India's Intellectual Property Right Enforcement Woes

In about mid nineteenth century, Charles Dickens urged America, the then developing nation with difficult economy, to join the fight towards better international copyright system for literary works. It was a time when literary works were reprinted and sold unauthorised in America, depriving authors of royalty. He met with strong criticism from the American press.

Today, we see the prominence of Intellectual Property (IP) rights around the globe. With globalization and increase in trade, IP related issues are important while doing businesses between nations. Courtesy the developed nations of World Trade Organisation (WTO), all the member countries, have  IP laws in accordance to the standard laid down by agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which came in effect from 1995. India with rapid economy change and huge consumer market caught business world’s attention and past decade has indeed witnessed better foreign trade and also effective increase in foreign patent applications. In recent times there has been criticism and apprehensions against India’s IP policies and also allegations that India discriminates against foreign patent applicants. A glance at data provided by India’s IP office last year regarding pharma patents substantiates that such unfitting allegations are overreactions and probably pressure tactics. As per the said data, out of the total pharma patents granted in India in the preceding 3 years about 77% were granted to the foreign drug makers.

As discussed in my previous blog article here , section 3(d) of India’s Patent Law has been the centre of international ire alongside the issue of compulsory license under sections 84 and 92. With rights come responsibilities. If a patent owner with 20 years long monopoly, wilfully or else, does not work his inventions satisfactorily  , specifically when it comes to healthcare system, in view to safeguard public interest, India’s Patent Law avails the flexibility under TRIPS and provides with provisions in favour of compulsory license, whereby certain parties are allowed to use or manufacture a patented product without the permission of the patent owner in exchange for a specified royalty. Under TRIPS, which provides flexibilities in order to prevent abuse of patent rights by the patentee (patent owner),each member country is free to determine the grounds upon which the compulsory licences are granted. In India subject to additional factors and strict process of law, compulsory license may be granted in following cases-

If reasonable requirement of the public has not been satisfied or,

If patented invention is not available to the public at a reasonable affordable price or,

If the patented invention is not worked in India or,

In a case of a national emergency.

In March 2012, Natco Pharma Ltd. was granted India’s first compulsory license to produce Bayer Corporation’s cancer drug “Nexavar” .The decision which although in full compliance with domestic as well international law, sparked international criticism, with strong observations against it. It was presumed that India jumped on the bandwagon of granting compulsory licenses. Two years have since passed with no further grant of compulsory license and applications not complying with strict criterias mandatory to grant have been rejected.

To be at par with developed nations in enforcing IP rights, is a challenge for developing nations. Overburdened with socio economic problems, India is striving hard to sustain as well grow. In a country with high poverty and illiteracy rate, where many are not only unaware of their rights but completely oblivious that they have any right at all, it would be a mammoth task to spread awareness towards IP rights at ground level including small urban and rural India.

The real issue which does demand immediate further attention are counterfeit products in the market. It is important to prevent legitimate businesses of brand owners from suffering loss and strict actions against producers and marketers of counterfeit products is necessary. Better knowledge on IP Rights amongst people as well police is needed, since the duplicate product market is now more sophisticated, it is often difficult to distinguish between genuine and duplicates. IP owners, whether patent, trademark, copyright or design need to be vigilant and keep an eye on market against current or potential infringements. Ideally police should not wait for requests to take action against infringers, but in practice such is not the case and brand owners have to play a very active role in the whole process to ensure appropriate actions against the law breakers . Serious efforts are required in sensitizing judiciary and police to treat IP infringements at par with other serious offences

As put in by Leo Tolstoy, "Writing Laws is easy but governance is difficult..." , to have a favourable IP legislation is job only half done, it is important to strengthen all mechanism crucial in the process of enforcement. It is rather difficult for India's already stretched resource of police and judiciary to allot special attention to IPR enforcement. Increase in infringement cases are indicative of the fact that strong police attention is required along with zealous efforts on the part of government in allocating better resource towards spreading IP awareness and strict implementation of IP laws.

Please share your views, suggestions and queries in the comment box below. I can be reached at securingipr@gmail.com

High Cost of Patented Medicines, Evergreening And Section 3(d) Patents Act 1970 - A Perspective

Being world's second largest population, having supposedly third of worlds poor, India has always struggled to strike a balance between demand of affordable medicine and obligations under changing international patent regime.There is no denying that one of the side effects of Patent System is the high cost of patented drugs, often rendering medical care inaccessible to the poor. Patents are vital, as we understand, but to what extent patent helps in promoting innovation and research is debatable. In our country where basic necessities like food , clothing and housing becomes unaffordable to many, the concern for health seems to take a back seat and masses often seek medical help only when ailment becomes work disabling.

Escalating medicine price made the Indian Government introduce "Drug Price Control Order" (DPCO) back in 1970s, aiming to gain control over price. Also, by Patent Act 1970 India banned patent for 'product' but recognized novel 'process' for manufacturing drug. The impact was seen , these reforms facilitated growth of Indian Generic Pharmaceutical Industry. Generic drug makers manufactured copies of the drugs by developing their own processes for the end product and providing medicines at a drastically reduced price.

But with mounting international pressure to make Indian Patent Law TRIPS compliant, India had to introduce "product patent" by 2005, thereby providing Patents both on pharmaceutical products as well the processes involved in manufacturing. Hence, pharmaceuticals now thrive in an optimum environment of monopoly over the production and marketing of medicines, allowing them to fix prices at high rates to gain maximum profit.With the introduction of product patent there also arose the possibility of patenting minor and insignificant improvements specially in pharmaceutical industry. A strategy known as 'evergreening' often practiced by pharmaceuticals , whereby patent protection of an original product is sought to be extended further by obtaining patent for minor improvements. thereby keeping competition at bay for longer period. Resulting in longer periods of monopoly and incidental higher cost of medicines.

By amended section 3 (d) of Patents Act 1970, which reads as under:

.............

"Section 3.-- What are not inventions.—

The following are not inventions within the meaning of this Act,--

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.--

For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they duffer significantly in properties with regard to efficacy."

...........

the law prohibits patenting minor incremental innovations, unless it results into enhanced efficacy.

Implementation of section 3(d) became more clear post Apex Court's decision in 2013 against further grant of patent in the case of advancement cited in cancer drug Glivec .It was observed that no 'enhanced efficacy' was shown by the drug component in treating the ailment. Hon'ble Court noted that Section 3(d) of the Indian Patents Act, does not allow patents of new versions of known drug molecules, unless they make the medicine significantly more effective than before, Thus, better functionality of substance if not resulting in better therapeutic effect , cannot pass the test of patentability. Detailed report on judgement can be found in my earlier post  here.

Also, in 2013 section 3(d) was relied upon for the first time in not granting plant patent to Monsanto. Monsanto was denied patent for “a method producing a transgenic plant, with increasing heat tolerance or drought tolerance”, since the claims of patent application fell under section 3 (d) of Patent Act, the structure and function of cold shock protein was already known in cited prior art and was obvious to person skilled in art, whereby mere application of already known cold shock protein one can produce cold stress tolerant plant.

Section 3(d) has been the center of strong reactions. International pharma community argues, it stunts research and developments in pharmaceutical sector, as most of the inventions are incremental in nature, but if we look at the ever increasing pharma output in India, it confirms the fact that amended section 3(d) is in no way deterrent to growth of pharma industry. So it seems where the intent should be providing accessible healthcare to the masses, the real agenda is maximizing profit and keeping competition at bay. Hence, in view of 20 years long patent protection , India's stricter control over patent law specially where public health is concerned stands completely justified. 

For any suggestions/query I can be reached at securingip@gmail.com or please drop in your comments