On July 27, while upholding the validity of one patent (the '017 patent) granted to Glaxo Group Limited, the Intellectual Property Appellate Board (IPAB) revoked another (the '171 patent), for lack of inventive step and as being hit by Section 3(d). Both the patents relate to lapatinib and its compounds. Interestingly, both decisions rest on the adequacy of the pleadings and evidence on record – while in the first case the IPAB concluded that the petitioner who challenged the patent failed to satisfy his burden of proof, in the second case, it was the patentee who failed to satisfy his burden of proof.
With respect to the '017 patent, the IPAB noted that there is an initial burden on the challenger to establish a violation of Section 3(d). In the words of the IPAB, the pleadings must clearly note which specific "kind of a derivative of known substance" the claimed compound is and also further show that it has the same efficacy as the known substance. It is only after this burden is fulfilled that the patentee is required to defend the patent in question. This initial burden was not fulfilled by the challenger in this case. This was true even in respect of the alleged Section 8 violation, where the challenger merely made a bare allegation that there was non-compliance, without any further substantiation.
With respect to the '171 patent, the "known substance" in this case were the bicyclic heteroaromatic compounds of the '017 patent itself. It was admitted facts on record that the claimed form was an improvement over the known substance since it possessed superior moisture absorbing properties and enhanced stability. The IPAB observed that as per the binding principle of law established by the Supreme Court in the Novartis case, not all beneficial properties will assist in overcoming Section 3(d) and instead, there has to be evidence showing that properties relate to the efficacy of the substance. "Efficacy" in the case of medicine is its therapeutic efficacy. The IPAB held that the improvements claimed in the patent do not show improvement in the therapeutic efficacy of the substance and revoked the patent under Section 3(d).
The renovation of the '171 patent under Section 3(d) is not unexpected in view of the Novartis ruling that mere physicochemical advantages in themselves may not be sufficient to establish enhancement of efficacy. At the same time, the decisions very clearly highlight that neither Section 3(d) nor Section 8 is a "bonanza for all those who want an inconvenient patent removed". The ruling as to the initial burden of proof on the challenger is an important one that would serve to prevent misuse of these provisions.
|
V Lakshmikumaran |
Lakshmi Kumaran & Sridharan
B6/10 Safdarjung Enclave
New Delhi 110029
India
Tel: +91 11 41299800
Fax: +91 11 41299899
