"Clearing the way”: A life-saving drug for chronic injunction battles in patent litigation?

Consider that a pharmaceutical company (for these purposes, the “innovator”) holds the patent for a vital drug for a statutory term. During the term of this patent (contextually referred to as the “genus patent”), the innovator has also obtained several other neighboring patents (contextually referred to as the “species patent(s)”), whose statutory term(s) will obviously survive the statutory term of the original genus patent.

When that genus patent is nearing expiry, and sometimes even before that, its rivals might attempt to launch generic forms of that drug (such companies, the “generics”) on the basis that the innovator’s genus patent is (and the species patent(s), if any, are) invalid. When the genus patent has already expired, the generics may launch their generic product on the basis that the species patent(s) is invalid.

After all, it is fundamental to patent jurisprudence that mere grant of a patent in accordance with the statutory procedure does not give rise to any presumption of its validity. The validity of a patent will have to be tested independently, when challenged by an adversary.

If the innovator seeks an injunction from a civil court to restrain the generic from launching its generic product, a judge is soon inundated with evidence for, and against, the grant of an injunction restraining the launch of the generic drug. She will have to form a prima facie view regarding the validity or invalidity of the patent based upon which an injunction is sought.

It is predominantly in this context that the concept of “clearing the way” has evolved in English law as one of the factors to be considered for evaluating whether a potential infringer of a pharmaceutical patent ought to be injuncted. There is now every sign that this concept is becoming an increasingly common point of contest in Indian pharmaceutical patent litigation. As a matter of principle, there is no reason for this concept to be limited to this industry or context. This article will continue to use the example of generics in the pharmaceutical industry as a convenient device, in harmony with the cases that have so far found fit to invoke the concept.

Simply, the principle of “clearing the way” requires that a company launching its product (in the case of pharmaceuticals, it is often a generic product) with the knowledge that another company has obtained a patent that might arguably be infringed by the launch of its product, must first challenge that patent by commencing proceedings for a declaration of non-infringement or by applying to revoke the innovator’s patent; failing which it risks suffering an injunction [See Section 64 (1) and Section 105 of the Indian Patents Act, 1970, as amended].

This merits further analysis, not least because it appears, at first blush, to create the impression of a legal duty to commence proceedings and an implied presumption of validity of the patent granted to the innovator. In practice, it should not.

The application of the principle of “clearing the way”, perhaps formulated for the first time by Jacob J in SmithKline Beecham plc v. Generics (UK) Limited, reported at [2001] 10 WLUK 610 (“SmithKline Case”), resulted in the grant of an injunction against the generic. In this case, the Judge found that although both the innovator and the generic would suffer irreparable harm either way, the generic knew that litigation was inevitable. It could have resolved the whole of this dispute by taking suitable legal steps before launch of its generic product by “clearing the way”. Having failed to do so, the Judge held that the generic must suffer the consequences of an injunction.

This principle of “clearing the way” has been affirmed even recently by the Court of Appeal in England in AstraZeneca AB v. Glenmark Pharmaceuticals Europe Limited, reported at [2025] EWCA Civ 480 (the “Dapalgliflozin Case”, named after the drug in question).

This line of reasoning in SmithKline Case was also found to be persuasive by a Division Bench of the Delhi High Court in Merck Sharp and Dohme Corporation and another v. Glenmark Pharmaceuticals Limited reported at 2015 (63) PTC 257 [Del][DB] (“Merck Case”), from which point it was cast into Indian law.

The Division Bench of the Delhi High Court considered “clearing the way” principle as part of six equitable principles affecting the grant of an injunction in patent infringement cases. The Division Bench reasoned that, although nothing could take away from a generic its right to challenge the validity of the innovator’s patent, even after the grant, the generic in this case was aware of a possible challenge to its own launch of a potentially (or allegedly) infringing product. The Division Bench held that the fact that the generic proceeded to launch its product, in these circumstances, without seeking revocation or negotiation is surely “a relevant factor” at the stage of granting an injunction.

Although the terms of the injunction granted by the Division Bench were subsequently modified by the Supreme Court, the body of principle in the judgement of the Division Bench of Delhi High Court remains authoritative [See Glenmark Pharmaceuticals Limited. v. Merck Sharp and Dohme Corporation and another, reported at (2015) 6 SCC 807].

Experience of practice suggests that this principle will be the subject matter of significant contest in patent litigation (specifically with respect to pharmaceutical patents) in Indian courts. Cases will be decided one way or the other based on this principle. The following five propositions about this principle will hopefully clarify the way in which Indian courts might apply it, as this jurisprudence develops.

First, it is useful to state what this principle is not. None of the cases suggest any positive or substantive duty on part of the generic (or the company launching a new product that might be potentially or allegedly infringing) to take legal proceedings [See, for authority, the Court of Appeal in SmithKline Beecham v. Apotex Europe Limited, reported at  [2003] FSR 31, at paragraph 39 (Aldous LJ); Merck Sharp and Dohme Corporation and another v. Glenmark Pharmaceuticals Limited reported at 2015 (63) PTC 257 [Del][DB] at paragraph 87].

The failure to commence proceedings is not a “breach” of any law which sounds in any remedy. The generic or the company launching a new product cannot, for example, be made to pay damages for it. What is clear from the judgments, from both English and Indian courts, is that it is only a factor (albeit a highly decisive one) in the exercise of discretion to grant an injunction.  

Second, even as a factor in that discretionary exercise, the principle of “clearing the way” does not modify the traditional test for the grant of an injunction, which remains: (i) a prima facie case, (ii) irreparable injury and (iii) balance of convenience. It only simplifies the way in which one of these limbs—the balance of convenience—is assessed.

A generic’s failure to “clear the way” can never result in establishing or inferring a “prima facie case” of infringement. This is because Section 13(4), read with Section 107(1) of the Indian Patents Act, 1970 (“Patents Act”) make it clear that the grant of a patent does not create any presumption in favour of the validity of the patent. The statute is, as a matter of policy, averse to presumptions about the prima facie validity of patents [See Boehringer Ingelheim Pharma GMBH and Co v. Vee Excel Drugs and Pharmaceuticals Private Limited and Others reported at 2023 SCC OnLine Del 1889, at paragraphs 37, 44 to 48].

It is open to a Defendant to attack the validity of the patent under Section 64 of the Patents Act at any point, including after its grant. If it can raise a credible challenge to the patent, then the injunction will not succeed as the injunction-claimant will not be able to demonstrate a prima facie case [See M/s. Bishwanath Prasad Radhe Shyam v. Hindustan Metal Industries, reported at (1979) 2 SCC 511, at paragraph 32; TenXC Wireless INC and another v. Mobi Antenna Technologies (Shenzhen) Co. Limited., reported at 2011 DHC 5605].

This distinction is vital to ensure that no legal duty to commence proceedings is introduced in Indian patent jurisprudence through the backdoor, which would indirectly create an implied presumption of validity in favour of a granted patent. If the failure to “clear the way” is by itself ever found to be enough to satisfy the test of prima facie case for the grant of an injunction, it would indirectly defeat the policy of the statute that there can be no presumptions about the patent’s validity.

Instead, the appropriate stage to consider the Defendant’s failure to “clear the way” is only at the stage of assessing the “balance of convenience” [See Terrell on the Law of Patents (20^th ed) at paragraphs 19-245, 19-246].

An analysis of the cases decided on the principle of “clearing the way” reinforces this theoretical foundation. Even in the original SmithKline Case, the failure to “clear the way” by the generic was considered for evaluating the balance of convenience because the generic had already progressed into an advanced stage for launching its product. The consideration of the failure to “clear the way” arose only after the Judge had already concluded that the innovator had a prima facie case. Similarly, even in EISAI Co. Limited and another v. Satish Reddy and another, reported at 2019 (79) PTC 568 [Del], the Court found that the balance of convenience favoured the plaintiff-innovator because the Defendant-generic had not cleared the way before launch, only after concluding that the innovator had a prima facie case.

Consequently, a Plaintiff is not entitled to invoke a Defendant’s failure to “clear the way” at the stage of evaluating: (a) the prima facie case for the grant of injunction and (b) the credibility of the Defendant’s challenge to the validity of the patent. It may do so only at the stage of evaluating the “balance of convenience” between the parties.

The implication of this distinction is best exemplified in AstraZeneca AB and another v. Torrent Pharmaceuticals Limited, reported at 2020 DHC 3270. The Single Judge in that case found that although the balance of convenience was in favour of the plaintiff-innovator, directly because of the defendant-generic’s failure to “clear the way”, it nevertheless could not obtain an injunction because it had failed to show a prima facie case in the first place. This is the correct application of the principle of “clearing the way”.

Third, “clearing the way” can in some situations be most usefully seen as a tiebreaker when the Court is unable to form a view on the prima facie test and irreparable harm, or that it finds that these factors are otherwise evenly balanced between the parties. However, the role of the principle of “clearing the way” as a tiebreaker is not small. In fact, as the Court of Appeal aptly pointed out in the Dapalgliflozin Case, the distinctive feature of patent injunction cases in the pharmaceutical sector is that injury will be irreparable on either side: loss from inevitable price cutting is not easy to reverse for the innovator, and the loss of first-mover advantage is not easy to reverse for the generic. This means that often, the injunction will be decided based on “balance of convenience” as a more dominant factor, in which a Defendant’s failure to “clear the way” will assume paramount significance. However, this proposition is nebulous. It must, therefore, be applied with extreme caution and in exceptional cases, perhaps only when any implication of the validity of the patent is an insignificant consideration for grant of injunction in the peculiar factual matrix of a case.

Fourth, placing “clearing the way” factors within the balance of convenience also opens the range of facts to be considered for a correct appreciation of that principle. The cases show us that “clearing the way” is one manifestation of the larger principle that a party’s conduct in litigation can lead to inferences against it. This characterization of “clearing the way” as a litigation management control device means that the inquiry does not end on showing that a generic has announced the imminent launch of a drug that it knew would raise challenges. Even after launch, it may be possible for the generic to apply for expedited trials to resolve the challenge before launch [See AstraZeneca AB v. Glenmark Pharmaceuticals Europe Limited, reported at [2025] EWCA Civ 480 at paragraph 88 (Arnold LJ)] The overall inquiry is to ask whether the generic has taken steps to bind a trial judge’s hands by engineering an irreversible status quo.

Fifth, understanding its place in the matrix of factors in the grant of injunction allows us to formulate more precise conditions in the application of this principle. This article proposes that “clearing the way” factors should be subject to an overall reasonableness criterion: a Defendant’s failure to clear the way should only count against it if it was reasonable for it to take certain steps. This will often be in cases where (i) the Defendant is about to launch a competing generic (ii) it knew that the innovator’s patent had been practiced for a long period of time, either without any successful challenge or has survived unsuccessful challenge(s) by others; and (iii) it knew that a legal challenge by the innovator is highly probable. 

Further, even where it is concluded that it was reasonable for the generic to have “cleared the way”, and that it did not do so, even that does not end the inquiry. The balance of convenience might still lie against the grant of an injunction by the weight of other compelling factors [See, an example of such a case in Cephalon Inc and others v. Orchid Europe Limited and another, reported at [2010] EWHC 2945 (Pat)]. The better view is that the onus shifts to the generic or the company launching a new product to show that despite its failure to “clear the way”, the balance of convenience still lies in its favour.

The principle of “clearing the way” is a useful tool to assess balance of convenience. In a jurisdiction that struggles from severe case pendency, such tools are welcome. But its practicality cannot outrun the limits of principle. It is not a cut and dry short-cut to resolve injunction applications. The application of the five propositions above, it is hoped, might produce fairer outcomes.

Gaurav Pachnanda is a Senior Advocate, based in New Delhi, whose practice includes a wide range of commercial litigation, international commercial arbitration and intellectual property litigation.