Strata

Application refused, among other grounds under section 3(d): the beta-crystalline form was a new form of a known substance without enhanced efficacy.

Section 3(d) upheld against the challenge that it was vague and arbitrary under Article 14; the Court declined to decide its compatibility with TRIPS.

The invention was found novel and inventive, but the refusal was upheld under section 3(d).

Beta-crystalline imatinib mesylate fails section 3(d). For a medicine, ‘efficacy’ means therapeutic efficacy, and physical properties such as better flow or bioavailability alone do not show it.

India’s first compulsory licence, for sorafenib tosylate: all three grounds in section 84(1) were found made out. Royalty set at 6 per cent.

Application for a compulsory licence rejected: no prima facie case that BDR had made reasonable efforts to obtain a voluntary licence.

The licence upheld; the royalty raised to 7 per cent.

Bayer’s writ petition dismissed; the compulsory licence stands.

Special leave petition dismissed.

Application for a compulsory licence rejected.

Interim injunction against Cipla’s generic erlotinib refused; the public interest in access to an affordable life-saving drug weighed in the balance.

Roche’s appeal dismissed; refusal of the interim injunction upheld.

After trial: the patent was held valid, but Cipla’s product (the polymorph B form) was held not to infringe it.

Injunction granted against Glenmark’s sitagliptin products.

Reversed on infringement: Cipla’s erlotinib was held to infringe Roche’s patent.