On July 5, 2024, Justice P.B. Balaji of the Madras High Court (MHC) delivered two decisions that overturned the Controller’s rejection of patent applications, siding with the appellants in both cases. These judgements emphasised the distinction between product and process for the patents and critically examined the validity of the prior art cited by the Controller as grounds for rejecting the applications.
Bitter Pill to Swallow: Controller’s Decision Overturned for Kyrorin’s Patent Application
The first one is Kyorin Pharmaceutical Co v. Assistant Controller Of Patents, where the patent application pertains to a claim of an “orally rapidly disintegrating tablet comprising imidafenacin”, thereby having the advantage of being easily administered to elderly people and children (application no. 5360/CHENP/2010). The Application was rejected on two grounds: lack of inventive step under Section 2(1)(ja) and non-patentability under Section 3(e) of the Patents Act, 1970 as mentioned in the Controller’s decision (pdf).
The Controller, referring to the First Examination Report (FER) (pdf) and using the assertions made from prior arts D1 and D5, argued before the Court that the tablet was merely a mixture of two substances controlled by a polymer. Moreover, the Controller argued that since the product in prior art D5 also disintegrated rapidly, the applications demonstrate a lack of inventive step. Given that Kyorin failed to prove the claimed photostability as well, he requested a dismissal of the appeal. Kyorin contested that certain prior art documents were divergent and others irrelevant. Additionally, they argued that the impugned order did not consider their responses to prior arts D1, D3, and D5, and the Section 3 objection.
The SB ultimately set aside the decision against the appellant on two grounds: firstly, the prior arts related to the process of manufacturing an orally soluble tablet, whereas the invention concerned the tablet as a product. Secondly, the respondent did not address the appellant’s responses (pdf) and passed the decision while erroneously maintaining that the objections raised in the hearing notice remained unresolved.
One of the most interesting observations by the SB was that the process in the co-pending application No. 5364/CHENP/2010 had been granted Patent No. 285816 on 28.07.2017 (Para 11). The SB found it perplexing that the Controller could argue the resulting tablet lacked an inventive step, considering a patent had already been granted specifically for the method of preparing an orally rapidly disintegrating tablet. The SB emphasised that the patented process and the resulting product are clearly distinct. The SB noted that the appellant’s counsel has correctly argued that since the patent was approved for the process, the Controller had no grounds for re-evaluating that process and using it to establish a lack of inventive step. The Controller was found to have made an error by citing the prior arts concerning the ‘process’ against the appellant’s claim for the ‘product’ patent, especially since the process was already patented.
What seemed to me like the most important takeaway from the judgement was the SB’s iteration of the following principle (Para 12): “Product Patents and Process Patents are different and merely because the Appellant had successfully obtained a Patent for the process, the Application for Patent for the product cannot be refused. No doubt, an owner of a Patent for a process cannot claim monopoly rights over the product of the process and such Patent holder also cannot stop a person from claiming a different process which may result in even the same product.”
Controller’s Analysis Not Worth its Salt in Frito-Lays Salt Patent Application
In the second case, Frito-Lay Trading Company-GmbH v. The Assistant Controller of Patents, the appellant filed an appeal against the Controller’s decision to reject their patent application (Patent Application No. 4689/CHENP/2010). The application pertains to an invention involving food products containing table salt formulations. The rejection was based on claims that the invention lacked inventive step (under Section 2(1)(ja)) and that it constituted merely a mixture of two types of inorganic salts (under Section 3(e)). It becomes important to discuss the SB’s contextualisation of the prior art used according to whether the patent grant is for a process or a product.
The appellant argued that prior art D1 was misleading as it diverged from the concept of agglomeration (a collection of particles tightly bonded through methods like partial fusion, sintering, or cohesive growth) or aggregation (a group of loosely connected particles), which was fundamental to their claim. They also asserted that D2 did not disclose aggregates of primary particles. Unlike the prior art, the appellant’s claim did not utilise citric acid as an enhancer, indicating a novel direction. They emphasised that their innovation achieved smoother and smaller particles through aggregation, contrary to existing teachings.
Furthermore, the appellant cited legal authorities such as Prathiba M. Singh’s “Patent Law” and Chisum on Patents to support their argument that if prior art teaches away (i.e., claimed invention is excluded based on the combination of known contents) from an invention, objections of obviousness do not apply. They also referenced the case of Bristol-Myers Squibb Holdings Ireland Unlimited Company v. BDR Pharmaceuticals International Pvt. Ltd. to highlight the importance of avoiding hindsight bias (i.e., “cherry-picking” prior art references in a manner not obvious to a person skilled in the relevant art) and not mosaicing (i.e., evaluating inventive step using more than one prior art references in such combination that a person skilled in the relevant art could reasonably do so) prior art. Additionally, procedural irregularities in the Controller’s actions were pointed out by the appellant.
On the other hand, the respondent argued that findings under prior art D1 were sufficient to deem the invention non-patentable under Section 3(e). Regarding the use of citric acid, the respondent noted that D2 did not employ it as an enhancer and highlighted differences in components. The respondent contended that achieving smaller particles through aggregation was not inventive, as the appellant did not explain the aggregation process or demonstrate any synergistic effect, thereby justifying the application’s rejection.
While referencing legal precedents, the respondent cited Bristol-Myers Squibb to assert the obviousness of the appellant’s claim, which combines two inorganic salts already known in prior art. They also referenced Galeta Ltd. v. The Controller of Patents to argue against granting patents for inventions obviously based on prior art, and Bishwanath Prasad Radey Shyam v. Hindustan Metal Industries to stress that patents should only be granted for new, useful inventions that exceed mere workshop improvements.
The SB concluded that none of the prior art documents rendered the invention obvious or involved the formation of aggregates or large-sized primary particles. It emphasised that while the ‘process’ was well-known, the applicant sought a patent for the resulting ‘product,’ making the cited prior art irrelevant. The SB criticised the respondent’s hindsight approach and acknowledged that the prior art actually taught away from the appellant’s claim by disclosing processes incompatible with it. Consequently, the SB rightly accepted the appeal and overturned the Controller’s decision.
Both the judgments are bound together by a similar string of reasoning with respect to the analysis of the prior art documents and reiterating the difference between ‘process’ and ‘product’ patents, coincidentally falling on the roster of the same judge on the same day. The SB has aptly contextualised the prior art documents with the applicants’ claims to reaffirm the fundamental patent concepts of distinguishing between processes and products in patent applications during prior art examinations and assessments.