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IN THE HIGH COURT OF DELHI AT NEW DELHI
C. HARI SHANKAR, J.
ALLERGAN INC – Appellant
Versus
THE CONTROLLER OF PATENTS – Respondent
C.A. (COMM.IPD-PAT) No. 22 of 2021
Decided On : 20-01-2023
Patents Act, 1970 – Section 3(i), 7, 54, 135 – Patent Cooperation Treaty designating India – Fundamental canons of patent law – Object of patent law is to encourage scientific research, new technology and industrial progress – Controller of Patents wrote to attorneys of appellant, objecting to application filed – Among objections which were raised by Controller was an objection that Claims in patent application were not patentable as they related to method of treatment of human beings/animals, in respect of which Section 3(i) [What are not inventions –Held, Amended claims of the appellant (as set out in Para 3 supra) are remanded to the learned Controller for consideration of their patentability afresh, keeping in mind Patents Act and all principles applicable in relation thereto – Decision would be taken by learned Controller in keeping with principles of natural justice and following due procedure in that regard as also after grant of an opportunity of hearing to appellant – It is clarified that present judgment is restricted to aspect of permissibility of amendments which were sought by appellant in original claims – Court has not expressed any view on patentability of amended claims – Learned Controller would examine patentability of amended claims uninfluenced by any of observations contained in this judgment – Appeal allowed.
JUDGMENT :
C. HARI SHANKAR, J.
1. On 13th August 2012, the appellant submitted Patent Application No. 7039/DELNP/2012 to the Patent Office, New Delhi, for grant of a patent for “INTRACAMERAL SUSTAINED RELEASE THERAPEUTIC AGENT IMPLANTS.” The application contained the following 20 claims:
Providing at least two biodegradable sustained release implants containing at least one therapeutic agent.
Implanting the at least two biodegradable sustained release implants into the anterior chamber of an eye.
Treating the ocular condition.
Wherein the at least two biodegradable sustained release implants release about 100 ng per day of the at least one bioactive agent for a period greater than about 1 month.
2. The method according to claim 1 wherein the ocular condition is glaucoma.
3. The method according to claim 1 wherein the ocular condition is elevated intraocular pressure.
4. The method according to claim 1 wherein the sustained release implant releases about 70% of the at least one therapeutic agent over the first month.
5. The method according to claim 1, wherein the at least one therapeutic agent is selected from the group consisting of latanoprost, bimatoprost and travoprost and their salts, esters and prodrugs.
6. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 30% therapeutic agent.
7. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 5% to about 70% poly(D,L-lactide).
8. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 5% to about 40% poly (DL-lactide-co-glycolide).
9. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 5% to about 40% polyethylene glycol.
10. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 30% therapeutic agent, 65% poly(D,L-lactide) and 5% polyethylene glycol.
11. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 30% therapeutic agent, 65% poly(D,L-lactide), and 5% polyethylene glycol.
12. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 20% therapeutic agent, 55% poly(D,L-lactide),10% poly(DL-lactide-co-glycolide), and 5% polyethylene glycol.
13. The method according to claim 1 wherein the implanting step is accomplished using an applicator.
14. The method according to claim 1 wherein the at least two biodegradable sustained release implants are settled out in the inferior angle within 24 hours of implanting within the anterior chamber.
15. A method for treating glaucoma in an eye comprising the steps of:
Providing at least two biodegradable sustained release implants containing at least one therapeutic agent.
Implanting the at least two biodegradable sustained release implants into the anterior chamber of the eye.
Allowing a sufficient time for the at least two biodegradable sustained release implants to settled out in the inferior angle.
Allowing a sufficient time for the at least two biodegradable sustained release implants to release the at least one therapeutic agent.
Treating glaucoma,
Wherein the at least two biodegradable sustained release implants release about 100 ng per day of the at least one bioactive agent for a period greater than about 1 month.
16. The method according to claim 15 wherein the sufficient time for the at least two biodegradable sustained release implants to release the at least one therapeutic agent is greater than about 42 days.
17. The method according to claim 15, wherein the at least one therapeutic agent is selected from the group consisting of latanoprost, bimatoprost and travoprost and their salts, esters and prodrugs.
18. The method according to claim 15 wherein the at least two biodegradabl
Amendments to patent claims are permissible to restrict claims as long as they remain within the scope of the original specification, supporting both clarity and legal compliance under Section 59.
Amendment of claims from ‘product by process’ claims to ‘process’ claims is permissible under Section 59(1) of the Patents Act, 1970, subject to certain conditions.
The decision highlights that patent amendment claims must fall within the initial disclosure's scope, and a lack of a reasoned decision violates the principles of natural justice in patent law.
The permissibility of amendments to patent claims prior to the grant and the broader permissibility for such amendments were established in the judgment.
The court allowed the amendment of claims at the appellate stage and found that the invention satisfied the criteria of inventive step.
Procedural irregularities in patent opposition must respect principles of natural justice, and amendments to patent claims cannot broaden their scope.
The main legal point established in the judgment is that amendments made to patent claims at the instance of the Controller, pursuant to the directions of the Controller, do not violate the principle....
The refusal of a patent application for a therapeutic drug composition based on the grounds of it being a method of treatment is erroneous; claims must be recognized as product claims, distinguishing....
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