On the 1st of April 2013, the Indian Supreme Court pronounced its judgment in the Special Leave Petition preferred by Novartis to determine the true import of Section 3(d) of the Patents Act 1970 as a result of the rejection of the product claims by the Controller of Patents and the Intellectual Property Appellate Board (IPAB).
The combined effect of the proceedings at the IPAB and the Supreme Court are as follows:
- The process claims for the manufacture of the beta version of ImatinibMesylate, were notin issue before the Supreme Court. Therefore, it cannot be said that the Novartis patent application has been rejected but that it is partially allowed. While the claims for the product have been rejected, the claims for the process were accepted.
- The findings of the Supreme Court are that the active compound inthe productmarketed by Novartis under the mark ‘Glivec’is ImatinibMesylate. This compound was covered by the Jurg Zimmermann patent of 1994 in the US as acknowledged by Novartis. No patent application was ever filed in India for ImatinibMesylate and therefore it cannot be said that the case that was decidedrelated to the product marketed under the brand of “Glivec,” but to a betapolymorph version of Glivec.
- The Supreme Court has elaborated and therefore defined the enablementrequirement in a patent document and has laid down that the coverage that is claimed in a patent cannot go beyond the enablement or teaching in the specification. There should, therefore, not be avast gap between the claims and the disclosure in the patent specification directed to the claims. In practical terms, this would mean that where there are claims for a Markush group or where a wide range of particular parameter is claimed, the specification will have to be exemplified with a much larger set of examples to support carrying out a process within the range and successfully making a compound or a formulation or using a device which is exemplified by several elements from the Markush group.
- The Supreme Court also had occasion to deliberate on the expression of the term efficacy in Section 3(d) of the Patents Act 1970. The Supreme Court has clarified that efficacy in terms of Section 3(d) continues to mean ‘therapeutic efficacy’ particularly when the claims are directed to pharmaceutical products. The Supreme Court has laid down directives that particularly in the case of medicines, the test of enhanced efficacy must be interpreted narrowly and strictly. The Hon’ble Court ruled out the relevance of advantages or beneficial properties of a drug which had no bearing on its efficacy. Thus, significant differences in physico-chemical properties of a compound will not qualify for the purposes of considering thecompound to be inventive. On the other hand, the Supreme Court has not ruled out that enhancements in bio-availability or reduction in toxicity can be equated to enhancement of therapeutic efficacy, to be considered on a case to case basis. The Supreme Court has recommended that such an improvement may be claimed and established by research data. Unfortunately, in the entire proceedings that is in the original specification or any of the documents submitted by the patent applicant during either the appeal proceedings or even before the Supreme Court, there is no document or date to show that the beta crystal form of ImatinibMesylate would be ableto produce enhanced or superior efficacy either in relation toImatinibfree base or in relation toImatinibMesylate.
- These findings of the Supreme Court can be interpreted to mean that data relating to efficacy can be produced and offered during the patent prosecution proceedings even subsequent to the filing of the patent application and included during the examination phase of the application. Post the Novartis judgment it should be the endeavor of innovators to file and offer as much therapeutic efficacy data as possible and discuss with a competent patent attorney in India as to the manner in whichthis data can be introduced in the proceedings.
- Another important lesson to be learnt from this case is that Section 3(d) can be used byinnovator entities to enforce their claims for patented compounds not only against the compounds themselves but also against other forms of the compounds listed in Section 3(d) whichbylaw are considered to be the patented compounds themselves.