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CRISPR

The week that it was – 19th to 25th June, 2017

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    Balancing the cost and availability of scientific research publications - by Fuzzy Synapse.

With the start of summer in the northern part of the world, CSG announced its first Annual Symposium- ‘STEMPeers: Connecting Scientists’ on Saturday, September 23, 2017, at the Aeronaut Brewery (Somerville, MA). Addgene’s co-founder, Melina Fan, is going to be the plenary speaker – get inspired with her story of building organizations to help scientists work more efficiently.

Unlocking Science – by IpsaWonders

How soon can total open access really work? On one hand, European leaders have asked for complete open access to scientific papers by 2020. And in the current open access model how do we get around the huge payments for publishing the open access journals? SciHub, the Robin Hood in Science, has been recently issued a penalty of $15 mn for Elsevier copyright infringements by US court, for making scientific papers illicitly available to public.

Adding to the woes of researchers troubled with paid access to scientific literature, non-reproducibility of pre-published data calls for immediate action towards better information. Those who are fretting over a horrible western blot result before the weekend hit, will appreciate the efforts taken by Biocompare to tackle the reproducibility issues of antibodies. While we appreciate efforts taken towards making the scientific community more informed about picking the right reagents and protocols, Chinese government went another step by announcing severe penalty, that can also lead to execution for scientists found fabricating their data – in an effort to restore scientific data integrity in the country. Data fabrication, a problem that plagues the community, might only be aggravated if such harsh measures are taken instead of tackling the root cause of it.

The rise of the age of nanotechnology in food sector – encompassing nutritional content of food to judging its freshness – also calls for the society to embrace newer technologies with newer regulations to understand. While most people still stay unclear about the moral and ethical concerns around gene editing, the CRISPR story gets more melodramatic with Doudna’s A Crack in the Creation. With more and more non-novel technologies being developed, it is also imperative for scientists to embrace easier forms of communication with public. Here is an example of a scientist’s pursuits of reaching people by drawing science. SciViz, NYC, USA is another avenue where you can be a part of network of people who work towards visualizing science.

The healthcare consulting enthusiasts might want to take a look at a list of top-rated firms in the field. The other life scientists among our readers might want to take a sneak peek at the companies that employees have valued in life science sector. Alfreda James, from Stony Brook University, gives insights from her experience as a career education professional.

Take a look at the opportunities shared on CSG –

  • PhD programme in Biology at Ashoka University
  • Postdoctoral fellowship, Scientific project management, Harvard Program in Therapeutic Science, MA, USA
  • Postdoctoral fellowships, Universidad Complutense de Madrid, linked with Marie Sklodowska Curie Individual Fellowship Actions, Madrid, Spain
  • Postdoctoral Scholar, Stream Hydro-Ecology, Department of Environmental Science, Policy and Management, Berkeley, USA

If you are interested in the above positions, you well might want to know what it takes to write an impactful proposal for postdoctoral fellowship.

And in case you feel dissatisfied with your performance – remember sometimes it is better that you just work, and let others evaluate your work – you are not always the best judge of your work. Keep calm and keep maximizing on your happiness. Everything else will have to fall in place!

Featured images are by IpsaWonders (on Facebook and Instagram) and Fuzzy Synapse (on Facebook).

About the author:

Somdatta Karak works with Club SciWri as a project coordinator and Corporate Liaison. She is a doctorate in Neuroscience from Georg August University, Göttingen, Germany and has been a Teach for India fellow (2014-16). She loves putting her analytical skills to build newer and more sustainable solutions, enjoys traveling and communicating and takes every opportunity to expand her horizon.

You can reach her here.

The week that it was – 8th to 14th May, 2017

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This Mother’s day, going beyond the commercial reasons behind existence of such a day, CSG and Club SciWri celebrate the mothers of many a scientific discoveries. Let’s use this as another opportunity to remind ourselves of gender inequalities that exist around us in academia and beyond, and appreciate efforts by groups like Million Women Mentors in STEM, and Healthcare Businesswomen’s Association.

Earlier this week, Europe reassured that they still are away from far-right ideologies. And not only this comes as a reassurance in the wake of US, UK and Turkish elections and growing Nazi-like inclinations in India, the newly elected French president, Emmanuel Macron has also assured support to climate change researchers. Europe, is probably, going through its best time to regain its older glory in scientific research and development by collaboration. Why collaboration? To translate grand ideas into reality – like the bipolar disorder researchers have analyzed roughly 9000 human brains worldwide.

For us to remember in our race for power, by Ipsa Jain (her work at IpsaWonders, on Facebook and Instagram)

That also calls us, the scientists into action for making sure that we are able to convey our messages correctly to public – it is an art to not over-simplify science and yet be able to reach masses, through the power of words. You might even want to consider applying for a summer school in learning the art of science communication by ASBMB. And if you need inspiration, get some from the geniuses like Carl Zimmer.

Patience is a virtue for innovators, one that hasn’t changed since the last 30 years, when the first 3D printer was made, or when Daniel Martinez first noted that hydra do not die to the present day often heard biotech startup failures or the success of newer drugs in increasing the life spans of HIV positive individuals to near normal.  Not every idea is necessarily successful, rather growing while learning from the failures is the skill that we need. In this current age, nothing values more than data. The amount of data that an organization can gather and analyze marks its success. It will be interesting to see how governments work around the big private enterprises that virtually monitor most of us. And there is someone else too, who is getting unsettled with data sharing – science publishing houses. Nature news reports that publishing houses are building strategies to cope up with the increasing trend of sharing paywalled papers. But until that happens, as sad it might be, you can technically get into legal troubles by sharing scientific research articles. Do your bit by speaking up for open access research – OpenCon is one such platform to get yourself educated and heard on open access.

Choose a mentor first, lab next – it helps to ensure both personal and professional growth. But unfortunately, since this isn’t followed by many yet, a lot of us stay confused how will our research advisors react to our possible decisions of transitioning into industry. Read Catherine Sorbara’s opinion on how industries do not care to get academic recommendation letters. Beyond graduate schools, future employers will want to have references, not recommendation letters. And they aren’t the same thing – see what’s different! Know what and how to discuss matters with employers and colleagues. A loose word can cost a lot. And know how to keep your focus on your existing job while you plan your transitions. Accessing these resources to learn is much easier these days. Be spoiled for choice rather to know what you would like to pursue among the list of online courses. Those working in bio/pharma discovery should consider Global BioPharma Summits to stay abreast the rapidly changing trends in the field.

Skim through the works of 41 international biomedical researchers who just got awarded by well-known philanthropies – it might help you as well to know what are the topics trending in the field. 26 biotech startups  in Karnataka, India are awarded funding by the state government. I hope that has gotten your brains active and you are ready to fish out where you see yourself in the coming years.

And then there are freelancers who can mix and match quite a few of these together, quite successfully, eventually with practice! Wonder if you have the right credentials to do it all? Count your relevant experience rather.

Those aspiring for MSL positions, might also consider attending the 2017 MSL Society Candidate Career Conference in North Carolina, USA from June 10-11 – Use the opportunity well for networking with hiring managers. Those who are lost on how to prepare for the HR interviews, here is a great resource. See what are the skills that the big pharma companies look for in their new recruits. Those who are not yet sure if a formal MBA course is what they are interested in, but still might want to gain some education into it, might want to consider the micro-MBA course at UCSD this summer. For the enterprising entrepreneurs, here is a dose of inspiration from Regeneron, on their path from basic research to commercialization.

Now we understand knowing which job suits you the best isn’t an easy job. But one has to start somewhere, sometime! At the same time, know the tricks to look and apply for jobs outside academia, if that is where your heart is.

And since I promised the last time that I will keep you all updated on the out-of-lab activities that you can indulge in this summer – check the live radio streaming worldwide, you might like some light music running while you are busy with your experiments. And because many of us at CSG are also keen on building a library of Goodreads in Science, there is one out by Prof. Jennifer Doudna and her former postdoc, Samuel Sternberg on gene editing by CRISPR, called ‘A crack in the creation‘.

And let me leave you with a food for thought – While India in her pre- and early post-independence days created the stalwarts in science from the likes of Raman to Ramachandran, how does the country still struggle coping up with scientific development when compared to many of her peers like China? Does the answer lie in simply better management of resources and adding accountability? If so, how might that be achieved? Read Prof. Gautam Desiraju’s latest opinion surrounding this.

Featured images are by Ipsa Jain, a Ph.D. student at IISc. She wants to gather and spread interestingness. She prefers painting and drawing over writing. She posts on Facebook and Instagram as Ipsawonders.

About her featured cover image: (From left to right) Shown are Sally Ride, Ada Lovelace, Maria Sibylla Merian, Henrietta Swan Leavitt, Hilde Mangold, Barbara McClintock in celebration of Mothers of Science by Club SciWri.

About the author:

Somdatta Karak works with Club SciWri as a project coordinator and Corporate Liaison. She is a doctorate in Neuroscience from Georg August University, Göttingen, Germany and has been a Teach for India fellow (2014-16). She loves putting her analytical skills to build newer and more sustainable solutions, enjoys traveling and communicating and takes every opportunity to expand her horizon.

You can reach her here.

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

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

MedNess-Pill for Alzheimer’s?

in ClubSciWri/SciBiz/Uncategorized by

Hello and welcome to yet another exciting week of MedNess. We bring the news from medicine and healthcare with greatest impact. It seems like; year 2017 will be the year of neurology! It is just the second month of the year and treatment strategies for various neurological disorders are making headlines.

Merck halts Phase 3 study on Alzheimer’s drug- another setback for amyloid theory

Clinical trials on Verubecestat- a small molecule BACE 1 and BACE2 inhibitor were called off after an interim analysis on Phase 2/3 studies did not show promising results. The analysis team concluded that there was “virtually no chance of finding a positive clinical effect”. However, another trial on patients with early symptoms of Alzheimer’s will continue. It has been speculated that the drug was too weak, or was dosed inadequately or the disease had progressed too far in patients for the drug to show concrete effect. The failure of this trial is another blow to the famous “amyloid theory”. According to this theory, the amyloid plaques are believed to be cause of the disease. Verubecestat is a beta secretase inhibitor. This disappointing cessation of clinical trial came months after Eli Lilly’s Alzheimer’s drug; Solanezumab failed in Phase 3 clinical trials in November last year. Unlike Verubecestat, Solanezumab targets plaque rather than beta secretase enzyme. This brings in disappointment not only for the patients but also for the researchers. The evidence suggests that once the disease has advanced and patients have established dementia, the removal of amyloid plaque might not yield effective outcome.

                              Do we have a pill to cure Alzheimer’s? Some quick facts:

  • Alzheimer’s is an irreversible brain disorder causing cognitive impairment
  • More than 5 million Americans are expected to suffer from Alzheimer’s
  • Sixth leading cause of death in the USA
  • No new drug has been introduced to provide symptomatic relief or to halt its progression since last decade

Picture source: https://unsplash.com/search/brain?photo=rmWtVQN5RzU

There are couple of drugs at various stages of trial that are being tested under the amyloid plaque hypothesis. These drugs either act on the plaque or beta secretase enzyme (BACE inhibitor) or available as amyloid immunotherapy. These candidate drugs are from Biogen, AstraZeneca, Eli Lilly, Amgen and Novartis. Apart from BACE inhibitors, hopes are also high for Axovant’s intepirdine. Intepirdine is believed to improve cognitive symptoms by targeting receptor 5-HT6 that stimulates the release of a neurotransmitter. Interestingly, intepirdine was abandoned by GSK in 2010. The drug failed when compared to placebo. However, one study showed tangible effect on cognitive symptom when intepirdine was paired with the approved Alzheimer’s drug Aricept.

MedNess: Merck’s stock suffered severe blow after the announcement of cessation of clinical trial. On the contrary, shares of Eli Lilly, AstraZeneca, Biogen and Roche, the fellow Alzheimer’s drug makers, increased. (Fierce Biotech, Business Insider, STAT news, The Boston Globe)

Axovant’s nelotanserin passes phase 2 study for Lewy body dementia

Axovant Sciences declared successful completion of phase 2 study of nelotanserin. The company is now setting its foot forward for phase 3 study that is expected to initiate later this year. Axovant Sciences reported preliminary results from the first small group of 11 patients.

Lewy body dementia or LBD is the second most common form of dementia. The hallmark characteristic of this form of dementia is the build up of abnormal proteins i.e. Lewy bodies thus affecting cognition, movement, behavior and alertness.

The study included patients with either LBD or Parkinson’s disease dementia. These patients experienced frequent hallucinations as assessed by mini mental state examination (Pharmaceutical Business Review)

CRISPR battle of patents: The Broad institute and MIT wins!

The scientists who first demonstrated the use of most powerful gene editing technology in biotech suffered a major blow on Wednesday, February 15, 2017, in their fight to gain exclusive rights on their invention. CRISPR gene editing system has revolutionized the field of biotechnology enabling scientists to make changes in DNA. Jennifer Doudna, a UC Berkely biochemist and her European collaborator Emmanuelle Charpentier first published this gene editing technology in prokaryotic system (type of bacterial system) in 2012 in Science. UC Berkely and University of Vienna filed for U.S. patent in March 2013. There were 155 broad claims to the CRISPR-Cas9 technology. Feng Zhang, a biologist at the Broad Institute, demonstrated the use of this technology in eukaryotic cells (type of plant cells, animal cells and human cells). The Broad Institute filed their patent in 2013; months after Berkeley group filed their patent. Since the patent claims by Broad Institute were fewer than Berkeley’s, the Broad Institute’s patent was issued on April 15 2014 through accelerated approval while Berkeley group is still awaiting their approval. After the Broad Institute was granted their patent, UC Berkeley filed an interference claiming that the Broad Institute should not have been granted the patent since Doudna’s and Charpentier’s CRISPR research outlined in 2012 paved the way for Zhang’s research in eukaryotic system. The Broad Institute argued that the research was not obvious and the patent claims from both the institutes were different. The federal Patent Trial and Appeal Board ruled out UC Berkeley’s claims and sided with the Broad Institute. With this decision, UC Berkeley plans to move forward with their patent application, which if approved, will provide them right on the use of CRISPR on all cells. This would also mean that if the technology will be employed commercially, the companies would have to get licenses from both the Broad and the Berkeley group.

MedNess: The patent decision in the favor of the Broad institute increased the stocks of Editas Medicine by 30%. Editas Medicine licenses Broad’s patents for human genetic disorders. (Fierce Biotech, STAT News, The LA Times, NPR, Wired)

Are pharmaceutical industries in favor of Trump’s FDA pick? The story so far….

Donald Trump is pushing deregulation of FDA in order to accelerate the drug approval process. His ideology: drug costs are higher, drug approval process through FDA takes forever, drug companies are involved in “unfair foreign trade”, drugs should be manufactured in the USA and finally, drug companies should add the innovation factor for the better cure of the diseases. This recipe will work in favor of patients to bring the overall drug costs down and patients can have quicker access to the newer agents. Not to forget, drug manufacturing in the USA brings back jobs and the “fair trade” promotes revenue generation. This all sounds good, except, the pharmaceutical industries have opposing views. The most common complaint of every patient and every healthcare researcher is the never-ending drug approval process by the FDA. So suddenly, when we might be able to overcome this hurdle, why is everyone (read the researchers, pharmaceutical companies and informed patients) so anxious? The truth is bitter sweet. Even though we rant over the FDA, we still knew, the FDA has best interests at heart and such a tight screen is probably important for the safety of the patients. In addition, a 2011, study found that the FDA usually approves cancer drugs before Europe does. Moreover, the researchers at Yale found the FDA’s drug review is at least a month faster than Europe’s or Canada’s.

The pharmaceutical industries on the other hand are concerned about the high drug costs. In addition to the limited patient safety, deregulation in the FDA might not provide enough time for pharmaceutical companies to justify high costs of the drugs to patients and to insurance companies. The pharmaceutical companies will not be able to account for high costs of the drugs owing the limited safety and efficacy analysis that ultimately affects both the patients and the companies. President Trump said last month he has a “fantastic person” lined up for the role of the FDA commissioner. A survey conducted by Mizuho Securities of drug company executives indicated that 72 percent agreed Scot Gottlieb should be Trump’s pick to head the FDA. Until then, we all wait! (Reuters, The New York Times, Forbes)

 

              

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.

Battle of Wisdom: CRISPR-CAS9

in Sci-IP/SciBiz/SciWorld by
Editor’s Note: Gene editing for a better (or worse) is coming to a store near you. Some of you may have followed the ongoing patent war on the ownership of CRISPR-Cas9 technology between University of California (Berkeley) and Broad Institute (MIT-Harvard). But there could be many who are wondering what is the fuss all about? At the Career Support Group (CSG) for STEM PhDs we might still continue the debate about CSG’s usefulness to biologists vs non-biologists, but as inventors we are always in unison about perfecting the art of claiming ownership. #ClubSciWri is always attempting to listen and respond to your expectations and we are pleased to present the “Battle of Wisdom:CRISPR-Cas9” from Dileep Vengasseri. Dileep has nicely deciphered the meshwork underlying this matrix of claims to the CRISPR invention. We hope this story helps make sure that the next big thing from your gray matter secures your rightful ownership to the intellectual property.- Abhinav Dey

My dear friend, this 60 minutes of my time and 1597 words are for you! As you rightly said, maybe we should discuss our opinion(s) in public at least for educating others on what we have learned during the due course of our time.

Disclaimer: All what is written/expressed here are my personal opinions, and are not to be construed in any manner as a reflection/opinion of the firm that I am associated with. My words are solely my words! I will try to be as generic as possible to ensure there is absolutely no conflicts of any interest. This is purely a personal blog, written within the constitutional freedom that my Country has offered me when I was born here.

Many great battles are won not in the battle fileds, but in the minds of the battle leaders. What we read, saw, and talked about were the after-effects of those battles won or lost inside those great minds. In the great epic Mahabharata, Arjuna was about to lose Kurukshetra battle even before it was fought. But, there was a Krishna to save him from that humiliation. Many may not be as lucky as Arjuna was.

Before I begin, with all due respect, let me remind all of us one trivia very clear. US is not the “World” … it is just one of the many countries [a privileged one, indeed] of this world.  A larger population residing outside that privileged country, do not play a “World Cup” between their states or clubs. They don’t re-spell a word to make it look like they have invented it. For them, the metal “Al” is still aluminium and not aluminum.

We, living at the periphery of the world of modern(?) science, have got enough fuel from CRISPR-Cas, the game-changing method of gene editing, to satisfy our ego of being a part of a ‘privileged community’ who understands (?) the words like ‘gene editing’ and ‘CRISPR-Cas’.  For all such ‘privileged souls’, the “IP Battle of CRISPR-Cas” is more than just another battle. Let me call it a “Battle of Wisdom”.

But, was this battle worth fighting?

Let me begin with disecting this IP battle to four main sections: (1) Technology (2) The Battle Field (3) The Win and (4) The Strategy. May be, in future, I can complete this article with “Lessons Learnt”.

  1. Technology: At least from what is publically available, we know that Doudna/Charpentier’s team made that beautiful gene editng system work in-vitro in prokaryotic cells, in a neater, simpler manner than what it was in the nature itself. Instead of using a 3-component system including tracrRNA, crRNA and Cas9, her team beautifully designed a 2-component system, including a key synthetic, single guided RNA (sgRNA), that effectively performed site specific genome editing along with Cas9 (It is interesting to note that in-vitro 3-component system is also IP protected!). What was the big deal? The big deal was its simplicity, efficiency, and marketability. It was not that gene editing methodologies never existed before… however, now the World has access to an elegant gene editing system that is much more easy to perform (no more protein engineering!) & predictable. We also know that Feng Zhang (don’t forget George Church’s back-to-back publication in Science along with Feng Zhang) made it work in the eukaryotic system.
  2. The Battle Field: No one (at least the majority of money makers) wants a gene editing system that works only in prokaryotic systems. So, the “Battle of Wisdom” eventually boiled down to the IP on gene editing in eukaryotic system with CRISPR-Cas. Duodna filed a US patent application (remember, US is not the World, more so when it comes to IP protection) first and Feng Zhang got the first granted patent in US (note that the USPTO could have  provoked an interference at that time itself, but they didn’t!). Feng Zhang’s patent ‘claims’ to ‘cover’ eukaryotic CRISPR/Cas gene editing system (no comments on its “claims” and/or its “coverage” as the battle is still on…at least let the battle be fought under the belief that the land that is going to be conquered is still fertile!).  Duodna had anyway made it easier for Feng Zhang to get his patent granted by ‘boasting about’ her team’s achievement in multiple forums and explaning ‘how difficult it is/was to make it work in a eukaryotic system’.   Alas! enough of such wisdom on eukaryotic system was passed on to that Patent Attorney who filed her provisional applications, at least before the one on 19th October 2012 that is prior to the Feng Zhang’s priority date of 12th December 2012. Now, the battle of wisdom (what we call as “Interference Proceedings”) is to establish who invented (i.e., conceived and/or reduced-to-practice) the “eukaryotic CRISPR-Cas” first. Duodna will be fighting to make a point that porting CRISPR to  eukaryotic system is just a non-inventive aspect. Feng Zhang is going to fight back at least on the ground that if it is that obvious why did it then take Doudna a good 6-9 months to achieve the same.   I refrain from making any comments on how long or short is 6-9 months in a field like Molecular Biology. I know that my dear friend, who forced me (as usual) to write this long article, has wandered in the wilderness of IISc campus behind an elusive protein for a good 6 years :-)). And, I must admit that I have made the entire story of this Battle of Wisdom to a deeply  abridged version as the facts of this case are much more than what this layman article can handle. But, I believe that this much background is good enough to make my “teaching moments” convincing.
  3. The Win: Does it matter who wins this battle? Of course, YES! All battles are known after the leader who has won it (Aravind Kejriwal and Hilary Clinton are no where near their counterparts, as of today). Generally, the winner get the privilege to write the history that we all can read and study. But, is this Battle of Wisdom the same as any other great battles fought, lost and won? No. What is required to win this battle? It is required to show that who has invented the “eukaryotic CRISPR-Cas” first; it is required to show what is inventive/not inventive in this field; and it is required to show what constitutes an adequate written description/enablement in this field so that the “public disclosure function” (spirit and letter of any patenting system in the world) of the patenting sytsem is intact.  But, as with any other battle, only one person can be the winner. But, what will they both win or lose? The loser will any way have a deep wound in ego that may take years to heal. But, will he/she lose everything? Need not be. It depends on what other IP portfolio or picket-fencing that he/she has done around this gene editing tool. For example, a good claim on the synthetic guide RNA, a good IP portoflio on a better Cas9 proteins,  a better method for transfecting the cell, or an alternative to Cas9 itself… all these can make or break a commercial deal.  Is the winner going to get everything? Need not be.  During this entire process, it might open a pandora box and a myriad of avenues to potentially invalidate the patent claims that the winner can take home, to limit its claim scope, to limit its application coverage etc.
  4. Strategy: Isn’t it important for everyone in the field of IP to realize that most often a “hand shake” may do more good than “a fight”.  Before taking the army to a battle, it is important to know if raisng a white flag will be more beneficial than a gruelling battle. It is important to understand for what one is fighting a battle.   Does anyone fight for satisfying an ego or to make a point?  It is imporant to  understand that in a patent battle field, a wiser does not fight from their heart, but from their mind!. It is  important for each of the fighting members to know “What will happen if we do not fight, but rather collaborate?”.  Both Doudna/Charpentier and Feng Zhang could have been still partners in Editas, and they could have ruled the field.  When you fight in public, you expose yourself…you expose more than what you wanted to. And, what you have exposed can kill you even if you win YOUR fight.

Three more points to ponder:

  1. IP protection of PCR technology made Roche the king of DNA amplificaiton for quite sometime. Why? It is true that PCR was a technology that literally transformed the world of Biotechnology. But, was the IP protection on PCR probes for important pathogens less important? Were Taqman probes for real time PCR less important? Were the chips that made thermal cycling easier less important? No. All of them “together” made PCR a “cult” technology. That’s what a strategy means.
  2. IP protection in the field of ESC took Thompson and Wisconsin Alumni Research Foundation (WARF) to the center of the scientific world. Many IP/Tech Transfer cells in the Universities across the world wanted to be like WARF. As far I know, WARF gave its rights for free to any academic instituties, but made any industry pay for the same. Great! What were the other things that were needed to sustain and progress that technology ? An environment that morally support ESC research, a completely synthetic media to grow ESC, a culture that is devoid of mouse fibroblasts … all these were essential for taking ESC to reach its maximum potential. In modern day science, it is unlikely that we will see a winner of a single battle emerging as the “real winner”. A real winner is going to be the one who knows the game and strategize accordingly.
  3. US is not the “World”, and IP rights are jurisdictional. So, make yourself open to strategize for the real world!

Another Disclaimer: While starting my blog in WordPress, I had promised that I will not proof-read what I have written. In the past, many times, I had become a victim of my perfectionism and my writings had never seen the light. So, please pardon any typographical, grammatical, or otherwise errors. I hope factual errors are not there. Please let me know if you find any errors so that I can correct the same.

Authored by

 

Dr Dileep Vangasseri, PhD (Indian Institute of Science, IISc); Post-Doctoral research, University of Pittsburgh; Senior IP Professional, John F. Welch Technology Center, GE India Technology Center Pvt. Ltd., GE Global Research, Bangalore, India). Dileep has over ten years of in-house IP experience in Life Sciences, Healthcare and Medical Diagnostics industry after eight years of academic research experience in Bio-Organic Chemistry, Gene Therapy and Cancer Immunotherapy. He is well versed in all facets of patent analytics, techno-competitive intelligence, technology forecasting and business development.

This blog was originally posted here on December 7 (2016).

Featured image source: Pixabay

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