Moving Targets. Liversidge v- Abbott Laboratories in the Patents County Court. Stuart Jackson Partner

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1 Moving Targets Liversidge v- Abbott Laboratories in the Patents County Court Stuart Jackson Partner Kempner & Partners Devonshire Hall, Devonshire Avenue, Leeds, LS8 1AW Tel : +44 (0) Fax : +44 (0) jackson@kempnerandpartners.com 1

2 Barry Liversidge V Owen Mumford Limited & Abbott Laboratories Limited [2012] EWPCC 33 His Honour Judge Birss QC 2

3 Three interesting issues: Which Court? Infringement of patent Validity of patent 3

4 Which Court? On the day of grant of the Patent two actions commenced: infringement action by Liversidge in Patents County Court, and revocation action by Abbott in Patents Court. 4

5 Liversidge argued: Limited financial resources, Uncapped costs recovery in High Court, No compolex technical or legal issues. 5

6 Abbott argued: Important to Abbott s global sales, Annual sales of Humira worldwide exceed $6billion, Injunction would necessitate inconvenient change for existing patients, and New delivery system would take several years to obtain regulatory appoval 6

7 Compromise agreed: No injunction, Damages to be calculated on basis of notional royalty in respect of device, but not the drug it contained, Permission to apply for injunction if Defendants failed to pay, Action to be heard in Patents County Court 7

8 Infringement The Humira Pen is an auto-injector comprising: a spring-loaded firing mechanism; a plunger to push the down the piston in; a syringe containing Humira; the syringe contained in a sleeve. 8

9 Infringement To ensure needle penetrates before Humira is expelled from syringe: the plunger has elbows to contact the top of the syringe barrel, and; move the whole syringe, without depressing the piston; until syringe reaches end of sleeve; when piston is depressed in barrel. 9

10 Infringement The Patent claims a syringe: within a sleeve; and a plunger with protuberances to contact the top of the syringe barrel, so that; the syringe barrel moves forward; until syringe reaches end of sleeve; when increased pressure depresses the piston. 10

11 Did the Humira Pen Infringe? Abbott s patents and applications for it say it works the same as the Patent; The designer, a named inventor of Abbott s PCT application, said that it did; The intention was that the Humira Pen should work precisely as described in the Patent. 11

12 But.. Abbott conducted an experiment using high speed photography, which showed that it is stiction that makes it work, not protuberances! 12

13 If it was intended to work like the Patent, designed to do so, and everyone always thought it did, including even the inventor, is that infringement? 13

14 NO! said HH Judge Birss QC, I find as a fact that the way the Pen works is by relying on stiction between the piston and the syringe. To move the syrings, the plunger has to push the piston. Therefore held no infringement. 14

15 Validity Initial PCT application was filed in 2003 as an invention for a safety arrangement for a medical needle or injector. The Patent arose from a divisional application filed in This was 3 years after the launch of the Humira Pen. 15

16 Validity There had been a change of focus since the original application. Original was for a safety device for manual syringe and prevention of needle-stick injuries generally by means of a blocking member; The plunger with protuberances is disclosed, but is only incidental to the invention (and is only in one of many embodiments.) 16

17 The divisional: Validity relegates safety devices to an optional extra: it does not focus on them at all, but is a clear, focussed teaching about protuberances as a solution to sequencing. 17

18 Validity New text was inserted into the description to explain the problem of sequencing, and the use of protuberances to solve that problem. This was a new problem relevant only to autoinjectors. Clearly added matter, so invalid. 18

19 Validity HH Judge Birss QC also held: Lack of novelty, and Lack of inventive step. 19

20 Was Abbott lucky to find that their device did not work as they thought or had intended? or, Was Liversidge hoping to be lucky by spoting that his old patent aplication could be stretched to cover someone else s commercially successful device? 20