Nexus: Patent amendment

Until When Can Patent Claims Be Limited in Civil Proceedings? Swiss Federal Patent Court Relaxes Strict Practice

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The last days of the year offer the opportunity to look back to those court cases that will potentially have a lasting impact. While many of the 20+ decisions of the Swiss Federal Patent Court (and counting) issued in 2019 will have clarified and developed substantive points of Swiss patent law, a recent case will also decisively and profoundly shape how invalidity proceedings are conducted in the future [to the extent the decision is confirmed by the Supreme Court in the pending appeal proceeding].

Background

In a patent invalidity proceeding (either as a separate lawsuit or in defense of an infringement action), the limitation of the scope of the patent-in-suit in order to overcome arguments related to lack of novelty or of inventive step, is a classic and popular means of defense. The point in time at which this defense is raised, probably more than any other defense, is a strategic issue. A limited patent claim necessarily re-opens questions that have already been argued (at least in part) and necessitates a fresh analysis of both invalidity and infringement.

In recent years, the Swiss Federal Patent Court (FPC) has followed a strict approach. Claim limitations had to be declared with the second exchange of briefs at the latest (in the claimant's reply or in the defendant's rejoinder). This practice was based on the principles of the Swiss Code of Civil Procedure (CCP), which sets forth, in brief summary, that all factual allegations and means of evidence must be filed with each party's second brief at the latest.

New facts can only be alleged after the second exchange of briefs if: (i) they are genuinely new (i.e. occurred after the closure of the file; "proper nova"); or (ii) the party making the allegation could not have filed them earlier (in spite of having conducted the proceedings diligently; "improper nova").

The Federal Patent Court consistently understood that limited patent claims are "new facts" brought into the proceedings by the patentee. Hence, limitations of patents after the second exchange of briefs have usually been declared inadmissible.

The Case

In a decision dated 28 October 2019, the FPC has departed from this practice. The lawsuit related to the distribution in Switzerland of an artificial joint prothesis. The patentee, Stemcup Medical Products, sued Implantec and Endoprothetik Schweiz for infringement of the Swiss part of EP 1 411 869. After the second exchange of briefs, the technical judge issued a technical opinion, finding the patent-in-suit to be invalid.

In response, Stemcup requested and was granted by the Federal Institute of Intellectual Property (FIIP) a limitation of the Swiss part of the patent-in-suit, thereby avoiding the technical judge's invalidity arguments. It then filed the limited patent claims in the pending proceedings.

The FPC issued a second technical opinion based on the new claims, finding the patent to be valid and infringed. After the main hearing, the FPC confirmed the second technical opinion and issued a permanent injunction against the defendants.

The FPC reasoned that a limitation granted by the FIIP created a genuine new fact within the meaning of the Code of Civil Procedure. That this new fact had been deliberately created by the patentee is not relevant. Ignoring the limitation of the claims would lead to a situation in which the decision would not be based on the patent-in-suit as it is registered at the time of the decision, but on a version of it that no longer exists. In this case, therefore, the lawsuit should be dismissed, meaning that the patentee would have to re-start the proceedings anew based on the limited patent. This would not be in the interest of efficiently conducting patent proceedings.

The FPC also dismissed the defendants' argument that the limitation, made so late in the proceedings, had been done so in bad faith. The Patent Act explicitly provides for the possibility of limiting the patent with the FIIP. Art. 138(3) EPC also explicitly requires that "in proceedings before the competent court or authority relating to the validity of the European patent, the proprietor of the patent shall have the right to limit the patent by amending the claims."

Underscoring the controversial nature of the matter, a minority of the court published a dissenting opinion (a highly unusual move in Swiss civil law). The dissent considers that if the limited patent is indeed a "new fact", it should be considered as having resulted from bad faith conduct by the patentee at this late stage. The patentee could have requested the same limitation in the Patent Office at the time of the second exchange of briefs, as the relevant arguments of invalidity had already been on file.

Comment

The defendants have appealed the decision to the Supreme Court, so this may not be the end of the matter. A decision on appeal is expected in the first half of 2020. If the result is affirmed, this decision will put patentees in a much easier position than today, as even multiple successive limitations will be possible at any point in time until the hearing, and potentially until a decision is given. This Kat understands that this is the position already adopted by many European jurisdictions (but should he be mistaken, corrective comments by readers are welcome).

Still, the decision should be viewed against the background of an important peculiarity of the proceedings in the FPC. Before the main hearing, one of the three (or five) judges renders a "technical opinion" on the validity and infringement of the patent-in-suit. This technical opinion is not binding, but it is more often than not confirmed by the court in the final decision. If limitations are allowed after the issuing of the technical opinion (as in this case), there is a risk that the technical opinion will become an “instruction manual” to the patentee on how then to limit the patent-in-suit to avoid a finding of invalidity.

Picture on the left (c) Diana Francey / Francey Vins

Teva v Merck - not a sight for sore eyes

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Article 123(2) of the European Patent Convention states, "A European patent application or a European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed". The same rule also applies to UK patents under section 76 of the Patents Act 1977 (implemented in a "cack-handed way", according to Jacob LJ here). The basic rule for both is that no amendments can be validly made which would allow something to be claimed (or even described) that was not clearly also there when the application was filed.

The above issue, among several others, arose recently in the case of Teva v Merck, a judgment of Mr Justice Floyd from last week and available from BAILII here. Teva applied for revocation of Merck's EP(UK) patent 0509752, relating to "Ophthalmic compositions comprising combinations of a carbonic anhydrase inhibitor and a beta-adrenergic antagonist", an eye drop formulation for the treatment of glaucoma. After the usual extensive analysis, Floyd J found that the patent was invalid for being obvious over an earlier scientific article in light of the skilled person's common general knowledge (see PatLit here for more).

What the IPKat found more interesting, however, was the argument over added matter relating to one of the claims of the patent. The claim as granted covered a method for making the eye drop formulation, and included a final step of "adjusting the pH of the composition obtained to 5.0-6.0 by the addition of a suitable reagant". This feature was not in the claims as-filed but was added during prosecution, imported from one of 33 examples in the specification, which were whittled down to only 10 in the granted version. Although several of the examples had the step of adjusting pH, none had the range 5-6 together with the composition being claimed. As Floyd J put it, "Once the claim is limited to the specific co-formulation of dorzolamide and timolol, there is no basis for the disclosure of a process for making a co-formulation by adjusting to a pH other than 5.5 to 6.0" (para 70).

Merck tried to correct this by further limiting the claim to the range 5.5-6.0, but this range was only specified in another example that related to a composition that did not fit with the rest of the claim, because it had some further features not in the claim. The amendment by itself would therefore amount to "an impermissible intermediate generalisation" (para 72). Floyd J found that the claim was invalid for added matter, and the amendment could not be allowed.

The IPKat thinks that this is a good example of a case where everything was thrown in to the application at the outset (33 examples seems like a lot), but where not enough thought went into ways in which the different examples could be linked together. In this case, putting in claims to different pH ranges probably would not have saved the patent from being invalid for other reasons. It could however have easily been more important, given the very small differences that often make all the difference, particularly in pharma patents.

The peril of perindropil patent litigation

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For those who like patents but don't want to spend their time reading all that law, here's a case that is pretty well all facts and arguments, with no analysis of statutes or earlier precedents at all. It's Les Laboratoires Servier and another v Apotex Inc and others [2007] EWHC 1538 (Pat), a Patents Court (England and Wales) decision handed down yesterday by Mr - soon to be Lord - Justice Pumfrey.

The two claimants (Servier) were the owner and exclusive licensee of a patent. The defendants (Apotex) belonged to a group of Canadian generic pharma companies. The patent was for "a new α crystalline form of perindopril tert-butylamine salt, a process for its preparation and pharmaceutical compositions containing it" (perindopril being an ACE inhibitor used in the treatment of hypertension). The patent in dispute claimed priority from a 2000 French application, but the original perindopril compound was patented in the early 1980s and another earlier patent for the compound patent 341) for "the industrial synthesis of perindopril" dated back to the late 1980s.

The patent was a lucrative one: Servier's turnover in the UK alone was £70 million and Apotex had sold £4 million worth of perindopril in the short period before Servier, alleging infringement, secured interim injunctive relief. Apotex then challenged the validity of the patent, while Servier sought leave to amend it. The problem, as Pumfrey J neatly summarised it, was not so much a matter of interpreting it, but rather that there was what he called "a lack of specification". In this hearing the principal issues were (i) whether the patent was anticipated and/or obvious in the light of patent 341 and (ii) if so, could Servier amend it?

Pumfrey J dismissed Servier's application to amend the patent, which he revoked. On the evidence, the patent's claims had been anticipated by, and lacked any inventive step because of, patent 341. Since the proposed amendments couldn't remedy this deficiency the patent was dead in the water.

The IPKat says, Pumfrey J made this observation in para.34 of his judgment in the context of the role of experiments in patent disputes:

"... the criteria for sufficiency of description on the one hand and the enablement of an inevitable result on the other are not the same. For the purpose of anticipation, the prior documents must enable something which inevitably falls within the claim. Where the prior art does not describe the end to be achieved, it is illegitimate to employ a refinement of technique or whatever to cause the desired result to be achieved. Where the sufficiency of a disclosure of a method is under discussion, ... the skilled person is entitled to do such preliminary work and carry out such uninventive refinements, without undue effort, with a view to producing a product falling within the claim".

Hypertension here, here and here
Hypertension in cats here

Nexus

Until When Can Patent Claims Be Limited in Civil Proceedings? Swiss Federal Patent Court Relaxes Strict Practice

Background

The Case

Comment

Teva v Merck - not a sight for sore eyes

The peril of perindropil patent litigation

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