COUNCIL REGULATION (EEC) NO. 1768/92 IN THE MATTER OF Application Nos. SPC/GB/96/030, SPC/GB/96/031, SPC/GB/96/032, SPC/GB/96/033, SPC/GB/96/034 and SPC/GB/96/035 in the name of Takeda Chemical Industries Limited DECISION The issues
Takeda Chemical Industries Limited (“the applicant”) filed six requests for the grant of aSupplementary Protection Certificate (“certificate”) on 28 August 1996. These requestswere given the application numbers SPC/GB/96/030, SPC/GB/96/031, SPC/GB/96/032,SPC/GB/96/033, SPC/GB/96/034 and SPC/GB/96/035, and sought protection for productscomprising three different combinations of active ingredients. Three of the requestsdesignated European patent no. 0174726 B1 (“EP 0174726”) and the other three requestsdesignated European patent no 0382489 B1 (“EP 0382489”). All six requests were basedon the same first authorisation in accordance with Directive 65/65/EEC to place a medicinalproduct on the market in the United Kingdom. It is easiest to show the relationshipbetween the requests, the combinations of active ingredients, the European patents and themarketing authorisation in tabular form.
Lansoprazole, Clarithromycin &Amoxycillin
Lansoprazole, Clarithromycin &Metronidazole
Lansoprazole, Amoxycillin &Metronidazole
Lansoprazole, Clarithromycin &Amoxycillin
Lansoprazole, Clarithromycin &Metronidazole
Lansoprazole, Amoxycillin &Metronidazole
After considering these requests, the examiner took the preliminary view that they shouldbe rejected on the grounds that they did not comply with the conditions of Article 3 ofCouncil Regulation (EEC) No. 1768/92 ("the Regulation"). In particular, the examiner'spreliminary view was based on non-compliance with the conditions of:
Article 3(a) of the Regulation, which requires the product to be protected bya basic patent in force;
Article 3(b) of the Regulation, which requires that a valid authorisation toplace the product on the market as a medicinal product has been granted inaccordance with Directive 65/65/EEC or Directive 81/851/EEC, asappropriate; and
Article 3(c) of the Regulation, which requires that the product has notalready been the subject of a certificate.
The applicant did not accept this view and the matter came before me at a hearing held on25 September 2001. Mr Daniel Alexander, instructed by the patent agents Elkington &Fife, appeared as Counsel for the applicant. Before the hearing I had the benefit of seeing askeleton argument provided by Mr Alexander and I thank him for this. The examiner,Mr Jason Bellia, also attended the hearing. Background
EP 0174726 relates to pyridine derivatives found to be useful as anti-ulcer agents. Claim 1of this patent defines a certain type of pyridine derivative by reference to a generalisedchemical structure. Lansoprazole is a specific embodiment of this pyridine derivative. On23 February 1994 a marketing authorisation was granted for a medicinal product which issold as Zoton (Registered Trade Mark) and which contains lansoprazole as the sole activeingredient, for the treatment of acid-related disorders of the upper gastro-intestinal tract. Subsequently, on the basis of EP 0174726 and this marketing authorisation, the applicantrequested and was granted a certificate for lansoprazole. This certificate was granted on23 September 1994 and will expire on 10 December 2005.
During the period running up to the launch of Zoton in the United Kingdom, the applicant,acting through its licensee, Wyeth, carried out further research. This research showed thatlansoprazole, in particular when used in combination with certain antibiotics, was effectivein the eradication of Helicobacter pylori. The antibiotics in question were clarithromycin,amoxycillin and metronidazole. On the back of this further research, a second patent(EP 0382489) was obtained. This patent also relates to a certain type of pyridine derivative,lansoprazole being one example, but because this derivative was already known in view ofthe earlier disclosure in EP 0174726, the claims were drafted in so called "Swiss-type" formwhich is used to protect second medical use inventions. In particular, the claims of thislater patent relate to the use of a certain type of pyridine derivative for preventing or treatinginfectious diseases caused by the microorganism belonging to Campylobacter pylori. Campylobacter pylori is nowadays usually referred to as Helicobacter pylori or H. pylorifor short. In 1995 the applicant, again acting through its licensee, Wyeth, applied
to vary the existing marketing authorisation for Zoton by adding the eradication of H. pylorias a new therapeutic indication for lansoprazole when used in combination with appropriateantibiotics. This variation of the existing marketing authorisation was allowed on28 February 1996 in the form of a "roll back" authorisation, by which I mean theauthorisation for the additional therapeutic indication was incorporated under the number ofthe original authorisation.
Although Zoton originally received marketing authorisation in February 1994,Mr Alexander explained at the hearing that it could not be marketed for the new therapeuticindication until an authorisation for the new indication was allowed in 1996. Thus,according to Mr Alexander, the applicant could not take advantage of EP 0382489 untilapproximately six years after its 6 February 1990 filing date. The six requests forcertificates, which lie at the heart of this case, were made in 1996 and are based on thevaried authorisation which was allowed in that year. Assessment The Medicinal Products Regulation and its underlying principles
It is convenient to consider each of the outstanding issues separately, beginning withcompliance with Article 3(a) of the Regulation before moving on to consider, in turn,compliance with Article 3(b) and Article 3(c). However, before I do so, I will set the sceneby looking at these and other relevant provisions of the Regulation, which are found inArticles 1 to 4.
"ARTICLE 1 Definitions
"medicinal product" means any substance or combination of substancespresented for treating or preventing disease in human beings or animals andany substance or combination of substances which may be administered tohuman beings or animals with a view to making a medical diagnosis or torestoring, correcting or modifying physiological functions in humans or inanimals;
"product" means the active ingredient or combination of active ingredients ofa medicinal product;
"basic patent" means a patent which protects a product defined in (b) assuch, a process to obtain a product or an application of a product, and whichis designated by its holder for the purpose of the procedure for grant of acertificate;
"certificate” means the supplementary protection certificate. ARTICLE 2
Any product protected by a patent in the territory of a Member State and subject,
prior to being placed on the market as a medicinal product, to an administrativeauthorization procedure as laid down in Council Directive 65/65/EEC or Directive81/851/EEC may, under the terms and conditions provided for in this Regulation, be thesubject of a certificate. ARTICLE 3 Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application
referred to in Article 7 is submitted and at the date of that application -
the product is protected by a basic patent in force;
a valid authorization to place the product on the market as a medicinalproduct has been granted in accordance with Directive 65/65/EEC orDirective 81/851/EEC, as appropriate;
the product has not already been the subject of a certificate;
the authorization referred to in (b) is the first authorisation to place theproduct on the market as a medicinal product. ARTICLE 4 Subject-matter of protection
Within the limits of the protection conferred by the basic patent, the protection
conferred by a certificate shall extend only to the product covered by the authorization toplace the corresponding medicinal product on the market and for any use of the product as amedicinal product that has been authorized before the expiry of the certificate.”
I am mindful that the Regulation is a Community instrument and as such I must take intoaccount the general principles underlying it when interpreting its provisions. In his skeletonMr Alexander stated that the text of the Regulation, including its recitals, the jurisprudenceof the European Court of Justice and the travaux preparatoires of this Regulation were allconsistent with an approach to the grant of certificates, which does not distinguish betweenthe kinds of research work, entitling an applicant to a certificate.
By way of support for his view Mr Alexander referred me to Recitals 2, 3 and 8 of theRegulation. I also think that Recital 9 has a bearing on the matters that I must consider. These recitals state (numbering supplied):
Whereas medicinal products, especially those that are the result of long,
costly research will not continue to be developed in the Community and in Europe unlessthey are covered by favourable rules that provide for sufficient protection to encourage suchresearch;"
Whereas at the moment the period that elapses between the filing of an
application for a patent for a new medicinal product and authorization to place themedicinal product on the market makes the period of effective protection under the patentinsufficient to cover the investment put into the research;"
Whereas the duration of the protection granted by the certificate should be
such as to provide adequate effective protection; whereas, for this purpose, the holder ofboth a patent and a certificate should be able to enjoy an overall maximum of fifteen yearsof exclusivity from the time the medicinal product in question first obtains authorization tobe placed on the market in the Community;"
Whereas all the interests at stake, including those of public health, in a sector
as complex and sensitive as the pharmaceutical sector must nevertheless be taken intoaccount, whereas, for this purpose, the certificate cannot be granted for a period exceedingfive years; whereas the protection granted should furthermore be strictly confined to theproduct which obtained authorization to be placed on the market as a medicinal product;”
I conclude from Recitals 2 and 3 that the purpose of the Regulation is to encourage researchby compensating for the period of patent protection eroded as a result of the time taken toget authorisation to market a medicinal product. I find support for this conclusion in DracoA.B.’s SPC Application  RPC 417, in which Jacob J described the purpose of theRegulation very succinctly at page 439:
"The scheme is not for the general protection of the fruits of research. It is tocompensate for lost time in the exploitation of inventions which are patented."
Recitals 8 and 9 reveal the operative policy behind the Regulation and these were alsoconsidered by Jacob J in Draco. Commenting on these recitals, he said at page 438(Jacob J’s emphasis):
“These are important. They reveal the operative policy. There is to be adequate effective protection. The period of exclusivity under the patent and SPC combined is a maximum of 15 years. This runs from the time the medicinal product in question first obtains authorisation. And the scope of protection is strictly confined to the product which obtained authorization etc. It will be noted that the two recitals use both the phrase medicinal product and product. Without more there could be ambiguity. This is because authorizations typically are not for active ingredients as such. They are much more tightly drawn,generally to dosage and formulation or presentation. That has to be so because theactual performance of an active ingredient depends on the matters in addition to theactive ingredient itself.”
After referring to the definitions in Article 1 of “medicinal product” and "product”, Jacob Jwent on to say:
“I have no doubt, nor do I think anyone else would have any doubt, that recitals 8 and 9 must be read as using these definitions. So strictly confined to the product which obtained authorisation means: strictly confined to the active ingredient of that which is presented for treatment.”
Thus, the compensation for the time lost in the exploitation of patented inventions should beby way of protection which is both adequate and effective This is achieved by providing fora period of exclusivity under the patent and certificate of up to 15 years and by restrictingthe scope of protection strictly to the active ingredient or combination of active ingredientsof a medicinal product which obtained marketing authorisation.
In Draco Jacob J focussed on the role of the marketing authorisation in confining the scopeof protection conferred by a certificate because this was the issue at the centre of that case. He did not therefore consider in any depth the role of the patent in the scheme ofsupplementary protection. However, from what I have already concluded on the purpose ofthe Regulation and its operative policy, it is clear that the protection conferred by acertificate for an active ingredient or a combination of active ingredients cannot go beyondthe protection conferred by the basic patent on that active ingredient or combination ofactive ingredients. In other words, a certificate cannot protect something that was notprotected by the basic patent or give something greater protection than was available for thatthing under the patent.
The definition of “basic patent” in Article 1(c) makes it clear that a patent, designated for acertificate, need not be restricted to one protecting a product as such but it may be a patentprotecting a process to obtain a product or an application of a product. Put another way andusing Mr Alexander's words, the basic patent may be one which protects a use of a productas defined in Article 1(b). This is consistent with the travaux preparatoires of theRegulation. In his skeleton Mr Alexander quoted paragraphs 12 and 29 of the ExplanatoryMemorandum which was presented by the Commission with their proposal for theRegulation in 1990. These paragraphs state:
However, the proposal is not confined to new products only. A newprocess for obtaining the product or a new application of the product may also beprotected by a certificate. All research, whatever the strategy or final result, must begiven sufficient protection.”The purpose of the expression “product protected by a patent” is tospecify what types of invention may serve as a basis for a certificate.The proposal does not provide for any exclusions. In other words, allpharmaceutical research, provided that it leads to a new invention that can bepatented, whether it concerns a new product, a new process for obtaining a new orknown product, a new application of a new or known product or a new combinationof substances containing a new or known product, must be encouraged, without anydiscrimination, and must be able to be given a supplementary certificate ofprotection provided that all of the conditions governing the application of theproposal for a Regulation are fulfilled.”
Thus, a certificate may be founded on a basic patent which protects a new therapeuticindication of an active ingredient or combination of active ingredients, provided that theother conditions of the Regulation are satisfied. One of these conditions, according toArticle 3(a), is that this basic patent must be in force on the date when the application for acertificate is made. There is also the condition of Article 3(b), which brings the marketingauthorisation into the scheme of supplementary protection in the way I have just considered. This leaves just one further condition which has relevance to this case, and that is thecondition of Article 3(c). Although Mr Alexander made various submissions to me on howI should view the law as it relates to Article 3(c), I do not believe I need consider them herefor reasons which will emerge later in this decision.
This then is the background which I should have in mind when considering the issues arisingunder Article 3(a) and (b) in this case. I can now move on the consider the first of theseissues. Is the product protected by a basic patent in force?
As indicated above, the examiner's preliminary view was that none of the requests compliedwith the condition of Article 3(a) of the Regulation that the product should be protected by abasic patent in force. The basic patent relied on for each request was clearly designated onthe relevant request form, lodged with the Patent Office on 28 August 1996, and in eachcase it was in force at that time. Each request form also identified the product as one of thecombinations of active ingredients specified in the table above. At the hearing I confirmedwith Mr Alexander that the products in question were in fact these specific combinations ofactive ingredients and not simply lansoprazole, so as to be absolutely certain that the Officeand the applicant had a common understanding on this matter.
Although the designated patents claim a certain type of pyridine derivative, such aslansoprazole, either in its own right or in the context of a Swiss-type claim, neither patentclaims or discloses the use of the pyridine derivative in combination with any other activeingredient. More particularly, there is no hint whatsoever in these patents that a derivative,such as lansoprazole, could be used in combination with two antibiotics chosen fromclarithromycin, amoxycillin and metronidazole. It is the absence of any such disclosure orany such hint that lay at the heart of the examiner's preliminary view that the productidentified in each of the requests was not protected by either of the designated basic patents. The applicant on the other hand took the view that EP 0174726 gives the right to preventothers from using lansoprazole, either alone or in combination with other active ingredients,and that EP 0382489 gives a similar right against others from using lansoprazole, eitheralone or in combination, in association with the treatment of infectious diseases caused by
H. pylori. Accordingly, in the applicant's opinion, the combinations of active ingredients areprotected by both patents. The applicant and the examiner in his preliminary view thereforehave a fundamentally different understanding about what "protected by" means in thecontext of the Regulation.
In his submission to me on the correct approach to take when determining whether or not aproduct is protected by a basic patent in force, Mr Alexander relied on the European Courtof Justice's judgment in Farmitalia Carlo Erba Srl’s Supplementary Protection CertificateApplication  RPC 580. In this case the European Court of Justice was faced with twoquestions, the second one of which was:
"According to which criteria is it to be determined whether the product is protectedby a basic patent within the meaning of Article 3(a), where the grant of a protectioncertificate is sought for the free base of an active ingredient including any of itssalts, but the basic patent in its patent claims mentions only the free base of thissubstance and, moreover, mentions only a single salt of this free base? Is thewording of the claim for the basic patent or the latter's scope of protection thedetermining criterion?"
Giving its answer to this question at page 585 the Court stated:
As Community law now stands, the provisions concerning patents have notyet been made the subject of harmonisation at Community level or of anapproximation of laws.Accordingly, in the absence of Community harmonisation of patent law, theextent of patent protection can be determined only in the light of the non-Communityrules which govern patents.As is clear in particular from paragraph 21 of this judgment, the protectionconferred by the certificate cannot exceed the scope of the protection conferred bythe basic patent.The answer to be given to the second question must therefore be that, inorder to determine, in connection with the application of Regulation 1768/92 and, inparticular, Article 3(a) thereof, whether a product is protected by a basic patent,reference must be made to the rules which govern that patent."
Thus, in its answer to the second question in Farmitalia, the Court said that it was necessaryto refer to the rules governing a patent to determine whether that patent protects a product. From this Mr Alexander construed that I must decide the present matter, arising underArticle 3(a) of the Regulation, on the basis of English law, more particularly on the basis ofthe Patents Act 1977 ("the Act"). In view of the Court's answer to the second question inFarmitalia I will proceed as suggested by Mr Alexander.
The concept of "protection" by a patent in English Law
At the hearing Mr Alexander opined that if you look at the concept of protection of a patentin English law, the conclusion you must reach is that protection is determined by the scopeof the claims as properly construed in the light of the specification, but primarily by askingthe question what, properly construed, falls within the scope of those claims. So far as this
goes, I would not disagree with Mr Alexander. However, I do not think that equating"protection" with "something falling within the scope of the claims" takes me any closer toanswering the question whether the present combinations of active ingredients are protectedby the designated patents in this case. I think it helps to clarify the concept of "protection"or "something falling within the scope of the claims" by looking at the function of claimsmore closely. In his skeleton Mr Alexander made the point that in English law the claimsare of special importance as was made clear by Robert Walker LJ in Cartonneries de ThulinSA v. CTP White Knight Ltd  RPC 107 when he quoted in paragraph 20 from LordRussell's speech in Electrical Musical Industries Ltd v. Lissen Ltd (1939) 56 RPC 23:
"The function of the claims is to define clearly and with precision the monopolyclaimed, so that others may know the exact boundaries of the area within which theywill be trespassers. Their primary object is to limit and not to extend the monopoly. What is not claimed is disclaimed. The claims must undoubtedly be read as part ofthe entire document, and not as a separate document; but the forbidden field must befound in the language of the claims and not elsewhere. It is not permissible, in myopinion, by reference to some language used in the earlier part of the specification,to change a claim which by its own language is a claim for one subject-matter into aclaim for another and a different subject-matter, which is what you do when youalter the boundaries of the forbidden territory."
and following on Robert Walker LJ quoted Lord Evershed M.R. in Rosedale AssociatedManufacturers v. Carlton Tyre Saving Co. Ltd  RPC 59 at page 69:
"It is no doubt true and has been well established (see, for example the speech ofLord Russell of Killowen in the EMI case) that you must construe the claimsaccording to their terms upon ordinary principles, and that it is not legitimate toconfine the scope of the claims by reference to some limitation which may be foundin the body of the specification but is not expressly or by proper inferencereproduced in the claims themselves. On the other hand, it is clearly no lesslegitimate and appropriate in approaching the construction of the claims to read thespecification as a whole. Thereby the necessary background is obtained and in somecases the meaning of the words used in the claims may be affected or defined bywhat is said in the body of the specification."
In his skeleton Mr Alexander also quoted from section 125 of the Act, which provides thestatutory basis for determining the extent of an invention in accordance with the guidanceprovided in Cartonneries de Thulin and other authorities. Section 125(1) provides:
For the purposes of this Act an invention for a patent for which an
application has been made or for which a patent has been granted shall, unless the
context otherwise requires, be taken to be that specified in a claim of thespecification of the application or patent, as the case may be, as interpreted by thedescription and any drawings contained in that specification, and the extent of theprotection conferred by a patent or application for a patent shall be determinedaccordingly."
Section 125(3) requires that The Protocol on the Interpretation of Article 69 of the EuropeanPatent Convention ("EPC") should apply for the purposes of section 125(1) as it applies forthe purposes of Article 69 EPC. This article, like section 125, provides rules fordetermining the extent of protection conferred by a patent or a patent application. TheProtocol provides:
"Article 69 should not be interpreted in the sense that the extent of the protectionconferred by a European patent is to be understood as that defined by the strict,literal meaning of the wording used in the claims, the description and drawing beingemployed only for the purpose of resolving an ambiguity found in the claims. Neither should it be interpreted in the sense that the claims serve only as a guidelineand that the actual protection conferred may extend to what, from a consideration ofthe description and drawings by a person skilled in the art, the patentee hascontemplated. On the contrary, it is to be interpreted as defining a position betweenthese extremes which combines a fair protection for the patentee with a reasonabledegree of certainty for third parties."
During the course of the hearing I explored with Mr Alexander the relevance of section 125and the Article 69 Protocol and especially the emphasis he placed on the references in bothto "the extent of the protection" conferred by a patent. Mr Alexander explained that in hisview what is of critical importance is the extent to which the claims of the relevant patent,which define the invention, read on to the subject matter which is sought to be protected bythe certificate. In his submission, the Regulation does not require consideration of thereason why any given product would infringe the patent, for example, by filleting theproduct in a particular way to identify particular aspects of it that would infringe. Compliance with Article 3(a) could be determined by asking the very simple question "doesit or does it not infringe?". If I accept, as I have done, Mr Alexander's submission that Ishould rely on English law to determine what in terms of the Regulation is protected by abasic patent, what this Regulation particularly requires or does not require on this matterdoes not help me. Nevertheless, it is worth considering the "does it or does it not infringe?"question postulated by Mr Alexander in the context of English law. The relevant provisionis found in section 60 of the Act, which concerns the meaning of infringement. Section 60begins:
“60.-(1) Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say-“
The references in this provision to “a patent for an invention” and “any of the followingthings . in relation to the invention” indicate, in my view, that the patent protects no
more and no less than the invention as construed by reference to the claims in accordancewith section 125. Thus, where there is a combination of things and only one of those thingsis identifiable with the invention of a patent, unauthorised use of the combination will resultin the one thing infringing the patent. However, the patent protects just this one thing. Theother things making up the combination have no bearing whatsoever on the question of
infringement because they are not identifiable with the invention and so are not protected bythe patent.
If I apply this view to the Regulation, I can only conclude that the product which is thesubject of a certificate, must be identifiable with the invention of the designated basic patent. I find support for this conclusion in the words of Jacob J when he commented in Draco onthe purpose of the Regulation:
“It is to compensate for lost time in the exploitation of inventions which are patented” (my emphasis).
This ties in with a statement in the Explanatory Memorandum for the Regulation, which is adocument that Mr Alexander urged me to consider when interpreting the provisions of theRegulation. Paragraph 29 of the Explanatory Memorandum states (again my emphasis):
"The purpose of the expression "product protected by a patent" is to specify what types of invention may serve as a basis for a certificate."
Do EP 0174726 and EP 0382489 protect the combination products?
Having concluded that the product “protected by” the basic patent has to be identifiable withthe invention of that patent, I can now apply this conclusion to the facts of this case. Ratherthan starting with the claims of EP 0174726 and EP 0382489 and construing them toidentify the inventions of each of these patents, I will take as my starting point the productsspecified in the requests and consider if they can be identified with the inventions of therespective patents when properly construed. This means considering whether any of thethree combinations of lansoprazole with two specific antibiotics, as shown in the table at thebeginning of this decision, are identifiable with the invention of EP 0174726 and whetherthe use of any of these combinations to treat H. pylori is identifiable with the invention ofEP 0382489. In his skeleton Mr Alexander stated:
In February 1994, the patentee's licencee, Wyeth, obtained a marketingauthorisation in the United Kingdom for the medicinal product sold under the tradename ZOTON ®, for the treatment of duodenal ulcer and oesophagitis. ZOTON ®contained, as active ingredient, lansoprazole, which was protected by the basicpatent EP(UK)174726. . .”
I agree with Mr Alexander that lansoprazole is protected by EP 0174726 because, as anembodiment of the invention of this patent, it is identifiable with the invention. Mr Alexander went on to state in his skeleton:
In the years running up to the launch of ZOTON ® in the United Kingdom,Takeda, acting through its licensee, Wyeth, carried out further research. Thisshowed that lansoprazole, in particular when used in combination with certainspecified antibiotics was also effective as a different treatment, namely theeradication of Helicobacter pylori (H. pylori). . .A second patent, EP(UK) 382 489, protects the use of lansoprazole in this
I agree with this as well. The use of lansoprazole for the manufacture of a medicament forpreventing or treating infectious diseases caused by the microorganism belonging toH. pylori is an embodiment of the invention of EP 0382489 and so is protected by thispatent. However, my difficulty comes when seeking to establish that combinations oflansoprazole with the specific antibiotics or the use of these combinations are identifiablewith the inventions of EP 0174726 and EP 0382489, respectively. Such combinations arenot claimed in these patents. EP 0174726 simply claims in its broadest aspects a pyridinederivative represented by a general formula, a method of making the derivative, and apharmaceutical composition comprising the derivative or its salt and a carrier, excipient ordiluent therefor. EP 0382489 claims in its broadest aspect the use of a pyridine derivativerepresented by a general formula or a pharmacologically acceptable salt thereof for themanufacture of a medicament for preventing or treating infectious diseases caused by themicroorganism belonging to Campylobacter pylori. As I have already stated, these patentsneither disclose nor suggest that the subject pyridine derivatives may be combined with anyother active ingredient, in particular with specific antibiotics. Against this background, I donot see that a combination of lansoprazole plus two of clarithromycin, amoxycillin ormetronidazole can be identified with the invention of either patent. Thus, I must rejectMr Alexander’s submissions on the question of compliance with Article 3(a) and find thatneither EP 0174726 nor EP 0382489 protects any of the products specified in the requestsfor supplementary protection.
In his skeleton Mr Alexander drew my attention to various certificates previously granted bythe Patent Office for combination products.
irbesartan / HCTZ granted: 21 December 1999
Referring to these certificates Mr Alexander made the point that in no case was there aspecific disclosure in the relevant basic patents of the combination of active ingredients,although in each case a combination was generically claimed. Since the hearing I haveconsidered the patents designated for these certificates in the light of Mr Alexander'scomments. EP(UK) 0012401 claims the related compounds lisinopril and enalopril. Thereis also a clear disclosure in the patent that compounds according to the invention, which
include the claimed lisinopril and enalopril, may be given in combination with otherdiuretics, such as hydrochlorothiazide (HCTZ). The other patent, EP(UK) 0454511, claimsirbesartan in association with a diuretic. The background to these three granted certificatesis therefore different from the current situation where the basic patents relied on contain noindication whatsoever that a compound of the invention, eg lansoprazole, might becombined with other active ingredients, let alone with a pair of specific antibiotics.
Therefore, I consider that these earlier, granted certificates should not influence my decisionin the present case. The Hässle case
Finally before I move on to consider the next issue raised by the examiner, I should saysomething about a case that was refused in Sweden in similar circumstances. During theprocessing of the present requests, the examiner dealing with them became aware of a casewhere the Swedish Patent and Registration Office had rejected an application in the name ofAB Hässle. This application was for supplementary protection for a combination of twoactive ingredients, namely felodipin and metoprolol. The grounds for rejection relied on bythe Swedish Office were that Article 1(c) and Article 3(a) were not satisfied because theproduct was not protected by the basic patent relied on by the applicant. At no point in thepatent claim or the general part of the description was there a mention or suggestion that anyactive compound in addition to felodipin would be contained in a pharmaceuticalpreparation. AB Hässle lodged an appeal against the rejection with the SupremeAdministrative Court in Sweden, and the examiner and the applicant in the present caseagreed to stay the proceedings on the present requests pending the outcome of this appeal. The Supreme Administrative Court delivered its judgment on 2 February 2000.
In this judgment the Supreme Administrative Court considered the distinction between onthe one hand a patent’s extent or scope of protection and on the other the rights the patentgives on the grounds that something - eg a product which consists of an active substance -falls within the scope of protection. In so doing the Court observed that:
“If a certain substance is covered by a patent (falls within the scope of itsprotection) in the sense that the substance is expressly referred to in the patent claimor is covered by a general definition of the invention therein, this circumstance may,by reason of the rules on infringement of patents, mean that the patent owner enjoysprotection not only against others making commercial use of the patent protectedsubstance as such but also against that substance being used in combination withany other active substance that is not covered by the patent. The rules oninfringement of patents may in other words entail protection against the use of acombination which is not in itself covered by the patent.The decision of the Patent Appeal Court is based on the understanding that thecondition in Article 3(a) implies that the product in question will be covered by thebasic patent (falls within the framework of the scope of its protection) in the sensejust stated. Where an application for supplementary protection relates to a productwhich consists of a combination of two active ingredients it is, according to thisunderstanding, a requirement that each of the ingredients in itself - or the combination as such - falls within the scope of protection. AB Hässle asserts for itspart that the condition is fulfilled whenever another’s use of the product comprisesinfringement of a basic patent which covers one of the ingredients. In the opinion ofthe Supreme Administrative Court there are wholly convincing reasons in favour ofthe former of the alternative interpretations. This alternative concurs with thecurrent terminology and may be regarded in a material respect as most consistentwith the purpose of the Regulation. The Supreme Administrative Court finds that thelegal situation, in so far as the question of interpretation at issue here is concerned,is so clear that there is no justification for requesting an interim ruling from the ECCourt on the matter.”
Thus, the judgment of the Swedish Administrative Court was that “protected by a basicpatent” in Article 3(a) of the Regulation means that the product must be covered by thepatent in the sense that the product is expressly referred to in a patent claim or is covered bya general definition of the invention in the patent.
In his submission to me Mr Alexander considered that I should not give this judgment of theSwedish Administrative Court any weight because, firstly, it relates to a law (ie Swedishlaw) which the European Court of Justice has said is not the right thing to be looking at forthe purposes of the present analysis; and, secondly, even if it were the right thing to belooking at, there are reservations that one may have on the analytical basis of this judgment,which does not appear to have taken account of the relevant authorities. As I have alreadyindicated, Mr Alexander’s view was that the approach of English law is the correct approachto take when determining what is protected by a patent giving rights in the United Kingdom. It is for this reason I have applied English law when considering whether the presentrequests satisfy the condition of Article 3(a) of the Regulation. In following this English lawapproach, I have nevertheless reached a similar conclusion to that of the SwedishAdministrative Court on the application of Article 3(a). Is there a valid authorisation to place the product on the market as a medicinal product?
I can now move on to consider whether the requests comply with Article 3(b) of theRegulation, which requires that a valid authorisation to place the product on the market as amedicinal product has been granted in accordance with Directive 65/65/EEC. Mr Alexanderreferred to two such authorisations at the hearing. The first was a UK MarketingAuthorisation (PL095/0264) which was varied with the agreement of the Medicines ControlAgency on 28 February 1996, and the second was a French Authorisation dated 9 February1996. It is important to be clear which of these authorisations is relevant to the condition ofArticle 3(b) of the Regulation. The chapeau to Article 3 states (with my emphasis):
“A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application -“
The application, referred to in Article 7, is the application for a certificate. It follows, whenconsidering Article 3 as a whole, that the authorisation to place a product on the market as amedicinal product, which is the subject of Article 3(b), must be one that has been granted
in the Member State in which the application is submitted. Thus in the present case, therequests for certificates were made in the United Kingdom and so the relevant authorisationfor the purposes of Article 3(b) must be the UK Marketing Authorisation. On this basis thecorresponding French authorisation referred to by Mr Alexander has no bearing onArticle 3(b) and I will restrict my considerations to the UK Authorisation.
At the hearing Mr Alexander drew my attention to a letter, dated 28 February 1996, from theUK Medicines Control Agency. In his view this letter varied the terms of the original 1994authorisation for lansoprazole by providing for an additional indication for lansoprazolewhen used in combination with appropriate antibiotics. Mr Alexander said that thisvariation amounted to an authorisation to place a combination of lansoprazole with theappropriate antibiotics on the market as a medicinal product. Following this authorisation itwas lawful to market the combination treatment, whereas before it was not lawful to do so. Mr Alexander stated that this fitted well with the aim of the Regulation to compensate forthe time when it is unlawful to market a product before an authorisation has been granted.
I have no reason to suppose that lansoprazole in combination with appropriate antibioticscould not be marketed lawfully for the eradication of H. pylori before the Medicines ControlAgency allowed the variation to the original authorisation. Moreover, I do not take issuewith documents filed by the applicant shortly before the hearing, which make clear thatZoton should not be used alone to treat H. pylori and therefore the combination of Zoton andappropriate antibiotics might be regarded as a new medicinal product. However, what Ihave to determine on the basis of the Regulation, and particularly on the basis ofArticle 3(b), is whether the varied authorisation was an authorisation to market acombination of Zoton and appropriate antibiotics as a medicinal product, or whether thevaried authorisation was merely an authorisation to market the previously authorisedmedicinal product (Zoton) for use with appropriate antibiotics as a new therapy.
In so far as the letter of 28 February 1996 from the Medicines Control Agency does not initself comprise a valid marketing authorisation, I have to look deeper. This creates a slightdifficulty for the purposes of explaining my reasoning in this decision because this letter aswell as a copy of the application to vary the original authorisation and a copy of thevariation, as agreed by the Medicines Control Agency, are all subject to a direction of theComptroller under rule 94(1) of the Patents Rules 1995 that they should be treated asconfidential. This direction was issued by the Comptroller in 1996 at the request of theapplicant who wanted to protect confidential technical information. However, no suchconstraints apply to the details of the varied authorisation as they were published in theLondon Gazette on 31 May 1996. These details are:
with the benefit of rapidsymptom relief. Also effectivein combination with antibioticsin the eradication ofHelicobacter pylori (H. pylori). Healing and long termmanagement of GastroOesophageal Reflux Disease(GORD). Healing andmaintenance therapy for patientswith duodenal ulcer. Healing ofbenign gastric ulcer. Alsoeffective in patients with benignpeptic lesions, including refluxoesophagitis, unresponsive toH2 receptor antagonists. Eradication of H. pylori from theupper gastrointestinal tract inpatients with duodenal ulcer orgastritis when used incombination with appropriateantibiotics. Prescription OnlyMedicine
I should explain that the Product Licence Number 00095/0312 was the number of theapplication made in 1995 for the use of Zoton capsules 30mg in the eradication of H. pylori. In the event this application was rolled back and kept the existing Product Licence Numberof 095/0264 for these Zoton capsules.
This extract from The London Gazette clearly indicates that the medicinal product is “ZotonCapsules 30mg” and that the relevant active ingredient is “Lansoprazole 30-000mg” . Thereis no suggestion whatsoever that the medicinal product includes appropriate antibiotics asactive ingredients. However, there are clear statements in the column headed “Indications”that Zoton is effective in combination with antibiotics in the eradication of H. pylori. Inthese respects, the extract from The London Gazette consistently reflects the content of thedocuments, particularly the application relating to the use of lansoprazole capsules in theeradication of H. pylori, treated as confidential. Thus, I am led to conclude that theauthorisation relied on to support the present requests is not an authorisation for a medicinalproduct comprising a combination of active ingredients, in particular a combination oflansoprazole and appropriate antibiotics.
Before I reach a final conclusion on this matter, I must consider Mr Alexander's point thatthe circumstances of the present case fitted well with the purpose of the Regulation to takeaccount of time lost when a medical product could not be marketed legally. However, it isclear from, for example, Article 4 of the Regulation that the purpose of the Regulation is notto compensate in every case for the lost time taken to obtain authorisation to market a
product. Article 4 provides that an existing certificate for a product shall protect any use ofthe product as a medicinal product that has been authorised before expiry of the certificate. Thus, it appears that a new use of a product, which has been authorised after a certificate hasbeen granted for that product, is protected by that certificate. Further compensation for theadditional time taken to obtain marketing approval for the new use is not envisaged by theRegulation. Mr Alexander sought to distinguish the situation envisaged in Article 4 fromthe present case by noting that what was authorised in the varied authorisation granted on28 February 1996 was not simply a new use for lansoprazole but a new combination ofactive ingredients, that is lansoprazole in combination with appropriate antibiotics, and thatthis new combination could not be marketed until the varied authorisation had been granted. In considering whether the Regulation was intended to deal with this situation in the wayMr Alexander suggested, I am drawn to Recital 9. In this recital there is the clearest ofpointers that to take account of all the interests at stake, the protection granted by thecertificate should be strictly confined to the product which obtained authorisation. Thus, if Iaccepted Mr Alexander's submission and agreed that a certificate could be granted for thecombination of active ingredients, including lansoprazole, it seems that this wouldundermine the purpose of the Regulation as expressed in Recital 9. On the other hand if Istand by my conclusion that the authorisation was simply for the use of Zoton withappropriate antibiotics for the eradication of H. pylori, this would be consistent with thepurpose of the Regulation in that, by virtue of Article 4 of the Regulation, protection for thisnew use seemingly would be available under the existing certificate for lansoprazole,
On the matter of Article 3(b) I therefore conclude that the varied marketing authorisationwhich was approved by the Medicines Control Agency on 28 February 1996, is not anauthorisation to place on the market a medicinal product comprising lansoprazole andappropriate antibiotics. It is merely an authorisation for the additional therapeutic indicationof the medicinal product, Zoton, for the eradication of H. pylori from the uppergastrointestinal tract in patients with duodenal ulcer or gastritis when used in combinationwith appropriate antibiotics. It follows that the condition of Article 3(b) is not satisfied forany of the requests. Has the product already been the subject of a certificate?
The final matter left for me to consider in this case is whether the requests comply withArticle 3(c) of the Regulation. In essence the examiner's preliminary view on this matterwas if it were accepted that EP 0174726 and EP 0382489 both protected the combination oflansoprazole, clarithromycin and amoxycillin, SPC/GB/96/030 and SPC/GB/96/033 couldnot both be granted for that combination. Likewise both of SPC/GB/96/031 andSPC/GB/96/033 could not be granted because they both relate to the same combination ofactive ingredients, and the same goes for SPC/GB/96/032 and SPC/GB/96/035. There wasalso a question whether further certificates could be based on EP 0174726 since this patenthad already been used to support the granted certificate for lansoprazole. However, I havefound that none of the six requests satisfy the conditions of Article 3(a) and 3(b) of theRegulation, and I see no need to consider also the position under Article 3(c).
the products identified in SPC/GB/96/030, SPC/GB/96/31 and SPC/GB/96/32 are not protected by EP 0174726;
the products identified in SPC/GB/96/033. SPC/GB/96/034 and SPC/GB96/035 arenot protected by EP 0382489; and
marketing authorisation PL095/0264 as varied on 28 February 1996 is not anauthorisation to place any of the products identified in SPC/GB/96/030 toSPC/GB/96/035 on the market as a medicinal product.
Therefore, in accordance with Article 10(2) of the Regulation, I reject all six requestsSPC/GB/96/030 to SPC/GB/96/035 on the grounds that none of them comply with theconditions of Article 3(a) and (b) of the Regulation. Opportunity to elect which requests should proceed
At the hearing Mr Alexander requested an opportunity to elect which of the six requests theapplicant might want to pursue if I found in the applicant's favour on the questions ofcompliance with Article 3(a) and (b) but I decided to refuse the requests for non-compliancewith Article 3(c). In the event, I have found against the applicant on Article 3(a) and (b) andit was my understanding at the hearing that Mr Alexander recognised that if this were theoutcome, there would be nothing the applicant could offer to address the situation. Therefore, I do not need to give the applicant the opportunity to withdraw certain requestsand to proceed with others.
This being a decision other than on a matter of procedure, any appeal against this decisionshall be filed within six weeks after the date of this decision. R J WALKER Deputy Director, acting for the Comptroller THE PATENT OFFICE
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