Category : Dutch Patent Litigation

A small revolution is about to happen in European Patent Practice. Professionals in IP have been brought up with the notion that after grant, a European patent is nothing more than a bundle of national patents in a number of European member states. The bundle often only covers three to six countries, and even though you might like to have a patent that covers the whole of Europe, the costs, in practice, are hard to justify. With the European Unitary Patent at the doorstep, patent protection in a larger part of the EU is becoming a more realistic option. Further, a second development is about to happen: the Unified Patent Court (UPC), a new court system which will deal with disputes involving the unitary patent and existing European patents. Together, the unitary patent and the Unified Patent Court represent the most important change in forty years of European patent law. It is expected that the new system will enter into force at the beginning of 2017. If you want to make optimal use of this new system, it is important to gain more in-depth knowledge of the matter now.

Main Characteristics

With the new unitary patent, the European market will get a new, practical, contemporary patent system for 25 European member states and 430 million inhabitants. This will co-exist alongside the two existing systems which innovators currently can choose from:

  • A national patent in each European country which the company considers relevant.
  • A European patent, which after having been granted centrally, is really a bundle of national patents.

A Third Option, the Unitary Patent

The third and new option is the unitary patent. The unitary patent will follow the same examination and grant procedure at the European Patent Office (EPO) as a European patent. Once granted, it is up to the patent owner to decide whether he wants a European patent or a unitary one. The unitary patent will be a great deal simpler from an administrative point of view than the existing European patent. The many translations required for registering the patent with the various national patent offices will become unnecessary. As is the case now, any patent drawn up in English will have to be accompanied by a translation of the claims into German and French. For the unitary patent, you only need to submit one complete translation in another language to the European Patent Office (EPO). Further only one annual renewal fee is required instead of the various payments which are made per country at the moment. Incidentally, these fees will be higher than we hoped, but not as high as we feared they might be. This makes the unitary patent a realistic alternative.

Unified Patent Court

In the existing system, disputes concerning patents are heard in each national court of the country in which the (alleged) infringement takes place. This frequently leads to the remarkable situation that a ruling in one country is completely opposite to the ruling on the very same patent issued by a court in another country. The unitary patent will put an end to this fragmentation with the introduction of a new court system: the Unified Patent Court (UPC). The rulings of this new court will have effect in all participating European member states. It is a true revolution.

Benefits

Geographically greater protection for your technology at a lower cost.

  • Less paperwork, so less bureaucracy.
  • The opportunity to tackle infringers effectively.
  • More choice, as the new system provides a third option.

Disadvantages and risks

  • Still relatively expensive, especially when only a limited number of countries are relevant.
  • A risk of losing your patent everywhere in a single court case.
  • No control on renewal costs by gradually reducing the number of countries for your patent.
  • For an infringer, being summoned to appear in a far-away country.

Why would you opt for a Unitary Patent?

A company generally aims to create shareholder value. Right now, a European patent is generally considered to be less valuable than an American one, because of the expenses and difficulties involved in maintaining and enforcing a European patent. It is partly for this reason that the number of patent applications filed in Europe is considerably smaller than in the US: around 274,000 patent applications were filed in Europe in 2014, compared to 578,000 in the US.

Increase in volume

It is believed that the establishment of the UPC will lead to an immediate increase of the value of an average European patent. This may be even truer for unitary patents. It is therefore believed that the number of patent applications filed in Europe will go up. In order to increase the future value of your company, it may already be worthwhile to file more European patent applications. This applies particularly if you have an exit strategy and want to cash in your stake after a while.

Introduction is expected in 2017

Unfortunately, it will still take more than a mere tick of a box for a patent granted by the EPO to have effect throughout Europe. Europe will continue to be a little fragmented, even after the introduction of the unitary patent. This is because the UPC Agreement was only signed by 25 of the 28 EU member states. 26 had initially agreed to join forces, but the Poles backed out. The ratification process can be monitored via the dossier: the Unitary Patent and the UPC at www.epc.nl.

About 17 EU states will make a start

The new system will enter into force once Germany, France and the United Kingdom, plus ten other states have ratified the UPC Agreement. Each country will ratify it in its own way. It is expected that a leading group of about seventeen states will make a start with the unitary patent and the UPC in 2017. These states are the Netherlands, Belgium, Luxembourg, Germany, France, the United Kingdom, Ireland, Austria, Sweden, Denmark, Finland, Latvia, Estonia, Lithuania, Italy, Portugal and Malta. With over 400 million inhabitants, they form a big market. Spain does not participate in the unitary patent.

Summary

According to Walter Hart, Jeroen Fluit and Johan Volmer, patent attorneys at EP&C, the new system will be a very important addition to the existing system, and will ultimately become the new standard for patent protection in Europe. It will be a simple and reasonably affordable patent, with clear advantages for a patent owner. Although there is still a great deal of uncertainty about the UPC, it is generally expected that expert judges will be appointed and properly trained for their new roles. It looks as though UPC procedures will become fairly friendly to patent owners.

Independent Specialist Advice

It remains to be seen whether most companies will want to run the risk of winning or losing a patent action for 25 countries all at the same time, by having it heard at the Unified Patent Court. On the other hand, a unitary patent may present a bigger threat to the competition than the classic bundle patent. This could be considered appealing. It will therefore be a decision for each individual company how it chooses to best protect its technology in the future. Independent specialist advice will be more important than ever before.

For more information, please contact Walter Hart at EP&C.

EP&C has published a White Paper on the Unitary Patent System. The brochure is available for download in a digital format in English and Dutch. You can request a printed version by clicking here.

 

Author: 2 years ago

Netherlands’  The Hague District Court Orange-Book decision brings up again the discussion about the compulsory licensing defense and the role of antitrust in patent infringement proceedings. Opposing’s Germany highest court the Dutch Court denies the possibility of responding with a compulsory licensing defense in a patent infringement proceeding. How damaging is it that two major patent courts in Europe differ on such important issues? After all, we are supposed to have a harmonized European legal order in patent cases. Or maybe not? At the time of the German Orange-Book-Standard decision the German jurisprudence was engaged in thorough discussions in which major voices called for the ECJ (European Court of Justice) for a preliminary ruling to clarify whether a compulsory licensing defense base on antitrust antitrust law is admissible in patent infringement proceedings . Especially the danger of conflicting court decisions and a threat of a further blow to unified European patent law, as well as a possible revival of forum shopping was a major theme in discussions in Germany.

In general, regarding the German Orange-Book-Standard decision there was nothing new by admitting to object antitrust considerations against the alleged infringement of intellectual property rights. The ECJ has already done so in the striking decisions Magill TV-Guide, IMS Health and lastly Microsoft, although with regard to the latter not in a really direct speech. What is different between the mentioned cases and the German as well as the Dutch Orange-Book-Standard cases is that the former ECJ decisions deal with a total refusal to license IP that is essential to entry a secondary market. The German as well as the Dutch Orange-Book cases differ from this initial position this way that there was not the total refusal of a license by the patentee in question. The sticking point between the parties was the royalty rate for which the technology should be licensed, where there is a general willingness to license the IP on the licensor’s side.

Against this background it becomes clear why it is not easy to reach a concurrent view among courts in Europe on the issues dealt with in the Orange-Book-Standard decisions. The predominantly accepted guidelines of the ECJ regarding compulsory licensing by antitrust law are not readily applicable to these Standard cases, but are open to interpretation. We fail to see how -in the light of ECJ rulings- the recent Dutch judgement more adequately solves the problem than the German judgment. We have to judge the Orange-Book-Standard decisions by their practicability and impacts on prospective licensing behavior.

Applied to the particular Dutch Orange-Book case, the German as well as the Dutch solution would not differ in their results. In both cases the plaintiff would prevail and in fact, that is really noteworthy, for the same reason. Both solutions presuppose that the alleged infringer must have seriously submitted a license proposal to the patentee. SK Kassetten GmbH & Co. KG, the defendant in the recent Dutch proceedings, has never done so. Therefore in the particular case the antitrust law defense would not be applicable, not even under the German rule. Thus, we have to run through the next conditions of defending against an alleged patent infringement just theoretically.

While the Dutch court completely denies the existence of an antitrust law defense the German BGH stipulates further conditions to apply it, namely that the alleged infringer has behaved like a real licensee and paid or at least deposit in escrow a FRAND[1]-like hypothetical royalty. Nonetheless, even the Dutch court acknowledges the problems resulting from determining and agreeing on a FRAND-royalty term, and offers its solution of an interim injunction against the potential licensor, which could be initiated to have the patentee to conclude a FRAND licensing agreement or even replace the patentee’s signature under such agreement. The striking point remains the assessment of a reasonable royalty rate and in both solutions the responsibility of ascertaining what is “reasonable” is left to the court to decide. But in contrast to the Dutch solution, the German judgement sees the court’s responsibility only as the second best approach. The BGH gives more leeway to the parties and would consider the requirement of a presupposed offer to license by the potential licensee also fulfilled, if the potential licensee makes an offer to conclude a license agreement in which the potential licensor determines the amount of royalties according to its own “reasonable” discretion. What is done by this provision is nothing else than giving the power to determine the royalty rate to the licensor. Under this thinking, the licensor still can behave anti-competitive (or against antitrust rules). This is rather unconvincing. It is also not convincing, that the antitrust law defense can result in a compulsory license that is not limited in time. If the defendant in a patent infringement proceeding can actually prove all presupposes of the antitrust law defense the patentee would be completely precluded from asserting its patent. Therefore, the result has rightly lead to vehement criticism as it could potentially result in a completely unwanted and de facto permanent license.

In contrast, the solution of the District Court of The Hague appears more preferable since it permits an interim license agreement which could, at least temporarily, satisfy both the alleged infringer of the patent and the potential licensor until they agree to a mutually negotiated agreement. Faced with the impeding decision of the court the parties would be highly motivated to come to a mutual agreement. Thus, under the Dutch approach there remains a chance to solve the negotiation problem between the parties affected by it. And in this way we have the chance to avoid the introducing of a general price control regarding the licensing of IP, which everybody considers to be undesirable.

On the other hand, the conditions to get a license against the wishes of the patentee appear to be reached easier under the Dutch approach. The potential licensee only has to request the patentee for a FRAND license before he can apply for an interim injunction to get a temporary license granted by the court, provided that the parties can not agree on a license mutually. Compared with this, the presupposed FRAND offer by the potential licensee under the German antitrust law defense appears to be more difficult to fit. The potential licensee risks by any offer that the court would not follow its notion of a FRAND royalty term and thus he would jeopardize the antitrust law defense on the whole by underestimating what figure really fits the FRAND royalty rate. Otherwise, by exceeding a FRAND royalty rate the potential licensee could improve its chance to get a license but he risks paying too much for the license as the patentee has only to agree to the presupposed unconditional offer by the potential licensee. In fact, the Dutch Court is right in criticizing the legal uncertainty which is produced by this approach.

Hence both approaches finally emerge as not really practicable. What we really need are proper and reliable concepts in valuing IP to which the stakeholders as well as the courts could align. We admit, that in regular a fair royalty rates comes from mutual negotiations. Thus, it might be a solution to give up the general secretiveness of royalty rates by establishing a system of an open accessible royalty rate database. With it, royalty rates in question would be more comprehensible for both parties and would give less incentives to raise a controversy.

Stephan Dorn


[1] FRAND refers to “fair, reasonable and non-discriminatory”. Especially in the context of Standard Setting, IP proprietors the technology of which would be essentially used to implement a given standard are asked for a commitment to license their IP on fair reasonable and non-discriminatory basis. The concrete meaning of FRAND is heavily discussed and therefore a contentious issue again and again in proceedings regarding licensing and infringement of IP.

Author: 8 years ago

In a combined court case between Philips and SK Kassetten regarding CD- and DVD-technology (CD-R and DVD+R disks), the District Court of  The Hague (Netherlands) ruled in favor of Philips, in a case that may revive the discussion about essential patents and competition law defenses (i.e. license under FRAND[1] terms). In our earlier blog we reported on the Orange-Book decision of the German Federal Supreme Court (of 6 May 2009), in which it affirmed the option for the defendant to raise a competition or antitrust Read more

Author: 8 years ago

On January 16th the UK Court of Appeal in Angiotech Pharm., Inc. v. Conor MedSystems Inc., [2007] EWCA Civ 5 (Jacob, L.J.) affirmed an invalidity ruling of critical claim 12 of Angiotech’s patent [2006] EWHC 260 (Pat) (Pumfrey, J.), while the very next day – in counterpart litigation – the The Hague District Court in The Netherlands upheld the same claim in Conor MedSystems Inc. v. Angiotech Pharm., Inc., No. 258022/HA ZA 06-261 (judgment January 17, 2007).The patent is about taxol as the factor to be used in a drug eluting stent. Angiotech Pharmaceuticals Inc. is the owner together with the University of British Columbia of European patent 0706376 (or “Hunter”). Boston Scientific Corporation is the licensee in the field of the cardiovascular medicine under EP 376.Beyond providing a comparative study of obviousness on counterpart patents where both courts were obviously aware of the progress of both actions, the British decision from one of the leading common law patent jurists provides an interesting comparative framework for the soon to be decided U.S. Supreme Court KSR decision which may occur in the February session of the Court that commences February 20, 2007.The British decision makes special note of the counterpart Dutch proceedings and an earlier Dutch decision involving different parties. See ¶ 65- ¶ 68 (pp. 24-25). Lord Justice Jacob made the following observation:

“One can, of course, postulate a different policy under which a [patent] monopoly might make sense. There are old or obvious ideas which take a lot of work, expense and time to develop and turn into something practical and successful. Without the incentive of a monopoly, people may not do that work or spend the time and money. The Fosamax case, Teva v Gentili [2003] EWHC 5 (Patent), [2003] EWCA Civ 1545, is an example of an obvious invention which cost lots to bring to market. But patent law provided no protection for all that investment because the basic invention was obvious. The courts’ job is not, however, to uphold any claim to a monopoly for an idea which requires investment and risk to bring to market, only those for ideas which are new, non-obvious and enabled.”

The British opinion also has an extensive discussion of the law of obviousness, particularly beginning at ¶ 39-¶ 60 (pp. 18-23), including extensive comparative law discussions with a quotation from Circuit Judge Rich:

“Slight reflection suggests, we think, that there is usually an element of‘obviousness to try’ in any research endeavour that is not undertaken withcomplete blindness but rather with some semblance of a chance of success, andthat patentability determinations based on that as the test would not only becontrary to statute but result in a marked deterioration of the whole patentsystem as an incentive to invest in those efforts and attempts which go by thename of ‘research’.”

Prof. Hal Wegner, Washington D.C

Author: 11 years ago

On December 22, 2006 the Dutch Supreme Court ruled in the case Dijkstra vs. Saier that the patent prosecution file history may be invoked to prevent the patentee disclaiming an aspect of his patent monopoly in order to get a patent granted, but then reclaiming it during infringement proceedings. In Anglo American practice this is known as file wrapper estoppel, “amendment estoppel”, or “argument estoppel”. This prevents a proprietor who has narrowed his claims during prosecution in order to meet requirements of patentability from then asserting the patent against any equivalent technologies falling within the scope of a surrendered territory. The latter type of estoppel (“argument estoppel”), is similar as amendment estoppel, in that where a patentee has made statements to the Patent Office (or in the Dijksta vs. Saier case) during prosecution – namely during the opposition proceedings before the European Patent Office – with regard to the scope of a claim, he cannot subsequently assert the patent against equivalent technology in contradiction of that assertion.The Court thus affirmed its findings in the first case on the use of prosecution file history in a patent infringement case, Ciba-Geigy vs. Oté Optics (NJ 1995/391). In that case the Dutch Supreme Court ruled that the scope of protection of a patent has to be ascertained by considering four factors: (1) in interpreting the terms of the claims, the Court is to determine the essence of the invention; in other words, consider the inventive concept behind the wording of the claims; (2) this interpretation then needs to be corrected to give a reasonable degree of certainty for third parties, which may sometimes justify a restricted, literal interpretation of the wording of the claims; (3) the skilled person may – with restraint – use the prosecution history file for the purpose of claim interpretation; (4) and all other circumstances of the case are to be taken into account, including the possible ‘breakthrough’ nature of an invention (justifying a broader scope). When considering factors (2) and (3), poor drafting of the patent may be construed to be patentee’s disadvantage. In subsequent decisions (including Impro vs. Liko, rendered three weeks after Amgen in the UK), the Netherlands Supreme Court has expressly confirmed this approach. The approach certainly appears to be more in line with the EPC requirements, although there is a lingering feeling amongst practitioners that, underlying the approach, the Supreme Court still continues to embrace its ‘essence of the invention’ approach. In Van Bentum vs. Kool (HR 29 maart 2002, NJ 2002/530 m nt. ChG), a clear case of non-literal infringement, the Supreme Court has clarified the approach in Ciba-Geigy vs. Oté Optics such that the skilled person is only to assume that the patentee has surrendered part of the protection (e.g. beyond the literal wording of the claims but within the full extent of the invention) if there is ‘proper ground’ for the skilled person to do so. Such “proper ground” can for example be found in the patent description or the prosecution history file. This was confirmed in the case Impro vs. Liko, HR 12 November 2004, NJ 2004, 674).

Author: 11 years ago

In Europe we had our time when the Netherlands courts, soon followed by courts in Germany, rendered cross border relief under a European Patent in most of the 90’s. This effort to create a truly European wide enforcement of patents after a uniformed granting procedure, was stalled after the ECJ’s decisions in GAT vs. Luk and Primus et al vs. Roche

In the US extra territoriality is now also at the heart of a judicial review. On October 27, the US Supreme Court granted certiorari (accepted to hear a case) in the Microsoft vs. AT&T case. In 1984 the US Patent Law (article 35 USC § 271(f) extended infringement liability for the export of unpatented physical components of a patented combination. The current precedent is the Deepsouthcase in which it was held that making and shipping component parts of a patented combination invention did not constitute ‘making’ the patented invention in the United States. In the pending US case this position will be reconsidered by the US Supreme Court. It will have vast consequences.

see Prof. Harold C. Wegner’s paper Microsoft Extraterritoriality: “Mutiny…Heresy where he argues that while the Microsoft case is generally understood in the business press as merely involving whether there is liability for the export of software to be loaded onto original equipment personal computers, this is an oversimplification of the issues. In fact, there are two issues before the Court, Prof. Wegner argues, the first questioning whether software or object code is capable of being a “component” of a patented combination for purposes of the statute, and only in the second instance whether there is infringement liability.

See also the US patent weblog Patently-O.

Author: 11 years ago

In patent infringement litigation (and for the infringement of certain other intellectual property rights), typically, a ‘letter before action’ will be sent as a final attempt to reach a settlement before issuing proceedings. In the Netherlands, these warning letters are often sent by means of having a bailiff issue a ‘writ of warning’. On 29 September 2006, the Dutch Supreme Court ruled in the case CFS Bakel vs. Stork Titan B.V, after comparing the warning letter regimes in Germany and the United Kingdom, that the patentee who invokes a pre-examined patent (i.e. the Dutch part of a European patent) which is subsequently revoked or nullified acts unlawfully if he knows, or ought to be aware, that there is a serious, not negligible chance that the patent will not be maintained in opposition or revocation proceedings (see: earlier post on this blog http://ipgeek.blogspot.com/). The rights-holder may now need to exercise more caution or risk facing an action for ‘unlawful enforcement’. 

Traditionally, the Dutch take a liberal approach regarding patentees (or other right holders, for that matter) for sending a warning letter to the competition (which is considered to be the first step in the enforcement process). In 2001, the Dutch Court of Appeal confirmed the rather strict test for the unlawful issuance of warning letters: the mere fact that a patent was ultimately revoked did not necessarily mean that the enforcement of the patent was unlawful. The patentee would be at risk of a claim that the enforcement was unlawful (only) if it knew or ought reasonably to have known at the time of issuing the threat that its patent was not valid [1].
In the Supreme Court decision in CFS Bakel vs. Stork Titan B.V., the test appears to have been somewhat revised, in that the patentee’s assumed knowledge has now shifted from the fact that the patent is invalid to the fact that there is a serious, not negligible chance that the patent will not be maintained in opposition or revocation proceedings.

While one could argue that in any patent case there is a serious, not negligible chance that the patent is invalid, it does not appear at all to have been the aim of the Supreme Court to hold a patentee liable per se for its action for the very reason that the patent is being revoked in the end (with the implication of an inherently serious, not negligible risk that this would happen which the patentee knew or should have known). Contrary to that, in the grounds of its decision, the Supreme Court refers back to its own decision of 1962 [2] in which it was held that to make the act of issuing a writ of warning unlawful it is not sufficient that the pretension embodied in the writ proves incorrect in retrospect (either the asserted patent being (partially) revoked and/or the patent not being infringed); it required that blame for this act can be attributed to the patentee.

Subsequently, the Supreme Court refers to the regimes in Germany and the United Kingdom as regards issuing warning letters, and concludes that in neither of those countries it is accepted that a patent proprietor who has invoked his patent, is liable to compensate the damage suffered by his competitors or others as a result of this act, on the mere ground that the patent is subsequently revoked or annulled; the regime in both countries equally requires that some sort of blame can be attributed to the patentee, according to the Supreme Court. On the basis hereof, the Supreme Court holds that the patentee who invokes a pre-examined patent which is subsequently revoked or nullified acts unlawfully if he knows, or ought to be aware, that there is a serious, not negligible chance that the patent will not be maintained in opposition or revocation proceedings.

In its decision making, the Supreme Court for the larger part has followed the opinion of the Advocate-General Huydecoper. The Advocate-General in his opinion emphasizes that given the fact that the patent survived examination before the European Patent Office – which requires quite considerable efforts from the later patentee, and particularly serves the interests of the competition – ‘one can not ask much more’ from a patentee to verify that its patent is valid. The Advocate-General makes an exception to the rule, however, in case the later patentee withheld relevant information from the patent office, or acquires new information after grant which sheds a new light on the validity of the patent as granted. Unfortunately, the Supreme Court did not rule on these particular aspects. It therefore remains to be seen whether the Supreme Court decision is to be interpreted in accordance also with this part of the AG’s opinion (which would definitively constitute a shift in case law).

Francis van Velsen, Simmons & Simmons (Rotterdam, Netherlands)

[1 Koppert-v-Boekestein, Court of Appeal, 20 September 2001, IER 2001/57
[2] Drefvelin-v-Wientjes, Supreme Court, 6 April 1962, NJ 1965/116
Author: 12 years ago

Last Friday, September 29, 2006 the Supreme Court of The Netherlands (“Hoge Raad”) handed down its decision in CFS Bakel B.V. vs. Stork Titan B.V. (Dutch, English translation here) which considered a patentee’s liability for actions taken on the basis of a patent which subsequently turned out to be invalid.
Whilst apparently endorsing the earlier approach as set out in a Supreme Court case dating from 1962 (in the case Drefelin vs. Wientjes, NJ 1965/116), where it was held that a patentee would not be liable in tort unless he acted reprehensibly, the Supreme Court gave a further gloss to the test. It would appear that the standard for tortious liability to arise is now lower than it was previously.
The Supreme Court in CFS Bakel vs. Stork held as follows:

“This means that the patentee who relies on an examined patent which is later revoked or cancelled acts tortiously if he knows, or ought to understand, that there is a serious, non-negligible chance that the patent will not survive opposition or invalidity proceedings. The mere fact that an opposition or invalidity proceedings are pending is therefore insufficient reason for tortious liability to arise.”

What the Supreme Court has done is to borrow a test from summary proceedings (where an injunction will be granted unless there is a serious, non-negligible chance that the patent will not survive opposition or invalidity proceedings) and use this as the basis for tortious liability. The test would seem to be more easily satisfied than the earlier test as applied by, for example, the Court of Appeal of The Hague in the case of Koppert vs. Boekestein (IER 2001/57). There, it was held that a patentee would behave reprehensibly if he exerted his patent rights whilst knowing or having a serious reason to suspect that the patent was invalid.
The test was similarly applied recently by the District Court The Hague in the decision of 13 July 2005 in the case of Astée Flowers vs. Danziger ‘Dan’ Flower Farm (BIE 2006/60), a case concerning plant breeders’ rights. Here, the Court held that whether or not liability was made out was likely to depend on whether or not the right was relied upon within or outside the framework of legal proceedings, and whether or not the threat was directed against a primary infringer or against his customers in the marketplace.
The same test was also applied by the District Court The Hague in Wijbenga Machines vs. Eisenkolb (April 19, 2006) and in interim proceedings (by the same court) in Novogen vs. Care for Women (January 11, 2006). There, it was held that the fact that 19 oppositions had been filed at the EPO against the patent was not in itself a reason to find the patentee tortiously liable vis-à-vis the defendant. (The patentee had threatened the defendant’s customers with infringement proceedings if they continued to stock the defendant’s allegedly infringing product, and had omitted to mention the fact that the oppositions had been filed). The judge did however imply that continuing to threaten the marketplace with the patent after his own finding that the patent stood a good chance of being invalidated would be likely to give rise to tortious liability in the future.
Clearly, there is a difference between a party knowing or having a serious reason to suspect that a patent is invalid on the one hand and the situation where a patentee understands (or ought to understand) that there is a serious, non-negligible chance that the patent will not survive opposition or invalidity proceedings. Estimating the chances of success in a patent action is not an exact science. In cases which end up in Court, there generally will be (at least in the eyes of the alleged infringer) a reasonable chance that the patent will indeed be defeated (or that infringement will not be made out): otherwise the case would presumably settle. How the lower Courts will come to terms with the new gloss remains to be seen.

Simon C. Dack, Barrister De Brauw Blackstone Westbroek The Hague, Netherlands

Author: 12 years ago

The District Court in The Hague, Netherlands ruled on September 13 mainly in favor of Warner Lambert (Pfizer) in two judgments against Ranbaxy, one decision related to EP patent 0 247 633 and the other decision on EP patent 0 409 281. The judgements are part of an ongoing patent litigation between Warner-Lambert (Pfizer) and Ranbaxy, an India based drugs manufacturer. 

Center stage of this litigation is the highly successful cholesterol-lowering drug Lipitor, consisting of “atorvastatin”, an enantiomeric substance, containing a dihydroxyheptanoic acid chain, suitable to inhibition of cholesterol synthesis in the human body. The District Court The Hague held Warner-Lambert’s European Patent 0 247 633 in the Netherlands to be valid. Warner-Lambert’s European Patent 0 409 281 — covering the calcium salt of atorvastatin which had been challenged by Ranbaxy — was held to be invalid in the Netherlands.

Pfizer has applied for a number of patents related to the inhibition of cholesterol synthesis, two of which are being dealt with in these two court decisions. The first patent, EP 0 247 633 was granted on 30 January 1991, upon an application as filed on 29 May 1987, with a priority claim as of 30 May 1986. The ‘633 patent expires in 2007. The second patent, EP 0 409 281 was granted in 2001, upon an application as filed in 1990, with a priority claim of 21 July 1989. The ‘281 patent expires in July 2010. Pfizer applied for Supplementary Protection Certificates (“SPCs”) in (most of) the designated states in Europe on the basis of the ‘633 patent for Lipitor. In The Netherlands, Pfizer obtained an SPC expiring November 5, 2011.

Ranbaxy argued that Pfizer’s SPCs are invalid as they are based on the ‘633 patent which patent – according to Ranbaxy – does not cover atorvastatin. Ranbaxy’s basic position is that atorvastatin is an enantiomeric substance, and that the scope of the ‘633 patent is limited to racemates only. Ranbaxy defended that support of their view could be found in the patent file history of Pfizer’s, e.g. correspondence by Pfizer’s patent attorney with the Danish Patent Office in the Danish application for the national counterpart of the ‘633 patent. Ranbaxy further supported this claim by pointing to Pfizer’s own statements in the prosecution stage of the ‘281 patent. In the ‘281 prosecution, the ‘633 patent was considered to be the closest prior art.

Ranbaxy and Pfizer are involved in disputes related to the (counter parts of the) ‘633 patent and the ‘281 patent on a world-wide basis. Actions are pending in the United States, Australia, the United Kingdom, and The Netherlands, as well as in other countries. Ranbaxy has been quite successful in revocation of the (counter parts of the) ‘281 patent. In view of the ‘633 patent as the closest prior art, the ‘281 patent has been nullified for lack of inventive step in multiple jurisdictions. However, Ranbaxy until now appears to be less successful in the nullification of the ‘633 patent and/or the corresponding SPC, which is Ranbaxy’s primary interest in order to be able to likewise market an atorvastatin product like Pfizer’s Lipitor. 

In several jurisdictions, Pfizer’s confirmation of Ranbaxy’s view with respect to the scope of the ‘633 patent has been excluded as evidence. In these proceedings, the scope of protection of the ‘633 patent has been assessed from the point of view of the skilled person only, while any and all representations limiting the objective scope as made by the patentee have been disregarded. For instance in the UK, Pumfrey J was very explicit clear in his judgment of 12 October 2005 regarding the scope of protection of the ‘633 patent, by ruling:

 

“At the outset of the trial, I ruled that Ranbaxy could not rely upon certain documents, largely representations made to certain patent offices, in which persons acting for Warner-Lambert had made representations about the disclosure of ‘633 much the same as that for which Ranbaxy now contend.

I excluded the documents because I considered that they were not admissible on the question of construction”.

Similarly, in the Dutch proceedings, the Dutch Patent Office (“Octrooicentrum Nederland”) was asked to provide its expert opinion on inter alia the question whether the skilled person would understand the ‘633 patent to exclusively cover racemates (and therefore not enantiomers). Octrooicentrum Nederland confirmed in its expert report of 28 March 2006 that it did not consider the file history of the ‘633 patent, let alone the ‘281 patent, – and therefore would consider the “objective scope” only – reasoning:

 

“Octrooicentrum Nederland in the first place stresses that the question,
which must be answered in this expert report, is how the skilled person will
understand patent EP ‘633 and not what Warner has stated in that respect in any
proceedings.”
 

The District Court The Hague followed this reasoning of the Dutch Patent Office . The result is that the ‘633 patent is being considered as the true “basic” patent (within the meaning of Article 3 sub a of Regulation 1768/92/EEC) covering the Lipitor product. The Court disregarded evidence filed by Ranbaxy – all based on prosecution file history of the’633 Danish counter part and the ‘281 patent – in assessing the scope of protection of the ‘633 patent. 

In most other European countries, like the UK, France and Germany, consultation of the prosecution file history is excluded as evidence, mainly from the point of view that it cannot contribute to the assessment by the skilled person of the scope of protection. In The Netherlands (like in some other smaller jurisdictions), quite a liberal attitude has been adopted in the past vis-à-vis consultation of the prosecution file history in assessing the scope of protection of a patent (often compared to the US “file history estoppel”).

The ruling means that Ranbaxy is prevented from launching its drug before Lipitor’s basic patent EP ‘633), which expires in November 2011.

See also “Lipitor battle in the Netherlands—District Court invalidates Warner-Lambert’s EP ’281 and holds EP ’633 infringed”, Klaas Bisschop, Ruud van der Velden, Journal of Intellectual Property Law & Practice, 2006, Vol. 1, No. 13 (December 2006)
Author: 12 years ago