AstraZeneca (hereinafter plaintiff) filed suit against P Kumar, Dr. Reddy’s Laboratories Ltd and Micro Labs (hereinafter defendants) to restrain the defendants from marketing, selling, distributing or dealing with TICAGRELOR or any product that infringes the subject matter of Indian patent No. 209907, 247984 and 272674.
The facts of the case are that the drug TICAGRELOR, which is an effective platelet aggregation inhibitor, falls within the scope of Indian patent No. 209907 and 247984 and finished formulation of the drug is covered under the scope of patent 272674. The drug is prescribed to patients who have suffered recent heart attacks as it works by preventing the formation of new blood clots to help reduce the risk of another cardiovascular event. In India, the drug was launched under the trademark “BRILINTA”. Later, plaintiff received business information through some credible sources that defendants were planning to launch a generic version of TICAGRELOR in the market. Hence, this suit.
The defendant’s contentions were based on the following grounds:-
1. The pharmaceutical formulation TICAGRELOR is sold in India by the plaintiffs under the name BRILINTA and AXCER. The formulation is not manufactured in India but is imported from Sweden and China.
2. Indian patent 241229 (the genus patent) expressly covers and discloses TICAGRELOR and same has expired on 14-7-2018 and is in the public domain.
3. Further, plaintiffs with the intention of illegally extending patent monopoly with respect of TICAGRELOR, obtained patent protection with respect of the same TICAGRELOR in Patent 209907 and 247984 after the expiry of the Patent 241229. The patents do not exhibit any therapeutic efficacy which is disclosed in Patent 241229. Hence, liable to be revoked under section 64(1)(k), section 2(1)(ja) and section 3(d) of Patents Act,1970.
4. Furthermore, the patents which correspond to Patent 209907 and 247984 have been refused in various countries like China, Europe, Korea, Brazil and Argentina.
The plaintiffs pleaded as follows:-
1. On defendant’s plea for anticipation it is stated that patent 241229 was published on 2nd February 1999. Therefore, it cannot constitute a prior art document for evaluating the novelty of the species patent.
2. On contention of defendants prior claiming, it is stated that the same requires a specific individualized claim. A broad claim covering TICAGRELOR among millions of other compounds is insufficient for the purpose of prior claiming.
3. Defendants could not point out any known substance from the genus patent of which TICAGRELOR could be considered a new form/derivative. Mere structural similarity is not sufficient to trigger section 3(d) of the act.
4. Regarding non compliance of section 8, it was stated that patent 209907 was revoked in China but an appeal has been filed which implies an automatic stay of the operation of revocation order. Further, 57 countries have granted the said patent.
The Hon’ble Court referred Apotex Inc. V. Sanofi-Synthelabo Canada Inc., and stated that:
“The concern expressed by Apotex is that the doctrine of selection patents allows a patent holder to evergreen an invention. The original genus patent is granted for a finite period of years. If a selection patent is later obtained by the owner of the genus patent covering the same invention as the genus patent, the number of years the owner is entitled to exclude other from making or using the invention is extended, contrary to the limited period of exclusivity provided by the original patent.”
In respect of objections under section 3(d) of the Patents Act, it was stated that patent 209907 shows advantage of lower predicated dose and increased metabolic stability. However, plaintiff could not explain lower dose and increased metabolic stability would tantamount to enhancement of therapeutic efficacy over patent 241229.
The Hon’ble Court held that plaintiffs have failed to make out a prima facie case and grant of patent does not ipso facto entitle the plaintiff to an interim injunction. Therefore, Court vacated the interim injunction.

Contributed by: Srishti Gandhi.