Guest Post: To be or not to be 3(d)

SECTION 3(D) –AGAIN?

In a recent article DNA reported that, several companies were filing patent applications for various forms of the same substance. The problem being that most of these forms did not satisfy the enhanced efficacy test laid down in section 3(d) of the Indian Patents Act. The example which follows is borrowed from the article and aims to illustrate how this new scheme works, “In September 2009, a patent application for AIDS drug darunavir was rejected as it did not meet patentability criteria laid down in the Indian Patent Act… But one patent rejection is not the end of the story for J&J… Darunavir still has six other patent applications for various forms floating in patent offices across India.” As is evident from the example, the concern which arises in this situation is that there is a very high likelihood that such practices could lead to grant of patents for non-patentable innovations. Apart from issues under section 3(d) of the Patents Act, there are other issues such as evergreening, which arise in this context.

The problem becomes more serious in light of the allegations published by Mint in December 2008 article with regard to the grant of substandard patents by the patent offices. The article states that such substandard patents (which fall foul of section 3(d)) are being granted as a result of a corrupt nexus between so-called patent agents, or lawyers employed by drug firms to manage their patent application process, and patent officials.

IT MUST BE THE BIG BAD MNC…

Interestingly, this new game plan isn’t used solely by the big bad MNCs, Indian innovators are also adopting this technique. The Mint report accounts for the likes of Cipla Limited having made use of this method to file patents for mere modifications. It is important to point out that, while one understands the media support for the Indian pharmaceutical companies in their fight against the International MNCs to maintain their market share, such support is clearly going the wrong way when the international MNCs are continuously painted in a negative light in the press but the Indian pharma companies get away with murder. Such leniency towards the Indian pharma companies does not help anyone. There is a need to go after all companies who are guilty of misusing processes, whether Indian or international.

NOT THE MNC, MUST BE THE GOVERNMENT!

All of this can easily be brushed aside with the usual rant which would read as follows, there are only four patent offices, all these offices are extremely short staffed and most importantly, there is no proper infrastructure to ensure effective communication between offices. Mr. Kurian himself in an interview with the Hindu admits all of these issues. All these problems stem from lack of planning by the legislature in the earlier stages. Though the laws are in place, the acts have been amended, the legislature clearly has not thought ahead to ensure that the infrastructure requirements are in place to meet the challenges which will be posed by enacting and enforcing additional laws, measures and regulations. Hence, with increased number of applications, devious methods employed by applicants and the poor infrastructure, the Indian patent officials are clearly fighting a losing battle. Even though the patent office is taking steps like upgrading the IPIRS, these measures are simply too small and tad too late in time. One can’t really blame the patent office for this debacle. In fact, the government might want to think of a ‘look before you leap’ strategy.

However, given allegations of the existence of a corrupt nexus and a generally non transparent process, the excuses given above work as a blind screen to hide the actual issues. While, the Mumbai patent office has undertaken investigations after the publication of Mint’s report, the accountancy levels on a general basis are still not satisfactory. As Shamnad stated in his interview to Mint, “If [the allegations of corruption and grant of sub-standard patents is] true, this lack of application of mind casts serious doubt on the level of scrutiny in examination and the situation needs to be remedied.”

It should be noted that none of this is to take away from the excellent work being done by Mr. Kurian, who is striving to increase the transparency and accountability levels at the Indian Patent offices. The best way forward is for the government to step up and support Mr. Kurian in hiring more manpower and having more resources and training.

WAIT, WHAT ABOUT THE LAW?

The Indian Patents Act allows for pre- and post– grant oppositions to be filed against patent applications and patents granted (post grant oppositions can be filed with the concerned patent office until 12 months after the grant of patent). Shamnad’s post titled, “Patent Oppositions in India: The “Efficacy” of Section 3(d)” elaborately explains the entire opposition process and its implications under the Patent Act. In the present case our concern is that, while the law allows for filing of oppositions to the grant of patents, we are not using this process effectively. As the Mint article provides, there were no pre- or post-grant opposition to the award of any of the 10 patents granted for mere modifications. Again it is the government which needs to step up and think of ways to incentivize the usage of the opposition processes under the Patents Act.

MEASURE OF SUCCESS

Some time back while going over some archived articles published by Managing Intellectual Property I came across the article, “All Eyes on India”. The article has quite a lot of fanfare relating to the 2005 amendment to the Patents Act and how India is stepping into the brave new world. The interesting bit comes under the heading modernization, where the author says that, “..the Indian Patent Office is doing a great job. The Indian Patent Office has granted a record 15,262 patents between 2007 and 2008, which is more than double the 7,539 patents granted between 2006 and 2007…” Note that this article isn’t alone in measuring success of the system on the basis of numbers; this method is adopted in several other instances (please discount the effects of the credit crunch while reading the report). However, any such measure of success loses relevance when the issues of corruption, lack of transparency and grant of sub-standard patents comes forth. Any assessment of success needs to be done on the basis of the quality of work by the Patent offices and not the quantity, simply because assessing success on quantity creates a perverse incentive to grant as many patents as possible, which obviously isn’t what we are looking for!

To end on a positive note: A spokesperson for Teva (one of the companies involved in this entire fiasco) stated that “Teva has faith in the Indian Patent Office, which is certainly well acquainted with the Indian Patent law…” Really? You think so!Oh well…

(Image from here)

P.s. I would like to thank Shamnad and Sai for their comments on the post and for tolerating me constantly pestering them.