Source: http://patlit.blogspot.com/2010/11/
Timestamp: 2017-10-22 11:54:39
Document Index: 636691456

Matched Legal Cases: ['application no. 200300857', 'art 63', 'art 7', 'art 20', 'art 7', 'art 16', 'art 63', 'art 22', 'art 15', 'art 63', 'art 31', 'art 45']

PatLit: the patent litigation weblog: November 2010
Last Friday, sitting in the Patents Court, England and Wales, Mr Justice Floyd gave judgment in Cephalon, Inc & others v Orchid Europe Ltd & another [2010] EWHC 2945 (Pat). PatLit is delighted to publish this note on the decision by Paul Cole (Chartered Patent Attorney, Lucas & Co, Professor of IP Law, Bournemouth University and an editor of the CIPA Guide to the Patents Acts). Writes Paul:
"An instructive decision concerning an application for an interlocutory injunction was handed down on Friday 19 November by Floyd J in Cephalon v Orchard Europe and Generics.
The patent in issue was based on the proposition that the size of particles of the drug modafinil in a composition in which it is contained is important to the potency and safety profile of the drug, and in the claimed composition at least about (sic) 95% of the cumulative total of modafinil particles were to be of diameter less that about (sic) 200μm.
A first question was whether the allegedly infringing product had particles of the correct size. The experts for the parties were in disagreement as to the effects of the test methods used on the measured particle size, and Floyd J held that the evidence as it stood was very weak that just about cleared the threshold of arguability. A second question was validity, and there was an extremely pertinent earlier reference. Although as the evidence was incomplete and inconclusive Floyd J was not prepared to hold that there was no arguable case that the patent was valid.
An interesting issue of law then arose under the American Cyanamid ruling as to whether prospects of success should be taken into account when deciding whether to grant interim relief pending the full trial. Floyd J held that this was not a case on facts about which there was no credible dispute that the strength of the defendants’ case was disproportionate to that of the plaintiffs. Accordingly the debate turned to balance of convenience, which was held not to favour grant of an injunction, although a speedy trial was ordered.
Although there can be little doubt that the overall result was correct, a more robust approach to the technical facts is possible. A little arithmetic illustrates the point. It seems common ground that the patent would need amendment and that the patentee’s prospects of success could be assessed as at most 50% on the evidence as it stood. On infringement, as the evidence stood, their prospects of success could also be assessed as at most 50%. Since it was necessary to succeed on both issues, their overall prospects stood at not more than 25%. It is not clear that the ratio decidendi in American Cyanamid is that a complete blind eye should be turned to the underlying facts. If the plaintiff needs to win on more than seriously disputed issue and his case appears the weaker on two or more of those issues, it is hard to see how it would be appropriate to grant an injunction except in the most exceptional circumstances".
Pubblicato da Jeremy a 9:16 am 1 comment: Link a questo post
Etichette: interim relief
In a ruling dated October 22, 2010, the Spanish Supreme Court accepts the amendments made during the appeal filed at the Spanish Patent and Trademark Office.
The case started in 2003, when patent application no. 200300857 for “Biological removal of metal contaminants” was filed. The Spanish Office requested the applicant for 3 times to amend several deficiencies and finally decided to reject the application. The decision, dated October 3, 2005, was appealed before the Office. With the appeal the applicant introduced further amendments. The Office considered that amendments are not admissible during the appeal and confirmed the decision, without taking in consideration those amendments. Further appeal was also dismissed by the Court of Valencia. The cassation appeal filed against this decision has now been admitted. Main argument for this decision is:
“It was compulsory for the Spanish Patent and Trademark Office to allow the correction of such deficiencies in the description by one the ways mentioned above: giving a new deadline for amendment or, where appropriate, accepting the amendment in the appeal. Regarding this possibility it should be noted that there is no legal obstacle to do it in those procedures, in which there is no lapsing term to amend and involve a kind of dialogue between the applicant and the Administration to correct any errors or deficiencies of patent claims that can by nature be corrected”.
Full text of the Spanish Supreme Court ruling here (in Spanish) (pdf alert).
Pubblicato da Antonio Selas a 8:34 am 2 comments: Link a questo post
"When to sue" training for university TTOs: is it US-only?
No longer havens of rustic reflection,
universities now have to develop
patent litigation savviness
Earlier this week PatLit commented on the availability of Boot Camp training for expert witnesses in patent litigation in the United States, and on the absence of such training in Europe. Another area in which the US seems to have taken the lead is in training university technology transfer office (TTO) heads how to identify the point at which to take legal action and how far to go. This advertisement, in a Technology Transfer Tactics email circular, caught my eye:
Patent Infringement: Deciding When and How Your TTO Should Take Action
University technology transfer offices have long had a reputation for being hesitant, if not outright pushovers, when it comes to enforcing their patent rights. The big companies that take liberties with university IP assume the worst case scenario is a non-punitive compulsory license -- and the result of this widespread perception is a weakening of university IP rights and, in essence, a huge discount from its real value. Breaking this cycle can have a massive impact on the overall monetary value of your patent portfolio, and also speaks volumes to both potential infringers, your licensees, and your own faculty innovators who entrust you with their patents. That’s why our Distance Learning Division has recruited a top attorney and a veteran TTO executive to assist you in erasing the “pushover perception,” identifying when a potential breach has occurred, determining when it’s best to take action against infringers, assessing other legal options short of a full-blown court case, and supporting your attorneys throughout the process.
Since universities in the US can be viewed as Non-Practising Entities (trolls), the need for them to mind not only their financial interests but their reputation may be a matter of sensitivity, though the rubric of the advertisement above does not suggest that trollism is part of the course content. Again, I wonder what level of infringement-response training is available for tech transfer offices outside the States and particularly in Europe. I'm sure that some information-sharing among universities takes place at national level and possibly even beyond, but at what level, how frequently and to what end? Can any readers advise?
Etichette: university tech transfer training
Expiration of a US patent 32 years after application
Merck v Teva: Prosecution laches and inequitable conduct
Last week, Merck reported a victory on appeal in the TEMODAR Patent Infringement Lawsuit here.
The claim (initial pleadings here - pdf alert) was dismissed on January 26, 2010 by District Judge Sue L. Robinson, concluding that the patent was unenforceable due to prosecution laches and/or inequitable conduct:
a) Prosecution Laches ("unreasonable and unexplained delay in prosecution"):
“51. It is the court's conclusion that the "ends" - commercialization of a very successful cancer drug - do not justify the "means" employed by CRCT in this case. Taken in the totality, this case involves eleven patent applications, ten bandonments and no substantive prosecution for a decade”.
b) Inequitable conduct (“applicants for patents and their legal representatives have a duty of candor, good faith, and honesty in their dealings with the PTO”):
“77. It is the court's conclusion, therefore, that the withheld information directly contradicts statements made in the '291 patent's specification regarding the utility of the claimed compounds, and directly contravenes the patentability of (broadly-written) claim 28. For these reasons, the withheld inactivity data is highly material.
83. … It is the court's finding that Stevens committed inequitable conduct by failing to disclose, in accordance with his duty, the information discussed supra”.
You can read Ms Robinson’s entire opinion here (pdf alert).
On November 9, 2010, The Federal Circuit reversed the District Court’s findings and conclusions. Main arguments are:
a) Prosecution Laches:
“to establish prejudice an accused infringer must show evidence of intervening rights, i.e., that either the accused infringer or others invested in, worked on, or used the claimed technology during the period of delay.
There has been no evidence presented that anyone was deterred from entering the market for temozolomide because Cancer Research’s patent issued in 1993 rather than several years earlier. Thus, the delay had only limited consequences to Barr and the public.
Barr has failed to establish either that it or that others developed or invested in temozolomide or any other claimed tetrazine compound between 1982 and 1991, the period of delay. Accordingly, Barr cannot establish prosecution laches as a matter of law, and we reverse the decision of the district court.
Because we conclude that the district court committed legal error in holding the ’291 patent unenforceable for prosecution laches in the absence of any evidence of intervening rights, we need not decide if Cancer Research’s delay in prosecuting the ’291 patent was unreasonable or unexplained”.
b) Inequitable conduct:
“... materiality and intent are separate requirements, and intent to deceive cannot be found based on materiality alone … In this case, evidence that Stevens coauthored articles that contradict the disclosure of the ’291 patent specification does not alone establish that Stevens with-held those studies
intending to deceive the PTO.
… While publication to the scientific community is not the same as disclosure to the PTO and does not foreclose a finding of deceptive intent, … the prompt publication of data in multiple articles over the entire course of prosecution is inconsistent with finding that intent to deceive is the single most reasonable inference to draw from the evidence in this case… Also, Stevens did not selectively withhold information; the withheld information includes both positive and negative data regarding the claimed tetrazine derivatives… Accordingly, an equally reasonable inference to draw from the evidence is that Stevens viewed publication of all the data as important to his career as a scientist but did not appreciate their potential importance to the patentability of the tetrazine derivatives patent claims”.
The decision has not been unanimous. Judge Prost, in dissent, considers that:
“the majority propounds a new and unsupportable legal standard for prosecution laches. With regard to inequitable conduct, the majority not only creates a new evidentiary standard, but it also ignores virtually unassailable credibility findings made by the district court after a four-day bench trial”.
Ms Prost interpretation of the case:
“Neither the Supreme Court nor this court has required a defendant to establish prejudice to assert prosecution laches.
... even if prejudice is required, there is no basis for the majority’s new requirement that one must confine himself to the period of prosecution delay in determining whether prejudice exists. Such a requirement (1) discounts the relationship between prosecution laches and broad public interests in the timely issuance of patents and (2) imposes a novel time restriction on the harm suffered.
By requiring this particularized prejudice, the majority sidesteps the real harm at issue in this case. The Supreme Court has explicitly recognized that delaying a patentee’s monopoly period harms the public by delaying its free use of the patented invention. Woodbridge, 263 U.S. at 48-49. Here, the applicant first filed the patent application disclosing temozolomide in 1982. By stalling prosecution for its own business purposes for nearly a decade, Cancer Research obtained a patent which does not expire until 2014—almost thirty-two years after the first application in this chain was filed”.
b) Inequitable conduct
“The majority veers from our precedent in at least two respects: (1) it creates
a new evidentiary standard for establishing inequitable conduct, and (2) it
inexplicably rejects the district court’s unassailable credibility determinations, which served as the basis for its conclusion that inequitable conduct occurred... an inventor, Dr. Stevens, withheld important data from the U.S. Patent and Trademark Office (“PTO”) that contradicted the disclosure in the patent applications”.
Full text of both appeal opinions can be found here (pdf alert).
Pubblicato da Antonio Selas a 7:29 am No comments: Link a questo post
Etichette: inequitable conduct, Prosecution laches
For some SMEs, budgeting for
patent litigation takes up all their
Pubblicato da Jeremy a 11:52 am No comments: Link a questo post
Etichette: enforcement costs, SMEs
I've just been reading an advertisement for a Patent Expert Witness Boot Camp presented by Patent Calls (details here). The very concept, and its presentation, signify instantly that it's a US initiative. The rubric reads as follows:
"Patent Litigation is often compared to war, and you wouldn't go to war without first going to Boot Camp, would you?
Patent Calls' Patent Expert Witness Boot Camp is intended to help technology experts learn and improve upon the skills needed to be an effective witness in patent trials. Successful participants will be able to approach their work with greater confidence and improved understanding of the role of the expert.
Participant cost is $6,000 and includes both lodging and meals".
An admittedly brief online search has failed to unearth any equivalent Boot Camps or training schemes for patent expert witnesses in the continent of Europe, or indeed anywhere else. It seems to me that what we regard as training an expert witness is something else -- training the witness to serve the requirements of the party paying hs or her fees and expenses. Have I missed something? If so, PatLit would like to receive comments from patent expert witnesses, and from those who hire and examine them, as to whether Europe should be building a corps of effective technology witnesses.
Pubblicato da Jeremy a 10:12 pm 1 comment: Link a questo post
Etichette: boot camps, expert witnesses
PatLit made reference in July (here and here) to the application for disclosure (evidence) made by Abbott in the course of an action in which it sought declarations of non-infringement, and orders for revocation, of three patents for coronary stents owned by Medinol, while this company counterclaimed for patent infringement.
A copy of the full text off the decision, dated November 12, is now available here.
The result: one of the patents is invalid since it lacks of novelty and none of them is infringed by the Abbott stents.
This decision follows those of The District Court in The Hague (Netherlands) and the Regional Court in Dusseldorf (Germany). A brief summary of both actions can be found in the Form 10-Q filed by Abbott at the SEC in May 4, 2010 (here):
“In its 2009 Form 10-K, Abbott reported that litigation is pending in the High Court of Ireland, the District Court in The Hague, Netherlands, and the Regional Court in Dusseldorf, Germany in which Medinol Limited asserts that certain Abbott stents infringe various Medinol stent design patents and seeks damages and injunctions, and in the High Court of Justice in the United Kingdom in which Abbott asserts that its stents do not infringe Medinol’s patents and seeks a declaration that Medinol’s patents are invalid. In February 2010, Medinol appealed the Dutch court’s finding that Abbott’s stents do not infringe Medinol’s patent. In March 2010, the Dusseldorf court found that Abbott’s stents do not infringe Medinol’s European stent design patent, a patent also at issue in the other venues, but that they do infringe two of Medinol’s German stent design patents. Medinol can seek to enforce its right to damages and a provisional injunction in Germany. Abbott has the right to appeal the decision of the Dusseldorf court. In addition, as previously reported in Abbott’s 2009 Form 10-K, Abbott filed an action in the German Federal Patent Court asserting that the three Medinol patents at issue are invalid. If the German Federal Patent Court invalidates Medinol’s patents, then any relief granted by the Dusseldorf court could be rescinded”.
The arguments used by Mr. Justice Arnold in the new Judgement seem quite usual, but from a procedural point of view, I would point out the following paragraphs:
190. The starting point is that, since Medinol now positively alleges infringement of 901, the burden lies on it to prove what happens to the loops in this scenario. Despite this, Medinol has not relied on any experimental evidence in support of its case. In particular, it has not relied on any finite element analysis ("FEA") of its own despite having in-house expertise in FEA. Following an order for specific disclosure which I made on 8 September 2010, it sought to rely upon an analysis of an FEA model created for Abbott, but ended up agreeing that the facts established by this did not go beyond points (i) and (iii) in paragraph 188 above. Nor has Medinol relied upon any photographs in support of its case.
191. Medinol did rely upon promotional materials issued by Abbott and evidence given by Mr Johnson as to the function of the loops in question in the Abbott Stents, namely to aid flexibility and conformability of the stents. This evidence does not establish, however, that the loops participate in expansion as distinct from bending of the stents.
193. … On the contrary, the burden lies upon Medinol to prove that the loops do widen in this scenario; Medinol have adduced no positive evidence to that effect other than Professor Snyder's opinion; Professor McHugh's evidence is to the contrary; and, even if the Abbott photographs and measurements cannot be relied on as positively proving that the loops do not widen, they are at least consistent with Professor McHugh's opinion. Certainly, Medinol did not conduct an experiment in reply to Abbott's experiment to show that taking photographs and measurements in a manner which was not subject to Medinol's criticisms lead to a different conclusion.
194. Counsel for Medinol argued strenuously that, even absent any other evidence, it should be inferred from points (ii)-(v) in paragraph 188 above that the loops on the outside of the stents widened when bent Abbott Stents were expanded. I am not persuaded that those matters do enable that inference to be drawn, however. Each of those scenarios involves some bending of the stent, whereas the scenario presently under consideration involves just expansion. In that respect, it is closer to scenario (i).
195. For these reasons, I conclude that Medinol has not proved that the loops do widen when the bent stent is expanded".
Pubblicato da Antonio Selas a 8:12 am No comments: Link a questo post
Etichette: Abbott, decision, Medinol
The PCC Page, no.6: Judge injects meaning into “SME Court”
The PCC Pages is a series of Tuesday features on the new regime for litigation before the recently revamped Patents County Court (PCC) for England and Wales, hosted by PatLit but furnished by the Chartered Institute of Patent Attorneys (CIPA). In this post, CIPA President Alasdair Poore focuses further on the rules relating to the transfer of litigation from the Patents Court.
Cautious Co: “So after all that stuff about costs [see The PCC Page No.5], tell me again what sort of case is suitable for the PCC, and what's all that about that transfer thing again?”
Optical Laboratories v Hayden Laboratories [1993] RPC 204 was a classic case under the “old regime” – that is the very old regime – of the PCC. It stands as one of the benchmarks of what went wrong with pleadings in the Patents County Court. More on that in future posts. Quoting Lord Justice Hirst, one can sense the incredulity: “The pleadings are by any standard astonishing documents” – in relation to a simplified procedure involving a defence of 128 pages and reply of 62 pages. Under the new rules, with Judge Birss QC, it seems likely that would be regarded as excessive. Indeed that concern about pleadings, and how the rules would address that, was one of the worries in the Working Group recommending the rule changes about the new rules. Now those worries are encapsulated in the rules in the word “concisely”.
This was a case started in the PCC, but Judge Ford refused to transfer it to the High Court. On appeal on an issue of calling two expert witnesses, McCowan LJ observed “I cannot help wondering if it is the sort of case for which the Patents County Court was designed”. The writer is sure that that would still be the case.
Judge Birss QC’s has given guidance on the transfer of cases in his judgment in ALK v Meridian Medical Technologies and Dey Pharma [2010] EWPCC 014, discussed here on the IPKat last week. This provides some useful insight into when a case is likely to be suitable for the PCC and when it is not, as well as when to transfer and when not.
Judge Birss QC repeated his conclusion from Technical Fibre, that the new rules apply to transfers, albeit taking into account that the case will be conducted on the basis of the old rules.
This case involved reasonably straightforward mechanical technology, involving a spring loaded syringe with a mechanism for covering the needle after use to prevent injuries by accidental stabbing – the well known Epipen, which allows patients to inject themselves with adrenalin in the case of a severe allergy reaction. The claim was for a declaration of non-infringement: infringement and validity were in issue, with one novelty citation and two obviousness citations. It was a case expected to last between 3 and 4 days at trial (and probably 2 days if it had been conducted under the new rules). In paragraphs 15 to 22, Judge Birss sets out briefly the framework of rules applicable to transfers. Of these, the amendments to the practice direction on transfers between the Courts in relation to the PCC, PD30 9.1 and 9.2 (affordability, value, complexity and trial length), are particularly important. His summary (para 25, last sentence) was that the Judge is
“to have regard to the financial position of the parties. He is not obliged to transfer if it is shown that the proceedings are likely to raise an important question of fact or law. But subject to those rules he should bear in mind that the Patents County Court was established to handle the smaller, shorter, less complex, less important, lower value actions. It was to provide cheaper, speedier and more informal procedures to ensure that small and medium sized enterprises, and private individuals, were not deterred from innovation by the potential cost of litigation to safeguard their rights”.
European Commission guidance on what a small or medium sized enterprise was found helpful (Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium sized enterprises" (2003/361/EC (see Article 2)) at OJ L 124/36 20.5.2003)
The judge found that it was a case which was suitable for the PCC in relation to the issues arising and the case management aspects. However, the value of the case (turnover over US$ 20 million) and the financial position of the parties (large parties) pushed it towards the High Court, but would not exclude it from being in the PCC. Ultimately (para 54) he found the decisive factor is that
"the court was set up to ensure that small and medium sized enterprises, and private individuals, were not deterred from innovation by the potential cost of litigation to safeguard their rights. With the new procedures in place I intend to devote my energies to making them work in order to achieve that objective. However this is not the case in which to do it”.
This will provide useful guidance for where to draw the line at least in some cases.
In Omnipharm Ltd v Merial, a dispute before the Patents Court for England and Wales (extempore, helpfully noted by the Lawtel subscription service), Mr Justice Norris ruled that a party seeking a declaration of invalidity of two patents was permitted to amend its claim to seek a declaration of non-infringement under the Patents Act 1977 s.71, on the basis that questions about its standing to secure such relief could be addressed later in the proceedings.
Omnipharm -- a company that specialised in evaluating pharmaceutical products and clearing obstacles to marketing them -- lodged a revocation claim against two of Merial's patents. One of these patents was a European patent, the other a United Kingdom patent: both were to do with formulations of fipronil used in veterinary applications.
In these proceedings Omnipharm applied to amend its amend its claim in order to include a declaration under the Patents Act 1977 s.71 that what it intended to do what not in any event infringe Merial's patents. Merial opposed the application to amend. According to Merial, Omnipharm had no reasonable prospect of success in getting such a declaration since it couldn't show that it had the requisite intention to carry out the allegedly non-infringing acts. In this assertion, Merial sought to rely on evidence showing that Omnipharm inter alia (i) had no website, (ii) had not filed accounts for more than three years and had insufficient assets, (iii) had a registered office care of a firm of accountants and (iv) had no traceable office. Said Merial, if Omnipharm's amendment was permitted the issue of its standing to obtain a declaration of non-infringement should be tried as a preliminary issue.
Norris J granted the application to amend. In his view, in order to show that it was a person intending to perform the allegedly non-infringing act, it was sufficient for a party to declare only that it should like to do the intended act if it could. This application was not however the occasion on which to consider the conflicting evidence concerning Omnipharm's standing and Omnipharm had sufficiently pleaded its case for the amendment to be allowed. He added that there had been no formal application for the trial of a preliminary issue, and it was too soon in the proceedings to consider ordering one; there would however be a window in the proceedings, after disclosure, in which to address the issue of Omnipharm's standing to seek declaratory relief.
Etichette: Standing to seek declaration of non-infringement
Navigating the PCC's new rules --
not a subject to take 'lightly'
The PCC Pages is a series of Tuesday features on the new regime for litigation before the recently revamped Patents County Court (PCC) for England and Wales, hosted by PatLit but furnished by the Chartered Institute of Patent Attorneys (CIPA). In this post, CIPA President Alasdair Poore summarises the topics covered so far.
Time to get on with it then? Cautious Co is on holiday. Unlike most clients, he did not send fresh instructions just as he was leaving. Your advice has left him thinking, and left you some revision time. This note provides you with a quick series of links and reminds you of the speed limits on the way.
The starting point is the amendments to Part 63 of the Civil Procedure Rules (CPR). PatLit provided a neat summary of the effect of the changes. The amendments tie into other provisions of the CPR, and this note provides links to those, as well as flagging up those costs limits again.
When you look at those costs limits again you might get pretty nervous – they look very tight (just look at the actual costs on a pre-New Rules application in Beechwood (II), where summarily assessed costs came to £16,000, admittedly for summary judgment, so not just a straightforward application (para 13)). Then compare it to the present limit, £2,500 (also interesting in that it sets out a order in full, although under the old rules). But remember:
• these are not limits on what you can spend -- just on what you recover from the other party or pay him. But make sure Cautious Co understands this;
• there are exceptions: conduct amounting to an abuse of the Court’s process (CPR 45.41(2)(a)), or a Certificate of Contested Validity issued by a court (but not the Intellectual Property Office?) (CPR 45.41(2)(b))
• Patent attorneys have better experience than other practitioners: working on cases in the EPO.
Another word of caution first. All the Civil Procedure Rules (CPR) are relevant – and it takes several volumes of the White Book to summarise those. But here are the references to the New Rules and bits referred to in them.
A good place to start is CPR 63 rules 17 to 26. They say that CPR 63 applies generally except to the extent modified, so you need to understand CPR 63. And there is a Practice Direction covering CPR 63. This sets out both useful information as well as specific provisions applicable to intellectual property cases. For example where to issues proceedings – more on that in a later note.
Starting a claim: A claim must be started in accordance with Part 7 (or Part 20 – where you are counterclaiming against the claimant or making any claim against a person who is not a party to the proceedings). Among other things, Part 7 explains that the claim must be issued with or followed within a short time by the particulars of claim.
Transfers: in the wrong place – CPR 63.18 applies and refers to Practice Direction 30.
Setting out the details: Particulars of Claim (speed limit £6,125 – including starting the claim). CPR 63.6 applies to the particulars of claim – it refers to Part 16, but adds some modifications. Then CPR 63.20 adds additional modifications for the PCC – the requirement that all facts and arguments be set out concisely, and confirming whether the claimant has complied with the Direction on Pre-action Conduct.
Statements of Truth (which need to be added to each statement of case and the claim form) – Part 63.21 applies and refers to the general requirements in Part 22 (and Practice Directions), but adds that a statement of truth must be given by the person or people who actually know the facts set out in the statement of case.
Defence (limit £6,125): CPR 63.22 provides that Order 63(7) does NOT apply to the defence; Part 15 applies with modifications set out in Order 63.22.
Case Management (limit for attendance £2,500). CPR 63.23 applies and refers to the Practice Direction on Part 63.
Disclosure and Inspection (limit £5,000): CPR 63.25 applies Part 31, and PD31A (general) and PD31B (electronic disclosure) with modifications, which mean that much will be of little interest.
Costs: there are other elements of costs you can claim. CPR 63.26 sets out all the details: where the Court makes a summary assessment of costs, it will do so in accordance with Section VII of Part 45. CPR 45 provides that in most cases the PCC will make a summary assessment of costs LIMITED on a scale basis (ie you may get less). As a reminder the scale is set out in the Costs Practice Direction at Section 25C. The scale is repeated below for quick reference. Note that the total of the figures adds to more than £50,000 – that does not mean you can get more than the limit set out in CPR 45.42 (£50,000 for the main proceedings; £25,000 for enquiry into damages).
Main proceedings: stage of a claim (maximum amount of costs)
Particulars of claim £6,125
Defence and counterclaim £6,125
Reply and defence to counterclaim £6,125
Reply to defence to counterclaim £3,000
Attendance at a case management conference £2,500
Making or responding to an application £2,500
Providing or inspecting disclosure or product/process description £5,000
Performing or inspecting experiments £2,500
Preparing witness statements £5,000
Preparing experts’ report £7,500
Preparing for and attending trial and judgment £15,000
Preparing for determination on the papers £5,000
Enquiry into damages: stage of a claim (maximum amount of costs)
Points of claim £2,500
Points of defence £2,500
Providing or inspecting disclosure £2,500
Preparing experts’ report £5,000
Preparing for and attending trial and judgment £7,500
Preparing for determination on the papers £2,500
The Italian Antitrust Authority (Autoritá Garante della Concorrenza e del Mercato), has opened a preliminary investigation affecting Pfizer’s Italian subsidiary in order to verify if it has artificially extended the patent protection of the active principle latanoprost in Italy, in order to prevent new generic drugs entering the market.
As the IAA informs in the press release published on October 26:
.- The investigation started with the information provided by Ratiopharm.
.- Investigation is addressed to verify if Pfizer Italy took some actions in order to increase the costs of Generic Companies, taking advantage of Pfizer’s dominant position in the market. Main actions taken by Pfizer would be:
a) Filing a divisional application for a patent, followed by a request for a Complementary Protection Certificate (eventually rejected by the European Patent Office) in order to extend patent protection until 2011.
b) Taking legal actions against Generic Companies that were working to commercialise the drug after patent lapsing term in 2009.
.- The decision was notified to the company today in the course of inspections carried out by officers of the IAA assisted by the Financial Police (Guardia di Finanza).
.- The proceedings will last approximately a year.
Just a few days before the press release, chatting with Jeremy on “strange times”, I made reference to “the US report Protecting Consumer Access to Generic Drugs: the Benefits of a Legislative Solution to Anticompetitive Patent Settlements in the Pharmaceutical Industry and the Executive Summary of the Pharmaceutical Sector Inquiry Report by the EU Commission”.
The investigation now started in Italy follows the second report, where the EU Commission concluded that “national policy makers and public authorities may decide to take further action”.
We will see how this interesting investigation ends.
In the meanwhile, you may find interesting reading the English translation we have made of the press release published by IAA:
DRUGS: COMPETITION AND ANTITRUST MARKET GUARANTOR AUTHORITY OPENS PRELIMINARY INVESTIGATION REGRDING POSSIBLE ABUSE OF DOMINANT POSITION BY PFIZER
The proceeding shall verify if the company has tried to artificially extend patent protection of the active principle latanoprost (used to treat eye glaucoma) to prevent or delay generic drugs entering the market.
The Italian Competition and Antitrust Market Guarantor Authority, at its meeting held on the 13th of October 2010, decided to open a preliminary investigation regarding the company Pfizer to verify if, by its actions, the company has artificially extended the patent protection of the active principle latanoprost in Italy, in order to prevent new generic drugs from entering the market.
As a note of the Authority informs, the decision, notified to the company today in the course of inspections carried out by officers of the Guarantor Authority assisted by the Financial Police, was taken in the light of a comprehensive report of the company Ratiopharm. In the complaint was highlighted the behaviour of Pfizer Italy S.r.l. aimed at preventing or delaying entry in the Italian market of generics drugs of specialty Xalatan, drug produced and marketed by Pfizer for the treatment of eye glaucoma. According to the documentation, Pfizer would have fraudulently applied for and obtained an extension of patent coverage, through a divisional application to a patent, followed by a request for a Complementary Protection Certificate (hereinafter CPC) in order to extend patent protection until 2011. The divisional patent, in respect of which the CPC was granted, has also been recently declared invalid by the same European Patent Office of Monaco.
The investigation - which fits in the wake of the recent Pharmaceutical Sector Survey completed in 2009 by the European Commission - will have to check whether the conduct of Pfizer had the purpose of preventing a new generic drug from entering the market, abusing the dominant position held in the market with regard to products for treating the eye glaucoma. In fact, considering that the patent protection would have supposedly expired in September 2009, the generic drugs producers were legitimately relying upon putting on the market a new generic drug on that date: in this context they had faced a series of investments, afterwards made vain with the extension of the patent protection period.
With his behaviour, also in Court, Pfizer would have tried to create a state of legal uncertainty about the possibility to market the new generic drug, in order to make more expensive - for the generic drugs sellers - the actual cost of market entry of the generic drug, in terms of programming and implementation.
The end of the proceeding is scheduled for October 15th, 2011.
Pubblicato da Antonio Selas a 10:56 am No comments: Link a questo post
Having opted for trial before the Patents
County Court, Cautious Co was no longer
tempted by other forms of dispute
To recap: the PCC Pages is a series of Tuesday features on the new regime for litigation before the recently revamped Patents County Court (PCC) for England and Wales, hosted by PatLit but furnished by the Chartered Institute of Patent Attorneys (CIPA). In this episode, CIPA President Alasdair Poore explains that the PCC does not exist in a vacuum and how its procedures can be complemented by Alternative Dispute Resolution.
Cautious Co., whom readers first met here, is quite keen on using the Patents County Court. The company's boss is however impatient to press on and asks:
"PCC: low costs, high speed; why do we need Alternative Dispute Resolution (ADR)? I just want the PCC to decide against my competitor!"
Is this not a good point? Doesn’t ADR just delay the final result? ADR is one of those widely misunderstood terms in the litigation lexicon. Most forms of alternative dispute resolution don’t resolve the dispute unless the parties agree that it can do so. But plenty of them could be helpful. They range from plain settlement negotiations, through conciliation and mediation (assisted negotiations), using Intellectual Property Office (IPO) opinions and early neutral evaluation (eg a trusted practitioner makes an independent assessment) to adjudication and arbitration – see ADR Now for a description of ADR processes, and CEDR, IPO, and the IPO’s list of providers for some mediation links.
Annex A 2.2(2) of the Practice Direction on Pre-Action Conduct suggests the parties should “set out the form of ADR (if any) that the claimant considers the most suitable and invite the defendant to agree to this”. And under the “old rules” His Honour Judge Fysh used to ask parties to add a preamble to the Case Management Order, confirming they had considered ADR.
But, bearing in mind lower costs and faster procedures under the new rules, and in the light of my warnings last week about the risks of forum shopping, does ADR have any place?
Beechwood House Publishing v Guardian Products [2010] EWPCC 12, just decided by His Honour Judge Birss QC and noted here, perhaps shows just why ADR could still be useful, but also highlights some problems. This case was a typical small intellectual property dispute – not a lot of money at stake; talk of settling for £3,000; but what about a “victory”? The parties spent rather a lot of time on getting towards settlement, but did not quite make it to the finishing line– at least in the claimant’s view.
The first lesson was flexibility (both of the Court and the parties). The old rules applied (see Technical Fibre Products v David Walton Bell [2010] EWPCC 11, noted here – old rules still (mostly) apply to old cases). The hearing was on an application for summary judgment on (a) whether a settlement had been reached, and (b) infringement of database right.
Judge Birss immediately showed the flexibility of the PCC. Having observed that a full trial on such a dispute would be an “unedifying prospect” (para 12), all agreed that the settlement issue be decided on the merits on the papers before the judge – just the sort of determination envisaged more generally for the PCC (to avoid a summary judgment, it would have been enough to show only a real prospect of success.) This is a victory for good sense.
Secondly, to take the case forward, although it was under the old rules, the judge steered the parties towards thinking of expedited procedures such as those under the new rules, with a heavy emphasis on proportionality (para 77).
The issues on settlement were also significant. In IP disputes, ADR is often ruled out on the grounds that an owners want a VICTORY and the publicity which goes with it. One of the reasons the settlement fell apart here was the defendant’s desire for confidentiality. Judge Birss stated “This approach [no confidentiality] by holders of IP rights is a common one and is in my judgment entirely fair.” (para 21)
Consequently, sticking to ones rights while seeking settlement is perfectly sensible and supportable. You can attempt to settle AND ask for a public admission of liability. But you need to make sure that there really is a settlement. ADR can also be valuable in reducing the issues (see the current Patents Court and Patents County Court User Guide para 10 (and in practice probably did so here), even if there is not settlement; and clearly in a case such as this, where the amounts in issue are small, ADR still makes good sense, even after proceedings have been started.
However, the other warning should stand out. If you want to use ADR, make sure it is within firm defined and controlled constraints – time-limited, cost-effective and preferably final. Beechwood House Publishing v Guardian Products [2010] EWPCC 12 can show you how long it could otherwise take take.