Two recent judgments in India related to pharmaceutical patents
In the realm of pharmaceutical patents, it is important to have clarity as to the precise boundaries of the scope of patent protection.
Such clarity is critical in ensuring that all stakeholders are aware of the extent to which patent protection can and cannot be granted for a particular invention, thus advancing both innovation and accessibility.
One area where this is especially important relates to the exclusions to patentability set out in Section 3 of the Patents Act.
This provision contains a set of filters that every invention must pass through for it to be patentable.
Two recent judgments from Justice Senthilkumar Ramamoorthy of the Madras High Court are notable.
The first, Novozymes vs Assistant Controller of Patents and Designs, relates to Section 3(e), which excludes from protection those compositions that amount to a mere aggregation of their components.
The court holds that Section 3(e) does not exclude from the scope of protection aggregates that are already known.
Therefore, means that if any ingredient independently satisfies the requirements for the grant of a patent, irrespective of its inclusion in a composition under Section 3(e), it would be patent eligible.
The court’s close scrutiny of the precise legislative text stands out.
It further held that the rejection of the composition in the instant case was justified due to the patentee’s failure to produce evidence to substantiate that the invention was more than a sum of its parts.
This insistence on producing evidence to demonstrate the synergistic properties of a composition of multiple ingredients is a welcome move from the perspective of clarifying the precise scope of Section 3(e).
The second case is Hong Kong and Shanghai University versus Assistant Controller of Patents which relates to Section 3(i).
This provision, excludes from the scope of protection, inventions which consist of any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or animals to render them disease-free or to enhance their economic productivity.
The judgment sheds considerable light on the kinds of diagnosis that are excluded by this filter.
It was held that the bar is not merely confined to an in vivo/invasive diagnosis which involves conducting tests on the body.
The bar is not so broad as to cover all processes involved in or having some value for a diagnosis.
The court proposed a standard of examining the claims, in the context of the complete specification, to determine whether it specifies a process for making a diagnosis for a disease.
On this basis, if a given test is, per se, capable of diagnosing a disease, even if it is not definitive, it would be patent ineligible.
If the test cannot diagnose a disease, it would be patent eligible.
To flesh out the test, the court provided an illustration of a non-invasive test for diagnosing a pre-natal disease.
If the process in question cannot uncover the pathology of the foetus, it would not be a diagnostic test and hence, not hit by the bar under Section 3(i).
Section 3 of the Patents Act
In light of the fact that research and development costs for the development of new pharmaceutical drugs and processes are extremely high, and the need to prevent the
grant of overbroad monopolies in the same in the public interest, bright-line rules are very critical.
Bright-line rules can help bring some much-needed consistency and certainty in the Indian Patent Office’s decision-making process.
Bright-line rules simplify decision making and are easier to administer, and would help reduce the burden of the Indian Patent Office.
Such judgments will provide inventors clarity about the extent and scope of protection that can be potentially sought for their inventions and will aid civil society groups that intend to oppose patent applications by helping them understand the boundaries of the law.
The present mix of a lengthy patent prosecution process along with the lack of certainty might not be the best path forward in terms of encouraging innovation.
Bright-line rules will allow inventors and pharmaceutical companies to better weather potential challenges to their patents and increase their chances of success in patent infringement litigation.
At least in the case of pharmaceuticals, the potential issues that could arise due to bright-line rules would be counterbalanced by the built-in safeguards within the statute.
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