Attorney:
Lisa M. Mandrusiak
July 7, 2020
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.<... Read more
Attorney:
Richard D. Kelly
July 6, 2020
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.... Read more
July 2, 2020
We appreciate your continued readership and wish to maintain your loyalty as we switch subscription software... Read more
Attorney:
Richard D. Kelly
June 29, 2020
The FDA has published a public notice requesting comments on the submission and listing of patent information. See the notice here. The information requested could lead to the implementation of changes having a significant impact on pharma, including combination products in the future, especially on combination products.<... Read more
Attorney:
Vincent K. Shier, Ph.D.
June 24, 2020
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.<... Read more
Attorney:
Marina I. Miller, Ph.D.
June 8, 2020
The USPTO has launched a new Covid-19 Prioritized Examination Pilot Program to help small and micro entities. The USPTO will accept requests for prioritized examination of up to 500 qualifying patent applications without requiring payment of certain fees associated with prioritized examination. Under this pilot, the USPTO will advance out of turn certain patent applications related to COVID-19 for examination, resulting in their prioritized examination. The USPTO aims to provide final disposition of patent applications in the pilot in one year or less after it grants prioritized status. <... Read more
Attorney:
Richard D. Kelly
May 21, 2020
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. <... Read more
Attorney:
Jeffrey B. McIntyre
May 12, 2020
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.<... Read more
Attorney:
Grace Kim
May 08, 2020
The Federal Circuit issued a public opinion in Boston Scientific Scimed, Inc., v. Andrei Iancu, No. 2018-2004 (Fed. Cir. May 6, 2020) (sealed opinion was previously issued on April 27, 2020), affirming the PTAB’s final written decision in IPR 2017-00060. The CAFC upheld that challenged claims 1-4 of U.S. Patent No. 8,992,608 to Boston Scientific are invalid as being obvious over prior art.<... Read more
Attorney:
Grace Kim
May 07, 2020
The Federal Circuit issued a precedential decision addressing standing requirements in Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., No. 2018-2273, slip op. (Fed. Cir. April 23, 2020).<... Read more