Background to the dispute
In summary, Warner-Lambert had a patent for the drug pregabalin which it marketed under the trade mark Lyrica for epilepsy, generalised anxiety disorder (non-patented indication) and neuropathic pain.
The patent and data exclusivity for the drug have both expired, but Warner-Lambert has a second medical use patent - European patent (UK) 0 934 061 with Swiss-type claims - claiming pregabalin for treating pain, and in particular neuropathic pain (patented indication).
Given these circumstances a generic drug manufacturer can apply for marketing authorisation to sell a generic version of pregabalin with a product leaflet that does not mention the patented indication. This is what Actavis did, and intended to market its version under the trade mark Lecaent.
Actavis launched proceedings to revoke the patent, and Warner-Lambert applied for an interim injunction, pending trial on infringement and revocation, requiring Actavis to take a number of steps to prevent Lecaent from being dispensed for the patented indication.
Refusing Warner-Lambert’s unconventional interim relief application, the first instance judge Mr Justice Arnold held that:
(a) There was no serious issue to be tried since Actavis will not infringe Warner-Lambert’s patent by marketing Lecaent;
(b) The construction of the word “for” in its Swiss-type claim imports “subjective intention” on the part of the Actavis that Lecaent will be used for treating pain; and
(c) The balance of risk of injustice was in favour of refusal since Actavis will suffer substantial unquantifiable loss if granted.
In reaching his decision, the judge appreciated the complexity in the case due to the involvement of third parties such as NHS England, and underlying UK healthcare practice (for doctors and pharmacists) which encourages prescribing and dispensing of generic drugs.
In subsequent related decisions, Arnold struck out Warner-Lambert’s indirect infringement claim under s.60 (2) of the Patent Act 1977 on the grounds that there cannot be infringement since no act of manufacture is carried out by pharmacists, but allowed the claim for direct infringement under s.60 (1) (c) of the Act to proceed to trial despite his views that it had no real prospect of success. The judge also ordered NHS England to issue guidance to GP practices and pharmacies on prescribing and dispensing pregabalin respectively.
Taking all the decisions together, Warner-Lambert appealed against Arnold’s refusal to grant its interim relief application, and the way the judge constructed the patent claim to require subjective intention. Essentially, Warner-Lambert’s argument was that Actavis intended to sell pregabalin with the knowledge that pharmacists were likely to dispense Lecaent for treating pain.
Two appeal decisions
The two decisions before the Court of Appeal (Lady Justice Arden, and Lords Justice Floyd and Ryder) were Warner -Lambert Company, LLC v Actavis Group Ptc EHF & Ors (Rev 1) [2015] EWHC 72 (Pat) (interim injunction decision) and Warner-Lambert Company LLC v Actavis Group PTC EHF & Ors [2015] EWHC 249 (Pat) (indirect infringement decision).
Delivering the unanimous judgment of the Court, Floyd (right) dismissed Warner-Lambert’s appeal against the interim injunction decision including its modified relief application, but allowed the appeal against the indirect infringement decision.
Although not under appeal, the Court also expressed its views on Arnold’s findings in relation to Warner-Lambert’s direct infringement claim. Floyd constructed the claim to conclude that the judge was wrong to require a test of subjective intention for infringement purposes.
On direct infringement, Floyd explained:
1. The skilled person would understand the manufacturing step in the claim avoids the prohibition of patenting method of treatment, so a medical practitioner is not held liable, and that the novelty of the patent comes from discovery of the new therapeutic use;
2. A skilled person would understand the word “for” in a Swiss-type claim to mean “suitable”, not “suitable for”, because it provides a link between the act of manufacture using pregabalin and use of the drug by end user to treat pain;
3. A subjective intention test will diminish the enforceability of Swiss-type claims since the patentee will find it difficult to establish that it is the manufacturer’s wish or desire to sell its product for the patented indication, in this case treating pain;
4. The appropriate mental element test for the purposes of establishing infringement of Warner-Lambert’s patent (a process claim) is what the manufacturer knows (constructive knowledge is enough) or can reasonably foresee about the ultimate intentional use of the drug (for treating pain);
5. There will be instances where a general injunction prohibiting the sale of a product is not justifiable or even unjust, especially where there are legitimate sales (such as for the non-patented indication);
6. The concern over the possible damages payable by the manufacturer and regulatory environment should not influence the scope of the claim, but unqualified relief will not follow as of right if infringement is found at trial; and
7. A manufacturer would have a defence to infringement if it can show that it took all necessary steps available to it to prevent the sale of the product that infringes a patent.
On indirect infringement, he explained:
1. Section 60(1) (b) of the Act makes it an infringement to use the process, and liability for this is strict;
2. Where there is threatened or actual infringement of a process claim under s.60(1) (b) of the Act, it means any dealings down the supply chain in the direct product of the process will also be infringement under s.60(1) (c) of the Act;
3. The potential for infringement downstream still exists by using the product derived from a process claim where the manufacturer has the requisite intention (that is, constructive knowledge or could reasonably foresee the ultimate intentional use by the end user); and
4. An invention can be “put into effect” under s.60 (2) of the Act if a drug is manufactured by one person and then supplied to another who intentionally uses it for treating the specified condition, so it may be necessary to look beyond the activities of just one person.
Other interesting points from the judgment:
1. Indirect infringement under section 60(2) of the Act has a wide interpretation in regards to “putting the invention into effect” (paragraphs 46 to 47). Whether a person other than the manufacturer can be held liable in this dispute remains to be seen;
2. What is meant by “unless the context otherwise requires” under section 125(1) of the Act has never been fully explored by Court of Appeal (paragraph 50);
3. Second medical use patents with Swiss-type claims are difficult to protect and there are criticisms of such claims as well as EPC 2000 claims (paragraphs 51 to 60);
4. There is a difference in scope between Swiss-type claims, which are purpose limited process claims, and EPC 2000 claims, which are purpose limited product claims (paragraph 56 to 58); and
5. Courts in Germany and the Netherlands have recently granted interim injunction against generic drug manufacturers for indirect infringement of a Swiss-type claim despite the absence of downstream manufacture of the pharmaceutical composition (paragraphs 74 to 97).
Unsettled area of patent law
Arnold anticipated the possibility of the Court of Appeal concluding that his construction of “for” to require subjective intention on the part of Actavis was wrong.
This case underlines the concerns in Europe over second medical use patents with Swiss-type claims: its construction; how much protection should be accorded to it; how they can be infringed; and who can be liable for its infringement.
Floyd said “the law relating to both direct and indirect infringement of Swiss claims is far from settled”. What remains to be seen is whether the Court of Appeal has provided the parties with much-needed clarification and reassurance, or whether the Supreme Court will soon be called in.
