Calcutta High Court
Oyster Point Pharma Inc vs The Controller Of Patents And Designs ... on 26 July, 2023
Author: Ravi Krishan Kapur
Bench: Ravi Krishan Kapur
IN THE HIGH COURT AT CALCUTTA
Special Jurisdiction
ORIGINAL SIDE
BEFORE:
The Hon'ble Justice Ravi Krishan Kapur
AID NO.10 of 2022
OYSTER POINT PHARMA INC.
VS.
THE CONTROLLER OF PATENTS AND DESIGNS ANR.
For the appellant : Mr. Kshitij Saxena, Adv.
Mr. Tanmoy Roy, Adv.
For the respondents : Mr. Indrajeet Dasgupta, Adv.
Ms. Puspita Bhowmick, Adv.
Reserved on : 15.05.2023
Judgment on : 26.07.2023
Ravi Krishan Kapur, J.:
1. This is an appeal under section 117A of the Patents Act 1970 challenging an order dated 16 September 2021 passed by the Assistant Controller of Patents and Designs rejecting Patent Application No. 1879/KOLNP/2011 dated 5 May, 2011 filed by the appellant.
2. Briefly, the appellant is a biopharmaceutical company focused on discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. The present invention relates to a stereospecific synthesis of (R)-5(E)-2- pyrrolidin-3- ylvinyl)pyrimidine, its salt forms, and novel polymorphic forms of these salts. The present invention also includes methods for treating a wide variety of conditions and disorders, including pain, inflammation, and 2 conditions associated with dysfunction of the central and autonomic nervous systems.
3. The appellant had filed an application with claims 1-35 and Form 13 making voluntary amendments to claims 1-9 on 31 October 2017 and 22 October 2018 respectively. Subsequently, a First Examination Report (FER) was issued on 10 July 2019. A detailed reply to the FER was duly submitted by the appellants on 11 February 2020 alongwith a revised set of claims. Thereafter, a hearing notice was issued on 6 July 2020. The appellant had also submitted detailed Written Submissions along with further revised claims 1-5 on 11 September 2020.
4. By the impugned order, the respondent no.2 rejected the application citing three prior art documents being D1, D2 and D3 respectively. The grounds for rejecting the patent application were under sections 2(1)(ja) and 3(d) of the Act.
5. It is contended by the appellant that, the prior art D1 describes a number of different compounds including galactarate salt of (R)-5-((E)- 2-pyrroliding-3-ylvinyl)pyrimidine. However, the same does not encourage a skilled person to focus on the compounds claimed in the subject invention nor does it render an obvious teaching of the advantageous properties of the claimed invention. It is contended that, (R)-5-((E )-2-pyrroliding-3-ylvinyl)pyrimidine in its free base form is a viscous oil with limited water solubility and stability. In order to commercialise the compound, it is necessary to discover means of formulating the compound to increase its stability, solubility and ease of manufacture which also enables accurate formulation and 3 reproducible dosing. In such circumstances, it is contended that the respondents have failed to understand that the disclosure in the PCT specification demonstrates that the mono-citrate salt could be obtained in stable, free-flowing solid forms both amorphous and crystalline, not sensitive to moisture or temperature, nor is it hygroscopic and the same does not deliquesce upon stability testing. This conclusion could not have been arrived at without additional experiments being conducted by a person skilled in the art. Hence, obtaining a particular salt is not a routine process and the mere application of acids of D2 and D3 does not result in obtaining a pharmaceutically acceptable salt. In any event, there has been no discussion in the order as to how the subject patent application lacked inventive steps.
6. It is also contended that the respondents failed to consider the enhanced efficacy of mono citrate salt of (R)-5-((E)-2-pyrroliding-3- ylvinyl)pyrimidine which is evident from the amended set of claims 1-5 filed by the appellant post hearing and also from Appendix C. The amended set of claims conclusively prove the enhanced efficacy of the salt compound. It is also contended that respondent erred in not considering the additional experimental data supporting the claimed invention filed with the Written Submissions. In support of their contention, the appellant relies on Novartis AG vs Union of India (2013) 6 SCC 1 to contend that experimental data showing efficacy of a drug or a compound may be filed during the course of prosecution and the same should be considered.
4
7. On behalf of the respondents it is submitted that, the claimed invention is a different form of mono-citrate salts of the compound (R)-5-((E)-2- pyrroliding-3-ylvinyl)pyrimidine and there is no specific enhanced efficacy. The subject claim is based on "improved properties, including purity, stability, solubility and bioavailability''. In respect of the objection raised under section 2(1)(ja) of the Act, it is contended that the Assistant Controller has in passing the impugned order failed to take into consideration Appendix A,B and C primarily on the ground that the same had been belatedly filed. The subject invention is alleged to be a "new form of a known substance" and the same is barred from being patented unless shown to differ significantly in properties with regard to efficacy. It is also contended that the lack of a Second Examination Report (SER) could not have prejudiced the claims of the appellant's invention.
8. Insofar as section 2(1)(ja) of the Act is concerned, it is evident that without rigorous and diligent additional experimentation being conducted by a person skilled in the art, the compounds worthy of commercial use could not have been determined. The compound (R)-5- ((E)-2-pyrroliding-3-ylvinyl)pyrimidine in its free base form is a viscous oil limited to solubility and stability. However, the PCT specification of the claimed invention clearly demonstrates that the mono-citrate salt could be obtained in a stable, free-flowing solid form both amorphous and crystalline. The same is not sensitive to moisture or temperature, nor is it hygroscopic and does not deliquesce upon stability testing. Such findings could only have been arrived at upon elaborate 5 investigations. The tests to determine if a patent has satisfied the requirement of inventive steps have been recently summarised in Agriboard International LLC vs Deputy Controller of Patents, C.A. (CoMM. IPD-PAT) 4/2022 dated 31 March, 2022 wherein it has been held as follows:
"24. In the opinion of this Court, while rejecting an invention for lack of inventive step, the Controller has to consider three elements- the invention disclosed in the prior art, the invention disclosed in the application under consideration, and the manner in which subject invention would be obvious to a person skilled in the art.
25. Without a discussion on these three elements, arriving at a bare conclusion that the subject invention is lacking inventive step would not be permissible, unless it is a case where the same is absolutely clear. Section 2(1)(ja) of the Act defines 'inventive step' as under:
"The invention disclosed in the prior art, the invention disclosed in the application under consideration, and the manner in which the subject invention would be obvious to a person skilled in the art.
It is apparent that while evaluating the inventive step, the basic element which is required to be seen is that the court has to evaluate the prior art in the manner to see whether, because of the disclosure made in the prior art, the subject invention would be obvious to a person skilled in the art. Of course, it has to be after identifying the relevant prior art."
26. Thus, the Controller has to analyse as to what is the existing knowledge and how the person skilled in the art would move from the existing knowledge to the subject invention, captured in application under consideration. Without such an analysis, the rejection of the patent application under Section 2(1)(ja) of the Act would be contrary to the provision itself."
6
9. In such circumstances, the respondent no.2 erred in arriving at the finding that "it would have been obvious to a person skilled in art to try and arrive at claimed alleged invention with reasonable expectation of success to achieve the desired result without any inventive ingenuity". None of the prior arts cited by the respondent authority directly teach or suggest that the claim of the appellant were obvious. There is no discussion in the order as to the manner in which the appellant had sought to distinguish D1 from the subject invention. The disadvantages of the cited document D1 which was an acknowledged prior art had been enumerated by the appellant. This aspect of the matter has not been dealt with in the order. Hence, the finding that the claimed invention could not be said to be lacking in inventive steps over the cited document D1 is unsubstantiated.
10. Section 3(d) of the Act provides as follows:
3. What are not inventions.--The following are not inventions within the meaning of this Act,--
(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.-- For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy; 7
11. In Novartis A.G. vs. Union of India (2013) 6 SCC 1it has been held as follows:
"157. What is "efficacy"? "Efficacy" means "the ability to produce a desired or intended result" [The New Oxford Dictionary of English, Edn. 1998.] Hence, the test of efficacy in the context of Section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be "therapeutic efficacy". The question then arises, what would be the parameter of therapeutic efficacy and what are the advantages and benefits that may be taken into account for determining the enhancement of therapeutic efficacy? With regard to the genesis of Section 3(d), and more particularly the circumstances in which Section 3(d) was amended to make it even more constructive than before, we have no doubt that the "therapeutic efficacy" of a medicine must be judged strictly and narrowly. Our inference that the test of enhanced efficacy in case of chemical substances, especially medicine, should receive a narrow and strict interpretation is based not only on external factors but there is sufficient internal evidence that leads to the same view. It may be noted that the text added to Section 3(d) by the 2005 Amendment lays down the condition of "enhancement of the known efficacy". Further, the Explanation requires the derivative to "differ significantly in properties with regard to efficacy". What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy."
12. A new form of a known substance can only be considered patentable provided the same demonstrates enhanced efficacy. However, it is not possible to determine the efficacy of a substance without considering the results of the experiments conducted and the comparative studies 8 made before arriving at any conclusion by a skilled person. The details of the experiments conducted, comparative studies made and their conclusive results had been discussed in Appendix A, B and C in support of the claimed invention and the same ought to have been considered before passing of the order. There is no substance in the contention that the additional documents could not be considered after filing of the patent application at a later stage. No specific time bar has been provided in the Act which prevents an applicant from filing additional documents after the filing of the patent claim.
13. Drug development is a lengthy and complex process. It may not be possible to provide all data at the time of filing of the application. Further screening may be required to be carried out before a prospective compound ultimately makes it to clinical trials. Appendix C included the data which showed the activity of the mono-citrate salt at different nAChR subtypes which provides for structural and functional flexibility to play different roles and enhance the efficacy of the compound. In fact, Appendix A, B, C contained data to show that the claimed compound possesses efficacy. The Controller has without assigning any reasons rejected Appendix C and has failed to deal with Appendix A and Appendix B. The object of the present invention was to obtain a stable salt for the preparation of a pharmaceutical formulation. The stability data was provided in Appendix A which has not even been dealt with nor considered in the impugned order.
14. There is also no merit in the contention that the Second Examination Report (SER) was not necessary to be issued and that non-issuance 9 could not prejudice the rights of the appellant. The statutory mandate of section 13(3) must be followed regardless of the consequences and the ultimate result thereof. Hence, the Assistant Controller also erred in not issuing the SER in compliance with section 13(3) of the Act.
15. For the foregoing reasons, the order is unsustainable and set aside. The matter is remanded to the respondent authorities to adjudicate the subject patent application afresh including the question of patentability, after giving an opportunity of hearing to the appellant. It is made clear that the aforesaid findings insofar as the merits of the case are concerned, are prima facie and do not bind the parties. With the aforesaid directions, AID 10 of 2022 stands allowed.
(RAVI KRISHAN KAPUR, J.)