Novartis AG v. Controller of Patents and Designs

9. However, the divisional application of the Appellant has been rejected by the Patent Office vide the impugned order dated 28th September, 2020 on the ground that the subject matter of the divisional application and the parent application belong to the same broad class and group of inventions linked so as to form a single inventive concept. The relevant portions of the impugned order are set out below: “From above discussion and analysis of the As filed claims and Granted claims, conclusion can be drawn that to meet the requirements of the office action (FER and objections raised in hearing notice), applicant has dropped the claims having compounds where substituted amino acid side chain is present and retain three compounds wherein the substituted phenyl ethyl group retained and not substituted alpha amino acid moiety. The objections related to distinctness or plurality were not raised correctly and only communicated the objections related to Novelty and Patentability u/s 3 with Hearing notice because all three compounds belong to same broad class of compounds and compositions thereof of parent application.

XXX XXX XXX In other words, pharmaceutical vehicle is used for transportation/administration of single active compound (in present case), there is no role of vehicle in enhancement of therapeutic efficacy of the composition but remain same as of the efficacy of single active pharmaceutical ingredient and considered as compound of claim 1. The compound claimed in parent application is individual and independent claims as independent compound and belongs to same broad category based on the chemical structure where substituted alpha amino acid moiety is absent. However, as applicant tried to show chemical structure differences in his written submission the chosen differences are not a valid reason for filing separate /further/ divisional application shown below.

XXX XXX XXX If terminal groups of the claimed compounds could be the reason for filing the divisional application, in that condition the controller might not allow to grant such compounds in claims of parent application or applicant (himself his own desire) could have been filed three separate applications for all three granted compounds of parent application as three divisional applications but that is not the case. In view of above discussion it has been concluded that subject matter of compounds of granted claims of Parent application (8114/DELNP/2007) and subject matter of claims of instant application (7863/DELNP/2014) belong to same broad class and belong to [a] group of inventions linked so as to form a single inventive concept therefore instant application 7863/DELNP/2014 is not a valid divisional (further) application.” Submissions

10. The submission of Mr. Pravin Anand, ld. Counsel for the Appellant is that a perusal of two paragraphs of the impugned order shows that the Assistant Controller seeks to take the view that the objection of plurality of inventions raised in the first FER dated 15th May, 2013 issued in respect of the parent application was wrongly raised. Hence, the divisional application was itself wrongly filed and thus liable to be rejected. It is his submission that the Appellant cannot be made to suffer on both counts. Since the Patent Office had itself raised an objection that the original parent application contained a plurality of inventions, the Appellant filed a divisional application. In any event, there is no prejudice being caused inasmuch as the claims of the divisional applications were part of the original parent application and the term of the divisional runs concurrently with the parent application under Section 16 of the Act. Thus, no additional protection is being given to the Appellant. However, qua the pharmaceutical compositions covered by the divisional application, the time of exclusivity is lapsing and therefore the Appellant’s interest is being detrimentally affected. Reliance is place upon the two judgments of the IPAB in OA/21/2022/PT/DEL titled National Institute of Immunology v. The Asst. Controller of Patents dated 25th March, 2015 and OA/47/2020/PT/DEL titled The Procter & Gamble Co. v. Controller of Patents dated 20th July, 2020 to argue that the patentee / applicant cannot be left in lurch mainly on the basis of the objections raised by the Patent Office.

11. Mr. Harish V. Shankar, ld. CGSC appearing for the Patent Office has filed his written submissions. His primary contention is that the divisional application filed by the Appellant was not maintainable inasmuch as there was no plurality which was shown in the parent application itself in respect of the compound for which the divisional application has been filed by the Appellant. He submits that the particular product / compound for which patent is being sought in the divisional application was part of claim 54 of the parent application as originally filed qua which no objection of plurality was raised by the Asst. Controller in the FER dated 15th May, 2013, issued in respect of the parent application. He relies upon point number 2 in the FER which reads as under: “2. Claims show plurality of distinct inventions:

1) Claims 1-20,21-30,48,50-51 and 52 defines a plurality of distinct inventions each independently belonging to a different method of treatment.”

12. He further submits that the compound sought to be patented in the divisional application was part of the original skeletal structure in the Markush in the parent application and having deleted the same from the parent application, a patent cannot be granted for the same compound in the divisional application.

13. In rejoinder, it is firstly submitted by Mr. Anand, that, in the FER in respect of the parent application, in addition to objection no. 2, objection NO. 5 was also taken by the Patent Office, which is already extracted above. Objection no. 5 clearly states that the Appellant’s formula as represented in claim 3 and dependent claims of LFA-1 antagonist showed plurality of inventions and the number of substituents of the formula showed variations that do not fall in a single inventive concept. Thus, it was the FER which asked the Appellant to restrict the claims in the parent application and in view of the plurality objection, the Appellant decided to divide out other applications for separate inventions.

14. It is further argued by ld. Counsel that in the first FER qua the parent application, the actual inventive concept is itself not identified by the ld. Asst. Controller. However, in the impugned order, while rejecting the divisional application, distinction is sought to be made between two categories of compounds, one, with amino acid side chains and, the second, without amino acid side chains. Even this has been derived from the claims itself where the Appellant has disclosed the substitution at R[2] as being belonging to two separate categories. Lastly, it is submitted there is no prejudice which is caused because the term of the divisional application, if granted, would be the same as the parent application. Analysis and discussion

15. Heard ld. Counsels for the parties and perused the record. The short question that arises in this case is whether the claims in the divisional application satisfy the conditions stipulated in Section 16 of the Act. In order to answer the said question, the granted claims of the parent application are captured below: “1. A compound having the formula:

2. A compound having the formula:

3. A compound having the formula:

4. A pharmaceutical composition comprising an effective amount of a compound as claimed in any of claims 1-3 and a pharmaceutically acceptable vehicle.

5. The pharmaceutical composition as claimed in claim 4, wherein the pharmaceutically acceptable vehicle is suitable for ocular administration and further wherein the composition is formulated as an insert, implant, subconjunctival injection, intraocular injection, periocular injection, retrobulbar injection, or intracameral injection.

6. The pharmaceutical composition as claimed in claim 5, wherein the insert or implant comprises a selective release device comprising a formulation wherein the compound is released in a sustained fashion.

7. The pharmaceutical composition as claimed in claim 6, wherein the formulation comprises a biocompatible polymer.

8. The pharmaceutical composition as claimed in claim 2, further comprising a preservative.

9. The pharmaceutical composition as claimed in claim 2, wherein the composition form is liquid drops, liquid wash, gel, ointment, liposomes, solution, cream, powder, foam, crystals, spray, aerosol, or liquid suspension.”

16. The claims of the divisional application are set out below: “1. A pharmaceutical composition comprising a compound having the formula: or a pharmaceutically acceptable salt thereof, an a pharmaceutically acceptable vehicle.

2. The pharmaceutical composition as claimed in claim 1, wherein the formulation comprises a biocompatible polymer.

3. The pharmaceutical composition as claimed in claim 1, further comprising a preservative.

4. The pharmaceutical composition as claimed in claim 1, wherein the composition form is liquid drops, liquid wash, gel, ointment, liposomes, solution, cream, powder, foam, crystals, spray, aerosol, or liquid suspension.”

17. The difference between the claims in the parent application and divisional application, as captured by the Patent Office in its hearing notice dated 22nd July, 2019, is as under: “Other Requirement(s)

1. Amended claims 1-6 filed on 01/02/2019 are reexamined. Compound of current claim 1 differs from the granted compounds (claims 1-3) of the parent application 8114/DELNP/2007 only by the presence indazole moiety instead of benzofuran as substituent in the main core structure. The replacement of benzofuran of the parent compound by indazole moiety in the current claim 1 did not bring out any increase in therapeutic efficacy and showed same therapeutic behavior. The core ring “1,2,3,4- tetrahydroisoquinoline-6-carboxamido)-3-(3- (methylsulfonyl)phenyl)propanoic acid” is same in both the compounds. Thus the current compound is considered as the part of the same invention. Current claims 1-6 did not show plurality of inventions under section 10(5) of the Patents Act, 1970. The main component of the said composition of claim 1 is the compound “(S)-2-(5,7-dichloro-2-(1H-indazole-6carbonyl)-1,2,3,4-tetrahydroisoquinoline-6carboxamido)-3-(3 (methylsulfonyl) phenyl) propanoic acid” only. Compound and composition of current claim 1 falls within the scope of parent claims 1-3. Thus current divisional application is invalid u/s 10(5) of the Patents Act, 1970.”

18. The objections, thus, recognise the difference between the granted compounds of the parent application and the compound claimed in the divisional application as being - the presence of indazole moiety instead of benzofuran as the substituent in the main core structure. It is not in dispute that the main core structure in the parent and in the divisional is the same. However, the main core structure is not in the granted claims in the parent application. Claims 1 to 3 of the parent application are specific compounds with specific substituents / carriers in each of the formulae at the terminal positions. The Markush formula, which originally existed in the parent application, no longer forms part of the granted claims as extracted above.

19. One of the substituents disclosed in the parent application, both in the complete specification and in the claims, is the presence of the indazole moiety. This is clear from a reading of page 41 of the description in the complete specification and claim 54 in the parent application as originally filed. Thus, the substitution at the AR[1] position of indazole moiety was fully disclosed in the parent application; in the body of the specification as also in the claims.

20. Under the Act, filing of divisional application is governed by section 16 of the Act. The said section reads as under:

16. Power of Controller toa make order respecting division of application- (1) A person who has made an application for a patent under this Act may, at any time before the grant of the patent, if he so desires, or with a view to remedy the objection raised by the Controller on the ground that the claims of the complete specification relate to more than one invention, file a further application in respect of an invention disclosed in the provisional or complete specification already filed in respect of the first mentioned application. (2). The further application under sub-section (1) shall be accompanied by a complete specification, but such complete specification shall not include any matter not in substance disclosed in the complete specification filed in pursuance of the first mentioned application. (3). The Controller may require such amendment of the complete specification filed in pursuance of either the original or the further application as may be necessary to ensure that neither of the said complete specifications includes a claim for any matter claimed in the other. Explanation.—For the purposes of this Act, the further application and the complete specification accompanying it shall be deemed to have been filed on the date on which the first mentioned application had been filed, and the further application shall be proceeded with as a substantive application and be examined when the request for examination is filed within the prescribed period.

21. Section 16 of the Act clearly stipulates that a patentee, at any time before the grant of the patent may, of its own volition if it so desires, or with a view to remedy an objection raised by the Controller on the ground that the claims of the complete specification relate to more than one invention, file a divisional application. Recently, this Court considered Section 16 of the Act in Boehringer Ingelheim International GMBH v. The Controller of Patents & Anr. [C.A. (COMM.IPD-PAT) 295/2022, judgment dated 12th July, 2022] and held as under:

28. From the above provisions, it is clear that a divisional application under Section 16 of the Act, has to be an application which arises from a parent application disclosing a “plurality of inventions”. In Section 16(1), the phrase “the claims of the complete specification relate to more than one invention” makes this position clear. Section 16(3) also makes it clear that there cannot be duplication of the claims in the two specifications i.e., parent specification and the divisional application. This leads us to the question as to how to determine “plurality of inventions”. For this, guidance can be drawn from Section 10 of the Act which elaborates on the meaning of complete specification and scope of claims.”

22. Thus, there are twin conditions under Section 16 of the Act for filing of divisional application: • The divisional application has to be in respect of an invention disclosed in the provisional or complete specification already filed in respect of the first mentioned application. • There cannot be duplication of claims in the two specifications i.e., the parent specification and the divisional specification.

23. Therefore, as per Section 16 of the Act, the claims of the divisional cannot be outside the scope of the claims of the parent specification and at the same time there cannot be duplication of claims. In the present case, it is not is dispute that the compound being claimed in the divisional application is within the scope of the parent application. The matter forming part of the divisional application is also disclosed in the original parent specification as well. The objection of the Patent Office is that the compound being claimed in the divisional application is already covered by the granted claims of the parent application and hence, there is duplication of claims. The crux of the argument of the ld. CGSC is that there can only be one patent for one invention.

24. Ld. Counsel for the Appellant has sought to highlight that the Patent Office has taken contrary positions in the original FER and in the final order in respect of disclosure of plurality of inventions. Insofar as this submission is concerned, the same may not be accurate inasmuch as the plurality referred to in the original FER and the plurality being discussed in the final impugned order relate to two separate aspects. In the FER issued in respect of the parent application, the objection of plurality, being referred by ld. Counsel for the Appellant, was in respect of various substitutions at different position of the Markush in claim 3 leading to a large number of permutations and combinations of the rings without being linked by a single inventive concept. The ld. Asst. Controller was also of the view that the large number of substitutions also made it impossible to ascertain the actual scope of the invention. On the other hand, in the final order impugned in the present appeal, the Asst. Controller examines compounds which have amino acid side chain and those which do not, and arrives at the conclusion that objections relating to distinctness and plurality in respect of this aspect were not raised correctly. This is clear from a reading of the following extracts from the impugned order: From above discussion and analysis of the As filed claims and Granted claims, conclusion can be drawn that to meet the requirements of the office action (FER and objections raised in hearing notice), applicant has dropped the claims having compounds where substituted amino acid side chain is present and retain three compounds wherein the substituted phenyl ethyl group retained and not substituted alpha amino acid moiety. The objections related to distinctness or plurality were not raised correctly and only communicated the objections related to Novelty and Patentability u/s 3 with Hearing notice because all three compounds belong to same broad class of compounds and compositions thereof of parent application.

25. Thus, while this Court may not agree with ld. Counsel’s submission in respect of the contradiction between the original objection in the FER and in the final impugned order, what would be relevant is i. Whether the compound claimed in the divisional was disclosed in the complete specification of the parent and claimed in the complete specification of the parent? ii. Whether the claimed compound in the divisional was granted in the parent application?

26. In respect of (i), there is no doubt that the formula in the divisional application was disclosed in the description of the specification as also claimed in the specification of the parent application. As far as (ii) is concerned, the ld. Asst. Controller has rejected the divisional application on the ground that subject matter of the said application belongs to the same broad class and group as the subject matter of granted claims 1 to 3 of the parent application.

27. The terminal group claimed in the divisional application could be one of the carriers or vehicles meant for better delivery of the pharmaceutical composition being claimed. Claim 4 of the parent application covers, in general, pharmaceutically acceptable vehicles of the compounds of claims 1, 2 and 3. However, the difference in substitution at the AR[1] position of the Markush would show that the claimed compound in the divisional application would not be one of the three compounds in claims 1 to 3 of the parent application as granted. A comparative chart of the compounds claimed in the divisional application and the parent application is as follows: 7863/DELNP/2014 (Divisional Application) 8114/DELNP/2007 (Parent Application) Compound in claim 1 Compound in Claim 1 Compound in claim 2 Compound in claim 3 Therefore, the terminal group as claimed in the divisional application would not constitute a pharmaceutically acceptable vehicle of the compounds granted in claims 1 to 3 of the parent application. If the Markush claim was retained in the claims of the parent application and were granted, then there would be no doubt that the compound in the claims of the divisional application would be covered in the Markush. The Markush claim has clearly not been retained in the parent application which is now granted only qua three compounds in Claims 1 to 3 and their pharmaceutical compositions. Under such circumstances, it cannot be held that the compound or composition claimed in the divisional application is covered by the granted claims of the parent application.

28. Further, in the objections taken in the hearing notice dated 22nd July 2019 issued in respect of the divisional application as also in the impugned order, the Patent Office seems to raise an objection that the replacement of benzofuran of the parent compound by indazole moiety in claim 1 of the divisional application did not bring about any increase in therapeutic efficacy and showed same therapeutic behaviour. The question of therapeutic efficacy under Section 3(d) of the Act would arise only if the application in question was a completely independent application and did not originate from a parent application. Since the divisional application traces its origin to the parent application, the test of therapeutic efficacy would not apply while judging as to whether the compound claimed in the divisional application is a valid claim in a divisional application or not.

29. In the present case, this Court does not find any reason to refuse the divisional application on the ground that it is not a valid divisional application. Under these circumstances, this Court is of the opinion that the divisional application in question is a valid divisional application and deserves to be examined in accordance with law.

30. Accordingly, the impugned order is set aside. The matter is remanded back to the Patent Office for considering the divisional application on its own merits in respect of other objections under Sections 2(1)(j), 2(1)(ja), 3(d), 3(e), 3(i) and 59 of the Act which were not gone into. Insofar as the issue of whether it is a valid divisional or not is concerned, this Court holds that the divisional application is a valid divisional application.

31. The appeal, along with all pending application is allowed in the above terms. No order as to costs.

PRATHIBA M. SINGH, J. AUGUST 23, 2022 dj/sk