A quia timet action for patent infringement may be disposed of if the defendant provides a binding undertaking not to commercialize the patented invention during the patent's validity, provided statutory research rights are preserved.

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O R D E R

1. Let the plaint be registered as a suit.

2. Issue summons.

3. Ms. Bitika Sharma, Advocate, accepts summons on behalf of the Defendant. She confirms the receipt of suit paper-book and waives the right of formal service of summons.

4. The present suit pertains to infringement of Plaintiff No. 1’s Indian Patent No. 269841 [‘Suit Patent’ or IN’841], which protects the novel and inventive compound ‘Ruxolitinib’. In particular, Claims No. 1, 17 and 21 of the Suit Patent coverand claim the patented compound ‘Ruxolitinib’, pharmaceuticallyacceptable salt, and composition thereof respectively. This drug is used in the treatment of intermediate or high-risk myelofibrosis, a type of myeloproliferative disorder that affects the bone marrow, and for polycythemia vera [‘PV’], when there has been an inadequate response to or intolerance of hydroxyurea. It works by blocking a group of enzymes known as Janus kinases [‘JAKs’], which are involved in the production and growth of blood cells.

5. The patent compound ‘Ruxolitinib’ is a new chemical entity, and has been given an International Non-Proprietary Name [‘INN’]), which is a name designated by the World Health Organisation [‘WHO’] given to new Active Pharmaceutical Ingredients [‘APIs’] to provide a unique name per pharmaceutical drug to help avoid the confusion that can be caused by the number of different ways in which an API can be chemically named based on their chemical structure.

The invented compound ‘Ruxolitinib’ is marketed and sold in India and other countries [except the United States of America] under the brand name ‘JAKAVI®’, which is a prescription drug containing ‘Ruxolitinib’ as its phosphate salt. The copies of Form 27, pertaining to the working of the Suit Patent, have been annexed with the plaint. Further, the sales figures pertaining to the drug in question, in India and globally, have been extracted in paragraph no. ‘37’ of the plaint.

6. Ms. Mamta R. Jha, learned counsel for the Plaintiffs, contend that on the basis of information received by them, the Plaintiffs strongly apprehend that the Defendant company is about to engage in manufacturing and sale of pharmaceutical drug products containing the patented compound ‘Ruxolitinib’. She states that if such a product is launched, the claims made in the SuitPatent would be infringed and accordingly, the present suit has been filed as a quia timet action.

7. At the outset, Ms. Bitika Sharma, learned counsel for the Defendant states on instructions that the Defendant has not commercialized any product containing the patented compound ‘Ruxolitinib’ and does not intend to do so during the validity of the Suit Patent. She states that this statement can be taken record and the suit can be disposed on this basis.

However, she requests that the Court protect the Defendant’s rights under Section 107A of the Patents Act, 1970, to use ‘Ruxolitinib’ for the purposes of research.

8. In light of the above, Ms. Mamta R. Jha is agreeable to the suit being disposed of by binding the Defendant to the aforenoted statement made by their counsel. She further states that the Plaintiffs does not wish to claim any monetary relief from Defendant.

9. Accordingly, the statement made by Ms. Bitika Sharma is taken on record and the Defendant is held bound by the same.

10. It is made clear that the Defendant shall not commercially manufacture, launch, import, export or deal in any API, pharmaceutic