The much awaited Roche vs Cipla judgment is out. And much like the Ayodhya judgment, it runs into innumerable pages, ensuring that only the most perseverant brave through it.
Rated as India’s first drug patent decision in the post TRIPS era (post trial), it marks an important watershed in Indian patent history. I have managed just one quick reading of the decision and will therefore offer very tentative observations and raise some questions.
As Shouvik noted in his post here, while the judge held the patent to be a “valid” one, he found that it was not infringed. On an initial reading, the decision appears a bit puzzling to me.
The judge upholds the validity of Roche’s main claim, and yet appears to restrict its scope during the infringement analysis. Let me elaborate.
Roche’s main claim is to the compound itself i.e. Erlotinib hydrochloride (as depicted by a chemical formula). The claim as it stands now covers the compound, and is not limited to any particular polymorphic version or variant of the said compound. However, the judge appears to suggest that since Roche was marketing a particular manifestation of the compound (polymorph A and B) and Cipla sold another form (Polymorph B of Erlotinib Hydrochloride), Cipla does not infringe.
To my mind, a patent law infringement analysis ought to turn only on the scope of a particular claim and a comparison of the said claim with the defendants’ product to determine whether or not the said product falls within the ambit of the claim. There is no question of comparing the defendants product with the plaintiffs patented product. In fact, the plaintiff may not have a product at all, but may sue a defendant who manufactures a product based on the plaintiffs patent. (in such cases however, judges may decline to grant injunctions on the basis of public interest, as the US Supreme court did in eBay vs Merckexchange, where the patentee itself did not have a product embodying the patent. However, we’ll leave this debate for another day, as the facts of Roche vs Cipla suggest that Roche did have a product).
Given that the claim was upheld, it is clear that any product that falls within the scope of the claim would infringe. Therefore, the moment Cipla makes a polymorphic version of Erlotinib Hydrochloride (EH), it automatically infringes the main claim, since its polymorph will also have the same chemical formula as that EH (Erlotinib hydrochloride). It is important to bear in mind that the main patent claim encompasses EH in its entirety, without limitations of any sort.
My questions are as follows:
1. If a claim has been upheld and not circumscribed during a validity analysis, can the judge curb its scope during an infringement analysis? Is not the issue of validity distinct from the issue of infringement?
2. If the judge was concerned about the scope of Roche’s claim and that it did not adequately disclose the fact that its preferred embodiment of the suit patent was a mixture of polymorphs A and B, could the judge have restricted the scope of Roche’s patent in some way, without upholding its validity in entirety?
3. Did the case turn effectively on evidence? The judge appears to indicate that Roche did not lead enough evidence to prove infringement. Did I read this part correctly? Or could one argue that there were enough admissions by Cipla to obviate the need for evidence on this count? Cipla admitted that it was selling Polymorphic B version of Erlotinib Hydrochloride. Given that the main claim in the suit patent was to Erlotinib Hydrochloride itself, does not Cipla infringe? Since one cannot make the polymorphic version of a certain compound without making the compound itself. I reflect on this aspect in my critique of the Division Bench order, but now that this present decision comes after a rigorous trial, I am uncertain as to whether or not I have it right.
Anyone out there who can help clarify these aspects?