Recently, Delhi High Court in Allergan Inc. v. the Controller of Patents set aside the order of the Indian Patent Office, and allowed certain claim amendments u/s 59(1). In this 2 part guest post, Amit Tailor discusses the Allergan order in part 1 and then assesses it in light of the previous decisions on the similar issue of claim amendments. Amit is a postgraduate in Pharmaceutical Sciences from National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar (Mohali) and LL.B. from Faculty of Law, Maharaja Sayajirao University of Baroda (MSU), Vadodara. He has also completed his graduation in Pharmacy from MSU, Vadodara. Amit is a registered Patent Agent and an IP practitioner and currently part of the IP litigation team at Sun Pharmaceuticals. He was earlier associated with Cadila Healthcare (now – Zydus Lifesciences). Views expressed on this blog are his own. He also writes poetry with penname “કાચબો” [Kācabō – meaning tortoise/turtle] at www.amittailor.com : અમિતટેલર.કોમ – કાચબાની કલમનું કાયમી સરનામું (Permanent Address of the Pen of Kācabō). His previous posts can be found here.
Claim Amendments u/s 59(1): Confusingly Evolving Landscape in India- Part I
The Delhi High Court (the “DHC”) has become the epicenter for Intellectual Property litigation (and adjudication) in India. Judgments with respect to various aspects of Intellectual Property laws, including the Patent Act, are being delivered on regular basis from the Intellectual Property Division (IPD) of the DHC. One such aspect of the Patent Act is ‘allowable claim amendments u/s 59(1)’. Recently the IPD, in Allergan, has allowed certain claim amendments u/s 59(1) by reversing a Controller’s rejection and remanding the case back for reviewing the so amended claims on merit. There have been, at least, two more decisions on the same issue in recent past from the IPD of DHC – the Boehringer and the Nippon. This post, in the first half, reviews the Allergan decision in detail; and in the later half, reviews the ruling and reasoning of Allergan with respect to that of Boehringer and Nippon and would try to find if the three are in sync with each other or not. The post also reviews how the landscape of allowable amendments u/s 59(1) is evolving in India in light of the three decisions.
The Allergan Case – Facts
An application [7039/DELNP/2012] was filed with a principle claim for – A ‘method of treatment’… wherein two ‘implants’ would provide specific release profile for the active compound therein (the “method of treatment” claims or the “method” claims). There were further claims, depending on the ‘method of treatment’ claims, which described the components and composition of the ‘implants’. The ‘method’ claims were objected to in the Examination Report as non-patentable subject matter u/s 3(i). In response, the applicant amended the claims to read an ‘implant’ comprising specific components and compositions thereof. Such an amendment, from ‘method’ (using implants) to ‘Compositions of the implant’, was objected to by the Patent Office as an unallowable amendment u/s 59(1), on the grounds that said ‘composition of implants’ claims do not find support in either of the claims as originally filed with the PCT application or in the claims of application as filed while entering the national phase. The amendments were finally rejected, after hearing, as unallowable u/s 59(1) as the amended claims did not fall wholly within the scope of the claims originally filed.
The Applicant Appealed the rejection before the DHC, which held that the amendment from ‘method of treatment using the implant’ to ‘the implant’ – the ‘product’, should be allowable u/s 59(1) and remanded the case back to the Patent Office to examine the amended claims on merit for patentability under other provisions of the Act.
Court’s Observations, Remarks and Reasoning
The Court while allowing the amendment from ‘method’ claims to ‘product’ claims, made certain comments and/or observations, which are being reviewed herein.
‘Different’ Reasons for Rejection in ‘Hearing Notice’ and ‘Rejection Order’
The Court opened their analysis with an observation/comment that different reasons for rejection were provided by the patent Office (the “PO” or the “Office”) in the Hearing Notice and the ‘Rejection Order’. The Hearing Notice indicated that the amendments were not allowed u/s 59(1) because (i) the amended claims did not have support in the originally filed claims; and (ii) that the claims for the ‘implant’ were not part of the PCT or the National Phase application as filed; while the rejection order indicated that the amended claims were rejected because the ‘claims did not fall within the claims as originally filed’. The Court, than, apparently concluded that the Office had ‘restricted’ their rejection to “… Claims does not fall within the scope of the as originally filed”.
However, on careful review, it appears that both the expressions used for rejection by the office, would convey one and the same thing that the amended claims do not fall within the claims as originally filed and hence not allowable u/s 59(1). Therefore, it is not apparently clear, that in what context or to press which point, the Court made such an observation or comment. (See especially para 8-11 of the decision). Even if assuming that the Office has ‘restricted’ their rejection to one ‘issue’ only, the Court has not indicated how and to what extent, such restriction would have impacted the final outcome of the issue(s) before it.
‘No Fault’ of the Applicant
The first, and apparently primary, reason provided by the Court to allow the amendments was, that the Controller was not justified (!) in raising non-claiming of the ‘implant’ in the PCT application or in the National Phase application, as ‘additional’ (!) grounds for rejection. It is not clear, in what context, the Court termed the grounds as ‘additional’; but probably on the ‘unjustified’ count, the could remarked that no fault could be attributed to the applicant for filing the application with ‘method’ claims in India, because –
the ‘method’ claims were allowed in the home country of the applicant; therefore, they could file the PCT application with ‘method’ claims; and
the PCT scheme allows the claims [& the title, description, drawing and specification] filed with the PCT application, to be treated as the complete specification (including the claims) for entering to Indian National Phase.
Thus, the applicant could file, and therefore could have filed the application in India, with the ‘method’ claims. And, because method claims are not allowed in India, the applicant should be allowed to amend the existing claims and/or to introduce (new) claims for product.
The argument and the reasoning by the Court may appear as just and reasonable, but only in isolation. The same may appear misplaced, when looked at with a different perspective. There can be no dispute over the difference in allowability of method claims in India and US. However, in the context of the facts of the case is, it was also relevant to review the allowability of the product claims for the ‘implant’ in the two jurisdictions. Going by the same logic of reviewing the allowability of method claims in US, the fact finder should have also raised a query to ascertain whether the product claims are allowed under the US Patent Act or not; and what is the corresponding position in India. But, unfortunately, the Court did not go into that analysis, and delivered their decision based only on the position with respect to method claims.
The US patent act may allow the method claims, but at the same time, the US patent Act also allows the product claims(!). Therefore, at the time of filing the PCT application, the applicant was at all his liberty, and was well within his rights, to include the product claims for the ‘implants’, along with the method claims (for using the said implants). However, the applicant chose not to do so.
Therefore, the argument, in isolation, that because US Patent jurisdiction allowed method claims therefore the applicant chosen to start with method claims (only) and they should be allowed to amend it to product claims in India, where method claims are not allowed, appears fairly misplaced.
Indian Patent Act is not the US Patent Act
The Court primarily appeared to have relied on the differences in the allowability of method claims in India and US while allowing the amendments. However, that is precisely the position which should have been considered by the Court – that the two patent statutes are different from each other and so shall be the provisions thereof. The application in India shall be subjected to Indian legislation and shall be adjudged based on the legislative intent of the Parliament of India. When an action is not allowed under the express mandate of the Indian legislation, it cannot be allowed by the Courts, in light of some provision in a foreign legislation which allowed such an action. And for the same reason the reverse is also equally true – if something is not allowed in a foreign legislation, shall not be disallowed in India merely for that reason.
Allowing Change of Scope is Contrary to the Express Mandate of the Act
Under the Indian statute, once an application is published, every amendment thereto has to fall wholly within the claims before the amendment, u/s 59(1). I have discussed the issue – ‘allowable claim amendments u/s 59(1)’ in more detail in my earlier post for SpicyIP (in two parts, Part-1 and Part-2). Therein, I have discussed that the proper inquiry while adjudicating a claim amendment u/s 59(1), would require the fact finder to look into the claims before and after the amendment, in addition to the specification as filed. The amended claim(s), for the purpose of this section, being disclosed in the specification is necessary but not the sufficient position; the claim(s) must also fall wholly within the scope of a claim before the amendment.
When the applicant in spite of being fully aware of the fact and their right to claim product, chose not to do so, even in their home country where the act there allowed them to do so, then accepting such arguments on differences in the patent acts and allowing the amendment to include ‘new’ claims in India, when the Indian statute expressly disallows such a practice, would be a manifest error and would be contrary to the Indian statute and the legislative intent thereon.