In Part I of this 2-part post, Amit Tailor discussed the key aspects of the Delhi High Court’s order in Allergan Inc. v. the Controller of Patents. In continuation to that discussion, he analyzes the order from the lens of previous decisions by Delhi High Court and makes key observations regarding public interest.
Claim Amendments u/s 59(1): Confusingly Evolving Landscape in India- Part II
Evolving ‘Amendments’ in India under Nippon, Boehringer & Allegan
Divergent Views on Similar Facts
As discussed in part 1, before Allergan, there are, at least, two more decisions from the IPD of DHC, Nippon and Boehringer, which dealt with the provisions of allowable claim amendments u/s 59(1). Counterintuitively though, when these three are read together, they appear to create more confusion than providing any clarity on the issue. The ratio set by them are so diverse that, in an adversarial proceeding such as patent prosecution or litigation, the opposite parties may pick their respective chosen or desired positions based on any of them, and no clear conclusion could be arrived at.
In Boehringer, the application was originally filed with claims for ‘method of treatment’ (using DPP-IV inhibitor Compounds) which were later amended to ‘product’ (comprising the same DPP-IV inhibitors). The amendment from ‘method’ to ‘product’ was rejected by the Patent Office and affirmed by the Court.
In Allergan, also, the application was filed with claims for ‘method of treatment’ (using ‘implants’ with specified release profile) which were later amended to ‘product’ (the ‘implants’ itself). Here also, the amendment from ‘method’ to ‘product’ was rejected by the Patent Office, but the Court in this case reversed the Patent Office decision and thereby allowed such amendments.
i.e. broadly the facts of the two cases were comparable, the applicable relevant statute for the two was also the same – Sec. 59, but the decision arrived at by the two Courts is different. In Boehringer, the Court categorically said that “If applicants are permitted to file such divisional applications on the basis of disclosure in the complete specification, without such inventions being claimed in parent applications, it would defeat the fundamental rule of patent law i.e., ‘what is not claim is disclaimed’…Section 59 also makes it clear that amendments beyond the scope of the specification and claims would not be permissible. This is the settled legal position, as also held by this Court in Nippon” [para.31, emphasis added].
Surprisingly, Boehringer was not cited by either of the parties, and not even by the Court. Allergan, though, cited another decision from the same bench – Nippon, which was also cited and relied upon by Boehringer as above. But here also both the Courts drew nearly opposite obiter and ratio therefrom. Boehringer observed that Nippon held that ‘it is the settled position of the law that amendments beyond the scope of (specification and) claims would not be permissible u/s 59(1)’ (para 31 of Boehringer), while the Allergan Court claimed to have found harmonies with Nippon in holding that when the amended claims were ‘supported’ by the specification, “it would be a travesty (to reject) the claims merely on the ground that the amendment was not permissible under Section 59(1)” (para 45-46 of Allergan).
When Boehringer had categorically held that the settled legal position, and the holding of Nippon, was that the amendments beyond the scope of the filed claims is impermissible u/s 59(1), then the finding of a position from Nippon, by Allergan, which is apparently opposite to that of Boehringer, arguing that doing so would be a travesty, is troublesome. This has made the legal position on this issue much complicated. We have now three decisions providing nearly opposite positions on an issue and we stand squared with practically no clear guidance.
Positions u/s 59(1)
The Court in Allergan allowed the amendments reasoning that the same ‘were indeed disclosed in the complete specification accompanying the Original claim. [para 22]. The Court repeatedly made efforts and made remarks that the amended claims for the implants were supported by the specification. However, the dispute therein was not whether the implants were disclosed in the specification, but whether the implants fell wholly within the scope of (filed) claims.
As already discussed herein above, looking for support in the specification only is not the correct inquiry u/s 59(1), under the ‘settled’ legal position on the issue. The correct inquiry would be whether the claims fall ‘wholly within the scope of the claims before amendment, and whether the same is supported by the specification. ‘Supported by the specification’ is necessary but not the sufficient condition to be met for a claim amendment to become allowable u/s 59(1).
Deviation from ‘Golden Rule’ is Problematic
The Allergan Court, citing three SC precedence, suggested that “Literal construction with faithful adherence to the plain words of the statute is … no longer the golden rule of interpretation, having given way to the principle of purposive interpretation.” [para 30, internal citations omitted] and went on to comment that if the provision of Sec 59 is read as suggested by the Patent Office, which is also the view concurred by Boehringer and Nippon, it would amount to creating an ‘artificial distinction’ and ‘discrimination’ (!) between claims and complete specification, and between the amendments to claims and complete specification; and would be against the ‘ethos and philosophy’ of the Patents Act.
When the language of Sec 59, especially the clause (1), and the precedence thereon, is reviewed carefully, it can be inferred that there is indeed a distinction, between the description and the claims; and the distinction is not ‘artificial’ but, in fact, an actual one being consciously created by the legislature, by incorporating specific and distinct languages, for the amendment of claims and of the specification. For detailed discussion on this position, read the Part-1 of the post on allowable amendments, especially under the heading ‘Provisions of Amendment, to Specification and to Claims, Under the Act’ – “Certainly, claims form a part of the specification itself, but still both the terms are not synonymous or interchangeable, at least, for the purpose of above Clause … the statute has clearly identified two distinct elements of a ‘complete specification’ – the ‘description’ and the ‘claims’; and apparently provides different standards for amendments to the two.”
When the legislation has clearly carved out distinction between the ‘description’ and the ‘claims’ of a ‘Complete Specification’, then terming the same as ‘artificial’ and ‘discriminatory’ to deviate from the ‘Golden Rule’ and to adopt an alternative interpretation; and allowing an act to be performed which is not expressly allowed, or rather which is expressly prohibited, is surely troublesome.
Stiffening Innovation vs Undue Advantage: Private Interest vs Public Interest
The Allergan Court also reasoned that any ‘unduly’ restricted or hyper-technical interpretation (of Sec. 59) would discourage inventiveness, would be counter-productive to the purpose of the Patent Act, and would render a possibly inventive invention non-patentable. Unfortunately, while doing so, the Court has weighed on the objective of the Patent Act from one perspective only – the patent applicant, completely disregarding the other stakeholder in the patent parlance, the public – the society, the government, the end user of the patented products, the competitors providing or capable of providing same/similar product in the industry etc.
The Patent Act, while providing the monopolistic rights to the patent applicants and holders promoting innovation, also provides for protecting the rights and interests of the public. One such public interest is to have the clarity and certainty with respect to what is (or shall be) claimed by a patent. To safeguard the public from any possible unjust ‘scope expansion’ by a patent applicant, the legislation has provided certain checks in the Patent Act; and one such provision is Sec. 59(1) which would require that a claim shall be amended such that it does not expand the scope of the claim(s).
Allowing such introduction of ‘new’ claims on the basis of ‘description support’ shall be contrary to the ‘public notice’ & ‘certainty’ requirements of the Patent Act. Introduction of new claims and importing of embodiments from the specification in to claims years after actually filing the application, would frustrate the public interest to work outside of the claimed subject matter with clarity and certainty to stay clear of any risk of infringement in future.
While deviating from the Golden Rule & adopting the Purposive Interpretation (of Sec 59(1)) to allow introduction of ‘new’ claim(s) or ’new’ subject matter which was not claimed as such in the application as filed, the Court has taken into consideration only the private interest of the patent applicant, and apparently, has nearly completely disregarded the public interest provision(s) of the Patent Act, as discussed above; and practically undoing the legislatively provided safeguard against such scope expansion or the scope change. It is not even needed to mention, when the two – public and private interests, are competing, which one shall get priority over the other.
The ‘Product’ Narrower Than ‘Use’ of It?
After concluding that the applicant should not be barred to introduce product claims by deleting method claims, the Court further reasoned that the original claims were for ‘method of using the implants’ and the amended claims were for ‘the implants’ themselves, therefore the claims were not beyond the scope of original claims, and should be allowable u/s 59(1). Such a conclusion of the Court is not clearly supported by the facts of the case and the practice in the field of the invention.
The examination authorities over the globe including various ISA for PCT applications, the USPTO, and the IPO, have time and again classified claims for i) Product, ii) Process for preparation of the said product; and iii) Method of use of the said product, as separate and distinct inventions and has asked for election/division of the group of claims, if more than one of such group of claims are included in one application. Of course, they may be joined by a single inventive concept in certain cases, but none the less they are considered as distinct inventions within the meaning of the concept of ‘Unity of Invention’.
Therefore, without going in to the discussion of whether ‘implant’ is within or beyond the scope of ‘use of the implant’, the two claims are related to different ‘inventions’ itself – they are subject to different patent classifications (e.g. International Patent Classification (IPC)). In light of which, it may not even be practical to suggest whether scope of one is subsumed in another, or whether one is broader or narrower than the other. Thus, the Court’s reasoning that the ‘Product’ claims were not beyond the scope of the ‘Use’ claims appears inappropriate and misplaced.
When the rejection orders from the Patent Office and the opinions of the Court thereon, in these three cases are reviewed with respect to their reading, interpretation and/or treatment of Sec 59(1) specifically, than it may be observed that the Patent Office appears to have adopted one interpretation nearly consistently, that the amended claims should fall wholly within the scope of the claims (before amendment or as filed) to be allowable. Whereas, the Court clearly appears to have taken flip-flop positions. The Boehringer and Nippon Courts interpreted Sec 59(1) in such a way that the amended claim(s) which do not fall within the claim(s) before amendment, shall not be allowed, even if fairly disclosed and supported by the specification; while the Allergan Court held such an amendment shall be allowable under the ‘Purposive Interpretation’ and the ‘No Fault of Applicant’ doctrines (which we has discussed are not free of shortcomings).
Deviation from the ‘Golden Rule’; reviewing and relying upon the patentability position of method claims in US to allow amendments in India; and comments on the scope of product and method claims; are also troubling.
The Allergan court has also made certain comments and observations with respect to –comments of the Apex Court in Bishwanath Prasad Radhey Shyam; the discussions in, and the recommendations of J. Ayyangar Committee Report; and the concept of ‘reading the specification and claims together’; amongst other things. These could have also been some minor points for discussion, but to a great extent, it would not have impacted or altered the overall discussion and perspective under any of the heads herein. Therefore, such discussion is not included herewith.
However, such a broad and overreaching interpretation of the statute and providing such reliefs by the Court, reminds me of recent remarks by Adv. J Sai Deepak with respect to patentee-friendliness vs patent-friendliness of the Indian Jurisdiction “… it appears that the patent establishment of the country has drawn a very different message — it has gone on an overdrive to prove its patent-friendliness, rather patentee-friendliness, …Provisions …of the Patents Act were expressly introduced …to prevent the mischievous practice of “evergreening” of patents, which pharmaceutical “innovator” companies had successfully resorted to in patentee-friendly jurisdictions …”. We shall have to introspect and see if we are becoming patent-friendly or a patentee-friendly jurisdiction, and more important is what should we prefer to be?