Process Patents and Product Patents

1The fact that pharmaceuticals were inevitably regarded as a part of public health, led many countries to provide for special regulations for them. Some countries which granted product patents for ordinary inventions allowed only process patents for pharmaceuticals. India too, till 2005, granted only process patents for pharmaceutical substances. This enabled Indian manufacturers to make copies of drugs patented elsewhere by finding out the constituents through reverse engineering. It is believed that the distinction between a product patent and a process patent was instrumental to the success of the pharmaceutical industry in India.

2The 1970 Act, in its original form, introduced the unique distinction between process and product patents. While the definition of invention under the Act provided for patents for both processes and products, it was the exception contained in s 5 that qualified instances where only methods or processes of manufacture were patentable. Section 5 of the Act has been omitted by the Patents (Amendment) Act 2005. Before its omission, the section read as under: 5. Inventions where only methods or processes of manufacture patentable.— (1) In the case of inventions— (a) claiming substances intended for use, or capable of being used, as food or as medicine or drug, or (b) relating to substances prepared or produced by chemical processes (including alloys, optical glass, semi-conductors and inter-metallic compounds), no patent shall be granted in respect of claims for the substances them selves, but claims for the methods or processes of manufacture shall be patentable. (2) Notwithstanding anything contained in sub-section (1), a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug, except the medicine or drug specified under sub-clause (v) of clause (1) of sub-section (1) of section 2, may be made and shall be dealt, without prejudice to the other provisions of this Act, in the manner provided in Chapter IVA. [Sub-section (2) of section 5 was introduced by the Patents (Amendment) Act 1999.] Explanation— For the purposes of this section, 'chemical process' includes biochemical, biotechnological and microbiological process. [Explanation to sub-s (2) of s 5 was introduced by the Patents (Amendment) Act 2002.]) Section 5 offered only a process patent for food, medicine or drug substances and specifically excluded product patents for the same. The exclusion of medicines and drugs from being a subject matter of a product patent enabled local companies to manufacture drugs that enjoyed a product patent protection elsewhere. This concession gave the Indian pharmaceutical companies a right to manufacture drugs patented elsewhere by employing a non-infringing process.

3A process patent refers to a patent granted to a process or method of making an article. 'Patented article', has been defined for the purposes of ch XVI of the Patents Act, to include any article made by a patented process. As we have seen, the right to manufacture a product is one amongst the many rights that accrue upon a patentee. In the case of a process patent, the patentee is given exclusive right to manufacture an article using a particular process for which the patent is claimed. The patentee can stop any person from using that particular process to manufacture the article. A point that needs emphasis here is that the right to manufacture the end product is not per se hindered. Only a particular way of manufacturing a product, that is to say, a particular process is claimed and protected. As such, there is no bar for a competitor to manufacture the same end-product using a different method or process. In this way, process patents for pharmaceuticals do not curb the manufacture of medicines and drugs. The competitors in the market are free to manufacture the product using different process. Thus, a process patent restricts only some of the means through which a product can be manufactured, but does not restrict the ends of manufacture.

4Product patent refers to patent protection granted to the end product. Any method of manufacture which results in the patented product would amount to an infringement.

5In Cipla v F Hoffmann-La Roche (2015) (paras 64 and 77) the Division Bench held that a "product patent protects the product in any form however it is made, or however it is formulated." The Court further held that where the product is a "single molecular structure" it will include all polymorphic forms which will have the same chemical structure covered in Claim 1 of the patent.