If you plan to attend next week’s 2016 BIO Intellectual Property Counsels Committee Fall Conference, please keep an eye out for members of the Big Molecule Watch team. Big Molecule Watch editor Cynthia Hardman will moderate the conversation during the day-two luncheon fireside chat, “Standing on the Front Lines: Trials…
The Federal Circuit will rehear en banc the appeal In re: Aqua Products, Inc., No. 2015-1177 to address whether the PTAB’s rules requiring the Patent Owner to demonstrate the patentability of proposed amended claims are consistent with the statute permitting claim amendment during an IPR challenge, 35 U.S.C. 316(d) and (e). A…
Check out our updated Inter Partes Review page with information about all of the IPRs filed on biologic products, including the patent challenged, product that may be covered by the patent, patent owner, challenger, IPR status, and links to the important documents. You can reach this page easily by clicking…
Today, the PTAB instituted IPR proceedings on claims 1-5 of U.S. Patent No. 8,889,135, drawn to a method of treating a rheumatoid arthritis patient with a TNFα-inhibitor. Humira®, marketed by Abbvie, is allegedly covered by the claims of the ’135 patent. The IPR petition was filed by Coherus Biosciences, Inc….
On April 1, the U.S. Patent & Trademark Office published new rules for AIA proceedings before the Patent Trial & Appeal Board, including inter partes reviews (IPRs). IPRs are becoming an important tool for biosimilar manufacturers to challenge patents on biologic drugs (for example, see here, here, and here). Some of the most…
Goodwin Procter announced today the publication of Pharmaceuticals at the Patent Trial and Appeal Board, a guide that addresses proactive measures for pharmaceutical companies involved in litigation before the PTAB. The guide explores key statistics and case studies that reveal how the PTAB is handling pharmaceutical matters and lays out…
Below we provide a short introduction to the world of biologics and the BPCIA. For a more comprehensive guide on biosimilars, check out Goodwin Procter’s Biosimilars: A Guide to Regulatory and Intellectual Property Issues. What are biologics? Biologics are medical products such as vaccines, therapeutic proteins, and gene therapies that…