BREAKING: Mr Justice Arnold refers questions on Article 3(b) SPC Regulation to CJEU

The AmeriKat after the end of this term....

With the swan song of this year's Trinity Term having ended today, the Patents Court has been a hive of activity.  Last minute applications, end of term hearings and judges clearing their desks of judgments are the usual features of the end of the English Court's term.  This term has been no different, but my, how they have ended in a dramatic fashion with....drum roll please...a reference to the CJEU from Mr Justice Arnold on the SPC Regulation in Merck Sharp & Dohme v Comptroller-General of Patents [2016] EWHC 1896.

The problem and the questions to be referred 

What do you do if your patent is about to expire, but despite notice that Member States have agreed to grant your marketing authorization (MA) under the decentralized procedure, a MS has not yet taken the step to actually grant it?  You still make your SPC application, of course.

What happens after that is now subject to the following referred questions to the CJEU (subject to further revision and refinement by the Court and the parties' counsel):

1.  Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation. 

2.  If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

Eye roll all you want, the AmeriKat actually
really does like SPC law

The SPC Regulation

Nothing makes the AmeriKat happier than SPC law (as far as "legal happiness" goes).  For those who have better things to do with their time than to understand the wonderful world of SPCs or to follow the myriad of national and CJEU decisions in this area, the key points are as follows:

• By law, before a medicinal product can be placed on the market, it requires a MA.  Getting a medicinal product to this point cant take upwards to 15 years. 
• By the time a MA for a medicinal product is granted, much of the term of the patent that protects the product will have expired.  
• This means that the effective protection under the patent is insufficient to cover the investment in R&D (see Article 4 of the SPC Regulation). 
• For this reason, a new right  - the Supplementary Protection Certificate (SPC) - was introduced by the SPC Regulation in order to address that problem.  
• SPCs provide an additional period of protection - up to a maximum of 5 years - for a product (i) subject to a valid MA at the date of the application (Article 3(b)) and protected by a patent (basic patent) in force at the date of the application (Article 3(a)).    
• National courts and the CJEU have spent many years wrangling with the interpretation and application of the SPC Regulation.  

What's the product?

Atozet is the medicinal product which contains the active ingredients of ezetimibe and atorvastatin.  It is used to lower cholesterol. Claim 17 of EP(UK) 0 720 599 (the basic patent) protects a pharmaceutical composition comprising ezetimible and atorvastatin (this was not in dispute).  MSD applied for a SPC for the "product" on the basis of this patent for:

"ezetimibe and atorvastatin or pharmaceutically acceptable salts thereof, including atorvastatin as atorvastatin calcium trihydrate". 

The problem was that at the time of the SPC application, there was no granted MA in the UK.

Background

MSD's arguments

MSD obtained a MA and SPC for the mono product - ezetimibe - in 2003.  It then obtained a MA and SPC for a combination of ezetimibe and simvastin - in 2004 and 2006, respectively (Merpel was struck by the relevance of this in the decision given that Article 3(c) objections were not in dispute, save for in the Dutch court).

In September 2006, MSD began development of the fixed dose combo of ezetimibe and atorvastatin.  However, it encountered formulation difficulties.  Seven years later, in September 2013, MSD filed MAs for Atozet in a number of Member States using the decentralized procedure (DCP) of obtaining a MA.  MSD designated Germany as the reference Member State (RMS).  As the RMS, the German medicines regulatory authority - Bundesinstitut für Arzneimittel und Medizinprodukte - coordinated the approval process, preparing the draft documents and, most importantly, the draft summary of product characteristics (SmPC) on which the other Member States comment.  All Member States' respective regulatory bodies need to be happy with the documents before the procedure is closed.  Thereafter, once agreement is reached, each Member State has 30 days to grant the MA.   The German medicines authority did not accept that MSD had filed a valid application until 13 February 2014 (another interesting inclusion, muses Merpel....).

On 12 September that year - a single day before the patent expired (remember the basic patent has to be in force under Article 3(a)) - MSD applied for its UK SPC at the UK Intellectual Property Office (IPO).  However, MSD did not have a granted UK MA.  Instead, MSD submitted, with their SPC application, a copy of the end of procedure (EoP) notice from the German medicines agency stating that the DCP had ended with approval.  MSD explained that the effect of the EoP notice was that concerned Member States, including the UK, had agreed to grant a MA for Atozet.  MSD therefore asked the UK IPO for permission to supplement their application when their UK MA was granted.

Five days later, the UK IPO's examiner said MSD's application did not comply with Article 3(b) because at the time of filing their SPC application, they did not have a valid UK MA.  The EoP notice did not satisfy that requirement.  The IPO also objected to the application on Article 3(c) grounds.  Three weeks later, the UK MHRA granted the MA on 10 October 2014.  MSD submitted a copy of the UK MA, together with the first EU MA (from France) and asserted that these documents would rectify any irregularities in the application.  The examiner maintained her objections, leading to a hearing in which the hearing officer agreed that Article 3(c) was satisfied but the SPC application fell foul of Article 3(b) which could not be cured under Article 10(3).

The Issues 

The Court was tasked with deciding whether:

(1) The SPC application complied with Article 3(b)
(2) The absence of a MA was an irregularity that could be cured under Article 10(3)

Arnold J sided with the Comptroller's
reasoning

Did the SPC application comply with Article 3(b)?

No (in his opinion).  Mr Justice Arnold sided with the Comptroller's arguments on the basis that:

• The focus of the SPC Regulation and regulatory approval is MA grant.  
• The SPC Regulation only talks about MA grant  There is no mention of EoP Notices in the SPC Regulation.  
• MA grant is necessary to launch a product. 
• EoP Notices have no legal effect.  Only national MAs have legal effect under national law and it is still for Member States to grant a MA (despite the mandatory provision of Article 28(5) of the Medicinal Products Directive which provides that once the approval is recorded, each concerned Member State "shall adopt a decision in conformity with the approved assessment report, [SmPC]...within 30 days after acknowledgement of the agreement". 
• SPC applications are made to national IPOs who are not medicines authorities subject to the Medicinal Products Directive. 
• Therefore, at the date of the application, there was no valid MA granted in the UK to place Atozet on the market.  The EoP Notice was not equivalent to a MA for this purpose. 

The judge ignored, in his decision, all the usual "go to" arguments about the underlying purpose of the SPC Regulation in compensating the R&D, which were made by MSD.  The AmeriKat notes the comments about the difficulties encountered in formulating the actives.  Indeed, it took seven years to get to the point of applying for a MA.   Surely, that is where the SPC Regulation's purpose should really kick in - as the time and expense in which it took to successfully formulate and take the product through Phase III trials should be recognized. Adopting an overly formalistic approach undermines the entire purpose of the SPC Regulation as set out in the Recitals, especially where there was only a month between the date of the SPC application and the grant of the UK MA.  But the text of Article 3 itself provides a harder line....

Is the absence of a MA an irregularity that could be cured under Article 10(3)?

No (in his opinion).  Mr Justice Arnold sided again with the Comptroller on the basis that DuPont[2009] EWCA Civ 966 - which held that Article 10(3) could be successfully used to remedy a defect in a paediatric extension application caused by the lack of all updated MAs being provided - was to be distinguished from the position in this case.  This was because of the following:

• An applicant for an extension has to apply by a specific date irrespective of whether it has all the relevant materials or not (i.e. two years before SPC expiry).  If no application is made by this date, no extension can be obtained.  By contrast, an application for an SPC can only be made after the grant of the patent and the grant of the MA.  Once those two events occur, the applicant has 6 months to make an application.  

• Article 3  - and therefore Article 3(b) - does not apply to an application for an extension.  Article 3(b) - a valid granted MA - is a condition of grant.  Such a condition is absent in extension applications, as noted by Jacob LJ in DuPont.  

• Even if Article 10(3) was employed to assist MSD, it was a dead end on the basis that you can't cure the incurable.  That is to say, a condition of grant under Article 3(b) is that there is a valid MA at the time of applying for the SPC.  At the date of application there was no granted MA and there was not until after the application for the SPC had been made.  Had the applicant merely forgotten to supply a copy of the MA, then that could be occurred by Article 10(3), but in this case there was no MA to supply.   

Doing everyone a favor,
Mr Justice Arnold refers questions
to the CJEU

So, why the reference then?

Mr Justice Arnold referred the questions as set out above.because:

• matters were not acte clair; and

• due to the presence of divergent decisions in other Member States on the SPC.  

On the latter, he noted that in Portugal and Sweden, the SPC was refused on the same ground.  However, in Denmark, Greece, Italy and Luxembourg granted the SPC.  The Dutch Patent Office refused the SPC but on Article 3(c) grounds (there was no objection on Article 3(b) as it accepted the EoP Notice as being equivalent to a MA).

One might as well cut to the chase and ask the CJEU what it thinks.  Or, as Mr Justice Arnold, put it:

"In these circumstances, I consider that it is only by referring the matter to the Court of Justice of the European Union that an authoritative ruling can be obtained."

Unfortunately for MSD, muses Merpel, unlike patent amendments she does not know of any "retrospective" provision when it comes to MA grants...

Quia timet, de minimis and Novartis v Hospira: Mr Justice Arnold speeds through Napp v Dr Reddy pain dispute

The IPKat is ready for a busy end of term

After a generally slow start to 2016 in terms of reported decisions emanating from the Patents Court, things have started to pick up in recent weeks.  Mr Justice Arnold has been particularly busy.  At the end of last month Mr Justice Arnold handed down not one, but two decisions in the Napp v Dr Reddy's and Sandoz dispute (see previous Kat report here).  In the first decision  -  [2016] EWHC 1517  - the judge held that there was no threat to infringe Napp's patent on the basis of the de minimis principle.  In the second decision - [2016] EWHC 1581 (Pat) (not yet on Bailii) -  he granted Napp an injunction pending appeal.

Talented Kat friend Amy Crouch (Simmons & Simmons) brings readers up to speed:

"First Judgment – No Threat to Infringe 

Background

Napp commenced infringement proceedings against both Sandoz and Dr Reddy’s in February 2016 for threatening to infringe its patent by preparing to launch generic buprenorphine transdermal patches. Buprenorphine is an opioid indicated for the treatment of non-malignant pain,  Napp’s buprenorphine transdermal patch, “BuTrans” is its most important product.  At the same time as commencing its actions, Napp applied for a preliminary injunction against Sandoz who had already obtained a marketing authorisation for its product. As a result, Sandoz provided undertakings not to launch pending the first instance decision.  Arnold J ordered an expedited trial for early June 2016. Validity was not challenged by either Defendant.

The Patent

The invention lay in the use of certain penetration-enhancing excipients which are solid at room temperature and were therefore thought to be of limited use in assisting diffusion out of the matrix into the skin. The patent disclosed that on melting and cooling, these excipients formed so called “supercooled melts”, which have a melting point above room temperature, but remain liquid after cooling to room temperature.

It was only necessary to consider claim 1:

“A buprenorphine transdermal delivery device comprising a polymer matrix layer containing buprenorphine or a pharmaceutically acceptable salt thereof, for use in treating pain in humans for a dosing interval of at least 7 days, wherein the transdermal delivery device comprises 10 %-wt buprenorphine base, 10 to 15 %-wt levulinic acid, about 10 %-wt oleyloleate, 55 to 70 %-wt polyacrylate, and 0 to 10 %-wt polyvinylpyrrolidone.”

buprenorphine

Construction

The main issues on construction were (i) whether the percentage values in the claim related to input or output values and (ii) the correct interpretation of the numerical ranges.

Arnold J preferred the Defendants’ arguments on both issues, finding that the skilled person would have understood the claim to mean (i) output values and (ii) values to be expressed in terms of whole numbers applying the conventional rounding approach e.g. to extend “10 %-wt” to ≥9.5 to < 10 .5 % wt. The word "about" should be taken to mean "a small degree of permitted imprecision over and above that implied by the usual rounding convention", although in Arnold J's view the inclusion of this word mean that the claim lacked clarity and he would have been tempted to find such a claim insufficient.

 Infringement - The de minimis principle in quia timet actions

The de minimis principle has been considered in previous patent authorities (Hoechst v BP [1998], Monsanto v Cargill [2007], Napp v Ratiopharm [2009], Lundbeck v Norpharma [2011]). In the present case Arnold J commented that the court was forced, as a matter of practical reality, to draw a line somewhere and referred to a hypothetical scenario in which only 0.01% of products fall within a claim as “precisely the kind of situation covered by the de minimis principle”.

In relation to quia timet actions, it was clear that if what the defendant threatens to do would only involve infringement on a de minimis scale, then that threat does not justify the commencement of proceedings by the patentee (whether to seek an injunction or a financial remedy). However, if there is a clear threat to do acts which fall within the claim sufficiently often that they cannot be discounted as de minimis then that is sufficient to justify bringing quia timet proceedings. In this case (i.e. where any infringement would be on a very small scale – see below), he concluded that even if the level of infringement cannot be discounted as de minimis, an injunction would be “both disproportionate and a barrier to legitimate trade”.

Both Defendants had served confidential PPDs which provided results of testing samples of their products. Uncertainty stemmed from the fact that the manufacturing processes for transdermal products are inherently variable and for this reason, it is not known how representative the tested samples are of future products.

Statistical evidence was put forward by experts by all parties and evaluated by Arnold J on the basis of his findings on construction. In relation to Sandoz’s product, even on Napp’s evidence, both of their figures of “1 in 69 million patches” (which was based on a confidence interval of 50%, which was accepted by Arnold J to be the correct interval for the balance of probabilities standard of proof) and “1 in 25,600 patches” (based on Napp’s argued confidence interval of 95%) would be de minimis and accordingly there was no threat by Sandoz to infringe.

Dr Reddy’s had provided a less detailed PPD but stated that to avoid infringement they would implement a testing regime based on a statistical protocol devised by its expert which would incorporate the Court’s findings as to what proportion of infringing patches amounts to de minimis. The protocol to be used by Dr Reddy’s was dependent upon the Court’s construction of the claims and required a finding of (i) the correct confidence interval and (ii) the threshold for the de minimis principle, which Arnold J found to be no more than 1 in 10,000 products falling within the claim. Arnold J concluded that Dr Reddy’s testing regime was sufficient to ensure its products would not fall within the claim other than to a de minimis extent. Accordingly, there was no threat by Dr Reddy’s to infringe either.

Second Judgment – Injunction Pending Appeal Granted 

The findings of no threat of infringement were dependent upon the findings on construction and permission to appeal was granted on construction alone.

Napp applied for an injunction pending the Court of Appeal decision. Arnold J considered the criteria set down by the Court of Appeal in Novartis v Hospira [2013], but noted that it was of concern that Lord Hoffman’s judgment in the Privy Council case National Commercial Bank Jamaica v Olint [2009] had not been cited. Whilst the Novartis guidelines state that “it will not usually be useful to attempt to form a view” on the prospects of the appeal, Lord Hoffman had stressed in Olint the need to consider “the relative strength of the parties’ cases” on appeal. Whilst this factor troubled Arnold J, and he considered Napp to have a weak case on appeal, based on Novartis this factor could not outweigh others.

The Novartis factors that persuaded Arnold J to grant an injunction in this case where:

The test for a preliminary injunction in life sciences...

i) Length of time before the appeal was likely to be heard:  

Dr Reddy’s solicitors had made enquiries to the effect that the Court of Appeal could, if it granted expedition, hear a one day appeal before the end of July 2016. On this basis, Arnold J decided to only grant an injunction until 16 August 2016. It is of note that, if such an expedited appeal does happen within this timeframe, then these proceedings will have progressed from Claim Form to Court of Appeal judgment in only 6 months!

ii) Balance of hardship to each party. 

Damages would not be an adequate remedy for Napp in respect of either Sandoz or Dr Reddy’s. This is a market where a price war is inevitable which will lead to significant price depression for Napp. Further, Sandoz had already effectively lost its first mover advantage due to the undertakings it had provided (in relation to which the correct remedy was a claim on the cross undertaking in damages).

Overall granting the injunction was the “lesser of two evils” and in such circumstances it is prudent to preserve the status quo. Echoing the Court of Appeal’s additional comments in Novartis, Arnold J provided a further warning to generic manufacturers by including in his reasoning the fact that the

 “Defendants could have avoided the problem if they had cleared the path for their products”.

Mr Justice Arnold rejects bid to hear infringement of German designation in Rhodia v Molycorp patent jurisdiction tussle

The AmeriKat on  a sleepless summer night
musing on the future of patent litigation

The late night witching hours have begun again for the AmeriKat.  It is during the quiet, warm summer nights without the ding of incoming emails or calls, that she can muse on the state of patent law.  One of the issues that has been preoccupying her time lately has been the future of harmonization for European patent and SPC law, especially in a post-Brexit landscape.  With the ultimate fate of the Unified Patent Court unlikely to be determined any time soon, her attention is returning back to a national court's ability to land grab an other EU Member State's designation for the purposes of patent infringement actions.   The extent of how long the English court's arm is in this respect was a question posed in various guises in last week's interim decision of Mr Justice Arnold in Anan Kasei Co., Ltd & Rhodia Operations S.A.S. v Molycorp Chemicals & Oxides (Europe) [2016] EWHC 1722 .  The IPKat's ever insightful friend, Eibhlin Vardy, picks up the tale:

"Background

Rhodia is the exclusive licensee of the UK and German designations of a European patent entitled "Ceric Oxide and method for production thereof, and catalyst for exhaust gas clarification". Rhodia commenced infringement proceedings in the English High Court alleging that the English domiciled Defendant, Molycorp, had infringed the UK and German designations of the patent.

Molycorp's solicitors filed an acknowledgment of service, indicating that the Defendant intended to defend the claim, but did not intend to challenge jurisdiction. However, on the same day, Molycorp's solicitors wrote to the Claimant giving notice of Molycorp's intention to challenge jurisdiction of the German designation of the patent in Germany, and asserting that in that situation, the English Courts would not have jurisdiction over infringement of the German designation of the patent.

 Rhodia then issued an application for an order for the provision by Molycorp of samples of its ceric oxide products for testing by an independent laboratory instructed on behalf of Rhodia for the purposes of infringement of both the UK and German designations of the patent. Shortly thereafter, Molycorp issued nullity proceedings in the Bundespatentgericht (Federal Patent Court) challenging the validity of the German designation of the patent on the usual grounds (lack of novelty/inventive step, and insufficiency). It was common ground between the parties that the German validity proceedings were due to take approximately two years.

Issues before the Court

There were two issues before the Court:

Ceric Oxide, not to be confused
with cornmeal....

(1) Does the English Patents Court have jurisdiction over the infringement claim in respect of the German designation of the patent?

Rhodia sought to amend its Particulars of Claim and Particulars of Infringement in order to try and bolster its case on jurisdiction in respect of infringement of the German designation of the patent.  The essence of its proposed Amended Particulars of Claim and Particulars of Infringement can be seen from the following excerpts:

"4. The Defendant has infringed the UK and German designations of the Patent as set out in the Particulars of Infringement served herewith. In respect of the German designation of the Patent, if German designation is not invalid (which is to be determined by the German courts) the Defendant's conduct has infringed, and/or would fall within the scope of the claims of, the German designation of the Patent. 

(1) A declaration that each of the UK and German designations of the Patent has been infringed by the Defendant. 

(1A) A declaration that, if German designation is not invalid (which is to be determined by the German courts) the Defendant's conduct has infringed the German designation of the Patent. Alternatively, a declaration that the Defendant's conduct falls within the scope of the claims of the German designation of the Patent (if not found invalid, which is to be determined by the German courts)."

As things stand, the UK remains a member state of the EU, and the issue of jurisdiction falls under Articles 24(4) and 27 of the Recast Brussels I Regulation, which provide as follows:

"Article 24 

The following courts of a Member State shall have exclusive jurisdiction, regardless of the domicile of the parties: 

… 

(4) in proceedings concerned with the registration or validity of patents, trade marks, designs, or other similar rights required to be deposited or registered, irrespective of whether the issue is raised by way of an action or as a defence, the courts of the Member State in which the deposit or registration has been applied for, has taken place or is under the terms of an instrument of the Union or an international convention deemed to have taken place. 

Without prejudice to the jurisdiction of the European Patent Office under the Convention on the Grant of European Patents, signed at Munich on 5 October 1973, the courts of each Member State shall have exclusive jurisdiction in proceedings concerned with the registration or validity of any European patent granted for that Member State; 

Article 27 

Where a court of a Member State is seised of a claim which is principally concerned with a matter over which the courts of another Member State have exclusive jurisdiction by virtue of Article 24, it shall declare of its own motion that it has no jurisdiction." (emphasis added)

It was common ground between the parties that the German Courts have exclusive jurisdiction over the validity of the German designation of the patent. The issue in dispute was whether the reformed allegations of infringement in the proposed Amended Particulars of Claim/Infringement were "concerned with" the validity of the German designation of the patent within Article 24(4), or "principally concerned with" the validity of the German designation within Article 27.

Rhodia contended that they were not, because the claim had been framed to exclude any question on the validity of the German designation. Molycorp contended that they did fall within these provisions of the Recast Brussels I Regulation, because the question of infringement is inseparable from that of validity.

As a vocal objector to tentacles ::shudder::, the AmeriKat is pleased
that the English court's long arm is cut short by
Recast Brussels I Regulation ...

Following a review of relevant case law (including GAT v LuK  and Solvay v Honeywell), Arnold J concluded that Rhodia's claim fell under article 24(4), or was at least "principally concerned with" the validity of the German designation of the patent under Article 27. The proposed amendments to Rhodia's Particulars of Claim did not assist - the matter in dispute was simply whether "Molycorp has infringed a valid claim" of the patent, and Rhodia could not separate the inseparable through some careful drafting. The reasoning of the CJEU in GAT v LuK was equally applicable here.  Mr Justice Arnold held that:

"First, Rhodia's amendments are a transparent attempt "simply by the way it formulates its claims, to circumvent the mandatory nature of the rule of jurisdiction laid down in that article". Secondly, to allow Rhodia's claim to proceed "would have the effect of multiplying the heads of jurisdiction and would be liable to undermine the predictability of the rules of jurisdiction laid down by the Convention". Thirdly, it would "multiply the risk of conflicting decisions which the Convention seeks specifically to avoid".

Arnold J elaborated on the third point, by reiterating that the same claim construction must be used for both infringement and validity. If Courts in different jurisdictions adjudicate these issues separately, this would allow litigants to overcome the pressure of an infringement/validity squeeze, and could result in conflicting decisions on claim construction (the judge noted that a similar potential issue raised by a bifurcated claim in Germany is avoided because only one claim construction will be adopted by the Court on appeal for both infringement and validity).

In response to an issue raised by counsel for Rhodia, Arnold J noted that the fact that Rhodia had not challenged jurisdiction in the usual way under Part 11 of the Civil Procedure Rules (CPR) was misconceived for at least three reasons: First, the CPR cannot override the mandatory effect of a Regulation, and the timing of the challenge to validity in the German Courts was irrelevant. Secondly, CPR Part 11 does not apply where it is triggered by the defence to the claim, and Molycorp's solicitor's letter giving notice of intention to challenge jurisdiction in Germany was sufficient to raise the issue. Thirdly, Article 27 requires the Patents Court to decline jurisdiction of its own motion, regardless of Molycorp's omission to issue a formal jurisdiction challenge under CPR Part 11.

In summary, this issue of jurisdiction was a matter of substance, not form, and the Patents Court had no jurisdiction over Rhodia's infringement claim in respect of the German designation of the patent.

(2) Should an order be made by the English Court for the provision of samples in aid of a claim by Rhodia in the German Courts?

Mr Justice Arnold  - "principally
concerned  with" being a Patents Judge
or just "concerned with"?

Rhodia undertook to bring an infringement claim in Germany in the event that jurisdiction was declined by the English Court. On this basis, Rhodia maintained its application for an order for the provision of Molycorp's samples for testing for the purposes of the German infringement claim. Molycorp opposed the application on the basis that the Court has no jurisdiction to make the order, and that it would be inexpedient to do so.

Section 25 of the Civil Jurisdiction and Judgments Act 1982 provides as follows:

"(1) The High Court in England and Wales or Northern Ireland shall have power to grant interim relief where –

(a) proceedings have been or are to be commenced in … a Regulation State other than the United Kingdom …; 

…

(2) On an application for any interim relief under subsection (1) the court may refuse to grant that relief if, in the opinion of the court, the fact that the court has no jurisdiction apart from this section in relation to the subject matter of the proceedings in question makes it inexpedient for the court to grant it. 

... 

(7) In this section 'interim relief', in relation to the High Court in England and Wales or Northern Ireland, means interim relief of any kind which that court has power to grant in proceedings relating to matters within its jurisdiction, other than— 

… 

(b) provision for obtaining evidence."

Arnold J sided with Molycorp. Rhodia's application was for the sole purpose of obtaining evidence to support its infringement claim in Germany, and therefore fell under the exclusion identified in s25 (7) (b) above. It was common ground that this exclusion was included because the proper means for obtaining evidence in aid of proceedings in the EU is now governed by Council Regulation No 1206/2001/EC. Rhodia also submitted that the Court alternatively had jurisdiction to make the order through its general power of injunctive relief under s37(1) of the Senior Courts Act 1981. The Court again disagreed - to rely upon this general provision for interim relief would circumvent the specific restriction which Parliament has placed upon s25 of the 1982 Act.

Comment

Let go and be free....a lesson of Rhodia v Molycorp

In previous cases, the English Court has not shied away from adjudicating on patent infringement actions involving designations of a patent from another EU Member State, where the validity of those designations has not been challenged (see for example the Actavis v Lilly saga, reported previously on the IPKat here -  with one chapter of the saga pending before the Supreme Court). In the present case, Rhodia attempted to further extend the reach of the English Patents Court, by slicing and dicing the issues of infringement and validity of the German designation of the patent in its pleadings. However, the issue of jurisdiction over such patent infringement actions is ultimately a matter of substance, not form. By analogy, an alleged infringer wishing to establish jurisdiction for a declaration of non-infringement of a European designation of a patent in the English Courts must relinquish a challenge to validity of that designation to maintain jurisdiction in the English Courts."