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Two Federal Circuit decisions clarify availability of patent term extension for approved drug products
  • Foley & Lardner LLP
  • USA
  • May 10 2010

In two decisions issued May 10, 2010, the Federal Circuit clarified the rights of patentees to receive patent term extension (PTE) based on FDA approval of a new drug product

REVATIO patent ruled invalid for lack of sound prediction and obviousness
  • Stikeman Elliott LLP
  • Canada
  • June 18 2010

In an application under the Patented Medicines (Notice of Compliance) Regulations (“Regulations”), Pfizer sought an order prohibiting the Minister of Health (“Minister”) from issuing a notice of compliance (“NOC”) to Ratiopharm for a generic version of the drug REVATIO (containing the medicine sildenafil citrate (“sildenafil”) the same medicinal ingredient contained in VIAGRA) until after the expiry of the 324 patent

Eli Lilly Canada Inc. et al. v. Novopharm Limited
  • Borden Ladner Gervais LLP
  • Canada
  • March 15 2010

Lilly commenced an action for patent infringement, and Novopharm, by way of counterclaim, brought an action for damages pursuant to s 8 of the Patented Medicines (Notice of Compliance) Regulations

Other industry happenings of note
  • Borden Ladner Gervais LLP
  • Canada
  • March 15 2010

Health Canada published a Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) and updated the Guidance Documents for Data Protection and the PMNOC Regulations

Apotex v. Pfizer (January 16, 2009) 2009 FCA 8
  • McMillan LLP
  • Canada
  • April 30 2010

This was the first case in which the Federal Court of Appeal considered the obviousness test set out in the 2008 Supreme Court of Canada case of Apotex v. Sanofi-Synthelabo

Section 112 includes a separate written description requirement
  • McDermott Will & Emery
  • USA
  • April 28 2010

Sitting en banc, the U.S. Court of Appeals for the Federal Circuit, in a 9-2 decision, confirmed that 35 U.S.C. 112, 1 includes a written description requirement separate from the enablement requirement

Second Circuit invites rehearing in reverse settlement case
  • Paul, Weiss, Rifkind, Wharton & Garrison LLP
  • USA
  • May 6 2010

In a recent decision regarding the validity of so-called “reverse settlement” agreements, the U.S. Court of Appeals for the Second Circuit affirmed the dismissal of plaintiffs’ antitrust claims on summary judgment, but took the unusual step of inviting plaintiffs to petition for rehearing by the full Court of Appeals

Federal Supreme Court passes stem cell case to ECJ
  • Cohausz & Florack
  • European Union, Germany
  • December 9 2009

On 12th November 2009 the Federal Supreme Court was due to consider the patentability of methods to generate cells from embryonic stem cells

An update on motions to transfer in the Eastern District of Texas
  • Morgan Lewis & Bockius LLP
  • USA
  • December 3 2009

On December 2, the U.S. Court of Appeals for the Federal Circuit issued a writ of mandamus (an order) in the case titled In re Hoffmann-La Roche, Inc., reversing the denial of a motion to transfer a case out of the Eastern District of Texas and ordering the district court to transfer the case

Follow-on biologics: a patent litigation perspective
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • August 22 2009

In whatever form biosimilar legislation might take, patent holders will need to review their patent portfolios carefully