Between landmark decisions on the treatment of variations of patented substances, the draft National IPR policy, and the proposed draft of The Patent (Amendment) Rules, 2015 truly was an active year in patent law in India. We spoke with the patent attorneys at LexOrbis about these big developments, the implications of the landmark cases and others from 2015, and also about what we can look forward to in 2016.
Conventus Law: In looking at the year in review, what were some of the highlights in Patent Law in 2015?
LexOrbis: 2015 was an eventful year in Indian Patent Law. Some of the highlights are as follows:
(a) The Department of Industrial Policy and Promotion (DIPP) had constituted a think tank to draft the National Intellectual Property Rights IPR Policy and to advise on IPR issues, and the draft of National IPR policy was released on 9th January 2015. Seven primary objectives were identified in the IPR policy, ranging from augmentation of IP awareness, creation, administration, commercialization, enforcement to fine-tuning of legislative framework and strengthening of human resources, institutions and capacities for skill building in IP.
(b) DIPP also proposed Draft of “The Patent (Amendment), Rules, 2015”, which were published in October 2015 for public comments. One of the major changes proposed in the draft rules related to reducing the overall prosecution time for the grant of patents. This included provision for making a request for expedited examination of applications. The draft also suggested for reducing the timeline for complying with examination reports from 12 to 4 months. The draft also imposed a timeline for the Controllers to dispose of the cases once the examination report is issued.
(c) The year 2015 also brought some significant patent trial decisions:
(i) Roche vs. Cipla (Decision delivered on) – November 27, 2015
[RFA(OS) Nos. 92/2012 & 103/2012]
One of the significant issues decided in this case was the scope of claims vis-à-vis section 3(d). The court clarified that, if a basic substance is claimed in a patent, it would cover under its scope, all its variations. Hence, the claim on erlotinib hydrochloride in Indian Patent 196774 was considered to include all forms of erlotinib hydrochloride, including its polymorph B, which the defendant was selling. Hence, Cipla’s Erlocip was found to infringe claim 1 of Roche’s patent.
(ii) Merck vs. Glenmark – October 7, 2015
[CS(OS) 586/2013 & CC No. 46/2013 & I.A. Nos. 9827/2013, 8048/2014 & 13626/2015]
This case also contained similar issues as in Roche vs. Cipla, and here also, the Court considered a claim on ‘Sitagliptin and its pharmaceutically acceptable salts’ to cover within its scope ‘sitagliptin phosphate monohydrate’, which the defendant was using and selling.
The above two cases provide a significant relief to all innovators who invent a new molecule (new chemical entity), as they need not bother to file separate applications for each new form, as the base patent would protect such new forms as well. On the other side, this ruling also provides a detriment to file patent applications for the purposes of ever-greening.
(d) The Controller of Patents decided the third compulsory licensing application related to Saxagliptin.
Lee Pharma Ltd. had applied for compulsory license for AstraZeneca AB’s Indian Patent No. 206543 for Saxagliptin (an antidiabetic drug). The Controller refused the application stating that no prima facie case was made out for the grant of license. A hearing opportunity was also offered to the applicant, but the Controller maintained his position and rejected the application for compulsory licensing.
(e) At the Indian Patent Office front, a new search facility “Indian Patent Advanced Search System” (InPASS) was launched, having full text search capability.
CL: Now that 2016 is underway, what noteworthy developments can we look forward to this year?
LO: In 2016 as well, significant changes are happening. For starters, the National IPR Policy was approved on May 13, 2016. Also, Patents Rules have been amended with effect from May 16, 2016. The major highlight of the amended rules is the provision for an expedited examination, and a reduction in the timeline for putting the application in order for grant from 12 months to 6 months.
The year 2016 has also made noise for the patent application related to the drug sofusbuvir (Sovaldi) of Gilead. While in 2015, the patent application was rejected for not passing the test under Section 3(d), in 2016, the Controller of Patents, has granted a patent for said application. We expect to see some more events in this case.
CL: You mentioned that Roche v. Cipla and Merck v. Glenmark cases were big cases in 2015 that addressed the issue of the patentability of variations of a substance. Can you further detail what those cases said on whether a patent for a substance covers variations of that substance?
LO: With the recent decisions in Roche v. Cipla [RFA(OS) Nos. 92/2012 & 103/2012], and Merck v. Glenmark [CS(OS) 586/2013 & CC No. 46/2013 & I.A. Nos. 9827/2013, 8048/2014 & 13626/2015], the Courts have taken a position that a patent for a substance would cover variations of that substance as well.
For a ‘variant of a substance’ to be patentable under Section 3(d) of Indian Patents Act, 1970, the said variant has to show ‘enhanced therapeutic efficacy’ over the known efficacy of the substance. However, with respect to the scope of the claim for the substance, the Court clarified that, a dual disadvantage cannot be ascribed to the innovator of the substance, who has also applied for a variant of that substance, but which is eventually not found patentable under Section 3(d), to lose protection both under the new application, as well as in the base application for the substance. More specifically, the Court clarified that, if the variant does not pass the test of Section 3(d), then it has to be considered the same substance, and hence, would get protection under the base patent for the substance.
However, the applicants need to be careful to sufficiently disclose the possible variants of the substance in the base patent.
CL: From a business and legal perspective, how can big pharma companies’ best protect their patents and variations of its patented substances?
LO: In view of the recent decisions in Roche v. Cipla, and Merck v. Glenmark, it would be a relief to companies who are innovating new substances. A base patent on the substance would cover and include the variations of the patented substance. In case the company invents any new variant of the substance, which has enhanced therapeutic efficacy over the known efficacy of the substance, then very well a separate patent application can be filed for such new variant. In case a variant does not show enhanced therapeutic efficacy, but has certain other advantages, the companies may consider making their applications for such specific application, instead of protecting the new variant per se.
CL: In Roche v. Cipla, the Delhi High Court Trial Judge gave considerable weight to the ‘public interest’ and ‘pricing/affordability of medicines’ factors when deciding not to grant an interim injunction to Roche. However, looking at the arguments that have generally been made by big pharma companies on this issue, does giving weight to these factors defeat the purpose of obtaining a patent for protection against infringers? Alternatively, if the drugs involved are lifesaving drugs made affordable by the generic version, should that be given significant weight when deciding to grant interim injunctions?
LO: In general, the grant of interim injunctions in pharmaceutical related litigations have been very frequent. In the cases involving Sitagliptin itself, injunctions were granted against many generic companies, including Glenmark.
The Roche v. Cipla case may be considered a typical case, but it does not deserve to derive a generalization of the practice. In Roche v. Ciplacase, in its 2012 judgment, the Court found that, based on the facts on record on balance of the probabilities, the defendant is not infringing the IN’774 patent, and hence, injunction was not granted. In the recent judgement of 2015, injunction was not granted to Roche, considering that the Patent was set to expire in March 2016, but Cipla was held liable to render accounts concerning manufacture and sale of Erlocip. In the earlier decision of 2008 as well in this case, although public interest factor was considered, but still, the defendant was asked to maintain its account and to furnish an undertaking to pay damages, if held liable.
The non-grant of injunctions, only on public interest grounds is very rare. To the contrary, in the Sitagliptin case (Merck v Glenmark), the Court did not consider the arguments raised by the defendant about ‘public interest’ to have much force. The Court held that merely because a defendant who is manufacturing a generic version is selling a tablet at a lower price than that of the plaintiffs, it cannot be made a ground to decline injunction against the defendant, who has been found to have been infringing the invention of the plaintiffs.
Hence, along with public interest, other criteria, like the prima facie case, balance of convenience, irreparable injury and credible challenge to the validity of patent right, are also considered before rejecting an interim injunction.
For further information, please contact:
Manisha Singh, Partner, LexOrbis
manisha@lexorbis.com
