Allergan Inc v Controller of Patents (2023)

Summary

"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'", and "The application contained the following 20 claims", the first "A method for treating an ocular condition" (para 1). "On 6th November 2017, the Controller of Patents wrote to the attorneys of the appellant, objecting to the application as filed", raising "an objection that the Claims in the patent application were not patentable as they related to the method of treatment of human beings/animals, in respect of which Section 3(i) of the Patents Act, 1970 (the Patents Act) forbore grant of patent" (para 2). "Pursuant to the aforesaid First Examination Report (FER), the appellant, submitted a set of amended Claims, reducing the number of claims from the earlier 20 to 5", the first claiming "An intracameral implant comprising" (para 3). "Thereafter, the appellant was granted a hearing by the learned Controller of Patents on 27th August 2019. Consequent thereupon, the impugned order has come to be passed by the learned Controller on 30th March 2020." (para 5) The Controller held that "the set of amended claims does not fall within the scope of the as originally filed claims as per the any clauses of the section 59(1) of the Patents Act" and ordered: "hence I hereby refuse the said invention/application (7039/DELNP/2012) u/s 15 of the Patents Act." (para 6)

The Court held that "These grounds for rejecting the request of the appellant to amend its claims, as originally envisaged were, therefore, without merit." (para 15) On Section 59(1) it held that "any interpretation of Section 59(1) along the lines suggested by Mr Vaidynathan would, in my mind, result in creating an artificial distinction between the claims in a patent and the complete specifications that accompany it" (para 29), and that "The very use of the expression 'scope of a claim' in the concluding part of Section 59(1) would, therefore, in my considered opinion and keeping in mind the avowed purpose of the Patents Act, require taking into consideration the complete specifications of the pre-amended claim, and not merely a textually cabined reading of the pre-amended claims themselves, de hors the complete specifications." (para 43) As "The amendment that was sought in the present case was at a pre-grant stage", "the learned Controller ought to have allowed the amendments which the appellant sought, and to have examined the claims as so amended, and their patentability, on merits" (para 47). "For the aforesaid reasons, the impugned order dated 30th March 2020, passed by the learned Controller, is quashed and set aside. The prayer, of the appellant, for permission to amend its claims, as advanced before the learned Controller, stands allowed." (para 48) "The appeal stands allowed in the aforesaid terms with no order as to costs." (para 51)

What the court decided

1. The ground of refusal. "Clearly, therefore, the learned Controller has not examined the aspect of patentability of the claims of the appellant as amended, as he has proceeded on the premise that the appellant was not entitled, in the first place, to amend the Claims as it had chosen to do. This finding is predicated on Section 59(1) of the Patents Act." (para 7) "The learned Controller has, therefore, essentially restricted the decision to reject the amendments to the Claims, as proposed by the appellant, as impermissible under Section 59(1) of the Patents Act, to the ground that the 'set of amended Claims does not fall within the scope of the as originally filed claims as per the any clauses of the Section 59(1) of the Patents Act'." (paras 7, 11)
2. Method claims in the PCT application. "Method claims are patentable in the US, whereas they are not patentable in India, by virtue of Section 3(i) of the Patents Act." "Different countries have, however, different patent regimes, and it would be impractical, nay impossible, to expect that the claims in the original PCT application, as filed (in this case, in the US), would be patentable in every designated country." "It was for this reason that the appellant amended its claim to a product patent." (para 12) The "appellant legitimately sought a method patent in its original international PCT application as patents laws in the US, where it was filed, allowed patenting of method patents. No fault can, therefore, be found with the appellant on that score." (paras 12, 14)
3. Entry into the national phase. "Section 138(4) of the Patents Act deems an international PCT application designating India to have the effect of filing of a patent application for grant of the patent in India and also requires the title, description, claim and abstracted drawings filed in the international application to be taken as the complete specification for the purposes of the Patents Act. At the time of entering the National Phase, therefore, there could be no occasion for the appellant to amend the Claims as originally filed in the PCT application in the US." (para 14) "These grounds for rejecting the request of the appellant to amend its claims, as originally envisaged were, therefore, without merit." (paras 14–15)
4. The objection under Section 3(i). "By way of a brief reiteration, owing to the proscription engrafted in Section 3(i) of the Patents Act, the claims in the PCT application of the appellant, as originally filed in the US, could not be granted in India, as they were in the nature of process/method claims." "That, again, was the reason why the appellant sought to amend the claims, as proposed in its reply dated 2nd August 2018 to the FER" ("First Examination Report") "and later, once again in response to the notice of personal hearing issued to the appellant." (para 17)
5. The component of Section 59(1) invoked. "Section 59(1) is, to say the least, a peculiarly worded provision." (para 19) The Court quoted the last component, "as it is this component which has been invoked by the learned Controller and with which, therefore, we are essentially concerned in the present case." (paras 19–20)
6. Disclosure of the implants. "A reading of the above table discloses, that indeed, the implants forming subject matter of the methods for which the claims had originally been filed, with all their peculiarities and characteristics, were indeed disclosed in the complete specifications accompanying the original claims." "As the above table shows, this position is replicated in respect every one of the amended Claims. Each claim stands fully disclosed in the complete specifications accompanying the unamended claims." (para 22) "Mr. Harish Vaidyanathan does not, fairly, dispute this factual position." (para 23) "A large part of the complete specifications in the subject patent, therefore, dealt with the implants themselves, and their peculiar compositional constitution." (paras 22–23, 33)
7. Claims compared with claims alone. Counsel for the Controller submitted that "The complete specifications accompanying the original claims, he submits, is entirely immaterial in such consideration." (para 25) The Court found "that the submissions of Mr. Vaidyanathan, seen purely and strictly in the light of the statutory provisions, are attractive. However, any interpretation of Section 59(1) along the lines suggested by Mr Vaidynathan would, in my mind, result in creating an artificial distinction between the claims in a patent and the complete specifications that accompany it, and would also discriminate between applications for amendment of claims and applications for amendment of specifications, according them treatment which is completely different, which would militate against the very ethos and philosophy of the Patents Act." (paras 25, 29)
8. Purposive interpretation of the Patents Act. "Literal construction with faithful adherence to the plain words of the statute is, after the decisions in Shailesh Dhairyawan v. Mohan Balkrishna Lulla, Richa Mishra v. State of Chhatisgarh and, most recently, X v. Principal Secretary, Health & Family Welfare Department, GNCTD, no longer the golden rule of interpretation, having given way to the principle of purposive interpretation. This would be especially so in the case of statues dealing with intellectual property, the main aim and object of which is preservation of intellectual property rights. Avowedly, as held in" Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries (1978), "the object of patent law is to encourage scientific research, new technology and industrial progress". (para 30)
9. Fostering inventiveness. "Fostering of inventiveness is, therefore, the very raison d'etre of patent law, to which end any meaningful interpretation of the provisions of the Patents Act must aspire. Placing unduly restricted, pedantic, or hypertechnical interpretations on provisions of the Patents Act, in a manner which would discourage inventiveness and entrepreneurship would, therefore, be counter-productive to its purpose. It would be completely impermissible, therefore, for the provisions of the Patents Act to be so interpreted as to render a possibly inventive invention non-patentable." (para 31)
10. Obiter. Public interest. "In such circumstances, the Court is also required to keep in mind public interest, being one of the cardinal aims of patent law, especially where the patent is pharmaceutical or therapeutic in nature." (para 32)
11. Claims read with the specification. "Any such view, in my considered opinion, would be completely contrary to the very ethos of the Patents Act, as well as the most elementary principles of patent claim construction." (para 36) After reproducing paras 43 and 44 of Bishwanath Prasad Radhey Shyam, the Court held that "The principle was enunciated, with even greater precision, in the judgement of the Division Bench of this Court authored by S. Ravindra Bhat, J. (as he then was), in the following passage from" Merck Sharp and Dohme v Glenmark Pharmaceuticals (2015): "the construction of claims is not something that can be considered in isolation from the rest of the specification". (para 36) "Dichotomizing the claims and the accompanying specifications is, therefore, contrary to the most fundamental canons of patent law." (paras 36–37)
12. The scope of a claim. "What the Section compares, therefore, is the amended claim with the scope of the pre-amended claim. Where the amended claim does not fall within the scope of the pre-amended claim, the amendment would not be allowed." (para 41) "As I have already noted, the claims and complete specifications in a patent have to be read together and as a whole. The claims have to be understood in the light of the complete specifications. They form an integrated whole, and cannot be treated as two distinct parts of one document. The claim by itself, and de hors the complete specifications which accompany it, cannot convey, to the Court, the exact scope of the claim." (para 42) "The very use of the expression 'scope of a claim' in the concluding part of Section 59(1) would, therefore, in my considered opinion and keeping in mind the avowed purpose of the Patents Act, require taking into consideration the complete specifications of the pre-amended claim, and not merely a textually cabined reading of the pre-amended claims themselves, de hors the complete specifications." (para 43) "While, therefore, examining whether the amended claim falls wholly within the scope of the specification in the pre-amended claim, therefore, the Court, in my opinion, cannot eschew, from consideration, the complete specifications in the pre-amended claim." (paras 41–44)
13. From method claims to product claims. "This is not a case in which there is a wide divergence between the claims for which the patent had originally been sought, and the claims as amended subsequently. The amended claims were in respect of the very same implants for the method of use of which the original claims have been filed." "In fact, the complete specifications, holistically read, clearly indicate that the appellant was effectively claiming both the implants as well as their method of use as its inventions." (para 38) "Particularly in a case such as this, in which the pre-amended claim was for the method of using certain implants for treating ocular ailments, and all details of the said implants were forthcoming in the complete specifications in the pre-amended claims, and the amendment was only to substitute the method of using the implants with the implants themselves, it would be a travesty, in my opinion, to shut out the appellant from seeking a patent in respect of the implants merely on the ground that the amendment was not permissible under Section 59(1)." (paras 38, 45)
14. Rejection at the threshold. "A hyper-technical view, in that regard, in my opinion, would not be justified, given the philosophy behind the Patents Act. If, indeed, the implants are inventive, the appellant, as the claimed inventor, ought to be given a chance to have the implants patented." "The application cannot, however, be thrown out without examination at the very threshold." (para 40)
15. Amendment before grant. "The view that I have taken also harmonises with paras 53 to 55 of the decision of the Co-ordinate Bench in" Nippon A&L v Controller of Patents (2022), which, as reproduced, held that "amendments to a patent specification or claims prior to grant ought to be construed more liberally rather than narrowly" and that "So long as the invention is disclosed in the specification and the claims are being restricted to the disclosures already made in the specification, the amendment ought not be rejected, especially, at the stage of examination prior to grant." (para 46) "The amendment that was sought in the present case was at a pre-grant stage." "I am of the opinion that the learned Controller ought to have allowed the amendments which the appellant sought, and to have examined the claims as so amended, and their patentability, on merits, and should not have shut out the appellant merely on the somewhat tenuous ground that the appellant was not entitled to amend its claims in view of Section 59(1) of the Patents Act." (paras 46–47)
16. Procedure. Remand to the Controller. "The 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 the Patents Act and all principles applicable in relation thereto." (para 48) "The decision would be taken by the learned Controller in keeping with the principles of natural justice and following due procedure in that regard as also after grant of an opportunity of hearing to the appellant." (paras 48–49)
17. Disposition. "For the aforesaid reasons, the impugned order dated 30th March 2020, passed by the learned Controller, is quashed and set aside. The prayer, of the appellant, for permission to amend its claims, as advanced before the learned Controller, stands allowed." (para 48) "The appeal stands allowed in the aforesaid terms with no order as to costs." (paras 48, 51)

What the court did not decide

"This Court is not presently concerned with whether the implants were, in fact, inventions within the meaning of Section 2(j) of the Patents Act or, whether, in their creation vis-à-vis prior art, any inventive step within the meaning of Section 2(ja) was, or was not, involved. It would be for the learned Controller, while examining the patentability of the said amended claims, to examine whether they satisfy all the pre-requisites of patentability as envisaged by the Patents Act." (para 34) "It is clarified that the present judgement is restricted to the aspect of permissibility of the amendments which were sought by the appellant in the original claims. This Court has not expressed any view on the patentability of the amended claims. The learned Controller would examine the patentability of the amended claims uninfluenced by any of the observations contained in this judgment." (para 50)

Subsequent treatment

• Followed — In Regeneron Pharmaceuticals v Controller of Patents and Designs (2024) the Madras High Court (K. Kumaresh Babu J) extracted this judgment, recorded that "the respondent herein had only considered the original claim and the amended claim dehors the complete specification that was before it", and held that "Such a decision is squarely covered by the judgment of the Hon'ble Delhi High Court" (para 8).