Cipla on a patent knock down spree – Successfully opposes Novartis’ Dulera patent

Cipla has continued its knocking down spree by successfully opposing Novartis’ Dulera patent. Dulera is an anti-asthma drug, which includes a combination Formoterol, and Mometasone furoate in a weight ratio of 1:1 to 1:1000. The drug was granted an Indian patent numbered 202350 in 2007. The grant of patent was opposed by Cipla by way of a post grant opposition filed in February 2008 on grounds including: Lack of inventive step and Insufficiency of Description. It is interesting to note that the drug has valid patents in jurisdictions including Europe, United States, Korea and Israel.

            Lack of Inventive Step or Obviousness

The drug was challenged on count of obviousness on basis of US patent nos. 5874063 (D1), 5674860 (D5) and WIPO publication no. WO9520393 (D2). The patent office acknowledged the following:
  1. The prior art D1 teaches already an anti-asthmatic drug having Formoterol, and Mometasone furoate.
  2. The weight ratio of 1:1 to 1:1000 as suggested in the impugned patent is obvious in light of D5, which teaches a combination therapy comprising Formoterol and Budenoside (steroid similar to Mometasone furoate) combined in a weight ratio of 1:60.
  3. The prior art D2 teaches administration of Mometasone furoate along with other drugs including bronchodilator, such as albuterol. Accordingly, any skilled person will be motivated to combine the teachings of D1 with teachings of D2 to achieve the therapeutic results as taught by the impugned patent.
The ground of obviousness as contended by the patent office though seem easily deducible, might not be reasonable. However, I would like to reserve an entire post on an analysis of the same.
            Insufficient Description
Interestingly, the opponent submitted that the impugned patent though mentions about unexpected therapeutic benefits of the combination as claimed, there is no disclosure or data in the specification to substantiate the same. Accordingly, the claims of the impugned patent are not sufficiently described and ought to be revoked on this ground alone. The patent office seems to have agreed to the contention of the opponent.
This ground of Insufficient Description further highlights the importance of amending or altering a patent application based on requirements of Indian patent laws. In the present case, inclusion of data showing synergistic effects of the combination of Formoterol, and Mometasone furoate in a weight ratio of 1:1 to 1:1000 was absolute necessary not only to prevent insufficiency requirements, but also, to circumvent all doubts that may arise under section 3 (e) of the Indian patent act. However, seldom do patent law firms follow such practices. A mere forwarding of an application written by a foreign patent attorney to the Indian patent office may result in problems such as the one illustrated above. Although, the patent attorney handling this case may be let off the hook as the application was filed way back in 2001, before the introduction of the critical 2005 amendments.
We at Inohelp, follow a strict practice of reviewing all national phase or convention patent applications, and suggesting our client possible amendments in the complete specification before filing the application at the IPO. The acceptance of these amendments is on the discretion of the client, who we find seldom disagrees with the suggestions. 

Inohelp Consulting Solutions Pvt. Ltd.

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