Ajinomoto Delaware Litigation Heads Toward Victory with Patent Owner's Asserted Claims Found Indefinite In Claim Construction Ruling
Recently Judge Mitchell S. Goldberg for the U.S. District Court for the District of Delaware approved and adopted Magistrate Judge Lloret's Markman decision in its entirety, finding Plaintiff Kyowa Hakko Bio Co.'s (KHB) asserted patent claims invalid as indefinite. KHB had asserted infringement of its U.S. Patent RE45,723 allegedly covering an Ajinomoto process for manufacturing glutamic acid commonly used as an additive in food products.
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.
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.
Oblon's Patent Prosecution practice and partners from the firm's Chemical, Electrical & Mechanical and Litigation practices have received top national rankings in the 2019 edition of IAM Patent 1000: The World's Leading Patent Professionals.