In a recent decision, a district court in the District of Delaware applied estoppel under 35 U.S.C. § 315(e)(2) to a defendant in Hatch-Waxman litigation, two and half years after the court conducted a bench trial on...more
Article III of the Constitution imposes a “case or controversy” limitation on the jurisdiction of federal courts: an actual case or controversy must exist between the parties at all stages of the federal court proceedings,...more
The USPTO has proposed a pilot program intended to make it easier to amend claims before the PTAB. (See the USPTO’s Request for Comments on Motion to Amend Practice and Procedures in Trial Proceedings under the America...more
11/5/2018
/ America Invents Act ,
Claim Amendments ,
Comment Period ,
Federal Pilot Programs ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Reform ,
Patent Trial and Appeal Board ,
Patents
In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds. Shortly thereafter, Novartis filed suit...more
7/30/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
We have published other blog postings relating to 35 U.S.C. §325(d), including a blog posting that addresses the PTAB’s October 24, 2017 notice designating three of its decisions as informative (here). Recently, the PTAB...more
On November 28, 2017, the PTAB issued a final written decision upholding the patentability of U.S. Patent No. 6,667,061 (IPR2016-01096). The ’061 patent is owned by Alkermes Pharma Ireland, Ltd. and Alkermes Controlled...more
In IPR2017-01054 and IPR2017-01055 (Fresenius Kabi USA, LLC v. Hospira Inc.), the PTAB denied institution of inter partes reviews of U.S. Patent Nos. 8,242,158 and 8,338,470, because Petitioner Fresenius filed the IPR...more
At least 19 IPRs have been filed against seven of Genentech’s patents covering its blockbuster antibody drug Herceptin® (trastuzumab). On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. (a subsidiary of Pfizer)...more
In orders entered July 10 and 12, 2017, the PTAB instituted further inter partes review (IPR) of six Allergan Inc. (“Allergan”) patents relating to cyclosporine compositions. Each of U.S. Patent Nos. 8,633,162, 8,685,930,...more
The PTAB issued a final written decision in IPR2016-00006, holding claims 1–22 of U.S. Patent No. 8,497,393 (“the ’393 patent”) unpatentable under 35 U.S.C. § 102(b) and 35 U.S.C. § 103(a). All of the claims are...more
On February 28, 2017, the PTAB held that the petitioner Lupin had not shown that the challenged claims in two of Pozen’s patents were invalid (IPR2015-01773 and IPR2015-01775). These cases show the advantage of using...more
On March 3, 2017, in a final written decision in IPR2015-01838, the PTAB rejected an obviousness challenge brought by DuPont against a patent owned by Furanix Technologies B. V. directed to methods for preparing the known...more
On February 8, 2017, the PTAB denied Fustibal LLC’s (“Fustibal”) petition to institute inter partes review of U.S. Patent 8,637,553 B2 (“the ’553 patent”) owned by Bayer HealthCare LLC (“Bayer”) (IPR2016-01490). The 553...more