Teva vs. Leo Pharma. Oliver Rutt RSC Law Group IP Case Law Seminar 18 November 2015

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1 Oliver Rutt RSC Law Group IP Case Law Seminar 18 November 2015

2 Points Of Interest Pharmaceutical patents directed to incremental inventions Provides guidance regarding g obvious to try doctrine Appeal recognises importance of reality when assessing obviousness

3 Background Leo s product: Dovobet Ointment t to alleviate symptoms of psoriasis Leo s patents: EP and EP (divisional) Teva applied for revocation on the basis of: Lack of inventive step Insufficiency Added matter

4 Background (Continued) An ointment t for treating ti psoriasis i comprising: i Active Component A: a vitamin D analogue (e.g. calcipotriol) Active Component B: a corticosteroid (e.g. betamethasone) Solvent Component C: H(OCH 2 C(R 1 )H) x OR 2 (II)* (e.g. polyoxypropylene-15- stearyl ether aka Arlamol E ) (*x = 2-60, R 1 = CH 3, R 2 = straight chain or branched C 1-20 alkyl or benzoyl )

5 1st Instance* Inventive Step Teva: Known to treat psoriasis using a combination of A + B. Would clearly be beneficial to provide both compounds in a single formulation. Obvious that could stabilise such a combination by use of polyoxypropylene-15-stearyl ether (Arlamol E) in view of US 4,083,974 (Turi). *Teva UK Limited & Teva Pharmaceuticals Limited v Leo Pharma A/S & Leo Laboratories Limited [2014 EWHC 3096 (pat)]

6 1st Instance (continued) Who is the skilled person? A team consisting of: A skilled clinician A skilled formulator

7 1st Instance (continued) Skilled Clinician Skilled formulator put off by ph problem? No Not concerned with formulation Not generally aware of ph problem Significant that no publication suggesting need for dual active product? No Calciptriol patented

8 1st Instance (continued) Skilled Clinician (cont.) Interesting points: Something can be common general knowledge and not be written down. Common general knowledge = known to all, not just to some. Pre-existing patents are a concern to the skilled person.

9 1st Instance (continued) Skilled Formulator Would it be obvious for the skilled formulator to try the solvent disclosed in Turi? Leo: Solvent not regularly used in pharmaceutical ointments Solvent not regularly used in pharmaceutical ointments Added uncertainty and cost (e.g. additional regulatory trials)

10 1st Instance (continued) Skilled Formulator (cont.) The notional skilled formulator would test some familiar compounds but would not be put off from including unfamiliar compounds merely because of their unfamiliarity [t]he fact that unlike many other possible solvents, this compound did not have a well-established track record in pharmaceutical formulation, would not be sufficient to put the formulator off including it in the test.

11 1st Instance (continued) Skilled Formulator (cont.) In my judgement commercial considerations, such as the uncertainties surrounding the regulatory process relating to an invention in the pharmaceutical field, are capable of playing a role in the thinking of the notional skilled person as a matter of principle. However, first, like any other factor their significance will vary from case to case; and second, given that t they are commercial rather than directly technical in nature, these factors are unlikely to outweigh technical considerations in any but the strongest cases.

12 Appeal* Birse J: It is wrong to ask whether something might achieve a particular desired effect. It is correct to ask whether it was obvious that it would achieve that effect. Court of Appeal: Birse J had erred in principle! *Teva UK Ltd & Another v Leo Pharma A/S [2015] EWCA Civ 779

13 Appeal (continued) Failure to attribute the necessary standard of expectation when applying the obvious to try test. Failure to impute to the notional skilled addressee the real prejudices and practices of persons skilled in the art. Failure to consider the long-felt want in the art for a dual active product.

14 Appeal (continued) "[t]he skilled formulator would carry out compatibility tests on a number of possible solvents. The number would be about 10 to 20" (paragraph 72), "[t]he notional skilled formulator would test some familiar compounds but. would not be put off from including unfamiliar compounds merely because of their unfamiliarity" (paragraph 79), and the disclosure of Turi "would be sufficient grounds to include g [Arlamol E] in pre-formulation tests. Based on what the skilled formulator knew about it at the time there was a sufficient prospect of a positive result in the tests with [Arlamol E] to make it worth testing. It was obvious to do so" (paragraph 92).

15 Appeal (continued) Court of fappeal: The inclusion of a specific solvent in a list of solvents to be tried is not sufficient i to render the claimed invention (which h covered only that one solvent) obvious. In order to render the invention invalid, Arlamol E itself has to be obvious to try and the prospect of success has to raise it over and above other candidates. well worth investigating a fair expectation of success

16 Appeal (continued) St-Gobain v Fusion Provida: Mere possible inclusion i of something within a research programme on the basis you will find out more and something might turn up is not enough. If it were otherwise there would be few inventions which were patentable. The only research which would be worthwhile (because of the prospect of protection) would be in areas totally devoid of prospect.

17 Appeal (continued) Significance of the evidence (Not all non-aqueous solvents actually work!) "It was that to the skilled person, identifying a non-aqueous solvent which would actually work to produce a stable ointment, was not easy. Having the property of fbeing non-aqueous was a necessary, but well short of sufficient, i condition. Finding one was a research project. And that was because there was no sufficient expectation of success. Yes, a particular candidate might work, but it was far from certain that it would. Indeed the formulator experts agreed that one would test a number of solvents. The Judge found about again by implication it is clear that the expectation of success with any one of them was not high. The Judge said such testing was entirely routine but that does not alter the expectation. It was not even proved that there was a good expectation that if you did try 20 one of them would work."

18 Appeal (continued) Arlamol E not an outstanding candidate in view of Turi Arlamol E not significantly used for topical pharmaceuticals. Turi not concerned with compositions containing two active components.

19 Appeal (continued) Long-felt want Desire for a dual active product since at least 1995 (earlier than the 1999 priority date) No satisfactory explanation of why that solution was not achieved previously

20 Applying Pozzoli 1. (a) Identify the notional "person skilled in the art", (b) Identify the relevant common general knowledge of that person; 2. Identify the inventive concept of the claim in question or if that cannot readily be done, construe it; 3. Identify what, if any, differences exist between the matter cited as forming gpart of the "state of the art" and the inventive concept of the claim or the claim as construed; 4. Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?

21 Applying Pozzoli (continued) "Putting this point into a Pozzoli structured analysis, the difference between the prior art (Turi) and the invention was that Turi was a mono active product using Arlamol E. The invention is a double active product. Turi would be seen as using one of a large number of possible non-aqueous solvents. It might provide stability for the two actives, just as any of the others might. But there was no reasonably optimistic expectation that it would. Finding that it really did was an invention and an advance in human knowledge".

22 Applying Problem-And-Solution Approach "In [Turi] the problem was neither mentioned nor even suggested and considering [Turi] as the closest prior art is merely the result of an ex-post facto analysis. "

23 Conclusions Court of Appeal recognises the importance of reality when assessing the validity of an invention For an invention to be obvious, it must be obvious to try what is claimed with a reasonable prospect of success

24 Thank you