Its strategies sans frontiers in pharma patent filings

Written by Pallavi Ail | Mumbai | Updated: Nov 6 2013, 05:54am hrs
PharmaA cursory look at the database reveals little difference between Big Pharma and homegrown companies on their patent strategies
India's patenting criteria receive both global censure as well as appreciation for their exclusion of incremental inventions of little curative value. But the country doesnt appear too stingy in granting these exclusive rights. A cursory look at the database reveals little difference between Big Pharma and homegrown companies on their patent strategies, after the country embraced product patenting in the pharmaceutical sector in 2005.

Of course, some like Swiss major Novartis appear to have been less choosy than others when it comes to patent filings in India, while a few others notably US major Pfizer have recorded much better success rates in securing patents in India due to their selective approach.

Novartis, it may be recalled, was in the eye of a storm over the stout defence of patent protection to its cancer drug Glivec and the Supreme Courts subsequent denial of the right in a landmark ruling in April. The court refused patent protection to Glivec on the grounds of the substance in question being an amended version of a known compound, failing to pass the scrutiny of Section 3(d) of Indias Patents Act. For the record, Pfizers cancer drug Sutent also lost patent protection in India last year.

The Indian government claims that Section 3(d) is compliant with the WTOs Trade Related Aspects of Intellectual Property Rights (TRIPS), a view more or less endorsed by the World Intellectual Property Organisation (WIPO).

Curiously, domestic drug-maker Cipla, an ardent votary of generic medicines and known for supplying an AIDS drugs cocktail to patients in Africa and elsewhere at a fraction of the innovator prices, is also a patent-seeker like any other large Indian company. To be fair, Cipla founder-chairman Yusuf Hamied has not denounced the concept of patents but only argued for generic producers getting the right to break patents by paying what he considers reasonable royalty to the patent-holder in case of national emergencies or other public health exigencies.

Novartis has applied for 1,435 patents in India since 1995, out of which only 267 were granted, a success rate of 19%, which is below par. Pfizer, however, has the distinction of getting the most number of patent applications approved. With 675 patents issued out of 1,402 applications (a success rate of 48%), it is quite ahead of its closest competitor Roche Holding with a success rate of 42%. Others, whether Indian or foreign, have success rates of between 10% and 25%. Cipla has filed for more than 360 patents, and has a grant rate of 20%.

The patent applications data reviewed by FE include those for which patents have been granted, are under examination or rejected by the Patent Office and also those abandoned/withdrawn by the company. Some of these pleas are in the to-be-examined category.

The applications database hosts data since 1995 while the patents granted data contain details of all the granted patents, irrespective of the date of filing.

The summary of the titles of patent applications exhibits a diverse variety of inventions. Drug developers do not limit their patent pursuit to only medicines or other end products but numerous other information/pathways that could potentially have a commercial utility. For example, in 2006, Ranbaxy Laboratories applied for a patent for method of providing product information using adhesive free printed literature, which it later withdrew.

Companies guard their data zealously: A Pfizer application dated May, 2011, describes the invention as an apparatus for handling capsules and capsule processing equipment including such an apparatus. The application is awaiting examination.

Drug delivery mechanisms have always been a field of intense research and new drug delivery systems (NDDSs) of extant drugs are vigorously patented. Section 3(d) excludes new forms (such as isomers, salts etc,) of existing substance from patenting unless it resulted in an appreciable enhancement of efficacy of the medicine in question. In other words, there is no explicit bar on patenting of NDDSs, an R&D area relatively less costly and within reach of leading Indian companies.

Frances biggest pharmaceutical company, Sanofi SAs German subsidiary Sanofi-Aventis Deutschland GmbH teamed up with Japanese medical device maker Terumo Corp in its 2007 application titled, dose display mechanism for a drug delivery device. The application is awaiting examination.

Gujarats Cadila Healthcare has an unusual patent application: Sugarless ice-cream and the process of producing it, is the title of its 2011 filing. The patent database puts the current status of the patent as, request for examination not filed.

However, the majority of the applications still tend to lean towards the process of drug development and novel pharmaceutical compounds or improved processes.

Indian companies are doing more R&D. There are some companies who have good research pipelines, but do not have enough funding to take it to the next level so that they are able to commercialise that research. You may see some collaborations with big companies. Overall awareness has definitely improved, said Nishith Desai Associates Partner Gowree Gokhale, an expert in Indian patent law. She added that more Indian companies have opted for patent filings in the last three to five years.

India is still grappling with an inadequate pool of patent examiners. Many of the patent filings are of international nature (simultaneous filing in multiple countries) thanks to the Patent Cooperation Treaty (PCT) route. There is also the system of pre- and post-grant objections to patents and this militates against bad and frivolous patents.

Lall Lahiri & Salhotra partner Rahul Chaudhry said it is fairly reasonable to expect patenting strategies of individual pharma companies to be dependent on how much the molecule is important to the firms business. According to Chaudhry, India presents pharma companies with unique challenges and opportunities, including a vast market, a robust manufacturing sector, potential for monetising patented inventions.

In the pharmaceutical industry, patents are sometimes applied for with basic, minimal data, which prove that the substance is efficacious. The company would then conduct in-vitro and in-vivo studies to validate these discoveries and establish their effect on particular illness, a process that may take years. The failures in the course of these experiments are common and therefore, a major chunk of patents applied for/granted never reaches the commercial arena. Pre-empting others from making use of the knowledge gathered by it is often the motive behind patent filings.