Patent Post

A lot more to patent

B K Keayla looks at the scope and issues of patentability in the Amended Patents Act

Parliament enacted Patents (Amendment) Bill 2005 and two other amending legislations in 2002 and 1999, to bring the Patents Act 1970 in line with the TRIPS Agreement. During a debate in the Parliament in April 2005 on the Patents (Amendment) Bill 2005, in regard to two important amendments, government announced that it would set up a Technical Expert Group to examine as to whether these amendments need further amendments. Dr R A Mashelkar, as the Chairman and four other eminent experts led the Technical Expert Group. The amended stipulations referred for examination to were as follows:

Section 2: Definition: clause (ta)

“Pharmaceutical substance means any new entity involving one or more inventive steps”.

Section 3: Inventions not Patentable clause (j)

“Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals”.

The first amendment has come into force with effect January 1, 2005 and the other from May 20, 2003.Since no notification was issued to suspend the above provisions, they are legally enforceable from the dates specified and the patent claims can be filed on the basis of these provisions. This Paper examines these amendments.

Definining pharma

The TRIPS Agreement in Article 27 on patentable subject matter stipulates that 'patents shall be available for any inventions, whether products or processes, in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application'. The TRIPS Agreement does not define 'inventions' and the other patent terminologies. They have been left to be defined by the member countries in their national patent legislations.

The UK Commission on IPR comprising of eminent international experts including Dr R A Mashelkar, in their Report (2002) in Chapter six on Patent Reforms provides as follows on scope of patentability:

“It (TRIPS) does not, however, define the term “invention”, nor does it prescribe how the three criteria for patentability are to be defined. Indeed we would note that it is not uncommon for different courts in Europe, even when applying identical law, to come to different conclusions on whether a patent is or is not obvious. There is therefore ample scope for developing countries to determine for themselves how strictly the common standards under TRIPS should be applied and how the evidential burden should be allocated”.

The above provision has clarified that developing countries are free to define patent terminologies including patentable invention in their patent legislations.

In the same chapter, the UK Commission also supports that “a pro-competitive strategy… is especially important in those areas of technology, such as, pharmaceuticals and agriculture, where, the cost of providing strong protection is likely to be greatest. Such a pro-competitive strategy is best realised by seeking to restrict the scope of patent protection provided”. In order to achieve this, the Commission specifically recommends “limiting the scope of subject matter that can be patented”.

There is yet another study by the National Institute of Health Care Management Research and Educational Foundation, which in their Report (2002) on Changing Patterns of Pharmaceutical Innovation points out that:

“Drug manufacturers patent a wide range of inventions connected with incremental modifications of their products, including minor features such as inert ingredients and the form, colour, and scoring of tablets”.

The above suggests that there is a need to be exceptionally careful in providing specific subject matter which should be patentable to deal with the phenomena of trivial patents as highlighted in the Reports.

There is a strong need to control or limit the scope of patentable subject matter because of liberal / flexible definition of invention in patent laws of USA and China, where now, over four lakhs patents are being filed annually. The US Federal Trade Commission in its Report (2003) has pointed out as to how the flood of patent applications were responsible for poor quality or questionable patents being granted in USA even when they had about 3000 patent examiners to examine patent claims. Such chaos would be unmanageable for our patent office and would result in high cost economy in the country with lakhs of patented products in our markets in a few years.

The Ministerial Declaration on TRIPS Agreement and Public Health of 2001 also clarifies that “the (TRIPS) Agreement can and should be interpreted and implement in a manner supportive of WTO Members’ right to protect public health and in particular, to promote access to medicines for all.”

Having stated some of the relevant aspects, which should be kept in view by the Technical Expert Group in framing an appropriate definition of patentable ‘pharmaceutical substance’, the appropriate definition should be as follows:

“Pharmaceutical substance means new molecular entity with significant therapeutic advancement involving one or more inventive steps.”

The definition of patentable ‘invention’ which is also relevant in the context of what has been stated above should also be amended as follows:

“Invention means a basic novel product or process involving an inventive step and capable of industrial application”

The above definitions are also in tune with the various stipulations under Section three relating to ‘inventions not patentable’.

The micro affairs

The other issue relates to patenting of ‘micro-organisms and non-biological and micro-biological processes’. Article 27 paragraph 3(b) of TRIPS Agreement reads as follows:

“(3) Members may also exclude from patentability:

(b) Plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by any effective sui generis system or by any combination thereof. The provisions of this sub-paragraph shall be reviewed four years after the date of entry into force of the WTO Agreement”.

The above provision has two aspects. One relates to the patenting of micro-organisms and non-biological and micro-biological processes and the other relates to the mandated review of the sub-paragraph by the WTO.

The mandated review process started in 1999. During this period of over six years, the WTO has not been able to come to an agreed solution on issues covered in para 3(b) quoted above. There is virtually a stalemate. The Doha Work Programme also specifically incorporated this issue for expediting decision.

In the absence of WTO decision, the question arises about the obligation of the member countries to provide for patenting of these subject matters in their national legislation. However, even in the absence of such an agreed solution, our government has already got enacted patenting of these subject matters through the Patents (Second Amendment) Act 2002. Even though the provision has been made in the Act, there is no definition of micro-organisms and non-biological and micro-biological processes. Thus, our Patents Act 1970 is wide open for interpretation.

Since the issue is still in a limbo, the best option available is to postpone application of the relevant provision in the Patents Act 1970 till after the final decision has been taken in the WTO on the mandated review. Section 1 of the Patents Act 1970 gives power to the government to notify the date enforcing any provision of the Act.

As regards the justification of patenting micro-organisms it may be stated that micro-organisms as such occur in nature and their discovery cannot be called invention and as such they are not patentable. Micro-organism, when genetically modified, can fall in the category of invention because of human input/intervention. Genetically modified micro-organism may perform any number of activities. If a researcher is able to research a particular activity, he should be allowed only process patent on that activity. If the patent is granted on genetically modified micro-organism as such, it will result in blocking of further research on that micro-organism. This will be a peculiar situation arising out of patenting of micro-organisms. In view of this aspect, it would not be appropriate to allow even patenting of genetically modified micro-organism. Under the circumstance, the best course would be to wait for a decision on the WTO mandated review and till then, this provision should remain suspended.

There are two other important amendments, which have been ignored by the government. They relate to grant of compulsory licence on commercial terms and conditions as stipulated in Article 31(b) of TRIPS and the other relating to stipulation in Article 70.3 on no obligation to restore protection to subject matter, which has fallen in public domain as on January1, 2005. These two amendments should also be considered for legislation.

The author retired as Commissioner of Payments. Presently, he is the Convenor of National Working Group on Patent Law and Trustee and Secretary General of Centre for Study of Global Trade System & Development