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Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Anor
Factual and Procedural Background
Company A (a subsidiary of Company Group) discovered that the known molecule pregabalin, previously patented and marketed for epilepsy, might also alleviate pain. Its original product-patent expired in May 2013. A second, Swiss-form European patent (EP(UK) No 0934061) covering the manufacture of pregabalin for treating pain—particularly neuropathic pain—remained in force. Company B and Company C, both generic manufacturers, began marketing generic pregabalin (sold by Company C as “Lecaent”) under “skinny labels” restricted to patent-free indications (epilepsy and generalised anxiety disorder). Company A sued Company C for infringement and Company B and Company C counter-claimed for revocation.
Judge Arnold in the Patents Court rejected lack-of-inventive-step arguments but revoked the principal claims (pain; neuropathic pain) for insufficiency and dismissed infringement. The Court of Appeal (Judges Floyd, Kitchin and Patten) largely affirmed. Company A appealed; Companies B/C cross-appealed. The Supreme Court (Judges Sumption, Reed, Briggs, Hodge and Mance) delivered the present judgment.
Legal Issues Presented
- Proper construction of Claim 3—does “neuropathic pain” mean all neuropathic pain or only peripheral neuropathic pain?
- Whether the patent’s disclosure was sufficiently “plausible” to support the asserted therapeutic effect (sufficiency).
- Whether Company A should have been allowed post-trial amendments narrowing Claim 3, and whether refusal was an abuse-of-process ruling.
- The correct test for infringement of a Swiss-form, purpose-limited process patent under section 60(1)(c) Patents Act 1977.
Arguments of the Parties
Appellant (Company A)
- Claim 3 should be read narrowly (limited to peripheral neuropathic pain).
- Plausibility threshold is low; animal-model data plus common general knowledge made efficacy for neuropathic pain plausible.
- Refusal to allow narrowing amendments unfairly punished legitimate post-judgment clarification.
- Infringement exists whenever it is foreseeable to the generic manufacturer that some product will be used for patented pain treatment.
Respondents (Companies B/C)
- “Neuropathic pain” in Claim 3 covers both peripheral and central forms.
- Specification lacks any basis making efficacy against neuropathic pain (particularly central) plausible—there is mere speculation: claim therefore insufficient.
- Post-trial amendment was abusive; issues should have been raised pre-trial.
- Infringement requires proof the manufacturer subjectively intended to target the patented use; that intention was absent.
Table of Precedents Cited
| Precedent | Rule or Principle Cited For | Application by the Court |
|---|---|---|
| Biogen v Medeva (House of Lords) | Concept of “Biogen insufficiency” – claim broader than contribution | Used as analogy for over-broad Swiss-form claims unsupported by disclosure |
| Conor v Angiotech (House of Lords) | Plausibility distinguishes invention from speculation | Cited when defining low plausibility threshold |
| EISAI/Second Medical Indication (G 05/83, EPO) | Legitimacy of Swiss-form claims | Background to allow second-medical-use patents |
| SALK Institute (T 609/02, EPO) | Requirement that patent disclose rationale making effect plausible | Majority relied on to demand concrete mechanism; minority thought threshold lower |
| ALLERGAN (T 1437/07, EPO) | Plausibility may exist absent experimental data unless convincing contrary evidence | Minority (Judges Briggs/Hodge) emphasised this lower bar |
| IPSEN (T 578/06, EPO) | Need for “substantiated doubts” before demanding data | Highlighted in critique of higher threshold |
| BRISTOL-MYERS SQUIBB (T 950/13, EPO) | Later data permissible to confirm prediction once plausible | Used to illustrate sufficiency can rest on modest initial disclosure |
| Exxon/Fuel Oils (T 409/91, EPO) | Patent monopoly must match technical contribution | General foundation for sufficiency analysis |
| Merrell Dow v Norton (House of Lords) | Strict liability for product infringement under s.60(1)(a) | Cited in comparing mental-element distinctions |
| Nikken v Pioneer (Court of Appeal) | Post-trial amendment principles and abuse of process | Applied to uphold refusal of late amendment |
Court's Reasoning and Analysis
Claim construction: A unanimous court agreed with the lower courts that a skilled reader would understand “neuropathic pain” in Claim 3 to cover both peripheral and central forms; none of the descriptive passages limited it to peripheral only.
Amendment & abuse: Citing the Nikken line of authority, a post-judgment bid to narrow Claim 3 was refused; it could have been pleaded earlier and would have necessitated a second trial.
Sufficiency / plausibility: The court divided. A majority (Judges Sumption, Reed & Briggs) held that the specification justified inflammatory-pain claims only; animal data plus common knowledge did not make efficacy against any neuropathic pain plausible. A minority (Judges Hodge & Mance) accepted the lower plausibility threshold from recent EPO case-law and would have upheld peripheral-neuropathic-pain sub-claims.
Infringement test: All judges rejected a mere foreseeability standard. The court split on the correct test if Claim 3 were valid. Three judges (Sumption, Reed, Mance) favoured an objective appearance test: infringement depends on how the product is presented (packaging, leaflet, dosage), intention being irrelevant. Two judges (Briggs, Hodge) preferred a subjective targeting test: liability requires proof the manufacturer positively intended to supply for the patented use.
Holding and Implications
Holding: The majority concluded that Claims 1 and 3 are INVALID FOR INSUFFICIENCY. Consequently, there is no infringement. The appeal by Company A is dismissed; the cross-appeal by Companies B/C succeeds.
Implications: The ruling narrows the scope of Swiss-form patents by reaffirming that a specification must furnish a scientifically grounded, plausible basis for each claimed therapeutic use. It also leaves unresolved—due to claim invalidity—the split between objective-presentation and subjective-intention tests for infringement; practitioners await future cases or legislation for clarification. No new precedent regarding valid claims was established, but the decision signals heightened scrutiny of wide second-use claims.
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