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?
Dr. Basheer
Issues of validity and issue of Infringement are two separate issues each having its domain of validation.
The Patent Act does not have any provision which allows direct correlation between validation and infringement.
A granted patent is likely to be infringed more by commercial considerations rather by its test validity or invalidity test.
The validity of a patent can be challenged as part of defense but it present status have no bearing on infringement.
Next is the scope of claims.
While it can be an intellectual case that the scope of claims cannot be differently altered and should always remain the same.
But we must look as to what is being compared with what both at the validation stage and at the infringement stage.
The most important criterion for comparison is the prior art when deciding the validity and hence comparison is between the claim of the patent in question and what the prior art claims. The apple is being compared with apple but the variety of apple is also being compared.
In case of infringement, the scope of claims is being interpreted in reference to the infringing product. The apple is being compared with apple of same variety but the different attribute like with seeds or without seeds are also being examined.
The point being stressed is that while the scope of the granted patent remains unaltered the fact that comparison at both validation and infringement are different and subjective exercises very much dependent on the products and the examiner. Issue of validation and issue of infringement are different and process of drawing inference on their claim scopes could lead to different re3sults.
Regarding the 2nd point, the judge has no recourse to limit the scope of patent claim unless it is judged to be invalidated. Only if a patent is invalidated can a judge seek amendment to claim to make it within the realms of validity. A patent capable of being valid will withstand al tests. But to submit that al polymorphs of a valid patent also fall in the scope is a case which is derived only by breading of section 3. In case of infringement analysis the comparison is not only on molecular structure similarity but also on chemical and physical properties and attributes which could lead to different subjective and different interpretations.
Regarding the final point on evidence. If the judge in his judgment gives the impression that not enough evidence was led then there is no point discussion the observation. The adjudicating authority was not convinced by absence of evidence or by not preventing it optimally. A thought for the lawyers of the appellate court.
Dr. Basheer
Issues of validity and issue of Infringement are two separate issues each having its domain of validation.
The Patent Act does not have any provision which allows direct correlation between validation and infringement.
A granted patent is likely to be infringed more by commercial considerations rather by its test validity or invalidity test.
The validity of a patent can be challenged as part of defense but it present status have no bearing on infringement.
Next is the scope of claims.
While it can be an intellectual case that the scope of claims cannot be differently altered and should always remain the same.
But we must look as to what is being compared with what both at the validation stage and at the infringement stage.
The most important criterion for comparison is the prior art when deciding the validity and hence comparison is between the claim of the patent in question and what the prior art claims. The apple is being compared with apple but the variety of apple is also being compared.
In case of infringement, the scope of claims is being interpreted in reference to the infringing product. The apple is being compared with apple of same variety but the different attribute like with seeds or without seeds are also being examined.
The point being stressed is that while the scope of the granted patent remains unaltered the fact that comparison at both validation and infringement are different and subjective exercises very much dependent on the products and the examiner. Issue of validation and issue of infringement are different and process of drawing inference on their claim scopes could lead to different re3sults.
Regarding the 2nd point, the judge has no recourse to limit the scope of patent claim unless it is judged to be invalidated. Only if a patent is invalidated can a judge seek amendment to claim to make it within the realms of validity. A patent capable of being valid will withstand al tests. But to submit that al polymorphs of a valid patent also fall in the scope is a case which is derived only by breading of section 3. In case of infringement analysis the comparison is not only on molecular structure similarity but also on chemical and physical properties and attributes which could lead to different subjective and different interpretations.
Regarding the final point on evidence. If the judge in his judgment gives the impression that not enough evidence was led then there is no point discussion the observation. The adjudicating authority was not convinced by absence of evidence or by not preventing it optimally. A thought for the lawyers of the appellate court.
R.K.jain
patent Agent
Do Roche really need to prove infringement or provide any evidence when the patent claiming compound erlotinib hydrochloride per se was itself found valid and enforceable? I strongly think that was more than enough ground/evidence to prove infringement (at least for anyone familiar with pharmaceutical patent practice).
I still can’t understand the reasoning behind the non-infringement. I think it is high-time that I again need to get my basics right.
First of all, thanks to Dr. Shamnad for this post which prompted me to peep into the 275 page judgement of the High Court of Delhi. I am at the page 240, but coud not wait to share my thoughts on this,
I have the follwing observations for the infringent of Roche’s patent,
1) The court has observed that -Roche’s case is that a polymorphic form B is subsumed in the IN776 patent as the claims are for the Erlotinib HCl and are not limited to any polymorphic form. Therefore evenif cipla markets the polymorphic form it is infringing the said patent.
regarding the refusal of patent appication covering polymorphic form B, roche’s stance is that if under section 3 (d) of the act, the polymorphic form B is not allowed a patent in view of the said compound, then under section 48 it can not be said different.
According to me the above stance is erroneous, because the section 3(d) denies the patentability (monopoly) on the polymorphic form of the known substance not resulting in the enhancement of efficay, this does not automatically mean that the two forms are same/identicle. They may be different but such difference is no invention in India and therefore this addresses the issue of evergreening.
As rightly pointed out by the judge the most effective approach from roche would have been to prove that the difference in polymorphic form has no material effect on the working of the invention by producing clinical evidenbce.
However, I believe this was a position between the rock and a hard place for cipla due to the folowing posible reasons:
1) Due to the instability of the polymorphic mixture (A+B) they themself were marketing Fom B and
2) If they accept that the changes made in order to achive form B of the drug are trivial, their granted US patent for Form B gets affected.
However, I stil have the following questions:
1) Is it ture that the cinstruction of claims and determination of scope would have been more critical in absence of roche’s admission in the form of the patent application for Form B?
2) if my granted claims are
1. Compound A
2 Process for preparation of compound A
If a company B markets compond A’ (different form of A). and if I can not show that the conversion has no role in the way invention works, Can I not effectively ague that even if the company B has modified my compound A it has tresspassed on my rights by using my innovative concept of Compound A???
The decision on infringement is surprising. Cipla’s product contains a polymorph of the same compound claimed in the Roche patent. This evidence alone is sufficient to prove infringement, irrespective of whether the different polymorph is separately patentable. At least that is how patent jurisprudence has developed elsewhere in the world.
Going by this ruling, anybody can avoid infringing a compound patent by using a polymorph or even making a formulation not particularly envisaged by a compound patent. The very purpose behind including product patents in the 2005 amendment of the Indian Patents Act is defeated by this ruling.
A polymorph of a compound is not even patentable under the Indian patent law, yet a company making a product using a different polymorph is exempt from infringing the corresponding compound patent.
Dear All,
I highly appreciate your subject knowledge and your comments. Here, i would like to mention few points in this case in a very simplified way.
1) for prosecuting Form B patent application, Roche clearly aruged that, the parent application does not cover erlotinib hydrochloride form – b.it covers or dicloses only the mixture.
2) when it was asked whether at the time of filing form b was know, they denied.
3) in recent case when it was asked why they have another patents, if the invention (Form B ) is already covered under the parent patents.?
2)
I am repositing the comment posted earlier…somebody please throw light ….
Anonymous said…
First of all, thanks to Dr. Shamnad for this post which prompted me to peep into the 275 page judgement of the High Court of Delhi. I am at the page 240, but coud not wait to share my thoughts on this,
I have the follwing observations for the infringent of Roche’s patent,
1) The court has observed that -Roche’s case is that a polymorphic form B is subsumed in the IN776 patent as the claims are for the Erlotinib HCl and are not limited to any polymorphic form. Therefore evenif cipla markets the polymorphic form it is infringing the said patent.
regarding the refusal of patent appication covering polymorphic form B, roche’s stance is that if under section 3 (d) of the act, the polymorphic form B is not allowed a patent in view of the said compound, then under section 48 it can not be said different.
According to me the above stance is erroneous, because the section 3(d) denies the patentability (monopoly) on the polymorphic form of the known substance not resulting in the enhancement of efficay, this does not automatically mean that the two forms are same/identicle. They may be different but such difference is no invention in India and therefore this addresses the issue of evergreening.
As rightly pointed out by the judge the most effective approach from roche would have been to prove that the difference in polymorphic form has no material effect on the working of the invention by producing clinical evidenbce.
However, I believe this was a position between the rock and a hard place for cipla due to the folowing posible reasons:
1) Due to the instability of the polymorphic mixture (A+B) they themself were marketing Fom B and
2) If they accept that the changes made in order to achive form B of the drug are trivial, their granted US patent for Form B gets affected.
However, I stil have the following questions:
1) Is it ture that the cinstruction of claims and determination of scope would have been more critical in absence of roche’s admission in the form of the patent application for Form B?
2) if my granted claims are
1. Compound A
2 Process for preparation of compound A
If a company B markets compond A’ (different form of A). and if I can not show that the conversion has no role in the way invention works, Can I not effectively ague that even if the company B has modified my compound A it has tresspassed on my rights by using my innovative concept of Compound A???
Shamnad,
Roche’s product consists only of polymorph B (as does the Cipla product). In its patent application for polymorph B (which was rejected in India), Roche indicated that the ‘774 patent covers a mixture of polymorphs A & B. As you rightly point out, only the claims in patent ‘774 (relating to the compound and its process of manufacture) and comparison of the defendant’s product against those claims should have mattered during the infringement suit. However, you will see in paragraph 248 of the decision that the judge decided to consider other elements (such as the plaintiff’s patent application for polymorph B) in view of the purposive construction of claims that he decided should be applied in this case. Hence, the plaintiff’s statement, contained in its rejected application for the polymorph B patent, that the ‘774 patent covers a mixture of two polymorphs was considered to limit the original claims in ‘774. One has to question why the judge decided to apply a purposive construction of claims.
Dear Ken and the others:
Thanks for your insightful comments. To me, the claim is to “Erlotinib Hydrochloride (a particular substance with a clearly spelt out chemical formula). Any other substance that comprises this chemical formula would infringe no? Unless of course you restrict the scope of the claim. But then you must explicitly do that (stating that the claim has to be commensurate with disclosure etc) and that the claim cannot be to the general chemical compound comprising this formula but to a particular variant only….the judge does not do so. How then can he rule that there is no infringement?
Dear Shamnad,
My reading of the decision is that the judge indeed restricted the scope of claim 1 of the ‘774 patent to a mixture of polymorphs A and B. He did so by referring to the plaintiff’s (rejected) patent application for polymorph B (PCT/2002/507/DEL), even though the said application was filed several years after the priority date of ‘774. His grounds for doing so seems to be his decision to apply a purposive construction of claims for the interpretation of claim 1 of the ‘774 patent. It sounds rather whacky but that is the only way in which I could interpret the decision.