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September 2017

There are a number of issues of direct patent infringement that frequently arise in the areas of pharmaceuticals, biologics and medical devices. The answers to these are not, however, always straightforward. They may also be treated differently in the UK compared to other national courts. We address some of these issues in this short series of articles, beginning with "offers" under Section 60(1)(a) of the Patents Act 1977.

Offers

Is an unlicensed offer to supply a pharmaceutical or other product protected by another party's patent an infringing act if: it is made prior to patent expiry, even though it is stipulated that the supply will occur only after the expiry of the patent?

Section 60(1)(a) states:

"a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say -

(a) where the invention is a product, he makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise;"

In the UK, a clear statement by the party making the offer that the product will not enter the market until after patent expiry will normally be sufficient to defeat a preliminary injunction against a party making the offer. However, without this, if the offer is part of activity suggesting that pre-expiry infringing acts are imminent, a preliminary injunction may result. Merck Sharp Dohme Corp & Anor v Teva Pharma BV & Anor¹ is such a case. Here, a marketing authorisation for generic efavirenz was obtained two years before the date of patent expiry. The defendant was asked by the claimant to disclose its marketing intentions for the drug, but refused to do so. The case also arose shortly after the defendant had marketed another drug, atorvastatin, 'at risk', which was a significant factor in persuading the court to grant the preliminary relief sought. The approach taken by the UK courts is to look first at the objective position without regard to the party's stated intentions, and then to consider their actual state of mind, before assessing the position overall^2.

The approach is different in many other countries, even under equivalent legislation. For example, German case law states that a pre-expiry offer is a patent infringement, even where there is a statement that supply of the drug will only take place after patent expiry. Associated promotional activity – for example, advertisements and pre-expiry information on the post-expiry ability to deliver the relevant products – may also be infringements of the patent. This principle extends to listing medicines in the so called “Lauer Taxe”. In Germany, medicinal products must first be listed in the Lauer Taxe before they can be put on the market. In the Simvastatin case³, the Bundesgerichtshof (Federal Court of Justice) held that the publication of generic simvastatin in the Lauer-taxe was an infringing “offer”, regardless of whether the product would only be placed on the market after expiry of the patent. The reasoning of the Bundesgerichtshof was that a pre-expiry offer can itself impact on sales of the originator's product. In other words, if medical professionals, pharmacists or consumers know that a cheaper generic product will come onto the market after the expiry of the patent, they may delay their orders to wait for it. The Dutch courts also take a similar approach to those in Germany. Pre-expiry publication of a generic medicinal product in the 'G-standard' – the Dutch pharmaceuticals database – has been held by the Hoge Raad (Supreme Court) to constitute an infringing offer of the relevant patent under the Dutch equivalent of Article 25(a) CPC 1989⁴.

These differences raise a question for the future Unified Patent Court. Will the new court detach infringement from regulatory requirements by focusing on the actions of the alleged infringer itself and any assurances they have given about the timing of launch, as in the UK, or will it consider listing, such as that in Germany and the Netherlands, sufficient to infringe?

¹ Merck Sharp Dohme Corp & Anor v Teva Pharma BV & Anor [2012] EWHC 627 (Pat).

² Actavis Group PTC EHF v ICOS Corporation and joined cases [2016] EWHC 1955 (Pat).

³ Simvastatin, BGH X ZR 76/05, 5 December 2006.

⁴ Article 53(1) Dutch Patent Act. See Pharmachemie / Glaxo, June 22 2012, IEPT20120622.

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