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Sandoz Inc. v. Amgen Inc.
  • Merchant & Gould
  • USA
  • June 16 2017

In a unanimous decision in Sandoz Inc. v. Amgen Inc., the U.S. Supreme Court held that injunctive relief was not available under federal law to

Reverse Payment PTAB Settlements in BioPharma?
  • Oblon
  • USA
  • July 28 2016

Print Anti-Competitive IPR Settlements for Orange Book Patents? The Patent Trial & Appeal Board (PTAB) has the power to terminate an Inter Partes

Federal Circuit Upholds Home Field Advantage in Generic Drug Cases
  • Cole Schotz PC
  • USA
  • March 28 2016

Under United States law, the holder of a patent on a brand-name, FDA-approved drug can bring suit for patent infringement against a generic drug

U.S. Supreme Court rules that generic pharmaceutical companies can counterclaim to correct use codes in FDA Orange Book when sued by brand companies
  • Blank Rome LLP
  • USA
  • April 18 2012

The U.S. Supreme Court ruled on April 17, 2012, in Caraco Pharmaceutical Labs. Ltd. v. Novo Nordisk AS, slip no.10-844, that a generic pharmaceutical manufacturer can counterclaim to have a “use code” for a method of use patent corrected in the FDA Orange Book.

Supreme court decides brand-name-drug "use code" case: Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk AS
  • Faegre Baker Daniels LLP
  • USA
  • April 17 2012

On April 17, 2012, the Supreme Court decided Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk AS, No. 10-844, holding that generic-drug manufacturers may use the counterclaim provision of 21 U.S.C. 355(j) to require a brand-name-drug manufacturer to correct a use code that inaccurately describes the brand-name drug's patent as covering a particular method of using a drug.

U.S. Supreme Court opens 2011-2012 term with IP cases on its docket
  • Shook Hardy & Bacon LLP
  • USA
  • October 7 2011

The U.S. Supreme Court returned for a new term on October 3, 2011, with two of the 48 cases already calendared for oral argument involving IP matters.

Antitrust alert: FTC releases report on authorized generic drugs
  • Jones Day
  • USA
  • September 23 2011

The U.S. Federal Trade Commission recently issued a report again criticizing the role that authorized generic drugs sometimes play in patent infringement settlements between branded pharmaceutical manufacturers and their generic counterparts.

President Obama proposes reducing the exclusivity period of brand-name biological products
  • Jones Day
  • USA
  • September 20 2011

President Obama, in his new budget plan, proposes reducing the exclusivity period for brand-name biologics from 12 years to seven.

Two new patent cases join Supreme Court’s fall docket
  • McDermott Will & Emery
  • USA
  • July 31 2011

The U.S. Supreme Court has granted certiorari in two patent cases, which will join Mayo v. Prometheus case (see IP Update, Vol. 14, No. 6) on the Court’s fall docket.

How the new multi-party patent infringement rulings will affect pharmaceutical treatment claims
  • Hamilton Brook Smith & Reynolds PC
  • USA
  • July 26 2011

The very recent and continuing focus by the U.S. Supreme Court and the Federal Circuit sitting en banc on multi-party infringement issues namely, induced infringement and divided, or joint, infringement portends daunting new challenges for brand pharmaceutical companies that attempt to assert method of treatment claims in Hatch-Waxman litigation against generic competitors.