Policies & Legislation
Indian high court allows sitagliptin generics
In the latest development in Merck Sharp and Dohme’s (MSD’s) court case over the patent infringement of its diabetes drugs, an Indian high court has refused to grant interim relief to MSD, thus allowing generics to remain on the Indian market.
Indian Supreme Court rejects Glivec patent
On 2 April 2013, the Supreme Court of India rejected drugmaker Novartis’ seven-year battle to patent its cancer drug Glivec (imatinib mesylate), ruling that the drug was not a new invention.
US FTC sides with generics makers over drug samples
The US Federal Trade Commission (FTC) has come out in support of generics companies trying to get hold of brand-name drugs in order to make generic versions.
Brand-name drug and generics makers fight to save pay-for-delay
Brand-name drug and generics manufacturers are joining forces to fight against the US Federal Trade Commission (FTC) in the case of reverse patent settlements or ‘pay-for-delay’, as the FTC terms these deals.
US state biosimilar substitution bill becomes law
On 21 March 2013, the US State of Virginia signed into law a legislation allowing for the substitution of biosimilars, but with many restrictions, making it the first US state to introduce such legislation. Brand-name biologicals manufacturers have praised the law as putting patients first, but the generics industry has accused it of pre-empting FDA guidance.
Evergreening patents may make drugs too costly for patients in Thailand
Many medicines will become too expensive for patients in Thailand in the near future if the government allows manufacturers to extend patents under the so-called ‘evergreen system’.
Biosimilars bills move on in two US states
The battle over biosimilar drugs is heating up in the US, with two states moving biosimilar bills along in the substitutability of biosimilars.
EU API law causing concern among API producers
Under the Falsified Medicines Directive the European Union (EU) is introducing new rules for importing active pharmaceutical ingredients (APIs) for human-use medicines into Europe. From 2 January 2013, all imported APIs were required to have been manufactured in compliance with standards of GMP at least equivalent to the EU’s GMP and as of 2 July 2013 this compliance must be confirmed in writing by the competent authority of the exporting country. Alternatively, the country may request listing (on the ‘white list’) if the country’s rules for GMP are equivalent to those in the EU before the EU will grant entry of the API.
Tighter EU rules on pharmacovigilance for biologicals
Last updated: 11 March 2013
The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilars and automatic substitution by pharmacists.
MEPs adopt directive to give quicker access to generics
Members of the European Parliament (MEPs) have adopted the text of the Transparency Directive 2012/0035(COD) by a large majority in a plenary session of the parliament on 6 February 2013.
