IP in India: right owners’ reasons for optimism

Recent decisions in intellectual property cases delivered by the Indian judiciary have made significant progress in interpreting some of the key statutory provisions of IP legislation, having far-reaching implications for the nature and extent of IP protection and enforcement in India. A few prominent decisions in this area and the trends being set are worth noting.

Patent revocation

A person aggrieved by the grant of a patent has several options to challenge the validity of the granted patent under the provisions of the Patents Act, 1970. These are (i) to challenge the grant through a post-grant opposition within one year from the publication of the grant; (ii) to apply for revocation before the Intellectual Property Appellate Board (IPAB); and (iii) to seek revocation via a counter-claim in an infringement suit. There have been instances where a litigant has exercised more than one option by making multiple challenges to the grant of a patent before different authorities.

The Supreme Court of India, in Dr Aloys Wobben v Yogesh Mehra, conclusively found in June 2014 that a defendant cannot pursue parallel proceedings before the IPAB and a high court to challenge the validity of the same patent. In an infringement suit filed before the Delhi High Court, the defendant attacked the validity of the patents through a counter-claim in the suit. The defendant also filed revocation petitions against the patents before the IPAB. The Supreme Court held that the “doctrine of election” precluded the defendants from pursuing similar remedies in different forums. Having once elected one mode of seeking remedy, the defendant could not subsequently raise the same plea in the other forum.

The Supreme Court’s decision is highly significant, especially for right owners which are faced with having to defend the validity of their patents repeatedly. This would also prevent conflicting decisions on the same patents laying down a clear path for patent litigation.

Public interest

Following the judgment by the Delhi High Court in Roche v Cipla in March 2008, a lot of emphasis was placed by courts on the factor of public interest as a relevant ground to deny a preliminary injunction, even in a case where patent infringement was made out. In cases of pharmaceutical patents, the ground of public interest has been extensively used by defendants as a tool to seek denial of a preliminary injunction in favour of the patentee.

The same ground was raised by Indian generic drug company Cipla when it was sued for infringement of patent in the drug Indacaterol by Novartis. However, notwithstanding such a plea, in Novartis v Cipla in January 2015 the Delhi High Court granted an interim injunction restraining Cipla from manufacturing a generic version of Indacaterol. Cipla contended that India is presently facing a chronic obstructive pulmonary disease epidemic and despite Indacaterol being an effective remedy for it, Novartis only imported the drug and at too high prices and in deficient quantities. Cipla further argued that it had petitioned the central government for cancellation of the patent, citing public interest.

The Delhi High Court rejected Cipla’s contentions, stating that Cipla neither raised a credible challenge to the validity of Novartis’s patent nor adequately disputed its infringement. The court further observed that a defendant cannot absolve itself from liability of infringement by merely citing public interest or grounds for compulsory licensing, since these were not grounds for revocation. Cipla has filed an appeal against the order, which is presently sub judice.

Vildagliptin

Following the Supreme Court’s denial of a patent to Novartis pertaining to its drug Gleevec covering the beta-crystalline form of the molecule imatinib mesylate, there was a worldwide perception created among patentees that inventions are not duly respected or protected in India. However, in a series of cases filed by Novartis for infringement of its patent in relation to vildagliptin, an anti-diabetic drug, this perception has, we hope, been duly corrected.

It is encouraging to note that different courts in India have granted injunctions in favour of Novartis, thereby protecting its patented molecule vildagliptin and negating the general perception that patents are not duly protected or that innovations are not respected in India.

“Markush” claims

In Roche v Cipla, it was vehemently argued by Cipla that a “Markush” claim ought not to be held as valid since it claims multiple compounds, running into millions, without any disclosure about the best method of their manufacture in the specifications. In this regard, the Delhi High Court’s judgment in Merck v Glenmark in October 2015 is a welcome decision for drug innovators. After an expedited trial, the court upheld Merck’s claim of infringement of its patented sitagliptin molecule and permanently injuncted Glenmark from manufacturing and selling sitagliptin phosphate monohydrate (SPM)-based drugs. The court also awarded costs in the proceedings to Merck. However, as a serious setback, the court denied relief of damages to the patentee.

Glenmark contended that Merck’s sitagliptin patent was too broad because it was a Markush patent, with numerous combinations being possible. Moreover, since all embodiments mentioned in the patent were confined to hydrochloride salts of sitagliptin, the claims themselves must be similarly restricted. The patent did not provide any enabling disclosure or teaching related to SPM, so use of SPM by Glenmark was not an infringement.

The court rejected these contentions, stating that the patent sufficiently disclosed sitagliptin free base (SFB), which was the compound that rendered the actual therapeutic effect, at the site of activity. Further, it would be obvious to anyone skilled in the art to arrive at SPM having known the structure of SFB, and SPM was covered by the patent in light of the specific claim covering all pharmaceutically acceptable salts of sitagliptin. On this basis, the court held that use of SFB by the defendant in its product amounted to infringement.

Non-disclosure

The provision of mandatory disclosure of corresponding patent applications for the same or substantially similar inventions filed in any overseas jurisdiction during the prosecution of an Indian patent application before the Indian Patent Office (IPO) had created serious concerns for patentees worldwide. The IPAB had gone to the extent of revoking patents even if some corresponding overseas applications were missed out inadvertently before the IPO.

This discrepancy, which arose from interpretation of the judgment of the Delhi High Court in Chemtura v Union of India in 2009, was corrected by the Delhi High Court itself in Philips v Sukesh Behl in 2014.Inthat case, the court said that such non-disclosure has no material bearing on the issue of patentability or the scope of claims which are granted, so such an omission is not a ground to invalidate a patent.

This decision brings much needed clarity and relief to innovators and patent applicants in India, which otherwise find it challenging to fulfil the procedural requirements under the Patents Act and consequently face the looming prospect of revocation even for absolutely valid patents.

Compulsory licensing:

According to the Patents Act, 1970, the grant of compulsory licences is made based, inter alia, on the following conditions: