News & Analysis as of

Teva Pharmaceuticals

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

The Federal Circuit’s First Application of the AIA’s On-Sale Bar: Implications for Bio/Pharma

When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner...more

Deal Watch: Teva Signs Agreement with Otsuka for Exclusive Rights to Migraine Antibody in Japan

by Goodwin on

Otsuka announced today that it has agreed to pay Teva $50 million and later milestone payments for the exclusive rights to develop and commercialize Fremanezumab in Japan. Fremanezumab, which targets the calcitonin...more

When Is Telling Someone You Have A Secret Revealing Too Much?

by Strasburger & Price, LLP on

Of course, telling someone that you have a secret is not the same as telling them what the secret is. Still, someone now knows that you have a secret. This has turned out to be an important concept for the “on-sale bar rule”...more

Helsinn v. Teva and the Status Quo: The Federal Circuit Opines on the Scope of the AIA's On-Sale Bar

by Faegre Baker Daniels on

In a case of first impression, the Federal Circuit recently interpreted the scope of the “on sale” bar under 35 U.S.C. § 102(a)(1) of the America Invents Act (AIA). In Helsinn Healthcare v. Teva Pharmaceuticals, the court...more

Fed. Cir. in Helsinn v. Teva Declines Limiting the Requirements of the “On Sale” Bar

In Pfaff v. Wells Electronics, 525 US 55 (1988), the Supreme Court attempted to focus the factors invoking the on-sale bar of s.102, by holding that the claimed invention must both be the subject of a “commercial sale”...more

Federal Circuit applies pre-AIA interpretation of on-sale bar to the America Invents Act

by Dentons on

In a much-anticipated ruling, Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., a three-judge panel of the US Court of Appeals for the Federal Circuit concluded that the on-sale bar provision under the America Invents...more

Public Sales Remain Prior Art After AIA Even Without Disclosing Invention

by Dorsey & Whitney LLP on

Public sales which do not themselves disclose an invention nonetheless continue to be available as prior art events after the America Invents Act (AIA). Innovators must file US patent applications within one year of any sale...more

Federal Circuit Clarifies Post-America Invents Act “On-Sale” Bar Based on Publicly Announced Sale Agreements: Invalidates Four...

by Dickinson Wright on

On May 1st, the Federal Circuit ruled that the America Invents Act (AIA) did not change the statutory meaning of “on sale” where the existence of a sale was publicly announced prior to patenting, even if the sale did not...more

Eli Lilly and Co. v. Teva Parenteral Medicines, Inc.

by Robins Kaplan LLP on

Case Name: Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., No. 2015-2067, 2017 U.S. App. LEXIS 555 (Fed. Cir. Jan. 12, 2017) (Circuit Judges Prost, Newman, and Dyk presiding; Opinion by Prost, C.J.) (Appeal from S.D....more

Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

by Polsinelli on

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787...more

Celltrion May Apply for FDA Approval for Rituximab and Trastuzumab by June

by Goodwin on

The Korea Herald reports that Celltrion is on track to file applications for U.S. FDA approval for its rituximab and trastuzumab biosimilars by June. According to the article (and as previously reported), once approved, the...more

Teva awarded section 8 damages regarding pregabalin and olanzapine

by Smart & Biggar on

On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”) regarding pregabalin (Pfizer’s LYRICA)...more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Just How Predictable Must the Invention Be to Lose Patent Protection? Depends on the Inventive Concept

by Bennett Jones LLP on

Only a true invention can be patented; a patent claim to an invention is not valid if the invention was obvious. Assessing obviousness can be thought of as bridging the gap between two cliffs: on one side is the existing...more

Top bribery and corruption developments in 2017 for ADG companies

by Hogan Lovells on

In recent years, U.S. and Western European military spending has decreased as military spending in other parts of the world has risen. As a result, aerospace, defense and government services (ADG) companies increasingly rely...more

Practice Tips for Patentees Asserting Method-of-Treatment Claims Involving Divided Infringement

by WilmerHale on

Do physicians ‘‘condition participation’’ of drug therapy based on patients’ compliance with drug manufacturer instructions regarding how to take drugs? Do physicians withhold medically necessary drug therapy from patients...more

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