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Tuesday, 10 January 2012

Misleading Affidavits

Canada has legislation based on the US Hatch-Waxman Act, which allows a generic pharmaceutical company to base its application for health regulatory approval on data provided by the brand, so long as the generic can show that its product will not infringe any valid patent listed against the drug by the brand. Validity of the patent is commonly challenged in so-called Notice of Compliance (NOC) proceedings but, because the proceedings are carried out by way of affidavit, with limited discovery, a determination of invalidity is not res judicata, but simply allows the generic to obtain regulatory approval for launch. When a generic launches its product after prevailing in the NOC proceedings, it is normal for the patentee to immediately commence an infringement action in which the same questions of validity and infringement are re-litigated between the same parties.

This occurred in respect of Plavix (clopidogrel), an enantiomer of a prior art racemate.  One question relating to validity of the Plavix patent is whether the separation method used by Sanofi was obvious. Litigation between Sanofi and Apotex went to the Supreme Court of Canada in the NOC proceedings, where the Court held that the separation method was not obvious, and the validity of the patent was upheld. The contrary conclusion was reached at trial in the subsequent infringement litigation, which invalidated the patent. In holding that the separation method was inventive, the Supreme Court pointed to the affidavit evidence of the inventor responsible for separation, which testified to the difficulty of achieving separation. In the infringement proceedings, the trial judge noted that there was no documentary evidence of the key series of failed experiments that established the difficulty of separation. These experiments were not recorded in the inventor’s lab notebooks, even though the lab notebooks were otherwise complete. The trial judge also pointed to a number of other discrepancies; for example, the inventor’s deposition in the US infringement proceedings was inconsistent with his affidavit evidence in the Canadian NOC proceedings in this respect. The trial judge consequently concluded that the inventor’s evidence as to the difficulty of achieving separation was “unpersuasive”.

This illustrates why the NOC proceedings are not binding on the subsequent infringement proceedings. But the discrepancy between the affidavit evidence and the evidence at trial, after discovery and cross-examination, also illustrates the inherent trade-off between speed and cost, on the one hand, and thoroughness on the other. Are misleading or false affidavits a real problem in EPO opposition proceedings? This Kat imagines the problem might be worse, as the issue in NOC proceedings are usually re-litigated, but if misleading or incomplete evidence kills a patent at the EPO, then the patentee will never have the chance to disprove this evidence in a national court. If so, what is the solution? The most obvious solution would be the sanction of contempt, but contempt is not available in the EPO, and in any event, I am not sure that would be cost-effective, given the relatively high standard for establishing contempt. (I note that there was no suggestion in the Plavix decision that the discrepancies at issue amounted to swearing a false affidavit.) Also, there is a free-rider problem, as one patentee bears the cost of a given contempt action, while the incentive to be accurate in swearing affidavits going forward benefits all future litigants. Are there other IP (or non-IP) contexts in which this problem arises and has been solved?

9 comments:

Anonymous said...

Are misleading or false Affidavits a problem at the EPO? That might depend on how much evidential weight an Affidavit carries, at the EPO. It was my understanding that tribunals at the EPO (lacking any experience of cross-examination as a tool to expose the truth) look sceptically at an Affidavit. They suppose it to convey simply what the Declarant's paymaster required the Declarant to sign. How much weight do they give, in their Decision, to the evidence of the Affidavit? Very little, I had thought.

What is it that keeps EPO written proceedings "clean"? The threat of parallel litigation in another jurisdiction, like the USA, or England, where there is discovery and there is cross-examination, and equity does still count for something.

Anybody in Germany (also inside DG3) reading this? If so, your comments would be of interest.

Anonymous said...

I think that the main reason for the inferior role of affidavits and sworn statements in Germany and in the EPO is that inventiveness is considered a question of law rather than a question of fact.

The skilled person is a legal construct and evidence proving that something was obvious or non- obvious for an individual real person (such as the inventor) is considered to be of little value for the assessment of inventiveness.

It is always preferable to have a whitness, whose statement is not necessarily accompanied by an affidavit.

MaxDrei said...

This law/fact dichotomy is false, isn't it? The legal conclusion of invalidity has to be based on facts. Where do those facts come from? Would that be A publications, statements of witnesses, or out of the minds of the judges making up the tribunal, and revealed for the first time after the event, in their reasoned written decision.

How do you determine the "mental furniture" of the imaginary (in both England and Germany) person of ordinary skill in the art except by acquiring statements from real witnesses who are experts on that furniture?

Anonymous said...

There are two issues related to affidavits at the EPO, one is that filing a false affidavit may well constitute a criminal offence in those jurisdictions which provide for them. If, for example, such an instrument were used fraudulently in appeal proceedings, it could form the basis for a petition for review as a criminal offence having a bearing on the case - Art.112a(2)(e) EPC, which has to be established by a competent court or authority under Rule 105 EPC (note this is not limited to EPC states).

The other issue is that the EPO can summon witnesses to give evidence before it under Art.117(1) EPC and Rules 117 and 118 EPC. In such cases, the first instance department (usually an opposition Division) is usually expanded to include a laywer (EPC Guidelines E-IV, 1.6.1). It is the legal member who then conducts examination of the witnesses. I don't know if this has the same probative value as a proper cross examination in court, but it certainly has a far higher probative value compared to the provision of an affidavit.

MaxDrei said...

How interesting, that answers to questions from the legal member will have a "far higher probative value" for the EPO than will a mere Affidavit. Has any reader ever witnessed a sesssion of questioning by such a legal member? Philip Archer well might (he wrote to CIPA J. about it), but can any other reader recall any T Decision in which they said "The witnesses did not contradict each other. Therefore the story they told us must be true"

Anonymous said...

@MaxDrei - Witness hearings for cases of alleged prior sale or prior public use are not uncommon at the EPO, although I do not know if the EPO maintains a database or data source where it might be possible to determine when such hearings will occur (other than file inspection for a case where you already know that a hearing will occur). They are usually held in conjunction with oral proceedings although they are strictly speaking a separate procedure. In such cases it is common for affidavits to be filed earlier on in the procedure, as a primary evidential source before hearing a witness.

I did not intend to imply that Affadavits are not taken seriously, they certainly are and they can be a valuable tool in prosecuting a case. However, cases of prior use/sale are subject to a higher level of proof (beyond a reasonable doubt) compared to the "balance of probabilities" usually applied to patentability objections (T782/92 and later decisions). Consequently, the dispelling of doubts and clarifications about the subject of an affidavit relating to a prior use/sale by means of a witness hearing takes on a more important role given this higher standard of proof, in particular since the proprietor will almost certainly contest facts alleged in respect of the alleged prior use/sale.

MaxDrei said...

Thanks for that last comment, which offers (for anybody who might want to pick up that ball and run with it) the different standards of proof thought to operate in civil proceedings, including: balance of probabilities (Europe), preponderance of the evidence (USA), up to the hilt (EPO), and beyond reasonable doubt (criminal cases). I recall the standard of proof applied by the TBA in the unique case where (it was pleaded)the opposition was unlawfully taken out of the over-stuffed EPO night letter box, late one night in the Cornelius Strasse, by a never-identified passing pedestrian. Soon afterwards, the EPO demolished that letter box and built a brand new one in the Kohlstrasse. During the case, the EPO was asked to make available the architect's plans for the defective Corneliusstrasse facility. It declined to do so.

What is a sufficient degree of proof? Getting a tribunal to climb down off the fence and commit to going beyond the 50% "balance" (with all the grim consequences for the parties that that entails) is sometimes just not possible (whatever standard of proof it thinks it is applying).

Basically, whenever you want something from a tribunal, you have to bring forward enough evidence to dissolve any qualms the tribunal might have, and give you what you are demanding. Otherwise it just tells you you haven't got over the 50% "balance". Depending what you are asking for, and how many "reasonable doubts" the tribunal has, you might need a "beyond reasonable doubt" standard, just to get over the civil law 50% balance.

Almost Emeritus said...

re Max drei's question, in R0003/10 the fact that 5 witness statements from persons who had been present at the oral proceedings, were essentially identical, seems to have been persuasive in overturning the Board's version of events.

MaxDrei said...

Good post, from Almost. I was thinking more about cases where two engineers from the same company tell the legal member details of the prototype that was prior used 12 years earlier. Witness evidence was needed in that case because the company had destroyed all engineering drawings of the prototype. The witness statements were consistent, and prior use was found.

I was left wondering how much the two engineers worked together in the weeks before oral proceedings, to refresh their memories of those long ago events.

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