Lack of industrial applicability: Neutrokine-α again

In August 2008 Mr Justice Kitchin delivered a mega-judgment in Eli Lilly & Co v Human Genome Sciences Inc, [2008] EWHC 1903 (Pat) on patent validity (noted by the IPKat here). HGS owned a patent that disclosed the nucleotide and amino acid sequence of a novel member of the TNF ligand superfamily, the polypeptide Neutrokine-α: this was a cytokine (a protein which acted as an inter-cellular mediator in inflammation and cellular responses). The history of the patent was as follows: a European application was filed on in October 1996 and it was granted nearly nine years later, in August 2005. The patent correctly identified the polypeptide as a member of the TNF ligand superfamily, listing a long description of its activities and uses. There was however no scientific data to support that description, which was really a prediction based on knowledge of other members of the TNF superfamily.

Eli Lilly sought to revoke HGS's patent on several grounds, including an allegation that there was no disclosure of an invention susceptible to industrial application in that HGS had filed its application without knowing the biological activity or function of Neutrokine, the identity of any receptor, the conditions which it caused or the diseases which it might be used to treat. Kitchin J revoked the patent for lack of industrial application, insufficiency and obviousness, holding that

* the court had to construe the "industrial applicability" provision of the Patents Act 1977 so that, so far as possible, it had the same effect as Article 52 of the European Patent Convention (EPC).

* in the context of industrial applicability, "industry" was to be construed broadly. It included all manufacturing, extracting and processing activities of enterprises that were carried out continuously, independently and for commercial gain. "Industry" need not however have been conducted for profit -- and a product which was shown to be useful to cure a rare disease could be considered capable of industrial application even if it had never been intended for use in trade at all.

* the skilled person had to be able to derive an invention's industrial application from its description in the patent, read with the benefit of common general knowledge. Accordingly that description had to disclose a practical way of exploiting the invention in at least one field of industrial activity. This requirement had recently been re-formulated as an enquiry as to whether there was a sound and concrete basis for recognising that the contribution was (or was not) capable of leading to practical application in industry. Even so, it was still necessary to disclose, in definite technical terms, the purpose of the invention and the manner in which it was to be used to solve the given technical problem.

* there also had to be a real prospect of exploitation of the invention that could be derived directly from the specification, if it was not already obvious from the nature of the invention or the background art. This requirement could not be satisfied it what was described was merely an interesting research result that could yield an as-yet unidentified industrial application.

* the purpose of granting a patent was not to reserve an unexplored field of research for the applicant -- nor was it to give the patentee unjustified control over others who were actively investigating in that area and who might eventually have found ways actually to exploit it.

* if a substance was disclosed and its function was essential for human health, its identification as having that function immediately suggested a practical application -- but if its function was not known, or was incompletely understood, and no disease had been identified that was attributable to an excess or deficiency of it, and no other practical use was suggested for it, the requirement of industrial applicability was not satisfied.

* the use of a claimed invention in order to discover more about its own properties was not of itself an industrial application for the purposes of patentabiity.

* applying all of these principles, HGS's patent -- however meritorious its discovery might have been -- was invalid for lack of industrial applicability.

HGS, having had some success in having its patent upheld by the Technical Board of Appeal of the European Patent Office on the basis of more restricted claims, appealed to the Court of Appeal (Lord Justice Jacob, Lady Justice Hallett and Mr Justice Lewison), which today in a 38-page judgment [2010] EWCA Civ 33 dismissed the appeal even in respect of the more restricted claims, on the basis that the invention was not susceptible of industrial application. Conscious of the fact that it was reaching a contrary decision to that of the EPO, the Court (in its judgment delivered by Jacob LJ) went to great lengths to explain and contrast the functions of the EPO and the Court of Appeal and the manner in which each reached its decision before concluding that (at paras 157-158)

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

158. For the above reasons I have come to the clear conclusion that the Judge was right to hold that the invention failed to comply with Art. 57".

The IPKat is greatly impressed with the care and sensitivity with which the Court expressed its difference of opinion to that of the EPO Board. Merpel says, this case is also notable for the degree of cooperation between the EPO and the Court, the former employing its accelerated procedure for the latter's benefit.

Accidental GB designation causes problems

When a European application is granted designating the UK, the resulting EP(UK) patent has, according to section 77 of the UK Patents Act, the same effect as a patent that was granted by the UK Office. One problem, however, is when the priority application was filed in the UK and also granted (rather than abandoned in favour of the EP application, as is often the case). Because two patents for the same invention cannot be allowed, the applicant (or, more usually, his agent) has to make a decision whether to go with the UK granted patent or to allow the EP(UK) version to override it. If no decision is made, only the EP(UK) patent can survive if both claim the same invention, according to section 73(2). If, once the EP application has been granted with the GB designation intact, the applicant wants to keep his original UK patent, it is by then too late, as there is no way to remove the UK patent from causing this conflict (at least not one that would leave the EP version unscathed).

So what happens if, hypothetically, an applicant fails to withdraw the GB designation from his EP application and allows both his original UK application and the EP(UK) version claiming the same invention to go ahead, but then deliberately does not pay renewal fees for the EP(UK) one? Restoration under section 28 would not be possible for the EP(UK) patent, because it could not be said that the failure to pay renewal fees was unintentional, but the fact that the EP(UK) existed, even if this was only for a short time, would mean that the UK patent would have to be revoked. Is there any way out of this pickle?

The above situation is, more or less, exactly what happened in the case of Orkli (UK) Limited, a decision recently reported by the UK-IPO (as BL O/302/09). Orkli's agent made an application to restore their EP(UK) patent, which had lapsed through non-payment of a renewal fee. Orkli's earlier GB application, from which the EP application claimed priority, had been granted while the EP application was pending. The applicant's agent had, without informing the applicant, decided to withdraw the GB designation to avoid double patenting. This decision was not, however, acted on by the EPO, possibly as a result of a letter withdrawing the GB designation not being received at the EPO (it certainly does not show up on the European patent register for EP1215473) . The EP application then proceeded to grant without the agent or applicant noticing that the GB designation was still present. Renewal fees were then not paid on the resulting EP(UK) patent. The GB patent was under consideration for revocation under section 73(2) by the time the duplicate EP patent had lapsed. The agent then applied for restoration of the EP patent.

The hearing officer considered that the evidence clearly showed that the agent's intention had been to not pay the renewal fee on the EP patent. The proprietor, however, who had apparently not been made aware of the agent's intention to withdraw the GB designation, did intend to pay the renewal fee, even though this intention may have been through lack of patent knowledge. On that evidence, the hearing officer was satisfied that the proprietor's failure to pay the renewal fee was unintentional, and the application for restoration was allowed.

The IPKat thinks that this decision has come to the correct conclusion, because otherwise the applicant would have been left with no UK patent through no fault of their own as a result of the rather strange way the law works in these situations. He cannot help thinking that there should really be a better way to avoid this kind of situation (apart from the obvious one, which is to keep a proper eye on which countries are designated). Why is it not possible for a patentee to choose to have their own UK patent revoked, as it is for their European patent as a whole (via Article 105a EPC)?

Dyson cleans up again

The IPKat has been reading yet another monster judgment from the Patents Court, Dyson Technology Ltd v Samsung Gwangju Electronics Co Ltd [2009] EWHC 55 (Pat), which issued just a couple of days ago on 22 January.  Alexa Highfield of Wragge & Co., the instructing firm for the claimant, was kind enough to let the IPKat peruse a copy of the judgment before it made its appearance online here.  Wragge & Co.'s particular take on the case can be read here. 

Dyson applied for revocation of two of Samsung's UK patents,  GB2424603 and GB2424606, both of which had been filed in 2005 and granted in 2007. Both patents related to cyclonic vacuum cleaners, or "cyclonic dust separating apparatus" as the patents called them.  Dyson claimed that the patents were invalid over various cited documents, and over their own vacuum cleaner models DC07 and DC08, both of which were based on their "Root Cyclone" technology, developed before the priority date of the patents.  Intriguingly, one of the documents cited by Dyson to attack Samgsung's patents was a Japanese utility model from 1977 (pictured right), showing a multicyclone vacuum cleaner that predated even Dyson's earliest patents on bagless vacuum cleaners.  The IPKat wonders whether, if this was brought up at the time the Dyson v Hoover case was being heard back in 2000 and 2001, this might have affected the outcome.  As we all know, Dyson prevailed that time and their patent was upheld. 

Samsung largely failed to show that there was much that was valid in their patents over the art known in 2005.  They seemed to realise this, and filed requests for amendments under section 75 to both of their patents, which involved a substantial re-writing of the claims.  Arnold J went to great lengths to determine whether Samsung's amendments complied with the requirements of section 76(3)(a), which prevents amendments being made that result in the specification disclosing additional matter.  Most of the amendments fell foul of this, and were disallowed, but a couple of their amendments were both allowable and not invalid for lack of novelty or inventive step.  The end result, as far as the IPKat can work out, is that at least one of the claims (in the '606 patent) would stand as being valid after all this.  

The IPKat cannot fault Arnold J's expert and very thorough job of going step by step through each of the issues involved, and is very impressed by the extensive citation of pretty much all the relevant case law on each subject along the way.  Although the judgment overall does not seem to be groundbreaking in any way, it seems to be a very good case study in how to go about looking at validity of patents and all that entails.  

What is puzzling the IPKat, however, is the absence of any arguments or discussion on the other bit of section 76(3), part (b), which states that no amendment to a patent shall be allowed if it "extends the protection conferred by the patent".  This issue, which is often looked at in detail in EPO opposition proceedings under the equivalent provision of Article 123(3) EPC, is designed to prevent the patentee from broadening the scope of their claims in any way after grant.  In effect, this means that any amended claims should not bring something within the scope of the patent that was not within its scope as-granted.  Was section 76(3)(b) simply not an issue for Dyson in this case, or was it just missed out? Given the extensive re-writing of the claims by Samsung, the issue should perhaps have been at least looked at.  All the discussion about admissibility of amendments, however, concentrated on whether the amended claims were based on the specification as-filed, and there is apparently nothing about how they affected the scope of the claims as they were granted.  Can any readers shed further light on this?

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

Indian Supreme Court fails to hit the bottle

The IPKat has learnt from Times of India that lovers of finest Indian whisky can breath a sigh of relief. The Indian Supreme Court has ruled that Indian distiller Khoday India Ltd remains at liberty to sell its whisky under the Peter Scot name. In a case which took only 20 years to proceed through the Indian judicial system, the Scotch Whisky Association challenged the Peter Scot trade marks, which was registered in 1974. Khoday argued that because the SWA waited 13 years to challenge the trade mark, its claim was time-barred.

Reports don't make it clear whether the Supreme Court decided in Khoday's favour because consumers just wouldn't be confused, or because the SWA waited so long to bring its action. The IPKat though can see the merits of the reasoning based on lapse of time. If an IP owner knows that someone else may be infringing its IP, but stands by and watches as that someone invests extensively in a business built on that IP, it is unconscionable for the IP owner to decide to challenge the business at a much later date.

That Aerotel patent again -- has it fallen?

A little bird has told the IPKat that the famously controversial Aerotel patent for a telephone system in the UK (see earlier posts here, here , here and here) was revoked earlier this week. Rumour has it that the patent was considered to fall within the non-patentable subject matter under Article 52 of the European Patent Convention and, for good measure, also to have been lacking in inventive step.

Right: the IPKat is all ears ...

Not having seen any corroborative evidence, the Kat wonders if his readers can provide any further detail -- preferably traceable to a reliable source.