Important RulingsRulings

HC rules in favour of Dr Reddy’s Laboratories, denies injunction on Astrazeneca on the grounds that “TICAGRELOR” is a patented drug

Astrazeneca AB & Ors vs. P Kumar & Anr.

HC vacates interim order and rules in favour of drug manufacturers; says grant of patent does not ipso facto entitle the plaintiff to an interim injunction.

The  Plaintiff – ASTRAZENECA AB & ANR has filed application for injunction under Order 39 Rule 1 and 2 CPC seeking an injunction to restrain the defendants from selling, marketing or dealing with TICAGRELOR or any product which is in violation of the registered patent of the plaintiff‘s company IN 907, IN 984 and IN 674. HC passed an interim order in favour of the plaintiffs restraining the defendants from selling, marketing or dealing with TICAGRELOR tablet or any drug which is in violation of the registered patents of the plaintiffs being IN 907, IN 984, and IN 674.

Plaintiff submits that TICAGRELOR falls within the scope of Indian Patent No.907 and 984and the finished formulation of TICAGRELOR is said to be covered within the scope of IN 674. Plaintiff further submits that by virtue of section 48 of the Patents Act, the plaintiffs have exclusive rights to prevent others from making, using, selling, offering for sale or importing TICAGRELOR as well as its crystalline form (IN‘984) and its finished formulation (as claimed in IN‘674) or any other product that falls within the scope of the claims of IN‘907 and the above two noted patents. Plaintiff states that defendant Micro Labs Ltd was planning to launch a generic version of TICAGRELOR under the probable name BIGRELOR. Further, Plaintiff states that defendant Natco Pharma Ltd. was planning to launch a generic version of TICAGRELOR. Plaintiff also submits that defendant Dr.Reddy‘s Laboratories Ltd. was planning to launch a generic version of TICAGRELOR under the brand name TICAFLO and that the defendant has taken steps to introduce and offer the same for sale to its business partners and C&F Agents and has also obtained a manufacturing license for TICAGRELOR and is ready for a full commercial launch of the product. 

Is TICAGRELOR disclosed and covered in the now expired patent IN229?

HC peruses the facts and submissions of the case and observes that a primary dispute entails defendants’ contention that IN 229 covers/discloses TICAGRELOR and that the suit patents cannot be said to be an invention and such is contradicted by plaintiff’s submission that TICAGRELOR is not disclosed in IN 229 and that TICAGRELOR is an invention and is patentable. HC refers to Novartis AG vs. Union of India, 2013 (6) SCC 1 and Bishwanath Prasad Radhey Shyam vs. Hindustan Metal Industries, AIR 1982 SC 1444. Defendants argue the presence of similarity of structure that exists between the prior patent IN 229 and the subsequent patents and their plea that IN 229 discloses TICAGRELOR while the plaintiff vehemently denies the same. Placing reliance on Bristol-Myers Squibb Company & Ors. v. Mr.J.D.Joshi & Anr., 2015 (64) PTC 135 (Del), HC finds that the aforementioned dispute is a question of law and fact. HC observes that the forms filed by the plaintiff indicate that the same product and quantity is stated to show the working of the three suit patents and the expired patent IN 229. Further, vide the submissions of plaintiff, HC observes that plaintiffs have acknowledged and stated that dealing in TICAGRELOR is in breach of US patent 910 (equivalent of IN 229) also. HC observes that the issue relating to coverage and disclosure of a genus patent was raised by the appellant before the Supreme Court in Novartis AGs v. Union of India & Ors.(supra) wherein SC rejected the argument that coverage in a patent might go much beyond disclosure. HC rejects the argument of the plaintiff that genus patent has worked through TICAGRELOR though TICAGRELOR is not disclosed in IN 229. HC observes that plaintiff has prima facie failed to explain the admissions/conduct as contained in Form 27 filed and the litigation commenced in USA against Mylan INC. HC finds that there is no averment in the plaint to claim that IN 229 (genus patent) was worked through TICAGRELOR though not disclosed in the said patent as sought to be pleaded in course of arguments and there is no averment in the plaint that IN 229 does not pertain to a commercialized patent. HC finds that plaintiff has concealed material facts and as such the claim of the plaintiff that TICAGRELOR is not disclosed in IN 229 and is not anticipated is subject to a strong challenge by the defendant

Objections under section 3(d) of Patents Act

Defendants plead for the revocation of the patent since TICAGRELOR is derived from a known substance/element disclosed in IN 229 and being a derivative of a known substance, the suit patents are squarely hit by 3(d) of the Patent Act. Plaintiff denies the averments stating that mere structural similarity is not sufficient to trigger Section 3 (d) of the Act and falls outside the scope of Section 3(d) of the Act. HC observes that the suit patents cannot said to be something altogether new or completely unfamiliar. HC observes that the plaintiffs had to show compliance of section 3(d) of the Patent Act but the plaint is completely silent about any enhancement of known therapeutic efficacy for the suit patents. Further, HC observes that the belated reliance of the plaintiffs on the affidavit filed by Dr.Robert J. Riley which categorically states that both the compounds, namely, equivalent of IN 229 and IN 907 can be used as pharmaceutical agents for “inhibition of platelet aggregation” does not help the case of the plaintiff. HC states that such view re-inforces the prima facie finding that the suit patents are not something altogether new or completely unfamiliar or unconnected to IN 229. HC observers that the plaintiff have prima facie failed to show enhancement of known efficacy of the suit patents over the products and fail the test of section 3(d) of the Act.

Non-compliance of Section 8 read with section 64(1)(m) of the Act

Defendants submit that plaintiffs have suppressed the pendency of the litigations in USA, South Korea and China and that plaintiffs have also suppressed that China Patent application which corresponds to IN 907 was invalidated on 17.10.2017, European Patent which corresponds to IN 984 was revoked by EPO on 24.06.2014. Defendants thus contend that the patent is liable to be invalidated under Section 8 and Section 64(1)(m) of the Patent Act. HC further observed the findings of the Co-Ordinate Bench of HC in Chemtura Corporation v. Union of India & Ors., 2009 (41) PTC 260 (Del) which noted the requirements of section 8 of the Act.  The corresponding rule is Rule 12 (1) of the Rules which states that the statement and undertaking to be filed in terms of Section 8 (1) of the Act will be in Form 3. HC finds that the plaintiffs have given reasonable explanation about the proceedings abroad and it cannot be said that there has been suppression of any material facts on this account which have a material bearing on grant of the injunction application by the plaintiffs to warrant vacation of the stay order. Placing reliance on the decision of Co-Ordinate Bench of HC in Bristol-Myers Squibb Company & Ors. v. Mr.J.D.Joshi & Anr and F.HOFFMANN-LA ROCHE LTD & ANR vs. CIPLA LTD., 2015 (225) DLT 391, HC finds that there is prima facie substantial compliance of the statutory requirements of Section 8 of the Act by the plaintiffs. Further, HC finds that the failure of the plaintiffs to mention about the proceedings in China, proceedings regarding the European Patent are not material enough to warrant vacation of the interim orders passed by HC.

HC reiterates the findings in F. Hoffmann-LA Roche Ltd. & Ors. vs. Cipla Ltd. (supra) which states that – “Notwithstanding the above, assuming that the plaintiffs held a patent for the product which was the subject matter of the suit for infringement, the grant of such patent to the plaintiffs will not ipso facto entitle them to an interim injunction if the defendant is able to satisfy the court that there is a serious question to be tried as to the validity of the patent. In the present case, the defendant has raised a credible challenge to the validity of the patent by raising a serious triable and substantial question that renders it vulnerable to challenge.”

HC further relies on the findings in Bristol-Myers Squibb Company & Ors. v. Mr.J.D.Joshi & Anr.(supra) and observes that the grant of patent does not ipso facto entitle the plaintiff to an interim injunction. If the defendant is able to show that there exist serious and substantial questions which render the patent vulnerable to its validity, an injunction may not be granted.  Further, HC finds that defendants have raised a strong credible challenge to the validity of the suit patent under Section 64(1)(f) read with Section 3(d) and Section 64 (1) (a), 64(1)(d), 64(1)(f) and 64 (1)(k) of the Patent Act. The issues raised render the suit patents vulnerable to challenge. HC observes that plaintiffs have failed to make out a prima facie case and the balance of convenience is also in favour of the defendants. Thus, HC rules in favour of the defendants and vacates the interim orders.

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