Search Results for Intellectual Property

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BIO Highlights IP Challenges Around the Globe By Zachary Brennan - Published 07 August 2017

As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products.

Categories: News, Africa, Asia, Middle East, Anvisa, CFDA, Biologics and biotechnology, Drugs, Government affairs

Tags: intellectual property BIO, biopharmaceutical patents, ANVISA, IP protections

Strategies Adopted by Innovator Companies in Response to Biosimilars Competition By Charu Manaktala, MD, MBBS, Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD - Published 10 April 2017

This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Biosimilars, Intellectual Property, Litigation, Patent Extension

Sovaldi Patent Rejected in China Following Third-Party Challenge By Michael Mezher - Published 19 June 2015

China's patent office has rejected a patent related to Gilead Science's blockbuster hepatitis C (HCV) drug Sovaldi.

Categories: News, China, Drugs, Government affairs, Regulatory strategy

Tags: Intellectual Property, I-MAK, Sovaldi

US, Switzerland Campaign to End 20-Year Moratorium on Non-Violation Complaints to WTO By Michael Mezher - Published 15 June 2015

At the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) meeting last week, the US and Switzerland called on the Council to end a 20-year moratorium on what are called "non-violation complaints," LiveMint reports.

Categories: News, India, Latin America and Caribbean, US, Drugs, Government affairs, Regulatory strategy

Tags: Intellectual property, Patents, World Trade Organization, TRIPS

Biologics Exclusivity Still Central in Trade Talk Debate By Michael Mezher - Published 05 June 2015

The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history.

Categories: News, Asia, Canada, Latin America and Caribbean, Oceania, US, Biologics and biotechnology, Government affairs, Regulatory strategy

Tags: Trans-Pacific Partnership, TPP, biologics exclusivity, regulatory data protection, PhRMA, intellectual property, IP, patents

WTO Reviews India's Trade Policies, Including Drug Patents, Compulsory Licensing By Michael Mezher - Published 03 June 2015

The World Trade Organization (WTO) is conducting its sixth review of India's trade policies this week.

Categories: News, India, Biologics and biotechnology, Drugs, Government affairs

Tags: Intellectual property rights, Patents, Nexavar, Compulsory license, WTO

After Court Rulings, Canada Proposes Changes to Combination Drug Requirements By Michael Mezher - Published 07 May 2015

Canada is looking to amend its Patented Medicines (Notice of Compliance) Regulations after two high-profile court rulings took a strict interpretation of the regulations that would make it more difficult to protect combination drugs under the regulations.

Categories: News, Canada, Health Canada, Active pharmaceutical ingredients, Combination products, Generic drugs, Prescription drugs, Government affairs, Submission and registration

Tags: Notice of compliance, Patented medicines, Intellectual property, Combination drugs

After Being Sued for Patent Infringement, Cipla Offers to License Novartis Drug By Michael Mezher - Published 29 April 2015

In the midst of arguments before a prominent court in India, generic drug maker Cipla has offered to pay a "reasonable" royalty to Swiss multinational Novartis, The Economic Times reports.

Categories: News, India, Drugs, Government affairs

Tags: Patents, Intellectual property, Trademark, Delhi High Court, Cipla, Novartis

Indian Court Sides with Merck in Patent Dispute By Michael Mezher - Published 23 March 2015

A prominent court in India has issued an interim injunction, overturning a previous ruling, in favor of US drug maker Merck in a patent dispute with Glenmark Pharmaceuticals over an active ingredient used in two of Merck's diabetes medicines, Januvia and Janumet.  

Categories: News, India, Active pharmaceutical ingredients, Drugs, Regulatory strategy

Tags: Intellectual Property, Patents, Delhi High Court, Merck, Glenmark, Januvia

Bayer, Boehringer Latest to be Hit by Indian Patent Office Decisions By Michael Mezher - Published 11 March 2015

In two recent decisions, India’s patent office struck major blows to German drug makers Bayer and Boehringer Ingleheim, saying their respective patents for Nexavar and Spiriva fail to meet the inventiveness requirements under the country’s controversial Patents Act.

Categories: News, India, Drugs, Government affairs, Regulatory strategy

Tags: Intellectual Property, Patents, Nexavar, Spiriva, India Patent Office, Bayer, Boehringer

Trade Group Wants to See Stricter Limits on Compulsory Licensing By Michael Mezher - Published 02 March 2015

A US-based trade group wants to see the United States Trade Representative (USTR) pursue stricter limits on the ability of countries to bypass patent protection. In its Special 301 Submission 2015, the Pharmaceutical Research and Manufacturers of America (PhRMA) argues that compulsory licenses should only be issued in “exceptional situations,” where there is a pressing public health need.

Categories: News, Asia, Europe, Latin America and Caribbean, US, Drugs, Government affairs, Regulatory strategy

Tags: Compulsory License, TRIPS, Intellectual Property, PhRMA, US Trade Representative

Trade Talks Stumble Over Biologics Data Exclusivity By Michael Mezher - Published 11 February 2015

Trade officials from around the world are potentially just months away from completing what would be the largest free-trade deal in history, but the completion of that deal is reportedly struggling to get past an issue related to the regulation of biologics.

Categories: Japan, Canada, Latin America and Caribbean, Oceania, US, Biologics and biotechnology, Government affairs, Regulatory strategy

Tags: Trans-Pacific Partnership, TPP, intellectual property, patents, regulatory data protection, data exclusivity, USTR, Michael Froman

US, India Commit to ‘Collaboration’ in Health Sector By Michael Mezher - Published 26 January 2015

The governments of the US and India released a joint statement affirming the two countries’ commitment to work together in a number of key areas, including intellectual property rights and healthcare-related trade. The statement comes after US President Barack Obama met with Indian Prime Minister Narendra Modi during with India’s his visit coinciding 66th Republic Day celebrations.

Categories: News, India, US, CDSCO, FDA

Tags: Intellectual Property, US-India Collaboration

New Chinese Patent Rules Could Make Country Compulsory Licenser to the World By Alexander Gaffney - Published 12 June 2012

Categories: China

Tags: Intellectual Property, Patent System, Compulsory License, CL, Latest News, Patent