Senate Patent Reform Moving Forward

     On March 12, 2008, Senate Judiciary Committee Chairman Patrick Leahy (D-VT) issued a press release outlining possible amendments to S.1145, the Patent Reform Act of 2007. As stated in the press release:

"Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.), Committee Member Orrin Hatch (R-Utah), and Ranking Member Arlen Specter (R-Pa.), have been working for months with a bipartisan coalition of senators in preparation of floor consideration of the Patent Reform Act, which would make the first reforms to the country's patent laws in more than 50 years. The Judiciary Committee passed the legislation last July, and Leahy, Hatch and Specter have held dozens of meetings and briefings in the months since, listening to concerns from stakeholders, and working to address the concerns of the wide cross-section of interested parties."

     Apparently, at least some of the Judiciary Committee members and other Senators have been "urging consideration of the legislation in the full Senate for months, and Majority Leader Harry Reid (D-Nev.) has signaled the chamber could take up the bill in April."

     The major proposed amendments to the bill are summarized below and contained in detail here (zip file):

  • “Best Mode” – eliminates ‘best mode’ as a ground for invalidating a patent, but maintains it as a requirement to obtain a patent

  • Ex Parte Provision – restores third party ex-parte reexamination

  • Federal Circuit Judges – ensures that any Federal Circuit judge who does not reside within a 50-mile radius of Washington, DC, must use the chambers of an existing courthouse in the district where they reside

  • Interference – provides technical amendment to allow for appeal to the Federal Circuit of USPTO board interference decisions commenced prior to the date of the Act; and amends the bill to delete interference-related provisions and replace with new derivation-related provisions

  • Interlocutory Appeals – limits interlocutory appeals of claim construction orders to those for which the District Court determines there is a reasonable basis for disagreement and the appeal may advance the ultimate termination of the litigation

  • Marking Provision – deletes the marking provision in the bill and maintains the current law

  • “Objective Recklessness” – codifies the Federal Circuit court’s ruling in Seagate, holding that infringement is only willful if the infringer acts with objective recklessness of the patent

  • Patent and Trademark Board Judges – ensures that the appointment of patent and trademark judges is consistent with the Appointments Clause

  • Patent Board Judges – technical amendment to clarify that the Patent Board’s duties include the conduction of derivation proceedings

  • Post-Grant Review – provides technical amendment to delete a redundancy in sec. 338 as created in S. 1145; corrects an inconsistency between S 337 (1) and (2), to preclude requesting or maintaining a post-grant review proceeding after a final decision in litigation on the same patent, based on any issue that was raised or could have been raised, in the litigation; defines “final decision” in the estoppel provision; and provides for technical amendment to delete a redundancy

  • Severability – establishes a severability clause in the bill 
     

    Several sources have reported in the last few weeks that proponents of the bill may not have the required votes to invoke the Cloture Rule, which limits the amount of debate on the floor prior to a vote (thereby blocking any filibuster).

Maryland IP Litigation 2008: Lawsuit Summary No. 7

     The following lawsuit filed in the U.S. District Court for the District of Maryland pits brand and generic drug makers (source: Justia).

  • #7: Forest Laboratories, Inc. v. Lupin Pharmaceuticals, Inc., No. 1:2008cv00239, filed January 28, 2008; assigned to J. Legg

     This Hatch-Waxman lawsuit involves Namenda® (memantine HCl). According to the complaint, plaintiff Forest Labs., Inc., a Delaware corporation based in New York, is the exclusive licensee of Orange Book-listed U.S. Patent No. 5,061,703. Plaintiff Forest Labs. Holdings, Ltd., is an Irish company based in Bermuda; plaintiffs Merz Pharma GmbH & Co. KGaA and Merz Pharma GmbH are German companies.

     Also according to the complaint, defendant Lupin Pharmaceuticals, Inc., a Virginia company based in Baltimore, MD, is the wholly-owned subsidiary and agent of Lupin Ltd., an Indian company based in Mumbai. Lupin Ltd. allegedly submitted, through its agent Lupin Pharma, an Abbreviated New Drug Application No. 90-051 to the FDA for approval to market generic Namenda®. It sent Forest the required notice of its ANDA submission on December 14, 2007.

     Plaintiff is asserting infringement of the ‘703 patent, and is seeking to enjoin Lupin from marketing its generic formulation before expiration of the '703 patent.

     Interestingly, plaintiffs also filed a concurrent lawsuit in the District Court for the District of Columbia because they claim not to be able to determine with certainty which one of Lupin, Inc., or Lupin Ltd. was the actual filer of the ANDA. This move was in anticipation of a jurisdictional challenge by Lupin (see related post here).