Indian jurisprudence is developing with the recent judgments and decisions issued by the courts and the Controller of Patents. Patent decisions are attracting the pharma industry and making both innovators and generics alike re-examine their strategies. In 2012, the grant of compulsory licence issued by the Controller of Patents against Bayer affected the pharma world, but the prima facie rejection of compulsory licence applications of BDR and Lee Pharma in 2014 and 2015, respectively, have made licence seekers reconsider their strategies. With respect to enforcement of patent rights, in 2012 the Delhi High Court held Cipla’s Erlocip drug not to have infringed Roche’s Indian patent No. 196774, but this position was reversed by the Division Bench (DB) in 2015. Cipla has now submitted a special leave petition to the Supreme Court of India, although the patent was set to expire on 13 March 2016.
Argument for non-infringement
Section 3(d) of the Indian Patents Act 1970 excludes certain subject matter from being considered to be an invention within the meaning of the act. Although this is a patent eligibility criteria, Cipla effectively used it to prove non-infringement before the single judge of the Delhi High Court in 2012. The argument relied on the fact that “polymorph B of erlotinib hydrochloride”, the molecule in Erlocip, was in the public domain for anyone to use because an application filed by Roche for the polymorph was not granted due to objection under section 3(d).
However, separate applications for this polymorph were granted in foreign countries. This argument further relies on the fact that, for grant of a patent application, the claimed subject matter should be novel. Even in selection inventions, the selection should be established as novel over the general group disclosed in the base patent. Hence, novel subject matter in a subsequent patent would mean that it is not disclosed in the base patent, and when a base patent does not disclose a subject matter, then how can a protection be extended to such non-disclosed subject matter? Therefore, Cipla’s argument has been that polymorph B is not covered under the base patent and the subsequent application did not protect such subject matter. This is a typical case of using a patent eligibility criteria while assessing patent infringement.
The DB considered the judgment of the single judge and concluded differently with respect to the assessment of Infringement. First, the DB clarified that the alleged infringing product (or process) has to be compared with the patentee’s claim, and not with the patentee’s product. Once a patent is granted, the patentee is not bound to sell a product falling within the scope of its granted claim, but it has the right to stop the unauthorized sale of a product falling within the scope of its claim. Hence, comparison of Erlocip with Tarceva was incorrect and not warranted while assessing infringement.
The DB further clarified that, once a patent is granted, it has a certain boundary preventing unauthorized entry, and the scope of such a boundary would not change by creating a future sub-boundary. Countering the argument that the subject matter of polymorph B was neither protected in the base patent nor in a subsequent patent, the DB observed that “merely because an inventor applies for a latter patent that is already objectively included in a prior patent, but which the inventor subjectively feels needs a separate patent application, doesn’t mean it is to be taken at face value and therefore neither section 3(d) or abandonment of subsequent patent application can be used to read into terms of prior application, which has to be construed on its own terms.”
Privilege of protection
Hence, the DB was of the opinion that if a new form of a known substance does not qualify under section 3(d) to be new, then it would have the same protection that is extended to the known substance. If the new substance qualifies under section 3(d) as new, then it can be the subject matter of a new patent, but it does not mean that the protection extended to the known substance would not extend to the new substance, if the new substance is indeed covered within the scope of the known substance.
Therefore, if a separate patent is granted to the new substance, then it may have the privilege of protection under two patents.
The use of patent eligibility criteria to restrict the scope of protection of a base patent was not accepted. The use of section 3(d), patent eligibility criteria, was also not accepted as a defence to infringement.
Although section 3(d) has been directed to be kept out of assessing infringement, an indirect link is set out by the DB’s decision, between section 3(d) and the scope of a patent covering the known substance. If an alleged new substance fails to pass section 3(d), then it automatically falls within the same basket of protection as extended to the corresponding known substance.
A similar situation was faced in the case of sitagliptin and sitagliptin phosphate monohydrate salt (SPM), where the Delhi High Court held Glenmark’s ZITA and ZITA-MET covering SPM to be an infringement of Indian patent No. 209816, with a claim on sitagliptin, where a separate patent was not granted for SPM.
India’s intellectual property policies have been criticized in the past, section 3(d) in particular, for being anti-patent. However, the recent court decisions justify the position of section 3(d) for allowing incremental innovations, and at the same time not allowing unjustified designing with the help of section 3(d), by providing sufficient scope of protection under base patents.
709/ 710, Tolstoy House, 15-17 Tolstoy Marg New Delhi – 110 001 India
Tel: 91 11 2371 6565
Fax: 91 11 2371 6556