Roche just scored its first big win in its long standing battle against Cipla with the Division Bench of the Delhi High Court (DB) holding that Cipla’s cancer drug ‘Erlocip’ infringes Roche’s patent IN ‘774. This decision follows the Single Judge’s decision that that while Roche’s patent IN ‘774 was valid (the counter claim for revocation could not be proved), Roche was unable to prove through evidence that the alleged infringing product does, in fact, infringe their patent. In a comprehensive (but laborious) judgement, the DB has laid down the standards applicable to many crucial aspects in a patent infringement suit, including the scope of Section 3(d) and hence has a wide impact over and above the context of this case. The DB directed Cipla liable to render accounts concerning manufacture and sale of Erlocip and decreed costs in favour of Roche and against Cipla in sum of Rs 5,00,000, but refrained from granting a permanent injunction as the Roche patent expires in March 2016.
We have blogged extensively on this litigation and a lot of the confusions and fallacies that the DB notes about the earlier decisions were directly raised by Shamnad in his posts here, here and here.
Roche sued Cipla in early 2008 over their lung cancer drug Erlocip on the ground that it infringed Patent IN ‘774 (the ‘suit patent’) for ‘A NOVEL [6, 7-BIS(2- METHOXYETHOXY) QUINAZOLIN-4-YL]- (3-ETHYNYLPHENYL) AMINE HYDROCHLORIDE’ also known as ‘Erlotinib Hydrochloride’ which was licensed to Roche. Roche had been manufacturing this compound as an anti-cancer drug under the brand name ‘Tarceva’ across the world and introduced it in India in April 2006. In the first round of litigation, Roche lost on the question of interim relief on the ground that injuncting against Cipla’s manufacture would be against public interest and hence the balance of convenience was not in Roche’s favour [The judge observed that a month’s dosage of Tarceva for a patient undergoing treatment for cancer was Rs.1.4 lakh whereas the equivalent cost of Erlocip would be Rs. 46,000]. On appeal, the DB upheld the decision, but focussed more on the failure of Roche to establish a prima facie case of infringement which is sine qua non for granting interim relief. It was argued that Erlocip comprised of only the B polymorph of Erlotinib Hydrochloride and hence was not covered by the suit patent which only disclosed a mixture of polymorphs A and B of the compound. The appellate court held that “to the extent that the defendant had raised a serious doubt whether the plaintiffs in fact hold a patent for the product sold in the tablet form as Tarceva, the plaintiffs must be held not to have been able to cross the first hurdle of showing that they have a prima facie case in their favour for grant of an order restraining the defendant from marketing Erlocip.” The SLP filed by Roche against this decision was also not successful and the parties returned to the Single Judge (trial judge) to commence the trial on the main relief in the suit. The Single Judge delivered judgement on 7th September 2012 and held while Cipla could not discharge its burden to establish revocation, Roche could not prove that Cipla’s manufacture of Erlocip infringed its patent ‘IN 774.
On validity of the patent on the ground of obviousness
Decision of the Single Judge (trial court):
The Single Judge, relying on the UK case of Dr Reddy’s Laboratories (UK) Ltd. v. Eli Lilly & Co. Ltd. 2010 RPC 9, held that no special understanding of inventive step under the Patent Act, 1970 is necessary in the case of pharmaceutical patents. In that case, the Court was not persuaded by the contrary position advocated in US and EU case law and rejected the stringent Teaching-Suggestion-Motivation (TSM) test stating that it raises a semi-presumption of validity when no such presumption exists in Indian law. It was held that while Cipla could show that the invention was from examples of the known prior art, it could not demonstrate ‘by positive evidence’ that the invention was not far removed from known range in the illustration and that it served no purpose. The Single Judge disqualified the references to the prior art submitted and referred to the commercial success of the drug to establish the purposefulness of the selection. It was held that Cipla was unable to discharge its burden to establish revocation.
Division Bench decision:
On a conspectus of US and Indian law on the question of obviousness, the DB laid down a five step test for an obviousness challenge to a patent:
“151. From the decisions noted above to determine obviousness/lack of inventive steps the following inquires are required to be conducted:
Step No.1 To identify an ordinary person skilled in the art,
Step No.2 To identify the inventive concept embodied in the patent,
Step No.3 To impute to a normal skilled but unimaginative ordinary person skilled in the art what was common general knowledge in the art at the priority date.
Step No.4 To identify the differences, if any, between the matter cited and the alleged invention and ascertain whether the differences are ordinary application of law or involve various different steps requiring multiple, theoretical and practical applications,
Step No.5 To decide whether those differences, viewed in the knowledge of alleged invention, constituted steps which would have been obvious to the ordinary person skilled in the art and rule out a hindsight approach.”
The referred to the TSM test and the POSA test under US law [William T. Graham et al. Vs. John Deere Company of Kansas 383 U.S. 1(1966)] and seems to endorse them while espousing this 5 step test. However, these standards are not as clear cut as the Court seems to believe. For example, in which the DB cites in relation to the TSM test, the US Supreme Court rejected a rigid application of the test and held that: “The obviousness analysis cannot be confined by a formalistic conception of the words ‘teaching,’ ‘suggestion,’ and ‘motivation,’ or by the overemphasis on the importance of published articles and the explicit content of issued patents.” Instead, the Court propounded an “expansive and flexible approach” that keeps in mind the purpose of patent law in protecting only innovative products/processes and not those developed “in the ordinary course.” It also reinvoked the “obvious to try standard” which is a much lower threshold for proving obviousness.
The DB also held that the teaching of the prior art document should be considered as a whole [reliance on Otsuka Pharmaceutical Co. Ltd v. Sandoz Inc., 678 F.3d 1280] and that similarity of structure alone was insufficient for prima facie unpatentability, but rather, to show obviousness besides structural similarity, there should be a reason or motivation shown in the prior art to make the particular structural change in order to achieve the properties that the applicant was seeking [adopting re: John R. Slemniski 444. 2d 581 and Pfizer Inc. Vs.Teva Pharmaceuticals 520 F.3d. 1358 and rejecting in re Dillon 16 USPQ.2d 1897].
On facts the DB held the Cipla’s expert witness DW-3 who was presented as a Person Skilled in the Arts (POSA), was not a medicinal Chemist and could not be considered as a POSA. For a series of reasons set out paragraph 168, it was held that DW-3 “has not been able to satisfy the tests laid down above thus could not establish prima facie that the suit patent was obvious,”
Test for Infringement
After a detailed discussion of the principle laid down in Catnic, the Single judge described the infringement determination as follows: “Whether the patent claim subsumes the product or the process impugned is a matter to be examined from the standpoint as to whether the patentee could have reasonably included the said product or process in question which is he is impugning on the fair reading of the invention.” However, he goes to say that “the question remains whether the said test is determinative one even in cases where there exists a patented claim for a product and another product which may substantially contain the patented product but also contain some other variants or some other parts in addition to the patented article or product”. The DB extracts this observation and notes that the Single Judge seems to have treated “a patent claim on the subject matter interchangeably with patent claim for a product which, in the present case, refer to distinct things – Claim 1 of IN ‘774 and Tarceva respectively.” The Single Judge eventually held that infringement had not been proved by “positive evidence which include the medical and clinical evaluation of the product of the defendant.”
The DB first explains exact enquiry involved in a patent infringement determination. As Shamnad noted in his earlier posts (here, here and here) the Courts, in this very matter, have repeatedly compared Erlocip to Tarceva in determining whether the former is infringing. The DB clarifies that an infringement examination does NOT compare an allegedly infringing product with the product marketed pursuant to rights under a given patent, but compares it with the claims of the patent itself. It adopts the ‘Markman’ test for infringement which involves a two step enquiry:
- First step is to determine the meaning and scope of the patent claims asserted to be infringed.
- Second step is to compare the properly construed claim with the device accused of infringing.
Thus, the DB notes that “the correct test of infringement in this case is to map Cipla product against the Roche‘s patent claims, which we find has not been done by the learned Single Judge, and this is the third infirmity on this aspect of the dispute.”
On step one, i.e., claim construction, the DB has laid down a 16 step test for construing claims of a patent for the purpose of determining its scope and whether the alleged infringing product is covered by it. These are at paragraph 67 and need to be printed and pasted on every patent lawyer’s desk. On facts, the DB held that on construing Claim 1 in IN ‘774, that it “is a sufficiently broad claim that is clearly not limited to any polymorphic version of Erlotinib Hydrochloride, but to Erlotinib Hydrochloride itself.” On step two, Roche argued that it is an admitted fact that Erlocip is Erlotinib Hydrochloride and that the Single Judge himself correctly notes that the packaging (Ex.P1), package insert of the Defendant (EX. P2) and the declarations/statements made before the Drug Controller (Ex.PW1/D2) all demonstrate that the API of Erlocip is Erlotinib Hydrochloride.
The crucial question is thus identified at paragraph 111:
“111. Thus the question at hand is really whether Cipla‘s Polymorph B (Erlocip) was subsumed in the claims of IN ‘774.”
The crucial finding is at paragraph 100 and 114:
“100. Any process involved in making Polymorph B of Erlotinib Hydrochloride would first involve the preparation of Erlotinib hydrochloride itself; in fact a perusal of US ‘221 reveals that it is clearly stated that Erlotinib Hydrochloride in Polymorph B form results from re-crystallization of Erlotinib Hydrochloride using different solvents and temperature conditions. Hence if the suit patent was found to disclose Erlotinib Hydrochloride, any polymorphic version of the same would infringe the suit patent as Erlotinib Hydrochloride itself would be underlying every such polymorphic version.
114. … This compound [Erlotinib Hydrochloride] may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent. Therefore as Cipla‘s Erlocip is admittedly one particular polymorphic form of the Erlotinib Hydrochloride compound (Polymorph B), it will clearly infringe the IN ‘774 patent. We thus conclude this issue by noting that the Single Judge‘s finding that ‘Tarceva’ and ‘Erlocip’ were based on the Polymorph B version of Erlotinib Hydrochloride, though correct factually, is irrelevant to the subject matter of the present patent as Cipla has clearly infringed Claim 1 of Roche‘s IN ‘774 patent in arriving at the said Polymorph.”
It is heartening to see the Court return to the fundamentals and widely consult comparative law on the various aspects of patent infringement. However, there can be a danger in uncritically adopting standard developed in foreign jurisdictions. I will spend some time on the US case law endorsed by the court and come back with comments. In the meanwhile, I urge our readers to share their impressions of the judgement on the points of obviousness and infringement. In Part II I discuss the court’s discussion of Section 3(d).