Patents Court rules on biotechnology divisional patents dispute

15 July 2011

Victoria Gardner

On 5 July 2011 Arnold J gave judgment in the case of MedImmune Limited against Novartis Pharmaceuticals UK Limited and Medical Research Council (“MRC”) before the Patents Court.  The judgment extensively reviews many of the issues encountered in biotechnology patent disputes.  

Background

MedImmune (formerly Cambridge Antibody Technology) and MRC (joined as a Defendant rather than as a Claimant because it took no part in the proceedings) were joint proprietors of two divisional European Patents (UK) 0774511 (“511”) and 2055777 (“777”) (together, “the Patents”).  The invention disclosed in the patents consisted of a particular technique (phage display) for selecting a binding molecule of interest (such as an antibody) from amongst a potentially large population of other binding molecules. MedImmune alleged that Novartis (the First Defendant) had infringed the Patents by sales of the pharmaceutical product ranibizumab, sold under the trade mark Lucentis, which is an approved treatment for the eye condition known as wet age-related macular degeneration. Novartis disputed infringement and counterclaimed challenging the validity of the Patents.

The Skilled Person

Following a comprehensive introduction in his judgment into the science and technology behind the Patents, Arnold J commenced his discussion of the law by identifying the skilled person (here a team of people), focussing on the required degree of specialisation of the team in the field of antibody engineering. The Judge referred to Jacob LJ’s discussion in Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819, [2010] RPC 33 (which applied the reasoning in Dyson Appliances Ltd v Hoover Ltd [2001] EWCA Civ 1440, [2002] RPC 22) and  held that the Patents were addressed to a team of scientists with differing backgrounds in areas such as immunology (in particular antibody structural biology), molecular biology and protein chemistry, but with a common interest in antibody engineering. It was reiterated that the notional skilled team must be deemed to lack inventive capacity and therefore a distinction must be drawn between routine experimental work not requiring invention and scientific research which does require invention. This was consistent with the EPO TBA decision in T 500/91 ‘Biogen II’ where it had been stated that “the average skilled person operated at a practical level, and the technical development normally expected of him did not include solving technical problems through scientific research”.

Expert Witnesses

The Judge considered in much more detail than is usual in such cases the duties and responsibilities of the expert witnesses. Arnold J explained that the nature of patent cases typically meant that experts had little or no prior experience of this role and   emphasised that the lawyers who instruct expert witnesses bear a heavy responsibility for ensuring that an expert witness is not put in a position where he can be made to appear to have failed in his duty to the court. The courts should also be cautious of criticising an expert witness for omissions from their report unless it is clear that the fault lies with the expert and not those instructing him.  This case provides important guidance as to the approach that lawyers should adopt in instructing expert witnesses and emphasis the importance of ensuring that the expert report is drafted in a manner as to accurately reflect the way the expert was instructed by the lawyers, and in particular the order in which the expert was shown the documents.

Priority

MedImmune conceded that if the claims in the Patents could not properly claim priority from the third of the priority documents they were invalid.  Reference was primarily made to the judgment by Arnold J in Intervet UK Ltd v Merial [2010] EWHC 294 (Pat), which both parties agreed was an accurate summary of the relevant principles relating to priority. Accordingly, a claimed invention will be entitled to priority from an earlier application, if it is supported by matter disclosed in the earlier application. In the present case Arnold J accepted Novartis’ argument that claim 8 of 511 and claim 1 of 777 were not entitled to priority from the third priority document due to differences in disclosure, particularly in terms of scientific content. Applying Abbott Laboratories Ltd v Evysio Medical Devices plc [2008] EQHC 800 (Pat), [2008] RPC 23 the Judge concluded that the third priority document had not as a whole disclosed, directly and unambiguously, information to the skilled person that was in the claims of the Patents that were in question.

Obviousness

Despite the fact that the priority finding rendered both Patents invalid, the Judge went on to consider the obviousness attack in the event that they could properly claim priority, applying the approach established in Pozzoli v BDMO SA [2007] EWCA Civ 588 (a reformulation of the classic Windsurfing test). Arnold J focused his assessment of obviousness on two pieces of prior art. The first was a paper referred to as “Parmley & Smith” published in 1988. The Judge considered that the Patents were not obvious over the published paper because it did not provide the skilled reader with an opinion that there was a reasonable expectation of success within a reasonable time frame, because of  a lack of information as to matters such as infectivity, breakdown and folding of the antibody fragments (applying the principles established in Condor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49, [2008] RPC 28; Biogen/Hepatitis B [1995] OJ EPO 627) . This decision was consistent with that of the Opposition Division concerning 877.

The second piece of prior art was a talk delivered by a Professor Smith at a conference in 1990. The Judge deemed that the talk provided a sufficient enough explanation to make it obvious to try the techniques claimed in the invention and thus the skilled team would have believed that there was a reasonable expectation of success within a reasonable time. Arnold J based this decision on the fact that Professor Smith, displaying a consistently positive and encouraging tone, demonstrating his underlying confidence in success, had explicitly proposed carrying out the claimed invention. He furthermore addressed the concerns raised in Parmley & Smith, put forward a number of solutions to potential problems and provided reasons as to why he considered nevertheless that the experiment was worth carrying out.  His decision as to this was in contrast to that of the Opposition Division who had rejected the allegation that 877 was obvious over the talk on the basis that the contents of the oral disclosure had not been sufficiently substantiated.

Insufficiency and Added Matter

The Judge also considered and rejected attacks of insufficiency and added matter.  As to former the attack was on the broad scope of the claims and the judgment reviews in considerable detail the UK and EPO case law on this issue, which has long troubled the English courts, particularly in biotechnology cases.  In the light of that review he held that the invention disclosed in the Patents was a principle of general application that did not depend on the precise identity of the binding molecule employed, and so the insufficiency attack failed.   

Infringement

The claims asserted to be infringed by the production of ranibizumab were to the production of binding molecules (such as antibodies) within a recombinant system into which nucleic acid isolated from particles selected by means of the claimed phage display technique had been inserted.  Based on his construction of certain scientific phrases in the claims that described how the phage display technology was employed (taking into account the specification, applying the principles established in Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062, [2010] RPC 8), and on the balance of probabilities, the Judge held the process of production of ranibizumab did not fall within claim 5 - 8 of 511 or claim 1 of 777 and therefore there was no infringement by Novartis.

Despite this finding, the Judge then went on to consider, in the event that he had incorrectly construed the claims, whether ranibizumab, which was manufactured in the USA, was obtained directly by means of the patented process in claim 8 of 511 and claim 1 of 777, and so, according to section 60(1)(c) 1977 Act its import into the UK would infringe.  This involved detailed consideration of the case law on this section and the leading case under it, Pioneer Electronics Capital Inc v Warner Music Manufacturing Europe GmbH [1997] RPC 757.  Novartis in effect argued that it did not infringe because the invention, if any, lay in the use of the phage display aspect of the claims and that it was only as a result of adding a conventional manufacturing process (production in a recombinant system) that MedImmune were able to allege infringement.  Although he accepted that this was an attractive argument Arnold J rejected it because the case law that bound him was expressed in terms of how the claims were drafted rather than what was the inventive concept.  Thus he concluded that if ranibizumab had been produced by a process falling within claim 8 of 511 and claim 1 of 777, it would be a product obtained directly by means of that process. He also went onto consider Novartis’ further argument, based on Article 8(2) of the Biotechnology Directive, but held that Article 8(2) could not apply to the relevant claims because the processes claimed by claim 8 of 511 and claim 1 of 777 were not processes that enable a “biological material” as defined in the Biotechnology Directive to be produced.

Conclusion

This case provides a thorough review of many aspects of current English patent case law and discusses some interesting questions, particularly in relation to “claim scope” insufficiency and the issue of when a product is obtained directly from an infringing process.  It also provides extensive guidance as to the duties of both experts and their lawyers have during the presentation of expert evidence, and from which lawyers in future will stray at their peril.