The case of F. Hoffmann-La Roche Ltd. & Anr. vs. Cipla Ltd. represents a pivotal moment in Indian patent law, particularly in the pharmaceutical sector. This high-profile dispute centered on the alleged infringement of a patent for Erlotinib, a groundbreaking cancer treatment drug marketed as Tarceva. The case raised critical questions about patent validity, infringement, and the scope of protection for polymorphic forms of pharmaceutical compounds.

It also highlighted the tension between intellectual property rights and public interest in access to affordable life-saving drugs. Decided by the Delhi High Court in 2012, the judgment offers profound insights into the application of India’s Patents Act, 1970, particularly Section 3(d), which governs the patentability of new forms of known substances.

Detailed Factual Background:
F. Hoffmann-La Roche Ltd. (Roche), a Swiss pharmaceutical giant, and OSI Pharmaceuticals Inc. (OSI), a New York-based company, were the plaintiffs in this case. Roche, known for its extensive research in pharmaceuticals and diagnostics, invests heavily in collaborative research, spending approximately 7 billion Swiss Francs annually. OSI, along with Pfizer Products Inc., jointly owned a patent for Erlotinib, a Human Epidermal Growth Factor Receptor (HER/EGFR) inhibitor used to treat advanced or metastatic non-small cell lung cancer (NSCLC). Erlotinib, sold under the Trademark Tarceva by Roche, was a tablet formulation approved by the U.S. FDA in 2004 and the European Union in 2005. In India, Roche introduced Tarceva in April 2006, following its registration by the Central Drug Standard Control Organization in December 2005.


The patent in question, Indian Patent No. 196774 (IN’774), was granted on February 23, 2007, to OSI and Pfizer for Erlotinib Hydrochloride, chemically named NOVEL [6,7-BIS(2-METHOXYETHOXY) QUINAZOLIN-4-YL]-(3-ETHYNYLPHENYL) AMINE HYDROCHLORIDE. The patent covered both the drug and its manufacturing process. Roche, under a licensing agreement with OSI dated January 8, 2001, was authorized to manufacture, market, and enforce intellectual property rights for Tarceva in India and other countries.

Cipla Ltd., a prominent Indian pharmaceutical company, was the defendant. Cipla announced plans to launch a generic version of Erlotinib, named Erlocip, in India and for export, as reported in the English daily Mint on January 11, 2008. This prompted Roche and OSI to file a suit against Cipla, alleging infringement of IN’774. Cipla, in turn, challenged the validity of the patent and argued that its product, Erlocip, was a polymorphic form (Polymorph B) of Erlotinib Hydrochloride, distinct from the patented compound, which was a mixture of Polymorphs A and B.

The dispute also involved a subsequent U.S. patent, US 6900221 (US’221), which described Polymorph B of Erlotinib Hydrochloride as a more stable form suitable for tablet formulation. In India, Roche’s application for a patent on Polymorph B (IN/PCT/2002/00507/DEL) was rejected under Section 3(d) of the Patents Act, which requires new forms of known substances to demonstrate enhanced therapeutic efficacy. This rejection became a focal point in the case, as Cipla argued that its product aligned with the unpatented Polymorph B, thus not infringing IN’774.

Detailed Procedural Background:
The suit, CS(OS) No. 89/2008, was filed by Roche and OSI on January 15, 2008, in the Delhi High Court, seeking a permanent injunction to restrain Cipla from manufacturing, selling, or marketing Erlocip, along with claims for damages, rendition of accounts, and delivery up. Concurrently, the plaintiffs filed an interim injunction application under Order XXXIX, Rules 1 and 2 of the Code of Civil Procedure (CPC). On January 16, 2008, the court issued a notice on the interim application, and Cipla admitted to marketing Erlocip for three weeks. The interim application was argued over several hearings, but on March 19, 2008, the court dismissed the injunction request, directing Cipla to maintain accounts and provide an undertaking to pay damages if the suit was decreed.

Roche appealed the interim order in FAO(OS) No. 188/2008, but the Division Bench dismissed the appeal on April 24, 2009. A subsequent Special Leave Petition (SLP) before the Supreme Court (Civil No. 20111/2009) was dismissed on September 28, 2009, with a direction to expedite the trial without being influenced by the Division Bench’s observations.

Cipla filed a written statement and a counterclaim (C.C. No. 52/2008) on January 21, 2008, seeking revocation of IN’774 on grounds including lack of inventive step, obviousness, and non-patentability under Section 3(d). The plaintiffs filed a replication and a written statement to the counterclaim. On September 18, 2008, the court framed five issues, covering infringement, patent validity, the effect of US’221, and the plaintiffs’ entitlement to relief.

Evidence was recorded by a court-appointed commissioner, with both parties submitting affidavits from witnesses, including experts in pharmaceutical sciences and patent law. The plaintiffs presented affidavits from Mr. Shivprasad Laud (PW-1), Prof. Roger Griffin (PW-2), and Prof. Nick Thatcher (PW-3). Cipla’s witnesses included Mr. R. Gopalakrishnan (DW-1), Ms. Shashikala Kanathala (DW-2), Prof. Ashwini Nangia (DW-3), and Dr. Rajender Kumar Lohiya (DW-4). Extensive documentary evidence, including patent specifications, X-ray diffraction (XRD) data, and prior art references, was exhibited.

Cross-examination occurred between April 2009 and November 2010, with final arguments concluding on June 1, 2012. The court reserved judgment on June 1, 2012, and pronounced it on September 7, 2012.

Issues Involved in the Case: The court framed the following issues for adjudication:

• Whether the manufacture, marketing, and sale of Erlocip by Cipla infringes the plaintiffs’ Indian Patent No. 196774? (Onus on Plaintiffs)
• Whether Indian Patent No. 196774 is liable to be revoked on the grounds raised in Cipla’s written statement and counterclaim?
• Whether the plaintiffs are entitled to a permanent injunction as prayed for?
• Whether Cipla proves that the plaintiffs’ US Patent 6900221 indicates that the compound of claim No. 1 of IN’774 is a mixture of Polymorphs A and B, requiring separation for acceptable efficacy, and its effect on IN’774?

Plaintiffs’ Submissions:

• Roche and OSI argued that IN’774 was a valid patent covering Erlotinib Hydrochloride, and Cipla’s Erlocip infringed it by replicating the patented compound. They emphasized Tarceva’s significance as a life-saving drug, developed after substantial research, and its global approvals.
• The plaintiffs contended that Section 48 of the Patents Act grants exclusive rights to prevent unauthorized use, and their licensing agreement authorized Roche to enforce these rights.
• On infringement, the plaintiffs asserted that Erlocip contained Erlotinib Hydrochloride, identical to the patented compound, and Cipla’s marketing violated their rights. They argued that IN’774’s claims were not limited to a specific polymorphic form, covering both Polymorphs A and B.
• The plaintiffs relied on the Catnic approach for claim construction, urging a purposive interpretation to include variants like Polymorph B.
• They cited clinical trial data from 1997 (Ex. PW1/X2) showing Erlotinib’s administration in tablet form, predating Polymorph B’s invention, to argue that the suit patent encompassed solid forms.
• Regarding Polymorph B, the plaintiffs argued that it was irrelevant to therapeutic efficacy, as per Dr. Nick Thatcher’s testimony (PW-3), who stated that polymorphism does not affect patient outcomes.
• They contended that Section 3(d)’s explanation, which considers polymorphs as the same substance unless differing significantly in efficacy, supported their claim that Polymorph B fell within IN’774.
• The plaintiffs also referenced the Controller’s order in pre-grant opposition (December 15, 2008), which treated Polymorph B as the same substance as IN’774’s compound.
• On patent validity, the plaintiffs argued that Cipla failed to prove obviousness or lack of inventive step and disputed Cipla’s reliance on European Patent 0566226 (EP’226) as prior art.

Defendant’s Submissions:

• Cipla challenged IN’774’s validity, seeking revocation under Section 64 of the Patents Act on grounds of obviousness, lack of inventive step, and non-patentability under Section 3(d).
• They argued that IN’774 was a derivative of known quinazoline compounds, particularly those disclosed in EP’226, filed by Zeneca Ltd. in 1993.
• Cipla contended that Example 51 of EP’226, a methyl-substituted quinazoline, was the closest prior art, and replacing methyl with ethynyl to arrive at Erlotinib was obvious to a person skilled in the art.
• They supported this with Prof. Ashwini Nangia’s affidavit (DW-3), which cited multiple patents demonstrating the interchangeability of methyl and ethynyl substituents.
• Cipla argued that IN’774 lacked inventive step, as quinazoline derivatives were known for anti-cancer properties, and EP’226 provided sufficient motivation to experiment with substitutions.
• Cipla also alleged that IN’774 was a derivative of Gefitinib and accused Roche of “evergreening” to extend patent monopolies.
• On infringement, Cipla asserted that Erlocip was Polymorph B of Erlotinib Hydrochloride, distinct from IN’774’s mixture of Polymorphs A and B.
• They relied on US’221’s specification and XRD analysis (DW-2) confirming that Tarceva and Erlocip were Polymorph B.
• Cipla also raised public interest concerns, noting the cost difference between Tarceva and Erlocip, arguing for affordable access to drugs.

Detailed Discussion on Judgments Cited by Parties:

• Daiichi Sankyo v. Matrix Laboratories (670 F. Supp. 2d 359, Fed. Cir. 2010): Cited by the plaintiffs to explain IC50 values as a measure of drug potency.
• Glaverbel v. British Coal Corporation (1995 RPC 255): Cited by the plaintiffs for claim construction principles, supporting a broad interpretation of IN’774.
• Pfizer Inc. v. Ranbaxy (457 F.3d 1284, Fed. Cir. 2006): Cited by the plaintiffs to argue that subsequent patents do not negate the validity or scope of earlier patents.
• Abbott v. Dey (287 F.3d 1097, Fed. Cir. 2002): Cited by the plaintiffs to reinforce that subsequent developments do not limit an earlier patent’s scope.
• Catnic Components Ltd. v. Hill & Smith Ltd. ([1982] RPC 183): Referenced by both parties, particularly by the plaintiffs, for purposive claim construction.
• Sudhir Engineering Company vs. Nitco Roadways Ltd. (1995 (34) DRJ 86): Cited by Cipla to address objections to document marking.
• EPO Board of Appeal Decisions (T 424/86, T 133/84, T 145/84): Cited by Cipla to support their obviousness argument based on prior art and chemical substitutions.

Patent Validity: The court examined Cipla’s counterclaim for revocation and upheld the validity of IN’774, finding that Cipla did not sufficiently prove obviousness or lack of inventive step. Infringement: The court’s analysis of infringement focused on whether Erlocip’s Polymorph B form was covered by IN’774’s claims, concluding based on the evidence and legal principles cited.

Case Title: F. Hoffmann-La Roche Ltd. & Anr. Vs. Cipla Ltd.
Date of Order: September 7, 2012
Case No.: CS(OS) No. 89/2008
Name of Court: High Court of Delhi, New Delhi
Name of Judge: Hon’ble Mr. Justice Manmohan Singh

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: ajayamitabhsuman@gmail.com, Ph no: 9990389539