Pharmaceutical Patent Validity, Infringement, and Public Interest Balance
#### Case Title, Order Date, Case Number, Neutral Citation, Name of Court, and Judge
The case titled *F. Hoffmann-La Roche Ltd. and Ors. Vs. Cipla Ltd.*, bearing case numbers RFA (OS) 92/2012 and 103/2012, was decided on 27.11.2015 by the High Court of Delhi, presided over by Hon'ble Judges Pradeep Nandrajog and Mukta Gupta, JJ., with a neutral citation MANU/DE/3672/2015.
#### Detailed Summary of the Case
##### Facts
The dispute centers on Indian Patent No. IN '774, granted to F. Hoffmann-La Roche Ltd. (Roche) and OSI Pharmaceuticals Inc. (OSI) on February 23, 2007, with a priority date of March 30, 1995, covering the molecule Erlotinib Hydrochloride, a quinazoline derivative used as an Epidermal Growth Factor Receptor (EGFR) inhibitor in the drug Tarceva. This patent stemmed from a U.S. application filed by Pfizer Inc. on March 31, 1995 (resulting in US '498 on August 5, 1998), which was assigned to Pfizer Products Inc. and subsequently to OSI via agreements dated May 18, 2005 (retrospective to May 3, 2004) and May 5, 2004. Roche held an exclusive marketing license from OSI since 2001. Further research identified Polymorph B of Erlotinib Hydrochloride, patented in the U.S. as US '221 (filed November 9, 2000, granted in 40 countries), but the corresponding Indian application (DEL '507, filed February 6, 2002) was rejected in December 2008 for lacking enhanced therapeutic efficacy under Section 3(d) of the Patents Act, 1970, and for being an evergreening attempt. Tarceva comprises Polymorph B, while IN '774 claims the base molecule, encompassing Polymorphs A and B.
In January 2008, Roche, alerted by media reports (e.g., a January 11, 2008, "Mint" newspaper article) of Cipla Ltd.'s intent to launch a generic version, Erlocip, filed a suit in the Delhi High Court seeking a permanent injunction, rendition of accounts, damages, and delivery up. Cipla countered by challenging IN '774's validity and denying infringement, asserting Erlocip was Polymorph B, not covered by the patent. Interim injunction requests were denied by a Single Judge on March 19, 2008 (reported as (2008) 37 PTC 71 (Del)), citing public interest in affordable life-saving drugs (Tarceva at Rs. 4,800 per tablet vs. Cipla's Rs. 1,600), a decision upheld by the Division Bench on April 24, 2009 (reported as (2009) 40 PTC 125 (Del)) on similar grounds, and affirmed by the Supreme Court's denial of special leave. The case proceeded to trial, with the Single Judge dismissing Roche's suit on September 7, 2012, finding no infringement but upholding validity on other grounds. Both parties appealed: Roche in RFA(OS) 92/2012 for infringement, and Cipla in RFA(OS) 103/2012 for revocation.
##### Dispute
The core issues were:
1. **Patent Validity**: Cipla sought revocation under Sections 64(1)(f) (lack of inventive step/obviousness), 64(1)(m) (non-compliance with Section 8 disclosure), 3(d) (no enhanced efficacy), and lack of title in Roche/OSI.
2. **Infringement**: Whether Cipla's Erlocip (Polymorph B) infringed Claim 1 of IN '774, which covers the base molecule Erlotinib Hydrochloride.
3. **Public Interest and Remedies**: Balancing patent rights with access to affordable medicine, and determining remedies given the patent's expiration in March 2016.
Ancillary disputes included suppression of information (e.g., US '221), arbitrary selection in invention, and evidentiary standards for obviousness and efficacy.
##### Reasoning
The Division Bench, through an exhaustive analysis drawing on Indian and international jurisprudence (e.g., *Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries*, *Windsurfing International Inc. v. Tabur Marine*, *KSR International Co. v. Teleflex Inc.*), tailored its reasoning to India-specific standards under the Patents Act, 1970.
- **Patent Revocation - Non-Compliance with Section 8**: Cipla argued that Roche's failure to disclose US '221 under Section 8 warranted revocation under Section 64(1)(m). The court held that pleadings must be specific about suppressed facts, and vague allegations were insufficient. Roche's bona fide belief that US '221 (a polymorph patent granted in 40 countries) was a distinct invention excused non-disclosure. Substantial compliance was achieved as NATCO revealed US '221 during pre-grant opposition. The discretionary nature of "may" in Section 64(1) and lack of proven prejudice precluded revocation.
- **Obviousness/Lack of Inventive Step (Section 64(1)(f))**: Cipla claimed IN '774 lacked inventive step over prior art, notably Example 51 of EP '226 (1993 priority), differing by a methyl-to-ethynyl substitution at the 3' position, motivated by bioisosterism and teachings from EP '507. The court applied the "Windsurfing/Pozzoli" test: (1) Identify the inventive concept; (2) Assume the POSA's perspective; (3) Identify differences from prior art; (4) Assess obviousness without hindsight. The POSA was a skilled worker in quinazoline derivatives for EGFR inhibition. Cipla's expert (DW-3) failed to prove motivation, relied on hindsight, post-priority documents (e.g., Google, Wikipedia), and non-analogous arts. No evidence showed Example 51's efficacy, and structural similarity alone was inadequate without motivation for enhanced properties. Secondary indicia (long-felt need, commercial success of Tarceva, failure of others like Gefitinib) favored Roche. IN '774 was deemed inventive.
- **Section 3(d) - Enhanced Efficacy**: Cipla argued IN '774 was a derivative of EP '226 without enhanced efficacy. The court, citing *Novartis AG v. Union of India*, clarified Section 3(d) bars evergreening unless efficacy is proven. IN '774's molecule was novel and inventive, with superior inhibitory concentration (IC50) values. DEL '507's rejection did not invalidate IN '774, as Polymorph B was subsumed in the base claim. No revocation under Section 3(d).
- **Lack of Title**: Not a revocation ground under Section 64; jurisdiction lies with IPAB under Sections 71, 117A-D. Assignments from Pfizer Inc. to Pfizer Products Inc. (May 18, 2005) and to OSI (May 5, 2004) were valid. OSI as co-patentee could sue alone under Section 50(2). Suit maintainable despite Roche's unproven license.
- **Infringement**: The Single Judge erred by comparing products (Tarceva vs. Erlocip) via X-ray diffraction instead of claim construction. Claim 1 covers Erlotinib Hydrochloride broadly, subsuming all polymorphs. Erlocip's use of the patented molecule as a starting material constituted infringement. Evidence (Cipla's declarations, Drug Controller approvals) confirmed this.
- **Public Interest and Remedies**: Public interest in affordable drugs was noted, but post-trial, it did not override patent rights. With expiry imminent, no injunction was granted, but accounts rendition was ordered.
##### Decision
The Division Bench dismissed Cipla's appeal (RFA(OS) 103/2012), upholding IN '774's validity. Roche's appeal (RFA(OS) 92/2012) was partially allowed: infringement established, but no injunction due to expiry; Cipla directed to render accounts of profits from Erlocip sales (launch to March 2016), with the matter remanded to a Joint Registrar for evidence and determination. Costs of Rs. 5,00,000 awarded to Roche. The judgment set precedents on obviousness, Section 3(d), disclosure discretion, and infringement in pharmaceutical patents.
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Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
