he Indian Patent Office has granted a patent to Sanofi-Aventis Deutschland GmbH (Sanofi) for a drug delivery device after rejecting pre grant oppositions filed by Biocon Limited (Biocon) and Mylan Laboratories Ltd. (Mylan). Anand Barnabas and Dipanjana Chakraborty of De Penning & De Penning successfully represented Sanofi in this matter.
The Patent Application No: 2423/CHENP/2011 (“DRUG DELIVERY DEVICE AND METHOD OF MANUFACTURING A DRUG DELIVERY DEVICE”) was filed on 11.04.2011 in the name of Sanofi-Aventis Deutschland GmbH.
The invention relates to a “drug delivery device” that can be “configured to allow setting of different dose sizes.” The invention seeks to provide a drug delivery device to improve “operability with respect to dosage control and/or improved reproducibility of the dosage in connection with different cartridges.” The device contains a spring washer arranged within its housing to exert a force on the cartridge to secure the cartridge against movement with respect to the cartridge retaining member.
The novel feature of the invention lies in fixing the spring washer to the outer surface of a sleeve member of the device by fixing elements. By fixing the spring washer in this way, it reduces the risk of contact between the spring washer and cartridge. Besides, the technique ensures stable fixation with respect to the radial forces and thereby preventing the washer from moving radially in either radial direction.
In 2019, two successive oppositions were filed against the grant of patent under Section 25(1) and Rule 55 of the Act, by Mylan and Biocon. Opposition procedures were also reportedly initiated against the corresponding patents in major countries like Europe and USA by the same opponents. Both Mylan and Biocon relied upon numerous citations alleging anticipation and obviousness, among other several grounds, such as:
– the subject matter claimed is not an invention under the meaning of the Act;
– insufficiency and lack of clarity in the description of the invention; and
– failure to disclose information of all corresponding applications filed in countries outside India.
The Controller in his decision dated 31 March 2023 held that the claimed invention is both novel and inventive over the prior arts, quashing the allegation of the opponents.
While deciding, the Controller relied upon the case law Farbewerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning Corporation Vs. Unichem Laboratories and Ors., AIR 1969 Bombay 255, wherein Bombay High Court ruled that:
“To anticipate a patent, a prior publication or activity must contain the whole of the invention impugned; i.e., all the features by which the particular claim attacked is limited. In other words, the anticipation must be such as to describe, or be an infringement of the claim attacked.”
The opponents cited new prior art documents during the hearing, which was strongly contested by the applicant to be non-analogous art. The Controller also affirmed that the prior art documents should be in the same field or discipline to yield proper result.
While deciding on inventive step, the Controller relied upon the five-step analysis as laid down by the Hon’ble Delhi High Court in F. Hof mann-La Roche Ltd & Anr. vs. Cipla Ltd., 2015 (225) DLT 391.
The opponents’ arguments were considered but rejected and the Controller affirmed to the contention of the applicant holding that, fixing of the spring washer to the sleeve member, according to the claimed invention, is both novel and inventive.
The allegations on prior Public Knowledge/ Use, were found to be without any merit or basis. The Controller also dismissed the opponent’s plea on insufficiency and non-patentability under section 3(d) and 3(f) of the Act.
On the objections of Section 8, it was established by the applicant that patents were granted in almost all the countries where applications were filed. Hence, there was no reason for the applicant to furnish any wrong information on the counterpart applications deliberately. While dismissing this ground of opposition the Controller observed that there does not appear to be an intent to suppress information or mislead the office and that the applicant has come with clean hands.
Finally, all the grounds of both the oppositions have been completely dismissed by the Controller and the application successfully proceeded to grant.
The European Board of opposition and the Board of Appeal have successively dismissed the invalidation plea of the opponents against the granted patent in Europe. Appeal proceeding in the USA is still pending, although the scope of claims of the corresponding US patent is different from that in India and Europe.
The victory has removed a long standing legal hurdle to commercializing Sanofi’s patent on a drug delivery device in India.
Author: Dipanjana Chakraborty