IP Connect

Delhi High Court: Cipla has Infringed Roche’s Anti-Cancer Drug Patent

In a recent decision rendered in the cases F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. (RFA (OS) 92/ 2012) and Cipla Ltd. v. F. Hoffmann-La Roche Ltd. & Anr. (RFA (OS) 103/ 2012), the Division Bench of the Hon’ble Delhi High Court has ruled that Cipla has infringed Roche’s patent in a lung cancer drug sold under the trade name Tarceva. Reportedly, Roche was selling its drug Tarceva at INR 4,800 per tablet whereas Cipla was marketing a generic version of the drug under the name Erlocip at the cost of INR 1,600 per tablet.

Brief facts

F. Hoffmann-La Roche Ltd. (hereinafter “Roche”) filed a suit to injunct Cipla Ltd. (hereinafter “Cipla”) from marketing a generic version of its lung cancer drug, Tarceva.

Roche’s plea for interim injunction against Cipla was dismissed by the learned Single Judge of the Delhi High Court on grounds of public interest involved and the life-saving nature of the drug in question.

Roche’s appeal to the Division Bench of this Court against the order passed the learned Single Judge was also dismissed in April, 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. The decision is reported as F. Hoffman-La Roche v. Cipla Ltd. (2009) 40 PTC 125 (Del).

The Division Bench further felt that Cipla had done enough to demonstrate a potentially credible challenge to the validity of Roche’s patent No. IN ‘774, including raising sufficient doubt over whether IN ‘774 had complied with full disclosure requirements.

Thereafter, Roche approached the Supreme Court of India by way of a Special Leave Petition which was also denied, and the case moved to trial.

Meanwhile, Cipla had sought revocation of Roche’s patent in the impugned drug; however the same was refused by the Single Judge during trial.

Aggrieved by the decision of the Single Judge, both Cipla and Roche appealed against the Single Judge’s order before the Division Bench of the Delhi High Court.

Contentions raised by Roche

1. Roche’s Patent IN 196774 was granted in February 2007 by the Indian Patent Office, which covered its patent rights over the Erlotinib Hydrochloride molecule which had 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. Roche alleged that Cipla had infringed its impugned drug under the name Tarceva by marketing the generic version of the drug under the name Erlocip.
3. Cipla’s drug was also Erlotinib Hydrochloride and manufacture of Polymorph B by Cipla was sufficient to trigger infringement of Claim 1 of its patent IN ‘774.

Contentions raised by Cipla

1. Roche’s patent IN ‘774 had not complied with full disclosure requirements as required under Section 8 of the Patents Act, 1970.
2. Roche’s patent IN ‘774 is invalid             under Section 64 (1)(f) of the Patents Act, 1970 for lack of inventive step and for being obvious.
3. Not only did Roche’s IN ‘774 specification fails to disclose how it was inventive but there were compelling evidences which indicated that it was more combination and less innovation.
4. That the closest prior art to IN ‘774 and EP 0566226 (admitted as prior art) had extremely materially similar, if not identical, structures.
5. That Roche had unsuccessfully applied for a Polymorph B form of Erlotinib Hydrochloride (Patent IN/507/Del), a claim which was rejected by the Indian Patent Office in 2008 with the findings on evergreening, structural similarities between IN ‘774 and EP ‘226 and a lack of conclusive comparative clinical data to prove efficacy.
6. That invention is required to be product specific, where products have to have commercial manifestation, since infringement is relatable to “that product‟ which is patented and not to any “substance”.
7. That while the patent sought to be enforced is for Polymorphs A+B, the product actually under manufacture by both Roche and Cipla is Polymorph B which ought to be assumed to be in the public domain and hence Cipla’s activities are non-infringing in nature.

Court’s Observations

The Division Bench of the Delhi High Court reversed the order of the Single Judge and passed a judgment in favour of Roche by holding that Cipla had infringed Roche’s impugned Patent for lung cancer drug. However, the injunction prayed for by Roche against Cipla in India was not granted considering that the life of the said patent would expire in March 2016. While arriving at its decision, the Division Bench made reference to a plethora of judgments dealing with the nuances of Patent Law including “inventive step”, “disclosures to be made under the Law” etc. and made the following observations:

1. That it was not in dispute that Roche’s unsuccessful patent application in India (DEL ‘507) was for a Polymorph B form of Erlotinib Hydrochloride, a claim that had been rejected by the Indian Patent Office in 2008 with observations on evergreening and structural similarities between IN ‘774 and DEL ‘507.
2. That the process claims for making Polymorph B in DEL ‘507 had already matured into Patent No. 231102 and only the product claims pertaining to Polymorph B were refused.
3. That the purpose of Section 3(d) of the Patents Act, 1970 is to encourage incremental innovation in pharmaceuticals. It lays down a threshold for what subject matter would qualify as the “same” or “known” substance and what would qualify as a “new” substance. The purpose of this qualification is that when something is same/ known substance, then the derivatives of such a substance as enumerated in the Explanation to Section 3(d) would be covered under the same protection that exists for the known substance (which could also mean that if the known substance is not covered by a patent then the derivative would not be covered as well).
4. That while the present patent covers Erlotinib Hydrochloride (or polymorphs A+B of the same), the rejection of the patent application for Polymorph B (DEL ‘507) by the Indian Patent Office leads to a direct conclusion that there was a lack of sufficient matter to suggest that Polymorph B qualified as a “new product” for consideration under Section 2(1)(j) of the Patents Act for patentability and should therefore be regarded for all practical purposes as the old product itself i.e. Polymorphs A+B.

In view of the aforesaid, the Division Bench of the Delhi High Court held that Cipla has infringed the said patent of Roche, and directed Cipla to render its accounts concerning the manufacture and sale of its generic drug Erlocip and also imposed a cost of INR 500,000/- on Cipla.

Conclusion

The Roche-Cipla dispute over the lung cancer drug “Erlotinib” was one of the initial patent disputes filed in the country and had been keenly watched ever since. The Division Bench of the Delhi High Court has referred to a plethora of judgments including that of foreign jurisdictions in order to arrive at the aforesaid decision. It is hoped that the final outcome of the infringement suit and the judgement would be helpful in deciding other similar pharmaceutical infringement disputes in India.