Finally, an ODP Decision in Favor of the Patentee
Attorney:
Richard D. Kelly
August 28, 2024
In Allergan USA, Inc v Sun Pharmaceutical Indus. Ltd, Appeal No. 2024-1061, August 13, 2024, the Federal Circuit reversed the district court’s holding that Allergan patent, U.S.P. 7,741,356 (‘356) was invalid for obviousness-type double patenting over USPs 11,007,179, 11,090,291, and 11,311,516. The relationship between the patents is shown below:
The ‘356 patent was entitled to significant PTA but because of the PTE it received, Allergan effectively disclaimed all but 487 days of the PTA. The total extension PTE plus PTA resulted in an expiration date of May 27, 2029, 15 years from the ‘356 issue date -- the maximum extension possible.<... Read more
USPTO Seeks Public Feedback on The Experimental Use Exception to Patent Infringement
Attorney:
Evan Smith
July 26, 2024
On June 27, 2024, the United States Patent and Trade Office (“USPTO”) published a request for comments (“RFC”) in the Federal Register inquiring about the current state of the experimental use defense to patent infringement and to determine the potential value of legislative action on the issue. This RFC both supports the President’s 2021 Executive Order on Promoting Competition in the American Economy and furthers the United States Department of Agriculture and the USPTO’s joint commitment to evaluate “New proposals for incentivizing and protecting innovation in the seed and agricultural-related space, including the addition of research or breeders' exemptions for U.S. utility patents.”[1]<... Read more
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