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International Trade Health Intellectual Property

Read need-to-know updates, commentary, and analysis on International Trade issues written by leading professionals.

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

by Fish & Richardson on

Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more

Limiting Extraterritorial Reach of U.S. Patents: "Substantial" Means More than One

by Foley Hoag LLP on

Last week, the Supreme Court provided much-needed clarity to U.S. companies concerned about their potential liability for supplying a single component of a multicomponent invention abroad. The Court’s decision in Life...more

News from Abroad -- Swiss-style Patent Claims Can Be Very Valuable in Australia

The scope for enforcement of Swiss-style claims may be broader in Australia than for method of medical treatment claims. Second medical use inventions can be claimed in an ever increasing number of claim formats depending on...more

Rx IP Update - February 2017

by Smart & Biggar on

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

Hurdles for Neulasta Biosimilars

A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far...more

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

Rx IP Update - December 2016

by Smart & Biggar on

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

News from Abroad: Antibodies in the European Patent Office

The European Patent Office (EPO) continues to grant many patents relating to antibodies, and in doing so applies the same patentability criteria as to other inventions. However, some commentators have suggested that...more

Stopping The Sale of Gray-Market Medical Devices

by Burns & Levinson LLP on

On November 3, 2016, the US Court of Appeals for the Second Circuit approved an injunction against about 200 importers and sellers preventing them from importing and selling gray market blood-glucose test strips. The case was...more

Rx IP Update - November 2016

by Smart & Biggar on

Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more

U.S. Biosimilars Pathway Under Trump

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies...more

CETA Implementation in Canada - Implications of Bill C-30 on the Pharmaceutical Industry

by DLA Piper on

Bill C-30 presents significant changes to Canada’s pharmaceutical landscape by introducing supplementary protection for pharmaceutical products and proposing substantial modifications to the Patented Medicines (Notice of...more

The Oman Update - 1162

by Dentons on

Amending MD 174/2014 Issuing the regulations on the work of establishments and companies that operate in contracting. Issued on 31 August 2016. Effective from the day after the date of publication....more

Samsung Bioepis Biosimilars Update

by Goodwin on

According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel®...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

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

Will the USPTO’s “Patents 4 Patients” Program Even Make It Off the "Cancer Moonshot" Launch Pad?

by Fenwick & West LLP on

The White House recently announced the Cancer Moonshot Task Force, an effort to “focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement...more

The Supreme Court - June 2016 #4

by Dorsey & Whitney LLP on

The Supreme Court of the United States issued decisions in three cases on June 16, 2016: Universal Health Services, Inc. v. United States ex rel. Escobar, No. 15-7: Yarushka Rivera, a teenage beneficiary of...more

Colombian Organizations Send Letter to CEWG Regarding Imatinib Compulsory License

In letter from three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) (posted on the...more

Public Health Organizations Urge Congress to Reject Trans-Pacific Partnership Agreement

In a letter sent to members of Congress earlier this month, 58 public health organizations urged Congress to reject the Trans-Pacific Partnership (TPP) in its current form, stating that the coalition was "alarmed by the...more

U.S. Market Entry for the German Healthcare IT Company

by Arnall Golden Gregory LLP on

The healthcare market in the United States is massive, with total spending in excess of $3 trillion. Federal government incentives for the adoption of electronic health records has resulted in an increasingly interoperable...more

European Life Sciences Review: Issue 2

by Morgan Lewis on

Welcome to the second issue of our EU life sciences alerter that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

International News: Focus on Tax - Issue 3, 2015

by McDermott Will & Emery on

The breadth of the articles contained in our Focus on Tax this issue demonstrates the perennial importance of this topic to global businesses and international high net worth individuals. We examine topics ranging from...more

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