The Delhi High Court has restrained Glenmark from making and marketing generic versions of Merck Sharp & Dohme (MSD)’s popular antidiabetic drug “Januvia” (sitagliptin) and “Janumet” (combination of sitagliptin and metformin) in its latest order dated October 7, 2015. The order restrains Glenmark from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin Phosphate Monohydrate or any other salt of Sitagliptin in any form, alone or in combination with one or more other drugs or from doing any other thing that infringes the claimed subject matter of MSD’s Indian Patent No. 209816, granted on 6th September, 2007.
- MSD Pharmaceuticals Pvt. Ltd. obtained Patent no. 209816 on 6th September, 2007
- Patent no. 209816 has 20 claims and is covered by claims 1 to 3, 5 to 10, 14 to 17 and Sitagliptin is specifically claimed by Claim 19 of the suit patent.
- Keeping in mind, the public interest “Januvia” was launched in India with a price tag of Rs.43 per pill which is roughly one-fifth of its price in the USA.
- Bulk packs of “Januvia” are imported from Italy and are sold by MSD Pharmaceuticals Pvt. Ltd.
- MSD Pharmaceuticals Pvt. Ltd. have also launched patient access program under the name “MSD Sparsh Helpline” which is the first of its kind in India.
- Objectives of this program is to facilitate optimal and comprehensive management of patients with Type II diabetes mellitus by improving patient‘s understanding of the disease and its management; patient‘s adherence and compliance to prescribed therapy and patient‘s self involvement in the disease management process.
- Glenmark manufactures, sells, offers for sale and advertises the pharmaceutical compositions, Sitagliptin Phosphate Monohydrate under the brand “ZITA” and Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride under the brand name “ZITA –MET”. These are the generic versions of “Januvia” and “Janumet”.
Contentions of the Defendant:
- Products that are marketed and sold by Glenmark are not covered by the suit patent.
- Suit patent discloses the products Sitagliptin/Sitagliptin Hydrochloride; whereas Sitagliptin Phosphate Monohydrate is a different chemical entity having different physical and chemical properties.
- Products disclosed in the suit patent are not capable of being administered as a medicine as the same are chemically and physically unstable in nature.
- M/s Teva Pharmaceutical Industries Ltd. had earlier opposed the grant of European patent 1654263 on the ground that it lacked novelty and inventive steps for MSD’s European Patent EP
- MSD did not pursue the application in respect of Sitagliptin Phosphate Monohydrate in India and voluntarily abandoned the same, thus resulting in Sitagliptin Phosphate Monohydrate being in the public domain.
- The Plaintiffs did not approach the Court with clean hands and have suppressed material facts.
- The generic drugs “ZITA” and “ZITA-MET” are beneficial to the public at large because of their low cost. Further in this light, MSD has been overcharging the Indian customers by charging the same price for “JANUMET” and “ISTAMET” regardless of potential and strength of the tablet.
In the counter claim, Glenmark prayed for revocation of the suit patent on the grounds that:
- The invention lacked inventive step within the meaning of Section 64(1) (f) of The Patents Act 1970, and was obvious to a person skilled in the art.
- The invention claimed lacks industrial applicability within the meaning of Section 64(1) (g) of the Act.
- Disclosure was insufficient within the meaning of Section 64(1) (h) as complete specification was not disclosed regarding the preparation of Sitagliptin base so as to enable a person in India, possessing average skill and knowledge to work the invention.
- Disclosures in the suit patent were extremely broad.
- Patent was obtained on a false suggestion or representation. Merck & Co. Inc. deliberately did not disclose the subsequent application filed by it for the dihydrogenphosphate salt of Sitagliptin along with its crystalline forms (both hydrate and anhydrate) before the patent office.
Contentions of the Plaintiff
- Sitagliptin in all its forms and salts (including Sitagliptin phosphate) are covered by claims 1, 15, 17 and 19 of the suit patent. The therapeutic moiety in Januvia and Janumet, is Sitagliptin.
- Suit patent is the basic patent for Sitagliptin and its pharmaceutically acceptable salts, in all its forms, be it chemical or physical. Phosphoric acid is disclosed as an acid that can form a salt with the Sitagliptin free base; and hydrates are also disclosed in the specification. One skilled in the art would know how to make the dihydrogen phosphate salt from the Hydrochloride salt.
- In India efficacy is restricted to therapeutic efficacy, therefore, such technical advantages are not sufficient to protect the invention claimed in 5948/DELNP/2005 from the prohibitory ambit of Section 3(d) of the Act.
Findings of the Court
The court noted that the onus to prove that the invention in the suit patent was obvious to a person skilled in the art, rested on the defendant and the defendant (Glenmark) in this case had failed to prove the same. The Honorable Court said that mere comparison of chemical structure is not sufficient, and neither is picking up parts of chemical structures of different patents and clubbing them, sufficient to prove that the invention is not novel or obvious. The Defendant witness in this case is said to have followed a methodology referred to as ‘hindsight analysis’ which is a prohibited methodology in patent law. Upon questioning this fact, the DW2 reserved his comments. The court felt the need to reiterate the reading of Section 2(1)(j) of the Patents Act, which defines “invention” as a new product or process involving an inventive step and capable of industrial application along with section 2(1)(ac) according to which ‘capable of industrial application’ in relation to an invention, means that the invention is capable of being made or used in an industry.
Another Section that has claimed significance in this judgment is none other than Section 83 of the Patents Act. The reading of Section 83 revealed that when an invention is said to be capable of being made or used in an industry. Such an invention should benefit the public and should be affordable. While answering the issue of infringement, two things that the court observed to be relevant were that, one Sitagliptin is the molecule with the therapeutic utility; whereas Sitagliptin Phosphate Monohydrate has advantage over the Sitagliptin Free Base, in that it has got better physical and chemical characteristics so as to make it in tablet forms.
On the issue of Lack of sufficient disclosure and broad claiming, the court in this case has observed that the disclosure in the suit patent is not for a lay person but is addressed to a person of ordinary skill in the art. Further, since the defendant (Glenmark ) itself has been successful in making Sitagliptin Phosphate Monohydrate, it cannot claim that the patent in question is too wide and broad. To quote the court “Defendant cannot be permitted to blow hot and cold in the same breath.”
The provisions under Section 64 of the Patents Act make it clear that it is not mandatory for the court to revoke the patent merely because any of the grounds mentioned in Section 64(1) are made out. It is the discretion of the court to revoke or not to revoke in the given facts and circumstances of a case. The word “may” used in Section 64(1) of the Act makes it clear that it is the discretion of the Court to revoke the patent under this provision if any of the ground(s) stipulated therein are disclosed or made out and “may” cannot be read as “shall” as contended by the defendant.
With respect to the arguments made about “public interest”, the court noted that Sitagliptin is not the only inhibitor for treatment of type II diabetes in the market and there are several other inhibitors, including the one manufactured and marketed by Glenmark, called “Teneligliptin”
Based on these findings Glenmark has been restrained by a decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin Phosphate Monohydrate or any other salt of Sitagliptin in any form, alone or in combination with one or more other drugs thereby infringing the suit patent.
Several issues important issues have been reiterated by the court in this case. The decision comes as a big blow to Glenmark who according to news reports is said to be contemplating further action. This Decision does not seem to have elicited favorable response from the Indian Generic companies who feel that, the decision favors the MNCs, which is in detriment to public interest. However, we have discussed this in earlier posts where we observed that the courts in India have always given decisions impartially based on available facts. As is said, “You can’t possibly keep everyone happy and you’ve just got to realize that you can’t be all things to all men.”
Authored by Gaurav Mishra
Sources-Original judgment [CS(OS) 586/2013 & CC No. 46/2013 & I.A. Nos. 9827/2013, 8048/2014 & 13626/2015 ] is available here.