Oren Langer understands his clients’ business in three ways. First, as the Managing Partner of the New York office, and having served on the firm’s Executive Board, he knows the nuances of what it takes to run and grow an organization. Second, having worked at Bristol-Myers Squibb Co. and Pharmacopeia as an organic chemist, he understands the industry and how business decisions affect the operations of a company. And third, as a highly experienced intellectual property litigator and counselor, he sees all sides of a legal issue when it comes to creating, protecting, and commercializing innovation.
As a member of the firm’s Intellectual Property & Technology group, Oren focuses on pharmaceutical patent litigation under the Hatch-Waxman Act’s regulatory framework. He represents clients through every stage of litigation, from pre-suit investigations, case-initiation, and discovery—electronic, fact, and expert—to dispositive motion practice, mediation, trial, and appeal. But as a legal strategist, Oren also understands that litigation is not always the best solution. He advises clients on how to use litigation to leverage results by providing opinions on transactional matters, including licensing negotiations and campaigns, and monetizing intellectual property in anticipation of prospective mergers or acquisitions.
Given the diverse nature of his clients’ business, he has also litigated complex commercial, trade secret misappropriation, medical device, copyright, and trademark infringement matters. Finally, in addition to the pharmaceutical industry, he has litigated cases in various industries including chemical, telecommunications, video gaming, and retail services.
Oren is the co-creator, principal editor, and contributor of the firm’s Hatch-Waxman Litigation quarterly newsletter, GENERICally Speaking, which reports on recently filed ANDA lawsuits, ANDA approvals, generic drug launches, relevant settlements, and case blurbs on meaningful court decisions. He also provides input in the legal trade press and presents on meaningful decisions and relevant topics at conferences and in publications. In 2020 and 2021, he was named a “Life Sciences Star” by LMG Life Sciences and a “Top Author” by JD Supra from 2018-2021.
Oren is also committed to using his skills to help those who need legal help but cannot afford or access it. One of his most rewarding experiences came after seven years of pro bono litigation, when an immigration court judge granted his client and her husband asylum in the United States from the Kyrgyz Republic on the basis of religious discrimination. In addition, he counsels various artists and takes part in clinics in association with the organization Volunteer Lawyer for the Arts. He also co-chairs the firm’s Well & Good writing and pro bono program, which teaches associates to develop sound writing principles while, at the same time, produce written work product for the firm’s partnering pro bono agencies.
Served as lead defense counsel for BioDelivery Sciences Int’l, Inc. (BDSI) in two patent litigations, after BDSI was acquired by Collegium Pharmaceutical, Inc. in March of 2022. Cases were pending in the Eastern District of North Carolina where BDSI’s products Bunavail® (buprenorphine and naloxone) buccal film and Belbuca® (buprenorphine) buccal film were accused of infringing Aquestive Therapeutic’s U.S. Patent No. 8,765,167. The parties had been litigating for nearly a decade in federal district courts and in multiple proceedings before the Patent Trial and Appeal Board. After appearing as substitute counsel for BDSI, Robins Kaplan developed and asserted strategic patent infringement defenses and—in a little over eight months—reached a favorable settlement achieving complete freedom to market for BDSI. Aquestive Therapeutics, Inc. v. BioDelivery Sciences Int’l, Inc., Civ. No. 19-505-D (E.D.N.C.); Indivior Inc. v. BioDelivery Sciences Int’l, Inc., Civ. No. 15-350-D (E.D.N.C.)
Represented Bioeq AG with respect to intellectual property matters and licensing for Biologics License Application Number 761165 for the proposed biosimilar ranibizumab product, including a license agreement among Bioeq, Coherus, and Genentech, Inc. Coherus owns the BLA for CIMERLI (ranibizumab-egrn) and commercial rights in the U.S. and its territories. Coherus licensed CIMERLI from Bioeq AG, a joint venture between Polpharma Biologics Group B.V. and Formycon AG. Coherus announced the commercial availability, beginning October 3, 2022, of CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all approved indications. CIMERLI is an anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.
Trial Counsel to the Trustees of the University of Pennsylvania in a patent infringement action against Eli Lilly and ImClone related to the manufacture and sale of Erbitux. Penn asserted US Patent No. 7,625,558 related to treatment of certain cancers using antibodies to erbB receptors followed by radiation therapy. The action was THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA v. ELI LILLY AND COMPANY, IMCLONE LLC and BRISTOL-MYERS SQUIBB COMPANY, No. 15-6133 in the Federal District Court for the Eastern District of Pennsylvania. The case was resolved on confidential terms.
Represented Collegium Pharmaceutical, Inc. at the Patent Trial and Appeal Board in a Post-Grant Review challenging Purdue’s U.S. Patent No. 9,693,961. Collegium prevailed in demonstrating that all claims of the patent were invalid for lack of written description support and anticipation. Collegium Pharm., Inc. v. Purdue Pharma L.P., PGR2018-00048 (Final Written Decision Nov. 19, 2021).
Represented Hikma Pharmaceuticals USA, Inc. in a Hatch-Waxman patent litigation concerning an intravenous medication, used when a patient cannot exercise adequately for a stress test, that increases blood flow through the arteries of the heart. Astellas US LLC v. Hikma Pharmaceuticals USA, Inc., 21-1785-CFC (D. Del.).
Represented Amneal Pharmaceuticals, Inc. in an 18-patent Hatch-Waxman patent litigation concerning a medication indicated in a woman after menopause to reduce moderate to severe hot flashes. TherapeuticsMD, Inc. v. Amneal Pharmaceuticals, Inc., 20-5256, 20-14933 (D.N.J.).
Trial counsel to Collegium Pharmaceutical in Collegium Pharmaceutical Inc. v. Teva Pharmaceuticals USA, a Hatch-Waxman litigation matter involving 14 Orange Book-listed patents for the oxycodone product Xtampza ER. The case resulted in a settlement in which defendant Teva agreed to a consent judgment confirming that its proposed generic products infringe on Collegium’s asserted patents. Under the settlement, Collegium will grant Teva a license to market its generic version of Xtampza ER in the United States beginning on or after September 2, 2033.
Represented Amneal Pharmaceuticals LLC in a Hatch-Waxman patent litigation concerning a medication indicated to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). Genentech, Inc. v. Amneal Pharmaceuticals LLC, 19-0190-RGA (D. Del.).
Represented Amneal Pharmaceuticals LLC in a Hatch-Waxman patent litigation concerning an anti-diabetic medication indicated in patients with type 2 diabetes and used to control high blood sugar. Shionogi Inc. v. Amneal Pharmaceuticals, LLC, 18-1564-MSG (D. Del.).
Represented Chinese pharmaceutical company Bostal Drug Delivery Co., Ltd. and CEO of NJ-based pharmaceutical company in defense of a shareholder derivative case alleging, among other things, misappropriation of trade secrets. Austar Int’l Ltd. v. AustarPharma LLC, 19-8356-KM-MAH (D.N.J.).
Represented Torrent Pharmaceuticals in a Hatch-Waxman patent litigation concerning an anti-convulsant medication indicated for the treatment of partial-onset seizures in patients four years of age and older. Bial - Portela & CA., S.A. et al v. Torrent Pharms. Ltd., 18-0279-VAC-MPT (D. Del.).
Represented Collegium Pharmaceutical, Inc. in a Hatch-Waxman patent litigation concerning an analgesic medication indicated for the management of severe pain. Collegium Pharm., Inc. v. Teva Pharms. USA, Inc., 18-0300-LPS (D. Del.).
Represented device manufacturer Ypsomed AG as a third-party in a Hatch-Waxman patent litigation concerning a drug for treating diabetes. Sanofi-Aventis U.S. LLC v. Merck, Sharp & Dohme Corp., 16-0812-RGA (D. Del.).
Represented Amneal Pharmaceuticals LLC in multiple Hatch-Waxman patent litigations concerning a drug for treating pain. Endo Pharms. Inc. v. Amneal Pharms. LLC, No. 15-2023 (Fed. Cir.); Endo Pharms. Inc. v. Amneal Pharms. LLC, No. 17-1094 (Fed. Cir.).
Represented Collegium Pharmaceutical, Inc. in a Hatch-Waxman patent litigation concerning a Section 505(b)(2) application for a drug for treating pain. Purdue Pharma, L.P. v. Collegium Pharm., Inc., No. 15-13099-FDS (D. Mass.).
Represented Amneal Pharmaceuticals LLC in a Hatch-Waxman patent litigation concerning a drug for treating secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis. Amgen Inc. v. Amneal Pharmaceuticals LLC, 16-0853-GMS (consolidated) (D. Del.).
Represented Vesture Group, Inc. and its retailer co-defendants, J. C. Penney Corp., Inc., Burlington Stores, Inc., and Sears, Roebuck and Co., in defense of trademark infringement claims concerning the mark “Pinky” used in girls’ clothing. We are currently awaiting resolution of Defendants’ motion to dismiss. Pulse Creations, Inc. v. Vesture Group, Inc., 1:15-cv-02496-KPF (S.D.N.Y.)
Represented Amneal Pharmaceuticals LLC in a Hatch-Waxman patent litigation concerning a drug for the treatment of ADHD. Alza Corp. v. Amneal Pharmaceuticals of New York, LLC, 16-0914-RGA (D. Del.).
Represented Novel Laboratories, Inc., in a Hatch-Waxman patent litigation concerning a drug for treating middle-of-the-night-insomnia. Purdue Pharma. Products L.P. v. Actavis Elizabeth LLC, 2:12-cv-05311-JLL-JAD (D.N.J.). The Federal Circuit summarily affirmed the district court’s decision.
Represented Digital River, Inc., an online e-commerce company, against class action complaint alleging a violation of the New Jersey Consumer Fraud Act and other state law claims. Augustine v. SWReg, Inc., 3:13-cv-2007-PGS-LHG (D.N.J.).
Represented Alcatel-Lucent USA Inc. against counterclaims asserting patent infringement concerning technology associated with router redundancy architecture and methods of employing the same. Alcatel-Lucent USA Inc. v. Amazon.com, Inc., 6:09-cv-422-LED (E.D. Tex.).
Represented IDT Corp., a global telecommunications company in New York state appeal of contractual dispute concerning transfer of telecommunications capacity in a subsea fiber-optic network. IDT Corp. v. Tyco Group S.A.R.L., Index No. 652097/10 (N.Y. App. Div., First Dep’t).
Represented SPI Pharma, Inc., a food and drug excipient manufacturer, against claims of patent infringement concerning sugar polyol additive. Mr. Langer managed the effort during claim construction, fact and expert discovery, which resulted in a JMOL decision at trial, and ultimately a settlement for the parties. Roquette Freres v. SPI Pharma, Inc., 06-540 GMS (D. Del.). (Prior to joining Robins Kaplan LLP)
Represented Daiichi Sankyo, a Japanese pharmaceutical company and its U.S. subsidiary, in Hatch-Waxman patent infringement action against generic company seeking to market generic equivalent of topical antibiotic eardrop medication. Daiichi Sankyo Co., Ltd. v. Apotex Inc., 2:03-cv-00937-WGB-MCA (D.N.J.). (Prior to joining Robins Kaplan LLP)
- "Extra Orange Book Scrutiny Poses Questions for Law Firm Strategy," Managing IP (September 21, 2023)
- "Orange Book Petitions Fall Signals PTAB Limits for Generics," Managing IP (July 21, 2023)
- "Trailblazers: Emerging Therapies and Life Sciences 2023," The National Law Journal (July/August 2023)
- "Delaware Delays Make Pharma Counsel Choose Patent Motions Carefully," Managing IP (February 24, 2023)
- "FDA Fixes for Generic Delays May Not Work, Says Patent Counsel," Managing IP (September 24, 2021)
- "Teva Inks Patent Deal With Collegium Over Painkiller," Law360 (September 30, 2020)
- "Hospira Loses Appeal of Sedative Patent Invalidity Decision," Bloomberg Law (January 9, 2020)
- "Robins Kaplan Trial Win for Amneal Pharmaceuticals Over Generic Sensipar," Legal Reader (September 5, 2018)
- "Amgen Loses Sensipar Generics Infringement Litigation," Intellectual Property Magazine (August 10, 2018)
- “Amneal Secures Non-Infringement Ruling in Sensipar Dispute,” IPPro Patents (July 31, 2018)
- “Purdue’s ‘Duplicative’ Suit Over OxyContin Generic Gets Ax,” Law360 (January 16, 2018)
- “Purdue Loses Bid to Fuse Jumble of OxyContin Patent Suits,” Law360 (December 13, 2017)
- “Teva Told to Pay Glaxo $235.5 Million for Infringing Patent,” Bloomberg BNA (June 21, 2017)
- “Vanda Succeeds in Getting Roxane Labs’ Case Booted,” Bloomberg BNA Pharmaceutical Law & Industry Report (December 28, 2016)
- “Amneal Tells Fed Circ. Endo Played With Numbers In Patent,” Law360 (June 14, 2016)
- “Fed. Circ. Upholds Invalidity of Purdue’s Sleep Aid Patents,” Law360 (January 8, 2016)
- “Purdue Insomnia Patents Wrongly Put To Bed, Fed. Circ. Told,” Law360 (January 4, 2016)
- “Purdue's Sleep Aid Patents Are Obvious, Judge Rules,” Law360 (March 30, 2015)
- “Novel Fights 'Patient' Claim Rehearing In Suprep Suit,” Law360 (July 7, 2014)
- “Fed. Circ. Flips Braintree Win In Generic Suprep Suit,” Law360 (April 22, 2014)
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