Patent

Mylan’s review petition before the Indian Patent office dismissed


Recently, a review petition filed by Mylan Laboratories in relation to a patent granted to Yeda Research Development was dismissed by the Indian Patent Office. The Controller held: 1. Mylan has no locus standi, 2. The petition was delayed by 10 year and 3. The matter was sub judice before the Delhi HC.

The main contention related to whether the IPO wrongly applied the 2002 amendment instead of the 1970 provisions to Yeda’s patent application thereby erroneously granting it a 20 year monopoly as against 7 years.

Facts and Procedure

A patent application for a “Method for manufacturing Copolymer I fraction” was filed by Yeda Research and Development on 23rd May 1995.

The First Examination Report was issued on 12th November, 2001. According to the Act, the applicant had 15 months (extendable to 18) to file its response to the objections.

On 23rd May 2003, the application was accepted. It was notified in the Gazette of India on 23rd August 2003.

In the meantime, the Patent Amendment Act 2002 came into force from 20th May 2003, which extended the time period of a patent monopoly to 20 years.

As per the provisions of the amending Act, opposition under S.25(1) could be filed within 4 months (extendable by 1 month) from date of notification in the official  Gazette. Since no opposition was received, a patent was granted on 15th March 2004.

Mylan contended that patent application dealing with pharmaceuticals/drugs could be given only a seven year monopoly under S. 53 of the 1970 Act and hence the patent expired on 23rd May 2002. It was argued that the patent office erroneously applied the 2002 amendments to this application and the grant of a 20 year monopoly was void ad initio.

Therefore, in October 2013, Mylan Laboratories filed a review petition against the grant of this patent.

Section 77(1)(f) of the Indian Patent Act allows a review petition be to filed one month after communication of acceptance i.e. one month from 23rd May 2003. This review petition was filed more than 10 years after the stipulated time period.

On the question of procedural irregularities, the Controller observed “I strongly feel that there is no infirmity in the matter upto this stage as far as the procedure followed by the Patent Office in processing this application”. However, this observation should be read in light of the other findings of the Controller i.e. no locus standi and the matter being sub judice.

Locus Standi

 An application for review of a decision passed under S. 77(1)(f) or 77(1)(g) can be filed only by an applicant or opponent or by a concerned party to the proceedings. Mylan argued that since a patent created rights in rem, anyone interested could file a review petition to correct procedural irregularities. However, the Controller held that Mylan was neither an applicant nor the patentee nor the licensee. Moreover, Mylan had not even opposed the patent. Therefore, Mylan had no locus standi in this particular matter.

Delay

There was a 10 year delay in filing the said review petition and Mylan requested for condonation under Rule 137. Alternatively, the petitioner argued that there was no delay since the patent was granted erroneously due to procedural irregularities. Therefore, the cause of action is continuous as the patent wrongly remains on the register.

The Controller, citing Nippon Steel v Union of India, held that the timelines prescribed under the Act are mandatory and not directory. Moreover, Mylan had made no previous attempt to oppose the patent or file a review petition. The delay was unreasonable and unexplained. In light of these circumstances, the Controller had no power to condone the delay.

Sub judice

The Controller observed that every action of the Controller of Patents in relation to the impugned application is under challenge before the Delhi HC in the Natco Pharma v Union of India. Therefore, the matter being sub judice was fit to be dismissed.

Even though the Controller held the matter to be sub judice, the observation on procedural irregularities may lead to a conflict if the Delhi HC rules otherwise. Contrarily, this observation seems more like an obiter than a ratio, since the Controller was clearly aware of the Delhi HC case and wanted to avoid conflicting decisions.

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Aparajita Lath

Aparajita graduated from the WB National University of Juridical Sciences, Kolkata. She was formerly an editor of the NUJS Law Review. She is a lawyer based in Bangalore. All views expressed by her on the blog are her personal views.

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