The Court of Appeal has given its opinion that subjective intent on the part of the manufacturer of a pharmaceutical product was not required for infringement of a Swiss-form second therapeutic use claim.
The grant of patents for second medical uses of known compounds must overcome two problems: that the compounds are not new, and that methods of treatment of the human or animal body by therapy are not patentable.
Since 2000, Article 54(5) of the European Patent Convention (EPC) has enabled the grant of claims in the form: product X for treating indication Y (a purpose-limited product claim). Before that, patents had to use claims in the Swiss form: use of substance X for the preparation of a medicament, or pharmaceutical composition, for treating indication Y (a purpose-limited process claim).
A patent for an invention is infringed by a person who keeps, disposes of, or offers to dispose of any product obtained directly by means of the claimed process (section 60(1)(c), Patents Act 1977) (1977 Act) (section 60(1)(c)). Indirect infringement occurs where an infringing invention is not put into effect by the defendant himself, but by someone who was supplied with means relating to an essential element of the invention (section 60(2), Patents Act 1977) (section 60(2)).
W marketed a prescription-only drug for three different indications under a single registered trade mark. Patent protection for the drug itself had expired but W also owned a current second medical use patent for pain relief, which was one of the three indications.
A applied for a marketing authorisation for a generic version of the drug limited to the other two indications.
W was concerned that, despite this, the generic drug would be dispensed for the patented second medical use because most prescriptions are written generically. As very few prescriptions state the indication for which the drug has been prescribed, the dispensing pharmacist will generally not know this. W also argued that, because the generic drug is usually cheaper than the patentee’s product, pharmacists would have a strong commercial incentive to dispense the generic version of the drug unless positive steps were taken to prevent this.
W sued for patent infringement and sought an interim injunction requiring A to take specific actions to prevent its generic version of the drug being dispensed for patients who had been prescribed the drug for the patented indication.
A applied to strike out the infringement claims.
The High Court refused to grant the interim injunction. The manufacturer of a medical product which was the subject of a second medical use claim in the Swiss-form had to have a subjective intent that the product be used for the patented second use in order to infringe the claim, so there was no serious issue to be tried. Granting the relief sought would create a greater risk of injustice than refusing it.
The High Court also struck out the claim of indirect infringement but it dismissed A’s application to strike out the claim entirely. Although W had still failed to plead direct infringement, the case should proceed to trial because this was a developing area of law.
W appealed the decisions in relation to the interim injunction and the indirect infringement claim.
The court dismissed the appeal in relation to the interim injunction but allowed the appeal in relation to the indirect infringement claim.
In relation to direct infringement the court disagreed that Swiss-form claims required subjective intent. The skilled person would understand that such claims owed their novelty to the discovery of the new therapeutic use of the drug. He would not construe the word "for" in the objective sense of "suitable for" since the claim so construed could not be distinguished over known uses of the known drug. The skilled person would understand the claim was concerned with the ultimate end use of the medicament, from which it derived its novelty. He would also understand that the word "for" required a link between the act of manufacture and the ultimate intentional use of the drug by the end user to treat the patented indication, pain. . . Based on that analysis, the skilled person would understand that the patentee was using the word "for" in the claim to require that the manufacturer knew (including constructive knowledge) or could reasonably foresee the ultimate intentional use for pain, not that the manufacturer have that specific intention or desire himself.
It was appropriate for the indirect infringement claim to go to trial for three reasons:
- The courts of two EPC member states, Germany and the Netherlands, have held that indirect infringement could arise in these circumstances.
- If there was a case of threatened or actual infringement of the process claim under section 60(1)(b) of the 1977 Act, then it followed that dealings downstream in the direct product of the process were also infringements under section 60(1)(c).
- "Putting the invention into effect" in section 60(2) might cover not just the situation where a single person carried out the invention, but also where the drug was manufactured by one person and supplied to another who intentionally used it for the treatment of pain. If the person supplying the drug has the requisite knowledge then they did provide means suitable and intended to put the invention into effect, although by the combination of manufacturer and user, rather than by any one person alone.
This decision only dealt with “Swiss-form” claims, although EPC second medical use claims also include "for", which is also a purpose-limited claim, without the manufacturing step required for the Swiss-form claim. So, the question of the necessary mental element for infringement in this context will continue to be relevant in the future to the pharmaceutical industry.
To date, the proceedings have related to interim relief. The issue of whether A infringes, and if so what remedy is appropriate, remains to be considered at full trial. Having refused interim relief, the court did not have to decide the issue of subjective intent at this stage, so arguably its comments and guidance in that regard were obiter. The Court also noted that, even if infringement was established at trial, it did not follow that unqualified relief in the form of a final injunction would be granted. It is possible that these issues will ultimately have to be considered by the Supreme Court. In the meantime, it will be more difficult for generic manufacturers to argue that because they have no specific intention that a product will be used for a patented indication they do not infringe a Swiss-form claim. So-called "skinny labels", which do not mention patented indications, may not be sufficient to to avoid a patent infringement claim if it is reasonably foreseeable that patients will use the generic product for the patented indication.
Case: Warner-Lambert LLC v Actavis Group PTC EHF and others v Secretary of State for Health  EWCA Civ 556.
First published in the August 2015 issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.