Source: http://europeanpatentattorney.co.uk/ip_novelty.html
Timestamp: 2019-04-20 20:45:56+00:00

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The purpose of this article is to explore the circumstances in which prior use or disclosure of a product or process makes "matter" form part of "the state of the art" such that an "invention" relating to that "matter" is deprived of novelty - Article 52(2) EPC and the corresponding Section 2(2) of the 1977 UK Patents Act.
The EPC (and also the 1977 Act) refer to "inventions" being "new" if they do not form "part of the state of the art" and refer to the "state of the art" as constituting "a product, a process, information about either or anything else" that has been "made available to the public".
"we should not assume that the new Act is just the old English law re&endash;written, or that statements of principle or passing observations on individual questions can now be culled from the reported cases and applied without reserve.....This is all the more so given that the source of the Act is a treaty...."(2).
Accordingly it is necessary to consider novelty without being bound by the common law assumptions which have arisen under the earlier cases.
The Court of Appeal held(3) that a metabolite produced by taking the patented antihistamine "Terfenadine" had been made available to the public by the previous administration of the drug and that a subsequent patent for the previously undiscovered metabolite was invalid. The patentee Merrell Dow had merely discovered the composition of something that had already been made and used and discoveries as such are unpatentable.
The defendant's counsel argued that the claim to the metabolite was anticipated by the prior use in clinical trials despite the lack of knowledge it conveyed on the ground that the phrase "all matter" in S 2(2) of the 1977 Act must include products or processes which conveyed no information about themselves - "otherwise why make separate mention of 'information about either'?" (p 8 final para of the report). However this argument was rejected on the ground that S 2(2) is one of the sections of the 1977 Act which was intended to have the same effect as the corresponding provisions of the EPC - and Art 54 EPC requires that the invention must have been made available to the public in order to constitute anticipation. Accordingly it was held that the invention (defined as "the making of the acid metabolite within the human body by the ingestion of terfenadine" - p 5 para 4 of the transcript) was not anticipated by the administration of terfenadine during clinical trials.
"It is important to note that anticipation by use relies solely upon the fact that volunteers in the clinical trials took terfenadine and therefore made the acid metabolite. There is no suggestion in the Agreed Statement of Facts and Issues that the volunteers were also at liberty to analyse the terfenadine to analyse its composition. If it was open to them to do so, they would have been in the same position as if they had read the terfenadine specification and the arguments for anticipation by use would have been the same as anticipation by disclosure."
Hence anticipation by prior publication was upheld.
He acknowledged that "the position may be different when the invention is a use for a product; in such a case, a person may only be working the invention when he is using it for the patented purpose" as in the Mobil case (infra).
It is interesting to speculate how prior use of terfenadine by members of the public under no constraint regarding analysis would have affected the patentability of the metabolite. It is submitted that a claim to the acid metabolite simpliciter would have been anticipated because the invention would have been the product and the product had been made available (albeit with no information about even its existence) - cf Decision T 300/86, infra.
Would a claim to the acid metabolite for use in therapy or to a pharmaceutical composition comprising the acid metabolite also be anticipated by such use?
Clearly the UK courts would be reluctant to allow such a claim by the patentee of the originating drug because it would have the practical effect of extending the patentee's monopoly on that drug without any corresponding benefit to the public in terms of a new teaching.
It is submitted that the reasoning of the Court of Appeal that the claim to the acid metabolite was not directed to an invention but to a discovery of the way in which a previously disclosed invention works still stands. The objection of anticipation by prior use which was accepted by the Court of Appeal was only rejected by the House of Lords on the narrow ground that the volunteers in the clinical trials were not free to subject their bodies to analysis. No criticism was made of the lower court's reasoning, which is consistent with numerous decisions of the EPO to the effect that the categories in Art 52(2) (including "discoveries" and "scientific theories") which are not to be regarded as inventions are claimed "as such" (Art 52(3)) and are therefore excluded from patentability if the only distinction over the prior art lies in one of the "non-invention" categories of Art 52(2).
Hence such a claim, being directed to a "discovery" "as such" would be excluded from patentability.
The UK and also the corresponding German decsions on anticipation of the metabolite by the Terfenadine patent have been criticised as being inconsistent with the Friction -reducing Additives decision (infra) and with other case law of the EPO by Vossius et al,(4c) who compared the occurrence of metabolic products in the liver with the occurrence of undiscovered products in nature, eg bacteria in the soil. The latter products are held to be unavailable to the public until isolated. However a distinction can be drawn on the basis that unlike the situation in the Friction-reducing Additives case, the effect of the metabolite would be made apparent by carrying out the teaching of the Terfenadine patent , thereby making the invention available (see para 3.2 of T 208/88, infra) . If the administration of Terfenadine had resulted in a multiplicity of metabolites, of which only a small number were effective, then it is submitted that the discovery of one of these could result in a separate invention which possessed independent novelty.
Both these cases related to the question of anticipation by a prior publication. In the Friction-reducing Additives case, a prior publication disclosed an additive for use as a rust inhibitor and the patentees wished to obtain claims directed to the use of the same compound for reducing friction. The means of realisation were the same in the prior art document and in the claim so that at first sight the only novelty lay in the intention of the user.
In the Plant Growth Regulating Agent case the prior published document described the use of certain compounds for influencing plant growth whereas the claims submitted by the applicant defined "use of (certain compounds) for controlling fungi and for preventive fungus control"(7).
"iii) is a claim to the use of a compound for a particular non-medical purpose novel for the purpose of Article 54 EPC, having regard to a prior publication which discloses the use of that compound for different non-medical purpose, so that the only novel feature in the claim is the purpose for which the compound is used?"
A similar question was posed in the Plant Growth Regulating Agent case. In both cases the Board replied in the affirmative, and applied the Protocol on Article 69 EPC to the interpretation of the "use" claims in question.
".... the claim in question should properly be construed, having regard to the Protocol to Article 69 EPC, as implicitly including the following functional technical feature: that the named compounds, when used in accordance with the described means of realisation, in fact achieve the effect (ie. perform the function) of controlling fungus. Such a functional technical feature is a technical feature which qualifies the invention: and the use claim is properly to be considered as a claim containing technical features both to the physical entity (the compound and its nature), as to a physical activity (the means of realisation). In other words, when following the method of interpretation of claims set out in the Protocol, what is required in the context of the claim to the "use of a compound A for purpose B" is that such a claim should not be interpreted literally, as only including by way of technical features "the compound" and "the means of realisation of purpose B"; it should be interpreted (in appropriate cases) as also including as a technical feature the function of achieving purpose B, because this is the technical result). Such a method of interpretation, in view of the Enlarged Board, is in accordance with the object and intention of the Protocol to Article 69 EPC".
"Thus with such a claim, where a particular technical effect which underlies such use is described in the patent, having regard to the Protocol, the proper interpretation of the claim will require that a functional feature should be implied into the claim as a technical feature; for example, that the compound actually achieves the particular effect".
The Enlarged Board of Appeal specifically repudiated the concept of subjective novelty (ie. that novelty could lie in the new intention in the mind of the user) as a basis for their decision.
"3.2 .......................... if a skilled person unaware of the invention had in fact observed a culture exhibiting an uncharacteristic growth process, he could have sought the cause - had he reflected on the matter at all - among various factors such as the particular properties of the soil, the time or type of cultivation, climate, fertilisation, etc. The public was thus unable - either by reading (1) or by executing its teaching - clearly to identify the essential character of the claimed invention, namely the growth-regulating effect of the compounds (I)."
Thus the "inventions" covered by the use claims did not form part of the "state of the art" because the technical effect (namely fungus control and friction reduction respectively) was not previously made available in the sense that executing the teaching of the prior document would not lead the skilled person to its cause.
Hence, it is submitted, a "use of X for purpose Y" invention, being limited to effect Y, is only anticipated by a prior teaching which, when executed,would enable the skilled person to identify X as the cause of Y, the cause being an integral part of the invention.
It is clear that an "invention" must, when the wording of the claim permits, be regarded as an abstract concept including not only the product or process features of the claim but also, in appropriate cases, the technical effect in the sense of the Mobil decision.
Before considering the conditions under which disclosure of an "invention" might make it "available to the public" it is necessary to consider the provisions of the 1977 Act and the EPC which relate to novelty but without reference to making available to the public.
Two starting compounds required to produce the herbicides disclosed in the cited earlier European patent application were disclosed in the patent literature and in an article in the Journal of Organic Chemistry but there were no specific instructions in the cited earlier European Application as to how to prepare the required starting materials.
"It is the view of the Board that a document does not effectively disclose a chemical compound, even though it states the structure and the steps by which it is produced, if the skilled person is unable to find out from the document or from common general knowledge how to obtain the required starting materials or intermediate. Information, which can only be obtained after a comprehensive search is not to be regarded as part of common general knowledge"(10).
iii) a compound cannot be "made available" if the skilled man cannot make the compound, if necessary using his common general knowledge.
The priority provisions of Section 5 of the 1977 Act differ somewhat from the corresponding provisions of the EPC but it has been held by the House of Lords(12) that an earlier unpublished patent application cannot be anticipatory if it is non-enabling.
It is noted that any publication of the contents of an earlier application can be cited against a later application claiming priority in respect of any invention in the later application which is disentitled to priority(13).
It is submitted that the overall effect of the above decisions is that the practical teaching derivable from the disclosure must be compared with the invention (which can in certain cases include the result achieved) in order to determine novelty.
It is now necessary to consider how matter is "made available to the public" so as to constitute "state of the art."
On the basis of Decision T 482/89, a single non-confidential sale can constitute anticipation.
An independent inventor in his capacity as such is not a member of the public, even if he intends to publish his invention without filing a patent application.
"Thus in deciding whether an invention is new within Section 1(1)(a) one must look solely at any matter which has been "made available" to the public. It is an objective question of fact and has nothing with the subjective qualities or knowledge of anyone."
"The answer to the question: "What is the public?" would appear in a case such as this to be that community of research workers skilled in the art in general; but not, I would think, merely known to one or two individual research workers pursuing their own experiments in private."
Similarly in the EPO the Technical Board of Appeal held(14) that a report bearing the note "This report is the property of the RCA Corporation and is loaned to its licensees for their confidential use with the understanding that it will not be distributed or disclosed to third parties or be published in any manner...." which was distributed to a large number of major TV manufacturers who were licensees of RCA was not made available to the public, which included researchers and other manufacturers, for example. There was no evidence that the circuits described in the report had been made available to the public by being incorporated in television sets.
Clearly some act of communication is required in order to make an invention available.
How is an invention "made available"?
Article 54(2) EPC and Section 2(2) of the 1977 UK Patents Act both specify that "state of the art" may be made available to the public "by written or oral description, by use or in any other way."
In Decision T 877/90 (Hooper Trading/T-Cell growth factor)(15) it was held that the contents of oral presentations at invitation-only meetings were made available to the public because the invited attendees of the meetings were not subject to any secrecy agreement. There was no evidence that the attendees had disclosed what they had heard prior to the relevant date. The Board held in para 2.1.5 of the Reasons that an oral disclosure is made available to the public "if, at the relevant date, it was possible for members of the public to gain knowledge of the content of the disclosure and there was no bar of confidentiality restricting the use or dissemination of such knowledge."
This clearly echoes Humpherson v. Syer (16) (1887) that a patent is invalid if some people "under no obligation of secrecy arising from confidence, or good faith towards the patentee, knew of the invention at the date of the patent."
In view of the freedom to use the invention given to the licensees in T300/86 (supra) which nevertheless did not destroy novelty it is submitted that a teaching is only "made available" once all fetters of confidentiality on its use or dissemination are removed.
When is an invention "made available"?
Decision T 381/87 of the Technical Board of Appeal(17) concerned a European Patent Application which claimed the priority date of 27th November 1981. An article in "Chemical Communications" by the inventors, describing the subject matter of the patent application, was dispatched by 2nd class mail to subscribers on 25th November 1981 and the Examining Division of the EPO objected that this Article was made available to the public on that date.
The Board held that while a document remains in the postbox, and at all times prior to its delivery to the persons to whom it is addressed, it is not "available to the public".
"It is not necessary as a matter of law that any members of the public would have been aware that the document was available upon requests on that day, whether by means of an index in the library or otherwise. It is sufficient if the document was in fact available to the public on that day whether or not any member of the public actually knew it was available, and whether or not any member of the public actually asked to see it."
It should be noted that the Board also held that since the Article was received by the Royal Society of Chemistry in confidence, and was obliged to keep the contents of the Article secret prior to any publication, the mere receipt of the Article, albeit intended for publication, did not deprive the patent application of novelty.
Thus the Board disregarded the intention of the communicator and concentrated instead on the objective situation resulting from his actions, in particular the date of removal of the fetter of confidentiality.
Similarly in decision T 444/88 (18) the Board of Appeal held that a disclosure in a Japanese patent file was made available to the public merely by being open to public inspection, even though it was proved that no-one had inspected the file.
It is submitted that these decisions are consistent with Decision G1/92 of the Enlarged Board of Appeal of the EPO in which it was held that a product's chemical composition is made available to the public by making the product available to the public, irrespective of whether particular reasons can be identified for carrying out a chemical analysis.
One further EPO decision which should be mentioned is T 461/88 which concerned a patented control system for a printing press. The control system included a programmed microprocessor and the key features of the invention resided in the program. The control system had been installed in a printing press which had been sold and delivered to a customer before the priority date of the patent.
The Board of Appeal, who relied on the fact that it would take several man-years to analyse the microchip during which time it might be destroyed and in any case would not be used, upheld the patent. They considered that the usefulness of the knowledge gained would be out of proportion to the economic damage incurred.
It is doubted whether this decision is correct, bearing in mind that the chip could almost certainly have been analysed within the lifetime of the patent.
It is submitted that the purpose for which an article is used in public is irrelevant to the determination of novelty, and that all the features that could lawfully be observed by members of the public are made available to them.
This view is at odds with the decision of the British Patents County Court in Prout v. British Gas (19). Prout invented a bracket for attaching warning lamps to fencing pillars which was designed to prevent theft and vandalism of the warning lamps. He filed a patent application.
Before the filing date, British Gas manufactured brackets in accordance with the invention and used them in public, in an area notorious for theft and vandalism, to see how secure they were. It was held that the public could see what the invention was, and the judge did not rely in his judgment on there being any necessity to remove the bracket from the post in order to understand how it worked. He referred to a commentary which cited definitions of "use" in German patent law as it stood prior to the EPC and noted that these defined "use" was "going beyond mere trials in public" (p. 486, middle paragraph).
Accordingly he held that the public experimental trial did not amount to "use" which made the invention available to the public.
Even if an experimental trial does not amount to "use", it should be noted that the EPC and the 1977 Act refer to the state of the art as comprising everything made available to the public "by use, or in any other way" which implicitly includes making available by experimental trial.
Thus it is submitted that Prout v. British Gas was wrongly decided.
In Lux Traffic Controls v. Pike Signals Ltd.(20) , one of the two patents at issue included a claim to a traffic light control system which functioned in a defined manner in response to detection of a moving vehicle.
The patentees modified two controllers for temporary traffic lights in accordance with the claim and the modified controllers were supplied to contractors for use on public roads before the priority date. The court found that the cabinet of the controller was locked, so that it could not be examined by members of the public.
"In the case of a written description, what is made available to the public is the description and it is irrelevant whether it is read. In the case of a machine it is that machine which is made available and it is irrelevant whether it is operated in public .... Thus what is made available to the public by a machine....is that which the skilled man would, if asked to describe its construction and operation, write down having carried out an appropriate test or examination." (emphasis added).
It was held that although the locked controller could not have been examined, it could have been tested and the claimed features discovered. Accordingly, anticipation was found.
The general approach taken by the EPO when considering a prior published generic disclosure is to consider whether the skilled man "would seriously contemplate" working within the sub-range corresponding to the invention(21). A recording layer was stated in a prior publication to be less than or equal to 3µm in thickness, but preferably 0.1 to 3µm. It was stated in the prior document "if the thickness of the recording layer is too small... a low or insufficient reproduced output is obtained.... Therefore... the minimum thickness of the recording layer is at least 0.1µm and preferably at least 0.5µm". It was held that in view of this reasoned statement dissuading the skilled person from utilising the thickness range below 0.1µm, a claim specifying a thickness range of 0.05µm to 0.1µm was novel over this disclosure.
c) not a mere embodiment of the prior description but another invention.
It is interesting to note the approach taken in item c), in which the EPO first identifies the invention before considering novelty.
In view of the EPO Decisions on enabling disclosure, it is submitted that the correct view is that if the prior disclosure enables the product to be made and the product is explicitly disclosed, then no invention can lie in the later preparation of that product, no matter what properties may be discovered.
Thus in Decision T 958/9023 claims to the use of IDA as an additive for improving the performance of NTA as a sequestering agent were held to be anticipated by an earlier disclosure of NTA/IDA mixtures as precursors in a process for obtaining NTA as a sequestering agent. The Board held that an additional reason to do what had already been proposed as a solution to the same technical problem could not be regarded as a new functional technical feature.
However a list of compounds in a prior document is considered to be a disclosure of each and every one of those compounds so that a later claim to one of those compounds or to a selection from the list lacks novelty irrespective of any selection advantage. A disclosure of one reactant in conjunction with a group of co-reactants defined by a generic formula is considered not to be a disclosure of a product formed by reacting the reactant with a co-reactant selected from the group(24) and a selection from two lists of starting compounds is considered not to anticipate a product obtained by reacting a particular pair of such compounds, provided that the selected starting compounds are not disclosed in association with each other in the prior document(25). By the same token, a generic formula having two or more ranges of numbers relating to respective substitutents is considered not to anticipate a later formula limited to respective subsets of the disclosed ranges of substituents. However a disclosed range e.g. C1-4 alkyl does disclose the compounds defining the ends of the range viz. C1 (methyl) and C4 (butyl).
Furthermore it has been held that(26) the individual enantiomers (the distinct right- and left-handed molecular structures) of a chiral compound are not anticipated by a disclosure of that compound in racemic form (ie the normally occurring 50/50 mixture of the enantiomers).
The discrepancy between the treatment of continuous variables and discrete variables was illustrated in Decision T 763/89, wherein it was held that a claim to a specified colour photographic material having 3 layers was not anticipated by a prior art document disclosing a corresponding material having "at least two" layers. Only two-;layer materials were exemplified in the prior art document. It was held that, unlike consecutive numeral ranges, numerical values which could only be whole numbers served to characterise objects which were clearly defined. Thus if an earlier document discloses a temperature of "at least 2 degrees C" a later invention limited to 3 degrees C or greater would be anticipated.
The discrepancy here between the consideration of discrete and continuous variables on the one hand, and continuous variables on the other could lead to odd results.
It is clear that the invention must first be identified and that only then can novelty be determined, by comparing it with the practical teaching derivable from the earlier disclosure. Accordingly decisions under the 1949 Act such as Bristol Myers(26) in which prior use of unanalysable material destroyed novelty and Wheatley's application(27) according to which the mere placement of an order was held to be "use" which anticipated the invention are submitted to be no longer applicable.
I acknowledge with thanks the support and assistance of Langner Parry and particularly Iain C Baillie in the production of an earlier version of this article.
27 1985 RPC pp 91 - 102"

References: Art 54
 Art 52
 Art 52
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