On May 9, 2016, the U.S. Court of Appeals for the Federal Circuit upheld the U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB) inter partes review determination that claims 1-6 and 8 of U.S Patent Number
BioLoquitur
The Life Sciences Patent Blog
BioLoquitur, published by Seyfarth Shaw LLP, focuses on legal issues related to biotechnology and pharmaceutical industries. The blog covers topics such as biosimilar patent litigation and inter partes review (IPR) strategies, regulatory exclusivity periods for generic and biosimilar drugs, patent eligibility and subject matter guidance from the USPTO, tribal immunity in patent proceedings, and FDA approvals of novel drug products including those derived from marijuana. It addresses the intersection of intellectual property law, FDA regulatory frameworks, and patent litigation strategies relevant to biologics, generics, and pharmaceutical innovations.
Latest from BioLoquitur - Page 5
USPTO’s Updated Guidelines for Rejections Based on Lack of Patent Eligible Subject Matter
Last week, the USPTO issued further guidelines for patent examiners, instructing that rejections of applications based on ineligibility require detailed explanations for the basis of the rejection. This new requirement is distinguished from the previous guidelines by requiring examiners to…
Federal Circuit Confirms That It Is Bound By Congress And Supreme Court In Its Standard Of Review Of Appeals Under The AIA
On April 26, 2016, the Federal Circuit denied a petition for rehearing en banc, filed by Merck and Cie. The Federal Circuit maintained that the “substantial evidence” review standard applies for an appeal from an IPR proceeding. Judge O’Malley, with…
Recent Changes in USPTO Rules for Post-Issuance Proceedings
On April 1, 2016, the U.S. Patent and Trademark Office (USPTO) released a number of amendments to the final rules of trial practices for post-issuance proceedings, i.e., inter parties review, post-grant review, the transitional program for covered business method patents,…
Federal Circuit Affirms District Court’s Motion To Dismiss Under Mayo
In Genetic Technologies Limited v. Merial L.L.C., the Federal Circuit upheld a district court’s determination that many claims of a patent relating to methods of analyzing sequences of DNA are invalid under 35 U.S.C. § 101. According to the…
Newly Approved Biosimilar Inflectra™ Market Launch Held Up in Court
In only the second decision of its kind, the U.S. Food and Drug Administration (FDA) approved Celltrion’s biosimilar Inflectra™ (infliximab-dyyb), a reproduction of Janssen Biotech’s immunosuppressant Remicade® (infliximab). Inflectra is, however, the first biosimilar monoclonal antibody to be approved in…
ANDA Filers Subject to Specific Personal Jurisdiction Based on Future Infliction of Real-World Market Injury
The Federal Circuit in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. held that U.S. district courts have specific jurisdiction over an ANDA filer in any state they intend to market.…
Federal Circuit Affirms Holding of Obviousness of Claims Covering Warner Chilcott’s Osteoporosis Drug, Altevia®
In Warner Chilcott v. Teva, the Federal Circuit used the appellant’s claim limitation, as defined in the specification, to uphold the district court’s finding that the claims of two patents were invalid as obvious. The claims at issue covered the…
Federal Circuit Determines that Certain PTO Delays May Not Necessitate Patent Term Adjustment
A patent has a term of twenty years from the patent application’s effective filing date. To compensate inventors for any undue delays in patent examination caused by the U.S. Patent and Trademark Office (“USPTO”), Congress established a system to adjust…
Practice Tips for Biotech Regarding Provisional Patent Rights After Rosebud v. Adobe
For the first time, the Federal Circuit addressed the requirement of “actual notice” of a published patent application in order for a patent holder to obtain damages before issuance of a patent. The case arose from the appeal of a…