Prometheus Laboratories receives a terminal diagnosis from the US Supreme Court

The United States Supreme Court found last week that the claims of Prometheus’ diagnostic method patents were invalid.  The Supreme Court’s decision reversed an earlier decision of the Court of Appeals for the Federal Circuit and in so doing has provided patent applicants and challengers with some guidance on when claims to unpatentable laws of nature might be transformed into patent eligible applications of those laws.  However, the case may call the validity of certain method claims, including diagnostic method claims, into question.  Those who have such claims sh read more…

Controversial licence granted over patented cancer drug

In September last year we reported that the Indian pharmaceutical company Natco had applied for a compulsory licence to manufacture and sell (in India) a generic version of Bayer’s patented anti-cancer drug sorafenib (Nexavar).  Last week the Indian Controller of Patents published a decision granting this licence.  The Controller’s decision is significant because it is the first time a compulsory licence has been grante read more…

Justice Jagot rejects ‘manifestly absurd and unreasonable’ construction of new copyright exemption for PI documents

When Justice Jagot handed down her judgment in Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) in August this year (read our Alert here, her Honour found that Apotex’s proposed supply of a generic leflunomide product would infringe Sanofi’s patent.  Her Honour also found that Apotex had infringed the copyright in Sanofi’s leflunomide product information (“PI”).  Un read more…

Natco pushes ahead with bid to compulsorily licence anti-cancer drug from Bayer

Natco Pharma, an Indian generic pharmaceutical company, has lodged an application with the Indian Patent Office requesting the grant of a compulsory licence to produce a generic version of Bayer’s anti-cancer drug Nexavar.  If granted, this would be the first-ever compulsory licence issued by the Indian Patent Office and would set the bar for future applicants.

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Review Panel prescribes greater transparency for the TGA

Last month, the Parliamentary Secretary for Health & Ageing, the Hon Catherine King MP, released a Report into ways of improving the transparency of the Therapeutic Goods Administration.  The Review Panel held public consultations and received 118 submissions from a variety of stakeholders representing consumers, healthcare practitioners and industry, following “community concern about the lack of information made available by the TGA.

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