Intellectual Property Rights

F. Hoffmann-La Roche Ltd. v. Cipla Ltd.

2015 SCC OnLine Del 13619; 2016 (65) PTC 1 (Del) (DB)

Facts

Roche owned Indian Patent No. 196774 covering erlotinib hydrochloride, sold as Tarceva.
Cipla marketed Erlocip, which contained a particular crystalline form known as polymorph B of erlotinib hydrochloride.
Roche alleged infringement.
Cipla argued that:
Roche’s patent did not specifically claim polymorph B;
the patent was invalid for obviousness and other statutory grounds;
Roche’s later application for polymorph B had been rejected under Section 3(d);
therefore Erlocip fell outside the earlier patent.
After a full trial, the Single Judge upheld the validity of Roche’s patent but found that Roche had not proved infringement.
Both parties appealed to the Division Bench.

How the patent claim should be construed.
Whether a claim to erlotinib hydrochloride covered its polymorphic forms.
Whether Cipla’s polymorph-B product infringed the earlier genus or compound patent.
Whether rejection of Roche’s later polymorph application under Section 3(d) affected infringement.
Whether Cipla proved that Roche’s patent was obvious or otherwise invalid.

Infringement analysis requires two distinct stages:
construe the patent claim from the perspective of the skilled person;
compare the properly construed claim with the accused product.
Claims are read purposively with the specification but cannot be restricted merely to the patentee’s commercial product.
A broad compound claim may cover later-discovered crystalline or polymorphic forms of that compound unless the claim language limits it.
Section 3(d) determines whether a new form independently deserves a further patent.
It does not create a defence allowing use of the underlying patented substance.
A species or new form may infringe an earlier genus patent even though the species itself is not separately patentable.
Obviousness must be established through prior art and the perspective of the skilled person without hindsight.

The Division Bench first examined the wording of Roche’s claim.
It covered the compound erlotinib hydrochloride without restricting protection to a particular crystalline form.
The specification did not indicate that only an amorphous form was claimed.
Cipla’s own evidence accepted that Erlocip contained polymorph B of erlotinib hydrochloride.
A polymorph is a different crystalline arrangement of the same chemical substance; it is not a different base compound.
Manufacturing or selling polymorph B therefore involved use of the erlotinib-hydrochloride molecule covered by Roche’s patent.
The Single Judge had placed excessive weight on the distinction between polymorphic forms.
Roche’s later attempt to patent polymorph B did not narrow the earlier claim retrospectively.
The rejection of that later application under Section 3(d) meant only that Roche had not demonstrated sufficient enhanced efficacy for an additional patent.
It did not place polymorph B outside the protection of the existing compound patent or into the public domain.
Cipla’s obviousness challenge also failed.
The cited prior art did not sufficiently lead a skilled person to erlotinib hydrochloride with a reasonable expectation of success.
Cipla’s argument depended substantially on hindsight after Roche’s invention was known.
The patent was therefore valid and the accused product fell within its claims.

The Division Bench held that Cipla’s Erlocip infringed Roche’s patent.
It upheld the patent’s validity and rejected Cipla’s obviousness challenge.
The Single Judge’s non-infringement conclusion was reversed.
Use this case for: a later polymorphic form may infringe a broad compound patent, and failure to obtain a separate Section 3(d) patent does not free the underlying patented molecule for public use.