Indian Supreme Court refuses to stay Cipla’s Nexavar (sorafenib) on Bayer’s plea

Indian Supreme Court has 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, reports said.

Bayer AG moved India’s Supreme Court following the Delhi High Court’s latest verdict upholding an earlier judgment in the case.

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

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.

Indian patent law provides the patent holder exclusive marketing rights for 20 years with no competition from generic companies.

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.

DCGI powers and jurisdiction are circumscribed by the Drugs and Cosmetics Act 1940, and not by the Patents Act, the HC had ruled, dismissing the petition.

Meanwhile, Cipla said it would to launch the generic version of sorafenib within two months at less than half the price of Bayer’s Nexavar.

Nexavar costs Rs 2.85 lakh for a monthly dose of 120 tablets.

Bayer, however, can move the court if Cipla launches the drug to establish the validity of its patents on Nexavar.

Cipla launched its generic versions of anti-cancer drug erlotinib, patented by Roche and branded Tarceva, even after the Swiss company was granted product patent in India.