IN THE HIGH COURT OF DELHI AT NEW DELHI
PRADEEP NANDRAJOG & MUKTA GUPTA, JJ.
F. Hoffmann La Roche Limited & Another – Petitioners
Versus
Cipla Limited – Respondent
R.F.A. (OS) Nos. 92 & 103 of 2012
Decided On : 27.11.2015
PRADEEP NANDRAJOG & MUKTA GUPTA, JJ.
1. Though at first blush the plot and premise of the Roche vs. Cipla dispute appears to be straightforward - Roche claims that on March 31, 1991, it filed an application for grant of patent in USA pertaining to Erlotinib Hydrochloride, resulting in grant of patent US 498 on August 05, 1998. During pendency of its application in USA, on March 13, 1996 it filed an application in India for grant of patent for the same molecule which was granted to it vide in 774 on February 23, 2007. The marketable physical form of the molecule comprised polymorph A and B. Further research revealed that polymorph B was more thermodynamic and as per Roche would qualify for enhanced efficacy and thus on November 09, 2000 it applied for grant of patent for polymorph B of Erlotinib Hydrochloride in USA resulting in grant of patent US 221. Similar application filed in India on February 06, 2002 i.e. Del 507 was rejected. As per Roche, in 774 granted in February 2007 by the Controller of Patents, per Claim No. 1, covered patent rights over Erlotinib Hydrochloride molecule which has demonstrated breakthrough capabilities as an Epidermal Growth Factor Receptor (EGFR) inhibitor which spiked survival benefit in cancer including non-small cell lung cancer (NSLC) patients.
2. The issues which were finally debated before us in the appeal had various hues. The marathon hearings have resulted in both of us having before us several pages of manuscripts, bearing encouraging and tactful notes penned by us, as learned counsel Sh. Pravin Anand who appeared for Roche and Sh. Arvind Nigam, Senior Advocate and Ms. Pratibha M. Singh, Senior Advocate who appeared for Cipla laboured through the case law, the provisions of the Patents Act, 1970 as amended from time to time, the pleadings of the parties, the various documents exhibited at the trial and the deposition of the witnesses of the two parties. We therefore begin by adequately thanking them in rendering valuable assistance. We are especially indebted to them for their uniform generosity and kindness shown to us with the most heroic reserve of patience in answering one simple but endlessly repeatedly question. But could you explain that again?
3. The endless labour by learned counsel, apart from making us understand the nuances of the law of patent, made us aware of something probably never highlighted about the Carbon atom. In the atomic world it would be the party animal, latching on to any atom it finds around it, including itself, and holding tight, forming molecular change the very trick of nature necessary to build proteins and DNA.
4. Claiming that it was based on media intelligence declaring Ciplas intention to launch a generic version of Roches drug based on in 774, in January 2008, Roche moved this Court on its original side seeking to injunct Cipla from marketing Erlocip.
5. Roches plea for interim injunction against Cipla was dismissed by a learned Single Judge of this Court on March 19, 2008, reported as F. Hoffman-La Roche vs. Cipla Limited, (2008) 37 PTC 71 (Del) with a fascinating characterization of the public interest involved in, and the life-saving nature of, the drug in question playing a large part in the evaluation of the imponderables.
6. Roches appeal to the Division Bench of this Court against the order passed by the learned Single Judge was dismissed on April 24, 2009, on the back of a heavily public interest-centric reading of the Patents Act, 1970 as amended from time to time, and a detailed discussion of the relative affordability of the two drugs to the common man and the decision is reported as F. Hoffman-La Roche vs. Cipla Limited, (2009) 40 PTC 125 (Del).
7. On the substantive legal issues, the Division Bench felt that Cipla had done enough to demonstrate a potentially credible challenge to the validity of in 774, including raising su
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