Actavis Group PTC EHF & Anor v Boehringer Ingelheim Pharma GmbH & Co, KG

Boehringer Ingelheim have a patent EP (UK) 0 502 314. Claim 5 is to a compound known as telmisartan. Telmisartan is the active ingredient in a medicinal product sold by Boehringer Ingelheim called Micardis and, among other things, it is used in the treatment of hypertension.

Boehringer Ingelheim has an SPC under Regulation (EC) 469/2006 based on the patent and the marketing authorisation for Micardis. This SPC expires on 10th December 2013.

Boehringer Ingelheim also sells a combination product consisting of telmisartan and hydrochlorothiazide. Claim 12 of the patent covers that combination. Boehringer has a second SPC on this combination also based on EP '514. That combination SPC does not expire until 30th January 2017.

Actavis wish to sell a combination product, that is to say a combination of telmisartan and hydrochlorothiazide, but to do so would risk infringement of the combination SPC. Actavis contends that the combination SPC is invalid and this action is Actavis' action to clear the patent and the SPC out of the way before launch.

The parties are agreed that Actavis will give an interim undertaking not to sell the combination pending the resolution of this dispute. Boehringer Ingelheim gives a corresponding cross-undertaking.

The parties also agree that to decide this case requires the resolution of certain issues of European law. They agree that they need to be referred to the CJEU and they have substantially agreed the questions and statement of facts. Two minor points on these emerged at the hearing and they will be finalised very soon. Annexed to the approved copy of this judgment are the finalised versions of the questions and the statement of facts. The reference which they propose will also contain brief statements by each party of no more than three pages in length setting out their submissions on the issues.

There are two matters I have to decide this morning. First, the fact that the parties are agreed to refer questions to the CJEU at this stage before trial does not mean that I should necessarily do so. I need to decide if that is the right thing to do. Secondly, there is a dispute about the cross-undertaking which I need to resolve. I will deal first with the reference to the CJEU.

I will not introduce the questions or rehearse the statement of facts. The reader is referred to those which are annexed to this judgment. The questions which arise are in four groups. I am satisfied that they are all issues which properly arise in this case and which need to be resolved in order to decide this case.

It may assist the CJEU in dealing with this case if I state my preliminary view along the lines contemplated by paragraph 24 of the Recommendations of the CJEU (2012/C 338/01):

"24.

If it considers itself able to do so, the referring court or tribunal may, finally, briefly state its view on the answer to be given to the questions referred for a preliminary ruling. That information may be useful to the Court, particularly where it is called upon to give a preliminary ruling in an expedited or urgent procedure."

Question 1 relates to the fact that claim 12 of the patent was introduced as a result of an amendment. My preliminary view about Question 1 is the following. The system of amending patents is an integral part of the patent system. Part of that system includes the retrospective effect of amendments. Amendments are only permitted if they comply with the law. There is nothing untoward or unusual or "wrong" in a patentee amending a patent. It does not and should not matter where an amendment is made. If the amendment is a lawful amendment, then I can see no good reason why it matters from the point of view of the validity of an SPC when the amendment took place. Indeed in many cases it is necessary to amend a patent in order to cure an invalidity as a result of a trial and that may well happen years after the grant of an SPC.

Question 2 relates to the question of whether the combination product is protected by the amended patent. In that sense this is one of a series of cases dealing with the same general question which have already been the subject of the decision of the CJEU in Medeva v Comptroller-General of Patents, Designs and Trade Marks [2012] RPC 25 and were recently referred and heard by the CJEU in Actavis v Sanofi [2012] EWHC 2545.

The idea that a combination may need to embody a separate inventive advance was raised in the Sanofi case. If it is a relevant factor, then a trial of the case currently before me will need to be heard to determine that question. If it is not a relevant factor, then not. I will not add to the already substantial volume of text and learning on these questions by expressing a preliminary view about Question 2.

Question 3 relates to the particular element of the facts of this case whereby there already exists an SPC for telmisartan and the question is whether and to what extent this bears on the combination SPC. The issue clearly needs to be dealt with in this case. I will say only, in relation to the second part of Question 3 that refers to duration, that I would be surprised if there could be said to be any basis in the Regulation for giving an otherwise valid SPC a lesser term than it would otherwise be entitled to for this sort of reason.

Question 4 relates to how the application for this SPC proceeded through the IPO and the possible impact of the procedure adopted by the IPO in this case. Again I will refer the reader to the statement of facts. I will express a view on this. I can see nothing wrong with what the IPO did in this case and I can see no good reason why the procedure adopted by the IPO in this case should lead to any difficulty or any problem with the SPC which resulted.

I will now turn to consider whether I should refers these questions and the timing of any reference. I am satisfied that Question 2 in particular needs to be referred now before any time or cost is spent on the issue. It may well be that there will be no need to deal with the substantive issue at all. Since that question should be referred and since the other underlying facts are not in dispute, it makes sense to refer to all these questions now. Question 2 is the only one which may lead to a substantial factual trial in this matter. The other questions do not arise from disputed facts and there is no reason to wait in order to refer them.

The alternative might be to wait for a decision in the Actavis v Sanofi case but since some of the issues in this case will need to be addressed in any event, it seems to me there is no point in waiting and every reason to push on with this reference.

Furthermore, pending the reference, the position relating to the telmisartan and hydrochlorothiazide combination and therefore the market for it will be regulated by the interim undertaking from Actavis and the cross-undertaking from Boehringer Ingelheim. Such interim undertakings or interim injunctions should not be in place for longer than necessary. They are interim remedies and are no substitute for allowing the market to be in its proper state, either with the product off the market because it infringes a valid SPC or alternatively with Actavis' product on the market because it does not do so.

I am satisfied that is in the interests of justice and the parties in particular and makes the most cost-efficient use of court time to refer this matter now and I will do so.

The other issue I have to decide relates to the cross-undertaking. Actavis has offered an undertaking not to commence marketing of the combination product. However, as I have said, an issue arises about the appropriate form of the cross-undertaking to be offered by Boehringer Ingelheim.

Paragraph 5.1A of the Practice Direction to CPR Part 25, that is PD25A states:

"When the court makes an order for an injunction, it should consider whether to require an undertaking by the applicant to pay any damages sustained by a person other than the respondent, including another party to the proceedings or any other person who may suffer loss as a consequence of the order."

I should say that it is common ground and I agree that the fact that in this case I am not making an order for an injunction but accepting undertakings from the respondent does not make any difference. This Practice Direction plainly applies in both circumstances.

The cross-undertaking sought by Actavis is as follows:

"The Defendant undertakes that if the Court later finds that any of the undertakings set out at paragraph 2 of this Order have caused loss to the Claimants (or either of them) and/or any third party who applies under paragraph 4 of this Order and decides that the Claimants (or either of them) and/or any such third party should be compensated for that loss, the Defendant will comply with any Order the Court may make."

The cross-undertaking sought refers to paragraph 4 of an order which reads as follows:

"Following final judgment in this Action (i) any company within the Actavis group of companies and/or (ii) any customer or potential customer (which expressions shall include any person to whom the Claimants' telmisartan and hydrochlorothiazide product would have been supplied, whether directly or indirectly by the Claimants or any other company within the Actavis group of companies and including ultimate potential customers thereof, but for the interim undertakings given by the Claimants) (a 'Customer') of any company within the Actavis group of companies and/or (iii) any Customer of the First Claimant and/or Second Claimant may apply to the Court (upon notice to the Defendant) to claim the benefit of the cross-undertaking given in paragraph 3 of this Order, for any loss it may have suffered from as a result of the said undertakings for which the Court may conclude that the Defendant should compensate that party."

Boehringer submit that this is too wide. They submit that, in order for the court to consider whether to extend the cross-undertaking in this way, the court needs to be told who the people to whom the order would extend are and there is no such evidence.

Mr. Carr, who appears for Boehringer Ingelheim, also points out that Actavis must know what other Actavis companies are involved and he refers to the letter dated 29th April 2013 in which the solicitors for Actavis made it clear that the particular company which will be making the relevant sales in the UK was Actavis (UK) Limited, the second claimant, and he submits that, if that is right, there is no reason to extend the cross-undertaking any further.

Mr. Carr also submits that the wording of the order in paragraph 4 referring to customers or potential customers is unclear and may lead to potential further significant disputes.

Each side have referred to cross-undertakings accepted in other cases. Mr. Carr refers to one that was accepted in Leo v Sandoz which was as follows:

"If the Court later finds that the injunction in Paragraph 4 of this Order has caused loss to the Defendant and/or Lek Pharmaceuticals dd and/or Sandoz AG and decides that the Defendant and/or Lek Pharmaceuticals dd and/or Sandoz AG should be compensated for that loss, the Claimants will comply with any Order the Court may make."

However, as Mr. Carr rightly pointed out, there was no argument about that in that case or at least none that is recorded in any judgment which is available and so one does not know whether the point was even argued.

By the same token, Mr. Meade, who appears for Actavis, refers to cross-undertakings and orders which were made in the ConvaTec v Smith & Nephew litigation, in particular a cross-undertaking and an order made by Warren J on 12th November 2010 (that is action No. HC 10 C03618) and another cross-undertaking and order made by me as a Deputy Judge of the High Court on 8th December 2010 in the same case.

Mr. Meade is right to point out that the terms of the order I made on 8th December in the ConvaTec case are to all intents and purposes the same as the order he seeks in this case. I can say, however, that I have absolutely no recollection of making that order and I do not, in particular, remember whether there was any argument about it. As far as I have been able to tell, there was not and although the order does not recite that any parts of it were made by consent, I have a strong suspicion that both sides in that case were content with that particular element of the form of the order. So again, Mr. Meade, just like Mr. Carr, is not able to point to any decision dealing with these issues.

Mr. Meade submits that the orders sought are fair. He says in particular that, in relation to the Actavis Group, that is a certain class of persons who will be covered by the undertaking and setting the cross-undertaking up in this way avoids a problem which might otherwise arise with a cross-undertaking which may well last for a couple of years, for example, if there was a corporate restructuring in the Actavis Group, which leads to different companies who would otherwise have been involved in the sale or the production of the tablets to be sold in this case becoming companies which ought to be able to recover on the cross-undertaking.

Paragraph 5.1A of the practice direction was, I believe, inserted into the practice direction following the judgment of the Court of Appeal in SmithKline Beecham v. Apotex [2006] EWCA Civ 658, in particular, I suspect, following what Jacob LJ said in paragraph 29 of that judgment. Since then, as far as I am aware and as far as counsel and the solicitors instructing them have been able to show me, there has been no case dealing with the principles to be applied in the application of paragraph 5.1A.

In considering the matters which the Practice Direction requires, the court ultimately is undertaking the exercise of discretion with the aim of doing justice not just to the parties before the court, but generally. If a class can be identified at this stage for whom justice demands a cross-undertaking should cover before an injunction is ordered or an undertaking accepted, then the court should require the cross-undertaking to be drafted accordingly. For example, in the case of freezing orders, as I understand it, it is common practice and has been for many years that the cross-undertaking in question is drafted so as to extend to cover the expenses of persons, such as banks, which they might incur in complying with the order.

However, it seems to me that for the court to exercise this discretion, it needs to know, in some way at least, who the relevant persons are. They do need to be identified at least in some suitable way and also the court needs to know what may be the nature of the potential loss or harm which is said may potentially arise.

A cross-undertaking has been called the price of an injunction and, in the end, it seems to me that the person paying that price needs to know with reasonable certainty what it is. It could be, in a given case, that the price demanded would be too high. A party seeking an interim injunction, or accepting undertakings in lieu of an interim injunction, is entitled to be wary of an indeterminate and open-ended cross-undertaking in favour of persons unknown.

There are two classes covered by the draft: other companies in the Actavis Group and customers or potential customers. I will deal with them separately.

As far as other companies in the group are concerned, I am told on instructions by Mr. Meade that the Actavis Group will be buying the API (that is to say, the raw chemical ingredients) in from third parties and will then manufacture the tablets and sell them. It seems to me that it is unreal for the patentee (the defendant) to say that they need to know precisely which companies in the Actavis Group will be undertaking these tasks. The tasks in question are clear. I can understand, as Mr. Meade submits, that when an injunction of this kind has to last for a significant period of time, it is quite possible that a group such as the Actavis Group will undertake restructurings in such a way that it would mean that although today the Actavis Group knows who exactly is going to sell the product, in future the chain of companies which might be involved will change. It would be extremely inconvenient, and ultimately pointless, to require companies in the position of Actavis in this case to keep coming back to court every time they may or may not be involved in any kind of restructuring in order to reorganise the companies for whom the cross-undertaking of benefit. The reason I say that is because the patentee in this case knows that this cross-undertaking is a cross-undertaking in favour of the group who is going to sell the product in question. The nature of the loss that the group would rely on in any claim on the cross-undertaking is not going to change during the course of the action and the pendency of this undertaking and cross-undertaking. Accordingly, it seems to me that the concept underlying the language proposed by Actavis in this case is a fair and proper one and the language proposed achieves the desired objective. I will accept the order proposed by Mr. Meade in so far as it relates to companies in the Actavis Group. I should emphasise that it does mean, in my judgment, that the cross-undertaking is now being granted for the benefit of those companies even though they may not be identified until after judgment.

I will now deal with customers or potential customers. First of all, as Mr. Carr rightly points out, there are no customers for the combination product because the point of the undertaking is to stop sales before they have even starting. I recall, for what it is worth (and this is purely a matter of memory), that in ConvaTec actually the product in question may have already been launched and this undertaking was taking it off the market. As I say, that is a memory and it may not be right. So it is possible that in the ConvaTec case, the reference to customers made more sense than it would do in this cross-undertaking.

More importantly, however, Mr. Carr is right that the expression "potential customers" is extremely vague. As he pointed out, in recent years the Department of Health have often come to court in pharmaceutical interim injunction cases and sought the benefit of a cross-undertaking since the National Health Service will be paying the putative higher price for the drug in question while the interim injunction is in place. It seems to me, as Mr. Carr said, that whether or not the Department of Health wish to do that is a matter for them and I must say, I do not see why the court at this stage should grant an order with a vague description of a class of persons if it is really intended to cover one entity, the Department of Health. The Department of Health, if they wish to seek the benefit of this cross-undertaking, are well able to come to court and ask for it and I do not think I should make an order now that prejudges that question, even though I think it is highly likely that if they asked for it, they would be permitted to be covered by the cross-undertaking.

Accordingly, I will not allow the wording which refers to customers or potential customers. It does not seem to me to be right or fair, both in that, as I have already said and will repeat, the class of persons it will cover is too vague but also because the nature of the loss they may suffer is not clear to me. For those two reasons it would not be an appropriate exercise of my discretion in this case to make the order in those terms.

I should emphasise that it is always possible for a person who is not covered by a cross-undertaking in a case such as this to apply to the court and seek permission to be joined in to the proceedings, or at least to be joined in such a way as to take the benefit of the cross-undertaking, if they believe they are suffering loss caused by the interim injunction, but that is a matter that can be dealt with if and when it arises and at that point the court and the person giving the cross-undertaking will be in a position to see whether it is a right or fair thing to do and, from the point of view of the person giving the cross-undertaking, whether they are prepared to continue with the interim injunction on the new terms that would be required.

For all those reasons, I will make the order I have indicated.

Annexes

(a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim could this patent, whether or not such an amendment is made, be relied upon as a "basic patent in force" for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2006/EC ("the Regulation")?

For the purposes of determining whether the conditions in Article 3 are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B, where (i) the basic patent in force includes a claim to a product comprising active ingredient A and a further claim to a product comprising the combination of active ingredients A and B and (ii) there is already an SPC for a product comprising active ingredient A (“Product X”) is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone ?

Where the basic patent in force "protects" pursuant to Article 3(a):

If the answer to question 1(a) is in the negative and the answer to question 1(b)(i) is positive and the answer to question 1(b)(ii) is negative, then in circumstances where:

This dispute concerns the effects of a Supplementary Protection Certificate belonging to Boehringer Ingelheim Pharma GmbH & Co. KG ("Boehringer"). Boehringer owns SPC/GB99/014 (the "Telmisartan SPC") and also the SPC in dispute, SPC/GB02/037 ("the Combination SPC"). The product description of the Telmisartan SPC is "Telmisartan, optionally in the form of a pharmaceutically acceptable salt" and the product description of the Combination SPC is "Telmisartan, optionally in the form of a pharmaceutically acceptable salt, and hydrochlorothiazide". The dispute is about the validity of the Combination SPC.

For the purposes of Article 3(a) of Regulation (EEC) 1768/92 (since replaced by the codified version Regulation (EC) No 469/2009) ("the SPC Regulation"), the designated basic patent for both the Telmisartan SPC and the Combination SPC is European Patent (UK) 0 502 314 (the "Patent").

The European Patent Application for the Patent was filed on 31 January 1992, claiming priority from three German patent applications, DE 41 03 492 (filed on 6 February 1991), DE 41 171 21 (filed on 25 May 1991) and DE 41 378 12 (filed on 16 November 1991). The Patent was granted on 20 May 1998.

The Patent is entitled "Benzimidazol derivatives, medicaments containing them and process for their preparation". It discloses and claims numerous molecules one of which is telmisartan.

Claim 5 of the Patent is as follows: "4'-[[2-n-Propyl-4-methyl-6-(l-methylbenzimidazol-2-yl)-benzimidazol-l-yl]-methyl]-biphenyl-2-carboxylic acid and the salts thereof with inorganic or organic acids or bases". The chemical name for the carboxylic acid is telmisartan.

Claim 8 of the Patent is as follows: "Pharmaceutical compositions containing a compound according to at least one of the claims 1 to 6 or a physiologically acceptable salt according to claim 7 optionally together with one or more inert carriers and/or diluents".

On 19 November 2003, after Boehringer had applied for the Combination SPC (see paragraph 24 below), Boehringer applied to amend the Patent as granted by inserting new claim 12: "Pharmaceutical compositions as claimed in claim 8 containing one or more inert carriers and/or diluents and a further active substance selected from bendroflumethiazide, chlorothiazide, hydrochlorothiazide, spironolactone, benzothiazide, cyclothiazide, ethacrinic acid, furosemide, metoprolol, prazosine, atenolol, propranolol (di)hydralazine-hydrochloride, diltiazem, felodipin, nicardipin, nifedipin, nisoldipin and nitrendipin" (the "Application to Amend").

On 5 May 2004, the Application to Amend was published and it was granted by the UK IPO on 10 November 2004 (the "Amended Patent").

Consistent with Articles 105a and 68 of the European Patent Convention, Section 27 of the Patents Act 1977 provides that: “An amendment of a specification of a patent under this section shall have effect and be deemed always to have had effect from the grant of the patent.”

The Amended Patent expired on 30 January 2012.

On 16 December 1998 one of Boehringer’s group companies was granted a marketing authorisation in the Community for telmisartan, EU/1/98/089/001-010 (the "Telmisartan MA").

On 22 March 1999, Boehringer applied for the Telmisartan SPC designating the Patent as the basic patent for the purposes of Article 3(a) of the SPC Regulation and the Telmisartan MA as the first authorisation for the purposes of Article 3(b) of the SPC Regulation.

The scientific basis for the Telmisartan MA is summarised in the European Medicines Agency (“EMA”)’s European Public Assessment Report (“EPAR”) Scientific Discussion at the following link:

The Telmisartan SPC was granted by the UK IPO on 9 August 1999 with the product description shown on the SPC as "Telmisartan, optionally in the form of a pharmaceutically acceptable salt".

The Telmisartan SPC will expire on 10 December 2013.

Pursuant to 98/C 229/03 “Commission communication on the Community marketing authorisation procedures for medicinal products”, it was necessary that a separate marketing authorisation for the combination of telmisartan and hydrochlorothiazide be obtained before it could be marketed in the EU.

On 19 April 2002 one of Boehringer’s group companies was granted a marketing authorisation for the combination of telmisartan and hydrochlorothiazide (the "Combination Product"), EU/1/02/213/001-010 (the "Combination MA"). Boehringer sells the Combination Product under the brand name “MicardisPlus”.

The scientific basis for the Combination MA is summarised in the EMA EPAR Scientific Discussion at the following link:

The Applicant for the Combination MA presented a dossier to the EMA that consisted of the results of tests and trials with:

The Application for the Combination MA was made on the basis of Article 4.8 a) ii) of Council Directive 65/65/EEC that required the demonstration of well-established use of HCT, as required by Commission Directive 1999/83/EC.

The application for the Combination SPC was filed on 6 September 2002, within six months of the grant of the Combination MA, and was made on the basis of the Patent as granted.

On 10 July 2003 the UK Intellectual Property Office (the “UK IPO”) wrote to the applicant for the Combination SPC and stated inter alia as follows: “It is a requirement under Article 3(a) that the product for which a supplementary protection certificate is sought is protected by a basic patent in force. Thus, for example, in relation to certificates for products which comprise a combination of active ingredients, it is necessary for the combination to be clearly claimed in order for the combination to be considered to be so protected…The basic patent identified for the current application only contains claims which relate to one of the active ingredients of the product, the telmisartan component. It is therefore suggested that you apply to amend the basic patent under s.27 of the Patents Act 1977 to insert a claim to the combination of telmisartan and hydrochlorothiazide. Such amendment, if allowed, would result in the requirement of Article 3(a) being satisfied.”

On 10 November 2003 Boehringer requested that the Combination SPC application be suspended.

As described in paragraph 7 above on 19 November 2003, Boehringer applied to amend the Patent.

On 22 December 2003 the UK IPO agreed to suspend the Combination SPC application for 4 months pending the outcome of the Application to Amend.

On 14 May 2004 the UK IPO extended the suspension of the Combination SPC application until the completion of the Application to Amend.

As described in paragraph 8 above, on 10 November 2004 the UK IPO granted the Application to Amend.

On 18 November 2004 Boehringer wrote to the UK IPO requesting that the Combination SPC application be recommenced. The Combination SPC application was recommenced on the basis of the Amended Patent on or shortly after this date.

The date on which the Combination SPC application was recommenced was not within six months of the date on which the Combination MA was granted. However it was within six months of the grant of the application to amend the basic patent in force.

The Combination SPC was granted on 13 January 2005.

The Combination SPC is due to expire on 30 January 2017.

Telmisartan is an Angiotensin II Receptor Blocker. Angiotensin II Receptor Blockers operate on the renin angiotensin system by blocking AT receptors. This blocking mechanism opposes both the vaso-constricting action of angiotensin II and its stimulation of the release of aldosterone.

Telmisartan is used in the treatment of high blood pressure (hypertension) and reduction of cardiovascular morbidity in adults with (i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral arterial disease) or (ii) type 2 diabetes mellitus with documented target organ damage.

Telmisartan is the sole active ingredient in the medicines sold by Boehringer under the brand name Micardis®.

In the UK, Micardis® medicines are sold in the form of tablets containing 20mg, 40mg and 80mg of telmisartan.

HCT is a diuretic that acts by inhibiting the kidney's ability to retain water. Telmisartan in combination with HCT are the sole active ingredients in the medicines sold by Boehringer under the brand name MicardisPlus®.

In the UK, MicardisPlus® medicines are sold in the form of tablets containing 40mg of telmisartan and 12.5mg of HCT; 80mg of telmisartan and 12.5mg of HCT; and 80mg of telmisartan and 25mg of HCT.