Intervention on SCP/24/3 under the agenda item: Quality of Patents
Madam Chair,
With respect to the proposal in document SCP/24/3, to our understanding, although it is clarified, let the Delegation of India to reiterate its stand that such study must not be construed as a tool for harmonization of concept of inventive step. The study should take into account the principles &objectives of the TRIPS agreement, as well as the obligations of Doha declaration on the TRIPS &Public Health, and also the flexibilities in the TRIPS agreement regarding the essential limitations of patentability as per the policy objectives of member countries.
And, as long as this mandate of the TRIPS agreementis maintained, our Delegation doesn’t have any issues against the proposed study in SCP/24/4. Also, it is expected to have the meaningful outcome as proposed and particularly, in the field of assessment of inventive step in the Chemical Sector (Markush claims, enantiomers, etc.). In addition, in the area of chemicals & pharmaceuticals, the study should also look at the inventive step assessment in the context of polymorphs, salts, ethers, esters and isomers.
Madam Chair,
The Committee may take note of the proposal submitted by the Delegation of South Africa on behalf of African Group & DAG, SCP/16/7 and may recall one of its component that the committee would conduct a cost-benefit analysis of admissibility of Markush claims.Needless to say those Markush claims deserve special attention in the proposed study, as millions &millions of compounds are claimed and buried under the coverage of a single formula covering, even compounds, which are to be discovered in future.
In this regard, the studySCP/22/3, presented by the Secretariat in the 22nd session, covered jurisprudence of different jurisdictions regarding various qualities of a skilled person. In almost all the cases, it is noticed that skilled persons have ordinary or average skills in the art. However, in the past, on certain occasions &in certain areas of emerging technology, the Courts conferred attributes of inventive ingenuity upon the skilled person.
For instance, on question whether the skilled addressee of inventive step should be have inventive ability or not, Lord J Mustil, in Genentech Inc v Wellcome Foundation’s TPA case, [Genentech’s Patent [1989] RPC 147] held that the hypothetical skilled man must be credited with a substantial degree of ability or ingenuity to solve the problems.
Further, J John Middleton, in his paper, “The Skilled Addressee”, [Intellectual Property Society of Australia &New Zealand, 9 September 2012] asked the question, Must the skilledaddressee always be non-inventive?Based on the opinions in Genentechcase and dissenting judgment in Alphapharmcase [AktiebolagetHässle v Alphapharm Pty Limited (2002) HCA 59, 12 December 2002, S287/2001, HIGH COURT OF AUSTRALIA], he concluded that the skilled addressee need not always be non-inventiveand determination of obviousnessis not boundto be determined with reference to persons who are not particularly imaginative or inventive.
However, as a tradition, almost the skilled person is presumed to be non-inventive, butthese case laws show a different thinking (ingenuityin certain areas of technology) that the skilled person may have different attribute and may be considered as inventive or imaginative.Therefore, the proposed study may also include these elements, which might be useful in the context of the policy objectives.
Madam Chair,
Further, in the same paper, J Middleton raised another question, whether the skilled person for inventive step and sufficiency must be the same entity? In Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] RPC 33, the UK Court held that they need not to be the same for both inventive step &sufficiency purposes. Hence, the study may further include the component whether the persons skilled in the art are always same in different legal issues like inventive steps &sufficiency of disclosure.As these are important issues from the policy objectives, we look forward for the meaningful study incorporating all these elements.
Thank you, Madam Chair