News & Analysis as of

Teva Pharmaceuticals

At The Bench: 2017 Mid-Year Case Review

Impression Prods. v. Lexmark Int’l, 137 S. Ct. 1523, 581 U.S. ___ (2017) The Supreme Court held that all patent rights are exhausted upon the first sale of a patented product, regardless of where the sale is made or...more

Rx IP Update - August 2017

by Smart & Biggar on

Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more

Anti-Corruption Risks and Drug and Device Companies

by Michael Volkov on

For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

Neupogen Dropped in New Formulary Exclusions

by Goodwin on

On July 31, Express Scripts identified new formulary exclusions that will go into effect on January 1, 2018. For example, Amgen’s rG-CSF product, NEUPOGEN, will be excluded in favor of Teva’s rG-CSF product, GRANIX, and...more

Teva Pharms. USA, Inc. v. Sandoz Inc.

by Robins Kaplan LLP on

Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc., Civ. No. 17-275(FLW), 2017 U.S. Dist. LEXIS 78002 (D.N.J. May 23, 2017) (Wolfson, J.)....more

PTAB Life Sciences Report - August 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Celltrion, Inc. v. Biogen Inc. et al. PTAB Petition: IPR2017-01230; filed March 30,...more

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more

Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®

by Goodwin on

Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

The Circuit issued only one precedential patent case this week, reversing a determination of obviousness as to a Millennium Pharmaceutical patent covering its blockbuster cancer drug Velcade®, thus extending the life of...more

PILLOW TALK: A Threat to Trade Secrets?

It turns out that, even in romantic relationships, some things are best kept secret. On July 7, 2017, Teva Pharmaceuticals USA, Inc. filed a complaint in the Eastern District of Pennsylvania alleging that a former executive...more

Settling the Discoverability of Settlement Agreements

by McDermott Will & Emery on

Settlement agreement between a co-defendant and plaintiff in a Hatch-Waxman patent litigation matter is discoverable, ruled Judge Bryson in Allergan, Inc. v. Teva Pharmaceuticals, Inc. et al., Case No. 15-1455 (E.D. Tex.,...more

Supply and Purchase Agreement Triggers On-Sale Bar Provision of 35 USC § 102(b)

by McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit reversed the district court and found that a Supply and Purchase Agreement between Helsinn and third-party MGI Pharma, Inc. (MGI) before the critical date of the asserted...more

Deuterated Drugs Are New Chemical Entities

by Pepper Hamilton LLP on

FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more

FDA accepts Celltrion/Teva BLA for biosimilar of Rituxan®

by Goodwin on

Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan®...more

Rx IP Update - June 2017

by Smart & Biggar on

Supreme Court of Canada News - SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more

Federal Court reaffirms and reissues section 8 venlafaxine judgments overturned by the Court of Appeal for hearsay

by Smart & Biggar on

As previously reported, in 2016 the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to $125 million in damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations...more

Court of Milan rules on interim measure ordering the halt of the pricing and reimbursement procedure of a generic product

by Hogan Lovells on

By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate),...more

Complex FCPA Plea Agreement Gives Federal Court Pause

by Fox Rothschild LLP on

On June 16, 2016, Teva Pharmaceutical’s Russian subsidiary (Teva LLC) pled guilty to one count of conspiring to violate the Foreign Corrupt Practices Act (FCPA). Judge Kathleen M. Williams of the United States District Court...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

FCPA: 2017 Mid-Year Review Webinar

by Bryan Cave on

Enforcement of the Foreign Corrupt Practices Act was a high priority for the Department of Justice and the Securities and Exchange Commission in 2016. There's interest in how the new administration could impact enforcement as...more

Federal Circuit Returns the On-Sale Bar to Status Quo for AIA Patents

by Latham & Watkins LLP on

Contrary to USPTO guidance, invention details need not be publicly disclosed to trigger on-sale bar for AIA patents. The Leahy-Smith America Invents Act (AIA)1 is widely considered the most significant overhaul of US...more

Ohio sues Big Pharma firms over harms of opioid drug abuse epidemic

With more than 4,000 overdose deaths last year alone and a fifth of its residents having received prescriptions for powerful painkillers, the state of Ohio has sued five Big Pharma companies, accusing them of mispresenting...more

Rx IP Update - May 2017

by Smart & Biggar on

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention

by Pepper Hamilton LLP on

The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more

Allergan, Inc. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S....more

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