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Tuesday, 21 October 2014

Obviousness, common general knowledge and expectations of success: Leo gets a mauling

Obviousness and common general knowledge are features of patent law that are of very limited application, if any at all, in most other areas of intellectual property.  For this reason it all too often happens that Katposts on these issues are skipped by readers who consider patent law too hard, abstruse or arcane to deserve their attention.  The decision of Mr Justice Birss in the case reviewed below is however so interesting that this Kat hopes that some of the good folk who habitually skip the patent stuff will give it a read. The author is occasional and much-appreciated guest contributor Suleman Ali (Holly IP), who writes as follows:
Teva UK Limited & Teva Pharmaceuticals Limited v Leo Pharma A/S & Leo Laboratories Limited [2014] EWHC 3096 (Pat) is a decision by Mr Justice Birss in the Patents Court, England and Wales. This case is about treatment of psoriasis with a combination medicinal formulation comprising two substances known to treat psoriasis (a corticosteroid and a vitamin D analogue) and a particular solvent that is able to stabilise the combination formulation. The invention lies in the putting together of the two therapeutic substances in the same formulation and the choice of the solvent. The decision mostly concerns whether this was inventive. Since the invention could be seen as an ‘incremental’ one which concerns optimising use of known drugs, rather than the discovery of new drugs, this decision provides insights as to how such incremental inventions will fare for inventive step in the Courts of England and Wales. More broadly the decision adds to the case law of how inventive step is assessed in a complex pharmaceutical setting. 
Other recent pharmaceutical cases concerning inventive step 
There have been several cases in recent times where inventive step been determined in the context of a pharmaceutical invention. In Novartis AG v Generics (UK) Limited (t/a Mylan) [2012] EWCA Civ1623, discussed by the IPKat (see here) the Court of Appeal had to review the decision of Floyd  J (here) in assessing inventive step where the compound went through several steps during research and development. Whether or not the compound would have passed each test would have been difficult to predict, and yet the compound was found to be obvious. 
In Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat), noted by the IPKat here, Birss J had to deal with inventive step of an ‘incremental’ invention, and he found the inventive concept, which related to a dosage regimen, to be obvious. 
In Glenmark Generics (Europe) Limited & others v The Wellcome Foundation Limited & Glaxo Group Ltd, [2013] EWHC 148 (Pat), reported by the IPKat here, Arnold J decided that a combination product for treating malaria was obvious. 
From these cases we can see how inventive step is being assessed by these courts where the invention concerns a multi-step R&D process. In addition it seems clear that incremental inventions in the pharmaceutical field are being found invalid for inventive step. 
The present invention 
In this case Leo was defending two patents, EP 1178808 and its divisional EP 2455083. The claims of EP 1178808 relate to a pharmaceutical composition comprising vitamin D or an analogue of it, a corticosteroid and a specific solvent. EP 2455083 relates to a more specific embodiment where the vitamin D analogue is calcipotriol and the corticosteroid is betamethasone. These therapeutic substances were known for treating psoriasis, and the solvent, polyoxypropylene 15 stearyl ether, was disclosed in a prior art publication ‘Turi’, US patent 4,083,974. There are several aspects to the contribution being made by the invention. One lies in realising that providing the two therapeutic substances in a single formulation would increase patient compliance in comparison to asking patients to take two separate products. However, given that the two substances are stable at different pHs, they cannot simply be added to each other in an aqueous formulation. A second aspect of the contribution is making a non-aqueous formulation choosing to use polyoxypropylene 15 stearyl ether as a solvent. 
The expert witnesses and the ‘team’ for inventive step 
The expert witnesses gave evidence on treatment of psoriasis with the two substances, whether they would consider combining them in a single formulation an whether the co-formulation would be stable. Under cross-examination it became clear that the expert reports contained ‘sweeping generalisations’ and in their testimonies they were guilty of ‘overstatement’. However Birss J was appreciative of the contribution of all the experts which allowed him to determine the common general knowledge in the art and on the skilled person being a team that included a skilled clinician and a skilled formulator of pharmaceutical compositions. 
Common general knowledge 
Birss J held that, from the common general knowledge, it was known that patient compliance was important in psoriasis and that using a single combination formulation would increase compliance over prescribing two different ones. However he did not accept Leo’s argument that the common general knowledge of the skilled clinician would assume that combining the two substances in a single composition was not possible. Birss J built up a complex picture of the common general knowledge of a skilled formulator and how such a person would tackle the making of non-aqueous solutions containing substances sensitive to pH. A key point was that the skilled formulator is an empiricist who would proceed to test solvents that might have worked. 
Birss J noted that there are some cases where inventive step can be decided on common general knowledge alone, and commented that Teva’s inventive step attack was slightly unusual in that it started from the common general knowledge (knowing that a single combination product would increase compliance) and involved adding a prior art reference, Turi, which disclosed the solvent. This was not a situation where inventive step was assessed by identifying the differences between the invention and primary prior art reference. 
The information in the patents 
Leo’s patents make note of the fact that patient compliance could be improved by using a single combination product. They also give the results of stability tests and provide evidence of a better therapeutic effect than using the substances separately. The patents also refer to ‘synergy’ occurring, but this aspect was not pursued by Leo in the trial to show inventive step. Had it been, it would have been a valuable addition to the case law in this area. 
The appropriate inventive step test 
Birss J recited the much-quoted statement from Generics v Lundbeck which opens:
‘The question of obviousness must be considered on the facts of each case. The court must consider the weight attached to any particular factor in the light of all the relevant circumstances.’ 
He considered this to mean that ‘obvious to try’ is simply ‘one of a variety of factors’ to be considered. He added:
‘Obvious to try cases usually involve consideration of the level of expectation of success but one cannot lay down a general characterisation of what the true level of expectation must be in every case beyond stating that it must be a fair one. In that way the differences between different cases is taken into account. 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.’
What does Birss J mean? Is he saying one should not judge inventive step by asking whether the skilled person would have predicted it would have worked but instead, once the invention has been found to work, one should then ask ‘was it obvious that it would have worked’? Is that the correct approach to ‘expectation of success’? Readers' comments in this point would be most appreciated. 
 From Birss J’s comment it seems that ‘expectation of success’ is something complex and very fact-specific. I also wonder whether the learned judge should have defined what ‘success’ would be in the present case. Was it simply production of a stable combination composition or was it providing better therapeutic results? 
Was the invention obvious? 
Birss J started his inventive analysis from the position that a combination formulation was desirable from the common general knowledge to increase patient compliance. The skilled clinician would expect the combination formulation to be more effective than using the therapeutic substances separately. It was well known, for example, that the corticosteroid would reduce the irritation caused by calcipotriol. 
Leo argued there would be ‘prejudice’ against use of corticosteroids due to potential side effects over the long term. However Birss felt there would not be prejudice against short term use or in the combination. 
The skilled formulator:
he ain't saying nothin'
 
Birss J then switched his analysis to the perspective of the skilled formulator. It was obvious to use a non-aqueous solution to overcome the issue of the substances being stable at different pH’s. The issue came down to whether the solvent disclosed in Turi would be obvious to use in the formulation. Turi disclosed a non-aqueous composition containing the solvent and betamethasone (one of the therapeutic substances used in the present invention) and based on this Birss J concluded that the skilled formulator would not ignore it or dismiss it. 
Leo criticised the benefits described in Turi as ‘illusory’, but Birss J felt this was an overstatement. Leo also put forward arguments based on the fact that the solvent disclosed in Turi was not widely used and this might would add potential cost, time and uncertainty, for example if a regulator required extensive testing of the solvent. However, Birss J felt that whilst factors such as this can be relevant they rarely outweigh technical considerations. 
A crucial point for inventive step was the skilled person’s perception of how difficult it would be to solve the pH problem. The expert witnesses had disagreed on this issue, but Birss J felt that Teva’s case on this was more persuasive. The skilled formulator presented with Turi would proceed to test the solvent it disclosed and result would be positive. A clinical study would then be carried out using the combination formulation and this would confirm it was an effective treatment. This meant the invention was obvious. 
Inventive selections and the Technograph test 
Birss J went on, tantalisingly, to discuss the situation in which the selection of the solvent would be inventive. If evidence had been provided that a ‘vast range of obvious agents had not worked’ then this could have been ‘compelling evidence of non-obviousness’. However Leo had not done this. 
Birss J also asked whether his analysis was an example of the unfair step-by-step approach identified in Technograph Printed Circuits Ltd v Mills and Rockley (Electronics)Ltd [1972] RPC 346. In that case Lord Diplock had said:
"The cross-examination of the respondents' expert followed with customary skill the familiar "step by step" course. I do not find it persuasive. Once an invention has been made, it is generally possible to postulate a combination of steps by which the inventor might have arrived at the invention…if he had started from something that was already known…"
Birss J felt he had not made this error since his analysis had considered the normal steps in development of a pharmaceutical product and thus could not have been influenced by hindsight. 
Unanswered Questions 
1. How should ‘expectation of success’ have been addressed for this case? Should Birss J have analysed this based on ‘would the skilled formulator have expected the solvent disclosed in Turi to have worked?’ instead of ‘would the skilled formulator have tested the solvent disclosed in Turi?’. Often in pharmaceutical cases there is little chance of success for any one candidate, but the skilled person would have had reasons to test it. 
2. If the inventive step analysis follows the normal steps in development of a pharmaceutical product, is there a danger of failing the Technograph test? How can one determine one has not failed the Technograph test? 
3. Are other incremental inventions also likely to be found obvious? It seems that often for such inventions the contribution is modest and there is a lot of relevant prior art. 
4. What does it take for a combination product to be inventive? Does it need to have an element of inventive selection or a demonstration of synergy?

35 comments:

Anonymous said...

The EPO was considering one of the same patents in an opposition yesterday, by the looks of things: https://register.epo.org/application?number=EP00901483&lng=en&tab=main. Does anyone know the result?

Anonymous said...

Sir Hugh Laddie, Patents - what's invention got to do with it? (Chapter 6 in Intellectual Property in the New Millenium, p.93):

"When patents and patent applications succumb to invalidity attacks, obviousness is the most common cause. This inevitably generates friction between the community of patentees and applicants on the one hand and patent offices and national courts on the other. A company which has spent millions of dollars on research and has produced a valuable new drug will be understandably irritated when, say, a court declares the patent invalid for obviousness, thereby opening up the market to competitors who are free to copy. That irritation is likely to be particularly acute when the raison d'être of the patent system is said to be the economic encouragement of research and development.

The problems can be approached by considering first the concept of 'obvious to try'. The classic statement of this principle is set out in the judgment of the Court of Appeal in Johns-Manville Corporation's Patent. It was said that a development should be treated as obvious if 'the person versed in the art would assess the likelihood of success as sufficient to warrant actual trial'. Statements to similar effect have been made by the EPO.

On its face, this produces an unworkable or irrational test. If the reward for finding a solution to a problem and securing a monopoly for that solution is very high, then it may well be worthwhile for large players to examine all potential avenues to see if one gives the right result, even though the prospects of any one of them succeeding are much less than 50/50. What makes something worth trying is the outcome of a simple risk to reward calculation. Yet, if the reward is very large, the avenues worth trying will be expanded accordingly. So, the more commercially attractive the solution and the more pressing the public clamour for it, the harder it will be to avoid an obviousness attack. In those circumstances a solution which is quite low down a list of alternatives, all of which are more or less worth trying, will fail for obviousness; a consequence which is consistent with the decision in Brugger v Medic-Aid."

Anonymous said...

No I don't. Hoping that it helps.

Anonymous said...

In Conor v Angiotech Hoffmann disagreed with the following from Conor: 'The invention thus lies in the idea of trying some, one or more, taxol/polymer combinations to determine whether restenosis can thereby be treated. It is at this level of generality that inventiveness must be assessed'. So obvious to test/try/experiment does not equate with the invention being 'obvious'. Expectation of success must be an important part of the inventive step analysis, and here Birss essentially said the formulator would 'proceed to test' the specific solvent. Birss's approach does not seem to be in alignment with the Conor v Angiotech decision.

Anonymous said...

Yes, pharma will try many avenues to obtain success. However, there are limitations to how many avenues can be takes. For example, it may be obvious to make any one of 10 to the power of 64 new chemical entities, but in reality that isn't going to happen. Therefore, a little inventive ingenuity is required to narrow down the field. Hence, non-obvious and patentable result.

That said, the challenged patent was rightfully overturned.

Anonymous said...

4. For a combination product to be considered inventive, where the individual drugs are each known to be useful in the therapy of concern, the combination must be synergistic, said synergy supported by data.

It should noted that this case is not about the obviousness of a combination product. Said combination was deemed to be obvious. The issue is whether the stable formulation was obvious. Even if unobvious, the first person to provide a stable formulation of an otherwise obvious combination would not be entitled to a monopoly for the combination per se, whatever the formulation.

3. Other incremental inventions are certainly likely to be found obvious. This isn't the last example of a patent being revoked or never granted. The modesty of the increment is not a relevant factor, however.

2. Following the normal steps in developing a pharmaceutical product could indeed result in an invention being deemed obvious in accordance with the Technograph test, possibly unfairly. In other cases it could fail fairly. An example springing to mind is Pfizer's besylate salt case in the US. If there are a limited number of obvious-to-try options then trial and error would either lead to success or failure. Irrespective of the inability to predict likelihood of success, such steps would still be taken. If one of the obvious steps works, congratulations, you have a working product, but no patent. If it fails, unlucky. Try something else.

1. The likelihood of expectation of success in this case using the claimed solvent was at least reasonable. Unless there SatNav pointed the skilled person away from this solvent, the Turi paper would provide a useful signpost for the formulator working on this product.

Anonymous said...

The above quote from Laddie shows the conundrum of the situation. We need to grant patents for pharmaceutical research, but this type of research does not fit easily into conventional inventive step considerations. Either it's mostly obvious because one is testing an obvious hypothesis or it's mostly inventive because which compound would pass all the tests could not have been predicted. The Courts are doing justice based on the facts in front of them by asking 'appropriate' expectation of success questions, but that makes the test quite arbitrary.

Anonymous said...

Anonymous @ 09:50

Here in the states, your comment would not be correct, as your use of "inventive" is synonymous with "Flash of Genius."

Our version of the law that covers this concept is 35 USC 103. Note the last sentence of that law.

Anonymous said...

There is no conundrum. We don't need to grant patents for pharmaceutical research. We need to grant patents for inventions which fulfill requirements of the Act, otherwise we may as well grant patents for perpetual motion machines. I'm getting a feeling of de-ja-vu.

Anonymous said...

Anonymous of 8.47 you forget the relationship between pharma and the patent system. They already have SPCs and see http://ipkitten.blogspot.co.uk/2012/01/should-duration-of-pharmaceutical.html for their further demands of extending patent term for pharma patents. I'm quite sympathetic as the patent system needs to serve the needs of the relevant industry, and that has to include how we look at inventive step. Birss clearly remains unsympathetic, and it will be interesting to see what the Court of Appeal says.

Anonymous said...

I am a pharma attorney so hopefully my memory of such things is maintained for a few more years.

Patents should only be granted fulfilling the requirements of the relevant statutes. Same goes for SPCs.

Demands for extension of patent term or other developments of patent law, which I may support, are not in conflict with the basic requirements.

There are cases where providing exclusivity for a drug not necessarily being patentable are sensible, such as Orphan Drug exclusivity.

If I had to clarify my point, it would be "We don't need to grant patents for pharmaceutical research. We need to grant patents for inventions within pharmaceutical which fulfill requirements of the Act, otherwise we may as well grant patents for perpetual motion machines."

The earlier commentator's comment, which prompted by response:

"but this type of research does not fit easily into conventional inventive step considerations"

is not an accurate statement. The facts of the specific case, and many other pharmaceutical cases (possibly all, but I've not done the analysis, so I am hedging my assertion.) fall perfectly into such an assessment.

Anonymous said...

Anonymous of 11.33, how should reasonable expectation of success be assessed if there is little chance of any one compound passing phase I, II and III, though there is a clear suggestion in the prior art to use the specific compound to treat the condition?

Anonymous said...

Anonymous @ 11:33,

May I ask your opinion (as a professed pharma attorney), how is it that as of the date of filing there are zero - as I have yet to see even one - applications that have exhibited meeting the utility requirement (I am thinking US patent system)?

Demands for extensions - as seen for what they are - show this to be true. With the continual examples of drugs that fall out of the process because they lack the desired utility, why do we continue to grant patents for such "gee, we hope this works" pharma patents before the utility is actually possessed?

Please keep in mind that the "race" aspect is not compelling, as everyone wanting a patent would need to jump through exactly the same hoops.

I have posted this question on several leading US patent blogs and have yet to receive anything close to a logical answer. I am hoping that you can do better.

Thanks.

Anonymous said...

Re: Anon at 13:38.

If a pharmaceutical company has data to support putting a compound through clinical trials, and that data is publicly available, I would suggest that it is then unquestionably obvious from a patentability point of view.

All compounds are put into the clinic at risk of failure. If a compound fails Phase I of the trials, it will not go into Phase II.

Compounds are, however, normally patented prior to completion of clinical trials demonstrating efficacy in a condition and are patented based on preclinical data
supporting the claimed benefit. The data required is such that it is scientifically plausible that the compound will have the desired efficacy.

Another point worth noting is that clinical trials are designed to demonstrate safety, efficacy and an improvement of other therapies or placebo. A compound may fail these trials yet still have some insignificant benefit. It is just not expected to be of use as a drug. It should therefore be noted that it is not a requirement for the compounds covered by a patent to be great drugs, hence the reasonable data requirements.

The question, however, specifies 'clear suggestion in the prior art'. This is very fact-dependant. There will clearly be cases falling in a grey area and the disclosure may not be sufficient to prejudice a future patent filing. There is an interesting EPO decision that is worth the effort of seeking out for those interested enough. It was in the EPO Case Law book at one point at least, if my failing memory serves me right.

Anonymous said...

To Anon at 13:45.

I posted my response to Anon at 13:38 prior to reading your comment. I don't know if you are the same anon, however, I believe my comments answer you main point.

I would just add that the data including in the patent application as filed supporting patentability for the purported therapeutic use is of the following standard:

Data is usually from an in vitro assay demonstrating, for example antagonist activty of a receptor that scientist have linked to a particular disease condition. There is high quality scientific evidence demonstrating the link. There are scientific theories and possible evidence demonstrating the potential benefit of an antagonist of a particular receptor in treating the disease. The evidence may be a benefit shown by the natural ligand, and may include in vivo testing.

The compounds themselves may have been directly tested in animals, either modelling a disease, or indeed suffering naturally from a disease.

I don't know what the 'race aspect is' and is not something I've come across in the pharma patenting field.

I'm guessing, based on you comment in bold of having seen zero examples demonstrating utility, that you are not going to believe a single word I've said.

Anonymous said...

It is not that I won't believe you - or rather, believe that you think that you have provided a sufficient case for HAVING utility at the date of filing - but what you HAVE presented is merely a theory of having that utility.

That is not the same thing as ACTUALLY having that utility, now is it?

Alas, all that you have done is confirm that pharma patents should not be granted in the first place for failing to have the "promised" utility rather than a possibility of that utility.

You have to have it - not the conjecture that you might have it - at the time of filing. This is true in every other single art field in the patent world - why should pharma be any different?

Anonymous said...

*ALL* claims were obvious -- see 98. I find this tough to accept for all of those dependent claims. What solvent was Teva using? 104 is vague about that.

Anonymous said...

The EPO register is today showing that the patent was upheld in amended form, but it doesn't say which claims survived...

Anonymous said...

@Anon 13:45/19:14

Pharma is different because you can't demonstrate full-clinical-trial-level-utility without public disclosure of the invention.

I was going to go into the way the EPO handles sufficiency, inventive step and later filed data in such cases, but I won't.

Anonymous said...

In response to the comment of 17.41 I completely agree. But then 'expectation of success' is tricky. To what does it apply, just assessment of the initial publication which might make the suggestion, or also to the testing process? Essentially Patent Office Examiners ignore the testing process, but Courts cannot always do so if the expert witnesses discuss it, but in practice they also ending up ignoring it, but for no clear reason as far as I can see, and the system somehow keeps going

Anonymous said...

The expectation of success is usually assessed in respect of the subject matter of the claims being active in the test considered evidence of utility in the therapy of interest.

The relationship of activity in the test to the therapy would be separate. A scientific rationale for the link should be sufficient for the EPO, but it could be overturned by other evidence including that of experts.

If a patent is challenged by a third party then it is usually because the case covers compounds subsequently marketed as pharmaceuticals, so the compounds did in fact turn out to be active. If a patentee was able to predict this utility without any data or only data not considered supportive of the benefit, they are either very good at guessing or have the ability to predict the future.

Anonymous said...

Dear Anonymous,

A comment like "Pharma is different because you can't demonstrate full-clinical-trial-level-utility without public disclosure of the invention."

only proves my point. Pharma patents - when filed - lack actual utility and "get by" on a mere possibility of utility. Snake oil passes such a test.

The patent system does not - nor should it - care about such differences. You either have an invention that fits the rules or you do not.

Sounds very much like you want special treatment - exactly as I first posted.

Anonymous said...

You asked why pharma should be different and I provided a response.

The rules you seem to hold in such high regard aren't fundamental laws of nature, you know. They were put together to serve a purpose. Ultimately they can be changed or interpreted differently if that better serves the intended purpose, which itself may change over time.

You can call it special treatment if you want; I call it pragmatism.

Anonymous said...

Ah, thanks Anonymous - but at least here in the states, those rules cannot be changed willy-nilly or at a whim just because special treatment is desired (whether or not such special treatment would be considered pragmatic). Bottom line is that the requirement of utility - AT THE TIME OF FILING - is not something that has been made special as you would have it.

I will also clarify that I did not ask why pharma should be different per se - my question was to how the different special treatment can accord with the law as written.

And the underlying point is that the law as written does NOT allow pharma to be different. As I indicated, this DOES mean that there are no legitimate pharma patents that have the required utility at the time of filing.

If your sense of pragmatism is great enough, I would suggest that you start talking to the legislators in order to change the law to properly incorporate your concerns.

Anonymous said...

Anon at 8:44 walked straight into previous anon's trap. That is exactly the comment that was wanted so that the anon could wade in with "PROVES MY POINT".

In addition to my explanation of the pharma tests, I posted a query to said anon asking what data they believe would support a pharma invention. We could then discuss the practicalities, realities, etc. Unfortunately, my comment was not posted, possibly because it failed the censorship test by asking a simple Q (maybe the Hong Kong govt were in charge of censorship yesterday) or maybe it slipped through Jeremy's iPhone while we was on his 3rd glass of port.

So, I'll try again:

Dear Anon who doesn't like pharma patents: Please explain in detailed scientific-speak what evidence you believe is required to prove the utility of a pharmaceutical invention.

As a side response to the zero-example accusation, VIAGRA was proven to have utility in humans prior to filing the medical use patent. The evidence stood up to intense scrutiny at the time.

Anonymous said...

"willy nilly"? more de-ja-vu or is someone micky-taking?

Anonymous said...

"willy nilly" is anon's way of denying the utility of the viagra patent.

Anonymous said...

Even Viagra was not KNOWN to have the utility at the time of filing.

Try to stay on point people - that point being that pharma patents - as a rule - are filed prematurely, and thus should not be granted.

There are no pharma patents that have completed and thus possessed the utility at the time of filing.

Whether or not the "hoped-for" utility is later confirmed is quite besides the point.

Anonymous said...

I said that the Viagra patent was filed with known utility. The evidence is in the patent application. If you'd bother to read it you would see that. However, you are not interested in the facts, because they would destroy your unsupported allegations. You have also not answered the question asked about the level of scientific evidence you believe is required.

As in a previous blog discussion, for which I guess you are the same person who spouts criticism, but fails to deal with issues, this discussion has now become tiresome.

Anonymous said...

If we look at the simple facts concerning Viagra, Anonymous at 22:37 is simply incorrect.

The patent application for Viagra was filed in 1994.

Proof was not obtained until 1999.

The point here is not what type of proof would be acceptable to any single poster's satisfaction, but rather, the point is that such patent applications routinely do not have the proof at the level that other sections of government require until well after the filing date.

No other art area gets such a pass of meeting the utility requirement as does pharma.

Since the utility requirement is not written to be art-specific (another fact that seems to elude the logical grasp of the "pro" pharma commentators), it is up to the pro-pharma commentators to come up with some (existing) legal rationale for the actual special treatment that pharma is receiving (and post-hoc "policy" wishful thinking does not cut it). The law as written simply does not accord with your desire. Wishful thinking - either in this argument, or in the application of the law as written - does not a compelling legal position make.

And no, neither am I against pharma patents, nor do I "dislike" them. Rather, I dislike the innate "airs" that seems to come from the pharma industry when it comes to patent law, which tends to create "logic blinders."

MaxDrei said...

Anon at 15:44

"the point is that such patent applications routinely do not have the proof at the level that other sections of government require until well after the filing date"

I disagree. "the point" it definitely is not. It is best that nobody here engage with a poster who wants to witter on (in an item about obviousness in England) about the concept of "utility" under the patent law of the USA.

Just so too, over the level of proof that a government agency requires before it deems a drug safe to be let loose on the public. Misleading and irrelevant.

Anonymous said...

WO9428902 Compounds for impotence. Medical use patent referred to by anon Fri 22:37

Priortiy date 9-6-93

http://resources.schoolscience.co.uk/pfizer/viagra/viagch5pg1.html

In 1991, trials looked at how effectively Viagra™ treated angina. Researchers wanted to see if it dilated the coronary arteries feeding the heart muscle and relieved the pain of angina. Results showed it would not be a good treatment for angina. However, some subjects reported some interesting side effects.

In small scale studies, some healthy volunteers reported that Viagra™ enhanced erections and so, in 1992, researchers changed direction and concentrated on developing Viagra™ as a treatment for erectile dysfunction.

The troll should go back in his box.

Anonymous said...

It does seem I rather walked into a trap with my "pharma is different because..." comment last week. Apologies for feeding the troll.

I had a little sarcastic joke planned (involving this) but I think MaxDrei has the right idea here. No more from me on this.

Anonymous said...

Those who are descending into name-calling should THINK for a moment about what is being discussed.

Patents are not given for plans for studying what MAY BE in a compound. You need to be able to show that you possess the utility at the time of filing.

All of those studies after filing merely prove that that utility was not in fact possessed - only at the conclusion of those after-filing studies could the applicant say they possessed the utility - not a moment before.

Let's not be quick to name call and instead spend that time thinking about what is being said.

Anonymous said...

EPO grounds in Opposition Case available here:

https://register.epo.org/application?number=EP00901483&lng=en&tab=doclist

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