Patent

Del HC Vacates Interim Orders Restraining Dr. Reddy’s & Ors. from Selling AstraZeneca’s Ticagrelor


Image from here

On 8th August, the Single Bench of the Delhi High Court vacated the interim orders granted in favour of AstraZeneca (‘plaintiff’) preventing Micro Labs, Natco Pharma and Dr. Reddy’s Laboratories (‘defendants’) from selling, marketing or dealing with TICAGRELOR (an effective platelet aggregation inhibitor) or any other product violating the plaintiff’s registered patents- IN 907, IN 984 and IN 674. The case relates to two important issues, namely, selection patents and the difference between coverage and disclosure in a patent. The interim applications dealt with in the instant case were IA 3986/2018 in CS (Comm.) 749/2018, IA 4771/2018 in CS (Comm.) 792/2018, IA 9332/2018 filed in CS (Comm.) 1023/2018 filed by the plaintiffs, and IA 5096/2018 in CS (Comm.) 749/2018 filed by the defendants seeking vacation of the interim orders.

Background

TICAGRELOR is a platelet aggregation inhibitor produced by AstraZeneca which is prescribed to patients who have suffered a recent heart attack or unstable angina (chest pain) for reducing the chances of another heart attack or stroke. According to the plaintiff, TICAGRELOR was first approved in the US in 2011 and is being marketed by the plaintiff under the trademark, BRILINTA. In India, the plaintiff received drug regulatory approval in May 2012 and was commercially launched in India in October 2012 as BRILINTA and AXCER.

In 2018, the plaintiff received information from various sources that the defendants were planning to launch generic versions of TICAGRELOR in India and accordingly filed patent infringement suits. In 2018, the Delhi HC passed orders in the plaintiff’s interim applications restraining the defendants from selling, marketing or dealing with TICAGRELOR tablet or any other drug violating the plaintiff’s registered patents- IN 907 (‘species patent’), IN 984 (‘polymorph patent’) and IN 674 (‘formulation patent’). The plaintiff alleged that the defendant’s drug TICAGRELOR fell within the scope of IN 907 (published in 2005) and IN 984. Further, the plaintiff argued that the finished formulation of TICAGRELOR was covered within the scope of IN 674. Micro Labs’ petitions for revocation of IN 907 and IN 984, are pending before the IPAB.

Defendants’ Arguments

All the defendants in the instant case filed similar arguments. The salient arguments are as follows:

  1. The plaintiff’s patent IN 229 is the genus patent which expressly covers and discloses TICAGRELOR and has expired on 14.7.2018.
  2. Form 27 filed in India for IN 229 expressly refers to BRILINTA and AXCER being covered by IN 229.
  3. The plaintiff has deliberately failed to mention that the foreign patent equivalents of the plaintiff’s Indian patents have been invalidated in contested proceedings in China, Europe and South Korea. In doing so, the plaintiff has failed to comply with section 8 of the Indian Patents Act which requires intimation to the Indian Patent Offices of the status of all corresponding foreign applications.
  4. The instant case is a “textbook instance of patent ever-greening by the plaintiffs”- As the genus patent IN 229 has already expired, any party is free to manufacture or sell generic versions of TICAGRELOR in India. By obtaining patents (IN 907 and IN 984) on the same Markush, namely, TICAGRELOR, the plaintiff has sought to illegally extend the monopoly granted under IN 229.
  5. The plaintiff’s patents- IN 907, IN 984 and IN 674- lack novelty and are obvious.
  6. The plaintiff is creating a false dichotomy between “coverage” and “disclosure” wherein they argue that IN 229 generically covers but does not specifically disclose TICAGRELOR; this amounts to artificially extending the monopoly under the expired patent 229 through subsequent patents on TICAGRELOR.
  7. The plaintiff’s patents are liable to be revoked under section 3(d) because they do not exhibit any enhanced therapeutic efficacy over the known substances disclosed in IN 229.

Plaintiff’s Arguments

The plaintiff rebutted the defendants’ arguments on the following grounds:

  1. The genus patent (IN 229) was published on 2nd February 1999 after the priority date of the species patent (IN 907). Therefore, the genus patent does not constitute prior art for evaluating novelty of the species patent.
  2. There is no specific or enabling disclosure of TICAGRELOR in the genus patent. The genus patent only discloses (1.5×1020) compounds one of which was later discovered to be TICAGRELOR. The defendants’ argument that TICAGRELOR can be derived from the general Markush formula in the genus patent is untenable and a case of hind sight basis (i.e. cherry picking based on ex post facto knowledge).
  3. Mere structural similarity is not sufficient to trigger section 3(d). The plaintiff relied on the affidavit of expert, Dr. Robert Riley, to argue that TICAGRELOR has demonstrably greater therapeutic efficacy than IN 229, owing to TICAGRELOR’s vastly superior metabolic stability and a far greater availability of the drug in the body.
  4. On non-disclosure of various revocation patents outside India, the plaintiff argued that the equivalent of IN 907 was revoked in China but an appeal was filed by the plaintiff; the appeal implies an automatic stay of the operation of the revocation order and does not amount to non-disclosure.
  5. Form 27 only states that the genus patent has worked through TICAGRELOR and does not imply that TICEGRELOR has been disclosed in IN 229. It is possible that multiple patents cover a single product.
  6. The plaintiff relied on Novartis v. UOI to argue that coverage (for the purpose of infringement) will not be granted by the court unless a specific disclosure has been made in the patent. However, this does not mean that disclosure is equivalent to coverage.

Court’s Analysis

Noting that the defendant’s claims challenged patentability of the plaintiff’s invention, the court stated that the issue of patentability of pharmaceutical inventions is highly technical and a mixed question of fact and law. Therefore, the court would rely on expert evidence to determine this issue (citing Merck v. Glenmark Pharmaceuticals (2015) and Martin F.D’Souza v. Mohd. Ishfaq (2009)). The court then proceeded to examine the claims made by the parties.

Statement of Working in Form 27 as Proof that TICAGRELOR is Disclosed in the Genus Patent

The court found that the plaintiff had declared TECAGRELOR as the patented invention in Form 27 filed for the local working of patented inventions of IN 229, IN 907, IN 984 and IN 674. In Form 27 for all the above patents, the plaintiff had stated the same quantum of sale of BRILIANTA and AXCER.

The court also referred to a litigation in the US by the plaintiff against Mylan Inc. to enforce US Patent 6251910 (equivalent of IN 229). In this litigation, the plaintiff had stated that dealing in TICAGRELOR was in breach of the US Patent 910.

The court rejected prima facie the plaintiff’s argument that although the genus patent had worked through TICAGRELOR, TICAGRELOR was not disclosed in 229. The court relied on Novartis v. UOI wherein the SC rejected the dichotomy between coverage and disclosure in a patent; the SC in Novartis held that such a dichotomy negated the fundamental rule underlying the grant of patents.

Suppression of Material Facts by the Plaintiff Related to the Genus Patent

The court found that the plaint did not disclose important information regarding IN 229, especially Form 27 for IN 229 and the US court proceedings instituted against Mylan. Further, it was only in response to the defendant’s arguments that the plaintiff had stated that IN 229 was worked (although not disclosed) through TICAGRELOR.

The court held that this was a case of clear omission of mentioning important facts in the plaint.

Section 3(d) – Lack of Proof of Enhancement of Known Therapeutic Efficacy for the Suit Patents

The court found that the plaint was completely silent about any enhancement of known therapeutic efficacy for the suit patents. The court then examined the affidavit of Dr. Robert Riley- the court found that while the affidavit stated that the species patent had some advantages over the genus patent, the fact that both IN 907 and IN 229 could be used as platelet inhibitors pointed to a prima facie finding that the suits were not altogether new or unconnected to IN 229.

The court relied on Novartis v. UOI wherein the SC held that only those properties of a drug which directly related to therapeutic efficacy were relevant in a case involving section 3(d).

The court found that the plaintiff’s argument that the suit patents had advantages such as lower does and increased metabolic stability did not prove enhanced therapeutic efficacy of the suit patents over IN 229.

No Suppression of Material Facts under Section 8 – Information and Undertaking Regarding Foreign Applications

On the issue whether the plaintiff had failed to disclose relevant patent revocation proceedings in foreign jurisdictions, the court was of the opinion that the plaintiff had not suppressed material facts. The court accepted the plaintiff’s submission that as the revocation orders had been appealed by the plaintiff, this implied an automatic stay on the revocation order.

According to the court, the determining factor when deciding whether the court should continue the interim injunction granted in a patent infringement case was whether the defendant had raised a credible challenge to the validity of a patent held by the plaintiff (citing F. Hoffman-LA Roche v. Cipla (2015)).

The court found that in the instant case the defendants had raised a credible challenge to the validity of the patent on various grounds including section 3(d). Accordingly, the court set aside the interim injunctions against the defendants.

Hat tip to Mr. Sandeep Rathod for bringing this important development to our notice!

[Update: An appeal against the Single Bench order has been filed in the Division Bench]

Devika Agarwal

Devika Agarwal

Devika is a Policy Analyst at Nasscom. She first started writing on Spicy IP in 2013 when she was awarded the Spicy IP Fellowship, which sparked her passion for writing on IP. Devika is interested in copyright and technology law.

9 comments.

    1. Devika AgarwalDevika Agarwal Post author

      No, this was not today. The date of the order is 8th August. It appears that the matter has been appealed to the Division Bench. We do not have a copy of the Division Bench order yet.

      Reply
  1. AvatarFrAn

    This case at the Delhi High Court hides a lot more systemic faults than is apparent at first glance.
    a) We have a single Judge who reserved the order in Oct 2018 but released it only in Aug 2019 – that too after the 1st patent has already expired.
    b) When the single Judge finally did make up his mind and ruled in favour of defendants, even then he apparently stayed the same for 1 week so as to allow Plaintiff to file appeal. If he was so clear on his decision, why this 1 week of extra relief? Should the Court not have allowed the parties to make their choices after such a long wait and expiry of first patent?
    c) Then we have the new saga at Division Bench. Patentee proceeded to file its appeal and the appeal bench too has ‘informally’ said that defendants must not launch the product, even when the single Judge ruled in their favour. The surprise is that these informal positions of the appeal bench do not appear in the orders on the Delhi HC site.
    d) So, here we are – almost 14 odd months from expiry of earlier patent and almost close to the expiry of the second patent and no generics in market even after a favorable order.
    The next hearing at the appeal bench is for Sep 06, 2019.

    Reply
  2. Avatarpranav gangwar

    1)How can one conclude from Form 27 disclosure that the product is disclosed in the genus patent until and unless thereis no specific disclosure of the compound in the genus patent than that prior art cannot be considered as novelty destroying prior art. You can have one product which can have n number of patents. All these patents will have same Form 27 since the monetary value is of only of the finished product .
    2) Section 3(d) arguements are only applicable to the compound and its derivatives such as salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and not to closely related other structures.
    3) Is it mandatory to inform the court about litigation of patent in suit in foreign jurisdiction? and if I dont do this should it be considered as suppression of facts

    Reply
    1. Devika AgarwalDevika Agarwal Post author

      Hi Pranav,
      On Point 3, please refer to Para 59 of the order:
      “The plaintiffs have filed proceedings for breach of IN 229 when the drug in question was TICAGRELOR in USA. These are important facts which have a material bearing on the issue as to whether TICAGRELOR is disclosed in IN 229 and is known and anticipated. The plaintiffs were obliged to have revealed the full facts in the plaint. This is especially so, keeping in view the fact that Micro Labs Ltd. had already filed an application for revocation of the suit patents before IPAB in 2015 where various grounds were urged including the fact that the suit patents are disclosed and covered in IN 229.”

      Reply
  3. AvatarAlways Anonymous

    Title of article is a little misleading. Was not thw Micro suit the first one? the judgement also shows that micro arguments had more impact on Single Judge. All points about US litigation, Forms 27, patent term extensions , approbate reprobate. Even in appeal, Micro doing all major arguments in Court.

    Reply
  4. AvatarAnonymous

    Also, does stay also apply to other cases like USV which secured conditional compliance, amd Lantech which merely piggybacked on the USV order. Or is stay specific to Micro, Natco and Reddy cases.

    Reply

Leave a Reply

Your email address will not be published.