On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more
2/16/2022
/ Competition ,
Data Management ,
Deceptive Intent ,
Drug Pricing ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Life Sciences ,
Monopolization ,
Patient Access ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
USPTO
The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more
1/21/2022
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Inducement ,
Intellectual Property Protection ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
10/26/2021
/ Anti-Competitive ,
Biden Administration ,
Biosimilars ,
Biotechnology ,
Competition ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
USPTO
Background -
On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more
9/21/2021
/ Generic Drugs ,
GlaxoSmithKline ,
Hatch-Waxman ,
Induced Infringement ,
JMOL ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals
Citing its priority to facilitate the timely development and approval of generic drugs, the U.S. Food and Drug Administration ("FDA") solicits stakeholder input on the types of patents that should be listed in the Orange...more
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
The Federal Circuit upholds the validity of a patent covering a polymorphic form of a chemical compound.
The United States Court of Appeals for the Federal Circuit recently held in Grünenthal Gmbh v. Alkem Labs. Ltd. that...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
The PTAB recently rejected a request for rehearing by Bayer CropScience LP (“Bayer”). Bayer Cropscience LP, v. Syngenta Limited, IPR2017-01332, Paper 15 (P.T.A.B. Apr. 2, 2018). The PTAB stated that when the prior art does...more
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
Allergan is typically the patent holder in these types of disputes, however, it recently successfully played the role of petitioner in an IPR against 1474791 Ontario Ltd.’s U.S. Patent No. 6,806,251 covering the use of...more
The PTAB found obvious all claims of U.S. Patent Nos. 7,582,621 and 7,767,657 in the three final written decisions issued on February 23, 2017 (IPR2015-01776, IPR2015-01780, and IPR2015-01785). This marks another victory for...more
On March 6, 2017, the PTAB issued a pair of final written decisions upholding the patentability of U.S. Patent Nos. 7,932,268 (IPR2015-01836) and 8,618,135 (IPR2015-01835), in challenges filed by the Coalition for Affordable...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