International Trade Intellectual Property Health

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Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Amendments in Kazakhstan’s medicinal products registration system: new hope for rights holders

In January and June 2015 Kazakhstan’s legislation was amended in order to protect the interests of developers of new pharmaceuticals and apparatus used in healthcare....more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

European Competition Law Newsletter – August 2015

Continuing an EU-wide trend, yet another trade association has been fined in the UK for cartel activities. This time it was a medical professionals’ association. The message is clear; trade associations of all types need to...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

Can My U.S. Company Offer Online Second Opinions in China?

This post is the sixth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market. As U.S. companies continue...more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

Legal and Ethical Risks of Healthcare Businesses in China

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

Australian High Court confirms that methods of medical treatment of the human body are patentable inventions

On 4 December 2013, the High Court of Australia handed down a decision confirming that methods of medical treatment can fall within the scope of patentable subject-matter....more

BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics

Last month, in a letter to the U.S. Trade Representative, Ambassador Michael Froman, Biotechnology Industry Organization (BIO) President and CEO James Greenwood expressed support for the efforts of the Obama Administration to...more

Breast Cancer Patents Research - Myriad Genetics in US | Trastuzumab in India | Angelina Jolie's Mastectomy

Breast Cancer – Patents Introduction: Breast cancer is a malignancy that effects women across the world and is most prevalent among various types of cancers. Patents are jurisdiction specific exclusive rights that are...more

News from Abroad: Bill to Diminish Term of Patents for Medicaments

Originally published in Olivares & Cia. on March 4, 2013. In January, the Mexican Senate published a Bill adding article 23 bis to the Industrial Property Law (IP Law). This Bill intends to establish a "special" life...more

January 2013: European Litigation Update

The European Court of Justice (ECJ) on European Supplementary Protection Certificate (SPC) for Further Medical Uses: With a remarkable ruling from July 2012 (Neurim Pharmaceuticals, C-130/11), the European Court of Justice...more

China Trade Marks – Inclusion of Retail and Wholesale services relating to medicines and pharmaceuticals

The China Trade Marks Office (CTMO) recently announced that from 1 January 2013 it is accepting applications to register trade marks in relation to retail or wholesale services for pharmaceutical, veterinary and sanitary...more

China Issues Human Genetic Resources Management Regulations

Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the...more

"The Global Competition Landscape: A Conversation With Sharis Pozen"

Skadden recently welcomed Sharis A. Pozen, former Acting Assistant Attorney General of the Antitrust Division of the U.S. Department of Justice, as a new partner in the firm’s Washington, D.C. office. Sharis discusses her DOJ...more

Russia's Accession to the WTO: Benefits and Risks

On August 22, 2012, the World Trade Organization welcomed Russia as its 156th member. As a result, Russia will lower its tariffs on imports of goods across all sectors of the economy and will reduce trade barriers. This will...more

China 20/20 Legal and Regulatory Developments - April 27, 2012

In This Issue: - Measures to Supervise Overseas Investments of Central Enterprises - Provisions Governing Overseas Manufacturers of Imported Food - China to Amend Measures for Foreign Invested Medical...more

"Skadden's 2012 Insights, January 2012: Global Litigation"

In This Issue: - 58 U.S. Supreme Court Cases to Watch - 59 Securities Litigation: Recent Supreme Court Decisions and Future Trends - 66 Continued Step-up in Government Investigations and White Collar Crime...more

WTO Accession of the Russian Federation - Implications for Pharmaceuticals and Medical Devices

Russia’s accession to the World Trade Organization (WTO) will create opportunities to increase exports of pharmaceutical products and medical devices. On 16 December 2011, WTO Members accepted the terms of the Russian...more

Trade Remedies Are Being Used to Combat Imports of Infringing Medical Devices

Medical device cases are being filed with increasing frequency at the U.S. International Trade Commission (ITC) to combat infringing imports. In particular, owners of intellectual property rights on medical devices regularly...more

Patent Opposition in India: Recent Trends

Therefore, as may be seen, the two-stage patent opposition process has particularly affected the pharmaceutical industry, as the patent applicants are now vulnerable to multiple pre-grant oppositions filed by competitors, or...more

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