“… pemetrexed disodium (Alimta®, Eli Lilly and Company, Indianapolis, IN) has demonstrated thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase inhibition.”
“The role of folic acid in modulating the toxicity and efficacy of the multitargeted antifolate LY 231514 (pemetrexed) was discussed in Worzalla et al. (Anticancer Research 18: 3235-3240 (1998) Worzalla JF, Chuan S and Schultz RM).”
“[0005] Surprisingly and unexpectedly, we have now discovered that certain toxic effects such as mortality and nonhematologic events, such as skin rashes and fatigue, caused by antifolates, as a class, can be significantly reduced by the presence of a methylmalonic acid lowering agent as vitamin B12, without adverse adversely affecting therapeutic efficacy. The present invention thus generally relates to a use in the manufacture of a medicament for improving the therapeutic utility of antifolate drugs by administering to the host undergoing treatment with a methylmalonic acid lowering agent as vitamin B12. We have discovered that increased levels of methylmalonic acid is a predictor of toxic events in patients that receive an antifolate drug and that treatment for the increased methylmalonic acid, such as treatment with vitamin B12, reduces mortality and nonhematologic events, such as skin rashes and fatigue events previously associated with the antifolate drugs. Thus, the present invention generally relates to a use in the manufacture of a medicament for reducing the toxicity associated with the administration of an antifolate to a mammal by administering to said mammal an effective amount of said antifolate in combination with a methylmalonic acid lowering agent as vitamin B12. [0006] Additionally, we have discovered that the combination of a methylmalonic acid lowering agent as vitamin B12 and folic acid synergistically reduces the toxic events associated with the administration of antifolate drugs. Although, the treatment and prevention of cardiovascular disease with folic acid in combination with vitamin B12 is known, the use of the combination for the treatment of toxicity associated with the administration of antifolate drugs was unknown heretofore.”
“The current invention concerns the discovery that administration of a methylmalonic acid lowering agent such as vitamin B12 or a pharmaceutical derivative thereof, in combination with an antifolate drug such as pemetrexed disodium reduces the toxicity of the said antifolate drug.”
“[0021] As used herein, the term ‘in combination with’ refers to the administration of the vitamin B12 or pharmaceutical derivative, pemetrexed disodium, and optionally the folic acid; in any order such that sufficient levels of methylmalonic acid lowering agent and optionally folic acid are present to reduce the toxicity of an antifolate in a mammal. The administration of the compounds maybe simultaneous as a single composition or as two separate compositions or can be administered sequentially as separate compositions such that an effective amount of the agent first administered is in the patient's body when the second and/or third agent is administered. … [0022]The terms ‘antifolate’ and ‘antifolate drug’ generally refer to a chemical compound which inhibits at least one key folate-requiring enzyme of the thymidine or purine biosynthetic pathways, preferably thymidylate synthase (‘TS’), dihydrofolate reductase (‘DHFR’), or glycinamide ribonucleotide formyltransferase (‘GARFT’), by competing with reduced folates for binding sites of these enzymes. The ‘antifolate’ or ‘antifolate drug’ for use in this invention is Pemetrexed Disodium (ALIMTA®), as manufactured by Eli Lilly & Co. [0028] The term ‘FBP binding agent’ as used herein refers to a folic binding protein binding agent which includes folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid, and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a physiologically-available salt or ester thereof. … [0029] ‘Physiologically-available salt’ refers to potassium, sodium, lithium, magnesium, or preferably a calcium salt of the FBP binding agent. ‘Physiologically-available...ester’ refers to esters which are easily hydrolyzed upon administration to a mammal to provide the corresponding FBP binding agent free acid, such as for example C1-C4 alkyl esters,and mixed anhydrides.”
“1. Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin. 2. Use according to claim 1 wherein said medicament is to be administered in combination with vitamin B12 or apharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and a folic binding protein binding agent selected from folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-forinyl-5,6,7,8-tetrahydrofolic acid or a physiologically available salt or ester thereof. 12. A product containing pemetrexed disodium, vitamin B 12 or a pharmaceutical derivative thereof said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo10- chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a physiologically available salt or ester thereof, as a combined preparation for the simultaneous, separate or sequential use in inhibiting tumor growth.”
“1. Use of a methylmalonic acid lowering agent in the preparation of a medicament useful in lowering the mammalian toxicity associated with an antifolate, and the medicament is administered in combination with an antifolate. 2. Use of a methylmalonic acid lowering agent in the preparation of a medicament useful in lowering the mammalian toxicity associated with an antifolate, and the medicament is administered in combination with an antifolate and a FBP binding agent.”
“Present claims 1-11, 13-16 relate to an extremely large number of possible combinations of compounds defined as ‘antifolate’, ‘methylmalonic acid lowering agent’, ‘FBP binding agent’. In fact, the claims contain so many options and variables that a lack of clarity (and conciseness) within the meaning of Article 84 EPC arises. Moreover claims 1-11, 13-16 relate to a compounds defined by reference to desirable characteristics or properties, namely ‘antifolate’, ‘methylmalonic acid lowering agent’, ‘FBP binding agent’. The claims cover all compounds having these characteristics or properties, whereas the application provides support within the meaning of Article 84 EPC and disclosure within the meaning of Article 83 EPC for only a very limited number of such compounds. In the present case, the claims so lack support, and the application so lacks disclosure. Support is only to be found in the present application for those parts relating to the compounds/compositions prepared in the examples and those specifically defined by chemical name in claims 8-10, 12, 14-17. Independent of the above reasoning, claims 1-3, 6-12 also lack clarity (Article 84 EPC): A therapeutic application is defined in terms of a result to be achieved: ‘reducing toxicity’ (claims 1-3). No therapeutically defined use or disease is clearly encompassed under such wording. Again, this lack of clarity in the present case does not comply with Art 84 EPC. (See also Decision of the Board of Appeal T1048/98). Furthermore the abbreviations ‘FBP’ expressed on claims 2, 6, 7, 9, 13, 16 and ‘ALIMTA’ expressed on claims 10, 12, 15, 17 are unclear (Art 84 EPC). They should be replaced by the appropriate wording. ….”
“1. Use of pemetrexed in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof. 2. Use according to claim 1 wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof and a folic binding protein binding agent selected from folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid or a physiologically available salt or ester thereof.”
“The Applicant, having reviewed the scope of the application and in order to expedite the application proceeding to grant, has elected to amend the claims so as to more closely reflect the specific examples provided. The present amendments are made without prejudice to the Applicant's right to obtain protection for other patentable subject matter in one or more divisional applications. Claims 1-12 have been refocused on the use of the antifolate compound pemetrexed. Basis can be found at page 2 line 6-7 and page 6 line 16 of the application as filed. The term ‘methylmalonic acid lowering agent’ has been replaced by ‘vitamin B12 or a pharmaceutical derivative thereof’. Basis for this can be found page 6 lines 19-21 and page 7 line 5 of the application as filed. … In claim 2 the term ‘FBP binding agent’ has been expounded in full following page 8 lines 6-7. Additionally, this term has been further refined according to page 8 lines 7-9 of the application as filed. …”
“Amendments (Art. 123 (2) EPC) The amendments filed with letter 23.12.2004 do not comply with the requirements of Art. 123(2) EPC in so far as they introduce subject matter beyond the content of the originally filed documents. The amendments concerned are the following: The subject matter of claims 1-16 and description pages 4, line 18- page 4a. The subject matter of present claims 1 reading ‘use of pemetrexed... ‘ and claim 13 "a product containing pemetrexed... ‘ do not find base in the application documents as filed. The term ‘pemetrexed’ in the wording of these claims and the corresponding passages on amended description is certainly a distinct compound (CAS Registry number 137281-23-3) of the ‘pemetrexed disodium’ (CAS Registry number 150399-23-8) expressed on original document description page 2, line 6 and page 6, line 16. Said amendment beyond the content of the original document is therefore not allowable (Art. 123 (2) EPC). Dependent claims 2-12, 14-16 in so far as related to ‘pemetrexed’ are consequently not allowable according to Art. 123(2) EPC. ”
“The Claims have been amended to refer to the preferred embodiment, the use of pemetrexed disodium (ALIMTA®) as manufactured by Eli Lilly and Company, as the antifolate drug. The Claims have also been amended to incorporate the list of vitamin B12 derivatives set out on page 7 lines 6-7 of the application as filed.”
“.. The board is clearly saying that this form of claim does not fall foul of article 52(4). Making up the substance for administration is not in itself administration—is not treatment. That would seem to be the case whether the substance is made up in a factory … or in a pharmacy (where it may even be patient-specific). We emphasise this because sometimes in the discussion there is a tendency to conflate the novelty and therapeutic treatment objections, as though one followed from the other. What worried the board was only novelty.”
“… There is nowhere near the degree of involvement of medical personnel which turned the case in the Bristol-Myers Squibb case. In its essence the claim here is to the use of finasteride for the preparation of a medicament of the specified dosages. It is not aimed at and does not touch the doctor—it is directed at the manufacturer. …”
“54. It is, I think, inherent in all this reasoning that the skilled person would generally understand a Swiss form claim to mean that the medicament must contain the active ingredient for which the new and inventive use has been found. But for the exclusion contained in art.52(4) EPC 1973, the claim would have been directed to the new and non obvious use of that ingredient. 55. I do not go so far as to suggest that a claim cast in Swiss form must always be construed as being directed to the use of an active ingredient for the manufacture of a medicament which contains that ingredient. The proper meaning of the claim must be determined having regard to the words of the claim when construed purposively in the light of the specification and the common general knowledge, as the Court of Appeal emphasised in Monsanto & Co v Merck & Co Inc (No.1) [2000] R.P.C. 77. However, it seems to me that is how it would normally be understood. Moreover, the skilled person would appreciate that to construe it otherwise would render the claim vulnerable to an attack of insufficiency.”
“… even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem to which the patent is addressed would acquire that information as a matter of routine. For example, if the problem is how to formulate a particular pharmaceutical substance for administration to patients, then it may be shown that the skilled formulator would as a matter of routine start by ascertaining certain physical and chemical properties of that substance (e.g. its aqueous solubility) from the literature or by routine testing. If so, it is legitimate to take that information into account when assessing the obviousness of a particular formulation. But that is because it is obvious for the skilled person to obtain the information, not because it is common general knowledge.”
“The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.”
“Article 1 General principles Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties. Article 2 Equivalents For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.”
“My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. ‘skilled in the art’), by which he informs them what he claims to be the essential features of the new product or process for which the letters patent grant him a monopoly. It is those novel features only that he claims to be essential that constitute the so-called ‘pith and marrow’ of the claim. A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked. The question, of course, does not arise where the variant would in fact have a material effect upon the way the invention worked. Nor does it arise unless at the date of publication of the specification it would be obvious to the informed reader that this was so. Where it is not obvious, in the light of then-existing knowledge, the reader is entitled to assume that the patentee thought at the time of the specification that he had good reason for limiting his monopoly so strictly and had intended to do so, even though subsequent work by him or others in the field of the invention might show the limitation to have been unnecessary. It is to be answered in the negative only when it would be apparent to any reader skilled in the art that a particular descriptive word or phrase used in a claim cannot have been intended by a patentee, who was also skilled in the art, to exclude minor variants which, to the knowledge of both him and the readers to whom the patent was addressed, could have no material effect upon the way in which the invention worked.”
“If the issue was whether a feature embodied in an alleged infringement which fell outside the primary, literal or acontextual meaning of a descriptive word or phrase in the claim (‘a variant’) was nevertheless within its language as properly interpreted, the court should ask itself the following three questions: (1) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no? (2) Would this (ie that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes? (3) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim. On the other hand, a negative answer to the last question would lead to the conclusion that the patentee was intending the word or phrase to have not a literal but a figurative meaning (the figure being a form of synecdoche or metonymy) denoting a class of things which include the variant and the literal meaning, the latter being perhaps the most perfect, best-known or striking example of the class.”
“32. …. Construction is objective in the sense that it is concerned with what a reasonable person to whom the utterance was addressed would have understood the author to be using the words to mean. Notice, however, that it is not, as is sometimes said, ‘the meaning of the words the author used’, but rather what the notional addressee would have understood the author to mean by using those words. The meaning of words is a matter of convention, governed by rules, which can be found in dictionaries and grammars. What the author would have been understood to mean by using those words is not simply a matter of rules. It is highly sensitive to the context of, and background to, the particular utterance. It depends not only upon the words the author has chosen but also upon the identity of the audience he is taken to have been addressing and the knowledge and assumptions which one attributes to that audience. ... 33. In the case of a patent specification, the notional addressee is the person skilled in the art. He (or, I say once and for all, she) comes to a reading of the specification with common general knowledge of the art. And he reads the specification on the assumption that its purpose is to both to describe and to demarcate an invention—a practical idea which the patentee has had for a new product or process—and not to be a textbook in mathematics or chemistry or a shopping list of chemicals or hardware. It is this insight which lies at the heart of ‘purposive construction’. … The purpose of a patent specification, as I have said, is no more nor less than to communicate the idea of an invention. An appreciation of that purpose is part of the material which one uses to ascertain the meaning. But purpose and meaning are different. … There is no presumption about the width of the claims. A patent may, for one reason or another, claim less than it teaches or enables. 34. ‘Purposive construction’ does not mean that one is extending or going beyond the definition of the technical matter for which the patentee seeks protection in the claims. The question is always what the person skilled in the art would have understood the patentee to be using the language of the claim to mean. And for this purpose, the language he has chosen is usually of critical importance. The conventions of word meaning and syntax enable us to express our meanings with great accuracy and subtlety and the skilled man will ordinarily assume that the patentee has chosen his language accordingly. As a number of judges have pointed out, the specification is a unilateral document in words of the patentee's own choosing. Furthermore, the words will usually have been chosen upon skilled advice. The specification is not a document inter rusticos for which broad allowances must be made. On the other hand, it must be recognised that the patentee is trying to describe something which, at any rate in his opinion, is new; which has not existed before and of which there may be no generally accepted definition. There will be occasions upon which it will be obvious to the skilled man that the patentee must in some respect have departed from conventional use of language or included in his description of the invention some element which he did not mean to be essential. But one would not expect that to happen very often. 35. One of the reasons why it will be unusual for the notional skilled man to conclude, after construing the claim purposively in the context of the specification and drawings, that the patentee must nevertheless have meant something different from what he appears to have meant, is that there are necessarily gaps in our knowledge of the background which led him to express himself in that particular way. The courts of the United Kingdom, the Netherlands and Germany certainly discourage, if they do not actually prohibit, use of the patent office file in aid of construction. There are good reasons: the meaning of the patent should not change according to whether or not the person skilled in the art has access to the file and in any case life is too short for the limited assistance which it can provide. It is however frequently impossible to know without access, not merely to the file but to the private thoughts of the patentee and his advisors as well, what the reason was for some apparently inexplicable limitation in the extent of the monopoly claimed. One possible explanation is that it does not represent what the patentee really meant to say. But another is that he did mean it, for reasons of his own; such as wanting to avoid arguments with the examiners over enablement or prior art and have his patent granted as soon as possible. This feature of the practical life of a patent agent reduces the scope for a conclusion that the patentee could not have meant what the words appear to be saying. It has been suggested that in the absence of any explanation for a restriction in the extent of protection claimed, it should be presumed that there was some good reason between the patentee and the patent office. I do not think that it is sensible to have presumptions about what people must be taken to have meant, but a conclusion that they have departed from conventional usage obviously needs some rational basis.”
“The Protocol, as I have said, is a Protocol for the construction of art.69 and does not expressly lay down any principle for the construction of claims. It does say what principle should not be followed, namely the old English literalism, but otherwise it says only that one should not go outside the claims. It does however say that the object is to combine a fair protection for the patentee with a reasonable degree of certainty for third parties. How is this to be achieved? The claims must be construed in a way which attempts, so far as is possible in an imperfect world, not to disappoint the reasonable expectations of either side. What principle of interpretation would give fair protection to the patentee? Surely, a principle which would give him the full extent of the monopoly which the person skilled in the art would think he was intending to claim. And what principle would provide a reasonable degree of protection for third parties? Surely again, a principle which would not give the patentee more than the full extent of the monopoly which the person skilled in the art would think that he was intending to claim. Indeed, any other principle would also be unfair to the patentee, because it would unreasonably expose the patent to claims of invalidity on grounds of anticipation or insufficiency.”
“41. There is often discussion about whether we have a European doctrine of equivalents and, if not, whether we should. It seems to me that both the doctrine of equivalents in the United States and the pith and marrow doctrine in the United Kingdom were born of despair. The courts felt unable to escape from interpretations which ‘unsparing logic’ appeared to require and which prevented them from according the patentee the full extent of the monopoly which the person skilled in the art would reasonably have thought he was claiming. The background was the tendency to literalism which then characterised the approach of the courts to the interpretation of documents generally and the fact that patents are likely to attract the skills of lawyers seeking to exploit literalism to find loopholes in the monopoly they create. (Similar skills are devoted to revenue statutes.) 42. If literalism stands in the way of construing patent claims so as to give fair protection to the patentee, there are two things that you can do. One is to adhere to literalism in construing the claims and evolve a doctrine which supplements the claims by extending protection to equivalents. That is what the Americans have done. The other is to abandon literalism. That is what the House of Lords did in the Catnic case … 44. Since the Catnic case we have art.69 which, as it seems to me, firmly shuts the door on any doctrine which extends protection outside the claims. … 49. Although art.69 prevents equivalence from extending protection outside the claims, there is no reason why it cannot be an important part of the background of facts known to the skilled man which would affect what he understood the claims to mean. That is no more than common sense. It is also expressly provided by the new art.2 added to the Protocol by the Munich Act revising the EPC, dated November 29, 2000 … 52. … When speaking of the ‘Catnic principle’ it is important to distinguish between, on the one hand, the principle of purposive construction which I have said gives effect to the requirements of the Protocol, and on the other hand, the guidelines for applying that principle to equivalents, which are encapsulated in the Protocol questions. The former is the bedrock of patent construction, universally applicable. The latter are only guidelines, more useful in some cases than in others. …. ”
“The German courts have their own guidelines for dealing with equivalents, which have some resemblance to the Protocol questions. In the ‘quintet’ of cases before the Bundesgerichtshof (see, for example, Kunstoffrohrteil [2002] G.R.U.R. 511 and Schneidemesser 1 [2003] E.N.P.R. 12 309) which concerned questions of whether figures or measurements in a claim allow some degree of approximation (and, if so, what degree), the court expressly said that its approach was similar to that adopted in Catnic. But there are differences from the Protocol questions which are lucidly explained by Dr Peter Meier-Beck (currently a judge of the 10th Senate) in a paper to be published in the International Review of Intellectual Property and Competition Law (IIC). For example, German judges do not ask whether a variant ‘works in the same way’ but whether it solves the problem underlying the invention by means which have the same technical effect. That may be a better way of putting the question because it avoids the ambiguity illustrated by American Home Products Corp v Novartis Pharmaceuticals UK Ltd [2001] R.P.C. 8 over whether ‘works in the same way’ involves an assumption that it works at all. On the other hand, as is illustrated by the present case, everything will depend upon what you regard as ‘the problem underlying the invention.’ It seems to me, however, that the German courts are also approaching the question of equivalents with a view to answering the same ultimate question as that which I have suggested is raised by Art.69, namely what a person skilled in the art would have thought the patentee was using the language of the claim to mean.”
“I do not dispute that a claim may, upon its proper construction, cover products or processes which involve the use of technology unknown at the time the claim was drafted. The question is whether the person skilled in the art would understand the description in a way which was sufficiently general to include the new technology. There is no difficulty in principle about construing general terms to include embodiments which were unknown at the time the document was written. One frequently does that in construing legislation, for example, by construing ‘carriage’ in a 19th century statute to include a motor car. In such cases it is particularly important not to be too literal. It may be clear from the language, context and background that the patentee intended to refer in general terms to, for example, every way of achieving a certain result, even though he has used language which is in some respects inappropriate in relation to a new way of achieving that result. ….”
“We think it would unrealistic – indeed perverse – for the law to say that the notional skilled reader, probably with the benefit of skilled advice, would not know and take into account the explicit drafting conventions by which the patent and its claims were framed. Likewise when there is a reference to the patent being a divisional application, it would be perverse to work on the basis that the skilled man would not know what that means. A real skilled man reading a patent which, as in the case of the Patent, refers to ‘the parent application’ would surely say ‘what's a parent application?’ – and he would go on to ask a man who knows, probably a patent agent.”
“Does the specification make it obvious to the skilled addressee that the reference to pemetrexed disodium as being the source of pemetrexed in an intravenous solution could not have been intended to exclude some other source of pemetrexed which made no material difference to the way pemetrexed worked when administered in conjunction with vitamin B12?”
“General comments on the French legal system After discussion, neither of the two experts noted any disagreement on this section. They also agreed, in particular, on the following conclusions: - They reiterate that case-law does not constitute a real source of law: Only legislation (whether or not codified, and administrative texts such as decrees) is applied by the Courts which never refer to previous case rulings. - The ‘cours’ and ‘tribunaux’ (Courts) are indeed prohibited from handing down ‘arrest de règlement’, i.e. from giving a general and impersonal solution in the particular case on which they are ruling. - It is nonetheless true that homogeneous sets of case-law, referred to as ‘jurisprudence constante’ may have an influence on the way the Courts rule, as do the rulings of the Supreme Court (Cour de cassation), since the role of said Court is, precisely, to harmonise the case-law of the lower Courts. Doctrine of equivalents After discussion, neither of the two experts noted disagreement on this section either. They comment in particular: - France is bound by Article 69 of the European Patent Convention (EPC) and by its Protocol on Interpretation, amended on revision of the EPC in 2000. Article L.613-2 of the Intellectual Property Code (IPC) introduced Article 69 of the EPC into French law. Regarding European patents designating France, said provisions are directly applied by the Courts. - However, the doctrine of equivalents is not, as such, enshrined in French law. It is the subject of a doctrinal definition which has been widely adopted by the Courts, inparticular the Supreme Court, according to which means which are different in form but perform the same function to achieve a similar result, are equivalent. Thus equivalence is characterised by identical function. - For this doctrine to apply, there is no need for the claim to be unclear or for it to be widely worded (thus referring to ‘general means’) - On the other hand, where the claim is narrowly worded, the doctrine of equivalents only applies on condition that the function is a new one. Should the function of the means be known, the scope of the claim shall be limited to the claimed structure. Should the function be new, any means which perform the same function with a view to the same result shall be considered to be equivalent to the claimed means, even if the latter is precisely claimed. - Equivalents are distinguished from simple embodiment variations (‘variants d’exécution’) which are insignificant changes affecting non-essential means of the invention, i.e. which do not produce or do not contribute to producing a technical effect. Use of the prosecution history before the EPO After discussion, neither of the two experts noted any disagreement on this section. In particular, they agree: - That the French Courts quite often refer to the prosecution history file where interpretation of the claims is concerned, and to assess the scope of protection granted. The Supreme Court accepts such a consideration so long as the claims remain the source of interpretation. - Said documents are considered as being factual data amongst all such data subject to the Court’s assessment. From this point of view, the French Courts do not distinguish between the different types of document arising from the prosecution file (letters from the examiner, statements by the patentee or by third parties etc.): all these documents have the same probative value. - Reference to said file is not restricted to cases where infringement by equivalence is alleged.”
“But whereas if it is accepted, in the presence of a groundbreaking invention, that the patent can describe a way of carrying out the invention and claim any other possible way of carrying it out, it cannot be given a general scope, even if it is groundbreaking, if its claims are drafted in restrictive terms; Whereas more specifically, a non-ambiguous claim with narrow scope cannot through interpretation be given a general scope, in particular when the patentee has been forced, in order to distinguish the invention from the prior art, to limit the scope of the claim in the context of the granting process; … Yet whereas the patentee who amended its clauses to give them a limited scope may not, without putting the safety of third parties at risk, claim that the amendments were not necessary, nor that the limited claims have the same scope as the broader claims; …”
“Articles 69 EPC and Protocol are directly applicable in Italy. There is in Italy a doctrine of equivalence which applies when not all the claimed features are reproduced literally by the accused product or process. No specific rules are set forth by Italian law on the relevance of the file history to the purpose of claim construction. No decisions of the Supreme Court have been delivered acknowledging the relevance of the file history. … The Supreme Court starting from the Barilla's case has broadened the scope of the doctrine of equivalence also to solutions which are inventive, even though Prof. Franzosi believes that the issue is not the inventive step of the infringing solution but the relation of the accused infringement and the claims. On the equivalence, Prof. Franzosi agrees with the summary of the principles of the case law of the Supreme Court in paragraph 70 of Prof. Guglielmetti's report, even though Prof. Franzosi believes that such case law does not properly reflect the present law. … As to the date to be considered for determining the common general knowledge available to the skilled person in order to assess the infringement, Prof. Franzosi and Guglielmetti agree that the date to be considered is that on which the infringement is to be assessed, although Prof. Franzosi thinks that the case law is not entirely clear.”
“1. Claims indicate, specifically, what is intended to form the object of the patent. 2. The limits of protection are determined by the claims; however description and drawings serve to interpret (have the function of interpretation) the claims. 3. The rule of sect. 2, above, has to be understood so as to guarantee at the same time a fair (equitable) protection to the owner and a reasonable legal security for third parties. 3bis. For determining the scope of protection conferred by a patent, due consideration is given to every element equivalent to an element indicated in the claims.”
“The description, including the indications laid down by Art.28 of [the LI] must begin with a summary that is for technical information purposes only, and must end with one or more claims in which it must be specifically indicated what is intended to form the subject matter of the patent.”
“(i) the ‘inventive core’ of the patent must first be identified; (ii) the contested device infringes the patent if it reproduces the ‘inventive core’of the patent, unless it is non-obvious in respect of the ‘inventive core’; (iii) when some elements of the infringing device include non-obvious modifications, it does not automatically exclude infringement by equivalence if the modifications do not exclude the use, even in part, of the patent; and (iv) the mere lack of some elements of the patented device in the contested device does not automatically exclude infringement if the ‘inventive core’of the idea protected by the patent is reproduced in the contested device, and if the removal of those elements in the contested device is not inventive.”
“a. General issues on Spanish Law (questions addressed in the reports issued by Prof. Bercovitz and Desantes) 1. The sources of Spanish Law. 2. The scope of binding effect of Spanish jurisprudence. 3. The direct effect and direct applicability in Spain of International Treaties, including the European Patent Convention (EPC). 4. The primacy of the EPC over national Law in Spain. 5. The EPC should be the basis for the interpretation of the corresponding Spanish patent Law. 6. The direct effect, direct applicability and primacy in Spain of Article 69 EPC and the Protocol on its Interpretation. 7. Art. 1 of the Protocol of Interpretation constitutes a compromise between the extremes of strictly literal claim construction and the relegation of the claims to the status of guidelines. 8. Art. 69 EPC and its Protocol of Interpretation have played an important role in Spain for extending the protection of the patent to infringement by equivalence cases. b. Direct patent infringement. Equivalents (questions addressed in the reports issued by Prof. Bercovitz and Desantes) 1. The notion of equivalence. 2. The Spanish Courts understand that the scope of the patent should be objectively based on claim content regardless of the subjective intention of the patentee. 3. The scope of protection of the patent extends to equivalents. 4. In Spain, the doctrine of equivalents is not applied to the invention as a whole but to each of the elements described in the claims - element by element analysis. 5. In Spain, the scope of protection of the claims must in all cases be construed in the light of the description and the drawings. 6. The EPC does not impose on national courts any specific and closed definition of equivalents. c. Application of the doctrine of equivalents by Spanish Courts (question addressed in the reports issued by Prof. Bercovitz and Desantes) 1. The doctrine of equivalents cannot be used to extend the scope of the patent beyond what the applicant has protected nor should equivalence be used to allow the patentee to portray a claimed feature as ‘irrelevant’ or to compensate for mistakes. 2. Spanish Courts have been alternating various types of tests, as shown by the Supreme Court judgment dated10 May 2011 (Olanzapine case). 3. The relevance of the test of obviousness, amongst others, in pharmaceutical cases (Olanzapine case) 4. Spanish Courts in fact apply the doctrine of one's own acts (doctrina de los actos propios) while sometimes they refer erroneously to the ‘prosecution history estoppel’ doctrine, which is not applied as such. 5. The doctrine of one's own acts is a general civil law doctrine which applies not only to patent claim construction but also to any other civil law issue. 6. An own act can be something different than a change of a claim. 7. The requirements for the application of the doctrine of one's own acts. 8. None of the judgments quoted in paragraph 60 of the Expert Report by Prof. Bercovitz refer to patents but to general civil law cases and there are cases where the doctrine has been applied to patents. 9. Limitations are also possible in other areas further than prior art. 10. The Spanish Courts have never considered whether the relevant date is the priority date or the publication date in a case on which this issue was relevant for the outcome of the case.”
“1. Does the variant alter the functioning of the invention? If the answer is yes, equivalence does not exist. If the answer is no, i.e. the functioning of the invention is not altered, it is necessary to ask the next question. 2. Would the variant have been obvious to a skilled person who read the patent on the date when it was published? If the variant was not obvious i.e. it is inventive, there is no equivalence. If the answer is yes, it is still necessary to ask the third question. 3. Would the person skilled in the art who read the patent have understood, given the terms used in the claim, that the patent holder intended that strict compliance with the literal wording was an essential requirement of the invention? If the answer is yes then there can be no equivalence. But if strict compliance is not essential then the variant may be equivalent.”
“The ‘actos proprios’ doctrine, as established in Spanish case law, is very clear on the requirement whereby the ‘statements’ must be unequivocal, clear, precise, conclusive, undoubted and must not reflect any kind of ambiguity. From that perspective, only explicit statements would have to be considered.”
“The Chamber deems it a contradiction with his own acts for the patent’s applicant to have renounced a broader scope of protection during the patent’s application proceedings, by introducing technical features which reduce the scope protected by its claims, and, subsequently, after the registration, to have attempted to broaden the scope of protection to include in its features that had been excluded from it by virtue of restrictions added by the applicant himself.”
“(2) Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom. (3) Subsection (2) above shall not apply to the supply or offer of a staple commercial product unless the supply or the offer is made for the purpose of inducing the person supplied or, as the case may be, the person to whom the offer is made to do an act which constitutes an infringement of the patent by virtue of subsection (1) above.”
“Prohibition of indirect use of the invention 1. A Community patent shall also confer on its proprietor the right to prevent all third parties not having his consent from supplying or offering to supply within the territories of the Contracting States a person, other than a party entitled to exploit the patented invention, with means relating to an essential element of that invention, for putting it into effect therein, when the third party knows, or it is obvious in the circumstances, that these means are suitable and intended for putting that invention into effect. 2. Paragraph 1 shall not apply when the means are staple commercial products, except when the third party induces the person supplied to commit acts prohibited by Article 25. 3. Persons performing the acts referred to in Article 27(a) to (c) shall not be considered to be parties entitled to exploit the invention within the meaning of paragraph 1.”
“3. Reconstitute 500mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed. Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 and 7.8. Further dilution is required. 4. The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.”
“The proper functioning of the internal market creates a need, in order to improve the predictability of the outcome of litigation, certainty as to the law applicable and the free movement of judgments, for the conflict-of-law rules in the Member States to designate the same national law irrespective of the country of the court in which an action is brought.”
“Scope 1. This Regulation shall apply, in situations involving a conflict of laws, to non-contractual obligations in civil and commercial matters. … 3. This Regulation shall not apply to evidence and procedure, without prejudice to Articles 21 and 22.”
“Scope of the law applicable The Law applicable to non-contractual obligations under this Regulation shall govern in particular: (a) the basis and extent of liability, including the determination of persons who may be held liable for acts performed by them; (b) the grounds for exemption from liability, any limitation of liability and any division of liability; (c) the existence, the nature and the assessment of damage or the remedy claimed; (d) within the limits of powers conferred on the court by its procedural law, the measures which a court may take to prevent or terminate injury or damage or to ensure the provision of compensation; (e) the question whether a right to claim damages or a remedy may be transferred, including by inheritance; (f) persons entitled to compensation for damage sustained personally; (g) liability for the acts of another person; (h) the manner in which an obligation may be extinguished and rules of prescription and limitation, including rules relating to the commencement, interruption and suspension of a period of prescription or limitation.”
“Burden of Proof 1. The law governing a non-contractual obligation under this Regulation shall apply to the extent that, in matters of non-contractual obligations, it contains rules which raise presumptions of law or determine the burden of proof. 2. Acts intended to”
“This amendment takes account of the universal principle of lex fori within private international law that the law applicable to procedural questions, including questions of evidence, is not the law governing the substantive legal relationship (lex causae), but, rather, the law of the forum.”
“A distinction should be made between the availability of a given remedy – generally, injunctive relief and/or damages – and the procedure(s) available to the plaintiff to request those remedies. It is submitted that only the latter is governed by the law of the forum. If this distinction is applied to the thorny question of the applicable law to an action for interim injunctive relief, a distinction must be made between two legal issues. First, the court must investigate whether the claimed remedy is available under the lex loci protectionis. Provided this is so, it is up to the national procedural rules to determine whether shortened and/or accelerated proceedings are available to the plaintiff.”
“Any person who proves exploiting industrially on the territory of a Member State of the European Economic Community, or serious and effective preparations to that effect, may invite the owner of a patent to take position on the opposability of his title against such industrial exploitation, the description of which shall be communicated to him. If such person disputes the reply that is given to him or if the owner of the patent has not taken a position within a period of three months, he may bring the owner of the patent before the Court for a decision on whether the patent constitutes an obstacle to the industrial exploitation in question, without prejudice to any proceedings for the nullity of the patent or subsequent infringement proceedings if the working is not carried out in accordance with the conditions specified in the description referred to in the above paragraph”
“The right of action is available to all those who have a legitimate interest in the success or dismissal of a claim, without prejudice to those cases where the law confers the right of action solely upon persons who it authorises to raise or oppose a claim, or to defence a particular interest.”
“In order to state a claim or to oppose the same, the claimant and the opponent must have a legitimate interest.”
“The most recent case law of the Supreme Court has in fact broadened the scope of enforceability of declaratory actions or of actions of mere declaratory assessment, observing that the interest in bringing forth a lawsuit for a mere declaratory judgment does not necessarily imply the actual occurrence of an infringement on a right or a dispute (contestazione) as a state of objective uncertainty is sufficient with regards to the exact scope of rights and mutual obligations arising from any legal transaction as in the present case.”
“1. Any interested person may file an action against the owner of the patent so that the competent judge may declare that a particular act does not constitute infringement of the patent. 2. Before filing the action, the interested person shall, through notarial channels, demand that the patent owner make known his position on the opposability of the patent to the industrial exploitation carried out in Spain by the claimant or serious and effective preparations being made for that purpose. The person making the demand may file the action provided for in the preceding paragraph if the patent owner has not replied within one month of the date of the demand, or if he does not agree with the reply. 3. The action specified in paragraph 1 above may not be filed by any person against whom a claim for infringement of the said patent has been brought. 4. Where the claimant proves that the act referred to in the claim does not constitute infringement of the patent, the judge shall grant the declaration that was demanded. 5. The claim shall be notified to all persons owning rights in the patent who are duly entered in the Register, so that they may appear and take part in the proceedings. Nevertheless, holders of contractual licenses may not appear in the proceedings where their license contracts so specify. 6. The action referred to in the present Article may be brought jointly with an action to declare the invalidity of the patent.”
“The purpose of this Section is to avoid future infringement proceedings in borderline cases. It is possible that a person’s present or future activity may perhaps be an infringement, but that the person is not certain. In order to clarify the matter, he may avail himself of the procedure provided for in this Section. If the outcome is favourable to him, in other words, if the court’s finding is that the performance of the act in question does not infringe the patent, the person may engage in (or continue) his activity without risk, whereas he will discontinue (or forgo) the activity if the court’s finding is unfavourable to him.”
“When starting or continuing a particular industrial activity it is of extreme relevance to have the assurance that no other’s patents are violated. Consider, in fact, that for any productive activity it is necessary to make investments that may be lost if later that activity cannot be developed because it infringes a patent. This unfortunate situation can be avoided if in cases of doubt the action for declaration of non-infringement is filed, avoiding therefore the invidious position of a defendant accused of having infringed the rights arising from a patent.”
"… the inherent power which any court of justice must possess to prevent misuse of its procedure in a way which, although not inconsistent with the literal application of its procedural rules, would nevertheless be manifestly unfair to a party to litigation before it, or would otherwise bring the administration of justice into disrepute among right-thinking people. The circumstances in which abuse of process can arise are very varied .... It would, in my view, be most unwise if this House were to use this occasion to say anything that might be taken as limiting to fixed categories the kinds of circumstances in which the court has a duty (I disavow the word discretion) to exercise this salutary power."
"... a broad, merits-based judgment which takes account of the public and private interests involved and also takes account of all the facts of the case, focusing attention on the crucial question whether, in all the circumstances, a party is misusing or abusing the process of the court ..."
"An abuse of process is of concern not merely to the parties but to the court. It is no longer the role of the court simply to provide a level playing field and to referee whatever game the parties choose to play upon it. The court is concerned to ensure that judicial and court resources are appropriately and proportionately used in accordance with the requirements of justice."
"The issues which the claimant seeks to raise are plainly public law issues and should properly be dealt with by judicial review proceedings under Part 54. The reason why the claimant has resorted to the Part 8 procedure is obvious. The claimant is seeking to circumvent the time limits contained in Part 54."
“… the problem which Lilly says exists is one which exists, to the extent that it does, by virtue of the First and Third Actions and the consequences of the pendency of those actions. There is, and can be, no dispute that the First and Third Actions are properly constituted actions over which it has been decided that this court has jurisdiction. Those actions have whatever consequences in terms of lis pendens that they have. If Lilly is correct in saying that the lis pendens consequences of those actions is to prevent Lilly from bringing actions in France and Spain and thus of depriving Lilly of the procedural protections to which it claims to be entitled under French and Spanish law, as to which I express no view, then that is a natural consequence of the existence of the First and Third Actions. It is not a consequence of the bringing of the Fourth and Fifth Actions. In those circumstances, I cannot see that the Fourth and Fifth Actions are an abuse. Actavis are simply taking ordinary procedural steps to overcome procedural obstacles raised by Lilly.”