JUSTIN TURNER QC The Defendant whether acting by

JUSTIN TURNER QC

The Defendant (whether acting by its directors, officers servants or agents or otherwise howsoever) be restrained from infringing European Patent (UK) XXXX.

The Defendant (whether acting by its directors, officers servants or agents or otherwise howsoever) be restrained until judgement in the trial of this action or further order from selling or offering for sale product X in the United Kingdom.

Use of [pregrabalin] or a pharmaceutically acceptable salt therefore for the preparation of a pharmaceutical composition for treating [nueropathic] pain.

Pregrabalin or a pharmaceutically acceptable salt thereof for treating neuropathic pain.

§ A generic supplier should not profit at the patentee's expense by the supply of drug for the patented second medical use. § A generic supplier is entitled to supply for a non-patented use. § Insofar as there is inadvertent cross-supply of generic product there is no reason why the patentee should not be compensated for this. § Pharmacists should not be punished for unknowingly supplying generic product for the patented use.

Section 60. - (1)(a) … a person infringes a patent for an invention if. . . 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-… (c) where the invention is a process, he 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.

Section 60. -(2)… a person also infringes a patent for an invention if… he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting and are intended to put, the invention into effect in the United Kingdom.

“The issue which this aspect of the case raises is, and remains, one of great difficulty. The law is struggling on the one hand to give the patentee a proper reward for his contribution to the art by elucidating the new use for the drug, whilst at the same time not excluding the competing manufacturer from making and marketing the drug for its known purpose. ”

“I think the debate in this case has been distorted by reference to notions of subjective intention. I have no doubt that an objective approach is necessary. From an objective standpoint one would normally regard a person to intend what he knows or can reasonably foresee as the consequences of his actions. ”

“If that is the basic test to be adopted, what is sufficient to negative the existence of intention? In my judgement the absence of the patented indication from the label cannot conceivably be sufficient to negative the intention. ”

“Viewed in this way I think the answer becomes clear. The intention will be negatived where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring. ”

"The process of preparing the composition can continue through to the packaging step performed by the manufacturer and includes the labelling step performed by the pharmacists"

The Defendant (whether acting by its directors, officers, servants or agents or otherwise howsoever) be restrained from selling X in circumstances where it is foreseeable to the Defendant that it is to be used for treating Y.

Section 60. - (1)(a) … a person infringes a patent for an invention if. . . 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-… (c) where the invention is a process, he 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.

Section 60. -(2)… a person also infringes a patent for an invention if… he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting and are intended to put, the invention into effect in the United Kingdom.