Key points
- In this opposition appeal, claim1 is a pure compound claim defined by a Markush formula. Claim 18 is a second medical use claim specifying a relatively long list of diseases. Claim 15 is a first medical use claim.
- " The appellant [opponent] argued in respect of [first medical use] claim 15 that the alleged biological effects had not been supported across the full range of compounds claimed, and that even for the tested compounds, the data of table 11 did not allow the skilled person to identify which compounds actually provided a suitable effect in the tests employed, i.e. whether a sufficient biological effect had been achieved."
- The Board: "The relevant biological activity ascribed to the claimed compounds in the patent is the treatment or prevention of diseases or conditions which [...] involve activity at the estrogen receptor. "
- "In table 1 of the patent (pages 24-115), 453 specific compounds, many of which fall within the scope of claim 1, are disclosed. In table 11 (page 211), biological data is provided for said compounds based on IC50 activity in an "MCF7 Viability Assay" (described in examples 84 and 85; paragraphs [0810] and [0811]) and an "ER-alpha In Cell Western Assay (ski)" (described in example 86; paragraph [0813]), both assays concerning breast cancer cell lines." (link)
- In the table, either A or B is shown for the IC50 value, and + or ++ for the max response (single value), it seems for all 453 compounds.
- "In the present case, biological activity data is presented for the large number of compounds exemplified. Even accepting that not all examples fall within the scope of the present claims, as argued by the appellant in opposition proceedings with reference to D2 [] the data presented for the claimed compounds is considered sufficient to support the therapeutic application for which they were tested.
- "As set out in T 609/02, absolute proof that a compound could be approved as a drug before it may be claimed as such (in a medical use claim) is not required. Rather, for demonstrating sufficient disclosure of a therapeutic application, the patent must provide some information in the form of, for example, experimental tests, to the avail that the claimed compound has a direct effect on a metabolic mechanism specifically involved in the disease, this mechanism being either known from the prior art or demonstrated in the patent per se. Showing a pharmaceutical effect in vitro may be sufficient if there is a clear and accepted established relationship between the shown physiological activities (in the present case, ER activity) and the disease (T 609/02, reasons, 9)."
- " Therefore, the data in table 11 of the patent sufficiently demonstrates the effect of the claimed compounds on the specific ER activity tested. Consequently, the appellant's argument that the effect would not be present for further compounds falling within the scope of the claims, but not tested, amounts to an unsubstantiated allegation, and therefore must fail. "
- " Consequently, the board found the invention defined in claim 15 to be sufficiently disclosed.'
- Turing to the second medical use claim:
- " Claim 18 is essentially directed to a compound (of any one of claims 1 to 10) for use in the treatment of a long list of specific conditions, including, inter alia, alcoholism, migraine, aortic aneurysm, susceptibility to myocardial infarction, aortic valve sclerosis, cardiovascular disease, coronary artery disease, hypertension, deep vein thrombosis, Graves' Disease, arthritis, multiple sclerosis, cirrhosis, hepatitis B, chronic liver disease, bone density, cholestasis, hypospadias, obesity, osteoarthritis, osteopenia, osteoporosis, Alzheimer's disease, Parkinson's disease, migraine, vertigo, anorexia nervosa, attention deficit hyperactivity disorder (ADHD), dementia, major depressive disorder and psychosis."
- " In T 2059/13, cited by the [opponent] it was accepted that the compound in question (aripiprazole) successfully bound to the 5-HT1A receptor. However, there was no evidence in the patent nor in the cited prior art of any link between said receptor and bipolar disorder, the subject-matter of the second medical use claim (reasons, 4.4.4 and 4.4.5). Consequently, sufficiency of disclosure was denied. ... The situation in the present case in relation to many of the conditions listed in claim 18 is similar."
- " With regard to a direct link between ER activity and the conditions other than estrogen-dependent cancer listed in claim 18, apart from mere verbal statements (e.g. paragraphs [0006] and [0061]), the patent is silent - both in terms of biological data demonstrating said link, and any reference to common general knowledge linking ER activity to the specific conditions listed. The situation in the contested patent is therefore similar to that underlying case T 2059/13, addressed above, in that the patent does not demonstrate the suitability of the claimed compounds for the treatment of claimed conditions other than estrogen-dependent cancer."
- It follows that with regard to the second medical use directed to therapeutic applications other than estrogen-dependent cancer, the invention defined in claim 18 is insufficiently disclosed.
- In an auxiliary request, claim 18 is deleted. The Board turns to inventive step.
- " The objective technical problem underlying contested claims 1-14 is therefore the provision of further compounds (and corresponding compositions) with ER activity."
- " the claimed compounds represent non-obvious alternatives to those disclosed in D4 as set out above."
- As a comment, the present decision also illustrates the basic rule that finding one new compound with one inventive use provides for the inventive step of the product claim, thereby giving protection for all uses of the compound. The same principle applies for sufficiency of disclosure. Also the non-enabled diseases, for which the 2nd medical use claim is invalid, fall under the product claim (and the first medical use claim, for that matter).
EPO T 2627/17
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2022/05/t-262717-sufficiency-of-disclosure-of.html
