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

Attorney: Jenna Logsdon, Ph.D.
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

Written Description of a Numerical Range

Attorney: Richard D. Kelly
February 14, 2024

The Federal Circuit on February 9 decided another written description case involving a range not found in ipsis verbis in the patent specification in RAI Strategic Holdings Inc. v. Philip Morris Products S.A. RAI appealed from a PTAB holding in PGR2020-00071 that claims 10 and 27 of U.S.P. 10,492,542 lacked written description in the specification. Claims 27 is reproduced below; claim 10 is identical except it depends on claim 9:<... Read more

When does a drug label induce infringement under 35 U.S.C. § 271(e)(2) of a patent not claiming an indication or method of use?

Attorney: Richard D. Kelly
January 23, 2024

In Corcept Therapeutics, Inc. v. Teva Pharmaceuticals U.S.A., Inc., C.A. 18-03632, December 29, 2023, the Chief Judge Bumb of the New Jersey District Court wrestled with the question of infringement under 35 U.S.C. 271(e)(2) where the drug labels of the generic and ethical drug were identical in the relevant parts.<... Read more

Invalidity of a Patent Claiming Antibodies Characterized by Their Function In View of Amgen

Attorney: Marina I. Miller, Ph.D.
January 12, 2024

Baxalta Inc. and Baxalta GmbH (Baxalta) appealed a district court decision that the claims of U.S. Patent No. 7,033,590 were invalid for lack of enablement. The Federal Circuit (the Court) affirmed the decision.<... Read more

USPTO Releases Examiner Guidance for The Amgen Enablement Decision

Attorney: Richard D. Kelly
January 10, 2024

The USPTO today published its guidance to the examiners on the impact of the Amgen v. Sanofi,143 S. Ct. 1243 (2023), on USPTO practice. The Guidance is basically steady as she goes but with the caveat that the enablement requirement and the Wands factors (In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)) apply across all technologies, noting the Court’s reliance on cases involving the telegraph, incandescent lamp filaments and wood glue.  The Guidance also noted that the post-Amgen Federal Circuit decisions had reaffirmed the continued validity of the Wands factors as consistent with Amgen, citingMedytox, 71 F.4th at 998- 999, Baxalta Inc, v. Genentech, Inc., 81 F.4th 1362 (Fed. Cir. 2023), and In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential).<... Read more