Patent Circle Exclusive: Tarceva Patent Litigation Analysis

Indian pharma market has been a major focused area by global analysts and research-based pharmaceutical companies importantly due to cost competitiveness, world-class infrastructure with highest number of US FDA approved plants outside the US, paragraph IV certifications and overseas acquisitions made by Indian generic companies, but what caught primary attention is introduction (or rather re-introduction) of patent protection for pharmaceutical drug products. Even in India, the analysts and generic companies are largely concerned knowing what drug products been granted patents or against what mail-box drug applications pre- and post-grant oppositions are been made. Noticeably, Indian bloggers particularly Delhi-based Shamnad Basheer of SpicyIP, Hyderabad-based Sandeep Rathod of Generic Pharmaceuticals & IP, Chennai-based Feroz Ali of Pharma Patent, and Mumbai-based Vikas Dandekar of Potent Potions are been instrumental in penning down such patent updates from India. Recently, Indian pharma major Cipla launched a generic copy of patented anti-cancer drug Tarceva which eventually lead Roche to file an infringement lawsuit against Cipla in the Delhi High Court. The case is in preliminary stage of hearing, and as the case proceed it would be interesting to watch the approach of Indian judiciary in handling patent infringement matters for complex compound chemistry. Although Indian bloggers will surely keep track of Tarceva patent litigation, but Patent Circle will additionally keep posting exclusive analysis of Tarceva Patent Litigation. This is the first of our analysis.

No Statutory Exemption!

On 13^th July 2005, Erlotinib hydrochloride, an active ingredient of Tarceva got marketing approval in India for tablet dosage form in 25mg, 100mg and 150mg strengths for the treatment of metastatic non-small lung cancer (source: List of drugs approval during 2005, Central Drugs Standard Control Organization). This gives our first critical parameter in Tarceva Patent Litigation Analysis – Date of marketing approval, which may trigger infringement exemption under section 11A of the Patents Act, 1970.

Reading sub-section 7 of section 11A – (7) On and from the date of publication of the application for patent and until the date of grant of a patent in respect of such application, the applicant shall have the like privileges and rights as if a patent for the invention had been granted on the date of publication of the application: Provided that the applicant shall not be entitled to institute any proceedings for infringement until the patent has been granted: Provided further that the rights of a patentee in respect of applications made under sub-section (2) of section 5 before the 1st day of January, 2005 shall accrue from the date of grant of the patent: Provided also that after a patent is granted in respect of applications made under sub-section (2) of section 5, the patent-holder shall only be entitled to receive reasonable royalty from such enterprises which have made significant investment and were producing and marketing the concerned product prior to the 1st day of January, 2005 and which continue to manufacture the product covered by the patent on the date of grant of the patent and no infringement proceedings shall be instituted against such enterprise.

Proviso of section 11A (7) provides a statutory infringement exemption to generic companies and allow patentee to receive reasonable royalty from generic companies only if the patented product was produced and marketed prior to January 01, 2005. In case of Tarceva, Roche received the first marketing approval post 2005 and Cipla launched the generic version in 2008, which mean Cipla cannot trigger section 11A exemption.

Too Long Compulsory License Period!

Compulsory License is our second critical parameter in analysis. According to section 84 of the Act, any person interested may make an application for compulsory license after the expiration of three years from the date of the grant of a patent, but conditionally on any of three grounds, namely –

(a) reasonable requirements of the public with respect to the patented invention have not been satisfied, or

(b) patented invention is not available to the public at a reasonably affordable price, or

(c) the patented invention is not worked in the territory of India.

As section 83 statutorily limit the application for compulsory license for Tarceva only after three years from the date of the grant of a patent, giving Cipla no option for compulsory license. Tarceva was likely granted patent in July 2007, so the application for compulsory license can only be made post July 2010, which seems to be too long for Cipla to launch the generic version.

Considering both compulsory license and section 11A exemption cannot be triggered by Cipla, Roche has definite case for wilful infringement and may claim injunction and damages under section 108 of the Act. Cipla deliberately infringed Indian Patent No. 196774 (the ‘774), which will further barred Cipla from claiming relief under section 111 of the Act for paying damages.

Roche Moved to Delhi High Court

On January 19, 2008, Roche filed an infringement lawsuit in the Delhi High Court seeking an ex-parte interim injunction against Cipla. As Shamnad pointed out, Roche’s application for an ex-parte interim injunction did not even contain the complete specification of the patent and merely filed a copy of the patent certificate. May be Roche do not have the copy of specification as the ‘774 patent is granted to Pfizer/OSI Pharmaceutical (little guess). In counterclaim, Cipla questioned the validity of the ‘774 patent. The case is still in progress and will likely take some more time to have a decision from the High Court.

Post-Grant Opposition!

According to news source, Cipla is likely to move a post-grant opposition against the ‘774 patent, which is our third critical parameter in analysis. The ‘774 patent was published in the Patent Office Journal dated July 13, 2007. Under section 25 (2) of the Act, any person interested may give notice of opposition at anytime after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, which gives Cipla gives a valid period for filing a post-grant opposition with the Indian Patent Office. The ‘774 patent will be open for post-grant opposition till July 13, 2008.

Patent Number: 196774 Patent Application Number: 537/DEL/1996 Date of Application: 13/03/1996 Date of Priority: 30/03/1995 Title of the Invention: A Novel [6,7-bis(2-methoxyethoxy)quinazolin-4-yl]-(3-ethynylphenyl) amine hydrochloride and a process for preparing the same Name of Patentee: Pfizer Products Inc., OSI Pharmaceuticals Date of publication of Abstract u/s 11A: 11/03/2005 Appropriate Office: Delhi

Source: The Patent Office Journal dated July 13, 2007

Cipla may likely contest the validity of the ‘774 patent under clause (e) and (f) of the section 25(2) of the Act, which read as –

(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the claim.

(f) that the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act.

To be continue…