Tuesday 20 October 2015

Glenmark Loses the Anti- Diabetic Drug Patent Battle to Merck: In Delhi High Court

We had previously reported in our newsletter Vol. VII, Issues 13 dated March 30, 2015 that the Supreme Court had stayed the injunction order passed by the Delhi High Court against Glenmark.

Merck Sharp & Dohme Corporation & Anr. (Plaintiff) had filed the suit against Glenmark Pharmaceuticals Ltd. (Defendant) for permanent injunction praying to restrain them 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 the plaintiff’s Indian Patent No. 209816. Click here to view the news reported earlier.

Now, after the trial the Learned Single Judge of the Delhi High Court on October 07, 2015 has restrained the defendant from selling, distributing, marketing or exporting its anti-diabetes drugs Zita and Zita-Met, on the ground that they infringed plaintiff’s patent. However, no issue has been framed in regard to the damages. Further, plaintiff is entitled to actual costs of the proceedings.

Highlights of the judgement are mentioned below:
  • The Learned Judge was of the opinion that it is the Sitagliptin Free Base which is the DPP-IV inhibitor and phosphate salt is used for delivery of Sitagliptin in the body. Sitagliptin Phosphate Monohydrate has enhanced properties in the sense that it has improved chemical and physical characteristics, but the active moiety is Sitagliptin. Therapeutic efficacy is not enhanced by Sitagliptin Phosphate Monohydrate since it is the Sitagliptin itself which is the active moiety and is effective for inhibiting DPP-IV enzyme and is useful for treatment of type II diabetes. Thus, use of Sitagliptin Free base alone in Sitagliptin Phosphate Monohydrate tablet by the defendant itself amounts to infringement of the suit patent.
  • Merely because the defendant selling the generic version of the tablet at a lower price than that of plaintiff’s, cannot be made a ground to decline injunction against the defendant under public interest.
  • Further, no evidence has been led by the defendant to show non-disclosure of information was deliberate and for malafide reasons.
  • It is not mandatory for the Court to revoke the patent merely because any of the grounds mentioned in Section 64(1) [Revocation of patents] 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” is 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.
Section 64 (1): Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the patent by the High Court on any of the following grounds, …
  • The Judge also found defendant’s witness taking shifting stand and hence unreliable.

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