The Federal Circuit Provides a Refresher on Joint Inventorship

Attorney: Daniel J. Pereira, Ph.D.
July 28, 2020

The decision in Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceuticals Co., Ltd, Tasuku Honjo, E.R. Squibb & Sons, L.L.C., Bristol-Myers Squibb Company (Fed. Cir., July 14, 2020) was an appeal of a determination of joint inventorship from the United States District Court for the District of Massachusetts.... Read more

An Automated Notification System for Providing Advance Notification of the Pickup or Delivery of Goods was Found Patent Ineligible

Attorney: Marina I. Miller, Ph.D.
July 20, 2020

Electronic Communication Technologies, LLC (“ECT”) sued ShoppersChoice.com, LLC (“ShoppersChoice”), alleging that ShoppersChoice infringed claim 11 of U.S. Patent 9,373,261 (“the ’261 patent”). The district court granted ShoppersChoice’s motion for judgment on the pleadings that claim 11 was invalid under 35 U.S.C. § 101. ECT appealed. The Federal Circuit (“the Court”) affirmed the judgment of the district court.<... Read more

Can One Have Too Many Patents?

Attorney: Richard D. Kelly
July 7, 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

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

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

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July 2, 2020

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FDA Seeking Comments on Orange Book Patent Listing

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

Final Rules on PTA Calculations in View of Supernus

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

Requirements Under COVID-19 Prioritized Examination Pilot Program

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

MCRO's Pyrrhic Victory

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

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

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