Merck Sharp & Dohme & Anr. v Glenmark Pharmaceuticals Ltd

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1 BIOTECH BUZZ International Subcommittee December 2015 Contributor: Archana Shanker Changing trends in Indian patent enforcement In the history of the Patent Litigation in India, at least since 1970, only two cases have gone to trial. The two decisions in the Merck and Roche cases are certainly reassuring for patent owners. Merck Sharp & Dohme & Anr. v Glenmark Pharmaceuticals Ltd On 7 th October, 2015, India got its first judgment in 45 years, in the Merck Sharp & Dohme & Anr. v Glenmark Pharmaceuticals Ltd., where the Delhi High Court granted a permanent injunction against Glenmark for the infringement of MSD s patent for Sitagliptin. The highlights of this case before the High Court and Supreme Court had many firsts, namely: - For the first time, the Supreme Court held that IP litigation is commercial litigation; - That commercial litigation needs to be disposed of on an expedited basis which is vital for national interest. In the MSD case, in less than five months from the ordering of an expedited trial, the Judgment had been finally delivered by the Hon ble Delhi High Court; - The first permanent injunction ever granted to a patent owner;

2 Briefly on the facts of the case, the MSD has a composition of matter patent for Sitagliptin and its pharmaceutically acceptable salts, which is a DPP-IV Inhibitor essentially used for treatment of Type-II diabetes. MSD had separately applied for a salt patent for Sitagliptin Phosphate Monohydrate (SPM) which due to the unique provision of Section 3(d), was abandoned. Glenmark took the defense that one patent is for a product and the filing of a subsequent application for SPM, is an admission by the MSD, that SPM is not claimed or covered in the basic patent and the abandonment of the SPM application put SPM in public domain. Some of the highlights of this case are: - A consideration (even if it is minimal i.e. Re. 1 or USD 1) for a license agreement would not be a ground to challenge its authenticity. - In highly technical matters involving chemical compounds in the medical field, the Court held that the opinion of the experts is critical. The Court found Plaintiffs independent expert witness to be a more trustworthy and reliable witness in the chemical, biological and medicinal field than Defendant s independent expert witness - On infringement, the court held that the use of Sitagliptin in the defendant s infringing products, by itself, amounts to infringement of suit patent, i.e. use of the Sitagliptin free base in SPM tablet. - The Court also held that the plaintiffs had succeeded in proving that suit patent discloses SPM generically and that Sitagliptin free base is also disclosed. It is the Sitagliptin free base which is the DPP-IV inhibitor and phosphate salt is used for delivery of Sitagliptin in the body. SPM has improved physical and chemical characteristics, but the active moiety is Sitagliptin. - On validity, the Court held that the onus to establish obviousness of the suit patent over prior art was on the Defendant which it failed to discharge by leading positive evidence. In fact, the prior art search by the defendants witness was a hindsight analysis, which is impermissible under law. A mere comparison of chemical structure is not sufficient, i.e. picking up parts of

3 chemical structures of different patents and clubbing them, keeping in mind the molecule structure of the suit patent, would be hindsight analysis. - On industrial application, the court held that at the time when a patent is granted, it is not necessary to have the product manufactured. If the invention can be commercialized subsequently, it is sufficient. That the compounds formed or substances derived from the suit patent would be a product within the meaning of the Act. Further the Court held that the Plaintiffs drug does not lack industrial applicability as it has been successfully worked for treatment of diabetes. - On insufficiency and Markush claims (Broad Claiming), the court took note of the inventor s testimony that billions of compounds may seem a very large number but the chemical space is infinite. The court further held that Markush claims of the suit patent were no different from the Markush claims of other patent documents including Glenmark s patents. - On a section 8 violation, the Court agreed with the ratio laid down by the Division Bench in Sukesh Bhel & Anr. v Koninklijke Phillips Electronics, that the power of the Court to revoke a patent on the ground of a Section 8 violation is discretionary. In such cases, revocation would only follow if the Court is of the view that omission to furnish the information was deliberate. - On public interest the Court held that public interest is irrelevant as Sitagliptin is not the only DPP-IV inhibitor drug available for treatment of type II diabetes in the market. There are several others, including Defendant s teneligliptin. The court also stated that the sale of generic drug at a lower price cannot be a ground to decline injunction against a competitor Defendant who has been infringing the Plaintiffs patent. Hoffman La Roche vs Cipla Then on 27 th November 2015 / 8 th December 2015, came the order of the Division Bench (DB) in the Hoffman La Roche vs Cipla reversing the decision of the trial court (Single Judge) that held the basic patent of Roche for Tarceva as being valid but not infringed. The DB upheld the patent validity and held infringement of the patent of

4 Roche by Cipla. However, in view of the limited term remaining of the patent, the court didn t grant an injunction. Instead, the DB sent the matter back to the trial court for calculation of damages. The major findings of the DB in relation to the statutory provisions are as follows: 1. On the application of Section 3(d), the DB held that Section 3 is an exclusionary clause that lays down a threshold for patent eligibility and if the subject matter falls within the scope of Section 3, an analysis under Section 2(1)(j) need not be employed as it will be rejected at the threshold. The DB further held that Section 3(d) recognizes incremental innovations in pharmaceutical patents and does not in any manner relate to the concepts of evergreening or patent extension. 2. With regard to one patent one product, the DB held that a product patent protects the product in any form however it is made, or however it is formulated and that the rejection of a subsequent patent(in this case for a polymorphic form of Erlotinib Hydrochloride) under Section 3(d) cannot doubly penalize an innovator. In other words, when a patent application is rejected on the grounds that it does not meet the threshold of patent eligibility, it does not effectively permit the manufacturers of the said polymorph from being deemed non-infringers under Section 48. Thus, Section 3(d) cannot be interpreted as constituting a defence to infringement. 3. The DB also laid down the principles of claim construction and held that patent infringement analysis entails two steps: (a) Determine the meaning and scope of the patent claims asserted to be infringed; (b) Compare the properly construed claim with the device accused of infringing. Test of infringement is to compare claims with the infringing product. The test is not to compare patentee s product with the infringing product. 4. The DB introduced concepts like 'inter'-molecular and 'intra'-molecular concept and held that the claim for Erlotinib hydrochloride, nowhere mentions any polymorphic form. The chemical structure describes the manner in which each molecule of the compound exists. It is not an 'inter'-molecular concept but an 'intra'-molecular concept. Irrespective of the polymorphic

5 form of Erlotinib Hydrochloride, it would have the same chemical structure as contained in Claim 1 of the suit patent and is therefore subsumed within claim 1 of the suit patent. 5. The Court also struck a distinction between commercial utility and patent utility and recognized that at the time the inventions are invented, they may not be commercially the most viable for immediate marketing. 6. The court further held that a claim must be interpreted on its own language and resort cannot be had to subsequent statements/documents either to enlarge or to narrow the scope. 7. In relation to submission of X-ray diffraction for establishing infringement of compound patents, the court held that XRD is used to determine crystalline structure of a compound which is not an accurate method to ascertain product patent infringement of new chemical entities/compounds. X-ray diffraction data is not relevant in the present case, as the issue is not whether Roche and Cipla's products are identical but whether Cipla's product is covered in the claims of Roche's patent. Roche s patent is not for a polymorph. 8. On use of Polymorph B in the infringing product, the court held that it would first involve the preparation of Erlotinib Hydrochloride itself and therefore the use and manufacture of Erlotinib Hydrochloride amounts to infringement. 9. On section 8 violation, the court held that the patentee s compliance with Section 8 is mandatory but the power of the Court to revoke a patent under Section 64 where the non-compliance of Section 8 is a mere clerical or bona fide error is directory as indicated by the use of the word may. 10. In relation to obviousness, the court the following findings: a. Obviousness has to be tested at the priority date of the patent under challenge; b. To test obviousness, the first test required to be applied is to see who is an ordinary person skilled in art and what its characteristics are; c. Hindsight analysis is not permissible

6 d. Patent challenger must demonstrate that the selection of lead compound based on its promising useful properties; e. Test of obviousness involves identifying POSA, inventive concept, common general knowledge, identify difference between the matter cited and alleged invention and whether such differences are obvious to POSA and ruling out hindsight approach. f. For obviousness, besides structural similarity there should be a reason or motivation shown in the prior art to make the particular structural change. These two orders of the Delhi High Court have reinforced our faith in the judiciary for times to come. Nothing herein should be construed as legal advice or legal representation. Click here for an expanded disclaimer. Archana Shanker, Senior Partner & Head (Patents & Designs) - Anand and Anand, India archana@anandandanand.com