Taking the Exudate - ConvaTec v Smith & Nephew [2011] EWHC 2039 (Pat)

Seeping wounds: not the name of a village in the West Country (the Kat has checked), and neither is it the most savoury of subjects for polite after-dinner conversation. However, it does form the background for the decision in Convatec v Smith & Nephew [2011] EWHC 2039 (Pat), handed down this morning by HHJ Birss – the Judge having discarded his usual Patents County Court hat for the matter and donned that of a Judge of the High Court.

When but a kitten, one of the first things that one learns about tearing around the place with reckless abandon is the fact that most inanimate objects simply cannot be trusted. Apparently immovable, this Kat lost count of the number of playgrounds and trees that conspired to take large chunks out of his paws, elbows and knees by subtly reorientating themselves in respect of his person at a critical point during a daring manoeuvre. Needless to say: there were often cuts and grazes, blood and associated ooze. Anyone that has suffered from high-speed playground contact syndrome will appreciate that the damage caused is usually relatively slight, and the blood loss low. The ooze factor, however, is high, and many a good pair of trousers has been the source of significant pain and discomfort by becoming firmly adhered to the graze site. Wounds, you see, seep, and fabric tends to stick to this seepage.

So back to the case in hand. ConvaTec own a number of patents relating to wound dressings. The patent in suit (EP(UK) 0 927 013) concerned a non-adherent dressing comprising certain fibrous material that operated to absorb wound exudate (i.e. seepage) whilst maintaining a moist environment around the wound. Keeping a wound moist is generally agreed to aid healing, but too much moisture is a bad thing as it can lead to maceration (i.e. over-hydration) of the surrounding skin. Accordingly, at the priority date of the patent there were a number of wound dressings on the market that promoted the maintenance of a moist wound environment by gelling – absorbing the exudate and forming a gel within the dressing itself.

Smith & Nephew wished to sell a wound dressing called Durafiber. ConvaTec alleged that this would infringe their patent, and so brought an action against them. Smith & Nephew, for its part, denied infringement and counterclaimed for revocation on the ground of invalidity.

Construction
Having orientated himself by considering the technical background to the invention, the identity of the skilled addressee and their common general knowledge, the Judge then addressed the issue of construction. Distinct issues of construction arose in respect of claims 1 and 3 of the patent:

Claim 1:
A wound dressing comprising a blend of discrete modified cellulose gel forming fibres with at least one other type of discrete gel forming fibres.
Claim 3:
A wound dressing as claimed in any preceding claim wherein the dressing comprises a wound contacting surface consisting of a blend of discrete modified cellulose fibres with at least one other type of discrete gel forming fibres.

Setting out the law, the Judge adopted the tried and trusted formulation found in Kirin Amgen Inc v Hoechst Marion Roussel [2004] UKHL 46, [2005] RPC 9, and also recited the 11-point plan endorsed by the Court of Appeal in Virgin v Premium Aircraft Interiors [2009] EWCA Civ 1062, [2010] RPC 8. When addressing claim 1, he explained that there 2 issues of construction: the first was the meaning of “blend of discrete fibres” and whether this rendered it a product by process claim; and the second was the meaning of the word “type”.

Rejecting the contention that claim 1 would be understood by a skilled reader to refer back to the process by which the product was made, the Judge explained that it was a simple product claim:

[55] “…The claim is a claim to a thing – a wound dressing. The thing comprises a blend of (at least) two types of discrete fibres. In other words a mixture of discrete fibres.”

[57] “No doubt the reader would expect it to be likely that one would make such a wound dressing by mixing (blending) the two fibre populations but that processing is not what the claim is talking about. The claim is talking about a product…. The reader would understand that the invention is about using the mixture of fibres which gives beneficial properties as a wound dressing. It is not an invention focussed on manufacturing methods. How you choose to make the mixture is irrelevant.”

Moving on to the construction of “type” within claim 1, the Judge noted (at [60]) that ConvaTec had argued that “type” referred to fibres with different absorbency properties. Smith & Nephew, by contrast, contended that “type” referred to a particular polymer – i.e. to the chemistry of the fibre. In a rather radical move, the Judge considered that “both the claimants’ and the defendants’ submissions are wrong.” He explained that

[63] “The flaw in each side’s submission is to approach the matter as one of construction of the word “type”. Type is a perfectly ordinary English word which ordinarily would not be expected to bear the kind of refined analysis each side have subjected it to. The key it seems to me is to appreciate that the correct question is to construe claim 1. Claims should, if they can, be construed as a whole.”

Accordingly, by focussing on the meaning of one word within the claim, the parties had missed the way in which claim 1 was written. As this Kat has long maintained, the process of atomising phrases within the claims is capable of distorting the message conveyed by the whole. The natural tendency when faced with a deconstructed sentence is to treat the individual particles as elements of precision. One assumes that the message conveyed by the whole is simply the sum of its parts, whereas often the true story is much more complicated. Or, as in this case, much simpler: accordingly as the Judge explained –

[65] “…[C]laim 1 is actually rather simple. If all the gelling fibres in the wound dressing are modified cellulose then the claim is not satisfied. The claim requires a blend of (gel forming) modified cellulose fibres and some other type of fibres, that is to say some other fibres which are not modified cellulose. If I ask in a shop for a bowler hat and another type of hat, I do not expect to be given two bowler hats, differing only in their size or colour or whatever.”

[66] “…Asking, out of the context of claim 1, what a “type” is, is an example of meticulous over analysis of the words. Once you embark on asking the (wrong) question of what is a type, there is support in the specification for many different answers.”

Moving on to claim 3, the Judge explained that the term “modified cellulose fibres” was not a term of art and was “not a term which reader would think was meant to impose a tight limitation. The term is broad and is not intended to be limiting.” Accordingly, it was not limited to chemical modifications.

Infringement
Given the Judge’s construction of the claims, there was evidently no infringement:

[104] “The only gel forming fibres in Durafiber are made of CES, i.e. modified cellulose. In other words, as regards gel forming fibres, Durafiber uses modified cellulose alone and there is no other type of gel forming fibre present. Therefore on the true construction of the claims, Durafiber does not infringe claim 1.”
[105] “Moreover since claim 3 is dependent on claim 1, Durafiber does not infringe that claim either, irrespective of the issues of construction of claim 3.”

Validity
Moving to validity: by the end of the trial ConvaTec had accepted that claim 1 of the patent was anticipated and therefore invalid. Claim 3, stated to have independent validity, was attacked on grounds of obviousness – it being alleged to lack inventive step over three pieces of prior art (Qin, Lassen and ‘746) and the common general knowledge. Diving in to the issues, the Judge applied the Pozzoli reformulation of the classic Windsurfing test and sought to apply this to the facts. In respect of the first two pieces of prior art (Qin and Lassen), claim 3 passed muster – it was not obvious in their light. ‘746 deserves special mention.

‘746 was a PCT application published about a year before the priority date of the patent in suit. It is entitled “Wound dressings” and relates a wound dressing employing CMC (i.e. carboxymethyl cellulose – modified cellulose) fibres in the wound contacting surface. On the Judge’s construction the point did not arise, however, on ConvaTec’s proposed construction – assuming that the defendants’ product did infringe the claims – then it was alleged that the product of ‘746 would also fall within the patent’s scope of protection. As such, the patentees were evidently on the classic “horns of a dilemma”: the defendants alleging that there was nothing patentably distinct between ‘746 and their actions which were alleged to infringe. As the judge noted (at [170]) this was “a Gillette defence of the purest kind.”

Nevertheless, as construed by the Judge, the patent was safe from these challenges. It was also not obvious in light of the common general knowledge – this being a case in which one could legitimately ask “if it was obvious why was it not done before?”

Accordingly the patent was valid, in part, but not infringed.

Nokia v IPCom - Round Two of the English Leg of the International Patent Battle

The tussle between Nokia and IPCom has reached the courts once again and is, in the mind of this Kat at least, beginning to appear a little like the legal equivalent of UK TV uber-serial Eastenders - not quite up there with the Coronation Street-like behemoth of the Chiron v Organon litigation in the 1990s, of which this Kat seems to recall at least 14 decisions, but nevertheless still on its way to epic status.

By way of a reminder: IPCom (described by the Court of Appeal in previous litigation ([2011] EWCA Civ 6) as a “non practising entity”, i.e. a patentee with no business of its own in products covered by the rights it holds), owned a number of patents (which it had bought from Bosch) in the field of mobile communications technology. It originally approached Nokia offering to licence these rights, but Nokia refused to pay the sum that IPCom requested. IPCom therefore commenced infringement proceedings against the Finnish company in Germany. This riled Nokia who retaliated, seeking revocation of a number of the patents in Germany and the UK, and the dispute escalated into what has been described as “an international patent battle”.

Floyd J had previously dealt with matters between the two on a number of occasions and had produced three judgments (of 20th November 2009, [2009] EWHC 3034 (Pat) (“the first amendment judgment”); 18th January 2010, [2009] EWHC 3482 (Pat) (“the main judgment”); and 31st March 2010, [2010] EWHC 789 (Pat) (“the second amendment judgment”)). The parties, having taken a little time off to visit the Court of Appeal (which pronounced on the matter on the 20th January 2011, [2011] EWCA Civ 6 – noted by the IPKat here), were recently back before the Judge for another round. Floyd J’s latest decision in the matter was handed down yesterday.

This particular episode of litigation concerned IPCom’s European Patent (UK) No. 1 841 268, a divisional of European Patent (UK) No. 1 186 189 which had found fame in the previous round. The judge had found the parent patent invalid in his January 2010 judgment ([2009] EWHC 3482 (Pat)), and Nokia now sought the same fate for its offspring. IPCom, for its part, made a conditional application to amend the patent and also counterclaimed alleging infringement. Nokia denied this and also sought a declaration of non-infringement in relation to a series of other mobile phones.

Those who take delight in the technical aspects of the UMTS mobile telecommunications standard will, once again, be in seventh heaven reading this judgment. For the rest of the IP population, a summary will suffice. As the Judge explained (at [5]), the patent concerned a “method of managing the problem of contention on a random access radio channel uplink between mobile phones and a network base station.” Essentially, it offered a manner of regulating a UTMS mobile radio network so as to distinguish between various user classes and to dynamically prioritise certain mobile traffic over others. Priority traffic would gain direct access to the network, whereas other traffic would compete for access in a ‘lottery’.

The meat of the judgment revolves around the obviousness attack upon the patent’s validity, although a significant portion of the judgment is also directed to discussion of added matter. Insufficiency gains a brief look-in as well.

Validity
Cutting to the chase, Floyd J was not convinced that any of Nokia’s three prior art references rendered the invention obvious. The same fate befell Nokia’s final challenge – that the alleged invention was actually obvious in light of the common general knowledge (CGK). Despite this being described (at [116]) as “a very simple and attractive argument, untrammelled as it is by any of the details of a practical working system”, it was nevertheless considered to fail. The Judge concluding (at [123]) that even though the patented invention may not have achieved anything in terms of general functionality when compared with the prior art or CGK, “it does not follow that IPCom’s approach to achieving that functionality is obvious. It is entirely possible that invention lies in achieving the same functionality in a different way.”

Objections to the amendment of the claim based on added matter went the same way: all failed. Similarly, all objections on the basis of insufficiency were also rejected, the Judge concluding that:

[176] “…The patent would not be understood to be pretending that the invention would work without modification in whatever UMTS system was ultimately agreed. This case is nothing like a patent where there is a missing essential ingredient. The cross-examination of Mr Gould did not show that a system could not have been built based on the draft standards: it merely showed that it would not have been possible to guess what choices would be made in the final standards, and that if there was a difference the phone would not work.”

Infringement
Having concluded that IPCom’s patent was valid, the Judge went on to consider the question of infringement. He noted that there was a “Product and Process Description for each of 14 types of Nokia device designated “the A1”, “the A2”, “the B1”, “the B2”, “the C1”, “the C2”, “the D1”, “the D2”, “the E1”, “the E2”, “the F1”, “the F2” , “the G1”and “the G2”.” A1 and A2 were found to infringe, but the B to G devices were not. As the Judge explained:

[206] “The only case of infringement which IPCom could have advanced on these devices would have to be based on class barring. But they cannot espouse that construction because they have now accepted that on that construction the patent would be invalid over GPRS.”

Accordingly, a declaration of non infringement was granted in respect of the B to G devices.

With this round going, on balance, to IPCom the next instalment in the €12 billion European saga is eagerly awaited.

The chips are down in spud-separator shoot-off

Hot(ish) off the press, the IPKat brings you news of the Court of Appeal’s (Jacob and Etherton LJJ and Sir David Keene on the Bench) judgment in Grimme Landmaschinenfabrik GmbH & Co KG v Derek Scott (trading as Scotts Potato Machinery) [2010] EWCA Civ 1110, handed down on Friday by Lord Justice Jacob. By way of background: Grimme had originally alleged that Scott was infringing its European Patent (EP(UK) 730 399) and unregistered design rights in a potato separator by sale of a machine called “Evolution”. [For those not versed in the day-to-day mechanics of the potato farming industry: the potato separator is an ingenious machine that (somewhat conveniently, given its name) separates potatoes from the assorted detritus that one would expect things wrenched from the ground to be duly associated with – i.e. weeds, earth, stones, stalks, etc.]. Scott, for his part, resisted those claims, and in turn sought revocation of the patent and relief for unjustified threats alleged to have been made by Grimme in respect of both patent and design right infringement.

At first instance [noted by the IPKat here], Mr Justice Floyd, had held that, while claim 1 of the patent was invalid as it lacked inventive step, claims 17 and 24 were valid. He found that Evolution infringed claim 17 “provided that at some point in the separating path it has two counter-rotating pairs of rubber rollers”. If, however, Evolution did not have two counter-rotating sets of rubber rollers at some point in the separating path, then because it was adaptable to include two such sets, its sale would infringe claim 17 under section 60(2) – Scott knowing, or it being obvious to a reasonable person in the circumstances, that users might swap the steel rollers for rubber ones. Furthermore, in cases where rubber rollers were already fitted to Evolution when sold, the sale of spiral replacement rollers was additionally, and of itself, an indirect infringement under s60(2) Patents Act 1977 (Scott once more being found to possess the requisite knowledge). Grimme’s design rights survived the allegation that they were commonplace, and were found to be infringed by Scott’s original roller (although not a subsequent incarnation). The fate of the counterclaims for unjustified threats was, as may be expected, tied to the outcome of the allegations of infringement and so succeeded in relation to the design right but not in relation to the patent infringement proceedings – in respect of the latter, although threats were made, they were justified.

THE APPEAL

The arguments raised upon appeal were confined to “issues about the Patent and the unjustified threats claim and include a point of general application about the meaning of s.60(2) of the Patents Act 1977.” All in all, 12 issues had been agreed at the outset of the hearing, but the Court was of the opinion that it would be advantageous to “consider first whether the Judge’s construction of claim 1 was correct or whether it was, as Grimme contended, narrower. If we concluded it was narrower, then we should consider the question of its obviousness. The advantage of this course was that if we concluded that claim 1 was valid, then the separate points sought to be raised by Mr Scott about claims 17 and 24 would fall away.”

(1) Construction & Validity

Approaching, therefore, the issue of construction, the Court considered that the Judge had construed claim 1 of Grimme’s patent too widely. In particular, Grimme had argued that the Judge had not addressed the “requirement that that the rib part (we use that as shorthand for lip, rib or like extension) should project beyond the contours of the cylindrical shell part”. It had been submitted that this meant that the rib had to project from the cylindrical surface of the roller as in fig.12 of the patent (reproduced below right) where the rib extends out of the cylinder. The Court considered that there may have been a number of reasons for this omission, but agreed with Grimme’s contention that the experts on both sides thought that the star wheels of Rollastar were not themselves within the language of the claim. Thus, whilst “the court is not bound by the views of the experts as to the meaning of ordinary words in the claim …, it is obviously a strong thing for the court to take a different view from a consensual view of the experts.” Furthermore, it was “consistent with the inventor’s purpose to read the claim in the narrower sense: “That purpose is to remove mud, stones and haulm by dragging them through the gaps between the ribbed rollers and the clod roller.

If you use star wheels of the sort in Rollastar you are not aiming to do that. You are aiming to remove stones and mud by a sieving action.” (see [35] to [43]).The Court therefore considered that the claim required that the “lip, rib or like extension” must rise out of the cylindrical portion – and thereby that it must have axial length and there must be a recognisable cylindrical portion from which it projects. This was a narrower construction than that adopted by the Judge and, accordingly, obviousness had to be looked at afresh – the Judge having concluded on a (now incorrect) wider reading of the claim that it was obvious. “The Biogen principle of deference by an appeal court … to the multifactorial assessment of a trial judge” not applying in such circumstances.

Therefore, applying the Pozzoli v BDMO ([2007] EWCA Civ 588, [2007] FSR 27), restructuring of the classic Windsurfing test, the Court concluded that to move from the prior art (Rollerstar) machines to Grimme’s patented invention would not have been obvious. There were a number of steps along the way that provided impediment to the allegedly obvious path that were such that “the skilled man simply would have no motive or reason for even embarking [it].”

In the Court’s words: “The upshot is that the Patent is wholly valid and Mr Scott’s machine sold with elastomeric clod rollers falls within claim 1. Its sale and offering for sale is a direct infringement prohibited by s.60(1) of the Act.”

(2) Contributory/Indirect Infringement under s60(2)

The Court considered that Scott’s sale of the Evolution machine with steel rollers fitted fell outside of claim 1. However, the fact that “the machines [were] designed so that the rollers were interchangeable …, and that those supplied with steel clod rollers could be changed by the ultimate user (or indeed a middleman) over to rubber rollers …, [when combined with the fact that] they were marketed on that basis”, easily supported a claim for contributory infringement under s60(2).

In relation to this latter point, the Court gave full treatment to the origins and scope of the section [by far the fullest treatment of the provision that this Kat has ever seen in an English decision]. It therefore noted that the section originates from Art. 30 of the 1975 draft of the Community Patent Convention, and which became, in unchanged form, Art. 26 of the 1989 version, neither of which ever entered into force, but is still one of those provisions of which the Patents Act 1977 is “so framed as to have, as nearly as practicable, the same effects in the UK as the corresponding provisions of the Community Patent Convention”. As with nearly all such provisions, the text of the CPC was taken and remixed when bringing it within the domestic legislation (a practice described as “preposterous” by the Court, which also notes that this practice “serves [only] to confuse”). Nevertheless:

[88] “Section 60(2) creates a statutory tort, but it does not spring from any previous notional or common law tort. Its distinctive features, by way of contrast with common law tortious claims, are that the tort is actionable (1) even though what is supplied is capable of perfectly lawful, non-infringing use, (2) even though what is supplied never has been and may never in fact be used in a way directly infringing the patent in suit, (3) without any damage being suffered by the patentee, and (4) at the moment of supply, irrespective of anything that may or may not occur afterwards.

…[90] [This] makes the description “contributory” as opposed to “indirect” infringement something of a misnomer. If and to the extent that Mr Scott’s case is that there can be no infringement under s.60(2) unless there is actual direct infringement, it is plainly wrong. In this connection it is particularly important to observe that there can even be infringement by “offering” to sell an essential means – at the time of the offer there is unlikely to be any particular end user in mind.

Therefore:

“[102] …Grimme’s invention is “put into effect” when the Evolution machine is fitted with rubber rollers. The supply of a steel-rollered machine, which is designed and indeed promoted to enable the steel rollers to be changed for rubber rollers, is plainly the supply of the means by which that can be achieved, and is the supply of a means essential for that purpose. The fact that a steel-rollered Evolution machine, so long as it remains steel-rollered, does not infringe and is capable of lawful use as a complete machine in that state is irrelevant. The section is clearly intended to apply to, among other things, products which are perfectly capable of being used in a manner which will not constitute a direct infringement within s.60(1). The requirements as to suitability and knowledge of intended use limit the scope of the statutory tort in relation to such products, not whether the product itself is capable of lawful use without alteration, addition or adaptation.”

However, s60(2) PA 1977 also requires knowledge for there to be infringement: specifically that the supplier “knows … that those means … are intended to put the invention into effect”. Accordingly, a number of questions concerning knowledge arose in this dispute. These are listed by the Court in [107] of the judgment, and the answers discussed in [108] to [132], but are condensed here:

(i) Whose intention is referred to?

The Court considered that it was self-evidently not the supplier himself. The required intention relates to putting the invention into effect, and so the reference to intention must be to the intention of the party that is in a position to put the invention into effect, i.e. the person supplied. “The question is what the supplier knows or ought to know about the intention of the person who is in a position to put the invention into effect – the person at the end of the supply chain.” However, the person whose intention is referred to need not be the person directly supplied as “if that view were right, a party who only supplied essential means to middlemen could never fall within the provision”, which cannot have been the intention of the legislation.

(ii) How specific must the intention be?

Here the Court considered that “it was enough if the supplier knew (or it was obvious in the circumstances) at the time of his offer to supply or supply that some (disregarding freak use) ultimate users would intend to use, adapt or alter the “means essential” so as to infringe.” Several decisions of the Bundesgerichtshof (German Supreme Court) were utilised to support this view (Deckenheizung [BGH X ZR 153/03], 13 June 2006; Haubenstretchautomat [BGH X ZR 173/02], 9 January 2007; and Pipettensystem [BGH X ZR 38/06], 27 February 2007. The three earlier cases are Luftheizgerät, [BGH X ZR 176/98], 10 October 2000; DI B.V. [2004] ENPR 194 of 25 March 1999 (Oberlandsgericht, Düsseldorf); and Antriebsscheibenaufzug [BGH X ZR 247/02], 7 June 2005).

(iii) When must the intention be formed?

Again referring to the German decisions, the Court considered that “[w]hilst it is the intention of the buyer (this must mean ultimate buyer) which matters, a future intention of a future buyer is enough if that is what one would expect in all the circumstances.”

In summary, the Court noted (at [131]) that:

“…[T]he knowledge and intention requirements of Art. 26 and section 60(2) are satisfied if, at the time of supply or offer of supply, the supplier knows, or it is obvious in the circumstances, that ultimate users will intend to put the invention into effect. That is to be proved on the usual standard of balance of probabilities. It is not enough merely that the means are suitable for putting the intention into effect (for that is a separate requirement), but it is likely to be the case where the supplier proposes or recommends or even indicates the possibility of such use in his promotional material.”

Therefore, the fact that Scott not only pointed out that users could adapt the Evolution machine by simple modification, but also sold the means to do so, clearly marked him with the requisite knowledge. The Court was not moved by the contention that only a few users actually made the change. “Mr Scott knew that users would intend to make their devices infringing if it suited them and positively encouraged that intention.”

As an endnote, this Kat was going to begin this post with a comment that potatoes and the law do not often find their paths crossing, however, upon searching a well-known legal database of case law for the word “potato” he received a not altogether unrespectable 1275 hits, and so shelved this comment on the basis that it was not, in fact, true. (For the curious (and despite the obvious dangers to any feline: who isn't?), “cat” receives 1748 hits, whilst “cat” & “potato” receives 25 - the mind boggles).

That potatoe: here

Famous potatoes: here and here

DSS' patent out of the money in Germany, too

Regular IPKat readers will already be familiar with Document Security Systems (DSS), which has been attempting to enforce their European patent (EP 455 750) relating to anti-forgery measures, and in particular against the European Central Bank, who DSS would argue are either already using or at least will want to use their patented technology in banknotes. The ECB has responded by attempting to have the patent revoked in each state in which it is in force. It has, so far, succeeded in the UK (noted here), in France (noted here) and in Austria (not noted), but failed in the first instance in the Netherlands (noted here) and Germany (noted here).

The ECB can claim another (and final) victory in Germany now, the BGH having overturned the decision of the Bundespatentgericht. In its judgment of 8 July 2010, the BGH comes essentially to the same conclusion as the English and Dutch courts, i.e. that the patent as granted contains added matter over the application as originally filed (the grounds for the decision are not yet available; press release here). The judgment is interesting insofar as the BGH has lately mostly overruled decisions of the Bundespatentgericht invalidating patents. Yes, adds Merpel, but mostly if the invalidity was based on lack of inventiveness; this challenge succeeded on other grounds.

As another Kat has noted earlier, these types of disputes involving the same facts in several jurisdictions, with courts coming to opposite conclusions, really are an argument in favour of centralised patent litigation. And, if I may add, sorry, Germans, but taking three years for an appeal (the Bundespatentgericht judgment dates of 27 March 2007) is too long.

Letter from AmeriKat: This 'n That

Last week the AmeriKat was hanging on tenterhooks constantly refreshing the US Supreme Court page hoping that the decision in Bilski had finally been issued. Low and behold, a watched Supreme Court webpage doesn't deliver opinions. Time was not completely wasted, however. (picture, left - the AmeriKat takes a nap while awaiting Bilksi) The AmeriKat has learned that waiting for someone or something to occur is generally a wasted activity and so she spent the interim time prowling the web for other IP news, going to the gym, tackling her two page To-Do list and various other ignored activities. After all of this, the Supreme Court still had not delivered a decision but that was no skin off the AmeriKat's nose leather. She had been extremely productive in the interim period. So productive, it seems, that the bulk of US news stories that she was to write about in her weekly Letter she already posted during the week. So this week, she delivers a some bits of bobs from the US IP.

Catcher in the Rye Back to Batts: Last Friday, the US Second Circuit Court of Appeals held that Judge Batts had erred in her reasoning by not applying all of the equitable principles required for the evaluation of a preliminary injunction when she granted the injunction to prohibit the sale of Fredrick Colting's sequel to Catcher in the Rye,60 Years Later: Coming Through the Rye. In June last year, JD Salinger, the now deceased author of The Catcher in the Rye, filed a lawsuit in the US District Court in New York claiming that 60YL infringed “both his novel and the character of Holden Caulfield” and aiming to prohibit the publication of the sequel in the US (for further background on the case see the AmeriKat's previous reports here). In overturning the injunction, the Court of Appeals found that Judge Batts had considered only the likelihood of success of Salinger's copyright infringement claim and not also, for example, whether Salinger would suffer irreparable harm if the injunction was not granted. Judge Guido Calabresi stated:

"Because Salinger had established a prima facie case of copyright infringement, and in light of how the district court, understandably, viewed this court's precedents, the district court presumed irreparable harm without discussion."

Judge Calabresi continued by saying that the lower court's decision was understandable given that the US Supreme Court's standard for granting injunctions in eBay Inc v MercExchange (2006), a patent case, was inconsistent with the 2nd Circuit's standard for preliminary injunctions in copyright cases. The Court of Appeals vacated Batts' decision but allowed the injunction to remain for 10 days so that Salinger's estate could apply for a temporary restraining order pending the rehearing. It is important to note that although the Court of Appeals vacated the injunction, the issues regarding Salinger's likelihood of success for the substantive issues remained in his favor.

Patent's inequitable conduct to get a rehearing: Last week the US Court of Appeals for the Federal Circuit granted an en banc rehearing of the appeal of a Californian district court decision in Therasense, Inc v Becton Dickinson & Co that held a patent to be unenforceable due to inequitable conduct. (picture, left - an example of inequitable conduct) The panel opinion delivered this past January affirmed the lower court's finding that the applicant's failure to disclose statements made to the EPO about their patent's European counterpart amounted to inequitable conduct. This opinion was also vacated by last week's order. Under Rule 56, patent applicants must disclose to the USTPO all information that is material to the patentability of the invention. Withholding any material information or making false representations along with the intent to deceive the USTPO is held to be inequitable conduct. Inequitable conduct is generally pleaded by defendants as an affirmative defence and allows a federal judge to void patents on a finding that a company deceived the USPTO in order to obtain a patent. The Federal Circuit's January decision was heralded by some as meaning that applicants had to submit all information relating to their patent application including documents submitted to foreign patent offices - a massive burden you can imagine for some international pharmaceutical and biotech companies! The en banc court will prove to be important in that setting out guidelines as to what documents and from where a patent applicant must disclose to the USPTO to avoid a finding of inequitable conduct. The Federal Circuit has asked the parties to submit arguments addressing these questions prior to the hearing. Also last week, a majority panel in last week's case of Avid v Crystal Import Corporation found there had been inequitable conduct on the part of the applicants.

Awaiting Judge Lee's Decision in Rosetta Stone - Last week, the AmeriKat and IPKat wrote about the breaking news of Judge Lee's granting of summary judgment in favor of Google in the Adwords case brought by Rosetta Stone. The AmeriKat has been prowling the Internet for the past hour and has determined that Judge Lee has yet to issue his formal decision. As soon as he does the AmeriKat will be on it!

Two bites and you're out

Readers with good memories may recall the decision of Mr Justice Warren (Patents Court, England and Wales) in Actavis v Novartis [2009] EWHC 41 (Ch) (noted briefly by the IPKat here) concerning the validity of Novartis's European patent EP0948320 which claimed a sustained release formulation for fluvastatin, a drug intended to prevent heart attacks caused by high cholesterol. Fluvastatin, as the name suggests, was a statin, used to lower levels of LDL cholesterol in the body by affecting its synthesis in the liver.

Presented with a large volume of evidence, Warren J considered that the matter was "finely balanced" but held the patent invalid for lack of inventive step in that fluvastatin was itself known for a long time before the patent was applied for and the sustained release formulations claimed in the patent were well known at the time. Since the skilled person, in the form of a research team, would know of these facts, it would be an obvious step to combine them. The patent was consequently found to be invalid for being obvious.

The Court of Appeal (Lords Justices Jacob, Lloyd and Stanley Burnton) today held, in [2010] EWCA Civ 82, that Novartis's appeal should be dismissed. Their Lordships agreed with the trial judge that the invention as claimed was obvious. Jacob LJ however took the opportunity to disagree with him about the "finely balanced" bit:

"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."

The same judge reminded us that the proper route to the determination of inventive step is via Pozzoli:

"I have to say I do not think that the two-bite approach [Merpel says, which are the two bites?] is actually a convenient way to deal with obviousness. It is, after all, a multi-factorial assessment. The thing to do is to identify all the relevant factors, orientate oneself à la Pozzoli and then decide whether the invention is obvious".

Says the IPKat, Pozzoli is a great case for big Kats, being possibly the first occasion on which Lions in the Path were linked with Paper Tigers in the same piece of judicial analysis.

Lion in the path here

Lions in the bath here

Paper Tigers here and here

Breaking news: Nokia triumphs over IPCom

A report from Reuters ("Nokia says UK High Court rules for it vs IPCom") declares that giant mobile phone-maker Nokia has claimed victory in its Patents Court (England and Wales) patent dispute with German company IPCom, from which it now plans to seek to recoup its legal costs. According to Nokia's spokesman,

"This is an important decision, as it is not possible to infringe an invalid patent [oh yes it is, says the IPKat. See Coflexip v Stolt, here]. Nokia is pleased with these results, having won all patent infringement cases between Nokia and IPCom that have come to judgment".

Back in December a district court in Mannheim, Germany, put on hold an application by IPCom for injunctions to ban the sale and distribution of Nokia handsets in Germany, pending final decisions on the validity of the patents by the European Patent Office. These decisions are due later this year. IPCom is the owner of what used to be Bosch's mobile telephony patent portfolio, created between the mid-1980s and 2000, which includes about 160 patent families worldwide that are key for mobile communications standards.

The IPKat hasn't yet had the chance to read the decision in full. It's vast (67 pages and 27,000+ words) and it's not yet available on BAILII. If there's one thing it clarifies, it's the question as to what Mr Justice Floyd might have been doing over the Christmas break. You can read the full text, courtesy of the Kats, here [not any more -- see Addendum 2, below].

Addendum 1: After posting this report, the IPKat received a helpful note from Richard Vary (Nokia). He explained that the Nokia spokesman quoted in the Reuters report was explaining that you can't infringe an invalid patent because IPCom had previously claimed victory in similar circumstances, announcing that "Nokia was found to infringe". Nokia then had to explain to journalists, analysts and investors, who know little about patent law, why Nokia hadn't lost but could carry on selling mobile phones. Richard also points out two factual errors: (i) the patents are not before the EPO, but their German equivalents are before the Federal Patent Court; (ii) IPCom doesn't claim to have 160 standards related patents -- they claim around 30 families on their website.

Addendum 2: the report is now available on BAILII, so you can click and get it here.

Haulm Sweet Haulm for the Grimme Reaper?

Some good folk would say that quite enough has already been said about Tuesday's Patents Court for England and Wales ruling of Mr Justice Floyd in Grimme Landmaschinenfabrik GmbH & Co. KG v Derek Scott (trading as Scotts Potato Machinery [2009] EWHC 2691 (Pat), an earthy tussle over rights in machines for separating potatoes from weeds, earth, clods, stones and haulm. Grimme alleged patent and design infringement.

Right: nothing to do with potatoes, this is actually a machine for recovering costs ...

Scott denied infringement and counterclaimed for (i) invalidity and (ii) ungrounded threats to sue for patent and design infringement. Both sides emerged as both winners and losers (see PatLit here for a brief explanation and some idle speculation as to what the costs order might look like), and Class 99 waxed lyrical on the analogy between the design issues in this action and those in the 'pig fenders' case ( C & H Engineering v Klucznik [1992] FSR 421: as David Musker notes, "for pig read potato").

So is there anything left for the IPKat? Yes, there is. The question is again raised as to whether the commercial success of a patent is an indication of inventive step. Says Floyd J:

"Commercial success

127. Grimme also rely on commercial success of machines made in accordance with the invention. Commercial success can, in some fairly rare and clear cases, amount to a secondary indication of inventive step. The reasoning behind why this is so was explained in characteristically lucid terms by Laddie J in Haberman v Jackel [1999] FSR 683 at 699 to 701.

128. Grimme have provided a table of the sales which it relies on to show commercial success. It relies on the Grimme MultiSep spiral segment separator sales from 2000 when it was launched. It contrasts these with sales of other separators, including the MultiSep with paddle star wheels. Grimme contend that the MultiSep spiral segment is made in accordance with the Patent but that the MultiSep paddle star is not.

129. I have not found the evidence of commercial success helpful on any issue of obviousness in this case. The basis on which I have found claim 1 to be obvious is that a Rollastar machine with rubber clod rollers is sufficiently adjustable that it falls within the claim. That being so, no amount of commercial success of either MultiSep machine can have a bearing on the issue. The same applies to claim 24.

130. So far as claim 17 is concerned, I have been able to find that claim to be inventive by a sufficient margin not to require secondary indicia of the kind provided by commercial success. But given the level of sales enjoyed by the paddle star, which did not have this feature, I do not think that it is established that commercial success is due to the features of claim 17.

131. I think it would be unwise to attribute the success of the MultiSep to anything disclosed in the Patent. The lips or projections taught by the Patent are nothing like those used in the MultiSep. The evidence showed that those used in the Patent would fill with mud and be difficult to clean. I believe that the commercial success of the machines relied on is likely to be due to a combination of factors including Grimme's market position and the decline of the Pearson business. It is impossible to distill from that evidence any indication that the features of claim 17 played a significant role".

The IPKat doesn't like to see himself as an extremist or an iconoclast; still less does he like to take issue with the late Sir Hugh Laddie -- but he fervently wishes that the 'commercial success' criterion were consigned to the scrapyard of legal history along with frankalmoign and enfeoffments. If you look at Article 56 of the European Patent Convention, there's a bit in it that read:

"An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art".

The Kat knows this sounds somewhat trivial, but this looks to him as though inventive step is measured by looking at the invention itself, rather than the receipts and invoices. He understands that, in the days when judges knew plenty of Latin and Greek but whose knowledge of science was confined to apples falling from trees, it was cruel and unfair to blind them with science, so lovely little rules of thumb like 'long-felt-want' and 'commercial success' were devised. Surely there's no room for them now, with specialist patent courts and even some judges with a science background to staff them. In any event, as one member of the Court of Appeal once pointed out (and there's a pint of beer for whoever first posts his name below together with the case he said it in), the absence of commercial success is as much an indicator as the existence of commercial success (i.e. if something's sufficiently non-obvious, people won't see how you can make it pay: think of Frank Whittle's invention of the jet engine).

At this juncture, three things occur to the IPKat. First, we are all supposed to be good Europeans now. So can anyone tell him how far 'commercial success' is used as a criterion of inventive step elsewhere in Europe?

Secondly, if we are all supposed to be looking for ways to streamline and accelerate patent litigation, can the judges make it a point of case management to say something like: "don't go bothering me with evidence of commercial success in support of a patent's validity unless I say so"?

Thirdly, it may only be a matter of impression, but 'commercial success' generally looks to the IPKat as though it's thrown in when the case in favour of a patent's validity is pretty weak. So, other than to make the client happy by letting him hear his patent praised and running the risk that he might be faced with disclosure of some of his more delicate financial and management records if he does so, does 'commercial success' really achieve anything?

Grimme reapers here

The Grim Reaper here and here

Cat potato here

That (es)citalopram patent again

Last week The SPC Blog featured news that The Dutch first instance decision in ratiopharm et al v Lundbeck, concerning the validity of Lundbeck’s escitalopram patent (EP 066) had been handed down by the Hague District Court, which held all the claims of Lundbeck’s escitalopram patent (and the Dutch Supplementary Protection Certificate which was based upon it) invalid for lack of inventive step. The SPC Blog's informants -- Richard Ebbink and Mark van Gardingen, Brinkhof -- mentioned that the court's decision contained many references in the decision to the 4 May 2007 decision of Mr Justice Kitchin of the Patents Court for England and Wales [noted here by the IPKat], with which decision the Dutch Court “respectfully disagreed”.

The IPKat has since heard from Jaap J.E. Bremer (BarentsKrans N.V.), who writes:

"You may be interested to know that my colleague Marleen van den Horst and I represented two out of three claimants (A.E. Tiefenbacher GmbH and Centrafarm B.V.) in these proceedings before the Court of The Hague. The Dutch Court clearly distinguished its judgment from the UK decision and the distinction was justified by new experimental evidence as well as expert evidence provided by Tiefenbacher, 

In the UK case, Kitchin J heavily relied on the interpretation by Prof Davies, Head of Chemistry at Oxford University, of certain organic chemistry rules called the "Baldwin Rules", which were created by Davies' predecessor at Oxford, Prof. Baldwin. In the Dutch proceedings, Tiefenbacher managed to have Prof Baldwin act as a expert witness to explain his own rules. He had not been involved in the UK proceedings. This lead to a very interesting confrontation in the Courtroom between the current Oxford Chemistry Professor and his predecessor. The explanation of the Baldwin Rules by Professor Baldwin himself (to set straight what went astray in the UK) was a very important factor in getting the Dutch Court to distinguish the case from Kitchin J's decision".

The IPKat has since received a short English-language summary of the Dutch decision from Jaap and Marleen: 

Tiefenbacher and Centrafarm, represented by M.H.J. van den Horst and J.J.E. Bremer and ratiofarm, represented by R.E. Ebbink and M.G.R. van Gardingen,
plaintiffs

against

Lundbeck, represented by P.A.M. Hendrick, T.M. Blomme and A.F. Kupecz,
defendants

The District Court has decided to invalidate Lundbeck’s patent EP ‘066 (escitalopram) briefly summarized the reasoning of the court is as follows.

Novelty

Claims 1-5

The court does not agree with Tiefenbacher et. al. that the publication of Smith constitutes a direct and ambiguous disclosure of the compound in the form of a technical teaching. From Smith, it cannot be derived if and, if so, how the enantiomer has actually been obtained in individualized form. Therefore the argument that claim 1 and depending claims 3 and 5 lack novelty is denied.

Inventive step

Claims 1-5

However, the court does agree with Tiefenbacher et. al. that claims 1-5 lack inventive step. The court concludes that the skilled person was motivated at the priority date to separate the enantiomers of racemic citalopram. Reference is made to publications of Ariëns and the Thalidomide incident and the expert report of Dr. Newton. The court also agrees with Tiefenbacher that the FDA regulations provided a strong incentive to investigate the activity of the separate enantiomers and therefore to separate the enantiomers. Reference is also made to Dr. Newton's declaration about his experience at Glaxo at the priority date. The court further finds that the skilled person would apply a number of methods that are part of his general knowledge, namely (i) resolution by converting the racemic mixture into a mixture of diastereomers, followed by separation (for instance through fractional (re) crystallization) and conversion to the pure enantiomer, (ii) creation of a salt or derivate of the racemic material, followed by resolution and (iii) stereo selective synthesis, for instance by separation of a racemic intermediate or precursor, followed by stereo selective conversion to the enantiomer.

The result of experiments conducted by Matrix laboratories at the request of Tiefenbacher show that the skilled person would at the priority date, by making use of fractional crystallization using obvious citalopram derivates and the usual chiral acids and solvents have obtained enantiomeric pure escitalopram through routine systematic experiments without undue burden. The court concludes that Lundbeck has done less than the average skilled person would have done using his general knowledge in search of the enantiomers of citalopram. Lundbeck’s objections to the submission of the Matrix experiments, and Lundbeck’s other arguments in defence of alleged inventive step are denied. The court remarks that, even if the skilled person would not have achieved in obtaining escitalopram through resolution of a derivate, he would still have tried to obtain escitalopram through stereo selective synthesis, which would also have been successful, as will be discussed in more detail in the context of claims 6 and 7.

The court concludes that claims 1 to 5 lack inventive step.

Claims 6 and 7

Tiefenbacher et. al. have also argued that claims 6 and 7 lack inventive step. The court agrees with Tiefenbacher et. al. that EP 943 should be considered the closest prior art. EP 943 describes a method for obtaining racemic citalopram, making use of the diol as an intermediate product and in which the last step consists of the ring closure of the diol. Parties agree that it would be obvious to the skilled person that, in order to achieve a stereo selective ring closure of the diol, the SN2-reaction would be the only possibility. However, the court does not agree with Lundbeck’s argument that the skilled person would never the less not expect that the synthesis of citalopram by means of an SN2-reaction would in fact be executed whilst maintaining stereo specificity. Lundbeck argued that the skilled person would foresee so many problems, that he would not have a reasonable expectation of success and would therefore not execute the SN2-reaction. The court agrees with Tiefenbacher that there is no reason for the skilled person to assume that the Baldwin Rules would only apply to saturated systems. Reference is made to the publications setting out the Baldwin Rules and the statements made by Professor Baldwin during the Court hearing. The Court explicitly distinguishes its decision from the - earlier - UK High Court decision on the basis of this new evidence presented by Tiefenbacher. The court disagrees with the argument of Professor Davies that the configuration necessary for the Walden inversion would not occur in the diol, since it does not take into account intra molecular movements which will always result in the occurrence of the correct configuration for the SN2-reaction to take place. Again, the court refers to the UK judgement and distinguishes its decision from this judgment, with the arguments that Kitchin J has been lead by Davies to incorrectly conclude that “the most favourable configuration for an SN2-reaction can be achieved in the case of a saturated system but not in the case of the unsaturated diol of the patent”. Reference is also made to three-dimensional models of the molecule, which have not been used in the UK court proceedings. All the other arguments of Lundbeck to support its statement that the skilled person would have doubts whether the SN2- reaction could be executed successfully (inter alia steric hinderance), ester swapping, the argument that tertiary alcohols would be bad nucleophiles etc. are rejected by the court with reference to publications of Jacobus, Cannone, Rosen and the declaration of Dr. Newton.

On the basis of the above, the court concludes that also claims 6 and 7 lack inventive step. Since the patent is considered invalid in its entirety, the supplementary protection certificate is also null and void. The court orders Lundbeck to pay an amount of € 709,000 as legal costs.

The full test of the decision is available in Dutch here

The IPKat understands that this decision is likely to the subject of some serious discussion at this week's Fordham Conference, which he very much regrets not being able to attend in person.

The Case of the Appeal-Proof Metaphor

Amazing, says the IPKat -- you wait years for a post on this weblog that has anything to do with Norway and then suddenly two come along, one right after the other, just like London buses. Today's Norwegian flavour is provided by the monumental judgment in the Patents Court for England and Wales by Mr Justice Mann in Schlumberger Holdings Ltd v Electromagnetic Geoservices AS, the latter being incorporated in Norway. This morning's judgment, all 330 paragraphs plus six appendices of it. comes after 17 days in court ([2009] EWHC 58 (Pat)).  It would probably take this scientifically uneducated member of the IPKat team almost as long to read and (pretend to) understand it. 

In short, Schlumberger sought to revoke three patents belonging to EG, a competitor in the field of oil and gas exploration, alleging anticipation and/or obviousness. In the end, validity hinged on identity of the hypothetical skilled addressee to whom the patents should be taken as being addressed. Said the judge in his introduction:

"The technology and physics involved is complex to a layman and requires a grasp of some less than everyday science and mathematics. The parties have agreed that I should have the assistance of an expert adviser .... His role was, of course, not judicial. It was to inform and educate on matters of science.  ... the court is grateful to him for his assistance. If any of the science in this judgment is wrong then the fault is that of the pupil and not the teacher".

"In what follows I set out the background against which the patents in suit operate. I shall have to deal with some physics and geology. I shall do so in terms which are generally appropriate for describing those matters at a lowish level, and which will not be a full scientific description of the phenomena involved. A pure physicist may well find some of the description inadequate in scientific terms. I am sure it is. It will, however, suffice for present purposes. My adoption of this technique, and in particular my adoption of what may seem to the purist to be less than wholly accurate metaphor from time to time, does not necessarily betoken a failure on my part to understand accurately the actual physics involved. Nor does it betoken a shortage of evidence on a properly expressed scientific basis - I was certainly not short of that in this case. It is merely an appropriate way of setting out the background at this stage. The same applies, to an extent, in the later, more detailed, parts of this judgment. As will be seen, the adoption of metaphor has a precedent in the facts of this case - the central patent itself adopts a metaphor rather than an accurate description of the physics, and uses scientific terms in a manner which the scientists involved in this case accepted was technically inaccurate".

It seems to the IPKat that technical assessors, the use of whom is provided for by the Rules, are not used as often as they might be.  Even patent judges with a scientific background sometimes appear to struggle when the dispute before them involves an area of science that was not on the syllabus in their younger days (or did not exist at all).   Merpel, in contrast, is fascinated by the judge's disclaimer of the use of metaphor as a means of blocking off a possible ground of appeal and wonders whether it has any precedents.

Other Kats may wish to comment on some of the other aspects of this case in due course, so keep an eye on this blog in case they do!  

Why London buses come in threes here

Zyprexa: "selection patent" doctrine briefly back in the limelight

Hot off the press comes the ruling today of Mr Justice Floyd (Patents Court, England and Wales) in Dr Reddy's Laboratories (UK) Ltd v Eli Lilly and Company Ltd [2008] EWHC 2345 (Pat). This was a revocation action brought by Dr Reddy's against Eli Lilly's patent for the drug olanzapine -- a widely-prescribed anti-psychotic agent used for the treatment of schizophrenia. The case raises the issue of the validity of patents for individual compounds selected from a prior class (what used to be called "selection patents"). The individual compound in this instance was olanzapine, which Lilly launched commercially under the name ZYPREXA in 1996.

Dismissing the revocation claim, Floyd J held the patent valid. So far as novelty was concerned, the judge must have brought waves of nostalgia upon older readers of his judgment by reviewing the old case law on "selection patents" under the Patents Act 1949, in particular the guidance laid down by Maugham J in I.G. Farbenindustrie's Patent (1930) 47 RPC 289 before summarising the post-1978 situation both in the UK and the European Patent Office before concluding:

"(i) In relation to lack of novelty, it is doubtful in the light of the EPO jurisprudence whether a newly discovered effect complying with Maugham J's principles could overcome a finding that a compound was specifically disclosed in a prior document.

(ii) Whether or not that is so, provided there is novelty on conventional grounds, obviousness is to be decided according to ordinary principles.

(iii) The existence of an advantage possessed by the selected compound will be relevant to the overall assessment of obviousness, but is not an essential pre-requisite.

(iv) Compliance with Maugham J's principles in IG Farbenindustrie's Patent is equally not an essential requirement for inventive step to be found".

The judge also took the opportunity to discourage optimistic arguments relating to non-obviousness based on commercial success:

"113 Commercial success can be a relevant secondary indicator of non-obviousness. Like all secondary indications it needs to be kept in its place. Why is it relevant at all? It is said that, when coupled with a long felt want which skilled researchers were attempting to meet, it is evidence that the claimed solution cannot have been obvious. In other words, commercial incentives would have driven those skilled in the art to the claimed solution but for one thing: it was not obvious.

114 Any influence an argument of commercial success might have on the issue of obviousness can be negated by a number of factors. In some cases the prior art over which the invention is said to be obvious was published only shortly before the priority date. So the commercial success just proves that the prior art made a good commercial idea obvious. In other cases there may have been some practical or commercial impediment to embarking on the line of enquiry in question, such as the existence of a prior patent. In yet further cases such commercial success as occurred can be demonstrated to be due to factors other than the invention: such as a newly created need or to marketing or other factors".

Since the judgment in this case is a lengthy and analytical one, the IPKat fully expects comments on it, both from other other members of the blogging team and from the patent profession. His own view, for what it is worth, is that it is too easy to justify in intellectual terms the invalidation of "selection patents" which can be adjudged meritorious in practical terms, and that it is a good thing that the law has come a long way since the dark days of the Patents Act 1949.

Left: do cats cause psychosis? See link below

Schizophrenia explained here
NICE clinical guidelines on schzophrenia here
Do cats cause schizophrenia? Click here

Balloons and oxymorons -- the Lords' decision

Further to this morning's earlier posts (see immediately below), the IPKat can now say a bit about the approach taken by the House of Lords to the proper test of inventive step in Conor Medsystems Inc v Angiotech Pharmaceuticals Inc. The facts, taken from the judgment of the trial judge, were as follows. Angiotech owned a European patent designating the UK for a stent used in coronary angioplasty. the basic idea of a stent is that, when it is inserted into a diseased artery in the course of angioplasty, a little balloon can be inflated which keeps the artery open.

Right: the humble balloon was part of the prior art -- they work best with taxol, though

Angiotech's patent claimed a stent coated with a polymer which was loaded with the drug taxol: this inhibited the development of tissue that might result in the gradual closure of the artery (a condition known as restenosis). Angiotech licensed the patent to Boston Scientific, which made stents. Conor, a competitor of Boston Scientific, sought to revoke the patent, claiming that it was obvious in the light of the prior art.

Pumfrey J allowed the application and revoked the patent. The mere fact that no-one had used stents like this before might make them new, but it didn't make them non-obvious. Given the state of the art, it was obvious to anyone who needed a stent of this nature that he would have to use taxol. Accordingly, in his view, the patent was invalid for obviousness. The Court of Appeal, for whom Lord Justice Jacob delivered the judgment, dismissed Angiotech's appeal.

Today the House of Lords took a different view, allowing the appeal and affirming the validity of Angiotech's patent. The opinion of their Lordships is contained in the speech of Lord Hoffmann, to whose words Lord Walker of Gestinthorpe could add nothing useful. Lord Hoffmann said as follows:

"2. Since the decision of the Court of Appeal, Angiotech and Conor have reached a settlement. Conor does not oppose Angiotech’s appeal. But a patent confers proprietary rights in rem and the validity of a patent cannot be established simply by a judgment in default of opposition. Your Lordships therefore invited the Comptroller General of Patents to assist the court in presenting what appeared to him to be the arguments against the validity of the patent. ...

3. There is still no European Patent Court. A European patent takes effect as a bundle of national patents over which the national courts have jurisdiction. It is therefore inevitable that they will occasionally give inconsistent decisions about the same patent. ... Sometimes one is dealing with questions of degree over which judges may legitimately differ. ... In this case ... there is a question of principle at stake. It is about how you identify the concept embodied in the invention which may constitute the “inventive step” for the purposes of article 56 of the EPC and section 1(1)(b) of the Patents Act 1977. ...

12. The Angiotech stent has been a great commercial success. It has the largest share of the market in drug eluting stents, which have very considerably reduced the incidence of restenosis.

17. ... It is the claimed invention which has to involve an inventive step. The invention means prima facie that specified in the claim: .... In the present case, the invention specified in claim 12 was a stent coated with taxol. There was no dispute that this was a new product. The question should therefore simply have been whether it involved an inventive step. As in the case of many product claims, there was nothing inventive in discovering how to make the product. The alleged inventiveness lay in the claim that the product would have a particular property, namely, to prevent or treat restenosis. ... So the question of obviousness was whether it was obvious to use a taxol-coated stent for this purpose. And this, as I have said, was the question to which the experts addressed themselves.

18. [Counsel for Conor] sought to avoid this question by watering down the claimed invention by reference to what he said were inadequacies in the specification. It did not contain information about human or animal tests which showed that it would work or provide enough information about doses and so forth to enable the skilled person to work it. It was therefore nothing more than an idea that taxol might work and any skilled person would have known that.

19. In my opinion, ... the invention is the product specified in a claim and the patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description. ...

28. The question was whether that was obvious and not whether it was obvious that taxol (among many other products) might have this effect. It is hard to see how the notion that something is worth trying or might have some effect can be described as an invention in respect of which anyone would be entitled to a monopoly.

Left: is this truly an oxymoron--or is it merely two individual contradictory statements?

It is therefore perhaps not surprising that the test for obviousness which Pumfrey J devised for such an “invention” was whether it was obvious to try it without any expectation of success. This oxymoronic concept has, so far as I know, no precedent in the law of patents. ...

37. The Court of Appeal upheld the judgment of Pumfrey J on the ground that the patent contained no “disclosure” saying that taxol was specially suitable for preventing restenosis. .... But there is in my opinion no reason as a matter of principle why, if a specification passes the threshold test of disclosing enough to make the invention plausible, the question of obviousness should be subject to a different test according to the amount of evidence which the patentee presents to justify a conclusion that his patent will work. ...

40. In the event, ... neither the judge nor the Court of Appeal answered what I consider to have been the correct question, namely, whether it was obvious to use a taxol-coated stent to prevent restenosis. ...

42. In the Court of Appeal, Jacob LJ dealt comprehensively with the question of when an invention could be considered obvious on the ground that it was obvious to try. ...

43. But Jacob LJ rejected this approach ... because “the patent has not in any way demonstrated that taxol actually works to prevent restenosis.” I agree with the Dutch court that patent law does not require such a demonstration. It was not a sufficient reason for not applying the ordinary principles of obviousness to the claimed invention. I would therefore allow the appeal".

It seems to the IPKat that Lord Hoffmann has sought to claw back the test of inventive step from the jaws of analytical oversophistication and to bring it back to basics. "Obvious to try" is a valuable tool for enabling patent lawyers to gauge the degree (if any) of inventive step in a patented invention, but it is only a means -- and not even an exclusive means, at that -- of assisting the court to reach a conclusion.

Right: this is how arteries get furred up ...

He also speculates whether his Lordship's comment at para. 12, relating to the patented product's great commercial success, throws a significant ray of light on Lord Hoffmann's thought-processes; in its day, "commercial success" was often a carefully deployed argument in favour of a patent's non-obvious nature. But the reality is that the test of inventive step is one that applies to the invention as patented, as embodied in its claims, not by the success or failure in the marketplace of any manufactured product which incorporates its functions. Merpel says, is that the sound of Champagne corks I hear from the celebrating Angiotech -- or is it the popping of stents?