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In a rather interesting turn of events, the Indian Patent Office has recently granted patent for the polymorph of a known compound, notwithstanding objections u/s. 3(d) of the Patents Act, 1970. Following are the details of the judgment:
Application Number: 106/DELNP/2008
Applicant’s Name: M/S ALFA WASSERMANN S.P.A., Italy.
Date of Decision: December 26, 2012.
Controller’s Name: Hardev Karar, Deputy Controller of Patents and Designs, Patent Office, New Delhi.
Facts: The application was filed for “POLYMORPHIC FORMS OF RIFAMIXIN, PROCESS FOR THEIR PRODUCTION AND USE THEREOF IN MEDICINAL PREPARATIONS” on January 3, 2008. The main non-procedural objections to the amended claims as voiced by the Examiner were as follows:
Some of the claims defined a mere admixture resulting only in the aggregation of the properties of the components and it was not clear whether they acted together to provide a technical effect greater than just the sum of the components.
Some of the claims fell under the S. 3(d) prohibition, since they defined merely a new form of a known substance without any enhancement in known therapeutic efficacy thereof.
There was lack of inventive step as per prior art documents and hence the subject matter did not constitute an invention u/s. 2(1)(j)(a).
One may bear in mind the fact that this hearing was held u/s. 15 and not as a pre-grant opposition u/s. 25.
Judgment: Following the arguments of the Applicant’s counsel in favour of the amended claims, the Controller held that the invention under consideration comprises a synergistic composition and has improved pharmaceutical properties. The enhancement in efficacy lay in the fact that the polymorph had an in vivo absorption level of about 100 times lower than the original form, resulting in reduction of the toxicity 100 times due to absorption. Therefore, the Controller was of the opinion that the disclosure by the Applicant for proving efficacy (i.e. same therapeutic value with 100 times less toxicity of the new polymorph of this invention) was appropriate until someone interested proved contrary to it. Hence the claims were set free of the clutches of S. 3(d), with the qualification that they might be examined in stricter sense in the proceeding if arising out of the opposition u/s. 25 and/or Revocation.
With regard to the inventive step objection, the Controller, after examination of the prior art documents, held that not only the finding of polymorphs of Rifaximin was unobvious over the prior art, but in addition, the finding of different polymorphic forms of Rifaximin had shown that a compound known to have a uniform property in fact is comprised of various polymorphic forms of said compound having different properties in the term of absorption. This objection was thus also set aside.
The other technical and procedural objections by the Examiner were also set aside by the Controller.
Decision: The patent was granted to the polymorph on the basis of the amended claims.
This decision may well indicate the beginning of a trend by the Patent Office to be willing to overlook S. 3(d) objections to the grant of patent to a polymorph in the presence of proven enhanced efficacy of the original form. This will be a welcome news indeed for the proponents of the school of thought firmly believing that polymorph patents will increase cost efficiency (see here). The Spicy IP team thanks Mr. Sandeep K. Rathod for bringing this matter to our attention.
Dear Shouvik and SpicyIP team:
Happy new year and many thanks for citing my name.
However, please note that neither I nor my employer may necessarily agree with the rationale in this decision. In fact, there are some aspects that I think are very unique!
I merely highlighted the decision but I think that the decision may need a revisit once the Supreme Court issues its decision in Novartis/ Imatinib.
Regards,
Sandeep K. Rathod
By simply introducing a statement that the compostion is synergistic just beacuse the additives not reacts with the compound is totaly wrong decesion.The purpose of additives is not to react with main molecule otherwise the purpose of additives is defeated.
Is it possible to get a copy of this decision?
Happy New Year!
Best regards, Lisa
Lisa,
The decision is available here:
http://164.100.176.38/decision/106-DELNP-2008-2054/106%20delnp2008%20decision.pdf
If you are unable to access this, send me an email at [email protected], and I will email it to you.
Kind regards,
Guru Nataraj
Hello All,
of course, this action can start a new chapter in Indian patent. But i have a small query. What is the meaning of efficacy ? Is it related to increased theraputic value or decrease in toxicity/side effect caused by any polymorph compound?
In december, 2012, A similar decision has published in astrazeneca ‘crestor’ related litigation in US where the court validate astra polymorph moiety of sandoz compound as the level of side effect decreased.
Regards,
ashutosh