Oren D. Langer

212.980.7456

Oren Langer

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board
Oren Langer

Experience

Oren Langer understands his clients’ business in three ways. As a member of the firm’s Executive Board and as the Assistant Managing Partner and Hiring Partner of the New York office, he knows the nuances of what it takes to run and grow an organization. Having worked at Bristol-Myers Squibb and Pharmacopeia as an organic chemist, he understands the industry and how business decisions affect the operations of a company. And 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, 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.

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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 Torrent Pharmaceuticals in a Hatch-Waxman patent litigation concerning a drug for treating COPD. Takeda GmbH v. Torrent Pharms. Ltd., 3:15-cv-03375-FLW-DEA (consolidated) (D.N.J.).

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 Novel Laboratories Inc., in a Hatch-Waxman patent litigation concerning pre-colonoscopy bowel prep drug. Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir. 2014).

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)

Super Lawyers 2021
JD Supra 2020 Award
  • Named a "New York Metro Super Lawyer," Super Lawyers (2021)
  • Named a “Life Sciences Star,” LMG Life Sciences (2020)
  • Recipient of “Hatch-Waxman Impact Cases of the Year” award, LMG Life Sciences (2016)
  • Named a "Top Author" by JD Supra (2016, 2020-2021)
  • Named a "New York Metro Rising Star," Super Lawyers (2014-2018)
Bar Admissions
  • New York
  • U.S. Court of Appeals, Federal Circuit
  • U.S. Court of Appeals, Second Circuit
  • U.S. District Court, Eastern District of New York
  • U.S. District Court, Southern District of New York
Spoken Languages
  • Hebrew
Education
  • Benjamin N. Cardozo School of Law, J.D., Intellectual Property Concentration (2003); Cardozo Journal of International and Comparative Law
  • Rutgers College, B.A. in Chemistry with Biology Option, minor in Hebraic Studies (2000)                         
Professional Associations
  • American Bar Association, Intellectual Property Law Section
  • New York State Bar Association
  • Intellectual Property Owners Association
  • New York Intellectual Property Lawyers Association

  • Disclosure-dedication Doctrine: A Primer on the Potential Pitfalls of This U.S. Form of Non-infringement
    Co-Presenter, World IP Forum, Webinar (April 30, 2021)
  • Examination of the Federal Trade Commission's Recommendations To Better Harmonize Patent and Antitrust Laws and Policy
    Fordham Annual Conference on International Intellectual Property Law and Policy, New York, New York (April 15, 2004)
April 30, 2021
WEBINAR | World IP Forum
Jeffrey Alan Hovden, Oren D. Langer - World IP Forum
Remote

RESOURCES

Links to full publications and news releases.

PUBLICATIONS

First Quarter
ANDA Approvals
GENERICally Speaking Spring 2021
First Quarter
Generic Launches
GENERICally Speaking Spring 2021
First Quarter
New ANDA Cases
GENERICally Speaking Spring 2021
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