The Bayh-Dole Act, 35 U.S.C. §§ 200-212[1], creates a program that, ostensibly, encourages the practical use of inventions that are supported by federally funded research. As stated in Bayh-Dole, Congress seeks “to use the patent system to promote the utilization of inventions arising from federally supported research or development.”[2] The Bayh-Dole Act aims to promote small businesses and provide fair compensation to the inventors of the underlying technology. Congress seeks to accomplish this goal through various requirements. Funding Agreements and the Requirement to Report on Utilization ..read more

In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., [2023-1169] (June 25, 2024), the Federal Circuit reversed the dismissal of Amarin’s complaint for failure to state a claim for induced infringement. Less than a month after Hikma launched its generic icosapent ethyl product, Amarin sued under 35 U.S.C. § 271(b), alleging that Hikma had induced infringement of U.S. Patent Nos. 9,700,537 and 10,568,861. through the content of Hikma’s press releases, website, and product label evidence Hikma’s specific intent to actively encourage physicians to directly infringe the asserted patents by pr ..read more

In Insulet Corp. v. Eoflow, Co, Ltd., [2024-1137] (June 17, 2024), the Federal Circuit reversed a preliminary injunction against manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on alleged trade secrets of Insulet. Insulet and EOFlow are medical device manufacturers that make insulin pump patches. Insulet began developing the wearable insulin pump OmniPod® in the early 2000s. The FDA approved the first OmniPod product in 2005, and a next-generation product, the OPI-2, came onto the market soon thereafter in 20 ..read more

In Warner Chappel Music, Inc., v. Sherman Nealy, [22–1078] (May 9, 2024), the Supreme Court finally clarified copyright’s 3-year statute of limitations (17 U. S. C. §507(b)), holding that a copyright plaintiff who timely brings a copyright infringement claim, can recover damages for the entire period of infringement, and not limited to the three year period before suit was brought. Sherman Nealy and Tony Butler formed Music Specialist, Inc., which recorded and released one album and several singles, including the works at issue. Nealy went to prison, and Butler (unbeknownst to Nealy) ente ..read more

The results-effective variable doctrine is a caselaw principle where prior art disclosing the “general conditions of a claim” invokes a presumption of obviousness if the particular workable ranges are identifiable through routine experimentation. The presumption can be rebutted with evidence that the given parameter was not recognized as being result-effective. Sanofi Pasteur, Inc. and SK Chemicals Co initiated an IPR (inter partes review) to invalidate U.S. Patent No. 9,492,559 (the “‘559 Patent”) owned by Pfizer based on the routine optimization theory. The ‘559 Patent is directed to composi ..read more

The USPTO released inventorship guidance on February 12, 2024, for inventions assisted by artificial intelligence (AI). The Federal Circuit previously held that an AI system cannot be listed as an inventor in Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022), and this release provides guidance regarding the open question of human inventorship for inventions developed by a person working with the assistance of an AI system.   At the outset, the USPTO guidance states that inventions developed with assistance from an AI system are still patentable, as long as a human inventor “significantly co ..read more

In Allgenesis Biotherapeutics Inc., v. Cloudbreak Therapeutics, LLC, [2022-1706] (November 7, 2023), the Federal Circuit dismissed the appeal of the PTAB’s final written decision that claims 4 and 5 of U.S. Patent No. 10,149,820 had not been shown to be unpatentable, because Allgenesis has failed to establish an injury in fact sufficient to confer standing to appeal. Although a party does not need Article III standing to file an IPR petition or to obtain a Board decision, the party must establish Article III standing once it seeks review of the Board’s decision in this Court. To ..read more

In view of the recent Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023)(hereinafter Amgen), the USPTO has published guidelines for determining enablement requirement (35 U.S.C. § 112(a)) compliance among all utility patent applications regardless of technology. You can access the published guidelines here. The guidelines are not intended to announce any major change to accessing the enablement requirement, and state that USPTO personnel will continue to use the Wands factors from In re Wands 858 F.2d 731, 737 (Fec. Cir. 1988) to ascertain whether the experime ..read more

Actelion Pharmaceuticals Ltd, v. Mylan Pharmaceuticals Inc., [2022-1889] (November 6, 2023), the Federal Circuit vacated the district court’s claim construction order with respect to the term “a pH of 13 or higher” in U.S. Patent Nos. 8,318,802 and 8,598,227 and the judgment of infringement, and remand for the district court to consider the extrinsic evidence and its impact on claim construction. The patents in suit were directed to improved epoprostenol formulations. The claim required “the bulk solution has a pH of 13 or higher.” Both parties proposed the plain and ordina ..read more

In Malvern Panalytical Inc., v. TA Instruments-Waters LLC, [2022-1439] (November 1, 2023), because the district court erred in construing “pipette guiding mechanism,” the Federal Circuit vacated the stipulated judgment of non-infringement of U.S. Patent Nos. 8,827,549 (“the ’549 patent”) and 8,449,175 and remanded for further proceedings. These patents both disclose microcalorimeters, which are machines that measure the amount of energy absorbed or released during a chemical reaction between two compounds. Malvern and Waters disputed whether the term “pipette guiding mechanism” encompasses onl ..read more