No Standing for ANDA Partner to Appeal Unfavorable IPR Ruling

The Federal Circuit recently dismissed an appeal of an adverse IPR decision by a generic pharmaceutical company for lack of Article III standing, finding that the company—which had yet to file an ANDA—had not suffered an injury-in-fact. The underlying IPR, originally filed by Apotex, involved U.S. Patent No. 9,187,405 (directed to methods of treating multiple […]

Clinical Trials Showing that a “Sufficient Percentage” of Prescriptions Will Practice Claimed Method Held to Prove Induced Infringement

Judge Du of the District of Nevada recently issued findings of facts and conclusions of law in a patent trial related to the drug Vascepa®.  Amarin Pharma, Inc. v. Hikma Pharma. USA Inc.  The court ultimately held that the asserted claims were all invalid as obvious.  But first it held that defendants proposed labels would […]

FEDERAL CIRCUIT AFFIRMS DISTRICT COURT ORDER DENYING REQUEST FOR PRELIMINARY INJUNCTION

Last month, the Federal Circuit affirmed per curium U.S. District Judge Colm F. Connolly’s order denying Genentech’s request for either a temporary restraining order or a preliminary injunction.  Genentech sought a preliminary injunction to prevent Amgen from selling a generic version of Genentech’s blockbuster cancer drug, Herceptin®.  Amgen launched on the same day the district court […]

PETITIONERS SHOULD ADDRESS OBJECTIVE INDICIA OF NONOBVIOUSNESS IN PETITIONS FILED WITH THE PTO

Recently, the PTAB denied Gilead Sciences, Inc.’s (Gilead) request to institute an inter partes review of two patents relating to HIV-prevention, U.S. Patent No. 9,044,509 (the ’509 patent) and U.S. Patent No. 9,579,333 (the ’333 patent). One key reason for the denial was because Gilead failed to adequately address unexpected results in its Petition. The […]

Federal Circuit Holds Claim Can Be Obvious Where a Combination of References Would Inherently Meet Claim Element

Just before the New Year, the Federal Circuit affirmed a decision from the District of Delaware finding patent claims related to using Zohydro ER in patients having hepatic impairment (liver disfunction) invalid as obvious. Persion Pharm. LLC v. Alvogen Malta Oper. Ltd. Some of the claims at issue included pharmacokinetic limitations requiring that the serum […]

MAGIC: Would Circumventing the Biosimilar Approval Process Expedite the Availability of Generic Insulin?

Part of the ACA’s sweeping healthcare reform was the Biologics Price Competition and Innovation (BCPI) Act of 2009, which re-classified certain drugs that had previously been regulated under the Food, Drug and Cosmetic Act. Insulin, for example, has historically been treated as a drug product, but will be classified as a biological product (and, therefore, […]

Success in an IPR Does Not Necessarily Ensure Success in Court

In a recent opinion, the District Court of New Jersey held that a decision in a parallel proceeding at the Patent and Trademark Appeal Board (PTAB) does not give rise to collateral estoppel in the court proceeding. The case concerns Sanofi Aventis’s (“Sanofi”) LANTUS® injectable insulin drug, indicated for the treatment of diabetes mellitus. After […]

Statutory Disclaimer Removes the District Court’s Authority to Invalidate Patent Claims

In a recent decision, the Federal Circuit held that the district court lacked authority to “disinter” and declare claims invalid where the patent owner had statutorily disclaimed the claims. Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., 933 F.3d 1367 (Fed. Cir. 2019). The case concerns the drug cabazitaxel, marketed as Jevtanta®, which is used […]

FDA INCREASES TRANSPARENCY THROUGH EXPANDED PARAGRAPH IV PATENT CERTIFICATIONS LIST

On June 18, 2019, the FDA announced plans to expand its Paragraph IV Patent Certifications List, a database used to list information about applications for generic drug approval.  The changes are part of the FDA’s on-going efforts “to provide the industry with greater transparency in order to provide greater certainty around timing of market entry […]

TERM Act Would Presume All Patents Covering a Branded Pharmaceutical Product Are Not Patentably Distinct

On June 11, a bipartisan group of Representatives including Hakeem Jeffries (D-N.Y.), Doug Collins (R-Ga.), Ben Cline (R-Va.), and Debbie Mucarsel-Powell (D-Fla.) introduced a new bill to address the rising cost of branded prescription drugs. The Terminating the Extension of Rights Misappropriated (TERM) Act of 2019, H.R. 3199, 116th Cong. (2019), aims to prevent pharmaceutical [...]