Experience

• • Secured a significant victory at the Federal Circuit for Braintree Laboratories, Inc. when the appeals court reversed a district court's grant of summary judgment of noninfringement for Breckenridge Pharmaceutical and remanded with instructions to enter judgment in Braintree's favor. This Hatch-Waxman matter involved a patent owned by Braintree pertaining to its product SUPREP®, a highly successful product designed to cleanse the colon safely before a colonoscopy.
  • Represented Braintree Laboratories, Inc. in its ANDA case against Novel Laboratories, after it proposed a plan to make a generic version of SUPREP ®. Following a six-day bench trial, WilmerHale obtained a favorable judgment in the District of New Jersey for Braintree. The judge found that defendant had not proven by clear and convincing evidence that the asserted claims of the patent at issue were invalid for obviousness, anticipation, or indefiniteness. In his opinion, the judge evaluated more than 20 pieces of prior art asserted by Novel and concluded that Braintree's expert was more credible than Novel's in arguing that the asserted claims were neither anticipated nor obvious. On appeal by Novel, the Federal Circuit upheld the validity of the patent and two of the claim constructions, reversed two claim constructions, vacated the infringement finding, and remanded the case to the district court for further factual findings on the issue of infringement. On remand, the judge found that Novel's proposed generic version of SUPREP and its use would infringe the asserted claims.
  • Represented GlaxoSmithKline in its ANDA suit involving its patent covering the active ingredient in Avodart® and Jalyn™ products. Following a three-day bench trial, the judge ruled that the patent at issue was not invalid for lack of enablement, written description and anticipation.
  • Conducted IP due diligence for a Japanese pharmaceutical company seeking to in-license two small molecule compounds for development as potential therapies for treating depression and anxiety.  
  • Represented a private pharmaceutical company with approved and pipeline products in the CNS and respiratory disorders space to file and prosecute US and non-US patent portfolios.  
  • Conducted IP due diligence for a public company seeking to acquire another public company's late-stage antibiotic candidate for the treatment of MRSA, methicillin-resistant Staphylococcus aureus.
  • Conducted IP due diligence on Intrexon's synthetic biology patent portfolio in connection with Ziopharm Oncology's global exclusive channel partnership in oncology, which leverages Intrexon's advanced transgene engineering platform for the controlled and precise cellular production of anti-cancer effectors
  • Conducted IP due diligence for a diversified technology leader seeking to enhance its medical technologies platform by acquiring a target company with a portfolio of integrated tissue diagnostic systems and reagents for cancer and infectious disease
  • Represent a privately held algae biofuel company in its patent portfolio development and technology licensing in the following strategic areas: algae strains, photobioreactor designs, extraction processes and refining processes
  • Represented a leading European specialty pharmaceutical company in performing IP due diligence for a potential in-licensing of a drug product for treating a women's health disorder that causes symptoms in up to 25% of reproductive age women, including a freedom-to-operate analysis, a patentability analysis and a market exclusivity analysis
  • Represented a publicly traded biotech company's $24.5M sale of IP assets related to the fields of prenatal and reproductive health
  • Represented several large pharmaceutical companies on their patent prosecution, reexamination, and counseling matters related to discovery and development of lead biologics and small molecule compounds, as well as a range of life cycle management issues regarding many different commercial products
  • Represented a specialty pharmaceutical company in its strategic patent portfolio management of and diligence activities for its FDA-approved pain product, co-developed with its partner, and the protection and clearance of other drug delivery technologies, pain products and formulations
  • Represented a private biotech company for its strategic portfolio development of its kinase switch inhibitor program, including protection of its BRL-ABL kinase inhibitor that recently entered the clinic, as its exclusive intellectual property counsel
  • Represented a biotech company in due diligence activities and an inter partes reexamination