by Dennis Crouch
Acorda Therapeutics, Inc., v. Roxane Laboratories, Inc. (Supreme Court 2019)
Obviousness is the core doctrine of patentability and primary focus of both patent examination and post issuances PTAB challenges. In this case, Acorda has asked the U.S. Supreme Court to spend some time on this important doctrine — and particularly consider the role of objective indicia of nonobviousness such as “commercial success, long felt but unsolved needs, [and] failure of others.” Quoting Deere.
The question presented is whether objective indicia of nonobviousness may be partially or entirely discounted where the development of the invention was allegedly “blocked” by the existence of a prior patent, and, if so, whether an “implicit finding” that an invention was “blocked,” without a finding of actual blocking, is sufficient to conclude that an infringer has met its burden of proof.
The infringement lawsuit was triggered when Roxane (and others) filed Abbreviated New Drug Applications (ANDAs) with the FDA to start making generic versions of Acorda’s drug treatment for multiple sclerosis (Ampyra). Roxane successfully defended the lawsuit by arguing that the asserted claims were obvious.
For the obviousness analysis, the patentee Acorda provided evidence of commercial success and long felt but unmet need that was tied to the invention at issue. However, the Federal Circuit found that those secondary factors did not apply because of a broader blocking-patent already exclusively licensed to Acorda.
The setup here begins with the fact that Acorda is the exclusive licensee of a broad patent for treating 4-AP to treat MS (Elan patent). The Elan patent has now expired, but it was firmly in place as Acorda conducted its research and obtained FDA approval. This petition here focuses primarily on four follow-on patents obtained by Acorda covering tweaks to the treatment plan. Despite the tweaks, it appears that Elan’s broad patent still covers the drug treatment at issue here. I.e., Elan’s patent is a “blocking patent.”
When it came to the secondary indicia of nonobviousness, the Federal Circuit majority determined that a key reason why Acorda was able to do research on its four follow-on patents is that it was protected by the blocking patent — no other company was ready to risk infringement liability to do the research. In other words, the commercial success, failure of others, and recognized but unmet need were all due to the Elan patent’s chilling effect on competition. From the majority:
“The risk of infringement liability for marketing in the US would have provided and independent incentive [for third parties] not to develop the invention of the Acorda patents, even if those inventions were obvious.”
The decision in Acorda falls in line with the court’s 2005 decision in Merck & Co. v. Teva Pharmaceuticals USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005) (en banc denied; cert denied). In that case, the Federal Circuit also held that a prior patent that precluded market entry was the cause of Merck’s commercial success — not the invention’s ingenuity.
In its brief, Acorda provides its legal case:
The Federal Circuit’s invocation and expansion of its judicially manufactured blocking-patent doctrine to negate Acorda’s “significant,” “convincing,” and unrefuted evidence of nonobviousness is plainly irreconcilable with this Court’s decision in Graham v. John Deere Co., 383 U.S. 1 (1966), which established that an inquiry into commercial success, failure of others, and long-felt but unmet need is an important protection against hindsight bias in the obviousness analysis. As Judge Newman recognized in her dissent—and as Federal Circuit judges have emphasized in prior dissents highlighting the blocking-patent doctrine’s deficiencies—the elimination of that essential safeguard makes it far more likely that courts will submit to the “temptation” of invalidating patents that are obvious only when viewed through the lens of the patents’ own teachings.
The Federal Circuit’s application of its blocking-patent doctrine in this case was particularly problematic because the court of appeals identified no evidence that anyone was actually deterred by the Elan patent from researching low-dose uses of 4-AP—and instead shifted the burden of proof to Acorda to “supply evidence” to negate the district court’s “implicit finding” of blocking. In so doing, the Federal Circuit upended the clear-and-convincing-evidence burden of proof for invalidity challenges that this Court recognized in Microsoft Corp. v. i4i Limited Partnership, 564 U.S. 91, 101–02 (2011), and obliterated the presumption of validity that Congress codified in the Patent Act, 35 U.S.C. § 282(a).
Read the petition here: Link.