| the Indian Patent office at New Delhi rejected a | | | | form. |
| patent application by German drug major | | | | Besides that the application was also opposed |
| Boehringer Ingelheim claiming syrup form of | | | | under section 3(e) of the Indian Patent Act that |
| anti-AIDS drug nevirapine. | | | | renders “mere admixtures” of substances |
| The brief facts of the case were as follows: | | | | resulting in aggregation of properties of the |
| The base salt i.e. Nevirapine used as anti-AIDS | | | | components from being a patentable invention in |
| drugs was invented way back in 1989 by | | | | India. |
| Boehringer Ingelheim and the base salt | | | | The relevant provisions of the Indian Patent Act |
| was never patented in India. But later on | | | | read as under: |
| Boehringer Ingelheim filed an application for Grant | | | | CHAPTER II |
| of Patent rights for syrup form of its anti-AIDS | | | | INVENTIONS NOT PATENTABLE: |
| drug nevirapine. In due course the application was | | | | 3. What are not inventions- the following are not |
| published in the Indian Patent Journal and under | | | | inventions within the meaning of this Act,--- |
| the provisions of Section 25(1) of the Indian | | | | (d): the mere discovery of a new form of a |
| Patent Act, the Indian Network of People Living | | | | known substance which does not result in the |
| with HIV/AIDS (INP+) and the Positive | | | | enhancement of known efficacy of that |
| Women’s Network (PWN) filed a pre-grant | | | | substance or the mere discovery of any new |
| opposition against the said patent application of | | | | property or new use for a known substance or |
| Boehringer Ingelheim in May 2006 at New Delhi | | | | of the mere use of a known substance or of the |
| Patent office. | | | | mere use of a known process, machine or |
| The effect of filing of Pre Grant Opposition by | | | | apparatus unless such known process results in a |
| any person is that the application may be | | | | new product or employs at least one reactant. |
| examined but would not be granted unless the | | | | Explanation: For the purposes of this clause, salts, |
| Pre Grant Opposition is set aside. The patent | | | | esters, ethers, polymorphs, metabolites, pure |
| application was objected under the most | | | | form, particle size, isomers, mixtures of isomers, |
| controversial provision of the Indian Patent Act, i.e. | | | | complexes, combinations and other derivatives of |
| Section 3(d) that prevents many “new | | | | known substance shall be considered to be the |
| forms” of known substances from being | | | | same substance, unless they differ significantly in |
| patented unless there is a significant improvement | | | | properties with regard to efficacy. |
| in their efficacy with regard to previously known | | | | |