Indian patent law: a new direction

The winds of change are blowing slowly over the Indian patent landscape. After the decision of the Supreme Court in the Glivec case and the series of revocations of patents by the Intellectual Property Appellate Board (IPAB), the Indian system seems to be changing direction towards developing sound patent law jurisprudence. It’s therefore worthwhile to examine how the various judicial forums have dealt with various aspects of Indian patent law in the last few months.

Compulsory licensing

In 2012, the Controller General in the Natco v Bayer case granted a compulsory licence to Natco for the patent covering Nexavar (sorafenib). In the appeal, the IPAB upheld the order of the Controller General with a slight, yet significant, revision to the order. The IPAB reversed the finding of the Controller on working and held that in some cases importation can amount to working.

Then, in 2013, came the second application for a compulsory licence, by BDR Pharmaceuticals International Pvt Ltd, for Bristol-Myers Squibb’s (BMS) patented molecule dasatinib. The Controller General rejected the application for a compulsory licence and held that BDR had not made a prima facie case for a compulsory licence and had failed to exhaust absolute efforts to obtain a voluntary licence from the patentee. The Controller further held that BDR did not meet the statutory requirement of having negotiated with the applicant in good faith for the grant of a compulsory licence. Since the 2005 changes, four applications have been made by generics for compulsory licences, including two applications in 2009 by Natco under the ‘Doha style’ compulsory licence provisions, all in relation to cancer drugs.

Next came the case of Mylan, filing a review petition under Section 77(1)(f) of the Indian Patents Act of the term of a Teva patent for the drug Copaxone (glatiramer acetate, a drug for treating multiple sclerosis). Teva itself filed an infringement case against Natco at the Delhi High Court, Natco being the manufacturing partner of Mylan for the sale of the drug in the US. The main contention of Mylan in its review petition was that the term of the patent for glatiramer acetate expired on May 23, 2002 (hearing dated March 13, 2014) and that the patentee was therefore not entitled to a 20-year term.

In March 2014, the Controller of Patents dismissed the review petition filed by Mylan against Teva’s patent for Copaxone. The main challenge in Mylan’s review petition was that the grant of patent to Teva was void as the process patent for Copaxone granted to Teva should have had a term of seven years, rather than 20, from the date of filing of the patent.

Prior to the Amendment Act of 2002, the term of a process patent in relation to drugs was seven years. That was extended to 20 years by the Patents Amendment Act of 2002. Dismissing Mylan’s review petition, the Controller held that as the patent was granted on March 15, 2004, which was after the Patent Amendments Act 2002 had come into force, there was no fault in the procedure followed by the patent office in processing the application and granting a patent for 20 years.

The Controller further held that Mylan did not have the locus standi to file such a review petition, as it was neither the applicant, nor the patentee, nor the licensee to the grant of the patent. Moreover, it had not filed an opposition. The review petition was further dismissed as being time-barred, having been filed after 10 years.

New entities

The first time a new chemical entity was dealt with by the IPAB was in the Fresenius Kabi Oncology v Glaxo Group Ltd case, a revocation action for the patent covering lapatinib. The IPAB upheld the basic patent for lapatinib and made several significant findings including that:

a. Evidence is necessary to assist the IPAB in ascertaining and understanding the technical documents;

b. Section 8 violations have to be pleaded and proved in order for the challenger to win on this ground; and

c. In an obviousness inquiry, ‘hip-hopping’ over the prior art would not be possible unless the hopscotch line of the invention was before a person skilled in  the art. It further held that too many randomly made ‘right’ choices could not be called a matter of obviousness.

Abraxane (paclitaxel) is a commercially successful product from Abraxis Bioscience (now Celgene). The patent application that covered the product Abraxane was opposed through a pre-grant opposition in 2009 by Natco Pharma; that pre-grant opposition was allowed. Abraxis appealed against the pre-grant opposition order before the IPAB and the IPAB held that in the interest of natural justice and in the absence of pleadings on the ground of insufficiency, the order of the Controller has to be set aside and the application be considered afresh.

In several decisions by the IPAB in revocation petitions, amendments were declined as being delayed. However in 2014, the IPAB, in Schering Corporation v Controller of Patents, set aside the order of the Controller of Patents rejecting a patent application for a crystalline polymorph thrombin receptor antagonist vorapaxar on the grounds that the Controller, before rejecting any patent application, should exercise discretion and give an opportunity to the applicant to amend the claims. This is a significant development given that it is the first time the IPAB has held that patent applications/patents should not be rejected without giving the applicant an opportunity to amend the claims.

In an IPAB order on March 26, 2014, the IPAB reinstated the patent granted to Pfizer Health AB covering its commercial product Detrol (tolterodine). The Indian patent of Pfizer Health AB was revoked in post-grant opposition proceedings filed by Ranbaxy Ltd before the Controller of Patents. On this same patent, Ranbaxy had filed a pre-grant opposition, which was dismissed by the Indian Patent Office, leading to the grant.

The IPAB held that Pfizer Health AB had made out a prima facie case for the grant of stay given that it had succeeded in a pre-grant opposition against Ranbaxy on similar grounds and that, in the post-grant opposition proceedings, the Opposition Board recommendations were in favour of Pfizer Health AB. Significantly, the IPAB also directed the Controller of Patents not to remove patents from the Register of Patents pursuant to a revocation order before the limitation period of three months for filing an appeal is over.

Biosimilars

The Delhi High Court dealt with the first biosimilar case in March 2014. Roche Products India Pvt Ltd filed a writ petition against the Drug Controller General of India, Biocon and Mylan. The High Court injuncted Biocon and Mylan against calling their products Cabmab and Hertraz, respectively, as being biosimilars of trastuzumab. Biocon and Mylan were further injuncted upon relying on Roche’s data for Herceptin, Herclon or Biceltis, or any other data.

"it is the first time the IPAB has held that patent applications/patents should not be rejected without giving the applicant an opportunity to amend the claims."

After the Merck Sharp & Dohme (MSD) v Glenmark case, wherein the division bench orders were reserved, MSD filed six infringement actions against third parties to enforce the patent for sitagliptin, a DPP-4 inhibitor. Of the six cases, two have already been decreed with damages and, in the remaining four, the defendants were injuncted from manufacturing or marketing sitagliptin. MSD v Shilpex Pharmysis & Ors is the first patent infringement law suit to be decreed granting an order of permanent injunction with damages following settlements in acknowledgment of the plaintiff’s right in suit patent.

In Bayer v MSN and Bayer v Symed Labs Ltd, the Delhi High Court granted ad interim injunctions restraining the defendants from manufacturing the drug rivaroxaban commercially except for the limited purpose of development or clinical trials.

In two actions by BMS against BDR and Shilpa Medicare, the High Court in a quia timet action granted BMS an injunction for the patents relating to Ixempra (ixabepilone).

Novartis in March 2014 received favourable orders for its patent covering the blockbuster drug vildagliptin. The High Court granted a preliminary injunction to Novartis against Biocon and Wockhart. In the Biocon action, the court recorded a statement according to which Biocon will not manufacture, sell or export vildagliptin for commercial purposes until the next court hearing.

The winds of change are blowing across all India’s judicial and quasi-judicial forums. The landscape for IP, particularly patents, is slowly becoming more innovator-friendly, with a more pro-innovator approach. It is steadily becoming easier to enforce patents and put in better perspective the intent to grant patents.

Decrees have been issued in the form of interim and permanent injunctions that have recognised the rights that a patent brings in its wake and have thus upheld the spirit of innovation. Many guidelines are in place for the examination for patents that spell out these changes to make future prosecution and litigation proceedings more effective.

Archana Shanker is a senior partner at Anand and Anand. She can be contacted at: archana@anandandanand.com