Life Sciences | Country Update



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  • Supreme Court’s Caraco ruling signals need for FDA fix

    April 18, 2012

    The US Supreme Court has once again reversed the Federal Circuit in a case some hope may result in the Food and Drug Administration clarifying its guidelines on use codes filed with new drug applications

  • Merck wins interim relief against Teva

    March 19, 2012

    The High Court in London has granted an interim injunction against Teva to stop it launching a generic version of efavirenz, even though Teva had done nothing more than get market authorisation

  • More compulsory licence applications to come in India

    March 19, 2012

    A senior figure within India’s generic drugs industry says that more domestic companies are waiting to file applications for compulsory licences over patented pharmaceuticals

  • What now for compulsory licences?

    March 12, 2012

    Today India has granted its first compulsory licence over a drug. But what of other countries that have used the IP system to make it easier for patients to access medicines?

  • Analysis: India issues first compulsory drugs licence

    March 12, 2012

    In one of his final tasks before leaving the job, the outgoing head of India’s patent office has issued the country’s first compulsory licence over a drug since India began protecting pharmaceutical products seven years ago

  • Bayer loses patent in Indian compulsory licence

    March 12, 2012

    India’s Controller of Patents has issued a compulsory licence over a cancer-treating drug, sorafenib, whose patent is held by Bayer

  • How Myriad could affect agriculture

    March 01, 2012

    As patent owners in the personalised medicine sector wait to see if the Supreme Court will hear the Myriad gene patent case, other industries are bracing themselves for unintended consequences

  • Why the Myriad case is on hold

    March 01, 2012

    The Supreme Court was set to decide whether to grant the Association for Molecular Pathology’s petition to hear its gene patent case against Myriad last Monday, but Mayo v Prometheus could be holding things up

  • The US approach to biosimilars explained

    February 15, 2012

    The FDA’s draft guidance for biosimilars has provided some clarity for biosimilar applicants and innovator biologic companies. But lawyers say many questions remain

  • EU-India negotiations prompt patent protests

    February 13, 2012

    The latest round of negotations between the EU and India over a free-trade agreement was disrupted by protests over the way the IP clauses in the deal could affect access to medicines in developing countries

  • Patent cliff prompts generics to rethink branding

    January 31, 2012

    As more blockbuster drugs tumble off the patent cliff this year, the generic industry is set to become more profitable than ever - but the spike in competition means generics may also have to become more brand-savvy

  • France undermines pharma marks

    January 20, 2012

    A new law has come into force in France that will allow generic drugs companies to copy the colour and shape of drugs made by branded pharmaceutical companies

  • Will the Supreme Court rule on gene patents?

    December 12, 2011

    The Association for Molecular Pathology has asked the US Supreme Court to consider whether isolated DNA sequences are patentable under US law

  • Reaction: what the Supreme Court’s questions mean for Prometheus

    December 12, 2011

    The questions asked by the Supreme Court last week in Mayo v Prometheus have led to speculation that the justices might disagree with the Federal Circuit’s application of last year’s ruling in Bilski v Kappos to this case

  • Gene patents safe down under

    November 25, 2011

    The Australian government has rejected a ban on gene patents but proposed adding an ethical test to the Patents Act that could cause IP owners some headaches

  • Mayo: Supreme Court case is about how far patents can go

    November 11, 2011

    Mayo Clinic is not asking the US Supreme Court for an “exotic” application of Section 101, and the personalised medicine industry will be fine without patents like that owned by Prometheus, the company’s counsel told Managing IP on Thursday

  • Arguments take shape in Mayo v Prometheus

    November 11, 2011

    With just one month to go before they present their arguments to the judges of the highest US court, the parties in Mayo v Prometheus have filed their briefs and interested parties are also making their views known

  • Conference report: The IP counsel/ investor divide

    November 07, 2011

    “Despite the fact that we may have the utmost confidence in your patent estate, just settle.” That was how one investor advised IP counsel in the pharmaceutical and biotech industries

  • Patent offices to revise stem cell guidance post-Brüstle

    November 02, 2011

    Patent offices in Europe are considering whether to change their approach to the patenting of stem cell-related inventions following a Court of Justice ruling last month

  • Court clarifies plant variety exhaustion

    October 27, 2011

    The owner of a plant variety right can bring an infringement action against a third party that has obtained material from a licensee, if the licensee has contravened the licence “to the extent that the conditions or limitations in question relate directly to the essential features of the Community plant variety right concerned”

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