“Now these are the laws of the jungle, and many and mighty are they…” – Rudyard Kipling wrote these lines over 100 years ago in his “Law for the Wolves” from the famous Jungle Book. As IP practitioners we are constantly reminded of the complex nature of today’s Indian IP jungle and the many and mighty laws therein. This article will discuss some of the peculiarities of the Indian patent laws with the 1st part focusing mostly on differences in patenting practice between Europe and India. The differences in practice between the four Indian patent offices will be discussed in the 2nd part of the article, incl how clients should use this strategically.
India is a WTO member and has signed the TRIPS Agreement which provides patent protection for a period of 20 years from the filing date of the application. In addition to the typical requirements for novelty, inventive step and industrial application the subject matter of the invention must moreover not fall under one of the (many!) excluded classes from patentability, the best known being the Section 3(d) exception relevant to many pharmaceutically active compounds, which holds i.a. that a new form of a known substance is not an invention unless it shows “enhanced efficacy”.
Indian case law (Glivec case: Novartis vs. Union of India) has established that by “efficacy” is meant therapeutic efficacy which means that arguments for inventive step accepted under EP law like eg. higher stability of new crystalline compounds or salts will not be accepted as “enhanced efficacy” under Indian law. Improved bioavailability is on the other hand specifically mentioned in Glivec as not ruled out as an example of “enhanced efficacy”. Thus some hope still exists!
India does not permit claims to a method of medical treatment, nor claims presented in 1st or 2nd medical-use format. Claims to a pharmaceutical composition containing two or more active components may be permitted, provided 1) all the active components and their concentrations are specified in the claim and 2) support for an unexpected synergistic effect are provided in evidence of an enhanced efficacy of the claimed composition in comparison to known compositions. Such comparative data (ie not stand-alone) must be present in the application at filing in India.
India does not allow for utility model protection, but does allow for “Patents of Addition” which relate to improvements or developments of the invention to which the patent application or granted patent relates; the subject matter does not have to involve an inventive step over the parent patent or application, but must share the same inventive concept and have absolute novelty. The term of a Patent of Addition is the unexpired term of the main patent. No annuity is payable. Patents of addition should be considered as an interesting option for European clients.
Publication of the unexamined Indian application occurs at 18 months after filing; an examination for novelty etc. is subsequently conducted before a decision is made whether to grant the application. Typically this process takes 5-8 years. In contrast to European practice, pre-grant opposition may be filed at the IPO by any party, and without payment of fee. Post-grant opposition may be filed within 12 months of grant at the Indian courts but only by an “interested party”, and can be a very longwinded affair. The grounds for both pre- and post-grant opposition include i.a. the right to the invention.
Once granted, India has a working requirement: Every patentee and licensee has to furnish annual statements regarding the working of the patented invention on commercial scale in India. Importation does not count towards the working of the invention. Compulsory licensing may be granted to local Indian companies in case working requirements are not met.
In the second part of the article we will discuss some further peculiarities of the Indian patent system incl. options for patent office “forum shopping”, the extensive disclosure formalities and compulsory licensing issues.
Michael Bech Sommer, European Patent Attorney