In a recent Patents Court decision, Judge Richard Meade of the Chancery Division of the High Court of Justice of England and Wales invalidated two patents in litigation between U.S. genomics companies, Advanced Cell Diagnostics Inc. and Molecular Instruments Inc.1
Advanced Cell Diagnostics alleged that Molecular Instruments infringed its patents EP U.K. No. 1 910 572 B1, covering a method for the in situ detection of nucleic acids by hybridization, and EP U.K. No. 2 500 439 B1, directed to a product for performing that method. While only the method claim was found to be infringed, both patents were held invalid on the basis of obviousness.
Notably, the April 23 decision considered the relevance, to an allegation of infringement by equivalence, of data from experiments conducted in the ordinary course of business that do not fall within the Patents Court regime. Further, the decision included noteworthy commentary on mindset as it relates to common general knowledge and mosaicking for the purposes of finding invalidity by anticipation.
Infringement
Experiments Done in the Ordinary Course of Business
Both patents' claims required an option to be chosen — either a label probe or a label probe plus an amplifier. These required that the L sections of two or more capture probes be complementary to non-overlapping regions of the label probe or amplifier. The overarching issue of claim scope depended on (1) claim interpretation, (2) equivalence and (3) what the skilled person's expectation would be as to how a method that had an overlap would function, if it functioned at all.
Molecular Instruments denied infringement on the basis that its products did not fall within the patents' claims. Molecular Instruments relied on experiments done for product design and development in the ordinary course of business, in relation to issues of fact relevant to infringement. The experiments were of two kinds: in vitro gel studies, and in situ studies.
The relevant question was whether the experiments showed Molecular Instruments' system involved an overlap that improved their system due to increasing the specificity, therefore distinguishing it from the claims.
Judge Meade concluded there was adequate evidence allowing the conclusion that the alleged improvement had a positive effect in the experiments, with a tangible effect in a range of practical circumstances. This was of little practical importance, however, as Judge Meade also concluded, based on a purposive interpretation, that Molecular Instruments' system would infringe even given the existence of the alleged improvement.
Although Judge Meade found infringement on a purposive construction, he also considered infringement by equivalence. Molecular Instruments relied on the experiments to suggest its variant did not achieve substantially the same result as the patents in substantially the same way because their overlapping configuration was better than a non-overlapping configuration.
Judge Meade characterized that argument as approaching matters at the wrong level of generality. Because there was no dispute that two stable duplexes are formed by two probes, and the benefit of doing so is shown by the experiments, Judge Meade found that the variant did achieve substantially the same result as the patents in substantially the same way.
This decision is of note for litigation parties that may wish to rely on evidence done in the course of ordinary business. An important takeaway is that context is key for assessing the weight of such evidence. Given that such experiments do not fall within the Patents Court procedural regime, this can mean, as in this case, that there will be no notice of experiments, no formal list of facts to be proved, and no opportunity for repeats. An additional aspect of context worth noting is whether experiments fall short of what would be required for peer-reviewed publication.
It was highlighted here that the court's function was to make findings to the civil standard of proof about how Molecular Instruments products work with what the court had before it. As such, parties should note that when relying on such experiments, they should prepare a formal statement as to what they say the experiments prove.
Joint Importation
Molecular Instruments' position was that it did not commit a relevant infringing act in the U.K. as Molecular Instruments' products passed to its customers in the U.S. The joint liability claim focused on the '572 patent only as the '439 patent concerned kits with a permeabilizing agent and given no permeabilizing agent was included when Molecular Instruments' products were imported, there would have been no infringement of the '439 patent.
Judge Meade ultimately found that Molecular Instruments would have been jointly liable with its customers, based on its acts of bespoke troubleshooting, had the '572 patent been valid.
This aspect of the decision is of note as it suggests that providing troubleshooting, which involves knowledge of the relevant parameters to get the product working and recommendation of those parameters, can lead to a finding of joint liability. Parties should note that, where such assistance has been provided, the legal standard for joint liability can be met even where the infringing party has no contractual obligation to provide troubleshooting support, and where the process is initiated by customers.
It should be noted however that a potentially infringing party goes no further than mere facilitation when providing customers with standard directions as to the use of its products. Suppliers of bespoke equipment requiring detailed advice for proper use should take note that, in the event they are supplying potentially infringing kits, they risk meeting the legal standard to be jointly liable with their customers.
Despite this finding, Judge Meade did note that, given many of Molecular Instruments' customers did not require troubleshooting support, a decision on relief might have been difficult had there been infringement of a valid patent.
Validity
Common General Knowledge and Mindset
Based on a finding that all the features of the claim would have occurred to the skilled person if they had read a combination of two academic articles, one by Mark Collins and one by Collins with David Kern, Judge Meade found that the framework2 for assessing obviousness from the Court of Appeal's 2007 decision in Pozzoli SPA v. BDMO SA was not applicable to this case, and the sole remaining question on obviousness was whether there was a reasonable expectation of success.
The parties disagreed as to whether the fundamental underlying molecular biology is the same between in situ and in vitro approaches, and in considering common general knowledge, whether there was a mindset against transposing techniques from in vitro to in situ.
The dispute on mindset relied on "negative common general knowledge." In other words, the invention can lie "in finding out that that which those in the art thought ought not to be done, ought to be done."3 Judge Meade noted the importance of inquiring whether prejudice is part of the state of the art, noting that for most purposes it will be so, if it is, because it is common general knowledge
Advanced Cell Diagnostics argued there was a perception of low or no expectation of success when seeking to take a technique from in vitro to in situ. In doing so, Advanced Cell Diagnostics relied on the 1996 article "RNA Molecules Lighting Up Under the Microscope" by Roeland Dirks, which listed the matters that would require attention in making an in situ assay work, as having a "pessimistic mindset."
However, Judge Meade found that there was no hint in Dirks' article that a good result cannot be achieved by appropriate care and diligence and, therefore, Dirks' article would not have justified a pessimistic mindset.
This decision provides key learnings for parties seeking to rely on a negative mindset argument. Such parties should therefore ensure any document being relied upon must go beyond merely necessitating high levels of care and diligence — if a good result can nevertheless be achieved, this would not justify a pessimistic mindset.
Parties should be alive to whether there are any reported successes in the evidence being relied upon, as this would undermine any negative mindset argument.
Parties should consider the following factors when relying on negative mindset:
- Whether the skilled person would be pessimistic in addressing the challenges in issue;
- Sources of pessimism, such as whether some facet of the task would have been recognized as especially difficult, or whether there was a track record of failure; and
- The sources of relevant common general knowledge, noting that pessimistic results and views are less likely to be reported.
Ultimately however, this decision highlights the difficulty of relying upon a negative mindset where there is no specific evidence providing there is low or no expectation of success.
Mosaicking for Anticipation
While the anticipation attacks over Collins' article and over Collins' article with Kern failed, the judgment provided some clarification as to the court's position on (1) combining documents, or mosaicking, and (2) prior art that discloses a number of options.
To properly establish anticipation based on a combination of documents A and B, there must be a clear and unmistakable pointer from document A to document B. In this case, Judge Meade found that Molecular Instruments did not meet this threshold.
The aspect of the decision is of interest as it confirmed there is no absolute bar against combining documents for the purposes of establishing anticipation. Parties seeking to argue that a particular combination shows anticipation should, however, take care to ensure at least one document in the combination clearly and unmistakably points to a relevant section of another.
It should be noted that a general cross-reference from document A to document B does not of itself entitle a party attacking a patent based on anticipation to pick and choose anything from the disclosure of document B to add to document A.
As to disclosure of options, while a generic disclosure of a class does not destroy the novelty of a particular member of the class, individually identified members of a group of options can. Parties should note that the correct approach is to decide first what the prior art discloses, and then to ask what, if anything, the disclosure renders obvious.
Key Points to Note
Judge Meade's decision provides noteworthy points on both substantive and procedural matters.
Parties should note the helpful guidance on incorporating into litigation the data from experiments conducted in the ordinary course of business, including the recommendation that parties prepare a formal statement to explain what they say the experiments prove.
The court's comments on mindset and common general knowledge appear to indicate that whilst a pessimistic mindset can be relied upon, parties would need to show that a good result cannot be achieved even where appropriate care and diligence is taken.
The decision offers helpful insight on assessing joint liability when it comes to suppliers and their customers.
Of note is the difference between providing only general directions to customers and providing specific troubleshooting and individualized guidance. The former situation is unlikely to amount to joint liability as it is "mere facilitation," however the latter risks assisting customers pursuant to a common design by working an infringing method.
As such, suppliers of bespoke equipment that could be at risk of patent infringement when put into use need to exercise care that they go no further than providing customers with standard directions to use of their products.
The judgment helpfully confirms that there is no absolute bar against mosaicking for the purposes of establishing anticipation. Parties should note however that combining documents for an anticipation argument will only be accepted where one document points the skilled reader specifically to the other document.
A further point of interest, is that Judge Meade confirmed that the well-established practice of sequential unmasking of information when speaking to potential expert witnesses is the ideal approach, but acknowledged it is not always possible. Of key importance to the parties and the court, is that the expert ensures and makes clear that they have made efforts to avoid hindsight.
Footnotes
1 Advanced Cell Diagnostics Inc and Molecular Instruments Inc [2024] EWHC 898 (Pat.).
2 Pozzoli SPA v. BDMO SA [2007] EWCA Civ 588 (June 22, 2007) at 23.
3 Union Carbide Corporation v. BP Chemicals Ltd. [1997] EWHC 373 (Pat) (July 31, 1997) at 63.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.