Developments in Obviousness Law and How It Could affect Your Invention
In the recent Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., No. 2017-2078 (Fed. Cir. Sept.10, 2018) decision, the Federal Circuit (the US appeals court for all patent cases) made a very harsh obviousness conclusion that may leave a big potential round of financing from Acorda investors out in the cold. I believe this decision, while directed to the life sciences specifically, is instructive in all areas of technology, and illustrates the importance of using an experienced patent attorney.
Essentially, this case suggests that patented products could be subject to obviousness challenges based on vague suggestions in the prior art. Almost every innovation, to a certain extent, is based on prior art. So the crucial work of a good patent attorney is to rigorously delineate where obviousness ends and innovation starts.
The patents in this case cover a drug called 4-aminopyridine, brand name “Ampyra®,” used in the treatment of multiple sclerosis (MS). The drug was originally developed by Elan (now Alkermes Pharma). Acorda took over the project, obtained the four patents at issue in this case as well as FDA approval. The claims cover dosing regimens and methods of improving walking in MS patients.
Generic applicants filed Abbreviated New Drug Applications (ANDA’s) seeking to market generic copies of Ampyra prior to the expiration of the Acorda patents, and Acorda sued them for patent infringement. The Generic defendants stipulated to infringement and challenged the Acorda patents as obvious. The Generic defendants prevailed in the District Court (slip op. at 4).
Without getting further into the weeds of the analysis, the Generic applicants prevailed on the appeal with a majority Opinion from Judges Dyk and Taranto. The court found that a person skilled in the art would have been motivated to try the claimed dosing regimen and would have had a reasonable expectation of success, and that “objective factors” were insufficient to overcome the other obviousness arguments.
However, I believe the well-reasoned and powerful dissent from Justice Newman is worth noting, in particular on the “objective indicia of obviousness” (slip op. at 22). Judge Newman’s dissent rebutted every argument point-by-point. She presents well-reasoned arguments that the patents should have survived the obviousness challenges, and future decisions may (and should) rely on her reasoning.
The majority conclusion of obviousness was in spite of substantial arguments that the claimed therapy was inventive and innovative. The Court in this case essentially took vague and incomplete suggestions in the prior art that this drug might be effective for MS, and relied on those suggestions to find the Acorda patents, which covered the practical innovations that took this drug to a finished product, were obvious.
Lessons: It is critical for clients to understand and distinguish the prior art from their invention when building on prior work. Inventors who don't clearly set their invention apart from previous disclosures are at risk for these kinds of obviousness problems. Ensure you have an experienced and knowledgeable patent attorney, one with extensive technical and subject matter expertise, on your team to help with this critical task. Contact us today.