PTAB Invalidates Regeneron Claims on Method of Treatment

Attorney: Cristina Lai
July 5, 2024

The Patent Trial and Appeal Board (PTAB) issued a final written decision on IPR2023-00442 determining that claims 1, 3-11, 13, 14, 16-24, and 26 of U.S. Patent No. 10,130,681 (“the ‘681 patent”) were unpatentable. The ‘681 patent is owned by Regeneron Pharmaceuticals, Inc., and was challenged in an IPR by Samsung Bioepis Co., Ltd.  The ‘681 patent claims priority to a number of patents that were invalidated in previous IPR proceedings.<... Read more

PTAB Reverses Examiners on Unexpected Results

Attorney: Derek Lightner, Ph.D.
June 11, 2024

In Ex parte Freeman (USSN 16/270,259; TC 1600; Appeal 2023-000512, the underlying application being referred to herein as the “Freeman application”), a finding of obviousness and obviousness-type double patenting (ODP) was reversed on May 24, 2024. Freeman’s application was examined by Devang Thakor initially, but the case was taken over by another primary examiner, Nicole Babson, whose position was supported by Supervisor Patent Examiners, David Blanchard and Bethany Barham.<... Read more

IOEngine v. Ingenico: Printed Matter Doctrine and Forfeiture of Claim Construction

Attorney: Xiaohua (Joyce) Guo, Ph.D.
May 30, 2024

In a precedential decision, the US Court of Appeals for the Federal Circuit partially reversed and partially affirmed the Final Written Decisions made by the Patent Trial and Appeals Board (“Board”) during a series of inter partes review (IPR) proceedings.<... Read more

PTAB Reaffirms Written Description Threshold When Claiming a Genus

Attorney: Sara Pistilli, PharmD.
May 21, 2024

On May 17, 2024, the Patent Trial and Appeal Board (PTAB) affirmed a rejection of a claim directed to a purification method using single-domain antigen-binding proteins that bind mammalian IgG as lacking adequate written description (Appeal 2023-000567). The claim at issue in U.S. Application No. 16/282,082 (the ‘082 Application) recites:<... Read more

Anything You (are Required to) Say May be Used Against You (as Prior Art): Federal Circuit Upholds Invalidity Based on Mandatory Publication of Clinical Trial Protocol

Attorney: Nicholas Rosa, Ph.D.
May 16, 2024

Clinical trials are a critical part of the development and approval process for drugs, biologics, and medical devices. The lengthy and public nature of clinical trials, however, can create challenges for protecting relevant IP.  A clinical trial is a study or investigation in humans to “evaluate the effect(s) of intervention(s) on biomedical or health-related outcomes.”  42 C.F.R. 11.  Interventions can take many forms that benefit from patent protection including drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); treatment strategies; prevention strategies; and diagnostic strategies. Id. <... Read more

PTAB Reiterates Prior Art Must Describe a Claimed Range with Sufficient Specificity to Support an Anticipation Rejection

Attorney: Sara Pistilli, PharmD.
April 30, 2024

On May 2, 2023, the Patent Trial and Appeal Board (PTAB) overturned a rejection of a claim directed to microparticles containing leuprolide and a biodegradable polymer, and a method for producing the same as anticipated and obvious (Appeal 2024-000508). The claim at issue of the application US 17/832,229 (the ‘229 Application) is directed towards:<... Read more

Federal Circuit Upholds PTAB Finding of Patentability in Medtronic v. Teleflex Life Sciences

April 1, 2024

In Medtronic, Inc. v. Teleflex Life Sciences Ltd. the Federal Circuit upheld the Patent Trial and Appeal Board (PTAB) decision that U.S. Patent No. 8,142,413 (“the ’413 patent”), owned by Teleflex, was not shown to be unpatentable over the asserted prior art. This post will focus on how the Federal Circuit affirmed the PTAB’s claim interpretation to find ’413 patent claims 1, 2, 4, 5, and 7–14 non-obvious.<... Read more

Federal Circuit Upholds PTAB Finding of Obviousness in Pfizer vs. Sanofi

Attorney: Cristina Lai
March 18, 2024

In Pfizer Inc. vs. Sanofi Pasteur Inc., the Federal Circuit upheld the Patent Trial and Appeal Board (PTAB) decision to invalidate portions of Pfizer’s pneumococcal vaccine patent on the grounds of obviousness. My colleague’s post discusses the Federal Circuit’s decision to vacate and remand to the PTAB to further consider Pfizer’s motions to amend with regards to proposed claims 48 and 49, holding that the PTAB has not actually addressed the additional limitations for these claims. This post will focus on the patentability of Claims 1-45, and specifically how the Federal Circuit affirmed the PTAB’s application of the result-effective variable doctrine and reasonable expectation of success in order to arrive at a finding of obviousness of Claims 1-45 of U.S. Patent No. 9,492,599 (“the ‘559 patent”).<... Read more

Federal Circuit Remands to PTAB to Further Consider Pfizer's Motion to Amend Claims

Attorney: Long Phan
March 13, 2024

In a recent ruling regarding Pfizer's pneumococcal vaccine patent (U.S. Patent No. 9,492,559), the Federal Circuit upheld most of the Patent Trial and Appeal Board’s (PTAB) decision to invalidate portions of Pfizer's ‘559 patent as obvious. The PTAB’s invalidation of the ‘559 patent occurred over five IPRs by Merck Sharp & Dohme Corp., Sanofi Pasteur Inc. and SK Chemicals Co.<... Read more

PTAB Finds Non-Obviousness for Missing Element

Attorney: Derek Lightner, Ph.D.
February 15, 2024

The Patent Trial and Appeal Board (PTAB) recently reversed the novelty, obviousness, and obviousness-type double patenting (ODP) rejections of the examining corps in a Track One case (USSN 17/342,945; Appeal 2023-004168; TC 1600). Led by Administrative Patent Judge (APJ) Richard Lebovitz, the PTAB panel further including APJs John E. Scheider and Eric B. Grimes reversed the rejections of Examiner Jake M. Vu, whose position was supported by Supervisory Patent Examiner (SPE) Michael G. Hartley, quality control SPE Scarlett Goon, and SPE Frederick F. Krass.<... Read more