Israel Patent Application No. 140665 to Novartis tited “Use of Combiantion Compositions comprising Valsartan and Amlodipine n the preparation of medicaments for the treatment and prevention of diabetes related hypertension” relates to preparations including Valsartan and Amlodipine for treating high blood pressure and diabetes.
The application was a national phase of PCT/EP1999/004842 from 9 July 199 and claims priority from an earlier US patent application. The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.
The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.
On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two publications from after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and expunged from the record.
Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.
Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known.
Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicate the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.
The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.
Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.
In this case, the additional information is not prior art in the public domain, or it would not have been accepted for publication. It post-dates the application and is, therefore, not prior art. The Deputy Commissioner did not consider this material as indicating what was widely known prior to the priority date. The Opposers are trying to use the citations of Lip to show what was known prior to the priority date, and to do this, they should have submitted these citations in their statement of case.
Whilst not wishing to rule out using a paper that provides history of what was known earlier, the Deputy Commissioner warns against the danger of a hindsight bias and of reading the authors conclusions into the prior art.
As to the Opposers argument that the Applicant should have submitted an affidavit to support the evidence, Ms Bracha rejected this as the dates are not contested and so an affidavit is unnecessary.
In conclusion, Ms Bracha ruled that Sections 25-26 and 86-88 of the second opinion should be deleted. Legal costs of 5000 Shekels were ruled against the opposers.
In the DSM vs. Mifalei Migun case, Judge Judith Schitzer of the District Court correctly ruled that one does not have to submit an affidavit with every piece of evidence or statement, so the Deputy Commissioner is correct on this account.
As to the late submission of evidence however, I think that the Opposers can fairly be penalized for not timely submitting these papers by having interim costs awarded against them for not submitting the evidence earlier, but the evidence should be related to substantively if it testifies to what was practiced prior to the patent being filed and not thrown out on procedural grounds. Ultimately the purpose of the Opposition proceeding is to clarify novelty and inventiveness to protect the public interest. If a drug becomes patented and should not be, the public will pay monopoly prices. Sure, the opposers have to answer as to why these papers were submitted late. Maybe the applicant should be given a second chance to respond and compensated for delays, but I disagree with this decision to throw out what could be key evidence.