F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2008)
Polymorphs, Erlotinib, and how courts compare claims vs product — in easy English.
Quick Summary
The Delhi High Court (Division Bench) dealt with Erlotinib. Roche owned the patent; Cipla sold Erlocip, said to be polymorph B. The court held that polymorphic forms are covered by the patent.
Result: Infringement found and patent validity upheld, but the court did not grant a permanent injunction because of public interest in access to medicines.
Issues
- Does Cipla’s Erlocip (polymorph B of Erlotinib) infringe Roche’s Erlotinib patent?
- Is Roche’s Erlotinib patent valid and enforceable?
Rules
- A drug compound can have multiple polymorphic forms; such forms can be subsumed within a valid patent’s scope.
- Infringement test: compare the accused product with the patent claims, not with the patentee’s marketed product.
- Clinical or medical evaluations by the defendant are not “positive proof” to defeat infringement if claim mapping shows overlap.
Facts (Timeline)
Citation: 2008 (37) PTC 71 (Del)
Arguments (Appellant vs Respondent)
Appellant (Roche)
- Erlocip falls within the claims of the Erlotinib patent; polymorphs are covered.
- Comparison must be to claims, not to the Tarceva marketed form.
- Cipla’s clinical assertions do not defeat claim mapping.
Respondent (Cipla)
- Erlocip is a different polymorph (B); no overlap with patented form.
- Alleged lack/weakness of patent coverage over polymorphic designs.
- Public interest and access to medicines weigh against injunction.
Judgment
Held: Cipla’s Erlocip infringes Roche’s patent. The patent is valid. Polymorphs are subsumed within the patent protection when covered by the claims.
- Test clarified: Infringement is shown by claim comparison, not by comparing the accused product with the patentee’s marketed embodiment.
- Evidence: Defendant’s medical/clinical evaluations are not decisive if claim mapping indicates overlap.
- Relief: No permanent injunction, considering public interest in drug access.
Ratio
When patent claims cover a compound, its polymorphic forms can fall within the same protection. Infringement is proven by mapping the accused product to the claims, not to the patentee’s sold product.
Why It Matters
- Guides pharma patent cases on polymorphs and claim scope.
- Confirms the claim-to-product comparison method.
- Shows how public interest can shape final remedies.
Key Takeaways
Different crystal forms can still be within patent coverage.
Infringement = claim mapping, not product-to-product comparison.
Clinical data alone cannot defeat clear claim overlap.
Courts may tailor relief to protect patient access.
Mnemonic + 3-Step Hook
Mnemonic: “PCM-P” — Polymorphs covered · Claim comparison · Medical proof not decisive · Public interest on remedies.
- Map: Line up accused product features with each claim.
- Check Polymorphs: Ask if forms are within claim scope.
- Balance Relief: Consider public interest before injunction.
IRAC Outline
Issue
Does Erlocip (polymorph B) infringe Roche’s Erlotinib patent, and is the patent valid?
Rule
Polymorphs may fall under claims; infringement is tested by claim mapping, not marketed product comparison.
Application
Erlocip’s features overlapped with claim elements; defendant’s clinical data did not displace claim overlap.
Conclusion
Infringement established; patent valid. No permanent injunction due to public interest.
Glossary
- Polymorph
- Different crystal structures of the same chemical compound; can affect stability and performance.
- Claim Mapping
- Step-by-step check of product features against each element of the patent claim.
- Marketed Product vs Claims
- Courts compare the accused product to the claims, not to how the patentee sells or formulates the product.
- Public Interest
- Courts may adjust remedies to balance patent rights with access to essential medicines.
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