicle

in Sci-IP by

Your weekly dose from the world of patents (April 4th, 2017). The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club.

EPO to give CRISPR rights to UCB

Decision: European Patent Office (EPO) indicated its intention to give a broad CRISPR patent to UCB.

Reason: EPO is convinced that UCB’s CRISPR application has been enabled for BOTH prokaryotes and eukaryotes.

Impact: UCB gains upper hand in Europe in the CRISPR battle. Broad can still file an opposition to the EPO decision. UCB could end up amending claims affecting the scope of the patent. This is more or less going to end up as in USPTO with UCB getting a broader patent and folks wanting to use CRISPR in Europe and US having to license from both, IF they use it in eukaryotes.

Read more here

 Troll paradise Marshall, Texas could get hit

Decision: Pending

Reason: Opposing precedents as to where a patent owner can initiate proceedings for infringement- one set says place of incorporation, the other says place of operations (however minimal it is). Patent owners and trolls have been flooding to Marshall, Texas (a town with 25,000 population) and case numbers in the town are around 34% of those filed nationwide.

Impact: Supreme court decision will direct which precedent is the law of the land. Trolls could lose on their strategy litigate in “friendly” jurisdictions.

Read more here

NIH funding cuts will impact patents and innovation

Decision: The Trump administration has proposed the following cuts to NIH budget- 1.6 billion USD for 2017 and 6 billion USD for 2018.

Reason: Divert funds to increased defense spending.

Impact: Study led by a Harvard Business School entrepreneurship professor shows that both basic and applied research contribute to commercial innovation. In one author’s own words “neither the progress of life sciences research nor its contribution to the economy is neat or easy to quantify”. “The sausage factory doesn’t look up-close very appetizing,”. “But in the sweep of history, this system delivers things.” 10 % of NIH grants resulted directly in a patent and 30% in articles were subsequently cited by patents. Innovation will take a hit as a result of the funding cut’s impact on both basic and applied research.

Read more in here and here

BMS Dasatinib patent dismissed for no utility

Decision: Federal court finds ability to inhibit an enzyme cannot to be extended to a utility to cure cancer without sufficient proof. It is an overarching promise and lacks utility.

Reason: Apotex wanted to sell Apo-dasatinib in Canada and was opposed by BMS. Apotex alleged inutility, obviousness and double patenting.

Impact: Apotex can sell its drug in Canada. Sets a precedent for questioning a patent’s utility and enablement without direct proof.

Read more here

Small Business Innovation Protection Act

Decision: U.S. Senators Gary Peters (D-MI) and Jim Risch (R-ID) have reintroduced the bill aimed to protect the IP of small businesses by improving education on patents prosecution and beyond.

Reason: Lack of awareness of international patent protection that affects small businesses ability to protect their inventions outside US, especially China and other major international markets.
Impact: More in person and online training and outreach programs from Small Business Administration and USPTO through Small Business Development Centers.

Read more here

 

Biogen wins MS drug Tecfidera dispute

Decision: USPTO’s Patent Trial and Appeal Board ruled that Forward Pharma failed to prove Biogen had infringed on its patent.

Reason: Insufficient scientific description for proving infringement.

Impact: Biogen does not have to pay royalty to Forward Pharma with this ruling. However, an appeal of PTAB decision by Forward Pharma in a court could reverse the fortunes. Biogen had earlier licensed the use of dimethyl fumerate (active ingredient of the drug) from Forward Pharma making this a self-inflicted wound in a court battle.

Read more here

 About the author:

Syam

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

Featured Image source: Pixabay

Creative Commons License
This work by ClubSciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The Patent Chronicle

in Sci-IP by

Your weekly dose from the world of patents

 

EU ends plant patents

Decision: Under the EU biotech directive and European Patent Convention, plant varieties are no longer patentable.

Reason: Allow breeders to access varieties to breed new varieties.

Impact: All proceedings that entirely revolve around the patentability of a plant (or animal) obtained by an essentially biological process will be automatically suspended. Existing plant patents will not survive. New patents of this type will no longer be granted either.

Read more in in this link

 

India’s CSIR-Tech closes down

Decision: CSIR-Tech, the commercialization arm of Council for Scientific and Industrial Research (CSIR), India closes down. CSIR tech had 4,500 Indian and 8,800 foreign patents filed.

Reason: No revenue from patents, although several patents have been licensed.

CSIR director commented that most of CSIR’s patents were “bio-data patents”, filed solely to enhance the value of a scientist’s resume and that the extensive expenditure of public funds spent in filing and maintaining patents was unviable.

Impact: Filings will reduce. Scientists will have to find alternative resources to file patent applications.

Read more in this link

 

Drug-abuse deterrent Guardian technology

Decision: Patents granted 9,549,899 (US); 2393487 (European); 2015200243 (Australian) owned by Egalet, a Pennsylvania-based company.

Reason: Novel Guardian Technology that encapsulates the drug in PEO polymer and a stabilizer makes it resistant to tampering. Methods for abusing prescription pharmaceutical compositions are varied and can include, for example, extraction, melting, volatilization, physical tampering (e.g., grinding, grating, crushing, etc.), or direct administration. Guardian protects against most.

Impact: Adoption of this technology by drug-manufacturers on formulations of major abused drugs.

Read more in this link

Win for generic Argentum on VIMPAT

Decision: Argentum, a generic manufacturer gets PTO to take UCB’s VIMPAT (antielpileptic/anticonvulsant) to Patent Trial and Appeal Board

Reason: The U.S. Patent Office granted Argentum Pharmaceuticals LLC’s petition for inter partes review and concluded that Argentum has established a “reasonable likelihood that it would prevail in showing that claims 1-13 of the U.S. Patent RE 38,551 are unpatentable.

Impact: Most likely UCB will loose the patent. A win for generic manufacturers who are questioning patents using post-grant review mechanisms.

Read more in this link

 

Myriad vs Esoterix (LabCorp) Tit for Tat DNA analysis patent fight

Decision: Pending. Esoterix is suing Myriad for patent infringement in the U.S. District Court for the Middle District of North Carolina, alleging that Myriad’s MyRisk Hereditary Cancer Test infringes the JHU patents that Esoterix licenses.

Reason: Myriad approached Patent Trial and Appeal Board for invalidating all four patents in question because they are obvious or anticipated because of prior research publications.

Impact: Unclear at the moment.

Read more in this link

 

iSPERSE Inhaled Drug Technology Patent

Decision: Patent EP 2410981 for iSPERSE owned by Pulmatrix.

Background: iSPERSE (inhaled Small Particles Easily Respirable and Emitted). A respirable dry powder comprising respirable dry particles that comprise a divalent metal cation salt; wherein the divalent metal cation salt provides divalent metal cation in an amount of about 5% or more by weight of the dry particle and wherein the respirable dry particles have a volume median geometric diameter (VMGD) of about 10 microns or less and a dispersibility ratio (1/4 bar) of less than about 2 as measured by laser diffraction (RODOS/HELOS system).

Impact: May replace aerosol and other blended dry powder formulations for inhalation. Pulmatrix applications pending in other patent offices as well.

Read more in this link

 

About the author:

Syam

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

Featured Image source: Pixabay

 

Creative Commons License
This work by ClubSciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

 

 

You had the Right to Remain Silent

in Sci-IP by
Editor’s Note: Silence is Golden, isn’t it? After reading #ClubSciWri’s Sunday Blog from Syam Anand, you will realize how the complications in the patent war on CRIPSR-Cas9 have resulted from the statements made by parties whose vested interests are at stake. So next time when you have a plan to cash your intellectual crop, look before you speak! –Abhinav Dey 

The patent system adopted by the constitution of the United States of America, is a pursuit to protect the rights and liberties of the individual vis-à-vis the interests of the state and the community it serves. It puts down common sense rules and laws to bestow privileges called patents to rightful inventors for a limited amount of time. Is it perfect? No. Is it good? Yes. Can it be improved? Certainly! Are the concerned people working to improve it? Yes.

Before the patent system, one should understand that we mostly had monopolies bestowed upon individuals based on the whims and fancies of the royals or whoever ruled. That was hardly democratic. The idea of the patent system (Venice had one of the oldest) was to put in place a democratic setup with weights and balances. Further, it meant to incentivize inventions and spur economic activity by stating rights and liabilities in commerce. From time to time, weights piling up on one side upset the balance. That is a natural consequence and the system usually adapts. It is a pursuit and not a static state.

One of the ways the changes for the better (at least that is the idea) happen is through amendments to old laws and passing new laws that replace old ones. Most of the wisdom that drives changes is derived from case law. Patent rights are often fought hard in the USPTO after a patent is granted and beyond that in the judicial system. Why? Because the outcomes have huge economic consequences- real jobs, real lives and real advancements in science and technology are at stake. There are aspects of the patent law that the USPTO can rely on to decide rights. For the aspects of the law beyond the USPTO’s gambit, the judicial system helps to decide rights and liabilities.

The title is a quote taken from Miranda rights, legally required to be read to any person in the United States of America by law enforcement personnel before they are interrogated to preserve the admissibility of their statements against them in criminal proceedings. The full version is

“You have the right to remain silent.

Anything you say will be used against you in a court of law.

You have the right to an attorney during interrogation;

if you cannot afford an attorney, one will be appointed to you”.

Much like criminal law, things that you say and do before and after filing a patent can affect your case. This could be anything- interviews, opinions, articles, conference talks, abstracts, emails…anything of which there is a record that can be accessed. Having a record can be as good or as bad as having no record. To top it all, you do not have a right to an attorney, when it comes to patent law. You will have to afford one yourself. Many of these aspects are technology-neutral. That is the key here- the technology and the finer details matter, but not in the way one would normally think.

In that sense, the CRISPR patent war that is going on currently in the USPTO (United States Patents and Trademark Office) is not unique. There are many cases prior to this that asked whether inventive step(s) were involved in taking something from one system and making it work in another?

The tests are simple:

  • Can an ordinary person skilled in the art (in this case a molecular biologist) have taken the system that Doudna disclosed in her patent application be practiced in the system that Zhang ALSO disclosed in his application without further experimentation?
  • Are there admissions that Doudna made (anywhere in any form of which there is a record) that incriminates herself in the sense that the invention was just an idea and the enablement (guarantee that it will work as described) was not present at the time of application?
  • Did Zhang enable the invention before Doudna did although she described the idea first?

If Doudna incriminated herself, making statements that it is not easy to move the system from prokrayotes to eukaryotes, but still has proof that she none the less did this successfully in eukaryotes, before Zhang did, she wins.

Does this mean that everyone has to license from the winner in this case? Not really. They have to license only in the countries were Broad Institute or UC Berkeley has pursued patents and obtained rights. Elsewhere, everyone can have fun with CRISPR-Cas9 and make money or go broke. Probably, even more so in countries where patent protection is lax.

About the author:

Syam

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

About the illustrator:

Ipsa Jain is a Ph.D. student at IISc. She wants to gather and spread interestingness. She prefers painting and drawing over writing.

Creative Commons License
This work by ClubSciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The devil is in the variables: correlation, causation and experimental controls

in Sci-IP by

On Jan 31, 2017, the New York Times reported the solving of a mysterious illness in India- the yearly seasonal deaths of children around areas of Muzaffarpur that abounded in litchi orchards. The report reads like a great epidemiological investigation piece. The supporting study was published in Lancet Global Health on Jan30, 2017 titled “Association of acute toxic encephalopathy with litchi consumption in an outbreak in Muzaffarpur, India, 2014: a case-control study”. In authors words, the key findings that led them to this conclusion were the results of their case-controlled studies where they identified metabolites of hypoglycin A or methylenecyclopropylglycine (MCPG) in patient samples BUT NOT CONTROLS. They did similar and SIMULTANEOUS INVESTIGATIONS to rule out viruses, heavy metals, and pesticides.

 

The study makes it the first complete investigation to identify the toxin as one of the factors required to setting off the illness. As pointed out by the authors, while discussing the results in their publication, they caution, “Although litchi fruits are ubiquitous in the orchards surrounding the villages in rural Muzaffarpur, typically only one child in an entire village develops this acute illness. The synergistic combination of litchi consumption, a missed evening meal, and other potential factors such as poor nutritional status, eating a greater number of litchis, and as yet unidentified genetic differences might be needed to produce this illness”. Clearly, there is more to learn about the mysterious illness although the main culprit has been identified. It is important to see that the authors are not rushing to judgment and concluding that the mystery is solved and the case rests.

 

As the saying goes, “the devil is the details”. In epidemiology, the devil is in the variables. Remember the old saying, “correlation is not causation”. This is a case in point. One variable has been associated with experimental evidence to an illness. But the results indicate that there are many other variables likely in play and more studies need to done to identify those. It is dangerous to assume that the mystery is solved and that is precisely what the authors are cautioning the readers.

 

Once a mystery is “solved”, the solution appears simple and even visible to plain sight. Such hindsight has to be applied with caution. That is a lesson many scientists would have learned from personal experience. Until one gets there, the road is paved with mines.

 

The solution to the mystery illness soon escalated into controversy. On Feb 3, 2017, The Hindu, a daily from India, reported complaints from Dr. T. Jacob John, a virologist who was earlier attached to the Christian Medical College, (CMC) Vellore. Dr. John’s contention was that the Lancet publication “quote our study but don’t honestly say what we have found. If they did that then they can’t claim originality. They have done a large case-control study but borrowed all important information connected with the illness from us,”. The questions are, did the Lancet publication borrow from Dr. John’s earlier work and whether adequate credit was given. It is a difficult question, as many times it may seem to depend on personal opinion. But careful analysis can help to dissect some of these contentions. If one looks at Dr. John’s publications, one can see several reasons why he is upset. He was very close to sealing the deal. We do not know the struggles he might have undergone to get even where he got. However, he failed to net the winning goal. My analysis is below.

 

Dr. John had published a lucid hypothesis on the illness in Current Science in 2014 that connected litchi and malnutrition with the illness. He was the first one to do so. His reasons were the correlation of phenotypes of litchi-associated illness with a similar ackee-associated illness, reported way back in the 1950’s from Jamaica. Well, he was lucky as his hunch turned out to be true. It could have turned out to be false also as he did not have the key evidence needed for his hypothesis when he published it- the presence of the toxin in the fruit. Further, as shown in Lancet, one would see that all malnourished children do not develop the disease. In that sense, Dr. John’s hypothesis is still a stretch and dangerous one too as it was ruling out other hidden variables that are still in play without adequate support. In essence, the hunch that was published as a hypothesis is an incomplete one in light of the experimental evidence from case-controlled studies published in Lancet.

 

Although Dr. John ruled out infection with Japanese Encephalitis virus  (JEV), based on other groups’ findings, he did not rule out many other infectious agents. The Lancet study tested for JEV, West Nile virus (WNV), Herpes simplex viruses 1 and 2, human herpes viruses 6 and 7, cytomegalovirus, varicella zoster virus, Epstein-Barr virus, parechovirus, adenovirus, 68 enteroviruses, and parvovirus B19. It ruled all of them out. They also tested for pesticides and heavy metals and ruled them out. More importantly, these and other studies they did were all simultaneous. Simultaneous is very important in epidemiology. Therefore, it is unfair to say that they borrowed all the important information. In fact, and as I said earlier, it looks like that more important information is yet to come that could explain why all the malnourished children in and around Muzaffarpur do not get affected by MPCG or Hypoglycin from litchi consumption.

 

In another publication entitled “Outbreaks of Hypoglycemic Encephalopathy in Muzaffarpur, India: Are These Caused by Toxins in Litchi Fruit?”, Dr. John contends that “Since the part of the fruit consumed by humans contains MCPG, and experimentally it has been shown to cause hypoglycemia in starved animals, the biological plausibility of causality by MCPG is thus confirmed.” However, it is important to note that the publication is a letter-type opinion article and a criticism of IAP members, who continued to call the illness a mystery illness. It does not present any additional data that the Lancet publication should have cited or considered. Just because a fruit contains MCPG, it need not cause illness. The Lancet publication discusses this.

 

In a Current Science publication entitled “Litchi fruit contains methylene cyclopropyl-glycine”, Dr. John’s group identifies MCPG for the first time in litchi fruits. But, it fails to associate it with the mystery illness. The experiments were all directed to the identification of MCPG in the fruit. The Lancet paper cites Dr. John’s publication where they mention, “Of specific interest was the potential role of methylenecyclopropylglycine (MCPG), a homologue of hypoglycin A, and a substance naturally found in the litchi seed and fruit known to cause hypoglycaemia in animal studies by inhibiting β-oxidation of fatty acids and gluconeogenesis”. They also cite other publications that studied hypoglycemia and toxicity of MCPG in animals.

 

In my opinion, the Lancet study can and should be considered original as it directly associates a key variable, namely the metabolites of the toxins from the fruits, with the mysterious condition, with proper controls and the simultaneous ruling out of several other variables that could have been associated with causing the illness. This goes beyond mere correlation. No doubt Dr. John on a hunch had hypothesized the cause based on a correlation. But correlation does not seal causation especially in the absence of proper controls as Dr. John himself admits in his publication “All case-children were given 10% dextrose infusion in addition to per-protocol anticonvulsants and supportive nursing care. The response to dextrose was encouraging. We are unable to compare it with any control children”. He further states, “We need to study if under-nutrition is a determinant (risk factor) or just background noise”.

 

What happened in the following days after the outcry in The Hindu national amounts to ethical misconduct. First, Current Science publishes another letter from Dr. John entitled, “Publishing on hypoglycemic encephalopathy, borrowing information without giving credit: is Current Science invisible?”, that complains about the Lancet group not giving him credit for his hypothesis. Second, without any due diligence, the Hindu national picks on the letter and rushes to judgment that “‘Litchi disease’ report: Lancet makes amends after failing to give ‘credit’.

 

First, Lancet is not making any amends after failing to give credit as they have only contacted the respective authors to find out what is going on and get to the facts. It is irresponsible on the part of the editor of a national to rush and publish such misleading articles that unnecessarily tries to mix nationalism with science, and emotions such as large funding, “large group” (Dr. John’s words) etc. Second, the step taken by the journal is routine in cases where there are complaints about not giving credit. They do not depend on newspaper items in national dailies for initiating such steps. I have personal experience myself and I am sure, the editor of the national would have found out if he discussed with a sufficient number of scientists before submitting his misleading piece for publication. It sets a dangerous trend and we should hope that the editors from the daily takes note of this and carefully reviews the material it publishes.

 

Worse, in the Current Science complaint, Dr. John misstates that an MMWR publication by the Lancet group in 2015 entitled Outbreaks of Unexplained Neurologic Illness — Muzaffarpur, India, 2013–2014, concluded that the illness is caused by Litchi consumption. His Dr. John’s own words, “the stating that the disease is acute hypoglycemic encephalopathy with putative association

with litchi as if they were the first to arrive at such a conclusion” is unethical and misleads the public. The MMWR publication does not make that conclusion. Their conclusion as stated in the publication is “Until an etiology for this illness is identified, current public health and clinical recommendations are focused on reducing mortality by ensuring families with affected children rapidly access medical attention, and health care providers promptly assess for and correct hypoglycemia”. What were the Current Science editors thinking? What were the editors of The Hindu reviewing? If there is ethical misconduct, this is one- misleading the public in a one-sided manner.

 

The Hindu article also puts words like “at a time when the Lancet authors were looking for a viral cause”. It is false. It is also unethical. If one reads the MMWR publication, one can clearly see that the authors are equivocal about the causes when they conclude their article. I have added the excerpt from their conclusion above.
Finally, it is funny that one of the authors of the Current Science article Dr. Das, says, “It is very decent of Lancet to have got in touch with us and seek our clarification on this issue. That shows Lancet is careful of its credibility, careful that any such issue is immediately sorted out. I admire Lancet . This is what we want from every journal publisher, every investigator and every paper. Caesar’s wife must be above suspicion,”. Yes. How about Current Science and The Hindu? Have they sought clarifications from the Lancet group before rushing and publishing complaints? Have they even bothered to read the controversial publications and asked for a third or a fourth opinion? The statement that “Dr. John and Dr. Das had exposed the “scientific misconduct” by the authors in a correspondence published in Current Science” in a national daily is dangerous and one-sided. It has to be condemned. It fails the ethical standards of journalism.

 

In spite of all this, I feel that the Lancet paper could have been more gracious to Dr. John’s publications. For example, the Lancet article says, “No studies implicated a direct epidemiological association between litchi consumption in affected individuals and encephalopathy”. The authors could have given Dr. John the credit for implying an epidemiological association between litchi consumption in affected individuals and encephalopathy and even removed the word “direct” from the above statement. Looks like “direct” epidemiological association” as opposed to correlation will haunt this mystery illness forever. That said, a hypothesis based on a hunch is just that and it cannot substitute for experimental evidence obtained from carefully executed research. Publishing piecemeal correlations and research without waiting to complete an investigation comes with its disadvantages. Lack and funding and support also have its disadvantages. But one cannot use that to inject moral superiority into research done by teams that operate under resource-limiting conditions. These are separate issues and should be discussed separately.

 

About the author:

Syam

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

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A Compendium on Patenting

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Image source: https://pixabay.com/en/motorcycle-bike-harley-davidson-1515873/

Editor’s Note: If you are interested in taking up Intellectual Property and Patenting as a career in USA, you need to clear the USPTO Patent Bar exam. Syam Anand’s book titled “Index Cards for USPTO Patent Bar Exam and Quick References on US Patent Process” is available on Amazon (https://goo.gl/dMKSvq) which is a set of more than 2000 index cards that he used to ace the USPTO Patent Bar Examination. He has been a regular author on ClubSciWri and has guided several PhD Career Support Group members on issues of patenting.  His regular discussions led him to compile a brief overview and a simplified set of FAQs to help novices understand the patenting process in US and the role of a USPTO agent in helping the inventors understand the legal language of ownership, i.e. Patenting.  

Brief Overview of the Patenting Process in USA

The U.S. Patent and Trademark Office (USPTO) offers different application routes to meet varied goals of inventors and owners of inventions. These are:

  • Provisional Applications
  • Utility Applications (Non-provisional Application)
  • Continuing Applications
    • Divisional Application
    • Continuation Application
    • Continuation-In-Part Application
  • Design Applications (only for ornamental design of a functional item)
  • Plant Applications (only for plants)
  • PCT International Applications

Inventor or owner or assignee of invention can apply. Selecting the right application route is critical for securing the right kind of patent protection for your intellectual property. The following is a brief description of the various routes available and their approximate costs.

Provisional Application

  • Lower cost to file.
  • USPTO filing fee of $260 for a large entity and $130 for a small entity.
  • Patent attorney/agent fees range from $1,500-$2,000 depending on the complexity of the invention.
  • Gives an early effective filing date. Establishing an early effective filing date is critical since this determines what references and other disclosures qualify as prior art.
  • Claims covering the invention are not required.
  • Not examined or published.

Utility (Non-provisional) Application

  • The “actual” patent application filed by the applicant that gets examined.
  • USPTO filing fee of $1600 for a large entity and $730 for a small entity.
  • Patent attorney/agent fees range from $3,000-$5000 depending on the complexity of the invention.
  • Claims priority to the provisional application. Must be filed within one year of the provisional application filing date.
  • Requires the presence of claims covering the invention.
  • Gets published after 18 months from the priority date.

 

Divisional Application

  • Pursues unelected claims of a parent application as a result of USPTO Restriction Requirement.
  • USPTO filing fee of $1600 for a large entity and $730 for a small entity.
  • Patent attorney/agent fees from $1000-2000 depending on the complexity of the invention.
  • Claims priority to the parent application. Must be filed before the parent application abandons or issues.

Continuation Application

  • A continuation application pursuing unclaimed subject matter of the parent application.
  • USPTO filing fee of $1600 for a large entity and $730 for a small entity.
  • Patent attorney/agent fees from $1000-2000 depending on the complexity of the invention.
  • Claims priority to the parent application. Must be filed before the parent application abandons or issues.

Continuation-in-part Application

  • A continuation application filed by the applicant to pursue new matter that is not disclosed in the parent application. The new matter must be closely related to the subject matter disclosed in the parent application.
  • USPTO filing fee of $1600 for a large entity and $730 for a small entity.
  • Patent attorney/agent fees from $1000-3000 depending on the complexity of the invention.
  • Must be filed before the parent application abandons or issues.
  • Preserves priority for the old matter that was shared in the parent application.
  • The new matter gets the priority of the filing date of the continuation-in-part application.

PCT Application (also called “international application”)

  • International Application under the Patent Cooperation Treaty (PCT).
  • USPTO filing fee of $240 for a large entity and $120 for a small entity.
  • USPTO search fee of $2,080 for a large entity and $1,040 for a small entity.
  • USPTO examination fee of $760 for large entity and $380 for small entity.
  • Patent attorney/agent fees from $3,000-$5,000 depending on the complexity of the invention.
  • Standard one format, one language application that can be used as a basis for filing patents in more than 140 member countries of the PCT.
  • USPTO accepts PCT applications in English by a U.S. national or resident.
  • Applicant has 30 months from the effective filing date of the PCT application to enter individual countries and file national stage applications.

Patent prosecution is said to begin once a patent application is filed. The application is eventually taken up for examination. Effective communication with the patent office and with the examiner, with an understanding of the nuances of patent law and the patent language, assists in making prosecution a smooth process resulting in savings of time and money. Some of the prosecution steps that applications invariably go through are briefly described below:

Restriction Requirement

  • Examiner states there are multiple inventions in the patent application being examined.
  • Applicant must elect one of the inventions designated by the examiner. Non-elected inventions can be pursued in a divisional application.
  • No USPTO fees if filed within time period for reply, extensions of time available.
  • Patent attorney/agent fee range from $500-1000.

Non-final Office Action

  • This is the first communication from the Examiner regarding the claims. Examiner raises objections or rejections to claims in view of the prior art.
  • Applicant is required to provide detailed responses to overcome the objections/rejections raised by the examiner. This advances the prosecution towards allowance.
  • No USPTO fees if filed within time period for reply, extensions of time available.
  • Patent attorney/agent fees range from $750-$1500 depending upon complexity of response required to overcome objections and/or rejections stated by the examiner.

Final Office Action

  • Examiner may again raise objections or rejections to claims informing why the response to the non-final action does not place the application in condition for allowance.
  • Applicant is required to provide additional detailed responses to each and every objection and rejection raised by the examiner and advance the prosecution towards allowance.
  • No USPTO fees if filed within time period for reply, extensions of time available.
  • Patent attorney/agent fees range from $750-$1500 depending upon complexity of response required to overcome objections and/or rejections stated by the Examiner.
  • Response either places the application in condition for allowance or Applicant files a request for continued examination (RCE).

Notice of Allowance

  • Informs the applicant that the patent is ready for issue.
  • USPTO issue fee is $960 for large entity, $480 for small entity
  • Patent attorney/agent fees $500.
  • After the application grants, you get 20 years of patent term from the filing date.

Maintenance Fees

  • Fees associated with maintaining the patent in force after issuance, late payment due if payment within 6 months after fee is due
  • 1st fee (due at 3.5 year): $1600 for large entity, $800 for small entity
  • 2nd fee (due at 7.5 year): $3600 for large entity, $1800 for small entity
  • 3rd fee (due at 11.5 year): $7400 for large entity, $3700 for small entity

Glossary of important terms

Abandon                                  Applications are usually abandoned when responses that are due are not submitted in a timely fashion to the USPTO. Abandoned applications cannot mature into patents. Prosecution stops.

Allowance                                A notice of allowance from USPTO informs that the application meets all the requirements for a patent to be granted.

 

Applicant                                 Can be the inventor(s), owner of the invention or assignee of the rights of the invention.

 

Assignee                                  The person(s) who hold rights to the invention, for example, the employer of the inventor(s).

 

Election                                   Choosing one of the inventions in an application for prosecution as a result of restriction requirement by an examiner.

 

Effective filing date                  The earliest filing date that can be claimed for an application. The effective filing date may be (i) actual filing date of the application; (ii) the date of the earlier-filed application to which priority is claimed.

 

Extension                                 Formal requests for extensions of time for filing responses can be obtained for a fee. Cannot exceed more than 6 months.

 

Filing date                               The date when the application is submitted to USPTO.

 

Grant                                      Grant of the patent. This gives rights to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time in exchange for public disclosure of the invention when the patent is granted. A bond paper copy of the patent grant is ribboned, sealed, and mailed by USPTO.

 

New matter                              Subject matter not initially disclosed in the application. USPTO does not allow new matter to be added at any time during prosecution.

 

Objection/Rejection                 The examiner issues an office action objecting/rejecting the claims during prosecution, based on prior art. When the office action is issued, the objections/rejections have to be overcome in order to advance the prosecution. A critical and significant portion of patent prosecution.

 

Patent Agent                            A person who has passed the Patent Bar examination administered by USPTO for registration at the USPTO.

 

Prior Art                                 The universe of printed publications, disclosures, talks, and other information that are publically available.

 

Publication                              USPTO publishes all applications around 18 months. The contents of the application are publicly available after this. In certain cases, a request can be made to withhold from publication.

 

Response                                 Formal filing of communications with the USPTO within the required time periods. They have to fully meet the requirements of form and content. A critical and significant portion of patent prosecution.

 

Restriction requirement           Placed on an application when the examiner believes that there is more than one claimed invention in an application. The applicant has to elect one invention for the prosecution to progress.

 

Subject matter                         The subject to which the application and the invention is directed.

 

 

Frequently Asked Questions (FAQs)

What is a patent?

A patent is an exclusive right for a limited time for an invention.

What are the exclusive rights for?

The rights are excluding others from making, using, selling, offering for selling and importing the invention.

For how long is a patent valid?

Twenty years from the application filing date.

What is an invention?

An invention is a novel and non-obvious useful tangible solution to a problem. Notable exceptions are design patents that cover external appearance of objects.

What is novel?

In simple terms anything that is new, man-made, and does not exist previously and has not been disclosed before.

What is non-obvious?

In simple terms anything that is not an incremental improvement (i.e. obvious improvement) over previously known product or process.

Can I patent anything and everything that meet the criteria of utility, novelty and non-obviousness?

No, you cannot. There are country-specific rules on what is and what is not patentable.

Can I patent, if I publish?

In the US, you may, within one year of publishing and obtain rights in the US. In all other countries you loose your rights if you publish before submit a patent application.

Can I patent, if I disclose?

In the US, you may, within one year of disclosing your invention. In all other countries you loose your rights, if you disclose your invention before submitting a patent application.

What kinds of disclosures affect the prospects of patenting?

In general, any public disclosure as opposed to disclosure within a confidential meeting (for example lab meeting) or disclosures protected by non-disclosure agreements.

Do I have to file a patent to practice my invention?

No. You are not required to file a patent to practice your invention. But without patent protection, you risk your invention being copied by others.

Can a person or entity that has already obtained a patent on the same invention, stop me from practicing the invention?

Yes. A patent gives the owner of the patent, exclusive constitutionally bestowed rights to stop others from practicing the invention described in the patent. This falls under patent infringement.

I have an idea that could be patentable, what should I do first?

The first question to ask is, who owns the idea. An easy way to answer this question is to ask yourself, what are your obligations to your employer.

I work in a lab and my idea is related to the project I work on for my employer. Do I own the rights to the idea?

In general, no. Your employer owns the right to the idea. Contact your technology transfer office/center. They will guide you.

I work in a lab and my idea is independent of the project I work on for my employer. But I used materials and equipment in the lab for testing and perfecting my idea. Do I own the rights to the idea?

I work in a lab and my idea is independent of the project I work on for my employer. Also, I did not use materials or equipment from my employer and instead used my own funds for testing and perfecting my idea. Do I own the rights to the idea?

Yes.

My employer decided not to pursue my invention. Is this a dead end for my invention?

No. They could give you the ownership rights for the invention for free or a cost. They could also license for free or a cost. Where federal funding is involved, even the federal government can give you the rights for free or a fee.

What are the things to remember when deciding whether to patent an invention or not on my own?

Two things to contemplate are money and time. Obtaining a patent costs money in terms of filing fees, maintenance fees, and attorney fees. It is up to the inventor to evaluate the cost benefit of filing and maintaining a patent.

I am good at generating ideas but not good at perfecting them. Can I file a patent application for an imperfect idea?

In fact yes, if the idea is not completely abstract and can be described adequately to convincingly prove that it can work as described.

I am good at generating and testing ideas and even perfecting them. But I do not have the experience or inclination to manufacture or market my invention. Is this worthwhile to pursue a patent application?

Yes. Patents can be sold or licensed to others who are interested buyers. They are a form of intellectual property.

Can I patent an idea that is just an idea?
No. Ideas that do not describe an identifiable embodiment or do not have any functionality are not patentable.

Who can file a patent application?
Inventors, owners and individuals or organizations with sufficient proprietary interest in the invention can file a patent application for an invention.

When should I file a patent?
Usually when your invention is enabled and before you disclose your invention to public, for example through seminars or trade shows, or even before signing a potential license agreement with a third party.

How do I know that my invention is enabled?
In simple terms, your invention is enabled if it functions as described by you and extensive experimentation is not required to practice it.

Do I have to submit a working prototype of the invention when I am filing a patent application?
No.

I do not know how my invention works, but it works. In other words, I do not know the scientific principle that makes my invention work. Can I file a patent application for the said invention?
Yes.

Why should I file a patent application?
Once a patent is granted, its gives the owner of the patent, rights to exclude others from using/copying, selling, offering for sale and importing the invention from another country.

Why should I file a patent application if my employer owns the rights to my invention?
You may benefit from financial and professional incentives that many employers give for generating intellectual property that adds value to the employer.

My employer owns the invention I wish to patent. How should I go about filing a patent application for my invention?
Please contact your employers. They will guide you. In general, industries have patent liaisons or counsels and academic organizations have technology transfer experts who will guide you.

My employer does not own the invention I wish to patent. How should I go about filing a patent application for my invention?
You can file a patent application all by yourself (called pro se) or with the help of a professional who has knowledge about patent laws.

What kind of professional help should I seek for when I am filing a patent application myself?
Almost all countries have patent agents who are qualified to represent inventors and registered with the country-specific patent office. You may discuss your invention with patent agents or patent attorneys (who are also lawyers) after signing non-disclosure or confidentiality agreements with them.

Am I required to go through a patent agent to file a patent application?
No. In fact, you can file patent applications pro se, that is, by yourself. However, most patent offices recommend that prospective applicants retain the services of a registered patent attorney or patent agent to prepare and prosecute their applications.

Can I take the help of a patent agent in India for representing me at the United States Patent and Trademark Office (USPTO)?
No. Only candidates who pass the USPTO registration examination (also known as the patent bar exam) and registered at USPTO can represent inventors in the US. However, inventors may utilize the expertise of other individuals including patent professionals in other countries to prepare and submit applications. In this scenario, the inventor will be representing himself/herself at the USPTO. Similarly, only candidates who have passed the Indian Patent Agent examination and registered at the Indian patent office to practice Indian patent law can represent you at the Indian Patent Office.

How does the services of a patent agent help in the preparation and prosecution of applications at the USPTO?
When filing an application at a patent office, there are technical and legal requirements to be met. A patent is only as good as what is claimed and how it is described in a patent application. A strong patent protection requires good patent application drafting skills. A good patent helps to prevent others from designing around your invention and prevent others from entering the same market space. An experienced patent attorney or agent brings such skills in drafting patent applications.

In addition, the attorney/agent also helps in prosecuting the application before the patent office. Once an application is examined, the patent office sends out office actions- official communications to the inventor, and may reject or allow based on the merits of the patent application. The attorney/agent, on behalf of the inventor, can present arguments to meet the legal and technical thresholds set by the patent office and help in obtaining a patent. This requires an understanding of the patent law and claim language.

What are the contents of a patent application?
The main contents of a patent application are a written description of your invention called specification, drawings that help to describe the invention and specific claims that you seek exclusive protection for based on the specification. Among other things, it also contains information about the inventor, owner and representative of the invention.

How long does it take to file a patent application?
It takes anywhere from one week to more than a month to file a patent application. The main factor that determines the time taken is drafting a patent application, which usually depends on the nature of the invention. Complex inventions, such as inventions in biotechnology and life sciences take around 2-3 weeks to draft good patent application.

How long does it take to obtain a patent after filing an application?
In the US it may take from 1-3 years depending upon the area and the procedure for examination used. There are accelerated procedures available for an increased fee. In India it takes up to 8 years to obtain a patent.

Where do I file my patent?
You need to file patents in countries in which you wish for patent protection. Many inventors choose to file in United States because United States is one of the largest economies in the world. Other regions that people consider are Europe, Japan, China, Brazil, and India.

I am not a US citizen, but my invention was made in the US. Should I file for patent in the US or the country of my citizenship?
Any person can file for a patent in US. However, if the invention was made in US and the inventor wants to first file a patent outside US, the inventor has to apply for a foreign filing license.

I do not want to obtain a foreign filing license for my invention. What are the consequences?
Not getting a license and still filing outside will cost US patent.

What are the typical initial costs involved in filing a patent application in the US?

Preparing a US patent application can cost anywhere from 1500-10000 US$ depending on nature, complexity of patent application, type of patent application and involvement and nature of patent agent (individual, small firm, big firm) or doing it pro se.

What are the typical initial costs involved in filing a patent application in India?

Preparing an Indian patent application can cost anywhere from 50,000 to 1,00,000 INR depending on nature, complexity of patent application, type of patent application and involvement and nature of patent agent (individual, small firm, big firm) or doing it pro se.

How does one choose a patent agent/firm?

The best way is to get referred to by someone who has used the agent/firm before. If not, look for registered patent attorneys and agents listed in the patent office one wishes to file. Other factors to consider are firm’s expertise with respect to the nature of invention (biology, chemistry, material science, computer software etc), experience, and affordability. Patent firms usually employ patent agents or technical specialists who assist patent agents and they cover most subject areas.

What are the typical steps involved in filing a patent application with the help of a patent agent or patent firm?

Submit an invention disclosure to the agent/firm that describes the invention. This is typically followed by an interview with the agent/firm. The agent/firm may request additional information during the drafting process. Professional drawings also may be required. The completed application is filed by the agent/firm on the behalf of inventor/owner of the invention to the patent office.

Can I obtain an international patent for my invention?

No. There is no such thing as an international patent. Individual countries grant patents.

How can I get patent protection in many countries?
There are two options.
1. One can file separate patent applications in the selected countries.
2. One can file an application under the Patent Cooperation Treaty (PCT). The PCT application acts a common patent application, and can be used as a basis to file country specific patent applications. These country-specific applications are called national stage applications.

What are the advantages of filing of a PCT application or patent applications in several different countries myself versus using a patent agent?

Experienced patent agents/firms will be familiar working with associates/firms in different countries. Without professional assistance, missed deadlines and incomplete responses to office actions originating from many countries at regular intervals may be become overwhelming and more expensive. Keep in mind that in addition to the technical and legal requirements there are language requirements in the different countries.

Can I use a patent agent/firm in US (or in India) for handling the filing of PCT applications?

Yes. PCT applications can be filed in any country that is signatory to the Patent Cooperation Treaty. Once the application enters the national stage in different countries, the primary agent/firm will coordinate with the foreign agents/firms who are registered to practice in the respective countries.

Are the contents of an application held in confidence by a patent agent?

Yes. It is a patent office requirement and there are penalties for not following this.

Can my patent agent disclose the contents of my application to a third party without my permission even if I do not sign a confidentiality or non-disclosure agreement?

No

My patent agent/firm is asking for a power of attorney for filing my application with the patent office. Should I give one?

Yes. The agent/firm requires a recorded power of attorney to communicate with the patent office on your behalf.

Are the contents of an application held in confidence by patent offices?

Yes, until the application gets published by the patent office after a certain period of time after filing of the application. This is 18 months in the USPTO.

Can I prevent publication? How long does it protect against disclosure?

Yes. You may submit a non-publication request in the USPTO. It protects against disclosure until the patent is granted.

What is patent infringement?

Making, using, selling, offering for selling and importing the invention to which one does not hold patent rights is considered infringement.

I have a US patent for an invention. I see that the product covered under the granted patent is sold commercially in India. Do I have the rights to stop this commercial activity?

No. Patents rights are only for the region/country that granted the patent.

I have a US patent for an invention. I see that the product covered under the granted patent is sold commercially in the US. Do I have the rights to stop this commercial activity?

Yes.

I have filed a US patent application for an invention. I see that the product described in the patent application is sold commercially in the US. Do I have the rights to stop this commercial activity?

No. A patent application is just a patent application. You have no rights until it is granted.

I have filed a PCT application for an invention made in the US. I see that the product described in the patent application is sold commercially in India and USA. Do I have the rights to stop this commercial activity?

No. A patent application is just a patent application. You have no rights until it is granted.

 

 

 

Syam

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

 

For more info, get Syam’s book from Amazon https://goo.gl/dMKSvq

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A BRIEF OVERVIEW OF THE US PATENT PROCESS*

in Sci-IP by

Syam

The U.S. Patent and Trademark Office (USPTO) offers different application routes to meet varied goals of inventors and owners of inventions. These are:

  • Provisional Applications
  • Utility Applications (Non-provisional Application)
  • Continuing Applications
    • Divisional Application
    • Continuation Application
    • Continuation-In-Part Application
  • Design Applications (only for ornamental design of a functional item)
  • Plant Applications (only for plants)
  • PCT International Applications

 

Inventor or owner or assignee of invention can apply. Selecting the right application route is critical for securing the right kind of patent protection for your intellectual property. The following is a brief description of the various routes available and their approximate costs.

 

Provisional Application

  • Lower cost to file.
  • USPTO filing fee of $260 for a large entity and $130 for a small entity.
  • Patent attorney/agent fees range from $1,500-$2,000 depending on the complexity of the invention.
  • Gives an early effective filing date. Establishing an early effective filing date is critical since this determines what references and other disclosures qualify as prior art.
  • Claims covering the invention are not required.
  • Not examined or published.

 

Utility (Non-provisional) Application

  • The “actual” patent application filed by the applicant that gets examined.
  • USPTO filing fee of $1600 for a large entity and $730 for a small entity.
  • Patent attorney/agent fees range from $3,000-$5000 depending on the complexity of the invention.
  • Claims priority to the provisional application. Must be filed within one year of the provisional application filing date.
  • Requires the presence of claims covering the invention.
  • Gets published after 18 months from the priority date.

 

Divisional Application

  • Pursues unelected claims of a parent application as a result of USPTO Restriction Requirement.
  • USPTO filing fee of $1600 for a large entity and $730 for a small entity.
  • Patent attorney/agent fees from $1000-2000 depending on the complexity of the invention.
  • Claims priority to the parent application. Must be filed before the parent application abandons or issues.

 

Continuation Application

  • A continuation application pursuing unclaimed subject matter of the parent application.
  • USPTO filing fee of $1600 for a large entity and $730 for a small entity.
  • Patent attorney/agent fees from $1000-2000 depending on the complexity of the invention.
  • Claims priority to the parent application. Must be filed before the parent application abandons or issues.

 

Continuation-in-part Application

  • A continuation application filed by the applicant to pursue new matter that is not disclosed in the parent application. The new matter must be closely related to the subject matter disclosed in the parent application.
  • USPTO filing fee of $1600 for a large entity and $730 for a small entity.
  • Patent attorney/agent fees from $1000-3000 depending on the complexity of the invention.
  • Must be filed before the parent application abandons or issues.
  • Preserves priority for the old matter that was shared in the parent application.
  • The new matter gets the priority of the filing date of the continuation-in-part application.

 

PCT Application (also called “international application”)

  • International Application under the Patent Cooperation Treaty (PCT).
  • USPTO filing fee of $240 for a large entity and $120 for a small entity.
  • USPTO search fee of $2,080 for a large entity and $1,040 for a small entity.
  • USPTO examination fee of $760 for large entity and $380 for small entity.
  • Patent attorney/agent fees from $3,000-$5,000 depending on the complexity of the invention.
  • Standard one format, one language application that can be used as a basis for filing patents in more than 140 member countries of the PCT.
  • USPTO accepts PCT applications in English by a U.S. national or resident.
  • Applicant has 30 months from the effective filing date of the PCT application to enter individual countries and file national stage applications.

 

Patent prosecution is said to begin once a patent application is filed. The application is eventually taken up for examination. Effective communication with the patent office and with the examiner, with an understanding of the nuances of patent law and the patent language, assists in making prosecution a smooth process resulting in savings of time and money. Some of the prosecution steps that applications invariably go through are briefly described below:

Restriction Requirement

  • Examiner states there are multiple inventions in the patent application being examined.
  • Applicant must elect one of the inventions designated by the examiner. Non-elected inventions can be pursued in a divisional application.
  • No USPTO fees if filed within time period for reply, extensions of time available.
  • Patent attorney/agent fee range from $500-1000.

Non-final Office Action

  • This is the first communication from the Examiner regarding the claims. Examiner raises objections or rejections to claims in view of the prior art.
  • Applicant is required to provide detailed responses to overcome the objections/rejections raised by the examiner. This advances the prosecution towards allowance.
  • No USPTO fees if filed within time period for reply, extensions of time available.
  • Patent attorney/agent fees range from $750-$1500 depending upon complexity of response required to overcome objections and/or rejections stated by the examiner.

Final Office Action

  • Examiner may again raise objections or rejections to claims informing why the response to the non-final action does not place the application in condition for allowance.
  • Applicant is required to provide additional detailed responses to each and every objection and rejection raised by the examiner and advance the prosecution towards allowance.
  • No USPTO fees if filed within time period for reply, extensions of time available.
  • Patent attorney/agent fees range from $750-$1500 depending upon complexity of response required to overcome objections and/or rejections stated by the Examiner.
  • Response either places the application in condition for allowance or Applicant files a request for continued examination (RCE).

Notice of Allowance

  • Informs the applicant that the patent is ready for issue.
  • USPTO issue fee is $960 for large entity, $480 for small entity
  • Patent attorney/agent fees $500.
  • After the application grants, you get 20 years of patent term from the filing date.

Maintenance Fees

  • Fees associated with maintaining the patent in force after issuance, late payment due if payment within 6 months after fee is due
  • 1st fee (due at 3.5 year): $1600 for large entity, $800 for small entity
  • 2nd fee (due at 7.5 year): $3600 for large entity, $1800 for small entity
  • 3rd fee (due at 11.5 year): $7400 for large entity, $3700 for small entity

 

Glossary of important terms

 

Abandon                                  Applications are usually abandoned when responses that are due are not submitted in a timely fashion to the USPTO. Abandoned applications cannot mature into patents. Prosecution stops.

Allowance                                A notice of allowance from USPTO informs that the application meets all the requirements for a patent to be granted.

 

Applicant                                 Can be the inventor(s), owner of the invention or assignee of the rights of the invention.

 

Assignee                                  The person(s) who hold rights to the invention, for example, the employer of the inventor(s).

 

Election                                   Choosing one of the inventions in an application for prosecution as a result of restriction requirement by an examiner.

 

Effective filing date                  The earliest filing date that can be claimed for an application. The effective filing date may be (i) actual filing date of the application; (ii) the date of the earlier-filed application to which priority is claimed.

 

Extension                                 Formal requests for extensions of time for filing responses can be obtained for a fee. Cannot exceed more than 6 months.

 

Filing date                               The date when the application is submitted to USPTO.

 

Grant                                      Grant of the patent. This gives rights to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time in exchange for public disclosure of the invention when the patent is granted. A bond paper copy of the patent grant is ribboned, sealed, and mailed by USPTO.

 

New matter                              Subject matter not initially disclosed in the application. USPTO does not allow new matter to be added at any time during prosecution.

 

Objection/Rejection                 The examiner issues an office action objecting/rejecting the claims during prosecution, based on prior art. When the office action is issued, the objections/rejections have to be overcome in order to advance the prosecution. A critical and significant portion of patent prosecution.

 

Patent Agent                            A person who has passed the Patent Bar examination administered by USPTO for registration at the USPTO.

 

Prior Art                                 The universe of printed publications, disclosures, talks, and other information that are publically available.

 

Publication                              USPTO publishes all applications around 18 months. The contents of the application are publicly available after this. In certain cases, a request can be made to withhold from publication.

 

Response                                 Formal filing of communications with the USPTO within the required time periods. They have to fully meet the requirements of form and content. A critical and significant portion of patent prosecution.

 

Restriction requirement           Placed on an application when the examiner believes that there is more than one claimed invention in an application. The applicant has to elect one invention for the prosecution to progress.

 

Subject matter                         The subject to which the application and the invention is directed.

 

*Disclaimer: The above information in only meant to serve as a guideline to understand the complexity of the patent process. It is in no way complete.

 

Syam Prasad Anand, PhD
Founder, Mainline Intellectual Property
Ardmore, Philadelphia, USA.

Frequently asked questions about patenting (part 2)

in Sci-IP by

Syam

• Can I patent an idea that is just an idea?
No. Ideas that do not describe an identifiable embodiment or do not have any functionality are not patentable.

• Who can file a patent application?
Inventors, owners and individuals or organizations with sufficient proprietary interest in the invention can file a patent application for an invention.

• When should I file a patent?
Usually when your invention is enabled and before you disclose your invention to public, for example through seminars or trade shows, or even before signing a potential license agreement with a third party.

• How do I know that my invention is enabled?
In simple terms, your invention is enabled if it functions as described by you and extensive experimentation is not required to practice it.

• Do I have to submit a working prototype of the invention when I am filing a patent application?
No.

• I do not know how my invention works, but it works. In other words, I do not know the scientific principle that makes my invention work. Can I file a patent application for the said invention?
Yes.

• Why should I file a patent application?
Once a patent is granted, its gives the owner of the patent, rights to exclude others from using/copying, selling, offering for sale and importing the invention from another country.

• Why should I file a patent application if my employer owns the rights to my invention?
You may benefit from financial and professional incentives that many employers give for generating intellectual property that adds value to the employer.

• My employer owns the invention I wish to patent. How should I go about filing a patent application for my invention?
Please contact your employers. They will guide you. In general, industries have patent liaisons or counsels and academic organizations have technology transfer experts who will guide you.

• My employer does not own the invention I wish to patent. How should I go about filing a patent application for my invention?
You can file a patent application all by yourself (called pro se) or with the help of a professional who has knowledge about patent laws.

• What kind of professional help should I seek for when I am filing a patent application myself?
Almost all countries have patent agents who are qualified to represent inventors and registered with the country-specific patent office. You may discuss your invention with patent agents or patent attorneys (who are also lawyers) after signing non-disclosure or confidentiality agreements with them.

• Am I required to go through a patent agent to file a patent application?
No. In fact, you can file patent applications pro se, that is, by yourself. However, most patent offices recommend that prospective applicants retain the services of a registered patent attorney or patent agent to prepare and prosecute their applications.

• Can I take the help of a patent agent in India for representing me at the United States Patent and Trademark Office (USPTO)?
No. Only candidates who pass the USPTO registration examination (also known as the patent bar exam) and registered at USPTO can represent inventors in the US. However, inventors may utilize the expertise of other individuals including patent professionals in other countries to prepare and submit applications. In this scenario, the inventor will be representing himself/herself at the USPTO. Similarly, only candidates who have passed the Indian Patent Agent examination and registered at the Indian patent office to practice Indian patent law can represent you at the Indian Patent Office.

• How does the services of a patent agent help in the preparation and prosecution of applications at the USPTO?
When filing an application at a patent office, there are technical and legal requirements to be met. A patent is only as good as what is claimed and how it is described in a patent application. A strong patent protection requires good patent application drafting skills. A good patent helps to prevent others from designing around your invention and prevent others from entering the same market space. An experienced patent attorney or agent brings such skills in drafting patent applications.

In addition, the attorney/agent also helps in prosecuting the application before the patent office. Once an application is examined, the patent office sends out office actions- official communications to the inventor, and may reject or allow based on the merits of the patent application. The attorney/agent, on behalf of the inventor, can present arguments to meet the legal and technical thresholds set by the patent office and help in obtaining a patent. This requires an understanding of the patent law and claim language.

• What are the contents of a patent application?
The main contents of a patent application are a written description of your invention called specification, drawings that help to describe the invention and specific claims that you seek exclusive protection for based on the specification. Among other things, it also contains information about the inventor, owner and representative of the invention.

• How long does it take to file a patent application?
It takes anywhere from one week to more than a month to file a patent application. The main factor that determines the time taken is drafting a patent application, which usually depends on the nature of the invention. Complex inventions, such as inventions in biotechnology and life sciences take around 2-3 weeks to draft good patent application.

• How long does it take to obtain a patent after filing an application?
In the US it may take from 1-3 years depending upon the area and the procedure for examination used. There are accelerated procedures available for an increased fee. In India it takes up to 8 years to obtain a patent.

• Where do I file my patent?
You need to file patents in countries in which you wish for patent protection. Many inventors choose to file in United States because United States is one of the largest economies in the world. Other regions that people consider are Europe, Japan, China, Brazil, and India.

• I am not a US citizen, but my invention was made in the US. Should I file for patent in the US or the country of my citizenship?
Any person can file for a patent in US. However, if the invention was made in US and the inventor wants to first file a patent outside US, the inventor has to apply for a foreign filing license.

• I do not want to obtain a foreign filing license for my invention. What are the consequences?
Not getting a license and still filing outside will cost US patent.

Read the first part here

Syam Prasad Anand, PhD
Founder, Mainline Intellectual Property
Ardmore, Philadelphia, USA.

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