Subverting The India Patent Act

THE Indian Patent Act was amended by the Indian parliament in March 2005, and due to the sustained pressure from the Left many problematic provisions of the Patents Ordinance issue by the government in December 2004 could be overturned. However, even at the time when the parliament passed the Patents Amendment Bill (2005) it was clear that certain sections in the government were not happy with the amended Patents Act.

PATENT OFFICE ISSUES DRAFT GUIDELINES

The CPI(M) had warned that we would require to be vigilant in order to ensure that the gains achieved by pushing through amendments suggested by the Left are not frittered away in the actual implementation of the amended Patents Act. The Controller General of Patents, Designs and Trademarks has recently published the draft guidelines for patent examiners, titled “Draft Manual of Patent Practice and Procedure” in the light of the amendments to the Indian Patent Act. These guidelines are important and in fact might hold the key to how the amended Act is actually implemented. While the Law embodied in the Patents Act provides the framework, its actual implementation is often determined by how it is interpreted through guidelines provided to patent examiners.

The major problem of the Draft Manual is that substantial portions of it are based on the documents and understanding of Patent Law of countries that are quite different from the amended Indian Patents Law. This is particularly true for the sections on Biotechnology and Software. All the examples in the software section, for example, are taken from the US and Europe, which currently grant patents on even naturally occurring genetic material, life form patents (US), software patents, business process patenting (US), new use patents, patenting of a minor variation of the original molecule, new dosage patents, etc. None of these are allowed in India under the Amended Patents Act, 2005. Therefore quoting extensively from case laws of these regions or judgements of such countries would make the examiner believe that the Patents Acts of these countries are quite similar and can be used as a basis for accepting or rejecting Patents in India.

Nowhere in the Draft Manual are these differences in Patents Laws of different countries brought out. Reading through the Draft Manual, particularly the biotechnology and software sections, it appears that the Draft Manual is specifically designed to defeat the purpose of the Amended Act.

PATENTING OF SOFTWARE

A case in point is that of software. During the debate on the December Ordinance on the Patents Act, the government repeatedly asserted that the amendment to the section of computer programmes was to allow for patenting of embedded software. Even though this provision was removed in the Act passed in March 2005, the Draft Manual states clearly that Embedded software is patentable. Not only that, software patenting has been sought now to be introduced by defining embedded software in such general terms that virtually any computer programme that runs on a computer can be patented. Therefore, the clause in the Indian Act that computer programmes per se cannot be patented loses any meaning. No computer programme can work without a computer; therefore defining embedded software in a way that allows a computer programme to be patentable by virtue of running on a general-purpose computer is to introduce software patents through the backdoor.

To prevent such interpretations, the guidelines should clearly state that the addition of conventional equipment to a software solution does not turn that solution into an invention. The Draft Manual should also make clear that data processing is not a field of technology in the sense of patents law and innovations in the field of data processing are not inventions in the sense of patent law.

In order to maintain the letter and spirit of the Indian Law the entire section on software in the Draft Manual needs to be redrafted. In this section the examples from the US are particularly misleading as the US Patents Office accepts Business Processes and software to be patented, unlike the Indian Law. The European Patent Office (EPO) has also started to grant software patents though the Act of European parliament, though the Patent Offices of many of the member EU countries do not accept software patents. Therefore quoting from US Court rulings or EPO rulings on software is completely mala fide and defeats the intent of the Indian Patent Law.

PATENTING OF GENE SEQUENCE

Similarly in the section on Biotechnology it is implied that a new gene sequence is patentable. As per the Indian law, only micro-organisms are patentable and not gene sequences. Clearly, the manual has based its guidelines on practices followed by the European Patent Office (EPO) or the US Patent Office.

The US Patent Law has always been liberal in granting patents in the area of biotechnology. The United States Patent Office (USPTO) has, since 1980, issued patents for over 6,000 genes and about 1,000 of these relate to human genes. Currently, there are more than 20,000 patent applications related to genes pending in the US. This is clearly the kind of practice that the Indian Patent Act seeks to prevent, but the guidelines in the Draft Manual would actually subvert this intention of Indian lawmakers.

MASHELKAR COMMITTEE

It must also be remembered that the Mashelkar Committee, set up by the government of India is mandated to look into issues related to:

1. Whether India would still be deemed to comply with TRIPs if it limited the grant of patents for pharmaceutical substances to new chemical entities or to new medical entities involving one or more inventive steps; and

2.Whether it would be TRIPs-compatible to exclude micro-organisms from patenting.

This Committee was set up on the recommendations of the Indian parliament as there was still no consensus on the above two issues. There was an explicit commitment given in parliament that the Indian law could be further amended if the recommendations of the Committee made this a necessity. Given this, the finalisation of the Draft Manual at this stage, amounts to anticipating the work of the Committee.

Clearly, there has been insufficient application of the mind in formulating the Manual in keeping with the nuances of the Indian law. It is imperative that the Manual not be finalised immediately and a much larger discussion should be held among those concerned with the issues. The Manual would be a very important tool in the actual implementation of the Indian Patents Act. As the Manual stands today, it has the potential to subvert many elements of the Indian Law. It is entirely unacceptable that a Manual on procedures should seek to patents overturn an Act that has been extensively debated and then legislated upon by the Indian parliament.