IP Protection: Safeguarding your Research for Commercialization

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The journey of taking a great new idea and advancing it to improving patient care can be long and often includes solving problems inventors have not previously faced. Understanding and navigating how the intellectual property (IP) behind an invention can be protected is among the more daunting of these challenges. Fortunately, with the development of a few new skills, and the help of people experienced in obtaining IP protection, PI’s can overcome these challenges and safeguard their invention.

Tuesday, October 17th, marked the second installment of the Innovation Symposium Series. Focused on the challenges of IP protection, the session featured keynote speaker David Kappos, the former Director of the U.S. Patent and Trademark Office, who discussed how recent Supreme Court decisions have impacted biotechnology, in particular. Also featured were top PI’s from MGH and BWH who provided insights into how they think about IP protection and the strategies they employ to better position their inventions for improving patient care.

Mr. Kappos presented a compelling analysis of the current US ranking in global patent strength, the major global issues impacting patent rights, and issues pertaining to access to patent protection for innovation in the life sciences. In short, according to Kappos, while more frequent fee shifting is combating nuisance patent challenges, the relative strength of the US IP system is trending down, due in part to patentable subject matter being narrowed dramatically. This trend has led to uncertainty whether issued patents can withstand challenges.

Keynote speaker David Kappos

In touching on the major global issues for patent rights, Mr. Kappos highlighted the challenges of standard enabling patents (SEPs), extraterritorial use of anti-trust law to undermine IP rights, and in life science the tension between incentivizing innovation and providing access to care. Early on, one of the concerns observers had with SEPs was that negotiating licenses and stacking fees could inflate the cost of technologies and be used to suppress competition. To date, all data indicates the problems with stacking fees and hold-up have not occurred, even where different jurisdictions are addressing the “fair, reasonable, and non-discriminatory” licenses differently.

Kappos also opined on the challenges faced in the life sciences, referring to a handful of recent Supreme Court decisions that have impacted applicant’s ability to protect their inventions and discoveries. According to Kappos, the non-obviousness analysis that arose from the decision in KSR((KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)https://www.supremecourt.gov/opinions/06pdf/04-1350.pdf)) initially made it difficult for applicants to overcome a collage of prior art. Fortunately, the Federal Circuit has begun pushing back on the USPTO requiring more justification as to why it would be obvious to combine the cited art. Kappos then cited that the narrowing of patentable subject matter that has resulted from the decisions in Myriad((Ass’n for Molecular Pathology v. Myriad Genetics,  569 U.S. ___, (2013) https://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf)) , Prometheus((Mayo v. Prometheus, 566 U.S. __ (2012) https://www.supremecourt.gov/opinions/11pdf/10-1150.pdf)), and Alice((Alice Corp. v. CLS Bank Int’l, 573 U.S. __, (2014) https://www.supremecourt.gov/opinions/13pdf/13-298_7lh8.pdf)) has had a more dramatic and lasting impact on life science discoveries and innovation. The current broad interpretation of what is considered a natural law has made obtaining protection around novel ways of diagnosing disease or implementing better care through computer software challenging. It should also be noted that the court’s denial to hear the appeal of Sequenom((Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1139.Opinion.6-10-2015.1.PDF )) does nothing to provide clarity for how these technologies can be protected and advanced. Finally, the decision in TC Heartland returns some level of certainty to patent holders by ensuring patent infringement suits are brought in the state they are incorporated in. Kappos indicated these decisions are challenging for life science innovation because they are already incentivizing companies and researchers to abandon efforts to make advances in this field, or to turn to trade secrets, which slows innovation globally.

Following Mr. Kappos, attendees had a chance to learn from the experience of three prestigious inventors from within Partners. The first challenge discussed focused on the tension between publication and IP protection. Dr. Emery Brown, Director, Neuroscience Statistic Research Lab, Massachusetts General Hospital; Warren M. Zapol Professor of Anaesthesia, Harvard Medical School discussed how he has dealt with that tension by engaging with Partners Innovation early in the process and actively engaging in weighing the benefits of earlier publication of a discovery over ensuring a robust patent application. In discussing the challenges of obtaining protection, Dr. William Austin, Chief, Division of Plastic and Reconstructive Surgery & Division of Burn Surgery, Massachusetts General Hospital; Associate Professor of Surgery, Harvard Medical School highlighted the importance of IP professionals providing enough information for inventors to actively engage in the process. In light of the challenges with protecting diagnostic discoveries Dr. Christine Seidman, Director, Cardiovascular Genetics Center, Brigham and Women’s Hospital; Thomas W. Smith Professor of Medicine and Genetics; Harvard Medical School shared her experience where the field of genetic diagnostics is moving to a more open framework because of the difficulty in obtaining IP.

Expert panel from left to right: Sharon Walker, PhD, Emery Brown, MD, PhD, William Austin, MD, Christine Seidman, MD

All three panelists also touched on the importance of engaging in the process of obtaining patent protection and how it has helped them think about the strategies for bringing new discoveries to the patient care.

I sincerely hope you’re able to join us on December 7th at the BWH Bornstein Family Amphitheater for the third Innovation Symposium Series session:


Navigating Healthcare IT: Winning Strategies to Commercialize Your HIT Invention

The opportunities and challenges of commercializing Healthcare Information Technology, or HIT, are different from those in typical patent-based licensing. Experts will identify these distinguishing features and provide insights about the direction of future technologies.

Space is limited, so register today!

Attendee asking a question!

To watch the full length video of this session click here.

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