Dmitry V. Shelhoff, Ph.D.

• dshelhoff@scciplaw.com
• Direct: 973.221.4539

• Rutgers Law School - J.D. (2004) 
• Wayne State University, School of Medicine - Ph.D., Biochemistry & Molecular Biology (2001)  
• Wayne State University, Dept. of Chemistry - M.S., Chemistry (1996)
• Moscow University, Dept. of Chemistry - B.S./M.S., Chemistry (1993)

• States: New Jersey, New York
• District Courts:  District of New Jersey, Southern District of New York, Eastern District of New York
• Appellate Courts: Federal Circuit

Dmitry has litigated and continues to litigate the most significant patent cases on behalf of generic pharmaceutical companies in district courts and the Federal Circuit. His experience is listed in more detail below.

With respect to trial presentation, Dmitry possesses outstanding speaking ability and tremendous court presence.  In the courtroom, Dmitry relishes the moments when a strong trial presentation leads to a clear victory, reaffirming his client’s position and his own skill and dedication. His hands-on approach combined with his fierce determination and his ability to distill complex scientific information into compelling legal arguments sets him apart as a powerful force in the courtroom.

With a background in chemistry, biochemistry, and molecular biology, Dmitry also possesses broad technical expertise directly applicable to the patent claims covering compounds, pharmaceutical compositions, and methods of use that are typically challenged in pharmaceutical patent litigation. This background allows him to work efficiently with the most renowned experts in the field and prepare them for their depositions and trial.

Dmitry thrives in high-pressure environments where his ability to manage several litigations concurrently truly shines. He meticulously handles every aspect of each case, ensuring that no detail is overlooked. Most importantly, Dmitry also understands the economics of Hatch-Waxman (ANDA) litigation and proper case management. It is this rare combination of proficiencies that affords his clients the best possible representation and makes Dmitry a leading pharmaceutical patent litigator.    

Hatch-Waxman Litigation for Generic Pharmaceutical Companies

• Salix Pharmaceuticals, Inc. et al. v. Carnegie Pharmaceuticals, LLC et al., 24-10356-ESK (D.N.J) – represented Carnegie re Xifaxan (rifaximin) (irritable bowel syndrome)
• In re Nexletol/Nexlizet ANDA Litigation, 24-5921-JXN (D.N.J.) – represented Aurobindo re Nexetol (bempedoic acid) & Nexlizet (bempedoic acid and ezetimibe) (hypercholesterolemia)
• Azurity Pharmaceuticals, Inc. v. Aurobindo Pharma Limited et al., 23-23273-JKS (D.N.J.) – represented Aurobindo re Firvanq (vancomycin) (antibiotic)
• Jazz Pharmaceuticals Research UK Limited f/k/a GW Research Limited, 23-3914-MEF (D.N.J.) – represented Zenara re Epidiolex (cannabidiol) (epilepsy)
• Pfizer Inc. et al. v. Aurobindo Pharma Limited, 23-923-GBW (D. Del.) – represented Aurobindo re Vyndaqel (tafamidis meglumine) (transthyretin-mediated amyloidosis)
• Chiesi USA, Inc. et al. v. Eugia Pharma Specialities Limited et al., 23-22-KMW (D.N.J.) – represented Aurobindo and Eugia re Kengreal (cangrelor) (antiplatelet drug)
• Intercept Pharmaceuticals, Inc. et al. v. Zenara Pharma Private Limited, 22-1215-MN (D. Del.) – represented Zenara re Ocaliva (obeticholic acid) (primary biliary cholangitis)
• AbbVie Inc. et al. v. Alkem Laboratories Limited et al., 22-1423-JLH (D. Del.) – represented Alkem and Zenara re Orilissa (elagolix) (endometriosis)
• Ferring Pharmaceuticals Inc. et al. v. Eugia Pharma Specialties Limited et al., 22-17-MN (D. Del.) – represented Aurobindo and Eugia re Firmagon (degarelix for injection) (prostate cancer)
• Merck KGaA et al. v. Hopewell Pharma Ventures, Inc., et al., 22-1365 (D. Del.) – represented Aurobindo re Mavenclad (cladribine) (multiple sclerosis)
• Bristol-Myers Squibb Co., et al. v. Biocon Pharma Limited, 23-392-GBW (D. Del.) – represented Biocon relating to Eliquis (apixaban) (anticoagulant)
• Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 22-377-GBW (D. Del.) – represented Aurobindo, Hetero, and Zenara re Steglatro (ertugliflozin) (diabetes)
• Allergan, Inc. v. Aurobindo Pharma Limited, Aurobindo Pharma U.S.A., Inc. and Eugia Pharma Specialities Limited, 21-1808-RGA (D. Del.) – represented Aurobindo re Alphagan P (brimonidine) (glaucoma)
• Taro Pharmaceutical Industries Ltd., et al. v. Encube Ethicals Pvt. Ltd., 21-1614-RGA (D. Del.) – represented Encube re Ovide (malathion lotion) (head lice)
• Newron Pharmaceuticals S.p.A et al. v. Aurobindo Pharma Limited et al., 21-843-GBW (D. Del.) – represented Zenara re Xadago (safinamide) (Parkinson’s)
• Merck Sharp & Dohme BV et al. v. Aurobindo Pharma USA, Inc. et al., 20-2576-CCC (D.N.J.), 23-2254 (Fed. Cir.) – represented Aspiro, Mankind, and Zenara re Bridion (sugammadex) (reversal of neuromuscular blockade)
• In re Entresto (Sacubitril/Valsartan) Patent Litigation, Nos. 20-md-2930-RGA (D. Del.), 23-2218-RGA (Fed. Cir.) – represented Hetero and Torrent re Entresto (sacubitril/valsartan) (heart failure)
• Otsuka Pharmaceutical Co., Ltd. et al. v. Zenara Pharma Private Ltd. et al., 19-1938-LPS/RGA (D. Del.) – represented Hetero and Zenara re Rexulti (brexpiprazole) (antipsychotic)
• Amgen Inc. et al. v. Annora Pharma Private Limited, 20-122-CFC (D. Del.) – represented Annora in re Corlanor (ivabradine) (chronic heart failure)
• Allergan USA, Inc. et al. v. Aurobindo Pharma Ltd. et al., 19-1727-RGA (D. Del.) – represented Hetero re Viberzi (eluxadoline) (irritable bowel syndrome)
• Pfizer Inc. et al. v. Aizant Drug Research Solutions Pvt. Ltd. et al., 19-743-CFC (D. Del.) – represented Hetero re Ibrance (palbociclib) (breast cancer)
• Bial - Portela & CA SA et al v. SPH Shanghai Zhongxi Pharmaceutical Co., Ltd., 18-00775-CFC (D. Del.) – represented SPH Shaghai re Aptiom (eslicarbazepine acetate) (epilepsy)
• Amarin Pharma, Inc. et al. v. Hikma Pharmaceuticals PLC et al., 16-02525-MMD (D. Nev.) – represented Dr. Reddy’s re Vascepa (icosapent ethyl)
• Horizon Pharma, Inc. and Pozen Inc. v. Dr. Reddy’s Labs. Ltd. 15-3324-SRC (D.N.J.) – represented Dr. Reddy’s re Vimovo (esomeprazole/naproxen) (osteoarthritis)
• AstraZeneca AB v. Reddy’s Labs. Ltd., 15-08267-MLC (D.N.J) – represented Dr. Reddy’s re Nexium (esomeprazole magnesium)
• Kowa Company Ltd et al. v. Amneal Pharmaceuticals, LLC, 14-2758-PAC (S.D.N.Y.) – represented Amneal re Livalo (pitavastatin) (hyperlipidemia)
• Otsuka Pharmaceutical Co., Ltd. v. Sciegen Pharmaceuticals Inc. et al., 14-8077-JBS (D.N.J.)
• In re Bendamustine Consol. Cases, 13-2046-GMS (D. Del.) – represented Dr. Reddy’s re Treanda (bendamustine hydrochloride)
• Horizon Pharma, Inc. and Pozen Inc. v. Dr. Reddy’s Labs. Ltd., 13-91-SRC (D.N.J.) – represented Dr. Reddy’s re Vimovo (esomeprazole/naproxen) (osteoarthritis)
• Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs. Ltd., 13-00925-RGA (D. Del.) – represented Dr. Reddy’s in Diprivan (propofol) (anesthetic)
• Horizon Pharma, Inc. and Pozen Inc. v. Dr. Reddy’s Labs. Ltd., 11-02317-SRC (D.N.J.) – represented Dr. Reddy’s re Vimovo (esomeprazole/naproxen) (osteoarthritis)
• Dr. Reddy's Laboratories, Ltd. et al. v. AstraZeneca AB et al., 08-2496 (D.N.J.) – represented Dr. Reddy’s re Nexium (esomeprazole magnesium) (proton pump inhibitor)
• Hoffmann-La Roche Inc. v. Dr. Reddy's Laboratories, Ltd. et al., 07-04516-SRC (D.N.J.) – represented Dr. Reddy’s re Boniva (ibandronic acid) (osteoporosis)
• In re Rivastigmine Patent Litigation (S.D.N.Y. 2006) – represented Dr. Reddy’s re Exelon (rivastigmine) (Alzheimer’s)
• Janssen Pharmaceutica N V et al. v. Dr. Reddy's Laboratories, Inc. et al. (In re ’318 Patent Infringement Litigation), 05-00380-SLR (D. Del.) – represented Dr. Reddy’s in Razadyne (galantamine) (acetylcholinesterase inhibitor for Alzheimer’s)
• AstraZeneca AB et al. v. Ranbaxy Pharmaceuticals, Inc. et al., 05-5553-MLC (D.N.J.) – represented Dr. Reddy’s in Nexium (esomeprazole magnesium)
• In re Glaxo ’845 Patent Litigation, 03-10260-LTS (S.D.N.Y.) – represented Dr. Reddy’s in Imitrex (sumatriptan) (anti-migraine compound)
• Eisai Co., Ltd. v. Dr. Reddy’s Labs. Ltd., 03-9053-GEL (S.D.N.Y.) – represented Dr. Reddy’s in Aciphex (rabeprazole) (proton pump inhibitor)

Hatch-Waxman Litigation for Brand Pharmaceutical Companies

• Nycomed US Inc. v. Glenmark Generics, Ltd., 08-05023 (E.D.N.Y.) – represented Nycomed, a global pharmaceutical company, in Cutivate® lotion (corticosteroid indicated for atopic dermatitis)
• Savient Pharms., Inc. v. Sandoz, Inc. and Upsher-Smith Labs., Inc., 06-5782 (D.N.J.) – represented Savient Pharmaceuticals in Oxandrin® (anabolic steroid to promote weight gain in AIDS patients)

Non-Hatch-Waxman Litigation:

• Batinkoff v. Church & Dwight Co., Inc. et al., 18-16388-BRM-LHG (D.N.J.) – represented plaintiff Hollywood actor Randall Batinkoff in a patent infringement action involving a dispensing device for a cosmetic product

Post-Grant Proceedings in the USPTO

• Church & Dwight Co., Inc. v. Randall Batinkoff, IPR2020-00168 (PTAB) – represented patent owner Hollywood actor Randall Batinkoff in inter partes review involving a dispensing device for a cosmetic product
• Dr. Reddy’s Laboratories, Inc. et al. v. Pozen Inc. et al., IPR2018-00894 (PTAB) – represented petitioner Dr. Reddy’s in inter partes review 
• Dr. Reddy’s Laboratories, Inc. et al. v. Pozen Inc. et al., IPR2018-01341 (PTAB) – represented petitioner Dr. Reddy’s in inter partes review

• Speaker, "Navigating Parallel Proceedings In Hatch-Waxman Litigation and the PTAB," Paragraph IV Disputes, New York, NY, November 10, 2021
• Speaker, "Horizon Pharma Inc. and Pozen Inc. v. Dr. Reddy's Laboratories Ltd., et al., Case No. 11-cv-2317," International IP Skills Summit, Hyderabad, India, February 28, 2020