Is it time to include laws related to Selection Patents in the Indian Patents Act?

Being in the domain of pharmaceutical and chemistry, the question which I most often encountered is what is the take of Indian Patents law regarding selection patents. This article shall talk about the selection of patents in the field of pharmaceutical and chemical inventions. 

Selection Patents in relation to pharmaceutical industries

It is observed that claims of the chemical and pharmaceutical patent applications are mostly drafted in Markush type claims that can encompass a large number of compounds. Markush claims are considered as a broad or generic claim that refers to a chemical structure of a compound with a plurality of functionally equivalent chemical groups in one or more parts of the compound. Such types of claims have an aim to have wider protection on the compounds of the invention and also their functionally equivalent compounds in a single patent application. There was a time when the Indian Patent Office used to grant such claims without examining the sufficiency or enablement of such compounds in the patent application. 

However, the time has changed now. The need of developing new drugs to cure or prevent disease is all-time high with the prevalence of this pandemic era. With the increase in the demand, the pressure on the scientists or researchers is increased to develop such molecules or compounds, which are highly effective drugs with fewer side effects in a short span of time. As we can see, the Indian pharmaceutical market is hoarded with various options of new drugs or medicines launched by different pharmaceutical companies to cure a particular disease every now or then.  

 The term “new drug or medicine” here should not be confused with a compound that is never known. In this article, we are considering those compounds which are existed or are covered in the Markush type claim but are never tested for their therapeutic efficacy. With recent launches of effective drugs, the trend of smart inventions is noticed by the pharmaceutical. These smart inventions relate to those compounds which are covered in a Markush Claims only to have broader protection but no such experimentation or data has been provided to support such compounds. These kinds of smart inventions not only save a lot of time or funds but also helps in utilizing the compounds more effectively. 

 Having said that, since such a smart move is helping pharmaceutical companies to hoard the market but this move seems to impede getting a grant of such patent application. It is because patenting a compound covered in Markush's claim of already patented application is considered as the road less traveled. These kinds of patent applications are called selection patents. However, the Indian Patent Act has laid no clear provision to examine such applications. 

Nevertheless, to judge the validation of selection patents, mostly Controllers of the Patents Act considered Section 3(d) of the Patents Act as a milestone to be achieved. Section 3(d) of the Patents Act prohibits those inventions which claim the new form of known substance without showing the enhanced efficacy. The Controllers mostly assume “new form” as a compound not been tested by the parent application and “known substance” as a tested compound in the parent application while examining these applications. Along with the said criteria, there is one measure, which is most often seen to be used while examining such applications, which is given in the Guidelines for Examination of Patent Applications in the field of Pharmaceuticals, October 2014, in point 7.2. The said measure is given for assessing novelty, for Markush type claims:

“It is also not permissible to combine separate items belonging to different embodiments described in one and the same document, unless such combination has specifically been suggested or essentially linked to one another…A generic disclosure in the prior art may not necessarily take away the novelty of a specific disclosure. A specific disclosure in the prior art takes away the novelty of a generic disclosure.” (Emphasis Added).  

Given the above, it is noted that the Guidelines mentioned the provision of assessing novelty of selected compound, which is broad compound does not take the novelty of specific compound. The said principle is mostly applied when a selection patent is examined.  

 Why it is important to have clear guidelines or provisions in the Indian Patent Act for selection Patents?

 In the field of pharmaceutical industries, broader patents are termed genus patents and selection patents are termed species patents. India has been recognized globally as home to the pharmaceutical industry. With such title and ever-growing market of pharmaceuticals, India has seen an increase in the patent pharmaceutical litigation matters, particularly infringement matters, in the last few years that has attracted global attention towards the Indian pharmaceutical market. These suits are mostly concerned with the infringement of genus patent given the species matter. The said matters gain more attraction as compared to others as there are no provisions for examining such applications and the judgment of these crucial cases depends on the discretion. Therefore, this leads to the disinterest of pharmaceutical industries in investing in India as such suits require a huge amount of time and investments, thus, blocking their way or delaying future investments in research and developments.

 Further, mostly the focus of every suit is on unsettled topics with the respect to “coverage” and “disclosure” of a particular compound in Markush claims. The term “coverage” is defined as covering a compound that has not been particularly exemplified or shown in any of the embodiments of the specification as-is. The term “disclosure” is defined as a particular compound either given as is in any of the embodiments of the specification or is explicitly exemplified. However, cherry-picking of the substituents from different embodiments to show disclosure of the particular compound is not considered a disclosed compound. 

Based on the above, examining the scope or novelty of these kinds of genus-species patents is considered to be a hard nut to crack. While considering the definition of “coverage” and “disclosure” of a compound in such applications, every analyser or examiner has its way to delve into a disclosed and covered compound. Further, the examination of such applications usually takes into account the precedents set in the previously settled case laws or Guidelines of the corresponding countries, which have laid down the provisions for examining the selection of patent applications. The aspects are as follows: 

 -Definition for selection patent is considered as “[t]selection must be in respect of a quality of a special character peculiar to the selected group.” 

 -Compound should be specifically disclosed in the genus application to destroy the novelty. However, cherry-picking of the substituents is not allowed just to show that the compound in question is disclosed.

 - Until and unless there is any motive or teaching in the genus patent application to select a particular compound, the species patent cannot be considered as invalid selection patent.

 Given the above, due to no straight provisions in the Indian Patents Act for examining the selection patent Application, the allowance of such applications or judgment are varied. Further, the recent judgments throw light on the never-ending topics in the field of pharmaceuticals/chemistry patent applications having Markush claims, for example, judgments passed in recent cases such as FMC Corporation & Anr. vs Natco Pharma Limited and AstraZeneca AB ORS & P Kumar. This is evident from these judgments that the principles for examining the selection patents are similar but their conclusions may differ. 

 Therefore, due to the absence of such laws, the allowance of the applications or judging these applications require extra efforts in assessing their validity, speedy disposal isn’t possible, time and expenditure on litigating or prosecuting this application is more as compared to what is required for the cases for which clear provisions are laid down. Therefore, there is an extreme requirement for laying down such provisions for examining selection patents in a manner provisions for divisional application or patent of addition have been defined in the Patents Act. Further, before amending the Patents Act to lay down such provisions, it is advisable to invite opinions or suggestions from the stakeholders. Therefore, laying down the provisions in the Patents Act for selection patents based on suggestions or opinions may result in effective regulation. 

Conclusion

With the growing competition in pharmaceutical industries and rapidly growing demands of the health care departments, as mentioned above, there is a dearth of clear guidance in the Patents Act on the topics such as the validity of species patent in view of genus patent, the definition of selection patents and its test of validity, the difference between coverage and disclosure of compound in Markush patent applications. The said topics have always been in debate in numerous pharmaceutical cases and will always be in debate as to the Indian Patents Act or pharmaceutical guidelines is silent on the definition or validity of the selection patents/genus-species patents. Though the judgments of the High Courts are always lauded and kept above all the provisions, which proves that the test of judging the validity of genus-species/selection patent is uniform across the world and lies in the teaching or motivation provided to the person skilled in the art in the genus patent to select a particular compound. But now is the time to include such clear provisions or guidance for examination of selection patents in the Indian Patents Act. The said move shall be welcomed by the Indian and International pharmaceutical industries and shall attract more investments in India in the said field. 

Authored by:

Aastha Sharma

Assistant Senior Patent Attorney & Registered Indian Patent Agent