Posts Tagged ‘EPO’

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Sustained release fluvastatin formulations – The UK Court of Appeal opinion in Activis UK Limited v Novartis AG [2010] EWCA Civ 82

Friday, February 19th, 2010

Post from Paul Cole

Sometimes a decision as to obviousness hinges on a single short point. In Graham v John Deere, the tipping point testimony was during cross-examination of the witness for the patentee, when he said that the allegedly inventive feature made no significant difference to the operation of the device. Once that evidence had been given, the outcome was inevitable, and references to Thomas Jefferson, though decorative, were mere dicta.

The controversy concerning the fluvastatin sustained release patent EP-B-0948320 (UK) falls into the same category. The patent was based on the premise that fluvastatin was so water-soluble that it was difficult to devise a sustained release formulation. Claim 1 as amended read:

A sustained release pharmaceutical composition comprising a water soluble salt of fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combinations thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.

The tipping point fact was that fluvastatin was not of such extreme water-solubility as to give rise to the difficulties alleged. After that had been established, the whole basis for patentability collapsed, as explained concisely by Jacob L.J. at the conclusion of his opinion, which also contains an implied warning that although it may be appropriate to rely on an earlier decision for a rule of law, the facts on which that earlier decision was reached are of little relevance:

Once the obstacle put forward in the Patent against being able to make a sustained formulation was shown to be illusory, then a sustained release formulation is obvious. You might get better efficacy or fewer side effects, but you would certainly get better compliance. In Pozzoli terms the only difference between the prior art and the claim is the idea of making a sustained release formulation. For that there was a technical motivation and no difficulty, real or apparent.

The PSA [problem-solution analysis] gives the same answer. What is the objective problem? Why that which the patentee himself stated – to produce a sustained release form of fluvastatin. Was the solution obvious? Yes, any of the standard methods for such formulations would clearly work: there is no reason why they would not.

There is no need and it would be wrong to re-formulate the problem as suggested by Mr. Meade. This is not a case where some prior art unknown to the patentee has turned up. Nor is it right to reformulate the problem as one of looking for better medical effects when that was not the problem as seen by the patentee or to reformulate the solution as having found such effects when the patentee has not promised any.

In the latter respect this case is quite unlike the case, relied upon by Mr. Meade, about a sustained release form of oxycodone recently considered by this court, Napp v Ratiopharm [2009] EWCA Civ 252, [2009] RPC 539. Oxycodone was, until the patent, known as a minor weak opiod generally administered, to the extent that it was administered at all, as a co-drug. The slow-release form transformed it, as the patent said, into a serious alternative to morphine – something that was wholly unexpected. Of course the invention was non-obvious.

The upshot is that I would uphold the decision of the Judge. Unlike him, however, I do not think the case was finely balanced. Once the basis of the Patent was proved illusory there was nothing left to save it.

Jacob L.J.’s opinion contains a lengthy discussion of the respective approaches to inventive step of the UK courts under Windsurfing/Pozzoli and of the EPO approach using PSA which may be valuable to students and has been praised as “a tutorial in the law of obviousness”. Readers may recall John Mortimer’s fictional barrister Rumpole, who knew little law, but was an expert on bloodstains and used his instinct for tipping point facts with devastating effect in the cases for which he was responsible. No magic touchstone is to be found either in the USA under Graham/KSR or in the UK under Windsurfing/Pozzoli because in both jurisdictions after certain mandatory preliminary enquiries the issue has to be decided on a case by case basis according to the evidence and without the distortion introduced by preconceptions in the mind of the decision-maker. The legal background is only a guide as to the appropriate enquiries to be made and what matters is the evidence as to the tipping point facts, of which in the present case there was only one.

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END OF AN ERA – “SWISS-FORM” CLAIMS ARE OUT

Friday, February 19th, 2010

The Enlarged Board of Appeal of the EPO issued a decision on February 19th (G02/08), that Swiss-form claims will no longer be permitted as a way to claim a “second medical use” of a bioactive agent – “The use of compound x to prepare a medicament to treat condition y”. Rather, the form of “first medical use” claims is to be used: “[Known compound x] for use in [treating condition y].” (First medical use claims are simply: “Use of compound x for treatment of condition y” – in older applications, first medical use claims often appear simply as “Use of compound x in medical therapy,” but this form is often deemed objectionably vague these days.)

The decision is not retroactive, and will apply only to applications having a priority date three months after the Decision is published in the Official Journal of the EPO (which has  not yet occurred). Thanks to Marks & Clerk UK for getting the word out so quickly.

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Views of the EPO Enlarged Appeal Board in Treatment by surgery/MEDI-PHYSICS G 0001/07

Thursday, February 18th, 2010

Under what circumstances is injection a prohibited surgical method? Views of the EPO Enlarged Appeal Board in Treatment by surgery/MEDI-PHYSICS G 0001/07 .  Opinion

From Paul Cole

The present proceedings resulted from a referral in decision T 0992/03 relating to EP-A-1066537. That specification was concerned with magnetic resonance methods for imaging the pulmonary and/or cardiac vasculature and evaluating blood flow using dissolved polarised 129Xe. Representative claims presented to the Appeal Board are set out below

1.  A method for MRI imaging the pulmonary and/or cardiac vasculature using dissolved-phase polarized 129Xe, comprising the steps of:

            positioning a patient in an MRI apparatus having a magnetic field associated therewith;

            delivering polarized 129Xe gas to a predetermined region of the patient’s body, the polarized gas having a dissolved imaging phase associated therewith;

            exciting a predetermined region of the patient’s body, having a portion of the dissolved phase polarized gas therein with at least one large flip angle RF excitation pulse; and

            acquiring at least one MR image associated with the dissolved phase polarized gas after said exciting step.

6.  A method according to any of Claims 1 to 5, wherein

          said delivering step includes having the patient inhale the polarized 129Xe gas into the lungs, the 129Xe having a gas phase resonance which is higher than the dissolved-phase resonance, and wherein at least a portion of the 129Xe gas enters into the pulmonary vasculature in a dissolved-phase, and wherein at least a portion of the dissolved-phase 129Xe then enters the blood stream with an associated perfusion rate.

22. Use of 129Xe for the preparation of a hyperpolarized imaging agent for use in methods of treatment or diagnosis involving performance of the method as described in any one of claims 1 to 21.

The Appeal Board held that the claimed subject matter did not fall within the diagnostic method exclusion because the claimed steps were confined to the examination phase and did not include steps considered constitutive for making a diagnosis. However the claimed method covered administration of polarised xenon into the heart by injection, and the method was intended to be used inter alia for providing real-time feedback during surgery. Existing case law of the Appeal Boards had held that introduction of a catheter into the pericardial pace was an excluded method of surgical treatment (T 0035/99; see also T 0182/90 as to methods of injection), but that applying radiation to the body for the purpose of cosmetic removal of hair was not excluded (T 0383/03). Issues arising in the appeal to the Enlarged Board included whether it was possible to exclude the administration step (“pre-delivered contrast agent”) or whether the claim would be allowable if the administration step were defined at a higher level of abstraction (“administering a contrast agent”).

In particular, the Appeal Board considered that clarification of the term “treatment by surgery” was required and referred to the Enlarged Board the following questions:

1. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04), which comprises or encompasses a step consisting in a physical intervention practised on the human or animal body (in the present case, an injection of a contrast agent into the heart), to be excluded from patent protection as a “method for treatment of the human or animal body by surgery” pursuant to Article 52(4) EPC if such step does not per se aim at maintaining life and health?

2. If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?

3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) to be considered as being a constitutive step of a “treatment of the human or animal body by surgery” pursuant to Article 52(4) EPC if the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention?

The above questions were answered in an 80 page opinion of the Enlarged Board handed down on 15 February 2010.

The Enlarged Board reaffirmed the position in G 0001/04 that any therapeutic or surgical feature in a method claim causes that claim to fall under the prohibition, and “surgery” is not to be interpreted as limited to surgical methods pursuing a therapeutic purpose. It could not give an authoritative once and for all definition of “surgery” since the scope of what is regarded as surgery may change over time, and the relevant criterion should be handled on a case by case basis. However, in answer to the first question, a claimed imaging method in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires. professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to a.53(c) EPC.

In response to the second question, the claim cannot be left to encompass an embodiment which is excluded by a.53(c). Omission of the excluded step should be considered on a case by case basis, but e.g. claims to operation of devices without requiring a surgical step have been held allowable, see T 0245/87, T 0789/96 and T 0329/94, compare T 0082/93. Expressions such as “predelivered” and “preimplanted” have been employed to make clear that the feature pertaining to that step was not part of the claimed invention. However, the remaining requirements of the EPC and in particular a.123(2) and in opposition cases a.123(3) must still be fulfilled.

As regards the third question, a claimed imaging method does not fall within the prohibition merely because during a surgical intervention the data obtained by the use of the method immediately allows a surgeon to decide on the course of action to be taken during the surgical intervention.

It will be appreciated that the function of the Enlarged Board is not in itself to decide the outcome of the appeal, but merely to answer the legal questions put to it by the referring board. The case will now be returned to that board, who will have to decide in the light of the answers given and any amendments filed by the applicants what claims might eventually be allowed.

Comments

The present decision provides useful clarification of the relevant law, but probably does little more than to provide more authoritative support for the general approach already adopted by the EPO. It is believed that the number of applications where the outcome will be materially different as a result of the present decision is likely to be small. However, it will be interesting to see what claims are eventually allowed in this case.

The prohibition under the EPC is to surgical methods rather than surgical apparatus so that in a situation such as the present it may be desirable to present apparatus claims, in this case apparatus for MRI imaging including firstly apparatus for administration of 129Xe to the human body and secondly MRI apparatus configured to supply exciting pulses with a large flip angle and to produce a resultant MRI image. The argument could then be that there would be no motivation to bring together these pieces of apparatus but for the discovery of the new imaging method. For an example of this approach compare the granted claims in EP-B-0436717 (Maddox, Cobe Lab) with the granted claims of the equivalent US-A-5474772, for a more detailed explanation see Fundamentals of Patent Drafting, Paul Cole, CIPA, London, 2006 at pp. 218-222.

The use claim has not been considered by the Enlarged Board, but it would appear in principle to be allowable. The recitation of methods of treatment or diagnosis merely specifying performance of the previously defined method may be too general, however, and it would be expected that the EPO would require further definition characteristic of potential disease states e.g. for the purpose of providing clinically useful images of the left and right pulmonary veins and associated capillaries, the left atrium and left ventricle, the myocardium, the ascending aorta, the coronary arteries, the aortic arch, the descending aorta, the left and right subclavian arteries, and the left and right carotid arteries as recited in the description of the application.

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Neutrokine-α litigation – On a different record from that before the EPO Appeal Board, the UK Court of Appeal finds different facts with a different result

Thursday, February 11th, 2010

From Paul Cole of Lucas & Cole

On February 9th the Court of Appeal ([2010] EWCA Civ 33; Jacob L.J.) held that Human Genome Sciences Patent EP-B-0939804 for Neutrokine-α did not meet the industrial applicability requirement of a.52(1) EPC and should be revoked for the United Kingdom. In reaching its decision the Court affirmed a first instance finding of Kitchen J. ([2008] EWHC 1903) but differed from a 2009 finding of the EPO Appeal Board (Neutrokine/HUMAN GENOME SCIENCES Case T 0018/09) that the patent was valid. Since the proceedings relate to the national phase of the granted European patent, protection in other EPC contracting states is unaffected by the decision.

The patent in issue reported the discovery of the new protein and stated that it might be relevant to the treatment of a wide range of diseases ranging from solid tumours to schistosomiasis and other parasitic diseases. No experimental evidence was included in the specification to support these claims which were described at first instance by Kitchen J as “extravagant and sometimes contradictory”. Kitchen J. commented:

“I accept Professor Saklatvala’s evidence that the idea that Neutrokine-α and antagonists to Neutrokine-α could be used to treat the extraordinary range of diseases identified was fanciful. He found it hard to believe that anyone could seriously suggest on the basis of no experimental data at all that that Neutrokine-α was the answer to so many conditions, from treating cancer to treating worms. In my judgment the skilled person would come to the conclusion that the inventors had no idea as to the activity of Neutrokine-α when drafting the Patent.”

In affirming the first instance decision, the court held that there was no difference as regards legal principles between the decision of Kitchin J. and the main decisions of the EPO Appeal Boards regarding DNA sequences and bioinformatics, including Max-Planck T 0870/04 (May 2005), Johns Hopkins T 1329/04 (June 2005), Genentech T 0604/04 (March 2006), ZymoGenetics T 0898/05 (July 2006), Bayer T 1452/06 (May 2007) and Schering T 1165/06 (July 2007). It was now settled that the research tool justification for patenting a new nucleotide sequence or polypeptide was not enough to satisfy the EPC. The following passage from the Max Plank decision showed the dangers if patenting too far upstream were allowed:

“[21] In the board’s judgment, although the present application describes a product (a polypeptide), means and methods for making it, and its prospective use thereof for basic science activities, it identifies no practical way of exploiting it in at least one field of industrial activity. In this respect, it is considered that a vague and speculative indication of possible objectives that might or might not be achievable by carrying out further research with the tool as described is not sufficient for fulfilment of the requirement of industrial applicability. The purpose of granting a patent is not to reserve an unexplored field of research for an applicant.”

However, the Court of Appeal emphasized that what was binding was applicable legal principle, and that each case should be judged on its own facts. It was therefore not legitimate to invite the court to decide the case by reference to the facts of other cases.

Kitchin J.’s factual finding that the potential uses were merely speculative was supported inter alia by a statement of the time from real experts with no axe to grind who were not prepared to say that mere membership of the TNF-ligand superfamily was enough to indicate that any member of the family could be “a candidate for a novel treatment protocol” and his decision on the evidence before him could not be faulted. Although Kitchin J. and the Technical Board of Appeal asked the same key question and identified the same “kernel” the real difference was that Kitchin J. found on the facts before him that the “kernel” did not provide any basis for supposing that the invention was susceptible of industrial application whereas on the facts before it the Board thought there was. One difference in the relevant records was a last minute affidavit by a Dr. Kelsoe which was not before the UK court, and which had never been tested by cross-examination. On the evidence before Kitchen J. the Court of Appeal was not prepared to find that a skilled person would read the patent in the way adopted by the Board, and it was not proper to equate “a first step at the onset of research work” with “an immediate and concrete benefit”. The factual findings of Kitchin J. were to be preferred since they had been arrived at following an intensive examination of the evidence. In conclusion:

“The upshot of all this is that Board, working on different evidence and using a different procedure came to a different conclusion on the facts. We are not bound to follow, or even give deference to, the Board’s findings of fact.”

It is not yet known whether a further appeal to the Supreme Court (the successor to the House of Lords) will be attempted. As there is no dispute as to the underlying law, it seems unlikely that any further appeal will be permitted.

Human Genome Sciences will become one of the most important UK authorities on industrial applicability. It is also likely to be widely read for its observations concerning the differences between proceedings in national courts and in EPO oppositions and concerning the limitations on the extent to which EPO Appeal Board findings should be of persuasive authority for national courts of the EPC contracting states.

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