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The Effect of Patents and Drug Price Regulation on New Drug Diffusion Globally

One of the great benefits of scientific inquiry is the capacity for presumptions and prejudices from experience to be challenged and explained in ways that are counter-intuitive. This is true even for disciplines like...more

Intellectual Property Newsletter -August 2016

Shearman & Sterling’s IP litigation team has published its quarterly newsletter. The newsletter covers a number of current IP topics, including a look at the America Invents Act, five years in; the U.S. International Trade...more

India’s New National Intellectual Property Rights Policy

On May 12, 2016 India published its National Intellectual Property Rights Policy (National IPR Policy) to raise awareness about the importance of IPR’s as a tool for financial and economic advancement. The mission of the...more

Brexit – Standards and Innovation: What’s Ahead?

This article is the second in an ongoing series of blog posts by Foley & Lardner LLP on the implications of the June 23, 2016 referendum decision in the United Kingdom (“UK”) to exit the European Union (“EU”). The first blog...more

Letter to Colombian President Encourages Grant of Compulsory License for Imatinib

Last month, we reported on letters sent by two Senators and fifteen Representatives to the U.S. Trade Representative, seeking clarification regarding the Administration's position on compulsory licenses. The letters were...more

Hudson Institute Report Refutes UN Panel Stance on Impact of Patents on Access to Medicines

In June, the Hudson Institute released a research report that analyzes several positions taken by the United Nations (UN) High Level Panel on Access to Medicines (HLP) on the impact of patents on global access to medicines. ...more

Advancing New Claims Under the Lanham Act

Implementing unique litigation tactics, on June 15, 2016, Foley & Larder LLP filed a complaint under Section 337 of the Tariff Act at the International Trade Commission (“ITC”) on behalf of Par Pharmaceutical and related...more

Intellectual Property and Technology News (Asia Pacific) August 2016

Intellectual Property and Technology News (Asia Pacific) is our biannual publication designed to report on worldwide developments in intellectual property and technology law, offering perspectives, analysis and visionary...more

Australian Regulators Approve Samsung Bioepis’s Etanercept Biosimilar Brenzys

On July 22, 2016, Australia’s Therapeutic Goods Administration approved Samsung Bioepis’s biosimilar of Amgen’s Enbrel (etanercept), which is approved for treatment of rheumatoid arthritis. Samsung Bioepis’s product, called...more

Inducement and Risk of Liability for Worldwide Sales

The Supreme Court of the United States agreed to review a decision by the US Court of Appeals for the Federal Circuit regarding active inducement infringement under 35 USC § 271(f)(1) in a case important to US manufacturers...more

FCPA Compliance and Ethics Report-Episode 269-Mike Volkov on the Johnson Controls FCPA Enforcement Action [Video]

In this episode Mike Volkov and I take a deep dive into the Johnson Controls FCPA enforcement action. ...more

Brexit May Stall Implementation of EU’s New Unitary Patent and Patent Court Systems

New unified patent grant and patent court systems, which were to have taken effect in early 2017, will likely be stalled because of Britain’s June vote to leave the EU, commentators and member nations fear. BACKGROUND...more

Packing Your Patent Application for Europe: Avoiding Problems Under European Patent Law

Planning an extended European vacation for your patent application? A lengthy stay in Munich with possible outings to The Hague, Berlin, Vienna, or Brussels? While your patent application won’t be strolling through the...more

Busy Week for Biosimilars Worldwide

United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is...more

Employment Law This Week: Password Sharing, Organizing Mixed Units, Mental Health Accommodations, Privacy Shield [Video]

We invite you to view Employment Law This Week - a weekly rundown of the latest news in the field, brought to you by Epstein Becker Green. We look at the latest trends, important court decisions, and new developments that...more

CJEU Confirms EU Competition Law Does Not Prevent Royalties for Revoked Patent Licences

On 7 July 2016, the Court of Justice of the European Union (CJEU) ruled that, provided that a licensee is free to terminate a licence agreement on reasonable notice, it can be obliged to pay royalties even after the patent...more

The PRICED Act Would Expedite Biosimilar Market Entry

Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more

No Waiver of Forum Selection Clause Despite Filing Declaratory Judgment Action in Non-Selected Forum **WEB ONLY**

Addressing waiver of a contractual forum selection clause, the US Court of Appeals for the Fifth Circuit affirmed a lower court’s enforcement of the clause and subsequent dismissal of a trade secrets case, finding that the...more

EU Court Rules That Royalties for Unpatented Technology Are Not Necessarily Anticompetitive

On 7 July 2016, the Court of Justice of the European Union (CJEU) handed down a judgment on whether Article 101 of the Treaty on the Functioning of the European Union (TFEU) must be interpreted as precluding effect being...more

The Brexit Effect on Medical Devices

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU). Until the breakup becomes official, British legislation should...more

Brexit: What You Need To Know - Intellectual Property

Until the UK formally leaves the EU following the triggering of Article 50, there will be no immediate change to the intellectual property (IP) regime currently governing the UK. Although the full extent of the impact on...more

Additional IP Considerations in Light of Brexit

Pharmaceutical and agricultural companies in particular should consider the effect of Brexit on their European patent portfolios. Supplementary Protection Certificates (SPCs) are governed by EU regulations and are thus...more

Deal Watch: AstraZeneca and LEO Pharma collaborate on skin drugs tralokinumab and brodalumab

AstraZeneca announced today that it has entered licensing agreements with LEO Pharma to develop and commercialize tralokinumab, a biologic that has completed a Phase IIb trial for atopic dermatitis, and brodalumab, which is...more

28 Organizations Seek Clarification from President Obama Regarding Colombian Compulsory License -- U.S. Chamber of Commerce...

On July 5, 2016, we reported on two letters sent by two Senators and fifteen Representatives to Michael Froman, the U.S. Trade Representative ("USTR"), seeking clarification regarding the Administration's position on...more

Letters from Congress Seek Clarification from USTR Regarding Position on Compulsory Licenses

Last month, we reported on a letter sent by three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination...more

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