Novartis AG & Cibavision AG v. Johnson & Johnson [2010] EWCA Civ 1039

The Court of Appeal roared back into action yesterday with its first patent decision of the new term: Novartis AG & Cibavision AG v. Johnson & Johnson [2010] EWCA Civ 1039 (available on Bailii here). Novartis and Cibavision appealed against the decision of Kitchin J ([2009] EWHC 1671 (Pat) – reported by the IPKat here), in which he had held that whilst Johnson & Johnson’s (J&J) Oasys contact lenses fell within the scope of claims 1 and 24 of Novartis’ European Patent (EP (UK) No. 819,258), the Patent itself was, however, invalid on grounds of insufficiency. J&J had also contended that the Patent was invalid for obviousness and lack of novelty, but these arguments were rejected at first instance.

The appeal centres around the issue of insufficiency, and J&J’s contingent cross-appeals (to be deployed if the insufficiency appeal was successful) got nary a look-in.The tone of the Court is apparent from the outset. Describing claim 1 of the patent, Jacob LJ noted:

"[10] “The reader might be forgiven for initially supposing that this apparently detailed list of elements would lead to a monopoly of reasonably defined scope, that each of the elements actually meant something by way of delineating the monopoly. But the reader would be wrong. Upon analysis it turns out that the elements are mostly meaningless and what is left is no more than a claim to a lens made from two types of polymer, provided it works.”

He continued:

"[19] Accordingly there is a lot to be said for the view that the claim should never have been allowed as not complying with Art. 84 of the EPC. This requires that:

The claims shall define the matter for which protection is sought. They shall be clear and concise and supported by the description.

Unfortunately failure to comply with Art. 84 is not itself a ground of invalidity. However some of the grounds which are available for an invalidity attack overlap with Art.84. The jurisprudence of the Boards of Appeal has had to deal with undue width of claim by resorting to either the requirement of non-obviousness or that of sufficiency or both. As will be seen I think they come into play here.”

However, the hammer-blow comes slightly further on into the judgment:

"[50] So we come to an astonishing conclusion. Although the claim has a number of elements, hardly any of them have any significance. The claim is to a lens made from a polymeric material consisting of two vast classes of polymerisable materials, one having a high oxygen diffusion rate and the other having a high ion or water diffusion rate provided the lens “works”. In substance the claim amounts to this: “if you try any pair of polymers, to see if they work (perhaps only after surface treatment) and find anything that does, we claim it.”

[51] What help does the teaching of the Patent give the reader to find a combination of polymers which “works?” The answer is again astonishing - hardly anything.”

Skipping on a little, Jacob LJ continues:

“[70] The only way the Patent offers to find out whether you have got everything right is to test it. You can test for oxygen transmissibility. But then you are on your own. You will have to do a clinical trial. If it “works” well and good – but that would tell you nothing about the remainder of the vast ambit of the claim.

[71] If it does not “work” then the Patent does not help you as to what to do next. Generally patents with functional claims give you guidance as to what to do if you embark on a trial and error process. The reader can learn from the errors so as to reach something that works. But not here.”

Thus, readers will not be surprised that the patent was held to be insufficient. Jacob LJ summarised his conclusions with damning criticism of the patent before him:

“[92] The upshot of all this is that the Judge was entirely right to decide that the Patent was insufficient. It is no more than a “if you can find it, we claim it” patent. Its avaricious ambit coupled with its failure to provide any help makes it nothing but a hazard to those conducting research into extended wear contact lenses. It should be revoked in its entirety. There is no need to consider any of the other points raised.”

Ouch!

History of contact lenses: here

When contact lenses attack: here

Added matter, intermediate generalisation and a good day for cricket

After a tennis-related post earlier this morning, it is tempting to link this article to another of England's frequently rain-affected summer sports, cricket. Sadly, this doesn't quite work. The Grace in this case is not the legendary WG Grace (right) by the presumably unrelated WR Grace -- it's a patent-y sort of case with lots of facts and not a huge amount of intelligible law. The case in question, decided by Mr Justice Floyd yesterday in the Patents Court, England and Wales, is Fosroc International Ltd v WR Grace & Co.-Conn [2010] EWHC 1702 (Ch), and it's largely about added subject matter.

This post isn't even going to try to explain the invention and the details of the patent in its pristine and putatively amended state. It was something to do with concrete (or was it cement?) -- or at any rate it was to do with substances that Kats don't like putting their paws into when it''s wet. The court essentially held that the patent was valid and that the amendments would be allowed. In doing so, Floyd J summarised the main principles involved when considering whether an attempt to amend a patent would fall foul of the "no added matter" rule. In short:

* When considering whether a proposed amendment added any matter to the patent, the court had to see first what was disclosed in the patent and then look at what was disclosed in the patent as amended. It should then compare the two disclosures and decide whether any subject matter relevant to the invention had been added [No rocket science here, in principle at any rate: it looks like a simple subtraction exercise].

* If the specification discloses distinct subclasses of the overall inventive concept, it should be possible to amend by whittling the patent down to one or more of those subclasses, regardless of whether they were presented as inventively distinct in the specification before amendment.

* when a proposed amendment seeks to take features which are only disclosed in one particular context and which are not disclosed as having any inventive significance, introducing them into a claim which is not limited by that context, we have "intermediate generalisation", a subtle, sneaky form of extended subject matter which has to be watched out for.

The IPKat has never been terribly sure what "intermediate generalisation" means, even if it gets the occasional mention on this weblog (see eg here), so he's hugely grateful for the clarification.

Cat's paw cement here

Because today is Friday: some "divine" patent entertainment

Our readers know that Friday is the traditional day of "light IP" on this blog and so the IPKat thanks Neil Thomson (Boult Wade Tennant) for alerting the kat to US patent US 2007035812 -"for amusement only" as Neil points out.

A divine cat (left) can be viewed at the British Museum.

The IPKat wondered how such an unusual patent could have gone unnoticed for so long and has conducted some background research into Chris Roller and his powers. So this Kat dutifully wants to give credit to the Patently-O weblog whose bloggers first reported on this patent in 2007. However, Merpel thinks that something as "divine" as this patent deserves to be mentioned at least twice: due to its heightened relevance in the times of the credit crunch and mostly because today is a Friday. Neil also raises a valid point when he muses that the patent "...kind of raises the question of whether he [Christopher Anthony Roller] is entitled to claim small entity status."

"Abstract of US 2007035812 (A1)

Christopher Anthony Roller is a godly entity. "Granters" had been given my powers (acquired my powers) (via God probably). These "granters" have been receiving financial gain from godly powers. These "granters" may be using their powers without morals. Chris Roller wants exclusive right to the ethical use and financial gain in the use of godly powers on planet Earth. The design of godly-products have no constraints, just like any other invention, but the ethnic consideration of it's use will likely be based on a majority vote of a group, similar to law creation. The commission
I require could range from 0-100% of product price, depending on the product's
value and use.

Description of US 2007035812 (A1)

[0001] Christopher Anthony Roller wants exclusive right to the ethical use and financial gain in the use of godly powers on planet Earth.

Please click here to retrieve the full patent details.
To read about the lawsuit between Christopher Roller and David Copperfield’s Disappearing, Inc., please click here.
To watch Christopher Roller talking about his powers, please click here.

Comfy lenses, shame about the patent ...

It was decided rather earlier this month, but the ruling of Mr Justice Kitchin in Novartis AG and Cibavision AG v Johnson & Johnson Ltd and another [2009] EWHC 1671 (Pat) has taken a while to reach the top of the IPKat's must-blog pile. 356 paragraphs can take a long time for a Kat to read and, though he hates to admit it, even longer to get the hang of what it's all about.

In brief, Novartis claimed that J&J's Acuvue Oasys products infringed its European patent for extended-wear silicone hydrogel contact lenses that could be left in the eye overnight or even for several days. J&J counterclaimed for revocation on the bases of insufficiency (ie the teaching in the invention as disclosed did not provide sufficient information for the person skilled in the art to make contact lenses within or across the range of the claims without undue experimentation), lack of novelty and absence of inventive step.

Kitchin J ruled that the patent was invalid for lack of sufficiency. He reasoned as follows:

* As to lack of novelty, it had to be shown that the prior art contained a clear description of, or clear instructions to make, something that would necessarily infringe the patentee's claim if carried out after the grant of the patent. Since the examples in two earlier patent applications cited by J&J did not satisfy all the requirements of any of the patent's claims, this burden of proof had not been met.

* The way of making a silicone hydrogel lens which was ophthalmically compatible over a period of extended wear was not obvious in the light of (i) the common general knowledge or (ii) the content of three earlier cited patents.

* For a patent to be valid its specification had to disclose the invention in a way that was sufficiently clear and complete for it to be performed by a person skilled in the art. In this context, the specification had to enable the invention to be performed to the full extent of the monopoly claimed (citing Biogen Inc v Medeva).

* Whether the specification disclosed an invention clearly and completely enough for it to be performed by a person skilled in the art involved a question of degree: the specification need not set out every detail necessary for performance, but the skilled person should not be required to carry out any prolonged research, enquiry or experiment.

* In this case, the ion permeability values taught by the patent and set by the claims were "extremely confusing and of little or no practical assistance to the skilled person seeking to make an ophthalmically compatible lens suitable for extended wear": it would require a research programme to identify silicone hydrogel formulations which were useful for producing such lenses.

Says the IPKat, this judgment has some interesting material on priority (paras 113 to 140), and a whole mini-thesis on insufficiency (paras 230 to 323). Kitchin J bases his reasoning on the House of Lords decision in Lundbeck, which he sees as reaffirming the reasoning in Biogen, both support the basic rule for sufficiency (see paras 233-234). He cites Lord Hoffmann quoting the Technical Board of Appeal of the EPO in Exxon/Fuel Oils (T 409/91) [1994] O.J. EPO 653: "the extent of the patent monopoly ... should correspond to the technical contribution to the art in order for it to be supported, or justified" (para 233).

Merpel adds: if you want to know all about the place of silicone 3-(methacryloxy)propyl tris(trimethysiloxyl)silane (TRIS) in the history of silicone hydrogel development, or the use of SANS, SAXS, TEM, EDX, AFM, DSC and FEGSTEM in the analysis of microphase structures, you will find the judge's analysis quite un-put-downable.

The Dutch proceedings, in which the same patent is held valid and infringed, here

Contact lenses for cats here

Wild Cat contact lenses here
Cats' eyes here

Thorn waxes lyrical and solders on ...

The IPKat hadn't forgotten the patent decision last week of the Court of Appeal (England and Wales) in Thorn Security Ltd v Siemens Schweiz AG [2008] EWCA Civ 1161 but there have been so many exciting distractions that he just hadn't got around to posting anything about it yet. In this case the Court, consisting of Lord Justice Mummery, Lady Justice Arden and Mr Justice Lewison, found themselves going back to basics, construing the meaning of the fundamental word "assignment" which appears in the apparently innocuous context of the Patents Act 1977 section 33(3) -- which deals with the relative entitlements of parties whose entitlement to a patent may or may not have been registered. Curiously enough this dispute almost slipped past the IPKat first time around (you can see his comment here).

Right: Siemens, in happier times before being licked by Thorn

In short, Thorn was appealing against the decision of Mr Justice Mann that its product infringed Siemens' patent and that Siemens was entitled to recover damages in respect of a period of infringement that actually pre-dated its registration as proprietor of the patent. Siemens become the owner of the patent by universal succession under Swiss law, following a series of mergers among Swiss companies. Siemens' patent was for a protective covering for printed circuit boards and method for their manufacture. The protective coating consisted of a plastic film to which wax was added. The wax was said to facilitate through-plating and soldering operations through the protective coating. The film was fused on to the printed circuit board by the action of heat.

Thorn's allegedly infringing product was a printed circuit board coated with a coating which contained wax installed in a smoke alarm. At trial Mann J held, as a matter of construction, that "facilitating" meant that there had to be practical benefits in making something easier in a way that could be appreciated by a practical user, and that the film had to be fused on to the circuit board by the action of heat alone. On that basis, he held, Thorn's product did indeed infringe. He then added that the mergers leading to Siemens' ownership of the patent did not involve any "assignment" within the Patents Act 1977 section 33(3) which had to be registered before a claim for damages (now, post-IP Enforcement Directive, costs and expenses: see link to earlier IPKat post for explanation) could be made under section 68 of the same Act.

Siemens argued that the judge was wrong in construing its patent as meaning that the notion of "facilitating" carried with it any element of practical benefit or that the practical benefits had to be capable of appreciation by a practical user, and that he also erred in holding that the fusion of the coating to the board had to be by heat alone. Thorn appealed against the finding of infringement, submitting that Mann J's findings were not supported by the evidence, and also and also maintaining that should have given a more purposive interpretation to the word "assignment" in section 33(3), so as to cover the mergers of the sort that had occurred here.

The Court of Appeal allowed the appeal. In its view

* The claim that the wax facilitated through-plating and soldering operations through the protective coating operated as a performance requirement of the claim. Mann J was right that "facilitating" required practical benefits and that, so far as the question of infringement was concerned, Siemens was entitled to rely on any means by which the wax in Thorn's product made through-plating and soldering through the coating easier in a practical sense.

* The specification stated that, in a "final process step" the coating was fused to the board by further heating. Accordingly it was not until that step, which consisted only of further heating, that the coating was fused to the board. Having regard to the way in which the process was described in the specification, the skilled reader would conclude that the fusion took place by the action of heat alone. Thus Mann J was right on that point too.

* The judge's findings that the nature of the waxed product (i) reduced the risk of charring, (ii) gave rise to a noticeable difference if a low temperature soldering iron were used and (iii) created a more easily-removable coating were not supported by the evidence.

* Mann J should not have inferred that Thorn's waxed coating would probably move aside more readily with less heat being applied. There were two characteristics of a coating with wax that pointed in opposite directions: (i) lower viscosity and (ii) increased wetting ability. The overall effect these competing factors had upon the coating was a question for direct expert evidence and was not a matter upon which an inference could safely be drawn. Nor should Mann J have found that Thorn's product was fused on to the printed circuit board by the action of heat. On the evidence, the adhesion of Thorn's product was produced by pressure. Accordingly, since Thorn's coating did not facilitate through-plating and soldering and was not fused by heat, its product did not infringe Siemens' patent.

* Finally, Mann J erred in holding that an "assignment" within section 33(3) had to be an express consensual bilateral document. Section 33(3) was wide enough to include an assignment by operation of law of the kind involved in universal succession following a merger.

The IPKat notes with awe that the Court of Appeal went all the way back to 1970, to the Report of the Committee to Examine the Patent System and Patent Law (1970 Cmnd 4407, the Bank Report) -- which led to the 1977 Act -- when deciding what was the mischief at which section 68 was directed. That report indicated that section 33(3) should be purposively construed. The moral of this story is, never throw away your old law reform reports: you never know when they might come in handy. The Report stated (with the IPKat's emphasis):

"The Patents Act should provide that where there has been a change of ownership of a patent, or where an exclusive licence has been granted on a patent, no damages for infringement should be recoverable by the new owner or the exclusive licensee in respect of infringing acts committed during the period in which the change of ownership or grant of exclusive licence was not registered, unless registration was effected within six months of the change of ownership or grant of exclusive licence.…".

Speaking for the entire court, Mummery LJ added:

"This recommendation applies to any acquisition of ownership, and is not limited to particular kinds of change of ownership".

Merpel's not happy about this highly principled and function-oriented approach. This is all very well, but it's not what the Patents Act says -- and who wants to rely on Banks at a time like this! I vote we seek leave to take this one to the House of Lords.

Famous Thorn here -- and here

"And with one bound, the Court of Appeal was free ..."

Fresh off the Air Berlin flight from INTA, the IPKat discovered this decision of the Court of Appeal for England and Wales (Lords Justices Ward, Jacob and Rimer) awaiting him: it's Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444 against the decision of Mr Justice Warren that Merck's patent for a medicament for treating baldness was invalid.

This case turns on the UK's Patents Act 1977, s.2(6), which is derived from Article 54(5) of the European Patent Convention, Art.54(5). Under s.2(6):

"In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art".

Merck held a patent for anti-baldness drug finasteride, which Actavis wanted to revoke. At the patent's priority date, back in 1993, Merck sold finasteride tablets as PROSCAR for the treatment of benign prostatic hyperplasia (prostate enlargement), the conventional dose being 5mg a day, this patent apparently dating back to 1978. The disputed patent claimed the use of a low dose of finasteride for the treatment of androgenic alopecia (a condition which included both male and female pattern baldness). Merck sold finasteride tablets for male baldness as PROPECIA, the dosage being just 1mg a day. Merck also filed a patent application ('382) in 1988 for methods of treating baldness with certain compounds that included finasteride.

When Actavis applied to revoke Merck's patent it argued that, for a second medical use claim to be valid, its novelty had to be in the new therapeutic application: novelty could not, it maintained, reside in nothing more novel than a dosage scheme for treatment of the same disorder as previously treated. According to Actavis, '382 disclosed the therapeutic application - the treatment of androgenic alopecia.

Warren J agreed with Actavis and revoked the patent. In his view it was well established that second medical use claims had to have a specified therapeutic application or purpose that was not only non-obvious but which was also new. That novelty had to reside in the second or subsequent therapeutic use. He added that, having regard to the description of the underlying chemistry of '382 and its specification, there was no novelty in the use of finasteride as a possible treatment for male pattern baldness. Even if a small dosage which it was now apparent could result in successful treatment, rather than the much larger doses mentioned in '382, that was just a different dosing regime.

Merck appealed, citing Eisai/Second Medical Indication [1985] OJEPO, 64, a decision in which an Enlarged Board of the European Patent Office had said, at para.23:

"It is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case where the process of manufacture as such does not differ from known processes using the same active ingredient".

This, said Merck, had become settled EPO practice -- though it was contrary to an earlier decision of the Court of Appeal in Bristol-Meyers Squibb v Baker Norton [2001] RPC 1. Merck maintained that Bristol-Meyers was not a good case to follow. Either it had no ratio decidendi at all or its reasoning was sufficiently unclear to preclude the court from following it. Failing that, even if there were a ratio, the court should recognise that this was an appropriate opportunity not to apply it.

The Court of Appeal allowed Merck's appeal.

* First, it held that a new dosage regime was enough to confer novelty in a Swiss form claim. In the EPO, Germany and New Zealand, Swiss claims in which the novelty depended on a new treatment by a different dosage regime or method of administration had been treated as novel and not as merely being claims to a method of administration.

* Bristol-Meyers did not rule clearly that a Swiss claim lacked novelty if the only difference between it and the prior art was a new dosage regime for a known medical condition.

* the function of rules of precedent was to produce certainty. Where a particular 'precedent' ws itself obscure, any attempt to follow it was likely to perpetuate uncertainty rather than achieve certainty.

* the Court of Appeal was free -- but not bound -- to depart from the ratio decidendi of its own earlier decision when it was satisfied that the EPO Boards of Appeal had formed a settled view of European patent law which was inconsistent with that earlier decision. In principle, therefore, the Court of Appeal would follow the settled view of the EPO in such a situation -- and this was such a decision.

The IPKat is content with this. On the assumption that Bristol-Meyers was a binding precedent to contrary effect, he thought Warren J had got it right -- but he's happy to see the Court of Appeal taking a view that has the effect of affirming the stability and predictability of the patent system rather than undermining it. Merpel bets the EPO is really happy to see Lord Justice Jacob waving an olive branch in its direction, after the post Aerotel/Macrossan debacle (see IPKat here and here).

Are bald men sexier? Click here and here
Should judges wear wigs? Click here and here
Why cats wear hats here