The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs designated as Competitive Generic Therapies. The FDARA, according to FDA commissioner, Scott Gottlieb, “is part of our broader effort to foster generic competition and help address the high cost of drugs […] key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”
Continue Reading Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”

The test for patentable subject matter under Section 101 lies at the heart of patent system. However, very little guidance is provided in the actual statutory language. It comes as no surprise that the “seemingly’ simple provision of patent eligible subject matter has caused a great deal of confusion among inventors, patent attorneys, district court judges, and even the Justices on the U.S. Supreme Court.

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.


Continue Reading USPTO Director Proposes New Patent Eligibility Guidance

Seyfarth Shaw is pleased to announce The BioLoquitur Bulletin: Drugs Available in 2018 for Generic Competition, published by the Life Sciences team. The BioLoquitur Bulletin provides a brief overview of selected New Chemical Entities (NCE) that were approved by the FDA in the year 2014. While not every NCE will be a target for

The Food and Drug Administration (FDA), as part of its Drug Competition Action Plan, published a draft guidance detailing good practices for the submission of ANDAs on January 3, 2018. The guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA and makes recommendations to applicants on how to avoid such deficiencies. A typical ANDA requires an average of four review cycles before approval. The delay happens when ANDAs are submitted without all the information that the FDA needs to determine whether the ANDA meets FDA standards for approval, which leads to additional review cycles.
Continue Reading Good ANDA Submission Practices: Summary of Draft Guidance

Seyfarth Shaw Offers Hatch-Waxman And Biosimilars Litigation: 2017 Year-in-Review

Today’s rapid scientific and technological advances demand not only a thorough understanding of the complex technology, but also a meticulous application of intellectual property law to protect the technology.

Seyfarth’s Intellectual Property and Hatch-Waxman Litigation practitioners are pleased to announce the release of Hatch-Waxman And Biosimilars

It was a busy year for patent litigation across the broad, including the U.S. Patent and Trademark Office Patent Trial and Appeals Board (PTAB), U.S. District Courts (USDC), Court of Appeals for the Federal Circuit (CAFC), and the Supreme Court of the United States (SCOTUS). A quick look at the number of patent litigation cases

This article provides a summary of the draft guidance[1] released by the FDA to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to the FDA. The draft guidance was released on October

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 whom Judges Wallach and Stoll concurred in the denial of the petition, stated that in light of §§ 7 and 144 of Title 35, “we review Board decisions ‘on the record of an agency hearing provided by statute,’ and that we should therefore review Board fact-finding for ‘substantial evidence.’” The court explained its decision to deny the petition, “[i]n light of In re Gartside, [it] has reviewed all of the Board’s factual findings including those in IPRs, for substantial evidence.”
Continue Reading Federal Circuit Confirms That It Is Bound By Congress And Supreme Court In Its Standard Of Review Of Appeals Under The AIA

Momenta brought suit against Teva and Amphastar asserting that (i) Teva’s importation into the U.S. of an enoxaparin product would infringe Momenta’s ‘886 patent under 35 U.S.C. § 271(g), (ii) Amphastar’s manufacture in the U.S. of enoxaparin infringes the ’886 patent under 35 U.S.C. § 271(a), and this infringement does not fall within the safe harbor of 35 U.S.C. § 271(e)(1), and (iii) Amphastar’s sale of enoxaparin in the U.S. infringes the ‘886 patent under 35 U.S.C. § 271(g).
Continue Reading Momenta v. Teva – Effective Claiming of Methods of Testing Drug Products