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Amgen Wins Right to Market Mvasi™ — Federal Circuit Interprets BPCIA Provision Regarding Notice

In 2013, the U.S. enacted the Biologics Price Competition and Innovation Act ("BPCIA"), 42 U.S.C. § 262 to allow for abbreviated biologics license applications ("aBLA") to be filed for complex products which are biosimilar to/interchangeable with FDA-licensed biologics.

Patent Assignments: Difficult Decisions in a Difficult Time

Assignments are important and necessary because they protect the ownership interests in inventions and provide the right to prosecute patent applications and enforce patent rights. But many issues can arise with the assignment of inventions and patent rights and even more issues arise in the era of COVID-19 social distancing.

Can One Have Too Many Patents?

As is common with a blockbuster drug, AbbVie's Humira faced an antitrust challenge from third-party payers. The third-party payers filed an antitrust action claiming AbbVie's patent strategy stifled competition by forcing prospective competitors to settle on terms allowing Humira to enjoy a monopoly long after patent protection should have ended. The complaint alleges that AbbVie cornered the market for Humira and its biosimilars by obtaining a thicket of patents which allowed it to gain the market power it needed to prevent competitors from entering the U.S. market (violation of Sherman Act section 2). It used this market power to enter into settlement agreements with potential competitors to keep their products out of the U.S. market in return for early launch dates in Europe, also an important market which they termed a pay-for delay and market division (violation of Sherman Act section 1). Judge Shah, of the Northern District of Illinois, dismissed the complaint without prejudice on June 8, 2020. The opinion begins with a discussion of three reasons Humira might hold its commanding position foreshadowing his decision. First, the more than one hundred Humira-related patents made it difficult if not impossible to seek a non-infringing competing product. Second, the FDA lengthy approval process imposes further costs on would-be competitive products. And, third, the "expansive, complicated, and expensive patent infringement litigation that often follows on the heels of FDA approval." Page 1 of slip opinion.

FDA Seeking Comments on Orange Book Patent Listing

Final Rules on PTA Calculations in View of Supernus

Although long overdue, the U.S. Patent and Trademark Office (USPTO) released its Final Rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu (85 Fed. Reg. 36335-36342, June 16, 2020). Unfortunately, the Final Rule does not fully address Supernus.

Requirements under COVID-19 Prioritized Examination Pilot Program

Boloro Tells Federal Circuit Arthrex Applies to Ex Parte Appeals As Well

Law360

MCRO's Pyrrhic Victory

On May 20 the Federal Circuit for the second time found McRO's patent for automatically generating animations to be patentable, this time reversing the district court's finding of invalidity for lack of enablement. In its previous decision, McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016) (McRO I), the Federal Circuit reversed the district court's holding that the claims were directed to a judicial exception, an abstract idea. In McRo I the Court had reversed based on its determination that the claims were to a genus limited to rules with certain common characteristics, a genus. Id. at 1313. In particular, the "rules are limiting in that they define morph weight sets as a function of the timing of phoneme sub-sequences." Id.

Biogen v. Banner Life Sciences -- The Limited Scope Of U.S. Patent Term Extensions (Hint: Metabolites Not Included)

Under 35 U.S.C. §156, a patentee can extend a patent's term to restore part of the term consumed during the Food and Drug Administration's (FDA) New Drug Application (NDA) approval process for a compound covered by the patent.

CAFC Affirms Invalidation of Replacement Heart Valve Patent – Reiterates that Reasonable Expectation of Success is not Absolute Certainty for Success