The division bench (DB) of the Delhi High Court has refused 9 appeals of AstraZeneca which were filed against the orders/judgments denying interim relief, in Patent infringement suits instituted by the appellants/plaintiffs, AstraZeneca AB, Sweden and AstraZeneca Pharma India Ltd.

The challenge in the nine appeals was to two orders/judgments; both the orders/judgments were pronounced within a span of 16 days. The first order of 2^nd November 2020 deals with interim relief in the first set of suits filed by AstraZeneca  for permanent injunction restraining the respondent(s)/defendant(s) therein from manufacturing, selling or otherwise dealing in any manner whatsoever, the product comprising the compound ‘Dapagliflozin'(hereinafter referred to as “DAPA”) which was the subject matter of Indian Patent No.205147 (hereinafter for convenience referred to as ‘IN 147’) and Indian Patent No.235625. The second order of 18^th November 2020 deals with second set of suits that were filed subsequently, after lapsing of the validity of IN 147, to restrain the respondent(s)/defendant(s) therein from manufacturing, selling or otherwise dealing in any manner whatsoever, the product comprising the compound DAPA, amounting to infringement of IN 625.

Some facts recorded in the impugned order/judgment dated 2nd November, 2020 are reproduced below for understanding of the background of the case:-

• that both, IN 147 and IN 625 were granted to Bristol Myers Squibb Company, which vide Assignment Deed dated 1st February, 2014, assigned the rights therein to the appellant/plaintiff AstraZeneca AB, Sweden, which stood registered as the patent holder qua the said patents;
• that DAPA, being the subject matter of the two patents, is used worldwide, to treat people suffering from type-II diabetes mellitus;
• that IN 147 is the genus patent and IN 625 is the species patent;
• that IN 147 is a Markush structure i.e. a patent covering a group of compounds, which disclosed the possibility of individual permutations and combinations running into several million structurally diverse compounds;
• that IN 147, bearing a Markush structure, covered DAPA, though did not disclose the same;
• that on further research and development, DAPA was invented;
• that the dates of grant and expiry of IN 147 are 15th March, 2007 and 2nd October, 2020;
• that the dates of grant and expiry of IN 625 are 9th July, 2009 and 15th May, 2023;
• the drug manufactured by the appellants/plaintiffs from the said new invention of DAPA got approval only in the year 2020;
• that Sun Pharma Laboratories Limited and Abbott Healthcare Private Limited are the distributors of the appellants/plaintiffs and sell the said drug;
• that the appellants/plaintiffs have been granted patent for DAPA, in approximately 70 countries;
• that DAPA, in India, had neither been subjected to any pre-grant or post-grant opposition, nor any revocation proceedings with respect to DAPA filed prior to the year 2020;
• that in the year 2020, the respondent(s)/defendant(s) started infringing IN 147 and IN 625 and some of the respondent(s)/defendant(s) also initiated post-grant opposition, revocation proceedings or counter-claims against IN 625;
• that since DAPA was first synthesized in 2001 i.e. after 12th August, 1999, being the priority date of IN 147, the question of DAPA being disclosed in IN 147 did not arise;
• that Markush formulae are well recognised under the Indian Patent Law;
• that merely because a particular compound falls within the scope or periphery of a particular claim, does not amount to the said compound being disclosed with specificity;
• that a single product may cover thousands of patents; example was given of a mobile phone, covered by multiple patents;
• that the invention claimed in IN 147 is different from the invention claimed in IN 625;
• that IN 147 claims a class of compounds of the Markush structure;
• that IN 625 has only one specific molecule i.e. DAPA;
• that it thus cannot be said that DAPA was claimed in IN 147;
• that DAPA is not obvious from IN 147;
• moreover, IN 147 was published under Section 11A of the Patents Act, 1970, only on 18th March, 2005 i.e. after the priority date of IN 625 of 20th May, 2002; there could thus be no question, of a person of ordinary skill in the art, from a reading of IN 147, being able to arrive at DAPA;
• that in the United States of America (USA/US) also, there was no publication of the patent corresponding to IN 147 prior to the filing of the patent corresponding to IN 625;
• that DAPA is not obvious from IN 147 because IN 147 has a million possibilities; any attempt to reach DAPA from the Markush structure of IN 147 is nothing but an attempt to take recourse to hindsight, which is discouraged under Patent Law;
• that there is no indication in IN 147, as to which parameters are critical or even which direction if taken out of the many choices available, would lead to DAPA;
• that had DAPA been obvious from IN 147, it would have been developed by someone else, prior to IN 625 or prior to the appellants/plaintiffs obtaining approval of the drug in the year 2020;
• that DAPA is a man made drug, used not only for treating type-II diabetes but also approved in the year 2020 for treating hypertensive heart failure;
•  that IN 625 is in the 18th year of its life-cycle and is an old and established patent and thus carries with it presumption of its validity;
•  that IN 625 was subjected to examination in the Indian Patent Office, between the years 2002 and 2009;
• that the proceedings initiated for the first time in the year 2020, for revocation of IN 625, are mala fide and a counterblast to the infringement actions undertaken by the

appellants/plaintiffs;

The division bench dismissed the appeals and maintained the impugned orders refusing the interim injunction, while doing so, the court made the following observations:-

• As per the division bench as the plaintiff claimed the action of the respondent(s)/defendant(s) of manufacturing medicines having DAPA as their ingredient to be an infringement of both IN 147 and IN 625, the appellants/plaintiffs are deemed to have admitted DAPA to be the invention subject matter of both, IN 147 and IN 625. Without DAPA being disclosed in IN 147, there could be no patent with respect to DAPA in IN 147 and which was being infringed by the respondent(s)/defendant(s) by manufacturing drugs/medicines with DAPA as ingredient.

• As per the Court, a single formulation as DAPA, is incapable of protection under two separate patents having separate validity period. The appellants/plaintiffs, in their pleadings, are not found to have pleaded the difference, save for pleading that DAPA was discovered by further research. From the field of the invention subject matter of the two patents being verbatim same, at this stage, it also appears that there is no enhancement of the known efficacy, within the meaning of Section 3(d) of the Act, between the product subject matter of IN 147 and the product subject matter of IN 625.

• The court also noted that there is complete identity, without any difference whatsoever, between the field of invention as set out in the two patents i.e. IN 147 and IN 625. For IN 625 to be with respect to a ‘new product’ involving an inventive step i.e. a feature involving a technical advance as compared to existing knowledge including of IN 147 or having economic significance and which was not anticipated by earlier publication or use including of IN 147, to say the least, the court expected the description of the field of invention in IN 625 to describe the technical advancement and / or the difference in efficacy, from that in IN 147.

• The court also noted that the example given by the counsel for the appellants/plaintiffs, of a telephone instrument comprising of several patents, is not apposite. A telephone instrument, though perceived by the consumer thereof as one product, comprises of several components, each of which is also a product in itself and capable of independent patent. However, DAPA is disclosed to be a single compound and cannot have more than one patent

• The Court also noted that at least at this stage they are unable to, in the face of the pleadings of the appellants/plaintiffs themselves, to find any difference between IN 147 and IN 625. The appellants/plaintiffs themselves are found to be pleading DAPA to have been disclosed generally in IN 147 and specifically in IN 625. In the face of the said pleading, no case injuncting the respondent(s)/defendant(s) during the pendency of the suits is made out.

• To hold, that an inventor, merely on the basis of his work, research, discovery and prior art, but which has not yielded any product capable of commercial exploitation, is entitled, by obtaining patent thereof, to restrain others from researching in the same field, would in our view, not be conducive to research and development and would also be violative of the fundamental duties of the citizens of this country, enshrined in Article 51A of the Constitution of India, to develop the scientific temper and a spirit of inquiry.

• The Court  also took the prima facie view, that once the appellants/plaintiffs, before the USPTO applied for and agreed to the validity period of US patent equivalent of IN 625 ending on the same day as the validity period of the US patent equivalent to IN 147, the appellants/plaintiffs, in this country are not entitled to claim different periods of validity of the two patents.