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

Approved Biosimilar Products Around The world

Please see full chart below for approved biosimilar products around the world. ...more

Biosimilar Uptake and Patent Litigation in Japan

Biosimilar uptake in Japan has been a bit mixed, but according to experts the volume shares of biosimilars suggests it could be a key market in years to come. The Pharmaceuticals and Medical Devices Agency (PMDA), which is...more

Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

[Webinar] Post-Sales Restrictions After Impression Products v. Lexmark - August 2nd, 10:00am PT

The United States Supreme Court recently decided that a patent owner’s authorized sale of a patented item exhausts all patent rights to that item in Impression Products v. Lexmark International. Although this forecloses...more

US Supreme Court Says No to Post-Sale Restrictions Under Patent Law

by Latham & Watkins LLP on

The Court also holds that patent exhaustion applies to both foreign and domestic sales in a historic decision. Key Points: ..Patent rights are exhausted by sale even if the patentee purports to impose post-sale...more

EU Regulation on Cross-Border Portability of Online Content Services in Force

by Reed Smith on

After publication in the Official Journal of the European Union, Regulation (EU) 2017/1128 of the European Parliament and of the Council of 14 June 2017 on cross-border portability of online content services in the internal...more

DSM Watch: On your marks! Deadline for EU online Portability Regulation compliance is 20 March 2018

by Hogan Lovells on

In our 21 June blog we reported that the text of this, the first legislative proposal published by the Commission under the Digital Single Market strategy banner, had been finalised by the European Parliament and Council. ...more

[Webinar] Venue and Exhaustion: Practical Effects of TC Heartland and Lexmark - July 26th, 10:00 am China, CST

The U.S. Supreme Court recently issued highly anticipated opinions in two patent cases, both of which may have a profound impact internationally....more

Global Patent Prosecution Newsletter - July 2017

Biosimilars Around the World - Last month’s Supreme Court ruling in Sandoz v. Amgen brought greater certainty to both biosimilar applicants and originators in the United States. The July 2017 issue of Sterne Kessler’s...more

Clarifying or Conforming? The EPO Bows to the European Commission

by Jones Day on

In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more

Bioverativ Files ITC Complaint Against CSL’s Idelvion® Alongside District Court Infringement Suit

by Goodwin on

In an earlier post, we discussed the recent rise in Section 337 proceedings against pharmaceutical products and medical devices at the International Trade Commission. Last week, Bioverativ, which markets the recombinant...more

Actavis v. Eli Lilly1: Back to the future - The UK Supreme Court changes the test for patent infringement

by WilmerHale on

The UK Supreme Court rarely hears patent cases, and will only hear cases that it considers to be fundamentally important. The court's July 12 judgment is most significant for changing the test for infringement in the United...more

Conviction for Economic Espionage, Sale of Trade Secrets to China

by McDermott Will & Emery on

The US Court of Appeals for the Ninth Circuit upheld the first federal jury criminal conviction for economic espionage and theft of trade secrets under the Economic Espionage Act of 1996 (EEA), even though the owner of the...more

EMA’s Issues Statement of Non-Compliance for Biocon’s Biosimilar Manufacturing Facility

by Goodwin on

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, and they have filed applications for marketing authorization in the European Union for three biosimilar products: Fulphila...more

New EPO Rules For Patenting Plants and Animals

The EPO has clarified its approach to the patentability of plants and animals by making changes to its rules. Article 53(b) EPC derives from an EU Directive (Article 4(1) of Directive 98/44 EC) and excludes from...more

Brussels Regulatory Brief: July

by K&L Gates LLP on

On 10 May 2017, the European Commission (“Commission”) published its final report (“Report”) concluding a wide-ranging two-year long inquiry into e-commerce (“Inquiry”). During the Inquiry – which was conceived as part of the...more

3M Seeks Order Blocking Unlicensed Shielded Ribbon Cables From U.S. Market

by McGuireWoods LLP on

In a recent ITC Section 337 patent complaint, 3M asked the U.S. International Trade Commission (ITC) to start an investigation concerning "Certain Shielded Electrical Ribbon Cables and Products Containing the Same" against...more

Board of Trustees of the Leland Stanford Junior University v. Chinese University of Hong Kong (Fed. Cir. 2017)

Detection of paternal cell-free fetal DNA (cffDNA) in maternal blood (the technology at issue in Ariosa v. Sequenom) was in a different incarnation the subject of an interference between professors at two universities; the...more

Digital Single Market: “DSM in 5 minutes” – Brochure

by Hogan Lovells on

In this brand-new publication, our pan-European DSM Taskforce helps you plan for the changes by providing an overview of the Commission’s Digital Single Market strategy; what the key legislative measures will bring about and...more

China's State Secret Laws: Five Unique Risks for Working With SOEs

by Kobre & Kim on

Despite opening its borders, the Chinese state still controls certain industries through majority or sole ownership. To participate in these industries, multinational companies must often set up equity or contractual joint...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

Intellectual Property and Technology News (Asia Pacific) June 2017

by DLA Piper on

Welcome to the latest Asia Pacific Edition of the Intellectual Property and Technology News, our biannual publication designed to report on worldwide developments in intellectual property and technology law, offering...more

[Webinar] What TC Heartland Means for Your Business: Practical Strategies For The Next Era Of Patent Litigation - June 29th,...

by BakerHostetler on

This timely webinar will provide insight for business leaders and legal counsel on the implications of the recent U.S. Supreme Court decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, which has reshaped procedural...more

The Supreme Court Clarifies Patent Rights After a Patented Item is Sold

by Miles & Stockbridge P.C. on

On May 30, 2017, in Impression Products, the U.S. Supreme Court ruled that a patent owner’s sale of an item, either within or outside the United States, exhausts all of the patent owner’s patent rights in that item,...more

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

One-E-Way, Inc. v. ITC, Fed. Cir. Case 2016-2105 (June 12, 2017) - A divided panel reverses a determination of indefiniteness by the ITC, ruling that under Nautilus, the claim language, in combination with the...more

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