Intellectual Property magazine 31 www.intellectualpropertymagazine.com July/August 2014 Does London have one of the most rigorous courts in Europe for testing patent validity? Gareth Morgan, Catherine Drew and Charles Hopper look at the evidence T he High Court in London has a reputation for exposing weaknesses in patents where any should exist. As such it has become a key battle ground where the validity of, sometimes weak, business critical patents is tested in the most thorough examination of a patent’s validity anywhere in European civil litigation. In particular generic pharmaceutical companies have considered London to be a favoured jurisdiction in which to initiate pan-European revocation strategies due to the speed of the High Court process relative to other jurisdictions and the quality of the judgments. In this context we review three patent cases concerning the infringement and/or validity of biotechnology-related inventions that have been litigated in the English High Court and examine whether the reputation of the patents court for scrutinising patents to the highest degree possible in Europe, can be said to increase the chances of revoking a biotechnology-related patent in this jurisdiction. Medimmune v Novartis [2011] EWHC 1669 and [2012] EWCA Civ 1234 This case concerned two patents of which Medimmune was joint proprietor. 1 The relevant claims of the ‘777 patent concerned a process for a technique called antibody phage display. Broadly speaking this technique was an advantageous way of discovering binding domains of antibody 2 based upon the ability of those domains to bind to particular antigens. 3 The technique is considered one of the more significant developments in biotechnology of that time. Medimmune claimed that the Novartis’ ranibizumab product infringed both patents, it being a product made using the patented process. Novartis denied infringement and counterclaimed for revocation of both patents. At first instance, Arnold J found both patents were not entitled to the priority date claimed and were invalid on grounds of obviousness. He further found that Novartis did not infringe the patents. The findings were upheld on appeal. We will focus on the obviousness element of the revocation case. Bearing in mind that the technique described in the patents was seen as such a substantial development by those in the field, it is perhaps surprising that both courts agreed it was invalid for lack of inventive step. In answer to Medimmune’s appeal against the first instance finding, Lewison LJ (writing a supporting judgment) endorsed Arnold J’s conclusion on obviousness as being “amply supported by his findings of fact”, but also took the opportunity to reiterate the importance of Focus on pharma and biotech The revocation location: biotech patents fail the High Court test
Does London have one of the most rigorous courts in Europe for testing patent validity? Gareth Morgan, Catherine Drew
and Charles Hopper look at the evidence
The High Court in London has a reputation for exposing weaknesses in patents where any should exist. As such it has become a key battle ground where
the validity of, sometimes weak, business critical patents is tested in the most thorough examination of a patent’s validity anywhere in European civil litigation. In particular generic pharmaceutical companies have considered London to be a favoured jurisdiction in which to initiate pan-European revocation strategies due to the speed of the High Court process relative to other jurisdictions and the quality of the judgments.
In this context we review three patent cases concerning the infringement and/or validity of biotechnology-related inventions that have been litigated in the English High Court and examine whether the reputation of the patents court for scrutinising patents
to the highest degree possible in Europe, can be said to increase the chances of revoking a biotechnology-related patent in this jurisdiction.
Medimmune v Novartis [2011] EWHC 1669 and [2012] EWCA Civ 1234This case concerned two patents of which Medimmune was joint proprietor.1 The relevant claims of the ‘777 patent concerned a process for a technique called antibody phage display. Broadly speaking this technique was an advantageous way of discovering binding domains of antibody2 based upon the ability of those domains to bind to particular antigens.3 The technique is considered one of the more significant developments in biotechnology of that time. Medimmune claimed that the Novartis’ ranibizumab product infringed both patents, it being a product made
using the patented process. Novartis denied infringement and counterclaimed for revocation of both patents.
At first instance, Arnold J found both patents were not entitled to the priority date claimed and were invalid on grounds of obviousness. He further found that Novartis did not infringe the patents. The findings were upheld on appeal. We will focus on the obviousness element of the revocation case.
Bearing in mind that the technique described in the patents was seen as such a substantial development by those in the field, it is perhaps surprising that both courts agreed it was invalid for lack of inventive step. In answer to Medimmune’s appeal against the first instance finding, Lewison LJ (writing a supporting judgment) endorsed Arnold J’s conclusion on obviousness as being “amply supported by his findings of fact”, but also took the opportunity to reiterate the importance of
the statutory test in determining the question of obviousness in all fields of invention.4
Undoubtedly the first instance court considered a wealth of information in reaching its decision on obviousness including both evidence from the experts at trial and secondary evidence from a number of sources at the time of the invention. An important factor at trial was the judge’s opinion that Medimmune’s expert’s deficiencies in experience in the relevant field at the priority date impacted the weight given to that evidence. Nevertheless, the consideration of “obvious to try” appears to have been very much at the front of Arnold J’s mind. At paragraph 411 of the first instance judgment, he said:
“I consider that there can be no serious dispute that [the closest piece of prior art] made it obvious to try [the inventive concept]…The only question is whether it would have given the skilled team a reasonable expectation of success within a reasonable time.”
In answering this question, the judge found that the skilled team would have received the message from the prior art (it being a presentation given by a leading professor in this area) that the presenter was reasonably confident of success, while recognising that success was not guaranteed because there were potential problems. He also took comfort from other surrounding evidence, including that others at the time were pursing the same lines of enquiry.
At the priority date, this field was moving incredibly quickly with experts exchanging research ideas in a dynamic fashion. A relatively small number of highly intelligent and inventive individuals were making substantial
contributions to the art at this time. To such individuals and teams, there may have been many lines of research enquiry that could have been followed with some expectation of “success”. When such individuals pursue these lines of enquiry in real life they are of course entirely dependent on their inventive capacity to adapt as they progress. In this case, it was arguable that not even the highly skilled individual responsible for the closest prior art could have been said to have had a reasonable expectation of success in adapting the art to antigen phage display. In such cases should such prior art really stand as proxy for the utterly uninventive skilled team harbouring such expectations?
Monsanto Technology LLC v Cargill International SA & Anor [2007] EWHC 2257 (Pat)This case concerned an infringement action brought by Monsanto against the importer of meal produced from genetically modified soya beans grown in Argentina. The action was part of a wider dispute between Monsanto and Argentina for what Monsanto saw as fair remuneration for the use of its RoundUp Ready technology in that country. The patent EP 0 546 090 broadly claimed the gene sequence of a bacterial enzyme that had been inserted into the soya beans in order to render them herbicide resistant, the application of that same herbicide then providing a way selectively to control weeds in the soya bean crop and thereby increase yields and decrease overall chemical use on the crop. This ruling is instructive in highlighting the difficulties presented to patent applicants when deciding how to frame their claimed invention in the biotechnology field.
Monsanto had certainly found a valuable enzyme, the main issue in this case was did the manner in which the patent had been framed and the claims structured permit its enforcement in circumstances such as those with which the court was now faced. The patent claimed the particular enzyme used as part of a class of enzymes all showing a certain result in an immunological assay and certain kinetic performance criteria. While claims to specific enzyme gene sequences were found in the patent, these did not precisely correspond to that found in the genetically modified plants. Also, the claims
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“The judge found that the skilled team would have received
to gene sequences in the patent were often limited by the use of the term “isolated”.
The use of the term “isolated” likely stemmed from US practice where this was used to distinguish the claimed DNA sequences from those found in nature. However the judge found that the Monsanto patent was valid but that the gene sequences found in the meal imported by Cargill could not be said to infringe the patent. The court accepted the evidence of Cargill’s expert witness in relation to the meaning of the term “isolated” which limited those claims in the patent only to instances where the claimed DNA sequences were found separated from other substances, ie, purified DNA. The DNA found in the imported meal was certainly not purified and so non-infringement of a number of claims was found on this basis.
The court also found that the particular enzyme expressed in the soya beans from which the meal was derived did not match the immunological tests required by the patent claims. While the court accepted that this was an unusual result, this shows the dangers of using a broad “class-based” or “test-based” structure for claims where often compliance with the test or membership of the class will depend upon the test conditions. Even where a genuine class-based invention has been made, it will usually be the case that the inventor will not know all members of that class and so defining the boundaries of the claim through a truly definitive test becomes an almost impossible task at the priority date.
Hospira v Genentech [2014] EWHC 1094 (Pat)By a judgment dated 10 April Mr Justice Birss invalidated two patents claiming secondary features of a product. Both patents had already been revoked by the European Patent Office during opposition proceedings, decisions which are currently under appeal.
While the litigation concerned trastuzumab, the entry into the UK market of trastuzumab biosimilar products in the field of each “invention” was quite different. The second patent,5 which claimed an improved
purity formulation of trastuzumab, was found to be anticipated by an earlier patent application of Genentech. The single claim not found to be anticipated was found to be obvious in light of a presentation by an individual from Genentech concerning analysis of trastuzumab in the context of phase III trials for the treatment of breast cancer with the agent.
Of more interest for us is the first patent6
considered by the court, which concerned the dosing regime for the antibody. As at the priority date of the patent (27 August, 1999) the approved dosage regime for Herceptin, published in the FDA label, was a dose of 4mg/kg followed by weekly doses of 2mg/kg. Importantly, this was indicated to be accompanied by another anti-cancer drug, paclitaxel, which was administered on a three weekly schedule. Understanding that patient convenience was an important secondary consideration when administering therapies, a skilled clinician would, the judge found, think of a possible three weekly dosing schedule for Herceptin. Provided it was safe and efficacious, it would be obvious to a clinician that such a regime would deliver “immediate and concrete convenience and quality of life benefits”. Once the idea occurred to him he would discuss with a pharmacokinetics expert whether a clinical trial of such a regime was warranted. Given the dose dependent half-life of the product and information concerning peak and trough serum levels, provided in both the Food and Drug Administration label and other scientific papers forming part of the common general
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“The main issue in this case was did the manner in which the patent had been
framed and the claims structured permit its enforcement in
knowledge, the judge concluded that the advice from the pharmacokinetics expert would be that there was no reason on pharmacokinetics grounds not to conduct a study of three weekly dosing. Once a study into a three weekly schedule was proposed, there was no evidence that the particular doses of 8mg/kg and 6mg/kg were inventive. On the basis of this advice from his pharmacokinetics expert, the skilled clinician would then proceed to carry out the small trial into the dosing regime and so the claim was obvious.
While Hospira submitted that the claim in the patent in suit was either obvious or insufficient, Mr Justice Birss nevertheless considered the sufficiency of the claim, concluding that on the basis of the information in the patent, taken together with the common general knowledge the skilled team would not conduct a clinical trial of the claimed three weekly dosage regime. In his view the patent did not render the claimed effect plausible. Hence Genentech was caught in a ‘squeeze’ – either the patent did not provide sufficient information over and above the prior art to make the invention plausible, or the invention was made obvious by the prior art.
The approach taken by the judge reflects the stringent approach UK courts tend to take towards patents claiming dosage regimes of a known active. The decision does not consider the nature of the active, which is different to that considered in previous dosage regime cases. For example it is possible that, when dealing with complex antibody based products as compared to small molecule drugs, the skilled team would not act in the same way when proposals are made as to new dosage regimes and further clinical trials to be undertaken. If the skilled team were to act in a different way, should this approach be reflected in the courts’ approach? The skilled team in this case were found to be clinicians and pharmacokinetics experts. There is no mention of an immunologist, or a regulatory affairs professional being consulted in the course of developing the new dosage regime. In developing a new dosing regime for a biologic product, it would seem odd not to include such individuals in one’s team. Hence perhaps the approach taken in the present case was an oversimplification to what would happen in practice?
Naturally the court cannot consider the input every single member of a team would have into clinical trial development, but it will be interesting to see whether in
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AuthorsGareth Morgan is a partner within the intellectual property practice at Winston & Strawn. Catherine Drew and Charles Hopper are associates at the firm.
“Genentech was caught in a ‘squeeze’ – either the patent did not provide sufficient information over and above the prior art to make the invention
plausible, or the invention was made
obvious by the prior art.”
the next case concerning dosage regimes of a complex active, the patentee seeks to demonstrate that in fact these are not simple questions, given the nature of the active.
SummaryIn reviewing the results of the three cases, we have seen that patentees have not succeeded in making out a case for biologic actives/products to be treated differently to small molecule drugs when placed into revocation proceedings in front of the UK High Court.
The likely problems we have identified include:• Fast-moving, highly-expert fields of
research activity, which require patentees carefully to choose their expert witnesses and ensure the evidence is able to give
the court a flavour of the true nature of the relevant field of research at the priority date;
• The difficulties of framing inventions in the biotechnology field if class-based or test-based claims are to be used or where jurisdiction specific patent drafting idiosyncrasies develop; and
• The added complexity that biologic actives bring to simple dosing changes and/or new formulation development.
The London courts are set to be a key battleground for biotechnology patentees and those companies interested in the revocation of patents within this invention/product class.
Footnotes1. European Patents (UK) Nos 0 774 511 (“511”)
and 2 055 777 (“777”). Medimmune was joint proprietor of the patents with Medical Research Counsel (“MRC”) and the exclusive licensee of MRC’s interest in the patents. MRC was joined to the action but played no active part in the proceedings. There was a further action between the parties regarding the validity of an SPC granted to Medimmune on the ‘777 patent but it was found invalid at first instance ((2012) EWHC 181 (Pat)) and on appeal (citation as above).
2. Antibodies being molecules generated by an animal’s immune system to neutralise or destroy foreign matter
3. Antigens are foreign molecules that may be the target of an antibody/antibodies.
4. At paragraph 181.5. EP 1,308,455.6. EP 1,210,115 (“EP115”).
