Monday, September 10, 2012

Roche-Cipla Judgment: A Primer

A dear friend and well-wisher of the blog has shared with me a copy of the Roche-Cipla judgment which runs into 275 pages. The copy of the judgment is now available on the Delhi High Court’s website here.

1. OSI Pharmaceuticals Inc. owns the Indian patent IN196744 along with Pfizer products Inc on “Human Epidermal Growth Factor Type-I/Epidermal Growth Factor Receptor (HER/EGFR) inhibitor”, also known as ‘Erlotinib Hydrochloride’. Erlotinib is sold under the name Tarceva by Roche which has a license from OSI Pharma to use, sell and offer for sale Erlotinib. Roche also has the license to enforce rights with related to Erlotinib.

2. Suit was filed by Roche and OSI against Cipla in January 2008. In its written statement, Cipla brought to the Court’s attention the fact that there was a US patent application of the Plaintiffs which claimed Polymorph B of Erlotinib Hydrochloride, and that Tarceva incorporates the polymorph B. The suit patent on the other hand claimed a mixture of Polymorphs A and B of Erlotinib Hydrochloride.

3. Cipla further raised the defense of Section 3(d) that the patented drug was a derivative of quinazoline compounds whose anti-cancer effects were well-known in the prior art. It was further alleged by Cipla that the patented drug was a derivative of AstraZeneca’s Gefatinib. A counter-laim seeking revocation of the patent was also filed by Cipla.

4. Roche’s capsule costs INR4800 per tablet, while Cipla’s costs INR1600.

5. Interim injunction was denied by the Single Judge on March 19, 2008. The denial of the interim injunction was upheld by the Division Bench on April 24, 2009. Plaintiffs filed an SLP before the Supreme Court, which too was dismissed on September 28, 2009.

In the meanwhile, on September 18, 2008, the following issues were framed by the Single Judge in the trial:

1. Whether the manufacture, marketing and sale of ERLOCIP by defendant is infringing the plaintiffs‘ Indian Patent 196774? OPP

2. Whether the Indian Patent 196774 is liable to be revoked on the grounds raised in written statement and counter-claim of the defendant? OPD

3. Whether the plaintiffs are entitled to permanent injunction as prayed for? OPP

4. Whether defendant/counter-claimant proves that the plaintiff‘s subsequent US Patent 6900221, is to the effect that the compound of claim No.1 of the suit patent is a mixture of two Polymorph A and B Compound and need to be separated to perform and get the claimed compound for acceptable efficacy; and its effect on the plaintiff‘s patent? OPD/CC.

5. Relief.

6. Cross-examination commenced in April 2009 and concluded in November 2010.

7. Final arguments commenced in November 2011 and concluded in June 2012. Verdict was delivered on September 7, 2012.

From Para 28 of the judgment onwards, the Single Judge discusses Issue No.2 i.e. validity of the patent. I will continue discussing the judgment in the next few posts. This is merely a primer.

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