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Indian court allows Ranbaxy to sell generic entecavir (Baraclude) for hepatitis B for now

Friday, March 26, 2010, 5:56 This news item was posted in Industry, Patents category and has 1 Comment so far.

Daiichi-controlled Ranbaxy may launch its generic version of entecavir to treat hepatitis B in India pending court case.

Ranbaxy’s entecavir is the generic version of Bristol-Myers Squibb (BMS) on-patent drug Baraclude.

The Indian Patent Office gave BMS a patent for entecavir in 2008, after the company had filed an application in 2001.

The Delhi High Court has rejected Bristol-Myers Squibb’s petition seeking to stop India’s Ranbaxy Laboratories from launching entecavir generic alleging infringement of the company’s valid patents on Baraclude.

The High Court, however, asked Ranbaxy to file a response within two weeks, reports said.

Entecavir posted global sales of $191 million for the quarter ended October 2009.

The Drugs Controller-General of India has recently approved Ranbaxy to market entecavir generic in India.

Other Indian companies such as Natco and Cipla are also planning to launch a generic version of Baraclude.

BMS can have  exclusive marketing rights for entecavir till 2021, as Indian patent laws allow 20 years of exclusive marketing rights to patent holders.

In a similar development the German drug maker Bayer has also moved Delhi high court with a petition against Indian firm Cipla alleging patent violation of its kidney cancer drug Nexavar (sorafenib tosylate).

The German drug maker had earlier approached High Court seeking an interim stay on Cipla’s prospective generic on sorafenib which is currently under regulatory review.

The Delhi High Court, which has refused to stay the generic approval, has issued notice to Cipla, in the patent infringement case, reports said.

Bayer AG then moved India’s Supreme Court. Bayer filed a special leave petition challenging Delhi High Court’s order, which had dismissed its attempt to introduce patent linkage in the country.

Indian Supreme Court has, however, rejected a plea from German drug giant Bayer AG seeking to block the marketing approval of a generic version of its patented kidney cancer drug Nexavar (sorafenib) by Cipla.

The Supreme Court only issued notices and refused to grant any interim order as sought by Bayer AG to stop Cipla from launching its drug until the court decides the case, reports said quoting legal experts involved in the case.

Bayer, which holds a 2007 patent for Nexavar in India had approached Delhi High Court appealing for an injunction to direct drugs regulator Drug Controller General of India’s (DCGI) deny marketing approval for Cipla’s generic sorafenib alleging that it amounts to the infringement of the company valid patents.

Bayer argued that Cipla’s generic sorafenib, which is branded as Soranib, if examined and granted marketing rights, will be seen as a spurious drug as per the Drugs and Cosmetics Act.

The Delhi High Court on a judgment delivered on 18th of August last year, dismissed the writ petition filed by Bayer Corporation and asked the company to pay costs amounting to Rs 6,75,000 in equal shares to the Union of India and Cipla.

Bayer again moved a petition to the divisional bench of Delhi High Court contesting that since it holds the patent for Nexavar (sorafenib tosylate) which is valid for 20 years, DCGI cannot give marketing approval for Cipla’s generic version.

Bayer argued for the need to bring in in the concept of linking patent grants under Section 48 of the Indian Patents Act to marketing approval of the drugs on Section 2 of the Indian Drugs & Cosmetics Act.

Cipla’s Soranib for which license was sought was a “spurious drug” under Section 17B of the Drugs and Cosmetics Act because Bayer is the genuine patent holder and owner of sorafenib.

Since the Drug Controller is aware of patent status of the drug (Section 18, Form 44, under Appendix 1 to Schedule Y of the Rules) granting of marketing approval to Cipla’s sorafenib would amount to contravention of Section 48 of the Patent Act.

Bayer also appealed to make it distinct that “generic drugs can only be legally produced for drugs which are free of patent protection”.

Cipla, however, maintained that the grant of marketing approval by DCGI does not amount to infringement of the patent and such violations, if any, is alleged which needs to be established in a court of law in accordance with the provisions of Indian Patent Act.

Moreover, the drug regulator is not a competent authority to decide on complex matters involving patents.

Section 107A of the Patents Act clearly exempts from patent infringement any of acts of making, using or even selling a patented invention, in so far as such acts are necessary to obtain information for the filing of a drug regulatory application before the authority, Cipla argued.

Soranib cannot be a ‘spurious drug’ under Section 17(b) as Cipla was not trying to pass of its generic version as that of Bayer’s.

The publicly funded drug regulator cannot be used to further the enforcement of the private rights of a patentee.

DCGI, on the otherhand, expressed his office’s inability to deal with complex patent issues pointing out lack of institutional expertise.

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One Response to “Indian court allows Ranbaxy to sell generic entecavir (Baraclude) for hepatitis B for now”

  1. Indian court allows Ranbaxy to sell generic entecavir (Baraclude … | Hepatitis treatements and cures said on Friday, March 26, 2010, 7:08

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