On July 11, 2019, more than 110 House Democrats wrote a letter to U.S. Trade Representative Robert E. Lighthizer expressing strong opposition to provisions in the United States-Mexico-Canada Agreement (USMCA) trade agreement, including the provision setting a minimum of 10 years of marketing exclusivity for biologic drugs.
As discussed here, in the United States,
On April 2, 2019, Eli Lilly and Company (“Lilly”) filed a Petition for Post-Grant Review (“PGR”) of Genentech’s U.S. Patent 10,011,654 (“the ’654 patent”). The ’654 patent, entitled “Antibodies Directed to IL-17A/IL-17F Heterodimers,” has just seven claims, with independent claim 1 drawn to “[a]n isolated humanized monoclonal antibody that binds to an IL-17A-17F heterodimer comprising
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for treatment of high cholesterol.[1] The case reached an important milestone recently as a jury entered a verdict largely upholding the validity of Amgen’s asserted patents, to the disappointment of Sanofi and Regeneron. A similar
On March 7, 2019, the U.S. Food & Drug Administration (FDA) released updated draft guidance announcing that it will create special names for biosimilar products to distinguish them from previously approved biologic products. Specifically, the guidance explains that:
On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”) seeking declaratory judgment of non-infringement and invalidity of Amgen’s U.S. Patent No. 9,643,997 (“the ʼ997 patent”). The ʼ997 patent is directed to methods of purifying a protein expressed in a non-native limited solubility form in a non-mammalian
As we previously reported, one of three Pfizer IPR petitions filed in April 2017 against Biogen-owned patents claiming methods of treatment with rituximab was instituted. The instituted IPR is IPR2017-01168 regarding U.S. Patent No. 8,821,873 (the “’873 patent”), and the PTAB recently issued its Final Written Decision.
Adhering to its institution decision where it
On November 5, 2018, twenty-nine organizations representing various groups including insurance companies, patient and consumer advocacy groups, unions, and retirees, submitted a letter to U.S. Trade Representative Robert Lighthizer to raise serious concerns that the recently renegotiated version of the North American Free Trade Agreement (NAFTA) – now proposed to be called the U.S.-Mexico-Canada Free
The August 2018 Update to the PTAB Trial Practice Guide added guidance regarding the Patent Trial and Appeal Board’s (“the Board”) discretion under 35 U.S.C. § 325(d) to deny institution of an AIA trial when the same or substantially the same prior art or arguments were previously presented to the United States Patent and Trademark
Recently, Pfizer was denied institution of two follow-on inter partes review (IPR) petitions, IPR Nos. 2018-00330 and 2018-00331 (“the 2018 petitions”), filed on December 18, 2017, asserting invalidity of Genentech patents, U.S. 6,339,142 (“the ’142 patent”) and U.S. 9,249,218 (“the ’218 patent”). The Patent Trial and Appeal Board (“the Board”) denied instituting the IPRs using
Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 (“the ’287 patent”). This is the third complaint that Amgen has brought against Apotex under the Biologics Price Competition and Innovation Act (the “BPCIA”), based on Apotex’s abbreviated biologic license applications (“aBLAs”) for biosimilars