Validity of patent considered at preliminary injunction stage

United Kingdom

1. Introduction

In a recent judgment, the High Court considered the validity of a patent at the preliminary injunction stage, on the basis of a summary judgment application brought by Dr Reddy’s Laboratories (UK) Limited (“DRL”), a generic pharmaceutical company. DRL brought the application against Novartis Pharmaceuticals UK Limited (“Novartis”) on the basis that the Opposition Division of the European Patent Office (the “EPO”) had already held the patent to be invalid on ground of added matter.

2. Everolimus

The patent relates to the compound “40-O-(2-hydroxyethyl)-rapamycin”, more commonly known as everolimus and sold by Novartis as Afinitor. Novartis held a second medical use patent for the use of everolimus in combination with exemestane for use in breast cancer; “40-O-(2-hydroxyethyl)-rapamycin in combination with exemestane for use in the treatment of hormone receptor positive tumor, wherein in the hormone receptor positive tumor is a breast tumor” (the “Patent”).

Although the Supplementary Protection Certificate on everolimus per se expired on the 17 January 2019, protection was still provided by the Patent. This Patent prevented DRL, who had obtained a marketing authorisation for everolimus in July 2018, from launching its generic version of the drug after 17 January 2019.DRL could have launched a skinny label product directed at smaller indications (by “carving out” the treatment of breast cancer from its marketing authorisation), but opted not to.

3. The EPO’s decision

In June 2018, a number of generic pharmaceutical companies brought opposition proceedings against the Patent at the EPO. The EPO’s Opposition Division found the Patent to be invalid on added matter grounds. Novartis had appealed this decision to the EPO’s Technical Board of Appeal. Appeals of this nature can take several years.

4. Novartis’ preliminary injunction and DRL’s summary judgment applications at the High Court

Based on DRL’s marketing authorisation, Novartis filed an application seeking a quia timet preliminary injunction against DRL. DRL resisted the injunction and brought its own application for summary judgment that the Patent was invalid on grounds of added matter. DRL cited the decision of the Opposition Division as a persuasive (but not precedential) authority that the Patent was invalid.

The High Court therefore considered the strength of Novartis’ Patent at the preliminary injunction stage, as it determined DRL’s summary judgment application and Novartis’ preliminary injunction application at the same time.

The High Court awarded a preliminary injunction to Novartis, as Mr Justice Birss formed a “clear but provisional view that there was no added matter” and that therefore the Patent was valid. Novartis submitted expert evidence suggesting that that the matter claimed in the Patent was disclosed in the application for the Patent as filed. Mr Justice Birss considered this evidence convincing, and DRL did not file any expert evidence of its own.

5. Points of interest

Opinion on the approach the English Court takes to granting injunctions in pharmaceutical patent cases is divided, unsurprisingly, along originator or generic lines. Originator companies consider it is only correct that generic companies are kept from the market whilst infringement and validity of a patent, presumed valid once granted, is decided. Generic pharmaceutical companies suggest that the Court grants preliminary injunctions with less regard to the strength of the patent and infringement claim in suit than ought to be the case.

The basic test for granting a preliminary injunction is set out in American Cyanamid [1975] 1 All ER 504. The Court will consider:

  1. whether the issue to be tried is serious;
  2. whether an awarded damages is an adequate remedy;
  3. where the balance of convenience lies; and
  4. if there are any special factors.

These criteria are discussed further in National Commercial Bank Jamaica Ltd v Olint Corpn Lit [2009] UKPC 16. The Privy Council held that the relative strength of the parties’ cases should be assessed, and the Court should consider the practical consequences of granting (and not granting) the injunction.

Pharmaceutical cases are often finely balanced, with each side citing unquantifiable harm and inadequacy of damages. In order to determine the balance, the Courts have, for many years, given weight to the doctrine of “clearing the way”, which originated from Jacob J’s judgment in Smithkline Beecham v Generics (UK) [2001] WL 1346930. Jacob J considered it a matter of commercial common sense that a generic pharmaceutical company intending to launch a generic product ought to “clear the way” of any patent right which might obstruct it. This can be done by taking action against the validity of the patent, or seeking a declaration of non-infringement, ahead of launch. Though not a statutory obligation, the principle has been cited in various cases and even extended to hold over injunctions to the Court of Appeal (once the patent has been held invalid or not infringed at first instance), see Hospira v Novartis [2013] EWCA Civ 538.

Typically,where the Court finds an award of damages would not be an adequate remedy for either party, a failure by a generic company to clear the way tips the balance of convenience in favour of the patentee. Generic companies suggest that a failure to clear the way is given more weight than it out to be, particularly in cases in which the claimed validity or infringement of a patent appears questionable. For example, a generic company might have invalidated a patent at first instance at the EPO, or designed a product which does not infringe the patent, but still find itself the subject of a preliminary injunction. Put simply, it might be said that generic companies would prefer to the Court to place more emphasis on the strength of the each party’s case, in line with Bank of Jamaica, and less emphasis on a failure to clear the way. Originator companies, in turn, feel they need the preliminary injunction to preserve the status quo whilst the validity and/or infringement of the patent is considered. They suggest the need for a preliminary injunction would have been obviated had the generic company taken steps to clear the way in good time. Generic companies are reticent to give competitors notice of their plans several years in advance in order to do so.

The summary judgment application in this case meant that the Court had to consider the strength of the case on validity of the Patent at length at the preliminary injunction stage. Though an interesting tacticby DRL, the Court found against them in this instance. It remains to be seen whether a more convincing Opposition Division decision might sway the Court in the other direction, or perhaps if DRL had submitted expert evidence of its own it might have stood a better chance (though the nature of, and requirements for meeting the standard for, a summary judgment application makes reliance on expert evidence by the applicant problematic). The application of this tactic in infringement only actions would appear limited.

Following the High Court’s judgment, the EPO are now invited to expedite the opposition appeal proceedings and DRL’s case for invalidity of the patent will be heard in due course.

Co-authored by Shayna-Radhika Patel.