Mr Justice Mann :
Introduction
- This is an appeal from a hearing officer (Dr S Brown) sitting in the Intellectual Property Office and delivered on 5th August 2011. In that decision Dr Brown refused an application made by Mr El-Tawil to register a patent on the grounds that it lacked support, was not new and did not involve an inventive step. Mr El-Tawil seeks to appeal from that decision on the basis that it is wrong, supplemented by assertions that the procedure involved by the IPO was improper and disadvantaged him.
The application
- Mr El-Tawil's application was filed on 6th June 2006 and published on 12th December 2007. The Examiner maintained the objections to its registration, in favour of which Dr Brown ultimately ruled. The application is entitled: "A novel effective treatment for patients with inflammatory bowel disease (Crohn's disease & ulcerative colitis)".
- The claims are short and were just three in number. They read:
"Claims:
1. The addition of zinc to current regimen for management of cases with Crohn's disease and ulcerative colitis will offer many advantages:
Controlling of diarrhoeal episodes, restoring mucosal integrity, reducing the associated increased intestinal permeability, modulating the immuno-response, delaying the rates of relapses and improving the quality of life of patients.
2. According to claim 1, zinc sulphate can be provided as an enema (new route) in a dose of 25-50 micromol/ml/60ml normal saline, once daily for a period between 25-90 days for management of cases of distal Crohn's colitis and distal colitis.
3. According to claim 1, zinc sulphate can be prescribed as an infusion in a dose between 180-250 micromols/days divided in 3 doses over five-seven consecutive days for controlling severe cases of inflammatory bowel diseases."
- The preceding description of the background and invention are extremely short. The background section contains some general descriptions of abnormalities which arise in inflammatory bowel disease ("IBD") and Crohn's disease and the next section is entitled "Statement of invention". It reads:
"To overcome this [i.e. the symptoms of the diseases and what are said to be the physiological effects], the present invention proposes prescribing zinc sulphate for cases with inflammatory bowel diseases (Crohn's disease and ulcerative colitis) in two forms:
1. Zinc sulphate enema for cases of distal Crohn's colitis and distal colitis once daily [continuing as in claim 2].
2. Zinc sulphate infusion for severe cases of Crohn's disease and ulcerative colitis in a dose of 180-250 micromols/day divided in three doses over five consecutive days."
- The third page is said to identify the invention. It reads:
"Advantages
- Zinc is a very effective measure for controlling diarrhoea (well-documented)
- Zinc can effectively tighten the junctions and in turn, reducing the associated increased mucosal permeability in cases with inflammatory bowel diseases
It, therefore, plays an important role in reducing the chances of future exacerbations of these diseases.
- Zinc is an essential component of the structure of the bowel wall and it is necessary for making the lining membrane of the bowel wall more resistant to any further damage or injury.
- Zinc enhances cellular multiplication and so it is very effective in restoring the mucosal integrity and in turn, reducing the frequency of relapses.
- Zinc can effectively modify the immuno-response in cases with inflammatory bowel diseases."
The decision appealed from
- The hearing officer first considered, or purported to consider, the construction of the claims. In fact, this section of his decision does not really record, or deal with, and questions of construction of the claims. The hearing officer said that Mr El-Tawil was:
"careful to explain that his invention was characterised by the mechanism of action of zinc in the treatment of IBDs."
Mr El-Tawil told me that that was wrong that was not what he said. However, as on many occasions at the hearing before me it was not at all easy to understand why he said that that was wrong, either in terms of what he said or what the hearing officer ought to have understood. Be that as it may the hearing officer went on to observe (paragraph 6) that new information about a mechanism of action of a known treatment could be considered to relate more to a discovery (and therefore to be non-patentable) than to an invention as such. Accordingly, in his view the discovery of a mechanism could not, by itself, provide novelty. However, for the sake of argument he was willing to accept Mr El-Tawil's point and to construe the scope of claim 1 to be the use of zinc in the management of patients with Crohn's disease or ulcerative colitis to provide certain clinical benefits, the zinc acting by the mechanism defined in the application. He went on to construe claims 2 and 3 as specifying that the zinc is delivered in the form of zinc sulphate in either an enema or an infusion form and further to specify specific dosage regimes.
- Next he went on to consider "support" and cited section 14 of the Patents Act 1977. Having referred to Prendergast's Applications [2000] RPC 446 he applied what he considered to be the principles arising out of that case, and in particular the need for this application to provide enough material to enable the relevantly skilled person to say that this medicament does treat the condition alleged, pure assertion being insufficient. He concluded that in the absence of test data or other evidence supporting the effectiveness of zinc to treat IBDs, the application did indeed contain no more than assertions and the claims lacked the required level of support. He rejected a submission by Mr El-Tawil that a journal article nicknamed "Cario" was sufficiently referred to in the application so as to provide relevant support, both because there was no adequate cross-reference in the application to that article and because it seemed to him that it had not been submitted with the application or otherwise provided in time. In the circumstances he concluded that the application lacked the required level of support.
- He then turned to novelty, and having set out the relevant parts of sections 1 and 2 of the Patents Act 1977 he considered a piece of prior art known as "Sturniolo" and found that Mr El-Tawil's mechanism for the action of zinc in IBD treatment was envisaged in, and therefore anticipated by, that piece of prior art, so Sturniolo anticipated claim 1.
- Next he considered whether the application contained an inventive step. He addressed himself as to the law on obviousness and found that claims 2 and 3 were obvious over Sturniolo and a Spanish patent application bearing the number ES 2238177 A1 ("the Spanish Application").
- Having decided against the application on the above grounds, he declined to address the question of whether claims 2 and 3 were not patentable as being no more than a method of treatment of the human body (s4(A)(a) of the 1977 Act).
- I shall have to consider a little more of the detail of the decision, but for the time being that route map will suffice.
The conduct of this appeal
- It is unfortunate but necessary that I should have to record the difficulties which arose in the conduct of this appeal. Mr El-Tawil is obviously very much personally involved in the application and in this appeal. He is a doctor and medical researcher who believes that he has found something genuinely useful for sufferers of very unpleasant diseases. However, as he did not seem to understand enough of what is required in the conduct of a patent application, and what is required to be able to register a patent, the result was that his submissions lacked focus and very often went off in a completely irrelevant direction. That direction usually consisted of an exposition of the science, and criticisms of the science of some of the prior art, in a manner which was simply not relevant to the appeal. He spent a very large part of his submissions apparently doing those things. His submissions were also presented with a vigour that was sometimes inappropriate. All this made it very difficult to understand what the basis for his appeal was, and to align any given part of his submissions with the law of patents. I was greatly assisted by the submissions of Miss Charlotte May for the Comptroller in getting to the bottom of some of what Mr El-Tawil was saying, but there still remained serious areas of impenetrability. The analysis of what this appeal is about which appears below is the best that can be done. I am afraid that the failure to do any better lies at the door of Mr El-Tawil himself.
- What follows is a combination of a consideration of Mr El-Tawil's orally delivered points, so far as discernible, his notice of appeal and skeleton argument documents, and a consideration of the merits of the decision independently of the points raised by Mr El-Tawil. This last exercise was conducted by Miss May, mindful as she was of the Comptroller's duties and her personal duties to the court when faced with a litigant in person.
Review, not rehearing
- As Miss May reminded me, this is a review, not a rehearing - Halliburton's Application [2011] EWHC 2508 (Pat) at paras. 9-13. It was difficult to maintain this distinction in the light of Mr El-Tawil's persistence in making scientific assertions which were, if anything, in the nature of unattested evidence. In all the circumstances this appeal roamed somewhat wider than an appeal normally would. This could only operate to Mr El-Tawil's advantage.
Skilled man
- In paragraph 32 of his decision the hearing officer found the person skilled in the art to be:
"A pharmaceutical scientist with an interest in the modes of administration of drugs. Such a skilled person may also have access to the advice of a clinician. I find the common general knowledge of that person to be standard techniques of administering drugs to patients, and access to information about basic anatomy and very well accepted therapies for a range of conditions including IBDs."
- Mr El-Tawil's skeleton argument seemed to dispute this, and argued that the person skilled in the art was:
"A person with experience in inflammatory bowel diseases, Molecular Biology and in Genetics with a background in physiology, pharmacology and in anatomy."
- Miss May accepted in her skeleton argument, and subsequently at the hearing (by which time some of the debates had moved on a little) that the difference between those two tests did not make any difference in relation to the results of this appeal, and was content to take Mr El-Tawil's skilled person as being the relevant one. I shall do the same, though I shall also record that I have reviewed my final decisions in this appeal on the assumption that the hearing officer's skilled person is the correct man, and none of my decisions would be any different in that event.
Physiological mechanism not an invention
- As I have described above, in his section entitled "Claim construction" (in which he did not really investigate any questions of construction of the claims) the hearing officer concluded that new information about a mechanism of action of a known treatment is more of a discovery than an invention and could not alone provide novelty, though he was willing to proceed thereafter as if it could. If his point was a good one it would mean that claim 1 is invalid.
- In my view his point was a good one. The application plainly relates to a second medical use, and as set out in the IPO's Examination Guidelines (made available to Mr El-Tawil and relied on by him) it is pointed out that "[a] claim [to] a different technical effect of mechanism of action, should be rejected as lacking novelty; how a treatment works is irrelevant." (Para 133). It is also suggested that such a claim would define a discovery, which is excluded by section 1(2)(a) of the Act. This appears from the judgment of Jacob J in Bristol-Myers Squibb co v Baker Norton Pharmacueticals [1999] RPC 253 at para 59. In describing a claim said to describe a newly perceived advantage of an existing drug he said:
" All you have is more information about the old use. In due course no doubt more information about the exact mode of action of Taxol will emerge. No-one could obtain a patent for its use simply by adding 'for' at the end of the claim and then adding the newly discovered details of the exact mode of action."
See also para 63.
- This decision was upheld in the Court of Appeal at [2000] RPC 1.
- Mr El-Tawil was always at pains to point out that what he discovered was the importance of the mechanism. He said that that was his inventive concept, and that concept is embodied in the last two bullet points on page 3 of the application. If that is the alleged invention, it fails for the reason just given so far as it relies on such an invention. Claim 1 contains 3 such mechanisms (restoring mucosal integrity, reducing intestinal permeability, modulating the immuno-response), and so far as it claims those then it fails. The other things that zinc is said to do is the removal or reduction of symptoms. Those are not patentable either. This is pointed out in paragraph 139 of the guidelines, relying on Bristol-Myers, which so holds.
- It follows that claim 1 fails for this reason too so far as it describes effects of mechanisms. This reasoning is confined to claim 1.
Support
- Section 14(5) of the 1977 Act requires that:
"The claim or claims shall -
(c) be supported by the description."
The description has to be in the specification - see section 14(2)(b).
- The level of support which is required appears from Prendergast's Applications [2000] RPC 446, in which Neuberger J held:
"
whether there is an adequate description, for the purposes of section 14(5)(c) of the 1977 Act must be judged by reference to the nature of the application. There is obvious force in the contention that, where you have a claim for the use of a known active ingredient in the preparation of a medicament for the treatment of a particular condition, the specification must provide, by way of description, enough material to enable the relevantly skilled man to say this medicament does treat the condition alleged, and that pure assertion is insufficient." (my emphasis).
He held that if tests were to be relied on they need not be "full rigorous detailed and conclusive tests".
"The tests can, where appropriate, be very rudimentary. It would be wholly inappropriate, and indeed impractical, to lay down what the tests should be in each case, but it is clear that, in general, relatively rudimentary tests will do."
- The same point is made in Salk Institute v Karo Bio AB Case No T0609/02, a decision of the Boards of Appeal of the EPO. At paragraph 9 the Board records:
"The boards of appeal have accepted that for a sufficient disclosure of a therapeutic application, it is not always necessary that results of applying the claimed composition in clinical trials, or at least to animals, are reported. Yet, this does not mean that a simple verbal statement in a patent specification that compound X may be used to treat disease Y is enough to ensure sufficiency of disclosure in relation to a claim to a pharmaceutical. It is required that the patent provides 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."
The hearing officer held that the application contained no support of this nature. In my view he was entirely correct. The inventive steps are said to appear in the last two bullet points of page 3 of the application, not including the averment of zinc's ability to enhance cellular multiplication, which is accepted by Mr El-Tawil as being common general knowledge. Assuming for these purposes that what appears there is capable of being an inventive step, those points contain mere assertions. There is no material which justifies it, or backs it up.
- Mr El-Tawil sought to counter this by referring to parts of the description which set out matters which he said were well known and did not require further evidence. That, of course, does not help him in trying to find support for those parts which he says were not well known and therefore inventive. He also relied on what he says were principles appearing in SmithKline Beecham Corporation Case No. T1001/01 and which he said were contrary to Prendergast and Salk. In that case there is the following passage:
"Furthermore, it has to be reminded [sic] that it is common practice that a patent literature document, in order to be an enabling disclosure of a medical indication for pharmaceutically active compounds, such as the treatment of ovarian cancer disclosed in document (2) does not necessarily need to include either clinical tests (Phase I, II or even III), or in vivo human assays."
However, that reliance overlooks the fact that the passage is dealing with another point. It is dealing with whether it is necessary to demonstrate human-based, as opposed to animal-based, trials or experiments; and the passage referred to is referring to what should be taken as disclosed by prior art, not what is required by way of support in a patent application (see the paragraph following the one just cited).
- That case does not assist Mr El-Tawil, and it follows that his patent application fails for this reason too.
- I would observe that I think Mr El-Tawil sometimes betrayed a misunderstanding of what is required under this head. A lot of his submissions (written and oral) were an attempt to say that his discovery (or invention as he would have it) was indeed supported by the science. That may or may not be the case, but the relevant question is whether there is appropriate support in the application. For the reasons I have given, there was not.
Procedural matters
- At this point it would be convenient to deal with a point raised by Mr El-Tawil to the effect that he was unfairly disadvantaged by the apparently inconsistent, and he would say improper, conduct of the IPO in dealing with him over his application. He claims that he submitted some supporting material with his application, and it should be taken to be part of his application. He also submitted that he had been disadvantaged by the conduct of the IPO in giving him an indication that he would be allowed to amend his application to include this sort of matter and that he was then deprived of that opportunity and the point decided against him.
- So far as the first point is concerned it was ventilated mainly in relation to a paper known as "Cario". Mr El-Tawil said that this paper provided a lot of support for what he was seeking to say in the description. There are, however, a number of problems with this.
- He asserted that he submitted this paper with, and as part of, his application. However, there is no record on the file of his having done so, and indeed such records as there are are inconsistent with it. No document in the initial stages refers to it, and when it is later referred to it is not referred to as a document originally enclosed. Furthermore, the application form (Patent Form 1/77) filled in by Mr El-Tawil when he made his application back in 2006 contains a section (a box on a page) in which he enumerates the pages of the documents that he was enclosing. This part of the form says that he was enclosing one page of claims (which is right) and three pages of description (which would be correct if, as is obvious, he is referring to the first three pages of the application which I have described above). It does not suggest that any further pages of anything relevant were enclosed.
- Mr El-Tawil sought to support his case that he provided additional material (such as Cario) with his application by pointing to what is apparently some additional writing in the box on the application form which enumerated his enclosures, which he said could refer to his additional material. All that appeared on the photocopy in the bundles was some marks which were likely to be writing (not aligned with anything else on the page), but which were indecipherable. Mr El-Tawil was insistent that there was something sinister about this, which supported his assertions that the Office had behaved improperly, even though he could not assist in deciphering the writing and did not produce any copy retained by him which showed what it said. The original was produced from storage by the end of the hearing. It turned out that the "writing" was in fact text from the other side of the piece of paper whose ink had partially bled through to the page Mr El-Tawil was concerned about. There was no reference to additional material disclosed. Mr El-Tawil's point on this was no more than wild speculation. He ought not to have indulged in it.
- There is no more than Mr El-Tawil's bald statement that he submitted such material. The hearing officer implicitly found that the document was not submitted, and in my view he was right to do so. He rejected the submission that the reference in the application to things being "well documented" was a permissible reference to Cario, and again he was right to do so.
- It is also the case that, whatever it said and whenever it was submitted, Cario does not seem to be capable of providing the support which is otherwise missing from the description. It is a document that precedes the invention. As described by Mr El-Tawil, it does not provide anything in the nature of evidence of tests which support the invention; rather it provides some support for the prior art from which the invention is then said to flow. If that is right, then it does not provide material support for the invention. If it did, then since it existed before the application was made, it would be novelty-destroying.
- The second major point taken by Mr El-Tawil is that the IPO resiled from an indication that he would be able to fix any problems by amending his application. The foundation for this assertion is an email from Dr Bill Thompson, the examiner, sent on 28th August 2007. He had been in receipt of various communications from Mr El-Tawil about his preceding search report and various other assertions made by Mr El-Tawil about the validity of his application. On 28th August he responded:
"My thoughts on your current application are as follows:
Currently I have nothing to add to the Search Report I sent dated 8th August 2007.
Your comments dated 8th August 2007 are noted and will be used when Substantive Examination takes place. It is estimated with the current backlog of cases that we have that this will occur some time in late 2008-mid 2009.
At the Substantive Examination stage you will most likely be asked to slightly amend your claims so they fit our established format of claim drafting. Nothing to worry about at present
."
The italics are mine to indicate the paragraph on which Mr El-Tawil relies in this respect. He says that that was a statement that he would be allowed to carry out amendments to his application, and he should have been, and should now be, allowed to amend to include some further material to remedy any defects in the patent, in the form of absence of support.
- Apart from statutory restrictions on amending to include added matter, this point fails because the passage relied on does not give the indications that Mr El-Tawil says it gives. It refers to the possibility of amending "claims". It says nothing about amending any other part of the application. It also indicates that any amendments would be slight, and that the purpose was to bring the document in line with formats rather than adding anything of substance. None of that describes what Mr El-Tawil says he would have wanted to do to the application. Various documents that had already passed from the IPO (not least the very search report referred to in the letter) had, very clearly and in terms, informed Mr El-Tawil of the difficulties that his application faced because of the lack of support. Nothing in the prior correspondence, or in the letter relied on, gives any indication that he would be allowed to have a free run at amending his application. In that context it is not a reasonable reading of the email relied on by Mr El-Tawil that he could simply fix the problem in due course by a straightforward amendment which would pose no problems. His point therefore fails for that reason and it is not necessary for me to go on and consider other reasons why an amendment was not, and is not, possible on the basis relied on.
- This is also a convenient place to deal with one or two other complaints made by Mr El-Tawil as to procedure. He complained that as a public office the IPO did not give him enough advice as to what he had to do, which caused any deficiencies in his application. He pointed to meetings that he had in Birmingham Central Library with representatives of the Office, and to various forms of guidance. There is nothing in this point, so far as it is intelligible. The Office is obviously inclined to be helpful to applicants, but it is not under a duty to provide full advice as to the content of an application. There is a difference between guidance and full advice. Mr El-Tawil's complaint is really that the Office did not provide the latter. It was under no duty to do so.
- There was also a complaint that the hearing officer's decision was published. Mr El-Tawil said that it ought not to have been published until he had exhausted his appeals. There is no basis for this complaint in law. The decision was published, in the sense of being put on a publicly inspectable file, in accordance with normal and proper procedures. The hearing itself was public under Rule 84 of the Patents Rules 2007.
Other reasons for invalidity
- Those conclusions would be sufficient to deal with this appeal. However, since the hearing officer ruled on them, and since Mr El-Tawil obviously feels so strongly about this case, I will deal with the other rulings on invalidity considered by the hearing officer.
Novelty
- The hearing officer held that a paper called Sturniolo anticipated claim 1. Sturniolo is a paper entitled "Zinc Supplementation Tightens 'Leaky Gut' in Crohn's Disease", and was published in 2001. Its summary reflects the fact that no effective prophylactic treatment was available for Crohn's disease patients with small intestinal permeability, and described a study:
"The aim of this study was to ascertain whether zinc supplementation may improve intestinal permeability
Patients received oral zinc sulfate supplements
for 8 weeks and were followed up for 12 months thereafter to monitor relapses."
The results were summarised:
"
During follow-up, 10 patients had normal intestinal permeability and did not relapse; of the remaining two who had increased intestinal permeability, one relapsed. Conclusions: Our findings show that zinc supplementation can resolve permeability alterations in patients with Crohn's disease in remission. Improving intestinal barrier function may contribute to reduce the risk of relapse in Crohn's disease."
In the trial all patients were already on mesalazine.
- The paper goes on to set out the effect of the experiment. It describes the measure by which intestinal permeability was found to have been reduced after the zinc supplementation; it describes the perceived effect on plasma and urinary zinc concentrations; and it gives details of the extent to which the Crohn's Disease Activity Index was not adversely affected and that only one patient suffered clinical relapse. These matters back up the summary.
- The hearing officer considered this piece of prior art and concluded that it disclosed the use of zinc (sulphate) to treat Crohn's disease to prevent relapses and provide greater gut barrier integrity and that some of the beneficial effects may be via immunological effects; and that it was used in conjunction with other treatments (and therefore was added to the existing regimen of treatments). He found it anticipated.
- I agree with him though for slightly different (albeit related) reasons. The mechanisms and effects of the treatment cannot be inventive, for the reasons given above. What is left is the opening words of the claim (up to the word "advantages"). The matters disclosed by those words, save for the reference to ulcerative colitis, are clearly disclosed by the elements of Sturniolo referred to above - the use of zinc, with other remedies, to manage Crohn's disease. If it matters, I also agree that it discloses the other elements as well, apart from expressly controlling diarrhoea and improving lifestyle, but they are non-inventive anyway.
- Mr El-Tawil sought to say that Sturniolo did not anticipate because it was a form of clinical trial, and he criticised some of the science set out there (as I understood his submissions). Both points are irrelevant. It matters not what the source of Sturniolo was; what matters was the disclosure. And even if the science is imperfect, it still discloses what it discloses. The assessment of a piece of prior art like this does not turn on giving it marks out of 10 for its scientific rigour. It involves assessing what it discloses.
- One further point arises. Claim 1 refers to "The addition of zinc
for management of cases with Crohn's disease and ulcerative colitis" (emphasis supplied). Sturniolo does not refer to ulcerative colitis. However, this does not prevent its anticipating claim 1. Miss May submitted, and I accept, that the word "and" should really be read as "or". The claim would be unduly restrictive if confined to patients with both diseases at the same time, and Mr El-Tawil did not suggest that that was the intention. The fairer construction would be to treat the "and" as disjunctive. However, that has a consequence on anticipation by Sturniolo. Since Sturniolo discloses treatment of Crohn's disease, and the "and" is disjunctive, it therefore anticipates notwithstanding that it does not refer to ulcerative colitis. If one imagines the claim construed with the disjunctive "and" and assuming validity, it would be infringed by treatment of Crohn's disease alone; so the reference to ulcerative colitis does not prevent Sturniolo anticipating.
- For the sake of completeness, I should record that Miss May advanced a case that Sturniolo anticipated claim 2 as well. This was not found by the hearing officer, and she did not serve a respondent's notice. I do not think it would be fair to Mr El-Tawil to allow her to advance this alternative defence of the decision, so I do not do so.
Want of inventive step (obviousness)
- The hearing officer proceed down the 5 steps prescribed by Jacob LJ in Pozzoli Spa v BDMO SA [2007] EWCA Civ 444, which he addressed in turn. His skilled addressee was not the same as the one I am assuming, but as I have said that makes no difference to the result at the end of the day.
- The second step involves identifying the inventive concept of the claim. He found that claims 2 and 3, on their true construction, related to a particular dosage range of zinc sulphate administered as an enema or infusion respectively for the treatment of specific IBDs. I could not detect that Mr El-Tawil criticised that as an analysis, but in any event it is plainly right.
- Then the hearing officer turned to the two relevant pieces of prior art - Sturniolo and the Spanish Application. It has to be said (as Miss May accepted) that this part of his judgment does not clearly and in terms separate out those two works when considering them. Miss May said that what he did did not amount to mosaicing them impermissibly. I agree.
- The hearing officer started his detailed consideration by setting out the claims in the Spanish Application. He used a machine translation which led to some odd English, and I will do the same save that I will anglicise the name of the chemical compound involved:
"1. Use of zinc acexamate for the pharmaceutical preparing a composition for the treatment in human of the intestinal inflammatory disease.
2. Use according to Claims 1, characterized because mentioned pharmaceutical composition is for the treatment in humans of Ulcerative Colitis.
3. Use according to Claims 1, characterized because mentioned pharmaceutical composition is for the treatment in humans of Crohn's Disease.
4. Use according to anyone of Claims 1 to 3, characterized because mentioned pharmaceutical composition only contains zinc acexamate like active principle
5. Use according to anyone of Claims 1 to 4, characterized because mentioned pharmaceutical composition is intended to the oral adminstration.
6. Use according to anyone of Claims 1 to 4, characterized because mentioned pharmaceutical composition is intended to the rectal administration."
- It is his next paragraph which demonstrates his collapsing of the treatment of the two pieces of prior art relied on under obviousness (Sturniolo and the Spanish Application). He said:
"36 The state of the art thus includes the knowledge that zinc [acexamate] could be used to treat IBDs in humans by rectal or oral administration. Sturniolo indicates that it was also known to use zinc sulphate to treat IBDs in humans by oral administration."
- One has to pause to wonder whether this paragraph is referring to common general knowledge rather than the disclosure in the Spanish Application per se, and whether he also mosaics the art in a way which is contrary to principle. However, having considered the rest of his reasoning I am satisfied that he does neither. In that paragraph he is providing himself with two discrete starting points, being each of the two pieces of prior art which are separate jumping off points for his obviousness consideration.
- His next step was again the correct one of identifying the differences between each of those pieces of prior art and the inventive concept in claim 2. He said they were:
"37
. the use of a specific zinc salt, zinc sulphate, in an enema, the use of a specific dose, for a specific period, and the treatment of a particular form of the IBD diseases confined to the distal part of the colon."
In my view that is entirely correct when one looks at the document as a whole..
- He then took each of those elements and held that they would all have been covered by obviousness. He implicitly ran both of the pieces of prior art side by side, but for the sake of clarity I will distinguish them.
- First, the Spanish Application:
(i) He found that a skilled person would have appreciated that an enema was an obvious form of rectal administration. I do not consider that that decision can be criticised on this appeal whichever skilled addressee one takes. Indeed so far as the Spanish Application is concerned, there are at least two express references to an enema as being one form of rectal administration.
(ii) It would be obvious to exchange a pharmaceutically tolerable salt for another. This finding cannot be criticised, not least because in the course of submissions Mr El-Tawil himself accepted that salts could be, to that extent, interchangeable, and the thrust of what he said indicated that that was actually part of common general knowledge.
(iii) The hearing officer found (paragraph 39) that since distal colitis affected the rectal end of the colon, the skilled person would not treat it any differently from non-distal colitis. No basis was advanced for criticising this finding, and I find there is none. At no point in his lengthy submissions, which sought to expound a lot of the medicine and science involved, did Mr El-Tawil seek to suggest that distal Crohn's disease (colitis) or distal colitis were distinct forms of the diseases which it would not be obvious to treat in the same way as the disease elsewhere, so this difference too is bridged by obviousness.
(iv) That left the dosage regime. The hearing officer referred to Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444 and found that dosage regimes were inventive only in unusual circumstances. The circumstances of claim 2 were not unusual, so this was not an inventive step either. In my view his decision cannot be impeached in that respect. At paragraph 32 of that case Jacob LJ held:
"So holding is far from saying that in general just specifying a new dosage regime in a Swiss form claim can give rise to a valid patent. On the contrary nearly always such dosage regimes will be obvious - it is standard practice to investigate appropriate dosage regimes. Only in an unusual case such as the present (where, see below, treatment for the condition with the substance has ceased to be worth investigating with any dosage regime) could specifying a dosage regime as part of the therapeutic use confer validity on an otherwise invalid claim."
- In the present case nothing that Mr El-Tawil said suggested that this dosage regime was inventive. Indeed, when describing the inventive concept from time to time, Mr El-Tawil referred to other things. In my view the hearing officer was correct in this finding.
- One of Mr El-Tawil's observations on this prior art was that the tests were on rats (not humans), that the tests were over only a week, and what was "treated" there were chemically induced burns, not a disease. He said that this made the Spanish Application irrelevant to his application. He is wrong about that. It would be relevant to what was really disclosed, but it does not automatically rule it out as being relevant prior art. Having considered the document in full (which I have) I consider that this matter makes no difference to the hearing officer's conclusions or to mine.
- The effect of this analysis is that claim 2 is obvious over the Spanish Application.
- Turning to Sturniolo, the differences between that piece of prior art and claim 2 are the route of administration (enema - Sturniolo discloses oral administration only), dosage, the distal nature of the diseases in claim 2 (not referred to in Sturniolo) and the fact that ulcerative colitis is not referred to in Sturniolo, which concerns itself with Crohn's disease only. The hearing officers findings on these are somewhat wrapped up in more generalised findings, but he seems to have concluded that the same reasoning applies here as applies to considering the Spanish Application. Breaking it down, in my view the result is as follows.
- First, the route of administration. The hearing officer did not consider this point in this context. In paragraph 38 of his decision he found that enema was an obvious form of rectal administration, which reasoning makes sense if one is starting with some prior art which discloses rectal administration. The Spanish Application does that, but Sturniolo does not. Paragraph 39 finds that a skilled person would find an enema to be an obvious way of getting to distal forms of disease. It seems to be a finding on the distal nature difference, not the enema difference, though that is not wholly clear. Miss May put the point differently. She said that an enema would be obvious to try. I cannot accept that submission on the basis of the material before me. There is simply insufficient material to enable me to do so. I am therefore not satisfied that this difference is bridged by obviousness.
- That means that I do not have to consider the other differences, but I will mention them briefly. The dosage point is dealt with as with the Spanish Application - the dosage regime is not inventive. The non-disclosure of the distal forms of the disease is dealt with likewise. Crohn's disease is disclosed, so on the disjunctive reading referred to above, there is no additional obviousness point here.
- The result is that claim 2 is obvious over the Spanish Application, but not over Sturniolo.
- The only difference between claim 3 and claim 2 is the method or route of administration - infusion rather than enema. On all other aspects the question of obviousness are the same. At paragraph 43 of his decision the hearing officer held that infusions are a well-known alternative for administering a wide range of substances, which was not disputed by Mr El-Tawil. He also found that the means to administer zinc as an infusion existed. I think that he meant by this that it was obvious to try to administer a zinc compound (from the Spanish Application) and zinc sulphate (from Sturniolo) as an infusion, though he does not expressly say so. It is far from clear to me that Mr El-Tawil actually relies on administration by infusion as inventive. I did not detect that he did. He emphasised matters appearing in the description on page 3 as being inventive, and frequently referred to administration by enema as if it was, but I did not detect much emphasis on infusion. In all the circumstances I would uphold the hearing officer's apparent decision on this.
- If infusion is obvious, then combining that with the conclusions on claim 2, it follows that claim 3 is obvious over the Spanish Application, and this time is obvious over Sturniolo, since infusion (unlike enema) is an obvious thing to try in place of the oral administration.
- It follows that, if it matters, the claims fail for obviousness over the prior art.
Method of treatment
- The hearing officer referred to, but reached no decision on, whether the application failed as being a method of treatment of the human body. There was no respondent's notice on the point, and I do not need to consider it.
Other points taken by Mr El-Tawil
- As I have observed, Mr El-Tawil's submissions were not usually focussed on the issues in hand. I do not need to deal with much of what he said, because it was irrelevant, but I would pick out the following:
(i) He criticised the deductions and reasoning in Sturniolo. Whether justified or not, it does not affect the disclosure in that document.
(ii) He criticised reliance on Sturniolo because it was a clinical trial and not therapeutic use. This does not affect the disclosure in that document.
(iii) He drew attention to a passage in the judgment of Jacob LJ in Aerotel Ltd v Telco Holdings Ltd [2006] EWCA Civ 1371 about how to deal with difficulties of fact in a patent application hearing:
"5. Of course, if a debatable question of pure fact is or may be involved at the application stage, things are different one cannot then say that the decision at that point must be the last word on the subject. Then the applicant must be given the benefit of any reasonable doubt."
The trouble is that he did not identify any relevant question of pure fact to which this principle might apply in his application . I listened carefully to what he said, and he seemed to dispute certain parts of the prior art. However, there was no relevant question of fact that I could identify of which he should be entitled to the benefit of the doubt. There is no finding of fact within this principle contained in the hearing officer's decision to which this principle could be applied, because no determination of primary fact (so far as there was one) was challenged.
(iv) One of his recurring themes was the requirement to read and construe the claims in the light of the description, and vice versa. In other words, he said one had to read the document as a whole. He referred to familiar jurisprudence on the point. Then he said that the hearing officer failed to do that. I can find no indication that the hearing officer so failed, either in terms of what he actually said or as an inference from his expressed words. It is clear that he took the application as a whole where relevant to do so. In fact, this point arises where there are questions of construction, and there were no real construction points in this case anyway.
(v) He was keen to tell me what his research had found about, inter alia, the relative incidence of Crohn's disease in various cultures, and across the genders. This has nothing to do with the validity of his patent application.
(vi) He relied on the Human Rights Act, under which he said remedies were available to him. But first he has to establish a contravention of his rights. He has not done so. I have already dealt with his procedural complaints. I could not detect any others.
Conclusion
- Accordingly I dismiss this appeal.
