Tag Archives: anda

New Estoppel Concern For Petitioners Raised In BTG v. Amneal

The Court of Appeals for the Federal Circuit is poised to decide a case which may create new estoppel concerns for AIA petitioners under 35 USC § 315(e)(2).   The appeal resulted from a Hatch-Waxman litigation in BTG v. Amneal, in which the lower court found that the patent claims at issue were invalid over the same … Continue reading this entry

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on June 14th, the Senate Judiciary Committee voted 16-5 to bring it to the Senate floor for a vote.  Presently, generic ANDA … Continue reading this entry

Timing Is Everything: Successful Joinder Motions At The PTAB

The joinder provisions of inter partes review (IPR) proceedings can be a great tool to circumvent the 1-year IPR filing deadline following service of a complaint for infringement. However, grant of a joinder petition by the Patent Trial and Appeal Board (PTAB) requires recognition that the Board is loath to delay a final hearing date … Continue reading this entry

Survey of Pharmaceutical IPRs Filed By Generic Drug Company Petitioners

We have reviewed a sub-group of 111 IPRs filed by generic drug companies against pharmaceutical patents to assess outcomes and trends.  While our survey was not  intended to capture every IPR filed by a generic drug company,  it does cover the most active generic company filers to date (see Fig. 2 below).  Examining this particular group … Continue reading this entry