Bristol-Myers Squibb Holdings Ireland Unlimited Company v. Zee Laboratories Limited

1. This hearing has been done through hybrid mode.

2. The present suit has been filed seeking permanent injunction restraining infringement in respect of the Plaintiffs’ patent bearing Indian Patent No. IN 247381, titled “Lactam-Containing Compounds and Derivatives Thereof as Factor Xa Inhibitors”. The same is a novel pharmaceutical preparation, also known by the INN name ‘APIXABAN’. The patent was granted by the Patent Office on 4th April, 2011 and the term of the patent is till 17th September, 2022. The case of the Plaintiffs is that the Defendants were manufacturing and offering for sale generic Apixaban products under the brand names ‘APIXAZ’ and ‘APIQUIS’ on third party ecommerce websites and on social media platforms.

3. Vide order dated 8th November, 2021, an ad-interim injunction was granted in the following terms:

4. Ld. counsel for the Defendants had entered appearance and vide order dated 14th January, 2022, the matter was referred to mediation. However, mediation had failed. At that stage, vide order dated 19th April, 2022, the Defendants were directed to file on record an affidavit disclosing the stock/quantum of the impugned products sold by them. The said directions in the order dated 19th April, 2022 read as under:-

5. An application under Order XXXIX Rule 2A CPC was also filed by the Plaintiff alleging that the Defendants continue to promote the impugned products on third party websites including IndiaMart. On 28th April, 2022, notice was issued in the said application and the Defendants had submitted that despite following up with the third-party website, the listings had not been removed. Accordingly, on the said date, ld. Counsel for IndiaMart had assured the Court that the listings would be removed within 36 hours of the Plaintiff providing them a list of the impugned URLs.

6. Today, ld. Counsel for Defendant Nos. 1 and 2 has handed over an affidavit of Sh. Chander Shekhar (Mb. No. 8130791122), the Assistant Manager of Defendant Nos. 1 and 2 companies, which reads as under:- “I, the above name deponent, do hereby solemnly affirm and declare as under:

1. I say that I am the Authorized Signatory of Defendant No. 1 and 2 in the captioned Suit, and I am conversant with the facts and circumstances of the captioned case and as such I am competent to swear this Affidavit.

2. I say that the present suit has been filed by the Plaintiffs against the Defendants with regard to the alleged infringement of an Indian patent bearing NO. 247381 dated September 17, 2022 having a validity till September 17, 2022.

3. I say that in due compliance of Order dated 08.11.2022 passed by this Hon’ble Court, the Defendant no. 1 and 2 have stopped selling the said alleged impugned products’Apixaz’ and ‘Apiquis’. Further, in terms of the order dated 19.04.2022 passed by this Hon’ble Court, the details of stocks/quantum of the alleged impugned products sold by Defendant no. 1 and 2 and the value of the same is mentioned hereinbelow: Brand Quantum of sales (No. of Tablets) Value of sales (INR) Unsold stock (No. of Tablets) APIXAZ- 2.[5] mg Tablets 6900 25896.01 23100 APIXAZ-5 mg Tablets 1200 8232.01 31800 APIQUIS- 2.[5] mg Tablets 37980 411933.06 11520 APIQUIS- 5 mg Tablets 30840 301304.66 18360

4. I say that Defendant no. 1 and 2 have sold a very limited quantity of the alleged impugned products ‘Apixaz’ and ‘Apiquis’, that too during the COVID period when the demand for the said products was high and due to increased market pressure during the said time.

5. I say that without prejudice to the rights and contentions of Defendant no. 1 and 2 in the alleged impugned products ‘Apixaz’ and ‘ Apiquis’, Defendant no. 1 and 2 do not intend to contest the present suit against the Plaintiffs as the suit Patent No. 247381 expires on September 17, 2022, and subject to the Plaintiffs not pressing for costs against the Defendants in the present suit. Further, Defendant no. 1 and 2 voluntarily appeared before this Hon’ble Court on the first date of hearing on 29.10.2021 on advance service even before issuance of notice in the present suit and offered to settle the present suit, which shows the bona fide on part of Defendant no. 1 and 2.”

7. Heard and perused the affidavit. It is noticed that the term of the suit patent has expired as of 17th September, 2022. Moreover the Defendants had entered appearance on the first day upon receiving advance copy of the suit and had not contested the matter. In fact, Mr. Anand, ld. Counsel for the Plaintiff, submits that the total sales made by the Defendants is to the tune of approximately Rs.8,00,000/- and some further stock is still lying with the Defendants.

8. Considering these facts and circumstances, as also that the term of the patent itself expired, there can be no injunction on the manufactured stock lying with the Defendants, from being sold as on date. Mr. Anand, ld. Counsel, also agrees that since the patent has lapsed, there can be no injunction qua the manufacture of the existing stock. However, he submits that the Defendants may be directed to pay nominal costs for the manufacture of impugned products during the life of the patent.