Merck Sharp & Dohme (hereinafter referred as MSD), an American pharmaceutical company and subsidiary of the German company Merck. MSD filed a suit against Glenmark Pharmaceutical Ltd. (hereinafter referred as Glenmark), an Indian Pharmaceutical company for permanent injunction in regards to salts of any form of SITAGLIPTIN, an anti-diabetic drug. Delhi High Court granted the first ever permanent injunction in a patent infringement suit and upheld the validity of the MSD’s patent. This judgement was first-of-its-kind order since the enactment of the Patents Act, 1970.
Brief facts of the case are as follows:
- MSD’s patent ‘Sitagliptin’ (Patent No. IN 209816) is directed to compounds, which are inhibitors of the dipeptidyl peptidase-IV enzyme (DPP-IV inhibitors) useful in the treatment of diabetes, especially type 2 diabetes.
- MSD along with its licensee, Sun Pharmaceutical Industries Ltd., (hereinafter referred as Sun Pharma) filed a patent infringement suit against Glenmark in April 2013 for making and marketing generic versions of MSD’s anti-diabetic drug ‘Januvia’(Sitagliptin) and ‘Janumet’ (combination of Sitagliptin and metformin)
- The molecule ‘Sitagliptin’ was invented by Merck. It claims the base molecule ‘Sitagliptin’ in free base form and also its pharmaceutically accepted salts thereof.
- On 28thMarch, 2008 the drug was approved for marketing in India. MSD also granted a license in India to Sun Pharma which sells the drug under the brand name Istavel & Istamet.
- Glenmark was restrained from manufacturing, selling, or dealing in “Sitagliptin Phosphate Monohydrate” or any salt of ‘Sitalgliptin’. They had launched the generic versions of “Januvia” and “Janumet” under the brand name “Zita” and “Zitamet” respectively.
- MSD launched “Sitagliptin” in India with a reduced price equivalent to 1/5 price of that was being charged in USA in accordance with the public interest at large.
- Initially the Single Judge of Delhi High Court disposed of MSD’s application seeking an interim injunction.
- On appeal, the Division Bench of Delhi High Court reversed this decision and held MSD’s patent to be prima-facie valid and infringed by Glenmark’s products.
- After that, Glenmark challenged this order before the Supreme Court.
Issues
The main issues before the Hon’ble Court were:
- Whether Glenmark’s manufacture and sale of Sitagliptin Phosphate Monohydrate infringe the said patent (Patent No. IN 209816)?
- Whether MSD’s patent ‘Sitagliptin’ (Patent No. IN 209816) is valid?
Arguments
By Plaintiff i.e., MSD
- MSD alleged that Glenmark’s products infringe its patent i.e., the Sitagliptin molecule. The sitagliptin phosphate monohydrate salt is sold under the trademarks Januvia, by MSD and Istavel, by its licensee Sun Pharma. Similarly, combination of metformin and Sitagliptin is sold under Janumet and Instamet respectively.
- Sitagliptin and its pharmaceutically acceptable salts are specifically claimed by Claim No. 19 of the suit. They further stated that ‘Januvia’ was launched at a very low price, roughly 1/5th of its price in the US paying special regards to public interest.
- They further contested that Section 48 of the Indian Patents Act, 1970 extends exclusive rights to exclude others from making, using or offering for sale of products which fall within the scope of a suit claim.
- They stated that Glenmark is selling Sitagliptin Phosphate Monohydrate under the brand name “ZITA” which cannot be prepared without the active ingredient Sitagliptin molecule. Hence, infringes the patent in question. (Patent No. IN 209816).
- They argued that Sitagliptin was the invention and Sitagliptin Phosphate was merely a derivative of the invention and therefore wasn’t eligible for patent protection under Section 3(d) of the Patents Act, 1970. Hence, MSD abandoned the phosphate salt application.
By defendant i.e., Glenmark
- They contended that the products sold by them are not covered by the said patent (Patent No. IN 209816). They claimed Sitagliptin Phosphate Monohydrate is a different chemical entity with different physical and chemical properties.
- 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.
- They argued that the invention lacked an inventive step under Section 64(1) (f) of the Patents Act, 1970 and there was insufficient disclosure regarding the preparation of Sitagliptin base within the meaning of Section 64(1) (h).
- They contended that the drugs “Zita” and “Zitamet” are beneficial to the public at large because of their low price. They alleged MSD for overcharging the customers by charging same for “Janumet” and “Istamet” regardless of potential of tablets.
Judgement
Court relying on various judgements held that:
“On 7th Oct, 2015, the Hon’ble Supreme Court upheld the decision of Delhi High Court and also took cognizance of the “commercial” nature of the matter. An expedited trial ordered by Delhi HC resulted in disposal of the law suit within 5 months from the date of order. The whole case was decided within 2 years. The Delhi High Court judgement smothered Glenmark by a decree of permanent injunction from making, selling, distributing or using, etc. and any dealings in Sitagliptin Phosphate Monohydrate, infringing the patent in question. The Court held that since the patent relates to an invention of a chemical molecule/compound in the medical filed it must be analyzed by technical experts as well. The court conceded with MSD’s argument that the conversion of salt to a free base and then to another salt is a very basic chemical transformation and hence the patent claims Sitagliptin and all its pharmaceutically acceptable salts. It also observed that the disclosure in the suit patent is not for a lay person but is addressed to a person of ordinary skill. Further, the provisions under Section 64 of the Patents Act, 1970 make it clear that the court may or may not revoke the patent in the given facts and circumstances of the case. The court gave a lot of weightage to expert testimony in this highly technical matter. On the question of lack of industrial applicability the court holds that Sitagliptin free base is the moiety that possesses the therapeutic effects claimed. The court also stated that in Glenmark’s drug there is no material effect. The Delhi High Court conclusively held that all the three ingredients i.e., prima facie, irreparable injury and balance of convenience for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.”
One-of-its-kind order was passed by the Hon’ble Supreme Court, which involved cross-examination of seven witnesses. This decision indicates that the Indian judiciary enacted Commercial courts; Commercial division- is cognizant of the urgent need for a proper, effective and efficient system to safeguard all intellectual property.
By: Runjhun Sharma, School of Law, Mody University
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