The IPO’s draft guidelines for biotechnology patents – A cause for worry?

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Close on the heels of finalizing the guidelines for examination of patent applications related to traditional knowledge (TK) and biological materials, the Controller General of Patents has recently published guidelines for the examination of ‘biotechnology patents’. The guidelines can be accessed over here and the public notice can be accessed over here. 

Comments on the same are due by the 11^th of January, 2013. I invite our readers to send in guest posts on the issue, to be published on Spicy IP.

Before discussing the new guidelines, I must voice my concern with the manner in which the guidelines for TK have been finalized. Why has the Controller General not published any of the responses received by the Patent Office? The DIPP always publishes all of the responses it receives to its discussion papers. Why pay only lip service to the process of public consultation? We deserve to be informed on how the guidelines have been received by the patent community.

With regard to the draft guidelines for biotech patents, it appears that the patent office has spent quite some time in preparing these guidelines. Although the guidelines fail to expressly state so, it should be remembered that, like the Patent Office Manual, these guidelines, do not have the force of law. They have not been prescribed under any provision of the Patents Act, 1970 and as such should not have any binding effect on the Controllers & Examiners involved in the examination process.

What I find particularly disturbing is the numerous examples and the definitive language used in the guidelines. This is not in keeping with the conventional practice of using manuals and guidelines to only collate judicial interpretation of patent law, in order to update the examiners and controllers on the latest judicial precedents along with patent office practices in past cases. Manuals and guidelines cannot be used to prejudge cases. 

   

The draft guidelines for biotech patents: The general theme of the current guidelines is aimed at increasing the standards of patentability for biotech patents and if implemented, I can only assume that these guidelines will make it very, very difficult to secure biotech patents in India.

I’ve discussed a few of the problematic issues with these guidelines below:

(a) The morality patents: On page 11, the guidelines deal with the impact of Section 3(b), which prohibits the patenting of inventions contrary to morality. The guidelines interpret this provisions to prohibit the following inventions: “A few non limiting examples may further clarify the issues: (a) a process for cloning human beings or animals; (b) a process for modifying the germ line of human beings; (c) a process for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such process; (d) a process for preparing seeds or other genetic materials comprising elements which might cause adverse environmental impact, like terminator gene technology; (e) uses of human embryos for commercial exploitation.”

Two issues arise with the above conclusions:

(1) Since when has the patent office started bothering itself with ‘terminator genes’ and how do ‘terminator genes’ offend anybody’s morality, especially when the Ministry of Agriculture seems to be encouraging Monsanto’s use of such genes? Is the Patent Office trying to call the Agriculture Minister Mr. Sharad Pawar an immoral man? The insertion of that phrase in the guidelines gives rise to the suspicion that these guidelines have been drafted by certain interest groups who are using the Controller General’s office to push forward their agenda;

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(2) Since when did India have a ‘moral issue’ with using human embryos for commercial exploitation? Although the guidelines do not state so, I am assuming that the prohibition is targeted primarily against harvesting stem cells from human embryos. This issue generated considerable heat in Christian countries where abortion is either prohibited or frowned upon. The situation is drastically different in India where there has been no debate on abortions and if I am not mistaken government hospitals themselves carry out abortions.  

Both of the above examples raise issues of how and why the Patent Office is seeking to define the standards of morality for the future of science. Such decisions are best taken by our elected representative and not bureaucrats. The guidelines on Section 3(b) should therefore be deleted without any mercy for its contents.      

(b) The bar against the patenting of micro-organisms: The guidelines deal with the patenting of micro-organisms under Section 3(c) and Section 3(j) of the Patent Act. Section 3(c) is a standard provision of patent law around the world and prohibits the patenting of scientific principles and discovery of any living or non-living substance occurring in nature. Section 3(j) prohibits the patenting of plants and animals other than micro-organisms.

The guidelines, on page 12, prohibit the patenting of micro-organisms which are directly isolated from nature, while on page 16 it states that a co-joined reading of Section 3(c) and Section 3(j) implies that only genetically modified micro-organisms are patentable subject matter.

Why is there is a need to read this provision along with Section 3(c) when Section 3(j) is so clear on the patenting of micro-organisms?

(c) ‘Therapeutic Efficacy’ in Section 3(d): At a time when the issue of interpretation of Section 3(d) is sub judice before the Supreme Court, one would have expected the Patent Office to have inserted a caveat in the guidelines, holding off on the interpretation of Section 3(d) until the interpretation of ‘efficacy’ is settled by the SC. Instead the guidelines declare that only ‘therapeutic efficacy’ of the inventions will be considered.

Should Section 3(d), which was drafted with the intent of checking ever-greening in the pharmaceutical industry, also be applied to the biotechnology industry? Was that the legislative intent?

(d) Method of treatments patents: Section 3(i) prohibits the patenting of “any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.”

This provision does prohibit certain methods of diagnosis, surgery and cure but the provision has always been interpreted by the patent office to permit the patenting of inventions such as diagnostic kits.

The examples provided by the guidelines, hints at a complete bar on the patenting of any gene-based diagnostics. This issue of gene based diagnostics is complicated. The U.S. Supreme Court has recently agreed to hear an appeal in the Myriad patent case. Given the complexity of the issue, why is the patent office jumping to conclusions, especially when its Manual has always been silent on the issue? It should cross the bridge when it comes to it.  

Conclusion: It will be interesting to see how the biotech industry responds to these guidelines. I can only imagine that their lawyers furiously typing away at their keyboards in preparing a response to these guidelines.