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April 25, 2013

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Changing Face Of The Indian Patent System


- Archana Shanker, Senior Partner (Head of Department, Patents & Designs) [ Anand And Anand ]
- Dr. Neeti Wilson, Partner [ Anand And Anand ]

Archana & Neeti

Ever since its inception, the Intellectual Property Appellate Board (IPAB) has been a catalyst in the evolution of the patent system in the country

Introduction

The Intellectual Property Appellate Board since its inception and with the Chairman, Hon’ble Justice Prabha Sridevan driving the IPAB has brought about a significant change and clarity in the Patent System.

The establishment of the Appellate Board (IPAB) in 2007 and the notification of Patent Rules in 2010 for patent matters completed the basic procedure for a smooth and effective functioning of the IPAB. Furthermore, the functional infrastructure of the patent office such as modern office buildings, training centre, support staff and most importantly, the patent Examiners and Controllers have also come a full circle with recent upgrades and appointments. The electronic filing system of the patent office has been recently upgraded in 2012 with a more transparent and user-friendly progression.

The patent office website provides for all the information related to the prosecution of a patent application and current status of granted patents. The decisions of the Controller can be easily accessed at the official website even as on the date of pronouncement of the order. The Right to Information provision has further benefited all patent information seekers. Though there is still room for improvement, patent related details are no longer away from public reach. Besides, the initiatives of the Government is worth a mention. The traditional knowledge guidelines and the Biotech draft guidelines to bring in uniformity are examples of such initiatives.

Having said this, procedurally, the provisions that have been clarified by the IPAB include the following:

Disclosure requirements

The disclosure of patent information of other foreign jurisdictions has put the patent applicant under tremendous pressure. The Indian Patent Act has a statutory requirement under Section 8 wherein during the pendency of the Indian application, the applicant is required to disclose the details of all patent applications prosecuted by him (or by someone on his behalf) outside India for the same or substantially same invention. The prescribed details have to be submitted within six months of the Indian application filing and subsequently, six months from any new foreign application filing. The obligation is up to the date of grant of the patent. Additionally, the Controller may also require the applicant to furnish details relating to the foreign application prosecution.

Recent decisions of the Intellectual Property Appellate Board (IPAB) and the High Court seem to have made the provision much more stringent. In Chemtura Corporation vs Union of India, it was held by the Delhi High Court that the obligations established under section 8 mandate the applicant to keep the patent office updated not only of the status but also of the nature of proceedings on the corresponding applications in various jurisdictions. It was further held that disclosures regarding the processing of corresponding applications should be periodic and include full particulars and should not hinge on the controller’s request.

In Hindustan Unilever (HUL) vs. Tata Chemicals Ltd. (TCL) 2012, the IPAB revoked an HUL patent for a ‘filter cartridge’ which was challenged by TCL under revocation proceedings as being anticipated and lacking inventive step. It is noteworthy that the HUL PCT application had been issued an extremely adverse IPER by WIPO and the same had not been disclosed before the Indian Patent Office. The most significant piece of prior art cited in the IPER, was reportedly an EP patent. Coincidentally, this same EP patent was also cited by the Indian Patent Office during its examination and HUL managed to overcome the objections. The IPAB considered the suppression vital enough to constitute a separate ground for revocation of the patent. What further emerges from this decision is that the IPAB considered the filing of a PCT application in India as a foreign application.

Divisional applications

Section 16 of the Patents Act relates to the filing of divisional applications which, as the name suggests, is divided out of the main application, called the parent application.

The IPAB has adjudicated on the maintainability of a divisional application filed under Section 16 of the Act and laid the following principles:

i. Divisional can be filed only if the parent application has more than one invention
ii. There should be no overlap of claims
iii. Same scope specification - The matter disclosed in the divisional application should not include any matter not disclosed in substance in the complete specification of the parent application

Section 16 therefore mandates that the filing of divisional application can be affected in two circumstances:

  1. A voluntary divisional application; or
  2. Mandatory divisional application with a view to overcome an objection raised by the Controller on the plurality of distinct inventions

In LG Corporations vs Controller of Patents 2011, the IPAB dealt with the issue of maintainability of voluntary divisional application from a parent application which has been abandoned under Section 21(1) of the Indian Patents Act by failing to respond to the objections issued in the first examination report within the stipulated timeframe is maintainable or not. The divisional application had been filed when the parent application was active and the parent application was subsequently abandoned after the filing of the divisional application.

Further, there was no objection in the parent application in the first examination report on "plurality of distinct invention or single inventive concept" and the claims of the divisional application were identical to those of the parent application. The IPAB interpreted Section 16, so as to mean that the applicant is entitled to file a voluntary divisional application only if there are more than one inventions in the parent application.

The IPAB held that filing of the divisional application as done in the present case, is only an attempt to revive the abandoned application and therefore, is not permissible. A further finding of the IPAB was that, if the divisional application status is denied, then the said application in any event is not entitled to a grant, as it would then be anticipated by the parent application.

The IPAB has provided further clarifications in Bayer Animal Health GMBH, Germany vs. UOI and ors 2012 and Syngenta Participations vs. UOI ors 2013, and held that, the word “division” cannot mean split one invention into splinters. It can only mean splitting one application into more than one so that each application is for a separate invention. This is how the word “division” is to be understood under section 16 of the Patent Act.

In view of the above decisions of the IPAB, the strategy for filing of divisional applications in India has completely changed, voluntary divisional to compulsorily showing distinctness of invention.

Compulsory licensing

Compulsory licensing (CL) is another facet of the Indian Patent System, which has evolved from dot to a full circle. There were no compulsory licenses applied or granted in the 1970 Act to any pharma product and in the last decade, almost all provisions of the CL have been tested.

A CL may be granted at any time after the expiration of three years from the date of grant of a patent under section 84 of the Indian Patents Act. Any person interested may make an application to the Controller for grant of a compulsory licence in respect of a patent on any of the grounds that the:

  1. the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
  2. the patented invention is not available to the public at a reasonably affordable price, or
  3. the patented invention is not worked in the territory of India.

Besides the above, Section 92(A) provides for CL to manufacture and export to any country having insufficient or no manufacture capacity to address public health problems and Section 92 allows CL upon notification by Central Government in case of national emergency or extreme urgency or public non commercial use. The 92(A) provision was tested by NATCO against Pfizer and Roche patents but the attempt was more like a swan song, with withdrawal of the applications in the end.

The establishment of the Appellate Board (IPAB) in 2007 and the notification of Patent Rules in 2010 for patent matters completed the basic procedure for a smooth and effective functioning of the IPAB

However, the history of Indian Patent System changed with NATCO being granted a CL under section 84 in 2012 for Sorafenib Tosylate (Nexavar), a life extending drug patented used for the treatment of advanced stages of kidney and liver cancer, developed and launched by Bayer Corporation at 6% royalty of the selling price. The price at which the generic drug will be sold appears to be the lowest price.

Even prior to invocation of these grounds, Bayer was not given an opportunity of being heard in the matter for establishing a "prima facie" case for "consideration" of the compulsory licence application filed by NATCO before the final disposal of the application for Compulsory Licence which resulted in the curtailment of the rights of the patentee.

The main ground which formed the basis for grant of Compulsory Licence was that reasonable requirements of the public were not met at reasonably affordable price. On a fair perusal of the Controller General's order, it is difficult to understand whether, the Patentee is required to sell his drug at a "reasonably affordable price" or "lowest affordable price" given that millions are spent on research and development for the development of a new drug and the expenditure incurred by the patentee in keeping the patent in force.

Further, the ground of the patented invention not being worked in India was also against the Patentee. Working statement for all granted patents is therefore being taken very seriously by the Indian Patent Office only recently. Bayer filed an appeal against the order of the Controller General at the IPAB and the order is expected on 4th March 2013.

Recommendation of the Opposition Board

In Diamcad N.V. Ors vs Sarin Technologies Ors 2012, the IPAB held that the recommendations of the Opposition Board in a post-grant opposition must be shared with the Patentee to allow addressing of the adverse findings of the Board, which the Controller may rely upon to revoke the patent. This direction was reaffirmed by the Supreme Court in December 2012 when the Supreme Court set aside the revocation of Sugen's patent on Sunitinib (Sutent) on the ground that principles of natural justice were not adhered to by the Controller, since the Opposition Board's recommendation was not shared with the parties.

The Patent office provided the opposition board recommendations to the parties, and after another round of hearings, issued a decision again revoking the patent in 2013. Sugen Inc. filed a writ petition on several preliminary issues before the Delhi High Court and the Delhi High Court directed the IPAB to hear the stay application of Sugen on 26th February 2013. The IPAB heard the matter and stayed the removal of the entry of the patent from the Register of Patent and the matter has been posted for hearing on the stay application on 25th March 2013.

The electronic filing system of the patent office has been recently upgraded in 2012 with a more transparent and user-friendly progression

Another important case is the Roche vs. Cipla before the Delhi High Court is for Roche's Indian Patent for Erlotinib (Tarceva). The patent was brazenly infringed by Cipla by introduction of a much publicised launch of the generic version, Erlocib, at one third the price. Roche rushed to the High Court however, did not receive any interim injunction for public interest reasons. After a full trial, the single judge held that the patent is valid but not infringed. This decision has been appealed by Roche and is pending before the Division bench.

There is of course one more important patent case, the cherry on the pie, Novartis vs. UOI that has tremendously influenced the Indian Patent regime and brought India to the centrestage of the global IP field. Novartis' product beta-crystalline of imatinib mesylate, (Glivec) patent application has been through a roller coaster since its filing in 1997. On one hand, the Exclusive Marketing Rights (EMR) led to injunctions against generic manufacturers, and on the other, the multiple pre-grant oppositions concluded with refusal to grant of patent. Novartis challenged the refusal as well as the constitutional validity of section 3(d).

The Madras High Court upheld the constitutional validity of section 3(d) whereas refusal order came before the IPAB, where various issues were dealt with such as patentability, novelty, inventive step, sufficient disclosure and efficacy under section 3(d). IPAB held the invention to be novel and inventive but still did not allow the application to proceed for grant mainly relying on public order and morality issues related to pricing and Section 3(d). Novartis challenged the IPAB’s order before the Supreme Court and after 100 hours of argument, the order is reserved and expected anytime now.

Conclusion

The Indian patent system is certainly in the limelight and is in constant evolution. The international recognition of the importance of Indian patents and the much better equipped patent office are sure to attract more pace to the state of events. The patent office recently issued draft guidelines for patenting inventions related to traditional knowledge, biological resources and in the area of biotechnology at large.

Disclaimer-The views expressed in this article are the personal views of the author and are purely informative in nature.

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