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England and Wales Court of Appeal (Civil Division) Decisions
You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Anor  EWCA Civ 646 (02 July 2009)
Cite as:  RPC 23, (2009) 109 BMLR 78, (2009) 32(9) IPD 32062,  EWCA Civ 646
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COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION (PATENTS COURT)
The Hon Mr Justice Kitchin
HC 07 C00988
Strand, London, WC2A 2LL
B e f o r e :
THE RT HON LORD JUSTICE JACOB
THE RT HON LORD JUSTICE LLOYD
| Generics (UK) Ltd
|- and -
|Daiichi Pharmaceutical Co Ltd
Daiichi Sankyo Co Ltd
for the Appellant/Claimant
Andrew Waugh QC and Thomas Hinchliffe (instructed by Herbert Smith LLP)
for the Respondents/Defendants
Hearing dates: 9/10 June 2009
Crown Copyright ©
Lord Justice Jacob (giving the first judgment at the invitation of Lord Justice Ward):
Validity of the Patent
The asterisk is by the chiral carbon atom.
i) By 1985 a number of quinolones were known. These included nalidixic acid (discovered in the late 50s), oxolinic acid (1966), cinoxacin, miloxacin, flumequine and pipemidic acid (1970s), norfloxacin (1979), perfloxacin (1979) enoxacin (1980), ofloxacin (1982), amifloxacin (early 1980s) and ciprofloxacin (1983).
ii) In 1985 this last compound, ciprofloxacin was seen to be the "class leader".
iii) The structures of quinolones varied – some were bi-cyclic and some tri-cyclic. You could put a wide variety of substituents onto the varied basic structures. Research was being done to find out if a better product resulted.
iv) In 1985 quinolones were seen as a field well worth researching further, the hunt being on for better molecules. "It was a time of excitement and optimism."
v) A particular reason for looking for new compounds was the avoidance of a compound to which bacteria had developed resistance.
 Overall, I think a relatively clear picture emerges. The quinolone field was unusual in that workers recognised the need for and perceived an opportunity to discover new chemical entities of ever greater efficacy. The discovery of norfloxacin, ofloxacin and ciprofloxacin put great pressure on researchers to identify new quinolones having even better bacterial profiles. It was here their energies were primarily directed. Hundreds of chemists were making new compounds each year and, not surprisingly, they would opt not to make a compound if its synthesis was difficult. Compounds which were difficult to make would get a low priority in the laboratory. This was not an environment conducive to the investigation of stereochemistry. Resolution of a racemate might result in a twofold increase in activity, at best, and it could be a good deal worse. It was quite possible that activity might lie more in one enantiomer than the other, but not greatly so. Moreover, resolution might prove very difficult to achieve. As a result, for many chemists, including those at Sterling-Winthrop, I am satisfied that resolution of racemates was something that would simply not have occurred to them at all. For others, it plainly did. But it was not a routine path to follow and, for the ordinary chemist, I believe it was something which he might well not have considered and, if he did, then it would not have been a high priority, absent some particular reason for doing so.
 … It must be remembered that flumequine had been known since 1973 and was recognised as an important advance as of that time. However, by 1985, its properties were considered unexceptional and it had made only limited progress as a human therapeutic. Consequently it was no longer an influential compound.
At  the Judge said he preferred that view to that of GUK's expert, Dr Spargo – perhaps hardly surprising since Dr Spargo was not only not in the quinolone field at the time (he was just completing his PhD) but he never became a quinolone man later, whereas Prof Wentland was, both in 1985 and thereafter, such a man.
flumequine and ofloxacin were different compounds and that the medicinal chemist could not take information from one to the other 
all the experts agreed that the obvious starting point would have been ofloxacin itself. Dr Spargo accepted this would have been the skilled person's 'first port of call'. Dr Newton agreed with Professor Davies that if the final product was available and could be made then typically the skilled person would try and resolve that first.
It was not GUK's case that resolution from the final product could be readily achieved. So the skilled man would find, on investigation, that the "first port of call" was closed to him.
 … Weighing the evidence as a whole against the background of the common general knowledge, I have reached the conclusion that by 1985 the skilled person would have been aware of the particular promise of ofloxacin as a pharmaceutical and its chiral nature. It was possible one enantiomer might have more activity than the other and that it would retain the other beneficial qualities of the racemate. Accordingly I believe he would have considered it worthwhile exploring whether ofloxacin could be resolved, but only to a point. I do not believe it was a goal that it was obvious to pursue relentlessly. The benefit in terms of activity might be relatively limited and it would have been recognised that resolution might be difficult or impossible to achieve. Moreover, the pharmacokinetics of a more active enantiomer would be unlikely to be better than those of the racemate and it might well be more toxic. It would also be susceptible to the development of resistance. By contrast, new molecules had the potential to be a good deal more active than ofloxacin and ciprofloxacin and I am satisfied the primary goal of those in the industry was to find them. Accordingly, I think it was obvious to investigate whether the enantiomers of ofloxacin could be separated relatively easily. If they could not, then I believe the skilled person would have redirected his efforts elsewhere, just as Professor Wentland explained workers would tend to avoid molecules they thought would be difficult to make. There were many other, potentially much more fruitful, avenues to explore.
The law of obviousness
(1) (a) Identify the notional "person skilled in the art".
(b) Identify the relevant common general knowledge of that person.
(2) Identify the inventive concept of the claim in question or, if that cannot readily be done, construe it.
(3) Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed.
(4) Ask whether, when viewed without any knowledge of the alleged invention as claimed; do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?
"In the Court of Appeal, Jacob LJ dealt comprehensively with the question of when an invention could be considered obvious on the ground that it was obvious to try. He correctly summarised the authorities, starting with the judgment of Diplock LJ in Johns-Manville Corporation's Patent  RPC 479, by saying that the notion of something being obvious to try was useful only in a case in which there was a fair expectation of success. How much of an expectation would be needed depended upon the particular facts of the case. As Kitchin J said in Generics (UK) Ltd v H Lundbeck A/S  RPC 32 , para 72:
"The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.""
"Secondly, if a particular route is an obvious one to take or try, it is not rendered any less obvious from a technical point of view merely because there are a number, and perhaps a large number, of other obvious routes as well. If a number of obvious routes exist it is more or less inevitable that a skilled worker will try some before others. The order in which he chooses to try them may depend on factors such as the ease and speed with which they can be tried, the availability of testing equipment, the costs involved and the commercial interests of his employer. There is no rule of law or logic which says that only the option which is likely to be tried first or second is to be treated as obvious for the purpose of patent legislation."
That is of course uncontroversial – but it does not mean that a skilled man will pursue every avenue relentlessly when he has only the mildest of motives for doing so. The important point is that this passage only comes into play when "a particular route is an obvious one to take or try." And it is only obvious to try when there is at least a fair expectation of success. Moreover it has to be a route which would at least occur to the skilled person – a point of particular relevance here.
The law as to the common general knowledge of the person skilled in the art
"It has never been easy to differentiate between common general knowledge and that which is known by some. It has become particularly difficult with the modern ability to circulate and retrieve information. Employees of some companies, with the use of libraries and patent departments, will become aware of information soon after it is published in a whole variety of documents; whereas others, without such advantages, may never do so until that information is accepted generally and put into practice. The notional skilled addressee is the ordinary man who may not have the advantages that some employees of large companies may have. The information in a patent specification is addressed to such a man and must contain sufficient details for him to understand and apply the invention. It will only lack an inventive step if it is obvious to such a man.
It follows that evidence that a fact is known or even well-known to a witness does not establish that that fact forms part of the common general knowledge. Neither does it follow that it will form part of the common general knowledge if it is recorded in a document. As stated by the Court of Appeal in General Tire & Rubber Co. v. Firestone Tyre & Rubber Co. Ltd.  R.P.C. 457, at page 482, line 33:
'The two classes of documents which call for consideration in relation to common general knowledge in the instant case were individual patent specifications and widely read publications'. As to the former, it is clear that individual patent specifications and their contents do not normally form part of the relevant common general knowledge, though there may be specifications which are so well known amongst those versed in the art that upon evidence of that state of affairs they form part of such knowledge, and also there may occasionally be particular industries (such as that of colour photography) in which the evidence may show that all specifications form part of the relevant knowledge'.
As regards scientific papers generally, it was said by Luxmoore J. in British Acoustic Films (53 R.P.C. 221 at 250):
'In my judgment it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.'"
"The common general knowledge is the technical background to the notional man in the art against which the prior art must be considered. This is not limited to material he has memorised and has at the front of his mind. It includes all that material in the field he is working in which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art. This does not mean that everything on the shelf which is capable of being referred to without difficulty is common general knowledge nor does it mean that every word in a common text book is either. In the case of standard textbooks, it is likely that all or most of the main text will be common general knowledge. In many cases common general knowledge will include or be reflected in readily available trade literature which a man in the art would be expected to have at his elbow and regard as basic reliable information. In this case, for example, the general technical discussion of conductive polymers in the Cabot technical report was common general knowledge well before the priority date. So too would be the general teaching in the leading articles and textbooks on the subject".
" It seems to me that a subtle but potentially significant point of principle emerges from these passages. I can readily accept that, faced with a disclosure which forms part of the state of the art, it may be obvious for the skilled person to seek to acquire further information before he embarks on the problem to which the patent provides a solution. But that does not make all such information part of the common general knowledge. The distinction is a fine one but it may be important. If information is part of the common general knowledge then it forms part of the stock of knowledge which will inform and guide the skilled person's approach to the problem from the outset. It may, for example, affect the steps it will be obvious for him to take, including the nature and extent of any literature search".
Principles about obviousness on appeal
"The need for appellate caution in reversing the judge's evaluation of the facts is based upon much more solid grounds than professional courtesy. It is because specific findings of fact, even by the most meticulous judge, are inherently an incomplete statement of the impression which was made upon him by the primary evidence. His expressed findings are always surrounded by a penumbra of imprecision as to emphasis, relative weight, minor qualification and nuance (as Renan said, la vérité est dans une nuance), of which time and language do not permit exact expression, but which may play an important part in the judge's overall evaluation. It would in my view be wrong to treat Benmax as authorising or requiring an appellate court to undertake a de novo evaluation of the facts in all cases in which no question of the credibility of witnesses is involved. Where the application of a legal standard such negligence or obviousness involves no question of principle but is simply a matter of degree, an appellate court should be very cautious in differing from the judge's evaluation".
The Obviousness Case
 Gerster I explains that the Riker group designed the tricyclic structure of flumequine to study how bacterial activity would be affected by restricting the free rotation of the N-ethyl group present in many of the quinolones under development at the time. They noted that an asymmetric centre was created and explained that they had succeeded in preparing both optical isomers. They found that one isomer had potent antibacterial activity and the other only very weak activity. They also prepared the simpler desmethyl achiral analogue and showed that it had less antibacterial activity than flumequine but was more active than the weakly active isomer.
 Weighing this evidence and taking care to avoid the dangers of hindsight as I must, I prefer the evidence of Professor Wentland and Professor Davis. Consequently I do not consider Gerster I would have rendered it obvious to the skilled person to take any step it would not already have been obvious for him to take in the light of his knowledge of ofloxacin. As I have found, by 1985 he would have been aware that ofloxacin had a chiral centre and comprised two enantiomers. He would also have appreciated that the activity of the two enantiomers might be different and that theoretically all of the activity might lie in one rather than the other. It would also have been apparent to him that there are significant structural differences between flumequine and ofloxacin and that their overall activities are very different, with ofloxacin being a markedly superior molecule. I conclude that these structural differences and the lack of any clear understanding of how the molecules bind to the gyrase target would have rendered it impossible to make a prediction as to the behaviour of the ofloxacin enantiomers on the basis of Gerster I, and the disclosure would not have rendered it obvious to take any step in relation to ofloxacin. Moreover, Gerster I provides no assistance as to how the enantiomers of ofloxacin might be resolved. Accordingly, the allegation of obviousness over Gerster I fails just as it did over the Daiichi publications.
In Gerster IP the intermediate for flumequine is resolved. The resolved enantiomers are each then used to make the enantiomers of flumequine to be made. There is no re-racemisation. So, it is said, the skilled person wanting to obtain the enantiomers of ofloxacin, would consider the same method of resolution, using the same agent, for the intermediate of ofloxacin. And if he tried that he would find that it worked – it is indeed process C of the patent in suit.
 To summarise my conclusions thus far: flumequine was not an influential compound by 1985 and I do not believe that information about its enantiomers disclosed in a poster from 1982 would have been of any real interest to those seeking to develop an improved quinolone some three years later. Further, the significant structural differences and the lack of any clear understanding of how the molecules bind to the gyrase target would have rendered it impossible to make a prediction as to the behaviour of the enantiomers of ofloxacin. Against this background, I must consider whether it would have been obvious to the skilled person to apply the method of resolution described in Gerster IP to ofloxacin. I think the following further matters are relevant. First, on reading the method the skilled person would have seen that an unusual derivatising agent was used, namely N-tosyl-L-prolyl chloride. Second, he would have seen it was reacted with an intermediate, which, on the evidence, is not the first approach the skilled person would take to resolution, which is to seek to resolve the final racemate by making diastereomeric salts. Third, GUK's case depends upon the skilled person recognising the similarities between 6FTHQ and intermediate (V) in Drugs of the Future. Whilst I accept that the skilled person could find out the method of making ofloxacin in 1985 without undue effort, I am not satisfied that he would have known that method as part of his common general knowledge. Accordingly, it is not established on the evidence how the skilled person would ever have come to compare 6FTHQ and intermediate (V). Fourth, even if the skilled person did come to compare the method of resolving flumequine with the method of making ofloxacin and noticed the similarity between 6FTHQ and intermediate (V), he would also have noticed the differences. As Professor Davies explained, both are anilines which means that the nitrogen to which the resolving agent is to be attached is a poor nucleophile and the position is made worse in the case of intermediate (V) by the presence of the additional oxygen and fluorine atoms. As he maintained under cross examination, it might or might not work and the skilled person would be faced with a huge choice of reactions to try. Moreover, there were other reactions staring the skilled worker in the face, namely those involving diastereomeric salts. Dr Spargo was much more enthusiastic. He thought the skilled person would regard Gerster IP as a strong encouragement, would have every reason to think N-tosyl-L-prolyl chloride would work with intermediate (V) and would give it a try as a reasonable reaction. I should also mention that GUK relied on the fact that Dr Hayakawa apparently made the invention after seeing Gerster II, which provides similar teaching in relation to the flumequine analogue S-25930 which differs in the presence of an extra methyl group.
The SPC Point
i) Daiichi filed the application for the '005 patent on 28 August 1981, the application was published on 10 March 1982 and the patent was granted on 14 November 1984.
ii) On 31 May 1985, German marketing authorisations were granted in respect of ofloxacin. Under the heading "wirksamer Bestandteil" (active ingredient) the licence details say "Ofloxacin".
iii) On 20 June 1986, Daiichi filed the application for the patent in suit.
iv) On 16 March 1990, UK marketing authorisations were granted in respect of ofloxacin. Under the heading "Active Constituents" the licence details say "Ofloxacin"
v) On 27 January 1993, the Patent was granted.
vi) On 6 June 1997, UK marketing authorisations were granted in respect of levofloxacin.
vii) On 23 October 1997, Daiichi lodged the application for the SPC, identifying the Patent as the basic patent, levofloxacin as the product and the 1997 UK marketing authorisation in respect of levofloxacin as the first authorisations to place the product on the market. It was duly granted on 13 July 1998.
viii) The Patent expired on 20 June 2006. The SPC is due to expire on 19 June 2011.
ix) At all material times a skilled man would have appreciated that ofloxacin was a racemate.
x) But until the patent in suit he would not have known:
i) how to make its enantiomers,
ii) whether the biological activity (as regards effectiveness or toxicity) of ofloxacin was due solely to one enantiomer or the other (and if so which) or was due to both of them in varying degrees, or was in part or wholly due to a synergistic effect between the enantiomers. He would expect that one enantiomer alone would be markedly different in biological activity from the other.
xi) From the patent in suit he would know that by far the most active ingredient was levofloxacin (by 10 to 100 times), that the other enantiomer (the R(+)) was not wholly inactive, that levofloxacin was not only much more soluble than ofloxacin but that it was less toxic and that the toxicity of ofloxacin is mainly due to the R(+)enantiomer. In short he would learn that levofloxacin was a superior medicine to ofloxacin: it could be given in larger doses, which matters a lot for an antimicrobial.
 … Protection is to be afforded to a product which is protected by a basic patent, has a marketing authorisation as a medicinal product and has not already been the subject of an authorisation or certificate. Protection is conferred for a maximum period of 15 years from the date of the first authorisation, including the life of the basic patent.
(1) ofloxacin is "a medicinal product" within the meaning of Art. 1(a);
(2) levofloxacin is the, or at least an, active ingredient within ofloxacin.
(3) So it is a 'product' as defined by Art. 1(b);
(4) Patent '005 claimed the chemical compound by its structure irrespective of chirality – so its claim extended not only to the racemate but to the component enantiomers in any proportions, including 100% of one or other of them. It thus claimed levofloxacin.
(5) So levofloxacin was protected by a "basic patent", i.e. '005;
(6) The first authorization to place on the market the product as defined by the Regulation was thus the 1990 (or 1985) authorisation, not the 1997 authorisation.
19. By the first part of Question 1, the national court is essentially seeking a definition of the concept of a product within the meaning of Article 3 of Regulation No 1610/96.
20. It must be noted that, according to Article 1(8) of Regulation No 1610/96, a product means the active substance as defined in Article 1(3) or combination of active substances of a plant protection product.
21. Under Article 1(3) of that regulation, active substances are inter alia substances having general or specific action against harmful organisms or on plants, parts of plants or plant products.
22. Under Article 1(2) of that regulation, substances are defined as chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process.
23. It follows from points 2, 3 and 8 of Article 1 of Regulation No 1610/96, taken together, that the concept of a product covers chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process, which have general or specific action against harmful organisms or on plants, parts of plants or plant products.
24. Article 3 of Regulation No 1610/96, which lays down the conditions for obtaining an SPC, is based on the concept of a product. There is no indication that that concept differs from that of a product as defined in Article 1 of the regulation for the purposes of that same regulation.
25. The answer to the first part of Question 1 must therefore be that the concept of a product within the meaning of Article 3 of Regulation No 1610/96 covers chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process, which have general or specific action against harmful organisms or on plants, parts of plants or plant products.
The second part of Question 1
26. By the second part of Question 1, the national court is essentially asking whether two products which differ only in the proportion of the active chemical compound to the impurity they contain, one having a greater percentage of the impurity than the other, must be regarded as the same product within the meaning of Article 3 of Regulation No 1610/96.
27. It follows from the answer to the first part of Question 1 that two products which are constituted of the same chemical compound having the same general or specific action against harmful organisms or on plants, parts of plants or plant products, and including any impurity inevitably resulting from the manufacturing process, must be regarded as identical.
28. It is therefore apparent that a product may be identified by its chemical compound and its action on the targets mentioned in the preceding paragraph, whatever the impurities it contains. A fortiori, the nature of a product cannot change solely because of an alteration in the unit quantity of impurities where both the chemical compound it contains and that compound's action on its targets remain unchanged.
29. The answer to the second part of Question 1 must therefore be that two products which differ only in the proportion of the active chemical compound to the impurity they contain, one having a greater percentage of the impurity than the other, must be regarded as the same product within the meaning of Article 3 of Regulation No 1610/96.
1. Does the concept of "combination of active ingredients of a medicinal product" within the meaning of Article 1(b) of Regulation [No 1768/92] mean that the components of the combination must all be active ingredients with a therapeutic effect?
2. Is there a "combination of active ingredients of a medicinal product" also where a combination of substances comprises two components of which one component is a known substance with a therapeutic effect for a specific indication and the other component renders possible a pharmaceutical form of the medicinal product that brings about a changed efficacy of the medicinal product for this indication (in vivo implantation with controlled release of the active ingredient to avoid toxic effects)?'
18. In this case, it is important to note that it is common ground, as the file in this case shows, that the expression 'active ingredient' is generally accepted in pharmacology not to include substances forming part of a medicinal product which do not have an effect of their own on the human or animal body.
19 In that regard, attention must be drawn to the fact that in point 11 of the Explanatory Memorandum to the Proposal for a Council Regulation (EEC), of 11 April 1990, concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final), to which the French Government referred in its oral observations, it is specified that '[t]he proposal for a Regulation therefore concerns only new medicinal products. It does not involve granting a [SPC] for all medicinal products that are authorised to be placed on the market. Only one [SPC] may be granted for any one product, a product being understood to mean an active substance in the strict sense. Minor changes to the medicinal product such as a new dose, the use of a different salt or ester or a different pharmaceutical form will not lead to the issue of a new [SPC].'
20 Therefore, the definition of 'product' in Article 1(b) of Regulation No 1768/92 does not in any way conflict with that referred to by the Commission in point 11 of that explanatory memorandum.
21 In fact, it is apparent from that memorandum that the pharmaceutical form of the medicinal product, to which an excipient may contribute, as noted by the Advocate General in point 11 of his Opinion and the French Government at the hearing, does not form part of the definition of 'product', which is understood to mean an 'active substance' or 'active ingredient' in the strict sense.
And he pointed to the Court's endorsement of policy by reference to the plant protection Regulation:
23. In this connection, in point 68 of the Explanatory Memorandum to the Proposal for a European Parliament and Council Regulation (EC), of 9 December 1994, concerning the creation of a supplementary protection certificate for plant protection products (COM(94) 579 final), it is stated that:
– it would not be acceptable, in view of the balance required between the interests concerned, for the total duration of protection granted by the SPC and the patent for one and the same product to be exceeded;
– that might be the case if one and the same product were able to be the subject of several successive SPCs;
– that calls for a strict definition of the product;
– if an SPC has already been granted for the active substance itself, a new SPC may not be granted for that substance, whatever changes may have been made regarding other features of the plant protection product (use of a different salt, different excipients, different presentation, etc.);
– in conclusion, it should be noted that, although one and the same substance may be the subject of several patents and several marketing authorisations in one and the same Member State, the SPC will be granted for that substance only on the basis of a single patent and a single authorisation, namely the first granted in the Member State concerned.
24 Thus, the first sentence of Article 3(2) of Regulation No 1610/96 itself provides that the holder of more than one patent for the same product is not to be granted more than one SPC for that product. As set out in recital 17 in the preamble to that regulation, the detailed rules in Article 3(2) thereof, in particular, are also valid, mutatis mutandis, for the interpretation of Article 3 of Regulation No 1768/92.
Although it is not mentioned anywhere in the basic patent (DE 28 12 571 C2) that the claimed compounds are present in the form of optical isomers, i.e., as R and S enantiomers, the structural formula of a compound with one asymmetrically substituted carbon atom is sufficient for the skilled person to easily recognise that he is dealing with optical antipodes, the R and the S form, and that the standard preparation process results in the racemate while the two enantiomers can be separated by standard methods. Thus, the racemate but also the two not expressly disclosed isomeric forms are protected by the basic patent pending according to formula I Y=H, Z1=C4-Alkoxy group, …
Thus, the marketing authorisations for fluazifop-butyl and fluazifop-P-butyl both concern mixtures of the same two active substances and, therefore, even from this perspective concern the same product in the sense of Regulation (EC) 1610/96. If it was possible to grant a protection certificate for the basic patent also on basis of the 1984 authorisation for fluazifop-butyl, the protection certificate, in accordance with consideration (13) of the Regulation, would protect not only the racemate but also the two enantiomers as such or in any mixing ratios. Any grant of a further protection certificate based on a later authorisation for the R enantiomer would no longer be possible in view of Art. 3c) Regulation unless that form was the subject matter of a separate patent wherein it is specifically claimed (cf. consideration (14) of the Regulation). However, this is obviously not the case with fluazifop-P-butyl, nor has this been asserted.
The research leading to the Turbohaler was formulation research. I see nothing indicating that formulation research (unless of course it warrants its own patent) is to be protected by the SPC scheme. The scheme is not for the general protection of the fruits of research. It is to compensate for lost time in the exploitation of inventions which are patented.
I do not resile from this view, which indeed seems to me the only possible and rational view of this EU legislation. I think the point is acte claire.
Provisions of the Medicinal Products Regulation 1768/92
Recitals (with numbering added):
(1) Whereas pharmaceutical research plays a decisive role in the continuing improvement in public health;
(2) 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 unless they are covered by favourable rules that provide for sufficient protection to encourage such research;
(3) 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 the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research;
(4) Whereas this situation leads to a lack of protection which penalizes pharmaceutical research;
(5) Whereas the current situation is creating the risk of research centres situated in the Member States relocating to countries that already offer greater protection;
(8) 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 of both a patent and a certificate should be able to enjoy an overall maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains authorization to be placed on the market in the Community;
(9) 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 into account; whereas, for this purpose, the certificate cannot be granted for a period exceeding five years; whereas the protection granted should furthermore be strictly confined to the product which obtained authorization to be placed on the market as a medicinal product;
For the purposes of this Regulation:
(a) 'medicinal product' means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) 'product' means the active ingredient or combination of active ingredients of a medicinal product;
(c) 'basic patent' means a patent which protects a product as defined in (b) as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
(d) 'certificate' means the supplementary protection 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:
(a) the product is protected by a basic patent in force;
(b) a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product."
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 to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate.
Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community reduced by a period of five years.
2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.
Provisions of the Plant Protection Regulation 1610/96
(13) Whereas the certificate confers the same rights as those conferred by the basic patent; whereas, consequently, where the basic patent covers an active substance and its various derivatives (salts and esters), the certificate confers the same protection;
(14) Whereas the issue of a certificate for a product consisting of an active substance does not prejudice the issue of other certificates for derivatives (salts and esters) of the substance, provided that the derivatives are the subject of patents specifically covering them.
(17) Whereas the detailed rules in recitals 12, 13 and 14 and in Articles 3 (2), 4, 8 (1) (c) and 17 (2) of this Regulation are also valid, mutatis mutandis, for the interpretation in particular of recital 9 and Articles 3, 4, 8(1)(c) and 17 of Council Regulation (EEC) No. 1768/92
For the purposes of this Regulation, the following definitions shall apply:
1. 'plant protection products`: active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:
(a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;
(b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
(c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;
(d) destroy undesirable plants; or
(e) destroy parts of plants, check or prevent undesirable growth of plants;
2. 'substances`: chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;
3. 'active substances`: substances or micro-organisms including viruses, having general or specific action:
(a) against harmful organisms; or
(b) on plants, parts of plants or plant products;
4. 'preparations`: mixtures or solutions composed of two or more substances, of which at least one is an active substance, intended for use as plant protection products;
8. 'product`: the active substance as defined in point 3 or combination of active substances of a plant protection product;
9. 'basic patent`: a patent which protects a product as defined in point 8 as such, a preparation as defined in point 4, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
1. A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted, at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorization to place the product on the market as a plant protection product has been granted in accordance with Article 4 of Directive 91/414/EEC or an equivalent provision of national law;
(c) the product has not already been the subject of a certificate;
(d) the authorization referred to in (b) is the first authorization to place the product on the market as a plant protection product.
2. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders.
Lord Justice Lloyd:
Lord Justice Ward: