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Expertise in Complex Legal Challenges

  • Assisted nutrition solutions company with coordinated regulatory and IP strategy to maximize and protect internal product value, and leverage client manufacturing expertise to produce product for others while preserving rights to IP created in context of contract manufacturing relationships.
  • Assisted client with multi-state potential regulatory discipline based on activities of prior management.
  • PeriphaGen, Inc. v. Krystal Biotech, Inc., et al.(Western District of Pennsylvania, 2020-22) (HSV-1 gene therapy): Co-lead counsel for plaintiff PeriphaGen in complex trade secret litigation. Case settled during discovery with the defendant making an upfront payment of $25 million, plus potential future payments totaling an additional $50 million. Law 360 Report on the Settlement
  • Represented Somerset Therapeutics LLC in settling Hatch-Waxman litigation related to 0.7% olopatadine ophthalmic solution in the United States, a generic version of PATADAY® Once-Daily, permitting entry into the market prior to patent expiry.
  • Represented Patrin Pharma in Hatch-Waxman litigation related to Assertio’s migraine medication, Cambia (Assertio Therapeutics, Inc. et al. v. Patrin Pharma, Inc., Civil Action No. 20-cv-05055 (N.D. Ill.). Achieved a settlement and license agreement related to all asserted patents.
  • Represented a generic pharmaceutical manufacturer in Inter Partes Review litigation related to a prescription drug resulting in an agreement to settle with a license date prior to expiration of patents.
  • Represented TheraCour Pharma, Inc., a research and development pharmaceutical company, in a license agreement with NanoViricides, Inc. (NYSE Amer.: NNVC), a global leader in nanomedicines against viruses. Under the license agreement, TheraCour licensed technology to NanoViricides for VZV, the virus that causes chickenpox in children and shingles in adults.
  • Represented Immunome, Inc., a biotechnology company focused on developing first-in-class cancer therapies by harnessing the human immune response, in a collaboration and licensing agreement with pH Pharma, a clinical-stage biopharmaceutical company focused on developing innovative healthcare products for unmet clinical and patient needs.
  • Sears Petroleum & Transport v. MLI Associates LLC, Case No. 03-cv-01120 (N.D.N.Y.): Obtained jury verdict of non-infringement in favor of Defendant MLI Associates LLC.
  • Senju v. Apotex, Case No. 07-cv-00779 (D.Del.) (Fed. Cir.): Obtained judgment of invalidity for obviousness following bench trial on patent concerning ophthalmic formulation of antibiotic gatifloxacin.
  • Apotex Glaxo Wellcome, Case No. 09-cv-00485 (M.D.N.C.): Patent litigation regarding patents related to valacyclovir.
  • IN RE: METHOD OF PROCESSING ETHANOL BYPRODUCTS AND RELATED SUBSYSTEMS ('858) PATENT LITIGATION (Adkins Energy, LLC), Case No. 10-ml-02181 (S.D.Ind.): Multi-district litigation member of defense team obtained summary judgment of invalidity and non-infringement of patents relating to methods for processing corn to produce corn oil.
  • AGA Medical Holdings v.  L. Gore, Case No. 10-cv-03734 (D.Minn.): Patent litigation relating to septal occluder medical devices.
  • Genentech v. Apotex, Case No. 11-cv-02410 (N.D.Cal.): Patent litigation regarding patents related to valacyclovir.
  • Shire v. Roxane, Case No. 11-cv-03886 (D.N.J.): Patent litigation relating to patents for lisdexamfetamine.
  • Senju v. Apotex, Case No. 11-cv-01171 (D.Del.): Won dismissal of patent lawsuit related to patent concerning ophthalmic formulation of antibiotic gatifloxacin.
  • Senju v. Apotex, Case No. 12-cv-00159 (D.Del.): Obtained stipulated dismissal of litigation on patents related to gatifloxacin ophthalmic formulation.
  • Apotex Allergan, Case No. 12-cv-00196 (D.Del.): Antitrust action concerning marketing of ophthalmic gatifloxacin formulations.
  • L. Gorev. AGA Medical, Case No. 12-cv-00827 (D.Minn.): Declaratory judgment action regarding septal occluder medical device.
  • Pfizer v. Wockhardt, Case No. 12-cv-00808 (D.Del.): Obtained settlement for ANDA filer to resolve patent litigation concerning desvenlafaxine.
  • Grunenthal v. Actavis, Case No. 13-cv-04507 (D.N.J.): Patent litigation regarding patents related to tapentadol oral tablets.
  • Forest Laboratories, Inc. et al. v.Glenmark , Case No. 1:13-cv-1602 (D. Del. 2013) Obtained settlement for ANDA filer to resolve patent litigation concerning milnacipran.
  • Eli Lilly v. Glenmark, Case No. 14-cv-00389 (S.D.Ind.): Obtained stay of litigation in favor of successful Inter Partes Review (IPR) petition invalidating patents related to uses of prasugrel.
  • AstraZeneca v. Wockhardt, Case No. 14-cv-00667 (D.Del.): Patent litigation regarding patents concerning saxagliptin.
  • In Re Copaxone 40 MG Consolidated Cases (Amneal), Case No. 14-cv-01171 (D.Del.): Obtained judgment of invalidity for obviousness of four patents related to glatiramer acetate 40 mg/mL. Affirmed on appeal 2017-1575, -1594, -1595, and -1596 (Fed. Cir.).
  • Galderma v. Glenmark, Case No. 15-cv-01416 (N.D.Tex.): Obtained settlement for ANDA filer to resolve patent litigation concerning common acne treatment.
  • Roxane Labs. v. Novel Labs., Case No. 15-cv-05618 (D.N.J.): Obtained settlement for ANDA filer.
  • Jazz Pharmaceuticals v. Wockhardt, Case No. 15-cv-05619 (D.N.J.): Obtained settlement for ANDA filer to resolve patent litigation concerning sodium oxybate.
  • Eaton Veterinary Pharmaceutical v. Wedgewood Pharmacy, Case No. 15-cv-00687 (W.D.Mo. And Fed. Cir.): Obtained writ of mandamus ordering transfer of case from Western District of Missouri to home forum in District of New Jersey.
  • Depomed v. Actavis, Case No. 15-cv-06797 (D.N.J.): Patent litigation regarding patents related to tapentadol oral tablets.
  • Eaton Veterinary Pharmaceutical v. Wedgewood Pharmacy, Case No. 16-cv-02086 (D.N.J.): Obtained settlement for compounding pharmacy in patent litigation related to veterinary uses of tacrolimus.
  • Amneal v. Teva, Case No. 17-cv-00074 (D.Del.): Obtained settlement for ANDA filer of patents related to methods of manufacture for glatiramer acetate 40 mg/mL.
  • Teva v. Amneal, Case No. 17-cv-00416 (E.D.N.Y.): Successfully challenged venue of case in E.D.N.Y. in favor of venue in Delaware.
  • Biogen v. Prinston, Case No. 17-cv-00823 (D. Del.): Patent litigation regarding patents related to dimethyl fumarate treatment for multiple sclerosis.
  • Glenmark Daichii Sankyo, Case No. IPR2015-00864 (PTAB): Won unpatentability of all challenged claims for patent related to uses of prasugrel with aspirin.
  • Wockhardt v. Jazz Pharmaceuticals, Case No. IPR2015-00554 (PTAB): Obtained settlement of IPRs and litigation for ANDA filer to resolve patent disputes concerning sodium oxybate.