Copyright gray market and Hatch-Waxman

The U.S. Supreme Court granted cert today in Kirtsaeng v. John Wiley & Sons, Inc. relating to gray market textbooks and the copyright first sale doctrine. Also today, the CAFC released two decisions relating to the Hatch-Waxman Act.

In Kirtsaeng, the defendant brought foreign authorized copies of textbooks into the United States and sold them. The publisher is alleging copyright infringement on the basis that the first sale doctrine does not apply to copies made outside the United States. In a recent gray market decision released in December 2010, Costco v. Omega, the United States Supreme Court split 4-4 with Justice Kagan sitting out.

The ScotusBlog has the lower court materials and cert submissions including a copy of the amicus brief submitted by the AIPLA in favour of a grant of certiorari.

In two “precedential” decisions released today, the U.S. Court of Appeals for the Federal Circuit considered two factual scenarios relating to patented medicines under the U.S. Hatch-Waxman Act:

  • In BAYER SCHERING PHARMA AG. V. LUPIN, LTD., the Court considered a motion to strike an action for infringement under the Act for an ANDA where the FDA approved use was narrower than the claims of the listed patent. The majority struck the claim while Justice Newman filed a dissent.
  • In DEY PHARMA, LP. V. SUNOVION PHARMACEUTICALS INC. a second ANDA filer brought a declaratory judgment action to trigger the first filer’s exclusivity period. The Court held that there was jurisdiction in spite of a covenant not to sue from the owner of a listed patent and ongoing litigation on other listed patents.

Scott Beeser has more detailed analysis of the Bayer decision.

[Update: It was pointed out to me that a third Hatch Waxman related decision was released on April 16, 2012. In Cephalon v Mylan Pharmaceuticals, the court reversed a finding of obviousness but upheld an appeal as to ‘best-mode’.]