Jay R. Deshmukh
Most recently a partner at Knobbe Martens Olson & Bear LLP, Mr. Deshmukh served as key member of the firm’s Hatch-Waxman practice by developing business with international generic pharma clients. He also served as co-lead counsel in major Hatch-Waxman litigations and as IP litigation counsel, settlement counsel, and Food and Drug Administration counsel for smaller generic pharma clients.
Mr. Deshmukh has conducted successful negotiations to resolve large, global patent and other litigation issues, and has prevailed in exclusivity matters against the Office of the Chief Counsel of the FDA. Mr. Deshmukh has experience working with the Federal Trade Commission and advises clients seeking IP counsel in the European Union, having defended against patent infringement claims in more than 10 EU jurisdictions.
Jay’s recent work includes:
- Forest v. Alembic, Teva, Accord, Apotex (D. Del) *
- Aptalis, Teva Europe v. Apotex (D. Del.) *
- Takeda v. Wockhardt (D. N. J.)
- Gilead v. Mylan (D. W. Va)
- BMS v. Mylan (D. W. Va)
- Novartis v. Mylan (D, Del)
- Depomed v. Wockhardt (D. N. J.)
- Orexigen v. Actavis (no entry of appearance — on behalf of brand)
- Lilly v. Wockhardt (D. Del)
- Managed extremely complex Compliance situation with team of outside counsel and technical advisors at Ranbaxy from 2007 to end of tenure.
- Over the last 5 years became a part of Ranbaxy's global Executive Team which was a body comprised of 6-10 Senior Management individuals who advised the Company's Board.
- Created from scratch Global IP department with 3 separate locations with 50-60 employees on a worldwide basis
- IP department supported traditional activities of a large generic, global pharma company including freedom to practice opinions, product reviews, process reviews, patentability and non-infringement opinions, searches for paragraph IV opportunities in the US and early entry opportunities globally, supported lawyers in IP department and outside lawyers in ex-parte and inter-partes matters.
- Personally conducted negotiations to successfully resolve large litigations globally such as atorvastatin, esomeprazole, valacyclovir, tamsulosin, quinapril, modafinil, imipenem-cilastatin, etc resulting in multi-billion dollar opportunities (cumulative) for Ranbaxy.
- Regularly met with all 5 FTC commissioners regarding above litigation resolutions and convinced FTC not to enforce against company on a matter in which there was enforcement against brand company.
- Litigated several exclusivity matters with the FDA resulting in establishing favorable law re delisting and 100 plus million dollar profit for company (simvastatin) and another "lost" opportunity in the case of pravastatin.
- Successfully obtained the overturning of a preliminary injunction against company in cefuroxime axetil and convinced FDA and USP to allow polymorphically mixed api in product by way of citizen's petition process.
- In the face of intense scrutiny in regards to Compliance issues, convinced the FDA by way of personal meetings with the FDA General Counsel to approve simvastatin resulting in significant profits.
- Initiated and completed unusual "transfer" of enjoined exclusivity from one generic company to Ranbaxy.
- Litigated with several teams of outside attorneys complex global IP litigation for atorvastatin resulting in several significant wins for company, starting from selecting outside lawyers to personally creating winning strategy.
Before joining Knobbe Martens, Mr. Deshmukh was the senior vice president of Global IP at Ranbaxy Laboratories Ltd., an international generic pharmaceutical company, where he was responsible for the creation of the company’s global IP department.
Bar & Court Admissions
- New York Bar
- New Jersey Bar
- Ohio Bar
Case Western Reserve University School of LawJD1992Cleveland State UniversityMSChemical Engineering1989Manipal Institute of TechnologyBEChemical Engineering1984