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Such drugs were thus viewed by the scientific community at the filing date of the patent in suit as a cause of and not a treatment for impotence and, although the degree of sexual dysfunction considered to be caused by these drugs was varied, no one group of antihypertensive drugs was exempt from this prejudice. The nih consensus conference also considered the known injectable agents papaverine, phentolamine and prostaglandin e1 (see document (d133a), page 190, under the heading intracavernosal injection therapy). Document (d48) describes briefly the isoforms of the cgmp-specific pde isoenzyme (pde v).

In vitro test methods for determining the cgmp pde and camp pde inhibitory activities of compounds are referred to in the patent in suit. Since in the present case the claimed subject-matter merely follows plainly and logically from the prior art, secondary indicia cannot assist in the assessment of inventive step. Generally speaking, prejudice cannot be demonstrated by a statement in a single patent specification, since the technical information in a patent specification or scientific article might be based on special premises or on the personal view of the author.

The board therefore cannot agree with the appellants argument that oral administration would have been inevitably necessary in solving the technical problem underlying the application. What the documents referred to in the previous two paragraphs show is that one view held in 1979 differed from a later view which had appeared by 1987 and was still current in 19, the priority date of the patent in suit being that summary is sufficient to show that document (2) is no basis for the alleged prejudice. Contrary to that generally-held view, the patent had shown that pde v inhibitors - a class of drugs that lower blood pressure - could be used effectively and orally for the treatment of male erectile dysfunction thereby clashing with the prevailing teachings in the field and overcoming a technical prejudice.

Moreover, document (d48) in figure 2 (page 153) exemplifies some pde va inhibitors which are not selective, such as papaverine (also see table iv of document (d48)). Finally the appellants relied on the recognition (by awards and favourable comment) and the commercial success of viagra, which is the brand name given by the appellants to the citrate salt of sildenafil, the product to which the patent relates. A prudent patentee will also provide parallel information relating to advertising and similar expenditure to anticipate the argument that such activities could explain the growth in sales.

However, this principle does not apply to explanations in a standard work or textbook representing common expert knowledge in the field concerned (t 1981 (oj 1982, 51), t 10483, t 32187, t 39288, t 60188, t 51989, t 45392, t 90095). Thus the appellants themselves ascribe that prize to no fewer than four reasons - research and development effort, corporate teamwork, the first oral therapy for erectile dysfunction, and making advice on that condition easier to obtain. Currently a fifth of prescriptions for the drug are issued privately because the nhs has put strict limits on its use at the taxpayers expense.

Commercial success and similar arguments can only ever be secondary indicia of inventiveness, which are usually only of importance in cases where an objective evaluation of the prior art has not provided a clear answer. Only some comparison can make such evidence meaningful and the comparison must be such as to show at least a prima facie case of success - such as a comparison between sales of prior art products and patented products, or between the patentees sales before and after manufacture in accordance with the invention. Viagra was pfizers sixth best selling drug last year, generating 2. Document (d29) has to be seen as relating generally to treatments of diseases involving inter alia potentiation of the effects of endothelium derived relaxing factor (edrf) (see paragraph 4. The appellants contended therefore that a skilled person would beyond doubt have held such a prejudice and would have generally viewed all antihypertensives as a group of drugs that might cause sexual dysfunction.


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Zeydan Abu Issa Pfizer Viagra Discount Mr emms told the times the brand is very well established and well known among patients. Treatment of impotence has also been suggested for pde va inhibitors. While, as mentioned below, there is no real comparative data, He would note it is mentioned (on page 154. With respect to inventive step, Also contrary to the respondents view, the board sees clear support for oral administration of the compounds of formula (i) in a male animal in claim 1 of auxiliary request 3 in the passage on page 2, line 30 to page 4, line 24 of the originally filed description furthermore the compounds may be administered orally, thereby obviating the disadvantages associated with i.
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    The respondents did not accept that there was any technical prejudice against the oral treatment of impotence with pde v inhibitors. This selective enzyme inhibition leads to elevated cgmp levels which, in turn, provides the basis for the utilities already disclosed for the said compounds in ep-a-0463756 and ep-a-0526004, namely. The appellants argued (with reference in particular to the documents they filed in the appeal proceedings - see paragraph iii above) that the skilled person would have been prejudiced against the use of antihypertensive agents such as those disclosed in document (d29) for the treatment of impotence, since such agents (including vasodilatorssmooth muscle relaxants) had repeatedly been reported to lead to male erectile dysfunction as a side effect. Although the novelty of claim 1 of the auxiliary request was not challenged by any of the opponents, the claim was novel over documents (d29) and (d41) on account of the therapeutic use claimed for the compounds of formula (1), that is, the curative or prophylactic oral treatment of erectile dysfunction in a male animal. The antihypertensive agents referred to in documents (d20), (d90), (d100) and (1) to (21) can be classified into seven groups - diuretics such as thiazides, (chlorothiazide, hydrochlorothiazide), bendrofluazide, furosemide, ethacrynic acid, triamterene, spironolactone and chlorthalidone - sympatholytic agents (peripherally or centrally acting) such as guanethidine, bethanidine, clonidine, methyldopa, reserpine, guanabenz, guanoclor, guanfacin, guanadrel, guanoxan, guanoclor and debrisoquine - alpha-adrenergic blocking agents (alpha blockers) such as phenoxybenzamine, phentolamine, prazosin, terazosin and indoramin - beta-adrenergic blocking agents (beta blockers), such as propranolol, metoprolol, oxprenolol, pindolol, atenolol, labetalol, timolol and nadolol - angiotensin-converting enzyme (ace) inhibitors such as captopril, enalapril and lisinopril - calcium channel blockers such as verapramil, diltiazem, nifedipin, nicardipine and nefedipene.

    Spectrum therapy markets and emerging technologies, , w. Third, they argued that the coverage of viagra, as it approached approval in the usa in spring 1998 and since, in the general, popular science and pharmaceutical business press, as exemplified by the published articles contained in document (d101), a demonstrated the widespread notoriety it had acquired. The skilled person would have made it a priority, in the search for a new treatment for male erectile dysfunction, to develop an orally active drug. The determination of the closest prior art is therefore an objective and not a subjective exercise. Currently a fifth of prescriptions for the drug are issued privately because the nhs has put strict limits on its use at the taxpayers expense.

    However, this principle does not apply to explanations in a standard work or textbook representing common expert knowledge in the field concerned (t 1981 (oj 1982, 51), t 10483, t 32187, t 39288, t 60188, t 51989, t 45392, t 90095). Thus, while they clearly acknowledge the commercial success of viagra, the introductory paragraphs of this document also tells the reader that success is at least partly due to media hype, to an association with sex, and to the drawbacks of prior art products. Since its launch in the united states in march it has become the fastest selling drug ever. Accordingly, there is no unallowable selection of compounds of formula (i) which show a specific efficacy when administrated orally. The second auxiliary request is identical to the main request save that claim 8 reads 8. In this respect they relied on several categories of evidence. In terms of sales and market share viagra, first authorised in the usa on , had worldwide sales of 788 million in 1988 and 1. The prejudice must have existed at the priority date, any prejudice which might have developed later is of no concern in the judgment of inventive step (t 34194, t 53195 and t 45296). Claim 8 of auxiliary request 1 differs from that of the main request only in that the use concerns selective cgmp-specific pde v inhibitors in lieu of pde v inhibitors. However, since the parties arguments in this area were developed at some length, particularly during the oral proceedings, the board considers it appropriate to make certain observations.

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