1. State of the art
Federal Patent Court, 7 October 2015 (O2013_006)
Keywords: novelty – public prior use – standard of proof
The patent at issue concerned a hydraulic pressing device for use in certain joining procedures. Its revocation was sought, inter alia for public prior use.
The Swiss Federal Patent Court, noting that parallel proceedings on this case had already been brought before an EPO board of appeal and before Germany's Federal Patent Court, observed that any related judgments by foreign courts should be taken into account, in the interests of harmonisation within Europe. Parties should therefore bring them to the Court's attention straight away, at whatever procedural stage they were issued.
The Court held that a party asserting prior use has to prove who disclosed what technical teaching to whom, at what point before the priority date and under what circumstances. That meant putting forward a chain of substantiated and clearly inter-connected assertions, supported by any evidence showing these facts in combination. In case of dispute, the party thus had to prove that a specific event or deed had actually taken place.
The Court regards an assertion as proven if, looking at the evidence objectively, it is convinced it is accurate. Absolute certainty is not required; it suffices if the Court no longer seriously doubts the alleged fact.
Proof can be provided in various different ways. One example might be a dated invoice or delivery voucher which is addressed to a specific third party not bound to secrecy and contains a specific reference (e.g. machine number) clearly linking it to defined technical subject-matter, backed up by a further document enabling this reference to be attributed to a specific technical teaching (e.g. a technical drawing bearing the same number). Inspecting a machine, on the other hand, can prove only how the machine looked when inspected, not when delivered.
In this case, the Court found that public prior use had occurred, partly allowed the revocation action, and limited the patent.
Federal Patent Court, 10 June 2016 (O2012_043)
Keywords: novelty – public prior use – secrecy agreement
The invention concerned a rail vehicle with a drive unit (EP 1 963 157). The alleged infringer (defendant) argued that the patent should be revoked by reason of public prior use: design documents disclosing all the claimed features had been sent out. The only question was whether these documents were covered by a secrecy agreement.
One of the defendant's competitors had sent a third-party supplier an enquiry in which it did mention an obligation to maintain secrecy. This third party had then e-mailed the design documents to both the competitor and the defendant. Neither the e-mail nor the actual design documents had indicated that they were secret.
The Court cited EPO board of appeal case law (T 173/83, T 958/91, T 602/91) holding that technical information sent to a client would not normally be considered secret. Unless the sender expressly stated that it was secret, he had to assume that it would become public, and the recipient that he was free to pass it on to third parties.
So in this case sending the documents had in principle made them public, unless in the given circumstances – e.g. co-operation on product development – an implied secrecy agreement had existed. That however was the exception, and had to be quite clear from the circumstances of the case in point.
The Court observed that in decision X ZR 6/13 – Crimping pliers (see also next summary below), Germany's Federal Court of Justice had ruled that an offer made to a (potential) contractual partner, as opposed to the public, counted as public prior use only if, judging from experience of life generally, it would clearly be passed on. If the offer related to manufacturing a product not yet developed, that would not necessarily be the case. Here, however, the information had been sent not only to a (potential) contractual partner but also, at the same time, to a third party (the defendant). And far from describing a product not yet developed, it directly enabled the skilled person to construct a rail vehicle as claimed.
The Court took the view that the third supplier who had sent the design documents clearly had no interest in treating the technology as secret, or in trying to patent it itself. The defendant too had no interest in keeping the documents secret, and any secrecy interests of its competitor were confined to information it provided to – as opposed to received from – the third supplier. The confidential tone purportedly used by the parties involved was not enough to substantiate an implied obligation to maintain secrecy. Nor had the information been sent in connection with an order for goods or services.
In parallel case T 477/14, the EPO board of appeal had not addressed public prior use. That however was immaterial: the board had not reviewed the documents in question, having declined to admit them into the proceedings.
The Court revoked the patent and dismissed the infringement action.
The plaintiff's (patent proprietor's) appeal against the judgment of the Federal Patent Court was dismissed as unallowable by the Federal Court (4A_427 / 2016).
Federal Court of Justice, 9 December 2014 (X ZR 6/13) – Crimping pliers
Keywords: novelty – public prior use – offer to contractual partner
The patent at issue concerned a crimping-plier device which could be fitted with either a manual or motor drive.
The claimant sought its revocation on the grounds of public prior use in the form of a device, marketed before the priority date, which was solely motor-driven but also had apertures which, in the claimant's view, were for subsequently fitting a manual drive yet to be developed. In particular, the patentee's sales company had suggested that the manufacturer develop a manual drive, and it had agreed to do so. Also, based on general experience, buyers would have asked – and been told – what the apertures on the device's lever arms were for.
The Court decided that this did not constitute public prior use. An offer addressed not to the public but to a (potential) contractual partner did not in itself constitute prior art unless the further disclosure, to indeterminate third parties, of the knowledge thus transmitted to the offer's recipient was self-evident based on general experience (Federal Court of Justice judgments X ZR 81/11 – Meter electronics for a Coriolis flow meter; X ZR 189/03 – Forming element; and I ZR 34/57 – Hot-plate press). That was not necessarily the case if the offer related to making a product yet to be developed, because the parties might then have an interest in keeping the development project secret until the product could be marketed.
Nor could the claimant prove that the apertures' function had been explained to buyers of the device; it was not enough that this was probable from general experience. To be able to conclude from such experience that it was more than remotely possible that any third party, including persons skilled in the art, might have obtained reliable knowledge of the invention through public prior use, at least one act of communication – such as an offer or a delivery – on which an empirical judgement could build had to have taken place. That the invention's owner was willing to make its subject-matter available to the public was therefore not enough for public prior use; rather, an act of communication to that effect was necessary (see judgment X ZR 159/98 – Continuous steel band). The mere fact that it was plausible that the apertures' function had been explained was not enough to convince the Court that it actually had been. No generalisations were possible about the extent to which buyers of technical devices were customarily given details about their future use, whether merely feasible or actually intended.
Paris Court of Appeal, 16 December 2014 (12/18548) – Decathlon v Time Sport
Keywords: novelty – public prior use – no definite date
Time Sport had brought an infringement action against Decathlon in respect of its European patent 0 682 885 – which had claimed the priority of French patent 94 06014 of 10 May 1994 for a "device for retaining a helmet on the occiput". In its counterclaim Decathlon challenged the European patent's validity but was found at first instance to have infringed the patent.
Ruling on Decathlon's appeal against that decision, the Court confirmed the validity of the French priority. On the request for revocation, it observed that the invention's novelty had to be assessed as at the patent's date of priority. For the prior art at the time to be novelty-destroying, it had to disclose the elements of the invention in the same form and arrangement and as functioning in the same way with a view to achieving the same technical result, such that the skilled person could reproduce the invention using what was disclosed there.
During the appeal proceedings, Decathlon cited new prior art, among it the "Avalanche" helmet made by Bell; Time Sport disputed its date of disclosure. The Court found that Decathlon's supporting evidence did not enable it to ascertain a definite date. It could not do so on the basis of an affidavit and a simple photograph by Bell's managing director, both of which he had produced for Bell when it had instigated revocation proceedings against Time Sport in Germany. Similarly, a single brief description of the helmet in a magazine article of August/September 1993, presenting it as the "only helmet on the market with an inflatable-membrane adjusting mechanism", could not, as such, be regarded as a relevant disclosure, nor did it prove that the helmet had actually been on sale at that time; the same went for the advertisements that gave only the helmets' selling prices. Decathlon itself had conceded in its written submissions that the article from the November 1993 issue ofBicycling magazine announced only "the upcoming release of Bell's new Pro range". In light of the above, a Bell "Avalanche" helmet box that referred to copyright from 1993 did not prove that it had actually been on sale then, especially as the date printed on the specimen helmet submitted as physical evidence was 1995.
The Court upheld the dismissal of Decathlon's counteraction at first instance.
Editor's note: An appeal against this judgment of the Court of Appeal was dismissed by decision of the Court of Cassation of 22 November 2016 (15-16647), see summary in PIBD (2017) No. 1063-III-1.
Paris District Court, 7 May 2015 (13/16172) – MGI v Aqua Consult
Keywords: novelty – public prior use – availability to the public of prototypes
MGI, proprietor of European patent 1 756 784 entitled "Device for detecting a fall into a swimming pool", sued Aqua for infringement of claims 1, 2 and 4 of the French part of the patent.
On the priority right invoked by MGI, Aqua challenged the validity of the assignment of the priority on formal grounds, citing Art. 72 EPC along with an EPO decision. MGI, however, argued that the name of the proprietor of the utility certificate (on which the priority was based) had been changed in order to rectify an error and not because of an assignment. Noting that the two parties had agreed to have the case settled under French law, the Court held that the formalities required to authorise MGI to claim priority as successor in title had been observed. It further found that this authorisation to exercise the priority right had been granted as a preliminary step prior to replacing the certificate proprietor's name with that of MGI, and that, in making this change, it had indeed been the two companies' intention not to assign the certificate but merely to rectify a mistake. The Court held that MGI was entitled to claim priority (7 April 2004).
On the patent's alleged lack of novelty, Aqua claimed that MGI's Aquasensor alarm was a complete anticipation and that it had been launched on the market before the priority date. In support of this allegation, Aqua produced a document about MGI's stock-market flotation which mentioned that it had started marketing its first product under the name Aquasensor in April 2004. The Court, however, considered that this statement was too imprecise to make the document a disclosure of the subject-matter of the invention prior to the priority date.
This document did not describe the features of the product in question, and so was not a technical document that could constitute disclosure of the protected product. Aqua also submitted a third company's catalogue offering these alarms, but the Court found that it had not been shown that it had been made publicly available before 7 April 2004; the mere production of this catalogue dated March 2004 was not enough to prove that the general public had been able to buy the Aquasensor products featured therein before 7 April 2004, and the descriptions of the alarms mentioned in the catalogue did not suffice as evidence of disclosure of the invention.
Aqua also argued that the alarms had been sent to a laboratory for testing and had thereby been disclosed. The Court observed that the report on the laboratory's findings dated 8 April 2004 described tests carried out on these alarms on 27 February and on 4 March 2004. However, providing this laboratory with the alarms for testing purposes could not be treated as a disclosure of the invention, the tester not being comparable with the general public and a laboratory of this kind having a duty to observe confidentiality towards the company giving it prototypes for testing. Making the alarms available to the laboratory did not therefore amount to disclosure of the invention.
The Court concluded that Aqua had failed to prove that the patent was invalid for lack of novelty.
Paris District Court, 14 April 2016 (14/05992) – SAS Bayer Healthcare & Bayer Animal Health GmbH v Intervet International BV
Keywords: novelty – inventors' own disclosure
Bayer had brought actions for revocation of the German, Italian, Spanish and French parts of Intervet's European patent 1 022 944 before the various national courts. In the French proceedings Bayer cited lack of novelty in view of the inventors' own disclosure of the invention in an article in a scientific journal published in April 1997 and so before the patent's priority date of 18 June 1997.
The Court found that for prior art to be prejudicial to the novelty of an invention, there had to be certainty as to its content and its date. It had to be established beyond doubt that an invention absolutely identical in all respects had been made available to the public before the date of filing or priority, which was the cut-off point for identifying the prior art. The benefit of any doubt had to be given to the patent proprietor, who enjoyed a presumption in favour of his patent's validity. The party seeking revocation thus bore the burden of proof, but disclosure – being a fact – could be established using any means of evidence.
The Court considered it established that the article had indeed appeared in a scientific journal dated April 1997, and that it therefore had to be presumed that it had been published and publicly disclosed during that month.
Intervet disputed this, arguing that the journal had not in fact been published until 19 June 1997, i.e. the day after the patent's priority date. That an EPO examining division had accepted that publication date during the grant proceedings was not, however, enough to convince the Court; Intervet had to prove that publication of the April 1997 issue had been delayed until then, or at least adduce evidence showing that such a delay was plausible.
Intervet, however, failed to provide any evidence of habitual delays in publishing journals at the time in question. It had merely produced two faxes dated January 1998: one from the journal's publisher to a Ms F about the publication date and the other from the British Library to a Ms T at Hoechst Roussel about when the journal was made publicly available to its readers but saying nothing about any delay in publication. Observing that Ms F was not only one of the article's authors but also one of the inventors behind the patent, while Hoechst Roussel was the patent applicant, and the fax recipients were therefore a person and a company with an interest in the patent and its disclosure, the Court considered that this undermined the faxes' probative value. In the absence of any other evidence, it held that Intervet had failed to refute that the article had been published in April 1997.
Editor's note: With regard to the foreign decisions mentioned, please note that in Germany, the Federal Patent Court revoked the patent on the grounds of non-patentability and lack of novelty on 14 April 2015. In Italy, the Court of Turin, having ordered an expert's report duly filed on 29 July 2015, revoked the patent for lack of inventive step. However, proceedings were still pending at the time of writing. In Spain, Intervet and Merck (Animal Health) sued Bayer Hispania for infringement of the Spanish part after it amended the summary of product characteristics for its Seresto collar. Proceedings were still pending at the time of writing.
Paris Court of Appeal, 27 May 2016 (14/02829) –Launch Tech Company Limited v FOG Automotive Distribution
Keywords: novelty – public prior use – written statements
This case was about European patent 1 813 568 ("EP 568"), for which the filing date of a French patent application had been claimed as the priority date.
It was for a lifting platform. The prior art included lifting platforms with rack-based anti-fall mechanisms; to lower the platforms, operators first had to disengage locks before issuing a command on a control device. EP 568 proposed a simpler, more compact mechanism.
Launch Tech argued that EP 568 was invalid because it lacked novelty, citing three platforms (TLT235SBA, TLT235SCA and TLTE240SBA) that it had exhibited at trade fairs, one in September 2004 (in Frankfurt) and one in October 2005 ("Equip Auto"). However the Court found that the photographs of those platforms it had submitted could not be dated with certainty. On appeal, Launch Tech then filed a statement from a patent attorney who declared that, in 2014, he had visited a workshop where he had seen a lifting platform and on it a metal plate bearing "TLTE240SBA" as the serial number, "2005/08" as the manufacturing date and Launch Tech and its address in Shanghai as the manufacturer. But the Court held that the attorney's submission that to him the plate had seemed to be the original one was evidently no more than his impression which could not date the platform with certainty; thus the platform could not be deemed novelty-destroying. Launch Tech also submitted a statement from a maintenance technician employed with it since 2004, but the Court had doubts as to its reliability, firstly because it had been written by a company employee and secondly because, although Launch Tech marketed various products and different lifting platforms, he had been able to recall as late as 2 May 2014 the serial number of a specific platform sold back in 2005. Thus the two written statements submitted on appeal – which related only to TLTE240SBA – could not be regarded as proof that there had been disclosure prior to the priority date, and so there were no grounds to examine further the description of that alleged disclosure.
Launch Tech also argued that EP 568's claims had been entirely anticipated by TLT235SBA, TLT235SCA and TLTE240SBA, plus a fourth platform TLTE232SBA. But the Court held that Launch Tech had failed to prove that allegation: it had not distinguished the four platforms from each other technically, submitting a mere user manual which, although it contained the numbers TLTE232SBA and TLTE240SBA and gave instructions on those platforms' use, did not describe their characteristic features.
GB United Kingdom
Patents Court, 1 December 2014 – Idenix Pharmaceuticals Inc. v Gilead Sciences Inc. & Ors  EWHC 3916 (Pat); Court of Appeal, 8 November 2016 – Idenix Pharmaceuticals Inc. v Gilead Sciences Inc. & Ors  EWCA Civ 1089
See Chapter F. Priority.
GB United Kingdom
Patents Court, 23 November 2015 – Unwired Planet International Ltd v Huawei Technologies Co Ltd & Ors  EWHC 3366 (Pat)
Keywords: novelty – state of the art – priority date – relevant time zone
In arguing lack of novelty in respect of European patent (UK) 2 229 744, the defendants relied on a document called the Ericsson TDoc. It was not in dispute that this document amounted to an enabling disclosure of the invention. The issue was whether it formed part of the state of the art at the priority date claimed by the patent, which was 8 January 2008.
The debate concerned a point of law based on international time zones. The Ericsson TDoc had been uploaded by Ericsson in Europe on 8 January 2008 and became immediately available to anyone anywhere in the world. The priority document was filed at the USPTO some hours later, at a time when the date both in Europe and the USPTO was 8 January 2008. The defendants argued that when the Ericsson TDoc was made available on the internet it was available to some people in the world, for example in Hawaii, on 7 January 2008. It should form part of the state of the art at this date.
According to Birss J, the starting point must be Section 2(2) Patents Act 1977 and Art. 54(1) EPC. To paraphrase both: the state of the art shall be held to comprise everything made available to the public before the priority date. These words referred to things made available before a date. The date mentioned was the priority date. There was no reference to ascribing a calendar date.
The first question was what the priority date was. At any given moment, the time and date around the world were different. Thus it was not meaningful to pretend that a given date has some absolute meaning. The priority date had to be based on some frame of reference and the only one which made sense was the one at the patent office at which the priority document was filed. The international system of priority (based on Art. 4A Paris Convention) ensured that the date on which a priority document was filed and the office in which it was filed were always known facts. Both these facts were all that was needed.
Once the priority date had been correctly characterised, the second question was simply whether the putative prior art had been made available before that date. Moreover, it was correct that the EPC accepted that a disclosure on the same day as the priority date albeit earlier in time is not prior art. Art. 54(2) EPC referred to disclosures before the priority date, not on it.
The judge thus concluded as follows. The priority document was filed at the USPTO on 8 January 2008. The frame of reference of the USPTO (Eastern Standard Time) was the correct one. The Ericsson TDoc was made available to the public at 02.36 on 8 January 2008 EST, therefore not before the priority date. The fact that this time was 7 January in some places in the world was irrelevant.
Editor's note: The judge's findings on this issue were upheld on appeal, see Court of Appeal, 12 April 2017 – Unwired Planet International Ltd v Huawei Technologies Co Ltd & Ors  EWCA Civ 266.
GB United Kingdom
Patents Court, 10 August 2016 – Actavis Group PFC EHF & Ors v ICOS Corp EWHC 1955 (Pat)
Keywords: novelty – conflicting PCT application as prior art – entitlement to priority – burden of proof
In their challenge to the validity of European patent (UK) 1 173 181, the claimants had cited a PCT application ("Stoner") as Section 2(3) Patents Act 1977 (Art. 54(3) EPC) prior art, i.e. in respect of novelty only. It was therefore necessary for them to establish that Stoner was entitled to its claimed priority. The point in dispute between the parties was not substantive priority, which required the application of the Art. 87(1) EPC "same invention" test, but legal priority, which required the legal formalities for a proper claim to priority to be established (seeEdwards Lifesciences v Cook Biotech Inc  EWHC 1304 (Pat)).
Birss J stated that in principle this point would arise every time s. 2(3)/Art. 54(3) prior art was relied on as long as the prior application's relevance depended on its own claim to priority and in particular when the applicant in whose name the prior application was filed was not a party to the proceedings. Legal priority was a mandatory requirement for priority. Without it the relevant application was not prior art under s. 2(3)/Art. 54(3). The legal burden of proof lay on the party attacking validity, in this case the claimants. However, if sufficient evidence was available to support an inference that legal priority existed, an evidential burden would shift to the patentee to call evidence to rebut that inference.
On the face of the priority document, the named inventors were Ms Stoner and Ms Waldstreicher. On the face of the Stoner application, applicants for all states outside the USA were Merck & Co. Inc. and Ms Waldstreicher. The inventor/applicant for the US only was Ms Stoner. The application taken at face value supported an inference that legal priority existed. Stoner was a PCT application. The relevant applications for s. 2(3)/Art. 54(3) would be the designations for a European patent (UK) and a UK national patent, both included in the PCT. The applicants for those applications were Merck & Co. Inc. and Ms Waldstreicher. Since Ms Waldstreicher was named as one of the inventors, prima facie her claim to legal priority was strong. Merck's claim was likely to be on the basis that they derived title from Ms Stoner. When the applicant was a major international pharmaceutical company, the court was entitled to take notice of the fact that organisations of that kind have professional patent departments, part of whose function is to ensure that these sorts of formalities are complied with correctly. The same would be true if the applicant was professionally represented.
Absent evidence to the contrary, there was sufficient evidence to support the inference that legal priority existed. The evidential onus had therefore shifted to the patentee to call evidence to rebut that inference. It had not done so. Stoner was therefore found to be entitled to its claimed priority.
Editor's note: The judge's findings on this issue were upheld on appeal, see Court of Appeal, 1 November 2017, Actavis Group PTC EHF & Anor v Teva UK Ltd & ors  EWCA Civ 1671.
GB United Kingdom
Patents Court, 28 October 2016 –Thoratec Europe Ltd v AIS GmbH Aachen Innovative Solutions  EWHC 2637 (Pat)
Keywords: novelty – public prior use – implied obligation of confidentiality – burden of proof
Thoratec claimed for revocation and a declaration of non-infringement in respect of AIS's two European patents (UK) 2 047 872 and 2 234 658, both for a catheter device. It argued lack of novelty and/or obviousness over, inter alia, a prior use of a device called the Reitan Catheter Pump ("RCP") in the Netherlands. This prior use was through the supply of an RCP by Jomed AB to Dr Dekker and his colleagues, who were employed by Maastricht University Hospital, for the purposes of a research study. AIS contended that the prior use was confidential. There was no serious dispute as to the construction of the RCP, and Arnold J stated that its features would have been apparent to a skilled person in the position of Dr Dekker and his colleagues.
It was common ground that the legal burden lies on the party relying on a prior use of a product to establish that the prior use made the construction of the product in question (so far as relevant) available to the public, but that the evidential burden of establishing confidentiality may shift to the other party (see Dunlop Holdings Ltd's Application  RPC 523).
AIS's contention was that Dr Dekker and his colleagues had been subject to an implied obligation of confidence under Dutch law. Arnold J summarised the relevant principles of Dutch law as follows:
(i) Like English law, Dutch law recognises that duties of confidence can arise not only from express agreements, but also impliedly from the circumstances in which information is obtained or received.
(ii) The test is an objective one.
(iii) There is, in general, a rebuttable prima facie presumption that research carried out by a university or other academic institution for a third party is confidential.
(iv) In determining whether that presumption has been rebutted, all the relevant circumstances are to be taken into account, including any documentary evidence available as to the terms under which the institution undertook to perform the work and the testimony of witnesses.
The judge stressed that what mattered here was whether the arrangement of the magnetic coupling in the RCP was made available to the public. Accordingly, the key question was whether Dr Dekker and his colleagues were free to disclose that information to others, or whether they were subject to an implied obligation to keep it confidential.
From his analysis of the evidence, which included in particular witness testimony from Dr Dekker and a body of circumstantial documentary evidence, Arnold J concluded that it firmly rebutted any presumption that the supply of the RCP by Jomed to Dr Dekker and his colleagues was subject to an implied obligation of confidentiality. In particular, the arrangement of the magnetic coupling was not confidential.
The Hague Regional Court of Appeal, 17 March 2015 – Doebros v Rijkswaterstaat
Keywords: novelty – availability to the public – obligation to maintain secrecy – burden of proof
On 30 October 2013, Doebros lodged an appeal against the Hague District Court's judgment of 31 July 2013 allowing a claim for revocation of the Netherlands part of its European patent for a fire extinguishing post (EP 1 224 954) brought by Rijkswaterstaat (the Netherlands government department responsible for roads and waterways – "RWS"). Among its grounds for revocation, RWS had argued that the patented invention lacked novelty because it had already formed part of the prior art at the priority date. It – along with Ajax Chubb Varel B.V. – had also filed opposition to the granted patent with the EPO.
RWS had cited a memo of 10 May 1999 it claimed to have sent to Ajax de Boer BV (one of Doebros's competitors on the relevant market) about a set of requirements it had drawn up for fire extinguishing posts. Casting doubt on the memo's authenticity and on whether it had actually been sent by RWS and received by Ajax de Boer before the patent's priority date, Doebros argued that RWS bore the burden of proving this. In response, RWS produced documents substantiating its claims, including a copy of the memo as received by Ajax de Boer. The Court found that the memo had to be considered part of the prior art.
The memo itself did not stipulate that Ajax de Boer was to treat it as confidential. Nor could it be inferred from its contents that it was bound by any express or implied duty of confidentiality. Besides, the nature of RWS's talks with Ajax de Boer militated against a finding of such an implied duty. It was sufficiently clear from the evidence on file, and not disputed by Doebros, that the aim of RWS's talks with Ajax de Boer had been to increase the number of suppliers on the market for fire extinguishing posts. It would have been at odds with that aim for RWS to want to suppress the memo's further dissemination.
The Court concluded that the memo had directly and unambiguously disclosed all the features of claim 1 and also, albeit implicitly, those of claims 2 and 3.
See also Chapter G.2. Stay of national proceedings.
2. Novelty of use
Paris Court of Appeal, 30 January 2015 (10/19659) – Merck v Actavis
Keywords: novelty – second medical use – dosage regimen
Merck is the owner of European patent 0 724 444, comprising three claims directed to low-dosage oral administration of a drug called finasteride to treat androgenic alopecia in humans. The Actavis Group, registered in Iceland, is a leading manufacturer of generic drugs. Ruling on Actavis's action for revocation on 28 September 2010 the lower court had revoked the French part of EP 0 724 444 as excluded from patentability under Art. 53 EPC 2000.
Merck had previously filed patents for different ways of administering finasteride (i.e. topical or systemic) and for specific doses from 5 to 2 000 mg. EP 0 724 444 states that "it would be desirable to administer the lowest dosage possible of a pharmaceutical compound to a patient and still maintain therapeutic efficacy".
Merck pointed out that EP 0 724 444 had been upheld by English, German, Italian and Dutch courts.
The Court's ruling considered the relevant provisions (as revised in the EPC 2000), the EPO Enlarged Board of Appeal's case law on "Swiss-type" claims and, lastly, decisions T 1020/03 (Genentech) and G 2/08 (Kos). Merck argued that dosage inventions were not excluded under Art. 53(c) EPC.
The Court ruled that – even under the EPC 1973 interpreted in the light of the EPC 2000 and the resulting case law – a second-medical-use claim based solely on a dosage feature was grantable, but had to contain a different technical teaching that related to such features. Merck argued that it did, and also that the invention's novelty lay in using finasteride in a low dosage which was still effective in treating androgenic alopecia; the patent's description stated that the applicants had "surprisingly and unexpectedly discovered that a low daily dosage of finasteride is particularly useful in the treatment of androgenic alopecia".
EP 0 724 444 did not show that the claimed doses achieved results that differed from those obtained by the different doses set out in earlier patent EP 0 285 382. Nor had Merck's claimed dosage been shown to have possible side effects different from those of prior-art dosages. On the contrary: Merck had submitted a doctor's expert report, drawn up for proceedings in Italy, stating that the side effects were the same in patient groups given dosages of 5 mg and 1 mg. That was borne out by the 1992 information leaflet about Proscar (a brand name for finasteride).
Merck could not argue that the technical problem was to identify a compound administrable in a form (low dosage) that was safer while still remaining effective, when the patent nowhere indicated that higher doses caused patient-safety problems that needed to be solved. The findings to the contrary set out in two reports (the one mentioned above, and one from another doctor) did nothing to establish novelty. Furthermore, oral administration of finasteride was known and already being used by Merck – albeit in a dosage of 5 mg – in its drug Proscar.
Actavis submitted an article by Ms S, a Merck laboratory researcher and co-inventor of Merck's patent. The Court found that it already disclosed everything taught in the patent, which did not contain any specific technical teaching different from that of prior-art patent EP 0 285 382, and therefore was not novel.
The Court upheld the revocation of EP 0 724 444, on the same grounds as the lower court.
Editor's note: On the same day, in other proceedings, Paris Court of Appeal invalidated the same patent for insufficiency of disclosure (Paris Court of Appeal, 30 January 2015 (10/23603)). See also Paris District Court, 5 December 2014 (12/3507) in PIBD (2015) 1022-III-143, and in chapter H.4."Dosage regimen", Paris District Court, 19 January 2015 (13/08566) – Mylan v Richter Gedeon.
Paris Court of Appeal, 3 November 2015 (12/23743) –Ethypharm v Alkermes
Keywords: novelty – Swiss-type claim – therapeutic method
Alkermes manufactures and sells nanoparticles of therapeutic and diagnostic agents and is the proprietor of European patent 0 644 755. Ethypharm is a French pharmaceutical company manufacturing a drug with fenofibrate as its active ingredient. Having discovered that Ethypharm was manufacturing fenofibrate nanoparticles and had obtained several marketing authorisations for a 145 mg fenofibrate product, Alkermes sued for infringement of claim 9 of its patent.
On the validity of this claim, the Court observed that, under Art. 54(5) EPC 1973, a European patent could be granted for any specified further medical use of a known substance or composition, provided that the relevant claim was drafted as a "Swiss-type" claim, i.e. directed to use of a product to obtain a drug for a new therapeutic application. This meant putting a specific substance to a new therapeutic use differing from the prior art; simple method claims directed to a therapeutic treatment were not patentable.
The claim at issue, however, was for the use of any drug substance other than naproxen or indomethacin, which were already known from the prior art, for the sole purpose of hastening the onset of its action after administration to a mammal. It did not specify any known substance or composition or any new therapeutic use. The claimed hastening of the onset of action was merely a mode of action of an unspecified drug, and could not be regarded as a therapeutic use of a drug. The claim thus taught nothing more than an accelerated method of therapy using any drug (other than naproxen or indomethacin) to treat any patient suffering from any illness, irrespective of how the drug was administered and its dosage.
The Court therefore revoked the claim.