H. European patents subject to litigation in multiple jurisdictions
1. Quetiapine (EP 0 907 364)
See also the third edition of "Case Law from the Contracting States to the EPC" (2011-2014), supplementary publication – OJ 2/2015, p. 135-144
BE Belgium
Brussels Court of Appeal, 10 March 2015 – AstraZeneca v Teva Pharma Belgium
Keywords: parallel proceedings – interim relief – presumption of validity
The judge hearing the application for interim relief referred to the rebuttable presumption that a patent is valid and noted furthermore that revocation of a European patent in other jurisdictions does not give rise to a presumption of invalidity for the Belgian part of the patent. As an interim measure, the judge ordered a recall of the generic versions of sustained-release quetiapine.
CH Switzerland
Federal Patent Court, 11 February 2015 (S2014_001)
Keywords: parallel proceedings – interim relief – prima facie evidence of invalidity – relevance of foreign judgments
The claimant was seeking interim relief on the basis of its patent for sustained-release formulations of quetiapine. The defendant objected that the patent was invalid. The Court observed that it had already been revoked in proceedings on the merits in Germany, England, Spain and the Netherlands, as well as in proceedings for interim relief in Italy. Only in Austria had a court – likewise in proceedings for interim relief – considered that the evidence of its invalidity was insufficient.
The Court found that the patent's revocation by five European courts was enough on its own to establish prima facie that the defendant's invalidity objection was well founded (see Federal Supreme Court decision of 11 November 2004, BGE 4P.89/2004). It could have refused the claimant's application for interim relief on that basis alone but decided to obtain the opinion of a technical judge in the interests of dealing diligently with the case.
Having analysed the judgments given abroad, the Court concluded that the German, English, Spanish, Netherlands and Italian courts had all had sound reasons for revoking the patent, whereas the Austrian court's reasoning was not persuasive.
It therefore refused the claimant's application in its entirety.
DE Germany
Federal Court of Justice, 13.01.2015 (X ZR 41/13) – Quetiapine
See Chapter C.1. Assessment of inventive step.
DK Denmark
Maritime and Commercial High Court, 17 June 2016 (T 2-12 and T-20-13) – AstraZeneca AB and AstraZeneca A/S v Teva Denmark A/S; AstraZeneca AB and AstraZeneca A/S v Accord Healthcare Ltd
Keywords: parallel proceedings – inventive step – skilled person – common general knowledge
Teva and Accord had challenged the validity of AstraZeneca's European patent (DK) 0 907 364 on the basis of lack of inventive step. The court agreed that the document "Gefvert" was to be considered the closest prior art. The court then concluded that the objective technical problem was to provide a formulation of a pharmaceutical product to be administered with lower frequency, while resulting in a more stable and uniform concentration of the medicament in the blood plasma.
The court held that the benefits of sustained-release (SR) formulations were part of the common general knowledge of the skilled person. Such benefits were: (1) the period in which there was a therapeutically effective concentration of the drug in the blood plasma was prolonged; (2) variations in the plasma levels were reduced, thus helping to avoid overdosing or inappropriate dosing; (3) the frequency of the doses could be reduced; and (4) problems concerning patient compliance could be reduced. The court then pointed out that the skilled person would be aware of the need to make the treatment as manageable as possible, which would include the lowest possible number of doses – particularly for schizophrenic patients – and that a sustained-release formulation would be the natural choice in this regard. Other lines of arguments did not affect the court's conclusion that the prior-art documents, together with the common general knowledge of the skilled person, made the invention obvious. The court thus declared the patent invalid in its entirety.
ES Spain
Supreme Court, 20.05.2016 (334/2016) – Accord Healthcare et al. v AstraZeneca
See Chapter C.1. Assessment of inventive step.
FR France
Paris District Court, 1 July 2016 (15/05880) – Mylan v AstraZeneca
Keywords: parallel proceedings – inventive step – problem-solution approach
AstraZeneca was the proprietor of European patent 0 907 364 for a sustained-release formulation of quetiapine comprising a gelling agent, and its use in treating psychotic states in humans.
Court actions for the patent's revocation had already been brought in a number of other countries, and in most cases it had been revoked for lack of inventive step (BE, DE, ES, IT, NL and UK).
The Court considered that the problem-solution approach was not the only but rather just one of several possible ways of assessing whether a patent involved an inventive step. AstraZeneca's proposed reformulation of the technical problem (as being to develop an effective antipsychotic drug for humans, as opposed to developing a sustained-release formulation for quetiapine) was designed to make the claimed sustained-release formulation appear inventive by artificially extending the scope of the problem. Documents available before the patent's date of priority in any case showed that the manufacture and use of quetiapine to treat schizophrenia in humans were already known, including from European patent 0 240 228, which indisputably protected quetiapine as a new atypical antipsychotic drug. So AstraZeneca's proposed reformulation of the problem was redundant, as an effective antipsychotic treatment based on quetiapine had already been known at the priority date.
The Court then turned to defining the skilled person and found that it might be a team headed by a pharmacist and a physician. Which of them was in charge had been discussed at length by AstraZeneca, but the Court did not consider this to be relevant.
The Court held that it was obvious to this skilled person from the prior art to consider using a sustained-release formulation for quetiapine and that studies provided all the information needed to arrive readily at that outcome by ensuring a controlled release of the active substance in sufficient amounts, in particular using a hydrogel-based matrix.
Lastly, since unexpected therapeutic uses alleged by AstraZeneca had not been mentioned in the patent specification as either an objective or a problem to be solved, and in the absence of any evidence that they were attributable to the sustained-release formulation described in the patent, they could not be considered for the purposes of establishing inventive step at the priority date.
The Court ultimately revoked the French part of the patent.
HU Hungary
Curia of Hungary (Kúria), 4 February 2015 (Pfv.IV.21.455/2014/8) – AstraZeneca AB v Teva Gyógyszergyár Zrt. and Teva Pharmaceutical Industries
Keywords: parallel proceedings – inventive step – sufficiency of disclosure
Teva sought revocation of AstraZeneca's Hungarian patent 225 152 (essentially corresponding to EP 0 907 364), which was for a sustained-release pharmaceutical composition containing quetiapine in combination with a gelling agent and excipients. In revocation proceedings before the Hungarian Intellectual Property Office (HIPO) the patent was upheld and limited to claim 2 and corresponding claims in which the gelling agent was restricted to HPMC, the only gelling agent discussed in the examples.
The patent was attacked on the grounds of lack of novelty, inventive step, sufficiency of disclosure and industrial applicability. The prior art included various textbooks on the formulation of pharmaceutical substances and articles on the dosage of quetiapine. The HIPO found the patent not novel over US 4 879 288, also based on the broad definition of the gelling agent, but rejected the attacks against claim 2 in its limited form. Claim 13 was a purpose-related product claim and as such permissible and industrially applicable. Both parties appealed. The Regional Court, acting as appeal court, upheld the decision of the HIPO with different reasoning. It found that the feature "sustained release" was a technical feature and not merely a purpose to be achieved. It also interpreted the "gelling agent" feature more narrowly, and therefore claim 1 was found novel but not sufficiently disclosed for gelling agents other than HPMC. The reasons for insufficiency of disclosure in respect of all gelling agents in turn supported the existence of an inventive step in respect of claim 2 over the cited prior art. The court further held that the skilled person was an expert team including a clinical expert and a formulation expert. The court did not take into account documents submitted at the appeal stage, either from the parties challenging the patent or from the patentee, who submitted experimental results with gelling agents different from HPMC.
The appeals against the decision of the Regional Court and subsequent requests to the Curia for revision of the decision of the Regional Court of Appeal were dismissed, the decisions of both higher courts confirming the decision of the Regional Court in essentially every point. Both found that the Regional Court's interpretation of the law and the procedure followed were correct, and that its disregarding of the later submitted materials was unobjectionable. The Regional Court had to assess the evidence before it, like the HIPO, and there was no sign that their assessment was manifestly unreasonable or wrong in law. The Curia held that a different assessment of a claim feature by the courts in infringement proceedings between the parties (for the purposes of a preliminary injunction) could not be taken into consideration, because it was not a subject of the present nullity (revocation) proceedings. Furthermore, the interpretation of claim features for the purposes of determining the scope of protection in infringement proceedings was not relevant in determining sufficiency of disclosure from the perspective of the skilled person.
Editor's note: For completeness the summary includes facts and findings taken from the decisions of the lower-instance courts (see Budapest-Capital Regional Court (Fővárosi Törvényszék), 3 April 2013 – AstraZeneca AB v TEVA Gyógyszergyár Zrt. and Teva Pharmaceutical Industries, No. 3.Pk.23.703/2012/14; Budapest-Capital Regional Court of Appeal (Fővárosi Ítélőtábla), 20 May 2014 – AstraZeneca AB v TEVA Gyógyszergyár Zrt. and Teva Pharmaceutical Industries, No. 8.Pkf.26.216/2013/11).
IT Italy
Turin Ordinary Court, 15 May 2015 (628/2013) – Sandoz S.P.A. and Sandoz A/S v AstraZeneca A.B. and AstraZeneca S.P.A.
Keywords: parallel proceedings – inventive step – problem invention – technical expert
Sandoz challenged the validity of European patent (IT) 0 907 364 for lack of inventive step. In order to decide this issue, the court referred to the problem-solution approach and its steps as developed in the case law of the EPO boards of appeal.
The Italian court agreed with the technical expert it had appointed that European patent 0 240 228, which disclosed an immediate-release formulation of quetiapine, was the closest prior art. Other documents that were held to be relevant were Tench, Gendron and Gefvert, which disclosed the advantages of the sustained release of other antipsychotic agents in terms of both maximum concentration available in the blood plasma and patient compliance.
The court held that the prior-art documents would provide incentives for reaching the patented solution and that the skilled person would have to carry out merely routine clinical trials in order to obtain the lacking pharmacokinetic data. Moreover, the use of a gelling agent for achieving the sustained release of medicaments was known and not discouraged by the prior-art documents.
The court then rejected the proposal made by the appointed technical expert that the case in hand could be classified as a problem invention. The court held that, regardless of any theoretical considerations on this concept being appropriate for determining the validity of a patent under Art. 48 of the Italian Industrial Property Code, it would not fit the facts of the case in hand since the problem of providing the sustained release of a medicament was well known in the art before the priority date of the contested patent.
The court therefore revoked the patent.
PT Portugal
Lisbon Court of Appeal, 13 January 2015 (1356/13.OYRLSB.L1-7)
Keywords: parallel proceedings – inventive step – arbitration – validity
The appellants had challenged the validity of European patent (PT) 0 907 364 before the arbitration tribunal, which had held that it had no jurisdiction to decide on this issue. Lisbon Court of Appeal reversed this finding and confirmed the validity of the patent.
Lisbon Court of Appeal held that the arbitration tribunal had no jurisdiction to revoke the patent, but that it could have issued a decision on its validity which would take effect only inter partes. This finding was supported by the travaux of Act No. 62/2011, which showed the intention of creating a swift settlement system for disputes concerning pharmaceutical patents, and by the principles of audi alteram partem and of the right to defend oneself.
On the validity of the patent, the appellants referred to its revocation in parallel proceedings in Great Britain, Germany and Spain for lack of inventive step. The appellants also based their request on the prior-art document referred to as Gefvert. However, the court confirmed the finding of the arbitration tribunal that Gefvert did not refer to the issue of the convenience of using a prolonged-release daily dose and, thus, did not make the invention obvious to the skilled person. The court held that the appellants had the burden of proving invalidity of the patent and that the evidence on file did not support the plea of lack of inventive step.
SE Sweden
Stockholm District Court, 31 May 2016 (T 9625-14) – Sandoz A/S v AstraZeneca AB
Keywords: parallel proceedings – inventive step – skilled person – common general knowledge
Sandoz had challenged the validity of AstraZeneca's European patent 0 907 364 on the basis of lack of inventive step. In the case in hand, the parties had agreed that the document "Gefvert" should be considered the closest prior art. The court held that the invention differed from Gefvert to the extent that the latter did not disclose an SR (sustained-release) preparation comprising a gelling agent. The court considered that the presence of excipients was not being a distinctive feature, since it is usual for pharmaceutical formulations for oral use to contain them and it could be expected that Gefvert too included them.
The court considered the objective technical problem to be finding a formulation of quetiapine that resulted in a stable and desirable level of quetiapine in the blood, without the need for frequent administration of the drug.
The court held that Gefvert in combination with another document ("Eurand") and the common general knowledge of the skilled person provided a clear instruction for solving the objective technical problem by preparing an SR formulation of quetiapine. Finally, the court concluded that the circumstances referred to by AstraZeneca as obstacles to reaching the technical solution were not sufficient to justify ignoring the solution that could be derived from the mentioned documents, as they referred to difficulties that the skilled person could normally be expected to encounter and handle in the course of his activities. The court then revoked the patent for lack of inventive step.
2. Pregabalin (EP 0 934 061)
DE Germany
Federal Patent Court, 24 January 2017 (3 Ni 3/15 (EP)) – Pregabalin
Keywords: parallel proceedings – sufficiency of disclosure – inventive step
The patent in suit (EP 0 934 061) concerns the use of pregabalin for its analgesic and antihyperalgesic properties in pain management. The compound is a known agent used in anti-seizure therapy for central nervous system disorders and as an antidepressant, anxiolytic and antipsychotic. Having held the action for revocation on the grounds of a lack of both reproducibility and patentability to be well founded, the Court revoked the patent for Germany.
According to the Court, what the teaching of the patent achieved lay not in the selection of a substance for pain management (pregabalin) but in the finding of an indication.
The Court left open whether the disclosure in the patent was enabling. However, it observed that it probably was, because the patent indicated outcomes showing the desired analgesic effect – and thus the expected technical success of pregabalin in managing pain – in examples with three animal models, thereby providing the skilled person with sufficient information to carry out the claimed teaching and achieve the desired outcome, without any inventive effort and undue burden, using the disclosure in the patent specification as a whole in combination with his common general knowledge.
Even so, the use of pregabalin could not be validly claimed; it was non-patentable because it did not involve an inventive step. From the prior art pregabalin was known as an anticonvulsant belonging to a class of drugs referred to as GABA derivatives; indeed it was the most potent anticonvulsant in that class. According to the teaching of one of the prior-art documents, gabapentin was another anticonvulsant belonging to that class of drugs. Pregabalin, however, had a significantly higher anticonvulsant effect in animal models than gabapentin. That knowledge would give the skilled person an expectation of success in finding further indications where pregabalin was more effective than gabapentin, and so motivate him to search the prior art for other uses of gabapentin where pregabalin might be used instead. Due to pregabalin's powerful anticonvulsant effect, the skilled person could also reasonably expect to succeed in finding potential applications for that agent by looking at other known effects of gabapentin and taking those indications as a basis for solving the problem underlying the patent in suit (Federal Court of Justice's Calcipotriol monohydrate judgment, X ZR 98/09; see also "Case Law from the Contracting States to the EPC" (2011-2014), supplementary publication – OJ 2/2015, p. 149).
FR France
Paris District Court, 8 July 2016 (14/14370) – Mylan & Generics v Warner-Lambert
Keywords: parallel proceedings – sufficiency of disclosure – therapeutic inventions in the pharmaceutical field
Mylan, a company specialising in the development and marketing of generic drugs, sought revocation of Warner-Lambert's European patent 0 934 061 for a second medical use of pregabalin to prepare a pharmaceutical composition to treat pain.
Mylan objected that the description did not disclose the invention sufficiently. The Court ruled however that descriptions of therapeutic inventions in the pharmaceutical field did not have to fulfil special requirements; to be sufficient, they did not have to demonstrate the product's pharmacological properties, which were entirely a matter for the authorities responsible for granting marketing authorisation. They merely had to present therapeutic indications and applications, and the actual research which made it plausible that the indication claimed did indeed have a pharmaceutical effect. The patent concerned the treatment of pain, especially chronic pain. Contrary to Mylan's pleadings, both hyperalgesia and allodynia had been shown to be symptoms of neuropathic pain. The Court held that the patent included tests and research which rendered the claimed treatment of neuropathic pain plausible. For disclosure purposes, there was no need to distinguish between peripheral and central neuropathic pain, and generalising the claim to cover every type of such pain was justified because they were all accompanied by or associated with hyperalgesia or allodynia. Besides, even if the composition had no effect on certain types of neuropathic pain, that did not mean the invention was insufficiently disclosed; the causal analysis and treatment of pain was complex, and the skilled person would not expect the treatment to work in every case and for all patients. The Court therefore dismissed Mylan's insufficiency objection as inadequately substantiated.
It also dismissed Warner-Lambert's counterclaim for estoppel; the fact that Mylan had dropped a particular ground for revocation before the English courts did not stop it from raising it in France. They were free to deploy different arguments in different jurisdictions.
On inventive step, the technical problem addressed by the invention was to find a composition effective against pain that was poorly treated by analgesics, narcotics or non-steroidal anti-inflammatory drugs because they were not effective enough or had limiting side effects. In support of its inventive-step objection, Mylan argued that the prior art disclosed that anticonvulsant drugs in general, and gabapentin in particular, were effective in treating pain, and that gabapentin and pregabalin acted in the same way. It was therefore obvious for the skilled person to test pregabalin for treating pain.
The Court however ruled that the skilled person would not regard every single anticonvulsant as useful for treating pain. Nor he would think that the promising results achieved with gabapentin established in a suitably scientific manner that it was effective against neuropathic pain; at the priority date, he still did not know how it worked. As the skilled person would have found no reason in the prior art to choose pregabalin, the Court also dismissed Mylan's inventive-step objection.
GB United Kingdom
Court of Appeal, 13.10.2016 – Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Ors [2016] EWCA Civ 1006
For a full summary see chapter D. Sufficiency of disclosure.
SE Sweden
Stockholm District Court, 12 August 2016 (T 258-15) – Actavis Group PTC ehf. v Warner-Lambert Company LLC
Keywords: parallel proceedings – inventive step – sufficiency of disclosure – plausibility
Actavis had challenged the validity of Warner-Lambert's European patent 0 934 061 with Swiss-type claims directed to pregabalin. The overarching questions in dispute were whether the patent fulfilled the requirements of novelty and inventive step in relation to the treatment of pain, especially neuropathic pain, with pregabalin. It was further in dispute whether the technical effect of the invention was plausible in view of the protective scope of the whole patent.
The court agreed with Warner-Lambert that it was in line with Swedish legal practice to use the problem-solution approach and applied it in the case in hand. The court held that the problem-solution approach consisted mainly of three stages. First, the closest prior art known at the priority date of the patent was determined. Then the objective technical problem was formulated. Finally, starting from the closest prior art, an assessment was made whether the solution presented by the invention would have been obvious to the skilled person who had to solve the objective technical problem.
The court held that the skilled person would use his common general knowledge in order to solve the problem presented in the patent. The skilled person could possibly also combine information from the prior art.
As already established by the court in its assessment of the common general knowledge of the skilled person with respect to the cited prior art, the invention was not obvious to the skilled person. Evidence given by the experts during the hearings did not provide unambiguous guidance. Information from one of the experts did not appear to be more reliable than information from others. Under these circumstances, the conditions were lacking to declare the patent invalid on the basis of lack of inventive step.
On sufficiency of disclosure, the court stated that there must be a serious deficiency for a patent to be declared invalid on this basis. The factors that were significant for the assessment of plausibility were also significant for the assessment of whether the invention had been sufficiently disclosed. The court also pointed out that a patent description could not be speculative.
The court noted that the patent had been examined by the EPO in opposition proceedings and it could be taken that during these proceedings the technical effect had been approved as being reasonable and probable ("plausible"). The court held that Actavis had the burden of proving lack of plausibility for different types of pain (including neuropathic pain).
On the question of neuropathic pain, the relevant tests were, however, only referred to in the patent description, without any results being shown. The tests were shown in such a way that the skilled person could carry them out, without undue burden, with this information. The court was of the opinion that the reference to the tests was in itself sufficient in that the technical effect could be considered reasonable and probable ("plausible"), even if the tests had not been carried out or the results had not been shown. It would thus be reasonable and probable for the skilled person to draw the conclusion from the basic patent documents that pregabalin was effective against various types of pain, such as inflammatory pain and neuropathic pain.
3. Method of operating a wind power station (EP 0 847 496)
DE Germany
Federal Patent Court, 27 October 2015 (1 Ni 25/14 (EP))
Keywords: parallel proceedings – novelty – inventive step
The European patent in suit (EP 0 847 496) dealt with how to increase a wind turbine's power yield while limiting the load on it at higher wind speeds. Instead of causing the turbine to shut down, high winds would now result merely in a reduction in its rotor speed.
The cited prior art included another patent, referred to as "Shozaburo". The Court found that it did not prejudice the patent in suit's novelty, because it disclosed only immediate and unregulated "feathering" of the rotor blades (i.e. pitching them out of the wind) once a given wind speed was reached, but not a reduction in their operating speed depending on the rise in wind speed.
Also cited was an article referred to as "Bossanyi". It disclosed a wind turbine whose power was gradually lowered as wind speed increased above a particular speed, but the Court could find nothing in it to induce the skilled person to consider additionally reducing the rotor speed.
The Court therefore concluded that the claimed subject-matter was patentable.
ES Spain
Barcelona Court of Appeal (Section 15), 7 January 2016 (3/2016) – Gamesa Corporación Tecnológica et al. v Aloys Wobben
In Spain, a significant prior-art document (Bossanyi) was not cited, whereas it was in proceedings in the UK and in Germany. The prior-art document JP 56 150 999 A ("Shozaburo") was analysed by the Spanish courts, which held it not to be novelty-destroying.
For a full summary see chapter E.2. Interpretation of claims and extent of protection.
GB United Kingdom
Patents Court, 20 July 2015 – Wobben Properties GmbH v Siemens plc & Ors [2015] EWHC 2114 (Pat)
Keywords: parallel proceedings – novelty – inventive step
In the infringement proceedings against it, Siemens contended that Wobben's European patent (UK) 0 847 496 was invalid for lack of novelty and lack of inventive step. The patent, which had a priority date of 1995, related to a method of operating a pitch-controlled wind turbine, and the heart of the invention was described by the judge in the case as the concept of running a VSVP (variable speed, variable pitch) turbine in high winds so as to reduce both speed and power in dependence on the rise in wind speed.
In respect of lack of novelty, Siemens relied on a Japanese application, Shozaburo, published in 1981, which was also concerned with the operation of a VSVP wind turbine. Siemens contended that Figure 3 disclosed a method of operation materially the same as Figure 1 of the patent and that the disclosed method therefore fell within the scope of claim 1. However, the judge found that, from a careful consideration of the document as a whole, Siemens' construction of Shozaburo and therefore also its novelty attack were to be rejected. He also specified that the disclosure of Shozaburo was to be considered as of its date in 1981. To read it as disclosing the approach in the Wobben patent would involve hindsight.
The relevant prior art for inventive step was Bossanyi, an article entitled "Probabilities of sudden drop in power from a wind turbine cluster" published in 1982, in which the judge identified a proposal to replace a shut down at a given high wind speed with a gradual ramping down of power above the conventional shut down wind speed. Comparing claim 1 and Bossanyi, the judge found that claim 1 called for a reduction in both the power of the turbine and the operating speed of the rotor in the relevant circumstances of high winds whereas Bossanyi only referred to a reduction in power. On whether claim 1 was obvious, the judge took the view that the skilled person reading Bossanyi would see the goal of improving network stability relating to wind energy as well worth pursuing. Furthermore, they would see its teaching as a general one that when, for example, a storm front passed through a wind farm, a turbine control strategy involving a gradual ramp down in the power of the individual turbines could help mitigate the risk of the grid experiencing sudden cluster power ramps. In view of the focus on VSVP turbines in the industry in 1995, a skilled person given Bossanyi at that time would seriously consider applying its teaching about gradual power reduction to a VSVP turbine, without any hindsight, and therefore think about how to implement the ramp down above the shut down speed. The judge concluded that it required no inventive activity at all for a skilled person given Bossanyi in 1995 to think seriously about how to implement the power ramp down proposal in VSVP turbines. They would consider how to put that into practice and, in terms of controls, it was obvious to think about "turning" the electric torque "knob" and the pitch control "knob". Reducing rotor speed as the wind speed increased as a way of reducing power accordingly was not the only way of putting Bossanyi into practice but it was an obvious approach. Reducing the speed this way had an obvious advantage in terms of loading and fatigue. Claim 1 was therefore obvious over Bossanyi.
Editor's note: Wobben's subsequent appeal was dismissed by the Court of Appeal – see Wobben Properties GmbH v Siemens plc & Ors [2017] EWCA Civ 5.
4. Dosage regimen and pharmaceutical composition for emergency contraception (EP 1 448 207)
DE Germany
Federal Patent Court, 1 December 2015 (3 Ni 23/14 (EP))
Keywords: parallel proceedings – exception to patentability – therapeutic method – novelty
At issue was European patent 1 448 207 for a pharmaceutical composition for use as a single-dose emergency contraceptive and the use of levonorgestrel in making this contraceptive.
On the technical problem solved, the Court observed that, while this depended on what the invention actually did (Federal Court of Justice's Articulated coupling judgment, Xa ZR 36/08), that did not mean that account had to be taken of each and every of its objective advantages (Federal Court of Justice's Quetiapine judgment, X ZR 41/13; see "Case Law from the Contracting State to the EPC" (2011-2014), supplementary publication – OJ 2/2015, p. 138). According to the patent specification, it had only been discovered after conducting clinical trials that administering a single dose of 1.5 mg of levonorgestrel as emergency contraception was equally beneficial in terms of side effects as the known administration in two doses of 0.75 mg. Moreover, the specification focused solely on simplifying the dosage regimen. The disclosures as to side effects were to be seen as aspects that had only become apparent on developing the claimed solution and therefore had to be disregarded for the purposes of defining the problem.
The Court had to decide whether the claimed subject-matter involved treatment of the human body by therapy within the meaning of Art. 53(c) and 54(3) and (4) EPC and the claim was thus directed to a second medical indication of a product. As a rule, contraception as such could not be regarded as therapy, because pregnancy was not a pathological condition and so not an illness (T 74/93 and Federal Patent Court judgment 14 W 122/63). Contraception could be classed as therapy only if it prevented a potential health risk associated with an unwanted pregnancy or where the concentrations of substances used had been selected so as to prevent or alleviate their likely pathological side effects. That was not the case here. According to the patent specification, the aim was to provide effective emergency contraception that could be taken according to a more convenient dosage regimen, without changing the overall dosage administered by the known method. It was not to prevent or alleviate side effects of emergency contraception (e.g. nausea or vomiting); that was – in the overall context – merely a subsidiary aspect, and anyway something the skilled person conducting clinical trials always had to have in mind as part of his duty of care. The claimed use thus had no additional therapeutic purpose.
Consequently, the features "for emergency contraception" and "up to 72 hours [after] coitus" could not render the claimed subject-matter novel over the prior art.
At a World Congress of Gynecology and Obstetrics, there had been a presentation on the results of a WHO study comparing three dosage regimes for emergency contraceptives including a single dose of "1.5 g" levonorgestrel within 120 hours of intercourse. That disclosure also covered the claimed period of 72 hours after intercourse. The skilled person would have recognised "1.5 g" as an obvious printing error and readily corrected it, given that such a dose – a thousand times higher than the standard dose in the field – was not disclosed in any of the prior art and had not actually been used in the WHO study. The presentation thus amounted to prior disclosure destroying the novelty of all the claimed features.
The defendant's objection that the High Court of Justice of England and Wales had refused to accept such a correction of the dosage when examining novelty made no difference to this conclusion, as that court too had conceded that 1.5 g of levonorgestrel was so far out of line with the standard dose that the skilled person would immediately have recognised it as a mistake.
ES Spain
Supreme Court, 18 June 2015 (325/2015) – Laboratorios Leon Pharma v Laboratoire HRA Pharma / Richter Gedeon Vegyészeti Gyar RT
Keywords: parallel proceedings – inventive step – dosage regimen – reasonable expectation of success
The appellant had sought revocation of European patent 1 448 207 (ES 2 239 727) in its entirety for lack of novelty and lack of inventive step. Reversing the judgments of the lower courts, the Supreme Court confirmed the novelty of the invention, but declared the patent invalid for lack of inventive step.
According to the description of the patent, the subject-matter of the invention was a dosage regimen for emergency contraception and a pharmaceutical composition for the application of this regimen. According to the invention, a single dose containing only 1.5 ± 0.2 mg of levonorgestrel as the active ingredient was administered to women within 72 hours of unprotected intercourse. The problem to be solved by the invention was the incorrect application of the existing emergency contraceptive treatment using two spaced doses of 0.75 mg levonorgestrel by failing to observe the proper time interval between taking the first and the second doses. The Supreme Court pointed out that, at the priority date of the patent, an important clinical trial was being conducted under the auspices of the World Health Organisation which was investigating, with a reasonable expectation of success, the effectiveness of a regimen involving a single dose of 1.5 mg of levonorgestrel, as compared (in particular) to the existing two-dose regimen.
Although the research results were published shortly after the priority date of the patent, the Supreme Court found that, due to the simple formulation of the problem and its anticipated solution after more than two years of clinical trials, the solution would have been obvious to the skilled person, as there was already a reasonable expectation of success.
FR France
Paris District Court, 19 June 2015 (13/08566) – Mylan v Richter Gedeon
Keywords: parallel proceedings – method of treatment by therapy – dosage regimen
Hungarian company Gedeon is the owner of European patent 1 448 207, claiming the priority of a Hungarian application of 27 November 2001 and entitled "Dosage regimen and pharmaceutical composition for emergency contraception". Generics company Mylan had brought an action against Gedeon, seeking revocation of the – in the meantime limited – patent in its entirety on the ground that it involved a non-patentable method of treatment by therapy.
Mylan argued it was settled case law of the French courts that a dosage regimen was not patentable, in particular because it fell under a physician's freedom to prescribe treatment and constituted a method of treatment by therapy of the human body (Art. 53(c) EPC).
Gedeon, in turn, argued that the position that dosage regimens were not patentable was very much a minority view in French case law and at odds with Enlarged Board decision G 2/08. It also asserted that the patented invention did not relate to a method of treatment by therapy.
On that point, the Court observed that, behind the editorial artifice in the patent, the invention actually related to a new method of administering the pharmaceutical composition as a single dose rather than as two doses. That did not amount to a new therapeutic use for that same composition, because the desired effect was identical. The patent did not claim that the invention was more effective at preventing pregnancy or reducing side effects. Rather its aim was to achieve at least the same results without any additional side effects, while resolving the problem of patient failure to take the second dose. Thus, the invention related to a dosage regimen designed to improve the practicalities of taking the drug.
Relating to the same pharmaceutical composition administered at the same overall dosage, but not involving any different therapeutic use or modes of action or achieving any distinct effects, the patent in suit merely provided a variation on the dosage regimen known from the state of the art – i.e. a new, more practical and convenient rhythm and dosage for administering the active agent – whilst keeping the overall dosage the same. The Court, while certainly giving all due consideration to the decisions of the EPO boards of appeal, was not bound by G 2/08 and was free to make its own interpretation of the relevant legislation. The new dosage regimen for levonorgestrel as an emergency contraceptive claimed in this case was clearly not a specific use of that substance in a method of treatment by therapy. Rather it was just one of the elements inherent in the method itself. Contrary to Gedeon's assertion, the dosage regimen chosen as part of a given treatment fell under a physician's freedom to adapt prescriptions to the specific needs of a category of patients or one particular patient. The fact that the marketing authorisation and the patient information leaflet indicated a specific dosage did not interfere with the physician's freedom. Here, the dosage regimen related to the rhythm of administration and as such was a non-patentable method of treatment.
GB United Kingdom
Patents Court, 22 May 2014 – Generics (UK) Ltd (t/a Mylan) v Richter Gedeon Vegyeszeti Gyar RT [2014] EWHC 1666 (Pat); Court of Appeal, 26 April 2016 – Richter Gedeon Vegyeszeti Gyar RT v Generics (UK) Ltd (t/a Mylan) [2016] EWCA Civ 410
Keywords: parallel proceedings – inventive step – skilled person – common general knowledge
Mylan sought revocation of Gedeon's European patent (UK) 1 448 207, which was for a dosage regimen for the use of a single dose of levonorgestrel of 1.5 mg taken within 72 hours of sexual intercourse as a method of emergency contraception. The use of this substance for the same purpose, but with a different regimen (two doses of 0.75mg taken 12 hours apart after intercourse), was already known. Sales J concluded that the invention was obvious. His decision was upheld on appeal.
For its obviousness case, Mylan relied upon the common general knowledge and the publication of a report discussing interim results of a research study organised by WHO on the effectiveness of a regimen involving a single dose of 1.5 mg of levonorgestrel, as compared (in particular) to the two-dose regimen, which was in widespread use. The prior-art document referred in error to the research study as relating to a regimen involving a single dose of 1.5 g of levonorgestrel (rather than 1.5 mg). The evidence established that a person skilled in the art would clearly realise that there was a mistake in the publication – a 1.5 g dose was too massive to be credible. However, the evidence did not go so far as to establish that the skilled person would appreciate what the dose used in the trial of the single dose regimen actually was. The judge held that the skilled person would contact the author of the research in order to verify the correct dosage. This finally led Sales J to conclude that the prior-art document made the dosage regimen obvious to try.
In the Court of Appeal, Gedeon argued that the trial judge had erred in law, by permitting the notional skilled person to "don the mantle" of a real person. This would also extend the common general knowledge to include the knowledge of a third person. Sir Robin Jacob, in his last judgment, rejected this line of argument. He observed that the notional person, hampered by lack of any spark of inventive capacity, would act in the same way as real people provided that action involved no imagination. The example he gave was ringing up a real person to verify the information. Sir Robin Jacob added that the facts of the case in hand were unusual. It did not follow that the "skilled man would ask" route to obviousness would follow for cases where the facts were not so precise or sure.