Representative Experience

Patent Litigation

Hatch-Waxman

  • Representing a major pharmaceutical company in an ANDA action involving challenges to patents covering a combination drug treatment for obesity.
  • Representing a major pharmaceutical company in an ANDA action involving challenges to patents covering a combination drug treatment for HIV.
  • Representing a major pharmaceutical company in an ANDA action involving challenges by multiple defendants to patents covering the crystalline form and processes for the manufacture of our client's blockbuster drug. Obtained summary judgment of infringement. After a three week trial, the district court found all patents valid and enjoined defendants from infringing the patents.
  • Representing a major pharmaceutical company in an action involving infringement of a patent covering the manufacture of a key component of an HIV drug.
  • Successfully represented a major pharmaceutical company in an ANDA action involving validity challenges by multiple generic manufacturers to patents covering our client's blockbuster protease inhibitor and methods of its use. After two years of litigation and the close of fact discovery, defendants abandoned their validity challenges and converted their Paragraph IV certifications to Paragraph III certifications.
  • Obtained a judgment of infringement and validity and enjoining defendants from infringing our client’s manufacturing patents.
  • Successfully represented a major pharmaceutical company in an ANDA action involving validity and enforceability challenges by multiple defendants to a patent covering our client's multi-billion dollar anti-psychotic drug. Affirmed by Federal Circuit.
  • Obtained dismissal of a generic manufacturer's declaratory judgment action for lack of subject matter jurisdiction. Affirmed by Federal Circuit.

BPCIA & Biotechnology

  • Representing innovator company in one of the first cases under the legislation for biosimilars (BPCIA) and the first involving an antibody product.
  • Obtained summary judgment of noninfringement based on a series of antibody tests in a case concerning a drug's mechanism of action.
  • Successfully represented a biotech company in a patent infringement action involving analysis of PCR amplified sequences.
  • Successfully defended a major pharmaceutical company in a lawsuit arising from a licensing dispute challenging the validity of biotech patents concerning the cotransformation of eukaryotic cells.

Medical Devices

  • In a case involving patents to surgical devices, obtained summary judgment of noninfringement and exclusion of two experts under Daubert as well as an award of attorneys' fees. Affirmed by Federal Circuit.
  • On appeal to the Federal Circuit, obtained reversal of a judgment of nonobviousness in a high-stakes case involving drug-eluting coatings.
  • On appeal to the Federal Circuit, obtained dismissal of a $593 million judgment in a case involving coronary stents.
  • Obtained reversal of a judgment that two related medical device patents were procured by inequitable conduct. Affirmed by Federal Circuit.

Inter partes reviews

  • Representing patent owner in an inter partes review (IPR) of a patent concerning the therapeutic use of a recombinant protein.
  • Obtained the denial of a generic manufacturer’s petition for IPR of a patent covering a crystal polymorph of a blockbuster drug.

License Disputes

  • In a patent license dispute concerning the use of a recombinant protein as an enzyme replacement therapy, obtained one of the largest settlement awards over the life of a contract.
  • In a patent license dispute involving a blockbuster biotech product, obtained dismissal of plaintiff’s claims and an award of attorneys’ fees.
  • Successfully represented a medical device company in a license dispute involving patents to the use of an anti-proliferative drug.
  • Successfully represented an orthopedic company in a license dispute involving patents to the use of biodegradable drug-containing coatings.

Other Patent Matters

  • Counseled clients on a wide range of intellectual property matters; drafted validity and infringement and freedom to operate opinions for biotech and pharmaceutical clients; negotiated and drafted settlement and license agreements.
  • Developing strategy and managing worldwide prosecution for patent applications and patents concerning the therapeutic use of a recombinant protein, including oppositions and appeals.
  • Obtained dismissal of a false marking action alleging that our client marked its products with inapplicable patents for failure to state a claim.
  • Obtained transfer of a false marking action and then dismissal for failure to meet pleading requirements for a claim of fraud.
  • Obtained judgment on the pleadings dismissing false marking action and rejecting plaintiff’s constitutional challenge to AIA. Affirmed by Federal Circuit.
  • Defended prominent law firm in a malpractice action involving biotech patents.

Pro Bono

  • After a two week trial, the district court found that our client’s hypoxic equipment did not infringe plaintiff’s patents. Affirmed by Federal Circuit.