IP India is holding a series of consultations on the manual. NN Prasad, joint secretary of the Department of Industrial Policy and Promotion at the Ministry of Commerce, chaired the first meeting in Delhi on July 24. After the meeting, IP India said in a statement that the meeting raised issues about “applications for patents in biodiversity, software, pharmaceutical products as well as on electronic filing”.
If approved, the Manual of Patent Practice and Procedure would not have the force of law, but would act as a guide for examiners. It contains a section that explains to examiners how to interpret the controversial section 3(d) of India’s Patent Act. Section 3(d) sets out what is not patentable subject matter, including: “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”.
The manual states that, to calculate increased efficacy the examiner should compare “the known substance and the new form of known substance. In case the new form is further converted into another new form, the comparison is made between the already existing form and another new form but not between the base compound and another new form”.
“This appears to be a clear attempt to prejudge the Novartis case,” said Shamnad Basheer, academic and founder of the blog Spicy IP. The case, which is still before the Intellectual Property Apellate Board, concerns Novartis’ application for a patent for imatinib mesylate, which is sold by Novartis under the brand name Glivec. The Chennai Patent Office rejected the patent application citing section 3(d). Deciding what is the known substance against which imatinib mesylate should be compared is crucial to deciding if it is patentable in India.
According to Basheer, the way the manual is phrased assumes that a new salt that emerges during an invention will be a “known substance”, which will make it harder to prove increased efficacy.
The Federation of Indian Chambers of Commerce and Industry has criticised the phrasing in the draft manual, stating: “This section does not cover guidelines about those inventions in which one crystalline form is converted into another crystalline form.”
Campaigners for open source software are also worried that the manual will open the way for software patents in India. Section 3(k) of the Patent Act states that: “A mathematical or business method, or a computer programme per se or algorithms, are not patentable.”
But Red Hat India has stated: “We find that the draft patent manual seeks to introduce software patents and we believe that this is not in consonance with the current legal situation in India.”
Section 4.11.6 seeks to draw a distinction between “software per se” and “software having its technical application in the industry”.
On August 23, the Free and Open Source Software group held a candlelit vigil in Bangalore, the home of India’s IT industry, to demonstrate against software patents. IP India has planned further meetings for Chennai on August 28. A meeting in Kolkata on August 21 has been postponed.
All comments received so far on the draft manual are available online here.
