Intention, off-label prescriptions and new use patents after Warner-Lambert

1. Intention, off-label prescriptions and new use patents after Warner-Lambert Kathryn Pickard Barrister 11 South Square

2. Second medical use claims Swiss-form claims: “Use of X for the preparation of a pharmaceutical for treating Y” EPC 2000 claims: “Product X for the treatment of Y”

3. Manufacturer Manufacturer Distributor Distributor Pharmacist Prescription Clinician Patient Generic skinny-label product Branded full-label product

4. The problem “The choice lies between defining infringement so widely that manufacturers will be dissuaded from producing generic drugs even to fulfil the original (no longer patented) use, and defining it so narrowly that patentees are inadequately protected from the invasion of their newly patented second use by generic manufacturers” Per Lord Briggs, §123

5. Competing policy considerations • Provide reasonable protection to the second medical use patentee to reward and incentivise research • Allow the public the benefit of the product for its original therapeutic use once the patent covering that original use has expired • Provide reasonable legal certainty for those engaged in the manufacture, marketing and prescribing of generic drug for the non-patented use that their conduct is lawful • Protect the autonomy of clinical judgments

6. Legal Context A person infringes a patent for an invention if, without the consent of the proprietor, he: where the invention is a product, makes, disposes of, offers to dispose of, uses, or imports the product or keeps it for those purposes (s.60(1)(a)) where the invention is a process, disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise (s.60(1)(c))

7. Statutory provision = strict liability Product claims – s.60(1)(a) - makes - disposes of -offers to dispose of - uses - imports - keeps Process claims – s.60(1)(c) - disposes of - offers to dispose of - uses - imports - keeps Claim construction = possibility of mental element Swiss-form claim “Use of X for the preparation of a pharmaceutical for treating Y” EPC 2000 claim “Product X for the treatment of Y”

8. What does ‘for’ mean? • “intended for” i.e. subjective intention • “where it is known or reasonably foreseeable that some of the medicine will be used for” i.e. reasonable foreseeability • “…some of the medicine will be intentionally used for” • “…where the manufacturer has not taken all reasonable steps to prevent use for the patented treatment occurring” • “where from its outward appearance it can objectively be said to be for” i.e. outward appearance – no mens rea at all

9. Reasonable foreseeability “The foreseeability test has the merit of being objective, but there is in my view little else to commend it” Per Lord Sumption, §79 • All product infringes • Flexible remedy regime? • Possibility of negating if all reasonable steps taken to prevent use for patented indication?

10. Subjective intention “It seems unsatisfactory that patent infringement should depend on investigation of a subjective intention, internal to the manufacturer” Per Lord Mance, §204 • Is manufacturer targeting the market for patented or non-patented use? • Reflects purpose of Swiss-form claim • Balances rights of patentee against those of generic manufacturer • Commercial certainty for third parties? • Evidential problems?

11. Outward appearance “…the intention of the manufacturer…is irrelevant to the question of infringement…in a purpose-limited process claim, the badge of purpose is the physical characteristics of the product as it emerges from the relevant process” Per Lord Sumption, §§83-84 • Objective test • Commercial certainty to manufacturer and third parties dealing in product • Sufficient protection for patentee? Charade?

12. Further issues • How should outward appearance test be applied? • What, if anything, must manufacturer do to make clear that permitted use is limited? • In what, if any, circumstances is it legitimate to look at factors external to the product? • What should the test for EPC 2000 claims be?