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2020 Supreme(Del) 56

IN THE HIGH COURT OF DELHI AT NEW DELHI
MUKTA GUPTA, J.
Bristol-Myers Squibb Holdings Ireland Unlimited Company and Others – Plaintiffs
Versus
BDR Pharmaceuticals International Pvt. Ltd. and Another – Defendants
C.S. (COMM) No. 27 of 2020
Decided On : 30-01-2020

Advocates:
Advocate Appeared:
For the Plaintiffs : Pravin Anand, Archana Shankar, Tusha Malhotra, Prachi Agarwal, Ridhie Bajaj, Devinder Rawat, M. Dubey.
For the Defendants : J. Sai Deepak, Avinash K. Sharma, Abhishek.

The court found that the suit patent was not obvious and was not amenable to revocation for being obvious.

Headnote:

Obviousness - Patent Law - Indian Patent Act, 1970 - Sections 64(1)(f) - The court analyzed the prior art documents and found that the suit patent was not obvious and was not amenable to revocation for being obvious. The court granted an ad-interim injunction in favor of the plaintiffs and against the defendants.

JUDGMENT :

MUKTA GUPTA, J.

I.A. 803/2020 (u/O XXXIX R 1 & 2 CPC)

1. The present suit and application came up before this Court on 21st January, 2020 when learned counsel for the defendants urged that he had additional material to oppose the ad-interim injunction de-hors what was argued in the earlier round of litigations between the plaintiffs and third parties wherein this Court had granted ad-interim injunction against which appeals are pending before the Hon’ble Division Bench.

2. Part arguments were addressed on behalf of the parties on 21st January, 2020 whereafter the hearing was kept at end of the board on 22nd January, 2020 and learned counsel for the defendant handed over nine documents including a revocation petition filed in December, 2019 on which he would base his arguments to the Court and learned counsel for the plaintiffs. In the post-lunch session on 22nd January, 2020 learned counsel for the defendant was on his legs in the Hon’ble Supreme Court when this Court directed learned counsel for the plaintiff to address arguments on the 9 documents relied upon by the defendant. Thereafter, arguments were heard and concluded on behalf of learned counsel for the defendant on 23rd January, 2020 and only for rebuttal by the plaintiff’s counsel to the extent additional material used by the defendant, the matter was kept on 27th January, 2020.

3. Case of the plaintiffs is that plaintiff No. 1 is a company incorporated under the laws of Ireland whereas plaintiff Nos.2 and 3 are companies incorporated under the Companies Act, 1956 in India. Plaintiff No. 1 is the owner of the suit patent titled as “Lactam- Containing Compounds and Derivatives Thereof as Factor Xa Inhibitors” and has been granted the Indian Patent No. 247381 (in short ‘IN-381’) pursuant to an application filed in India on 9th March, 2004. The date of grant of the patent is 4th April, 2011 and the date of publication is 8th April, 2011. The suit patent would expire on 17th September, 2022. As per the plaintiff US Patent 6967208 is equivalent to the suit Patent IN-381.

4. Plaintiffs’ claim is that the suit patent has not been subjected to any pre-grant or post-grant opposition in India except by one i.e. NATCO Pharma Limited which filed a petition seeking revocation of the suit patent on 9th May, 2016 which is currently pending before the appellate board and the one now stated to be filed by the defendant in December, 2019.

5. The suit patent specifically describes and covers a molecule having an International Non-Proprietary Name (INN) APIXABAN and the IUPAC name 1-(4-methoxyphenyl)- 7-oxo-6-[4-(2-oxopiperidin-1-yl) phenyl]-4,5,6, 7-tetrahydro-1H-pyrazolo[3,4-c] pyridine -3-carboxamide. It is used for the prevention and treatment of thromboembolic diseases. The molecular formula of APIXABAN is C25H25N5O4. APIXABAN has the following structural formula:

“IMAGE”

6. Claim of the plaintiffs is that APIXABAN addresses many limitations of the problems associated with the prior standard of care for the treatment of thrombosis with an oral anticoagulant (i.e. warfarin) by (i) reducing bleeding without compromising efficacy and (ii) dramatically reducing drug-drug interactions with other therapeutic agents, which makes APIXABAN suitable for concurrent administration with other drug products.

7. Prior to the suit patent IN-381 the plaintiff No. 1 had been granted Indian Patent No. 243917 for Nitrogen Containing Heterobicycles as Factor Xa Inhibitors. On 11th November, 2010 the plaintiff No. 1 filed the PCT international application bearing No. PCT/US99/30316 on 17th December, 1999 and thereafter the national phase PCT application, bearing No. IN/PCT/2001/00587/MUM in India on 24th May, 2001 before the Indian Patent Office claiming priority date from 23rd December, 1998. Finally the plaintiff was granted a patent IN 243917 (in short ‘IN-917’) generically covering millions of compounds including APIXABAN by virtue of Markush claim but it did not specifically disclose APIXABAN. IN-

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