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EDITORIAL
In addition to the bumper packed December edition of the patent newsletter we have published a supplement which considers how much data are required for patentability of an invention in respect of European patents in light of recent Court decisions.
Aylsa Williams, December 2008.
HOW MUCH DATA ARE ENOUGH FOR EUROPEAN PATENTS?
The trade off between the interests of the commercial world and those of the public is well established in the patent system: the patent must disclose the invention to such an extent that the public can put it into practice. In return, the applicant obtains a defined period of legal monopoly in respect of the invention.
As the rewards for obtaining a dominant patent can be huge, there is often a surge to be the “first out of the blocks” in the race to the Patent Office. However, recent decisions of the UK Courts and the EPO Boards of Appeal have shown that making a very quick start can be a serious risk.
HOW MUCH IS ENOUGH?
It has always been considered to be advisable to include in a patent application data which support the inventive concept of the invention in question. However, as it has been pointed out on a number of occasions, neither the UK Act nor the EPC (in both its original and recently revised formats) specifically requires the presence of experimental data or worked examples.
In view of this lack of legislative guidance, applicants have been forced to argue their case in legal proceedings before the authorities in EPO opposition or appeal proceedings, or in national infringement and revocation proceedings.
As a result, applicants often ask:
“What is the minimum amount of information that a patent application must provide at the filing date in order to obtain a valid legal monopoly?”
The answer to this is not straightforward.
In fact, the amount of data (if any at all) may differ depending on a number of factors, including the nature of the invention itself and the common general knowledge in the technical field. The amount of data required might also differ for the various patentability criteria that must be satisfied in order to achieve grant. It is this last point that has been relevant in a number of important decisions of the UK Courts.
The recent rulings of Justice Kitchin in the Patents Court in Eli Lilly & Company v Human Genome Sciences Inc [2008] EWHC 1903 (Pat), 31 July 200 (Lilly) and that of the House of Lords in Conor Medsystems Inc v Angiotech Pharmaceuticals Inc & Others [2008] UKHL 49, 9 July 2008 (Conor) have laid down important principles on the requirement of data. However, these decisions rule primarily on two “distinct” criteria for patentability - viz industrial application and inventive step. Furthermore, the conclusions for each criterion appear to differ subtly.
Accordingly, when drafting the application is there scope for reconciling the data requirement for each of the criteria? Or must the patentee assess the requirement for inventive step and industrial applicability individually?
To answer this question one must look at the two cases in a little detail.
Conor Medsystems Inc. v Angiotech Pharmaceuticals Inc, and others, 2008
In a very important ruling from the House of Lords [1], delivered largely by Lord Hoffmann, the threshold for inventive step attacks based on the “obvious to try” approach appears to have been raised. However, it may be that this ruling could have more subtle implications which possibly reach beyond inventive step.
Although the main independent claim in this case was for a stent coated with taxol, it was claim 12 (which was dependent on claim 1) directed to a stent for treating or preventing recurrent stenosis, which was at issue.
In coming to the conclusion that the subject matter of claim 12 was not obvious, Lord Hoffmann stated:
“But there is in my opinion no reason as a matter of principle why, if a specification passes the threshold test of disclosing enough to make the invention plausible, the question of obviousness should be subject to a different test according to the amount of evidence which the patent presents to justify a conclusion that his patent will work”.
Indeed, Lord Hoffmann went on to emphasise that for the purposes of inventive step of a product (such as in claim 12), patent law does not require that an application demonstrates that an invention actually works [2]; if it did not work, it may well be invalid for lack of sufficiency. However, Lord Hoffmann did stress that such situations were in contrast with situations where the invention is mere speculation [3].
All that seems to be required for the purposes of inventive step is that it would be plausible that the inventive concept has been realised. Or, in the language of the EPO, that it is plausible that the solution solves the problem in question
(T 1329/04). Indeed, this requirement of plausibility seems to be in line with the leading Board of Appeal case of AGREVO (T 0939/92).
As noted by Lord Hoffmann, the Board of Appeal said:
“… [A] technical effect which justifies the selection of the claimed compounds must be one which can be fairly assumed to be produced by substantially all the selected compounds [emphasis added]”
Thus, the skilled person must be able to make a “fair assumption”, i.e. it must be plausible from the point of view of the skilled person that the inventive concept has been realised.
Eli Lilly and Co. v Human Genome Sciences, Inc.
It has been widely acknowledged that this decision has given much needed guidance on the interpretation of Section 4 of the UK Patents Act, especially with regard to those inventions having a biotechnological slant.
Although all the claims were found invalid, claim 1 at issue was as proposed to be amended by HGS and is as follows:
An isolated nucleic acid molecule comprising a polynucleotide sequence encoding a neutrokine-a polypeptide wherein said polynucleotide sequence is selected from the group consisting of:
(a) a polynucleotide sequence encoding the full length neutrokine-a polypeptide having the amino acid sequence of residues 1 to 285 of SEQ ID NO:2; and
(b) a polynucleotide sequence encoding the extracellular domain of the neutrokine-a polypeptide having the amino acid sequence of residues 73 to 285 of SEQ ID NO:2.
In formulating the decision, Justice Kitchin made numerous references to relevant decisions of the EPO [4], as well as to leading decisions of the US Courts, viz Brenner v Manson 383 U.S. 519 (1966) [5] and US Court of Appeals for the Federal Circuit in Fisher v Lalgudi (2005) 04-1465, 09/619,643 [6].
Of the EPO Board of Appeal decisions referred to by the Judge, the most relevant issue seems to be the requirement for a disclosure to be “immediate” in the sense that it is directly derivable from the description, if it is not already obvious from the nature of the invention or from the background art.
EPO Board of Appeal decision T 0898/05 explains that the expression “profitable use” should be understood in the sense of “immediate concrete benefit”.
EPO Board of Appeal decision T 0870/04 found that the only practicable use disclosed in the application was to use the invention to ascertain further knowledge about the invention itself – i.e. the immediacy requirement was not met.
Thus, both of these EPO Board of Appeal decisions appear to place an onus on the applicant to make a disclosure which requires nothing more from the public, other than to apply the common general knowledge.
The Judge’s analysis of the position in Europe, the US and the UK was summarised in a series of important principles concerning the requirements for industrial applicability:
i) [7] The notion of industry must be construed broadly;
ii) [8] The capability of industrial exploitation must be derivable by the skilled person [9] from the description read with the benefit of the common general knowledge;
iii) [10] The description must disclose a practical way of exploiting the invention in at least one field of industrial activity;
iv) [11] (a) There is a sound and concrete basis for recognising that the contribution could lead to practical application in industry, (b) there is a need to disclose in definite technical terms the purpose of the invention and how it can be used to solve a given technical problem, and (moreover) (c) there must be a real prospect of exploitation which is derivable directly from the specification, if not already obvious from the nature of the invention or the background art;
v) [12] (a) A speculative indication of possible objectives that might or might not be achievable by carrying out research is not sufficient, and (b) it should not be left to the skilled person to find out how to exploit the invention by carrying out a research programme;
vi) [13] The purpose of granting a patent is (a) not to reserve an unexplored field of research for the applicant, and (b) not give the patentee unjustified control over others who are actively investigating in that area and who might eventually find ways actually to exploit it;
vii) [14] If a substance is disclosed and its function is essential for human health then the identification of the substance having that function will immediately suggest a practical application [15];
viii) [16] Using the claimed invention to find out more about its own activities is not in itself an industrial application; and
ix) [17] It is no bar to patentability that the invention has been found by homology studies using bioinformatics techniques.
These principles are said by the Judge to be:
“consistent with the Directive and with the approach adopted by the US courts … that in return for his monopoly the patentee must make a full disclosure of his invention, including a practical use to which it can be put”.
In his concluding paragraphs, Justice Kitchin said:
“The Patent is invalid for lack of industrial applicability, insufficiency and obviousness. Whatever the merit of the discovery of Neutrokine-a, the specification contains no more than speculation about how it might be useful. It does not teach the person skilled in the art how to solve any technical problem and its teaching as to the range of applications of Neutrokine-a is implausible. Moreover, the claims to therapeutic and diagnostic products are insufficient in any event.”
“This was a field in which many researchers were active. The application was filed at a time when rapid advances were being made in terms of the public availability of gene sequences and how they might be searched. Not surprisingly, other teams found Neutrokine-a soon after the priority date. Perhaps anticipating this, HGS filed its application very promptly. But in doing so it failed to disclose how the protein might be used and it required a research programme to make good this deficiency. HGS secured broad protection over an unexplored technical field without providing an adequate compensating benefit to the public.”
It is unlikely to be in dispute that the HGS application disclosed a practical use to which the invention can be put (in fact, it disclosed many practical uses). What was in dispute however, was whether the offering of this practical use was merely “speculation” or, in the alternative, whether it could be considered to be something more – such as something which the skilled person would be convinced by and indeed attempt.
The Judge decided in this case that the mere identification of a protein, without anything more, was not sufficient to establish that an industrial application of the inventive concept had been disclosed. For some commentators, this may well be in line with the “immediate” criteria of the Board of Appeal cases mentioned above.
However, does this approach sit with the “plausible” requirement espoused in Conor as well as the number of EPO cases concerning the data required for the assessment of inventive step? Indeed, despite referring to Conor, there does not appear to have been an analysis by the Judge of whether or not the performance of the invention in one of the disclosed practical uses was at least “plausible”.
PLAUSIBLE YES...BUT NOT WITHOUT AN UNDUE BURDEN?
Setting the principles from Lilly and Conor side by side, it would appear that for an application to disclose enough information to meet the requirements of industrial applicability, there must be sufficient information present to allow an immediate (in the sense of EPO Board of Appeal decision T 0898/05) practical use to be derived, whilst for an inventive step to be acknowledged, only sufficient information in order to render the inventive concept at least plausible should be present.
Is it the intention of the UK courts and the EPO Boards of Appeal that more information is required to satisfy the industrial applicability criterion than inventive step?
To some this may seem to be particularly harsh, particularly considering that it is well established that industrial applicability is to be given a broad interpretation (see the first limb of the criteria laid out above). However, if the standard was considered to be in line with that for inventive step (i.e. at least plausible), the applicant may err on the side of caution and include as many applications as possible, because the person skilled in the art would no doubt think it at least plausible that the invention could be made or used in at least one of them.
Of course, such an approach may be risky. In this respect, Judge Kitchin was not particularly impressed about the large range of applications disclosed in the HGS patent [18].
Also, in a valuable addition to the decision in Conor, Lord Walker noted that the patent specification in suit contained so much information that the inventive concept “nearly got lost” [19].
Thus, perhaps Judge Kitchin considered that whilst it was plausible that the invention could be made or used in at least one of the disclosed practical uses this could not be proved without an undue burden being placed on the skilled person.
OK THEN, HOW MUCH IS ENOUGH?
It is important to point out that, in all cases, the provision of supporting data in an application is invaluable. Thus, the preferable route is likely to be that of a “belt and braces” approach.
However, it is understood that in some situations time is of the essence and the need to beat the competitors to the patent office is paramount. In these situations, it appears that in order to secure a valid UK patent, sufficient information which satisfies as closely as possible the nine principles mentioned by Judge Kitchin is needed.
IN THE FUTURE?
Looking to the future, perhaps what is required for all patentability criteria is the presence of sufficient information in the application as filed to ensure that the invention as defined in the claims is at least plausible without placing an undue burden on the skilled person to confirm it.
NOTES
[1] This is highlighted by Lord Neuberger of Abbotsbury in paragraph 55 when he says:
“I have had the benefit of reading in draft the opinions of my noble and learned friends Lord Hoffmann and Lord Walker of Gestingthorpe. I agree with them that this appeal should be allowed. Although the decision represents a significant development in United Kingdom patent law, and we are differing from the views of highly experienced Judges in that field, I do not think there is anything that I can usefully add to the reasons given by Lord Hoffmann, or to the additional remarks of Lord Walker, with both of whom I entirely agree.”
[2] Lord Hoffmann at paragraph 19:
“In my opinion, however, the invention is the product specified in a claim and the patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description. There is no requirement in the EPC or the statute that the specification must demonstrate by experiment that the invention will work or explain why it will work. As the Dutch court said (at paragraph 4.17): “... it is not required in the view of the court that experimental data concerning such use of taxol stents in humans and the actual prevention of restenosis be included in the patent to further substantiate [the claim].””
[3] In paragraphs 29 and 30, there is stated:
“It is true that a patent will not be granted for an idea which is mere speculation, unsupported by anything disclosed in the specification. Article 84 of the EPC says that the claims must be “supported by the description” and this requirement is reproduced in section 14(5)(c) of the 1977Act. So in Re Prendergast’s Applications [2000] RPC 446, the applicant attempted to patent the use of two known pharmaceuticals to treat--
“battle fatigue, combat stress reaction, post-traumatic stress disorder in civilian and military emergency situations, neurological symptoms associated with chemical warfare and nausea associated with chemical or biological warfare.””
“The specification contained no information whatever to support the claim that the products in question would have any effect on these ailments. Neuberger J upheld the Comptroller’s rejection of the claim on the ground that it was not supported by the description.”
[4] For example, reference was made to T0338/00; T0604/04; T0870/04; T0898/05; T1452/06 and the Decision of the Opposition Division in the ICOS Corp case {OJEPO (2002) page 293 etc.}
[5] In the famous case of Brenner v Manson 383 U.S. 519 (1966), the Court held:
“The basic quid pro quo contemplated by the Constitution and by Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point -- where specific benefit exists in currently available form -- there is insufficient justification for permitting an applicant to engross what may be a broad field.”
[6] In the HGS case, the Judge further referred to and quoted from the US cases as follows:
“The rationale presented herein, having been drawn from principles set forth by the Supreme Court in Brenner, applies with equal force in the fields of chemistry and biology as well as in any scientific discipline. In Brenner, the Supreme Court was primarily concerned with creating an unwarranted monopoly to the detriment of the public:
“Whatever weight is attached to the value of encouraging disclosure and of inhibiting secrecy, we believe a more compelling consideration is that a process patent in the chemical field, which has not been developed and pointed to the degree of specific utility, creates a monopoly of knowledge which should be granted only if clearly commanded by the statute. Until the process claim has been reduced to production of a product shown to be useful, the metes and bounds of that monopoly are not capable of precise delineation. It may engross a vast, unknown, and perhaps unknowable area. Such a patent may confer power to block off whole areas of scientific development, without compensating benefit to the public... This is not to say that we mean to disparage the importance of contributions to the fund of scientific information short of the invention of something “useful”, or that we are blind to the prospect that what now seems without “use” may tomorrow command the grateful attention of the public. But a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. [A] patent system must be related to the world of commerce rather than to the realm of philosophy.”
“Here, granting a patent to Fisher for its five claimed ESTs would amount to a hunting license because the claimed ESTs can be used only to gain further information about underlying genes and the proteins encoded for by those genes. The claimed ESTs themselves are not an end of Fisher’s research effort, but only tools to be used along the way in the search for a practical utility. Thus, while Fisher’s claimed ESTs may add a noteworthy contribution to biotechnology research, our precedent dictates that the ‘643 application does not meet the utility requirement of § 101 because Fisher does not identify the function for the underlying protein-encoding genes. Absent such identification, we hold that the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent.””
“This conclusion contains a powerful citation from the decision of the Supreme Court in Brenner. In return from his monopoly the patentee must disclose how his invention can be used. A patent is not a hunting licence to find a use for the claimed product. It is a reward for the successful conclusion of the search.”
[7] T0870/04; Chiron vs Murex [1996] RPC 535; T0898/05
[8] T0604/04
[9] This can be held to be a team of people – as evidenced by Lord Hoffmann’s comments in paragraph 281:
“Materially, I have accepted in paragraphs [31]-[32] that it is a team including or with access to a bioinformaticist.”
[10] T0870/04
[11] T0898/05
[12] T0870/04; T0898/05; T0338/00
[13] T0870/04; T0898/05
[14] T0870/04
[15] This may not be the case where the function of that substance is not known or is incompletely understood.
[16] T0870/04
[17] T0898/05
[18] See, for example, the statements made in paragraphs 100 etc. For convenience, paragraphs 132 to 134 are presented below:
These very long lists are again not supported by any data or in vitro or in vivo studies.
Finally the Patent contains various examples which primarily relate to the expression of Neutrokine-a.
Conclusion as to the teaching of the Patent
Overall, the Patent contains extravagant and sometimes contradictory claims. By way of illustration, it suggests in paragraph [0123] that Neutrokine-a inhibits immune cell function and in paragraph [0143] that antagonists of Neutrokine-a also inhibit immune cell function. There is nothing by way of experimental evidence to support the claims made and I accept Professor Saklatvala’s evidence that the idea that Neutrokine-a and antagonists to Neutrokine-a could be used to treat the extraordinary range of diseases identified was fanciful. He found it hard to believe that anyone could seriously suggest on the basis of no experimental data at all that that Neutrokine-a was the answer to so many conditions, from treating cancer to treating worms. In my judgment the skilled person would come to the conclusion that the inventors had no idea as to the activity of Neutrokine-a when drafting the Patent. It teaches the skilled person nothing useful about its activity other than that Neutrokine-a is another member of the TNF ligand superfamily.
[19] At paragraph 53:
“The European Patent Office focuses on the need for an invention to solve a particular technical problem: see for instance AGREVO, Case-T0939/92, paras 2.4 to 2.4.2. So far as the focus was on stents, there was a particular technical problem, clearly highlighted in the “Holy Grail” paper published in 1993. The specification, fairly construed, did put forward a taxol-eluting stent as the answer to this problem. But that teaching had to be disentangled from so much extraneous matter that it nearly got lost.
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Aylsa Williams, Partner |
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Charles Harding, Partner |
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Connor McConchie, Assistant |