T 1777/12 - Suffiency for all the diseases

Key points

• The Board accepts sufficiency of disclosure of claim 1 for a compound for use in the treatment of a metabolic disorder selected from the group consisting of "obesity, diabetes mellitus, insulin resistance, insulin resistance syndrome (also known as Syndrome X), dyslipidemia, and cardiovascular disease".
• " It was common ground between the parties that the patent disclosed that [the compund] achieved a reduction of weight or weight gain in obese mice when administered at certain concentrations". However, " Obesity is only one of several therapeutic applications claimed []. The question is thus whether or not the patent discloses further evidence that [the compound] is a suitable therapeutic agent for all of them."
• The board finds it does. " Slowing weight gain down in obese or overweight patients - compared to such patients untreated for obesity - is already in itself a beneficial therapeutic effect in the therapy of obesity, and [] reduces the risk of these patients developing any of the obesity-associated disorders referred to in claims 1 and 10. Moreover, slower weight gain might also postpone the need to administer further disease-specific therapeutic agents, such as insulin in case of diabetes mellitus." " Accordingly, the board concludes that the disclosure in the patent demonstrates the suitability of [the compound] for achieving a beneficial effect in all of the claimed therapeutic applications by reducing weight or weight gain." 

EPO T 1777/12 -  link

Summary of Facts and Submissions

V. With its reply to the appellant's statements of grounds of appeal the patent proprietor (hereinafter the "respondent") submitted a main request - identical to auxiliary request 1aa underlying the impugned decision - and eleven auxiliary requests.

Claims 1, 4, 8, and 10 of the main request read:

"1. Use of a PYY agonist in the manufacture of a medicament for treating a metabolic disorder in an obese or overweight subject in need of said treating, wherein said treating comprises reducing weight or reducing weight gain, wherein the PYY agonist is to be administered peripherally to said subject in an amount therapeutically effective to reduce weight or reduce weight gain, wherein the PYY agonist is the peptide PYY[3-36] and wherein the metabolic disorder is selected from the group consisting of: obesity, diabetes mellitus, insulin resistance, insulin resistance syndrome (also known as Syndrome X), dyslipidemia, and cardiovascular disease.

Reasons for the Decision

[] Sufficiency of disclosure (Article 83 EPC)

6. Claims 1 and 10 are medical use claims. It is the established case law of the boards of appeal that for such claims to fulfil the requirements of Article 83 EPC the patent has to disclose the product's suitability to be manufactured for the therapeutic applications claimed. Clinical trials are not required to establish suitability. It may suffice that in vitro or in vivo data directly and unambiguously reflect the therapeutic effect on which the claimed therapeutic application relies or, alternatively, that there is an established relationship between the physiological activities of the compound under consideration and the disease in question (see Case Law of the Boards of Appeal, 8th edition 2016 (hereinafter "CLBA"), section II.C.6.2).

7. In the present case, the therapeutic applications according to claims 1 and 10 are metabolic disorders in obese or overweight subjects selected from the group consisting of obesity, diabetes mellitus, insulin resistance, insulin resistance syndrome, dyslipidemia, and cardiovascular disease. According to these claims, the mechanism of action underlying the therapeutic effect of PYY[3-36] is the reduction of weight or weight gain.

8. It was common ground between the parties that the patent disclosed that PYY[3-36] achieved a reduction of weight or weight gain in obese mice when administered at certain concentrations, i.e. at 300 and 1000 myg/kg/day, over a certain time period (see example 6). Therefore, the experimental evidence disclosed in the patent establishes the suitability of PYY[3-36] in the therapy of obesity in obese or overweight subjects.

9. Obesity is only one of several therapeutic applications claimed (see point 7 above). The question is thus whether or not the patent discloses further evidence that PYY[3-36] is a suitable therapeutic agent for all of them.

10. The patent discloses that "Obesity and its associated disorders are common and very serious public health problems in the United States and throughout the world. Upper body obesity is the strongest risk factor known for type 2 diabetes mellitus, and is a strong risk factor for cardiovascular disease [...] insulin resistance [...], insulin resistance syndrome, or Syndrome X" (see paragraph [0010], emphasis added).

11. Accordingly, the patent reports that obesity and therefore also overweight are established risk factors in all of the disorders according to claims 1 and 10, i.e. the probability of developing these disorders is higher in obese and overweight subjects than in subjects with normal body weight. In other words, all the diseases referred to in claims 1 and 10 are associated with obesity or overweight. Therefore, the board considers that agents which have a beneficial effect in obesity therapy by reducing weight or weight gain concomitantly have a beneficially effect for all obesity- or overweight-associated disorders, since the risk of developing these disorders is likewise reduced. As a result of the therapy, patients may either not develop the disorders or their onset may be postponed. Alternatively, the disorders may be less severe than in non-treated obese or overweight subjects.

12. The appellant argued that the etiology underlying the claimed obesity-associated therapeutic applications was complex and not solely caused by overweight. However, as set out in point 11 above, obesity or overweight are established risk factors in these disorders, thereby contributing to the etiology of all of them. Also, obese or overweight patients affected by any of these disorders benefit from a weight or weight gain reducing effect mediated by PYY[3-36], even if obesity is not their sole disease-causing factor. Therefore, the reduction of weight or weight gain in obese mice mediated by PYY[3-36], as disclosed in example 6 of the patent, is a beneficial effect which can in fact be relied on for the therapeutic applications claimed (see e.g. decision T 1642/06, point 2.2 of the Reasons).

13. The appellant further submitted that the use of PYY[3-36] in reducing weight gain in obese or overweight patients in the claimed therapeutic applications was an embodiment of claims 1 and 10. However, the slowing down in weight gain did not have a beneficial effect in all the claimed therapeutic applications, since despite the therapy the patients continued to gain weight, albeit at a slower rate than previously.

14. The board does not agree. Slowing weight gain down in obese or overweight patients - compared to such patients untreated for obesity - is already in itself a beneficial therapeutic effect in the therapy of obesity, and in addition for the reasons set out above (see point 11), reduces the risk of these patients developing any of the obesity-associated disorders referred to in claims 1 and 10. Moreover, slower weight gain might also postpone the need to administer further disease-specific therapeutic agents, such as insulin in case of diabetes mellitus.

15. Accordingly, the board concludes that the disclosure in the patent demonstrates the suitability of PYY[3-36] for achieving a beneficial effect in all of the claimed therapeutic applications by reducing weight or weight gain.

16. In a second line of argument relating to insufficiency of disclosure, the appellant submitted that the subject-matter of claims 1 and 10 encompassed non-working embodiments since the feature "the PYY agonist is to be administered peripherally to said subject in an amount therapeutically effective to reduce weight or reduce weight gain" was not defined by a specific dose of PYY[3-36], although the patent reported in example 6 that the minimum effective therapeutic dose of PYY[3-36] was 300 myg/kg/day. The same objection applied to embodiments falling within the range of "about 1 µg to about 5 mg" referred to in claim 4 and to the therapy of human patients according to claim 8, for whom even the administration of 300 myg/kg/day PYY[3-36] was "likely too low".

17. However, claims 1 and 10 explicitly require that the PYY[3-36] used is parenterally administered in an "amount therapeutically effective to reduce weight or weight gain". Thus, any amount of PYY[3-36] not fulfilling this functional requirement is excluded from the claims.

18. Furthermore, the patent informs the skilled person that effective doses of PYY[3-36] are, for example, "about 1 µg to about 5 mg per day in single or divided doses or at about 0.01 µg/kg to about 500 µg/kg per dose, more preferably about 0.05 µg/kg to about 250 µg/kg, most preferably below about 50 µg/kg" (see paragraph [0024], or the similar disclosure in paragraph [0043]). Paragraph [0043] further discloses that "The exact dose to be administered is readily determined by one of skill in the art and is dependent upon the potency of the particular compound, as well as upon the age, weight and condition of the individual."

19. The skilled person would derive from the passages of the patent indicated in point 18 above that effective doses of PYY[3-36] are available but that the exact dose has to be determined individually, depending inter alia on the age, weight and condition of the patient. Therefore, although example 6 of the patent reports a minimum effective dose of 300 myg/kg/day of PYY[3-36] to reduce weight or weight gain in obese mice, it is evident to the skilled person that this is not the minimum effective dose of PYY[3-36] in the therapy of all obese or overweight patients falling within the ambit of claims 1 and 10.

20. With regard to claim 4, the board notes that some doses of PYY[3-36] in the range of "about 1 µg to about 5 mg" may indeed encompass non-working embodiments when administered to obese mice, in view of example 6 of the patent. However, the appellant has submitted no evidence that doses of PYY[3-36] below 300 myg/kg/day fail to reduce weight or weight gain in patients other than obese mice falling within the subject-matter of claim 4. The same applies to the alleged failed efficacy of 300 myg/kg/day of PYY[3-36] in the therapy of human patients according to claim 8. In contrast, in the paragraphs indicated in point 18 above the patent discloses sufficient information on the relevant criteria to identify appropriate alternative dosages of PYY[3-36] without undue burden.

21. Therefore, in view of the considerations in points 17 to 20 above, the board concludes that the subject-matter of claims 1, 8 and 10 does not encompass non-working embodiments, and the fact that claim 4 may embrace some non-working embodiments is not detrimental to sufficiency of disclosure (see e.g. decision T 238/88, OJ EPO 1992, 709, point 4.1 of the Reasons).

22. Lastly, the appellant argued that the protection conferred by the claims of the patent as granted was not commensurate with the patent's actual contribution to the art and that the patent therefore did not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (decision T 1063/06, published in OJ 2009, 516).

23. The board notes that the legal principle of fair patent protection cited by the appellant is not applied per se for assessing whether or not the requirements of Article 83 EPC are fulfilled. Rather such protection is achieved by a proper application of all of the requirements of the EPC. Moreover, since the board has concluded above that the patent demonstrates that PYY[3-36] is suitable for use in the therapeutic applications referred to in claims 1 and 10 (see point 15 above) and that the subject-matter of claims 1, 4, 8 and 10 does not contain non-working embodiments, at least not to an extent detrimental to compliance with Article 83 EPC (see point 21 above), this argument too must fail.

24. Accordingly, the board concludes - from the evidence on file - that the the main request meets the requirements of Article 83 EPC.