Search Results for patents

Showing 1 – 22

European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs By Zachary Brennan - Published 19 October 2017

The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Supplementary Protection Certificate, Bolar exemption, research exemption, pharmaceutical patents

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

US Supreme Court to Consider Biosimilar Patent Process Next Week By Zachary Brennan - Published 20 April 2017

The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Ethics, Government affairs

Tags: biosimilars, Amgen, Sandoz, patents

EU Pharma Patent Settlements Still Limiting Entry of Generics By Zachary Brennan - Published 13 December 2016

Almost three-quarters of 125 patent settlements in the EU between originator pharmaceutical and their generic competitors resulted in a lengthening of time to bring the cheaper generic version to market.

Categories: News, Europe, EC, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, patent settlements with generic drugs

Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? By Zachary Brennan - Published 17 August 2016

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, pharmaceutical IP, generic drugs, ANDA approval process

How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives By Zachary Brennan - Published 16 May 2016

The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent.

Categories: News, US, FDA, Drugs

Tags: Merck KGaA, Bayer, Beyaz, contraceptives, fax machine, drug patents

European Commission Clears First Enbrel Biosimilar Ahead of US By Zachary Brennan - Published 18 January 2016

The European Commission over the weekend signed off on the first biosimilar for Amgen’s blockbuster rheumatoid arthritis treatment Enbrel, a version of which is also making its way through a separate review by the US Food and Drug Administration (FDA).

Categories: News, Asia, Europe, US, EC, EMA, FDA, MFDS, Clinical, Due Diligence, Submission and registration

Tags: Enbrel, anti-TNF, MFDS, Amgen patents

US, EU Face Off Over Permanently Exempting Least-Developed Countries from Pharma Patents By Zachary Brennan - Published 14 October 2015

Tomorrow and Friday, members of the World Trade Organization (WTO) will meet to discuss whether the world's poorest countries should be permanently exempt from rules governing pharmaceutical patents, and the EU and US have publicly taken separate sides.

Categories: News, Africa, Asia, Canada, Europe, US, EC, WHO, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence

Tags: WTO, TRIPs, LDCs, pharmaceutical patents, European Commission

Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection By Zachary Brennan - Published 08 October 2015

Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies.

Categories: News, Europe, EC, Biologics and biotechnology, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: CJEU, pharma patents, SPCs, Seattle Genetics, Austrian Patent Office, marketing authorization

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 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 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

Follow the Rules, Indian Court Tells Patent Office in Sovaldi Case By Michael Mezher - Published 04 February 2015

A prominent Indian court has ruled that India's patent office erred when it invalidated a patent application owned by the pharmaceutical company Gilead, giving the company another chance to save its patent on the hepatitis C drug Sovaldi while the patent office revisits the application.

Categories: News, India, Prescription drugs, Government affairs, Regulatory strategy

Tags: Delhi High Court, Patents, Sovaldi, sofosbuvir, Gilead

Indian Court Sides with Gilead in Patent Dispute By Michael Mezher - Published 02 February 2015

The Delhi High Court has ruled that India’s patent office failed to follow proper procedures in evaluating Gilead’s patent application, LiveMint reports. The ruling invalidates the Patent Office’s recent decision to reject Gilead’s patent application for one of the active metabolites of its hepatitis C drug Sovaldi.

Categories: News, India, CDSCO, Generic drugs, Prescription drugs, Government affairs, Regulatory strategy

Tags: Delhi High Court, Sovaldi, Patents

Landmark Ruling Clears Way for Use of Compulsory License in India By Alexander Gaffney - Published 18 September 2012

Categories: India

Tags: Compulsory License, natco, Patents, Bayer, Latest News

Brazil: Anvisa Issues New Technology Transfer Regulation for Local Companies By Louise Zornoza, RegLink - Published 14 September 2012

Categories: Regulatory Update, Anvisa

Tags: Imports, Transfer Regulation, Exports, Patents, pharmaceutical, brazil, drug

Senator Looks to Spur Development of Medicines Through 'Prize Fund' By Alexander Gaffney - Published 15 May 2012

Tags: Hatch-Waxman, Prize Fund, Sanders, AIDS, HIV, Patents, Latest News, Senate, Congress, innovation

PLoS: Pressures on Doha Declaration Signatories Preventing Overuse of Compulsory Licenses By Alexander Gaffney - Published 12 January 2012

Tags: Middle-Upper-Income Countries, MUIC, CL, Patents, Compulsory Licenses, Doha Declaration, Latest News