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

Entrepreneurship Experience in Bangalore

in Entrepreneurship/Face à Face/SciBiz by

 

I have been asked to put down my experience of starting and running a business in Bangalore. All of us have lived in Bangalore for at least 2 years inside the IISc campus. Our view of Bangalore is heavily skewed by our experience at IISc. My view of Bangalore was that it is a very settled, slow moving, high-tech and amazingly green city.

I graduated from IISc in December 2008 and returned to Bangalore only in January 2015. This time I was in a different part of Bangalore, the startup region – south Bangalore. I was pleasantly surprised to see the speed of development here. Everywhere you go, you will find boards of companies hanging over houses, buildings and shops, new buildings being constructed to house more and more companies. No street is left untouched by the startup buzz.

We started our company at a coworking space. The concept of cowork space is pretty amazing as it gives you a feel of office without being too hard on your budget. Most companies are bootstrapped at least in the initial period of their existence, our case was no different. Companies providing cowork spaces most often convert big houses into workspaces, where they charge you per seat (~5k) and also provide you with a registered address for your company. You can also get a dedicated room or cabin for your team at a slightly higher cost per month.

Being in a cowork space you get to interact with other startups and participate in their journey. I will often see a 3 member founders team suddenly getting a lot of funding and increasing their team to 30-40 in a matter of a week and then moving out of the coworking space. Others will remain stable and work on their product. Some will stop coming as their startups were not going anywhere.

Our company is now 1 year old, unofficially (0.5 years, officially). We are now incubated at IISc. Instead of putting everything in one post, what I have decided is to write to you in intervals as I go through more experiences.

 

Neha Satak Astrome Tech

 

Neha
Astrome Technologies (www.astrome.co)
(An Indian Space Technology Company)

 

 

 

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

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