The curious case of medical method patent: Can doctors patent surgical procedures?

Around a month ago, the Times of India reported that a Satara-based Gynaecologist Dr.R. S.Katkar had received a patent for microsurgical recanalisation operation. This story made us do a double take! Did the patent office err and grant a medical method patent or was it a case of misreporting by the Times of India? Well, we did a little bit of research on this and turns out that the patent application had just been published in the patent office journal as 698/MUM/2013. We contacted the inventor Dr.Katkar, and were astonished to find that he was blissfully unaware of the fact that a published patent application is not the same as a granted one and that it takes at least a year or two (often times more) to get a patent. Even more surprising was the fact that he had no clue that methods of treatment were not patentable under Indian patent law [Section 3(i)] .Apparently, his patent agent through whom he filed the application never informed him of any such prohibition. 

In the TOI article, Dr. Katkar has been quoted as saying “The success rate of microsurgical recanalisation of fallopian tubes is 80% in developed countries. I studied the reasons for 20% failure rate and developed one unique technique to minimize this. The patent has been awarded for this modified procedure.” 

Patent eligibility of medical method patents 

Section 3(i) of the Indian patents act precludes medical method patents from the scope of patent eligible subject matter because they compromise patients’ rights by limiting access to inexpensive treatments and also restrict practitioner’s freedom. Section 3(i) states “Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products is not an invention.” Any operation on the body which requires the skill and expertise of a surgeon, any therapy or diagnosis practiced on a living human or animal body are excluded from the scope of patentability under Section 3(i).

Unscrupulous patent agents 

The patent application and prosecution procedure in India is lengthy, not to mention complicated. For a patent application to advance to issuance stage several criteria should be met. Firstly the subject matter should be patent eligible (section 3). Additionally a comprehensive prior art search must be conducted to determine state of art and the invention should be novel and possess inventive step over the existing art. Then there is this enablement requirement, claim construction so on and so forth. One has to have a clear understanding of the nuances of the invention and intricacies of the laws. Obviously this is an overwhelming amount of information for an inventor to grasp, understand and comply within a short period of time. So hiring a patent agent/attorney becomes essential. This is an expensive exercise and sometimes inventors are taken for a ride by unscrupulous agents. 

In this case, Dr.Katkar informed us that a patent agent a certain Mr.Bhavesh had charged Rs.70, 000 for drafting the patent application alone!! A search at the electronic register of Indian patent agents reveals that there is no agent registered by this name. Section 129 of Indian patents act clearly states “No person either alone or in partnership with any other person, shall practise, describe or hold himself out as a patent agent, or permit himself to be so described or held out, unless he is registered as a patent agent or, as the case may be, unless he and all his partners are so registered.” This particular person (Mr.Bhavesh) posing as a patent agent, not only did he charge an exorbitant amount but he also failed to provide sound advice regarding patentability of the invention. Incredible! 

Empowerment of Independent inventors 

The national innovation foundation (NIF) and affiliated organizations have wonderful cost effective initiatives to help and advice grassroot innovators throughout the process of filing and commercializing the invention Anubha had blogged about this here.

The patent facilitating center(PFC) a wing of TIFAC,department of science and technology, Govt of India provides techno-legal as well as financial support for securing patents and post issuance support. However this support is restricted to innovations funded by Indian universities/governmental agency. 

On the international platform USPTO has a specialized cell dedicated to independent inventors. This cell has various tools and provides inventors access to a wide array of resources. Inventors are strongly encouraged to file patent applications on their own behalf (pro se). Else the USPTO along with several IP law associations has designed pro-bono programs to assist financially under resourced independent inventors so that no worthy invention is left undiscovered. 

In India more such initiatives are needed to assist independent inventors in patent filings, to increase awareness among inventors and improve the overall innovation ecosystem.