Amidst the swirl of speculation regarding the generic litigation and associated risks to Amarin, I'm focusing on one overriding concept that I believe ensures a resounding Amarin win should the parties not settle.
The Defendants' arguments for non-infringement and patent invalidation together strike at the heart of US intellectual property law. Those laws serve the essential purpose of protecting the value of novel inventions in order to encourage commercial entities to go to the often extraordinary effort and expense of bringing those inventions to market. It so happens that in this particular case the innovations at issue will likely save millions of lives in the US and around the world, and are arguably among the most impactful pharmaceutical innovations in the past 50 years. This will not be lost on Judge Du.
Defendants are asking Judge Du to:
1) rule that both the USPTO and FDA "clearly and convincingly" erred in judging the non-obviousness of Amarin's inventions,
or
2) rule that Defendants can essentially sneak through a back door into what will clearly be a huge market for prescription EPA used for the treatment of cardiovascular disease.
For issue #1, the Defendants are asking Judge Du to prefer a narrative where Amarin was never provided intellectual property protection for Vascepa. Under such a scenario, any company that approached the FDA with a desire to bring this ground-breaking therapy to the American public would have been asked to conduct one of the largest and most expensive outcome trials in US history without the benefit of intellectual property protection. The FDA would have required the CVOT based on the nation's leading experts in the field determining that all the prior art was unconvincing (i.e. "non-obvious) with respect to CV benefit. Given that value of their proprietary intellectual property is the asset against which fledgling pharmaceutical companies essentially borrow to fund expensive trials, the lack of IP protection would have effectively prevented the necessary CVOT study, and in doing so, prevented this life-saving innovation from coming to market and saving millions of lives. Judge Du will not endorse this narrative.
For issue #2, the Defendants are asking Judge Du to accept a narrative according to which:
1) doctors prescribing a Vascepa bio-equivalent for a chronic condition will rarely, if ever,
prescribe that bio-equivalent for more than 12 weeks;
and
2) Defendants are not intending to capture some portion of the huge CV market with their
Vascepa bio-equivalent.
Federal judges do not simply adjudicate the facts of the particular case. They act as stewards of the law, ensuring that the intent of the law is honored. Judge Du is an experienced judge who will undoubtably grasp the momentousness of this case, and the implications of the Defendants' arguments with respect to the intent of intellectual property law. The story of Amarin and Vascepa is, objectively, a heroic one in which an enterprising company overcame hurdle after hurdle, including multiple court cases, to finally bring this ground-breaking therapy to market. Millions of people around the world stand to benefit from those efforts, their lives improved and extended thanks to Vascepa. These accomplishments would have never been possible without the protection afforded to Amarin by our intellectual property laws. In ruling for Amarin based on the intent of those laws, Judge Du will not only reward Amarin's great work as an innovator, but she will also embolden similar innovators to emulate Amarin's story in bringing the next ground-breaking invention to market.
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