Acorda Therapeutics Decision & Dominant Patent Doctrine

Acorda Therapeutics Decision & Dominant Patent Doctrine

Acorda Therapeutics, Inc. et. al. v. Roxane Laboratories, Inc. et. al. No. 2017-2078, 2017-2134 (Fed. Cir. Sept. 10, 2018)

Background

The Federal Circuit’s ANDA Acorda decision affirming the district court’s decision to invalidate several Acorda patents under 35 USC 103 was in my opinion the correct outcome based on all the evidence considered. However, part of the Court’s analysis dealt with the relatively new “dominant patent doctrine” (DPD). As I explain below, I disagree with the use of DPD in the context it was used. Acorda of course disagrees with the Court’s decision on its patents and likely will, or already has, appealed for further review. The Court’s decision in Acorda provided a thorough explanation and analysis of the key evidence related to the so-called objective indicia of non-obviousness but chose to do so through the lens of DPD.

The Dominant Patent Doctrine?

DPD, as I understand the theory, suggests that a blocking patent, in this case the Elan patent exclusively licensed to Acorda, negatively impacts or otherwise diminishes the value of certain traditional objective indicia of non-obviousness such as long felt and unmet need, failure of others, copying, commercial success, and possibly others. In simple terms, a blocking patent has the effect of “allegedly” discouraging third parties from entering into the market covered by the dominant patent, which in turn negatively affects the full probative value of some or all of the objective indicia of non-obviousness.

This is where I part ways with the courts who are advancing this theory. We can all agree that dominant patents have existed from the inception of the U.S. patent system. More importantly, our patent system was created in the first place to spur innovation and to allow subsequent inventors to protect that innovation with new patents. Our patent system encourages inventors to make their new inventions public, thereby contributing to the wealth of technical knowledge in the universe and allowing other parties to then further improve upon that knowledge with their own contributions and improvements, to obtain additional patents. Simply stated, our U.S. patent system was created with one singular goal in mind – share your invention (publicly), receive a patent that protects your idea for a set period of time (today, for 20 years from your initial filing date), and others will be inspired to further innovate, invent and receive their own patents.

And because the patentability of subsequent innovations is not precluded by the existence of a dominant patent in the same space, third parties are permitted to (and encouraged to) further innovate and protect that innovation by filing so-called “improvement patents” – patents that build on already existing technology. Much of this innovation naturally falls under a dominant patent. However, there are far more improvement patents than dominant patents – by orders of magnitude. In some instances, these newly claimed and patented inventions fall within the scope of the claims of a so-called dominant patent. That is the case with Acorda, who obtained a license to a dominant Elan patent so that it had the freedom to operate in the desired space and, at the same time, who was also applying for and obtaining its own improvement patents based on the earlier Elan work. This innovation cycle is part of the patent ecosystem, and it benefits everyone.

Ok, back to DPD. The DPD is a relatively recent creation that arguably justifies reducing the weight or probative value of these well known objective indicia of non-obviousness when there exists a dominant patent. See Acorda Therapeutics, Inc., slip op. at 45-50 (for a more detailed discussion of DPD). In my humble opinion there is no reasonable justification that supports the use of DPD in this context. Assuming for sake of argument that a dominant patent does in fact prevent some companies or individuals from entering a field of endeavor as alleged, why would fewer innovators in a space dominated by a broad patent render any of the current objective indicia of non-obviousness less objective or of reduced probative value? Stated differently, the failure of others to enter a field of endeavor dominated by a broad patent, for whatever reason, should have no bearing on the weight of the evidence accorded each objective indicia of non-obviousness.

Moreover, the law is generally clear that there must be a clear nexus (link) between the selected objective indicia and the claimed invention. Each separate objective indicia considered in any obviousness analysis should stand on its own merits and be evaluated based on all relevant facts bearing on that indicia – plain and simple. DPD

should not play any role in this analysis because there is no causal connection between DPD and the objective indicia of non-obviousness. And to my knowledge none has been offered. Hypothetically, one could make an argument that courts are attempting to use DPD as a way to explain or justify their view of the strength and/or weaknesses of the objective indicia of non-obviousness. Some might call this the tail wagging the dog, looking for the answer.

Conclusion

Ultimately the U.S. free market economy will decide what technology, including pharmaceuticals, will make it to the market and whether or not it will be successful. We should not inject yet another hurdle into the existing patentability (obviousness) calculus. Whether or not DPD is considered a pharmaceutical doctrine, the case law addressing the objective indicia of non-obviousness is well established and already heavily fact dependent. In my opinion we do not need DPD to further interpret, analyze, or determine the weight of, the objective indicia of non-obviousness.

All rights reserved (2018)

Michael McGurk

Mike McGurk has more than 30 years of experience in virtually all aspects of patent law. Working with clients ranging from small start-ups to large Fortune 100 companies, he provides counsel in due diligence matters, global portfolio development and adversarial proceedings, including litigation, post-grant reviews, interferences and re-examinations. Mike works primarily with pharmaceutical, chemical, medical device and mechanical technology businesses. For at least the last fifteen (15) years, approximately 50-70% of Mike’s work has been focused in life sciences, including ANDA litigation support and pre-filing due diligence. Mike’s practice is informed by his background as a patent examiner in the chemical arts for the United States Patent and Trademark Office (USPTO), as a litigator for ten years, and as an expert in due diligence matters. He regularly provides strategic litigation counseling support to clients across the nation, and has handled numerous patent matters before the Patent Trial and Appeal Board of the USPTO. His extensive due diligence experience includes pre-litigation, acquisition, in-license, freedom-to-operate product and/or process clearance, design around, validity and patentability matters. Mike works with teams having the appropriate technical and legal abilities.