H Lundbeck AS v Norpharma SPA & Ors

Forney was a scientist working in the Research and Development Laboratories of Mobil Chemical Company in Edison, New Jersey. Forney 1 is a short “Note” appearing in the Journal of Organic Chemistry, a highly respected and peer-reviewed journal. “Notes” are intended for disclosing the important information about a piece of research. A Note will often be followed up by a more detailed paper, in that journal or elsewhere.

Forney 1 is entitled “Reaction of Terephthalic Acid with Formaldehyde in Sulfur Trioxide Media”. The author explains that terephthalic acid is an aromatic molecule which is strongly resistant to electrophilic substitution – a particular mechanism of chemical reaction. The burden of the disclosure is contained in the third paragraph:

“We wish to report the condensation of terephthalic acid with formaldehyde in sulfur trioxide media, a process which produces [5-cbx] cleanly and in excellent yield. The reaction is generally free of by-product formation over a fairly wide range of reaction conditions, although terephthaloyloxyacetic acid (2) has been identified (as its dimethyl ester) from reaction in the presence of excess formaldehyde and from reaction media containing <20% SO₃.”

This passage therefore indicates that a range of reaction conditions have been tried and found successful. “Reaction conditions” normally include such matters as temperature and pressure, but include other matters such as relative amounts of reactants and the nature of the solvent. Those two matters are called out for specific mention here. Whilst excellent yields have been obtained, the by-product terephthaloyloxyacetic acid dimethyl ester (“the by-product”) has been observed if the SO₃ concentration in the reaction media falls below 20%. There is a dispute about whether the skilled person would understand the “reaction media” as the whole contents of the reactor or merely the solvent for the reaction. I think it is clear that it means the solvent. Indeed that is what Dr Moses, Infosint’s expert, said in paragraph 10 of his second report (although he later seemed to suggest in cross examination that

This passage therefore contains a clear implication that the reaction has been tried at SO₃ concentrations in a solvent of 20% or above. Furthermore, it conveys the information that the reaction is generally free of by-product formation unless and until one lowers the SO₃ concentration in the solvent to below 20%.

Forney 1 points out that prior routes involved several-step processes or provided a mixture which was difficult to separate. He says that his synthesis is believed to represent the first reported substitution of terephthalic acid with an electron-deficient carbon species.

In the “Experimental section” Forney 1 discloses two experiments. The first reaction is on a reasonably large scale – much bigger than one could perform in a glass tube. It would be understood as intended to demonstrate that the reaction works at a preparative scale. It is noted that SO₃ is used in the form of Sulfan B. The skilled person would be able to discover that Sulfan B is 100% SO₃, in a stabilised form. It is pointed out that the reaction is exothermic. The resultant slurry was heated at 120130^oC and the excess SO₃ distilled off. Forney gives no express indication in this experiment as to the nature of the reaction vessel. The write up is also silent as to pressure. The effect of the evidence was, however, that in the absence of any indication of the use of pressure, the skilled person would assume that the reaction was carried out in what would be regarded as an open, unpressurised reactor. If the reaction being reported was indeed carried out under pressure, then the writer would have been guilty of a serious omission, as such a detail is as important to the reader as the temperature. Furthermore, it is clear that when Forney did use sealed vessels, he said so.

A second experiment is directed towards making the by-product. This experiment was conducted in a sealed glass tube. Terephthalic acid, formaldehyde (in a large excess) and sulphuric acid (98%) are reacted together at 150^oC. The reaction products were analysed by gas chromatography. They included 83.2% of dimethyl terephthalate, 1.1% of 5-cbx and 15.7% of the by-product.

This second experiment therefore discloses that, in the absence of significant amounts of SO₃ and in the presence of a large excess of formaldehyde, the yield of 5-cbx is very low, even in a sealed tube which would raise pressure. 5-cbx is, nevertheless, formed. The second experiment also shows that concentrated sulphuric acid (probably with no significant amount of SO₃) can be used as the solvent.

There was some evidence of the significance of the fact that the by-product reaction was conducted in sealed glass tubes. Mr Ward’s explanation (with which Dr Scott agreed) was that reactions are often conducted in sealed glass tubes when an analysis is being performed, to ensure that no product escapes and to allow accurate analysis of the reaction products. Dr Moses was cross-examined on this, but I was not clear that he disagreed with Dr Scott and Mr Ward. He accepted that this could be one reason for doing the experiment in a sealed tube, but equally it could be because one wanted to pressurise the reaction.

I think that the skilled person would infer from the fact that Forney does not at any stage discuss the need for pressure, and his reference to the fairly wide range of reaction conditions where by-product formation does not occur, that pressure is not required for the preparative reactions which Forney describes in the third paragraph of the paper.

I would add that the skilled person would understand that the reaction described for making the by-product was entirely consistent with the third paragraph of the paper. Having observed by-product formation when there is excess formaldehyde and where solvents with low SO₃ concentrations are used, Forney does an experiment with concentrated sulphuric acid and a large excess of formaldehyde. These reaction conditions are designed to maximise the production of the by-product which can be then be isolated and analysed. There is a very clear hint here that the reaction media with 20% SO₃ would be based on sulphuric acid: i.e. oleum. Lundbeck now accept however that this is not a clear disclosure of oleum for the purposes of a novelty attack.

Forney 2 is a much longer contribution than Forney 1. It too is concerned with the reaction of formaldehyde and terephthalic acid. Much of it is concerned with questions of the precise chemical mechanism of the reaction which is not relevant to the issues I have to decide. It cross refers more than once to the work reported in Forney 1.

Experiments reported in the paper (see Table II) include a run using oleum with a 30% SO₃ concentration as solvent. Forney 2 reports that the conversion is quite sensitive to the nature of the solvent used for the reaction, but that conversion in 30% oleum and one other solvent were much greater than those using other media. “Relatively high conversions were observed in solvents characterised by their free SO₃ content” with the exception of methanesulfonic acid. In a strictly noncomparable run with 100% SO₃ an excellent conversion (recorded as 94%) was achieved.

Figure 1 in Forney 2 is a graph of conversion against “mole % SO₃” in sulphuric acid and one other solvent. I reproduce it here:

Later the author says: “The conversion in both solvents reaches a maximum at 60 mol % SO₃ content”. The skilled person would understand that, as these reactions were stopped after one hour, the comparison in Figure 1 is simply an indication of rate of reaction in that first hour – a point made elsewhere in the paper (page 691, left hand column). The reactions reported in the Table II runs were conducted for two hours and show near complete conversion at 30% SO₃, whereas Figure 1 shows less than 50% conversion for this concentration after one hour.

There is again a dispute about whether the “mole %” recorded on the x-axis of Figure 1 means mole % in the solvent or mole % in the reaction pot. I prefer the evidence of Mr Ward that what is being shown in Figure 1 is the percentage of SO₃ in the solvent, not the percentage of all the ingredients in the pot. The use of mole % rather than weight % is explained by the fact that there are two solvents being shown on a comparable basis in the Figure. To use weight % would give a misleading comparison.

Forney 2’s reactions are all conducted in sealed glass tubes. At page 693 he says this:

“When the [5-cbx] synthesis is run with a large excess of formaldehyde, or in dilute oleum mixtures, terephthaloyloxyacetic acid appears as a product of the reaction.”

This passage echoes the corresponding passage in Forney 1, although it is now expressly made clear that the “reaction media” included oleum. There is a dispute about whether “dilute oleum mixtures” would be understood differently from “<20%” in Forney 1, to which I will return.

Finally, other experiments in Forney 2 concerned with added salts all use 30% oleum.

Forney applied for (in 1969) and was granted (in 1971) US patent No 3607884. This is not cited as prior art, but for reasons which appear below is relied on by Infosint as part of their response to the obviousness attack as they say it would be found on an obvious search conducted by the reader of Forney 1 or 2. It is therefore convenient to describe its disclosure here as well.

The essential disclosure of the Forney patent is that terephthalic acid and formaldehyde dissolved in liquid SO₃ react at atmospheric pressure to produce 5-cbx. Example 1 is effectively the main preparative example which was subsequently published in Forney 1. The patent includes a reference to some prior art (three US patents and an article by Le Blanc et al) in which a phthalic acid (not terephthalic) is reacted with formaldehyde in 10-65% oleum. It is said that these references also mention the use of liquid SO₃ but that it is necessary to use pressure equipment. It is against this background that performing the reaction with terephthalic acid and liquid SO₃ at atmospheric pressure is presented as inventive.

The Danish application with which I am concerned is the priority document of Lundbeck’s Patent Application PCT/DK00/0585. The Danish Application discloses a method for making 5-cbx. It is available for an attack on novelty only under section 2(3) of the Act. The significance of that fact is that it is therefore not available for obviousness.

The Danish Application refers to Forney 1 in the following terms:

“According to [Forney 1] [5-cbx] is the synthesised by reaction of terephthalic acid with trioxane in oleum. During this process, trioxane sublimates and precipitates thereby obstructing the equipment."

This is reading more into Forney 1 than was actually expressly disclosed. Read strictly, Forney 1 disclosed “reaction media” containing <20% SO₃ and pure SO_3. But the disclosure in the Danish application is nevertheless a disclosure of oleum.

The Danish application continues by describing its invention as providing a process for the manufacture of [5-cbx] comprising the reaction of terephthalic acid and paraformaldehyde in oleum. It is explained that:

The reaction is said to be most preferably carried out at about 120° C. There is no indication of the concentration of SO₃ in the oleum used. The description is silent about pressure.

513 is a Lundbeck international patent application published in May 1998. It discloses a method of making citalopram from 5-cbx. Its relevance is that Lundbeck seek to combine its disclosure with Forney 1 in an obviousness attack. Lack of novelty

Section 2 of the Act which gives effect to Article 54 of the European Patent Convention (“EPC”) provides:

“2.-(1) An invention shall be taken to be new if it does not form part of the state of the art.

(2)

The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way.

(3)

The state of the art in the case of an invention to which an application for a patent or a patent relates shall be taken also to comprise matter contained in an application for another patent which was published on or after the priority date of that invention, if the following conditions are satisfied, that is to say-

(a)

that matter was contained in the application for that other patent both as filed and as published; and

(b)

the priority date of that matter is earlier than that of the invention.”

This part of the law of patents was reviewed by the House of Lords in Synthon’s Patent [2006] RPC 10. There are two requirements for a claim to be anticipated by a prior document: disclosure and enablement. As to disclosure, Lord Hoffman, who gave the leading judgment, began by citing passages from what he described as two judgments of “unquestionable authority”: the speech of Lord Westbury LC in Hills v Evans (1862) 31 LJ Ch (NS) 457 at 463 and the judgment of the Court of Appeal in General Tire and Rubber Co v FirestoneTyre and Rubber Co Ltd [1972] RPC 457 at 485-486. In the latter case the Court of Appeal said:

“If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will be shown to lack the necessary novelty”.

At paragraph 22 Lord Hoffmann says this:

“If I may summarise the effect of these two well-known statements, the matter relied upon as prior art must disclose subject-matter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. But patent infringement does not require that one should be aware that one is infringing: "whether or not a person is working [an] ... invention is an objective fact independent of what he knows or thinks about what he is doing": Merrell Dow

Pharmaceuticals Inc v H N Norton & Co Ltd [1996] R.P.C. 76, 90. It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so.”

It follows from the above that a generic disclosure will not normally take away the novelty of a subsequent claim to a member of the class. For example disclosure of “fixing means” is not a disclosure of a nail.

Mr Turner submits that different considerations apply when one comes to a disclosure of a broad range in a prior art document and an overlapping range in the patent claim. He relies on the decision of the EPO in Unilever Case T 666/89. In that case the patent required 8-25% anionic sufactant with 0.001-0.1% cationic polymer. The prior art disclosed 5-25% anionic surfactant (a larger numerical range) and 0.1-5.0% cationic polymer, a small overlap. The Board held the patent nevertheless lacked novelty, despite the fact that a combination of percentages falling within the claim was nowhere specifically taught in the prior art:

“The Respondent also submitted in the course of oral proceedings that, as a matter of law, it was not permissible to cross the legal borderline between novelty, in the strict sense of a clear and specific disclosure in a prior document of the particular narrow combination of claimed ranges in question on the one hand, and the obviousness of choosing such a combination of ranges from that prior art document containing a disclosure of the broader range, on the other hand. In this connection the Board wishes to set out the general legal principles that apply to so-called “selection” patents. The most important one is that under the EPC patents are not granted for inventions for the sole reason that they are “selections”, but only for new and inventive subject–matter of certain defined kinds (Articles 52 to 57 EPC). Selection is in fact only a conceptual tool, used principally in the field of chemical inventions, for deciding novelty in certain situations, which novelty can, however, only be decided under the express provisions of Article 54, and in particular Articles 54(2) and (3) EPC. Article 54 (2) EPC defines the state of the art as comprising “everything made available to the public by means of written or oral description, by use or in any other way”. The term “available” clearly goes beyond literal or diagrammatical description, and implies the communication, express or implicit, of technical information by other means as well. Now it is of course true that in the case of documents the natural mode of communicating information is by written or diagrammatical description. However, this is not the end of the matter in deciding what information content has been made available: cf. G 02/88, OJ EPO 1990, 003, para. 10 of the reasons. One example of the available information content of a document extending beyond this literal descriptive or diagrammatical content is the case where the carrying out of a process, specifically or literally described in a prior art document, inevitably results in a product not so described. In such a case, the prior art document will destroy the novelty of a claim covering a product; cf. T 12/81, “Diastereomers”, OJ EPO 1982, 296. It is thus content, express and implied, rather than mere form, that is decisive of the issue of novelty in general, and “selection” novelty in particular (cf. T 198/84, ‘Thiochloroformates”, OJ EPO 1985, 209, para, 4 of the reasons, English version corrected in T 124/87, “Copolymers”, OJ EPO 1989, 491, para 3.2 of the reasons; T 26/85, “Thickness of magnetic layers”, OJ EPO 1990, 22, para. 8 of the reasons).

Clearly, the decision on this issue will depend on the facts of each case. Nevertheless, the Boards’ jurisprudence has generated certain general principles and broadly applicable concepts, sometimes (erroneously) referred to as “tests”. Thus it is clear, (cf. G 02/88 cited above), that matter that is hidden, not in the sense of being deliberately concealed but rather in the sense of being reconditely submerged in a document, will not have been “made available” in the above sense. In the case of overlapping ranges of physical parameters between a claim and a prior art disclosure, what will often help to determine what is “hidden” as opposed to what has been made available, is whether or not a skilled person would find it difficult to carry out the prior art teaching in the range of overlap (T 124/87, OJ EPO 1989, 495, para. 3.4). A similar approach adopted by a Board of Appeal (cf. T 26/85 OJ EPO 1990, 22) for assessing the novelty of a claim in a case where overlapping numerical ranges of certain parameters exist between a claim and a prior art document, is to consider whether a person skilled in the art would, in the light of all the technical facts at his disposal, seriously contemplate applying the technical teaching of the prior art document in the range of overlap. Provided the information in the prior art document, in combination with the skilled person’s common general knowledge, is sufficient to enable him to practise the technical teaching, and if it can reasonably be assumed that he would do so, then the claim in question will lack novelty.

In the Board’s view, there is no fundamental difference between examining novelty in situations of so-called “overlap” or “selection”, and in doing so in other situations, although it may be helpful, in order to verify a preliminary conclusion of a novelty examination in cases of overlap, to investigate whether or not a particular technical effect is associated with the narrow range in question. It needs to be stressed, however that such a particular effect is neither a prerequisite for novelty nor can it as such confer novelty: its existence can merely serve to confirm a finding of novelty already achieved (following T 198/84, OJ EPO 1985, 209, para 7).

The above concept of “seriously contemplating” moving from a broad to a narrow (overlapping) range, while seemingly akin to one of the concepts used by the Boards for assessing inventive step, namely, whether the notional addressee “would have tried, with reasonable expectation of success” to bridge the technical gap between a particular piece of prior art and a claim whose inventiveness is in question, is fundamentally different from this “inventive-step concept” because in order to establish anticipation, there cannot be a gap of the above kind.

In summary, and in dealing with the Respondent’s submission outlined previously, under the EPC novelty must be decided by reference to the total information content of a cited prior document, and in assessing the content for the purpose of deciding whether or not a claim is novel, the Board may employ legal concepts that are similar to those used by them in deciding issues of obviousness, without, however, thereby confusing or blurring the distinction between these two separate statutory grounds of objection.”

I derive the following guidance from this passage of relevance to this case:

What I find, with great respect, more difficult to follow is the notion that it may be legitimate to find lack of novelty because the skilled person would “seriously contemplate” moving from a broad range to a narrow range. Merely by stating the proposition in that way one can see that it is inconsistent with the approach approved by the House of Lords in Synthon. There is no disclosure of the narrower range. Moreover, assuming no specific individual value is disclosed, there are no clear directions to use a value within the narrower range. A person carrying out the disclosure of the prior range will not inevitably fall within the claim of the later patent. If the “serious contemplation” approach is indeed the correct approach in the case of overlapping ranges, then overlapping ranges are a special case in the law of novelty, a proposition which is inconsistent with the third proposition derived from T 666/89 itself.

As will appear, however, I have not found it necessary to reach a concluded view on whether the cited EPO decision is correct.

Lundbeck asserts that the 614 patent is invalid for lack of novelty over the Danish Application. The Danish application does not disclose any specific percentage of SO₃ in sulphuric acid. It just talks about oleum.

Mr Turner submitted, firstly, that the Danish application nevertheless disclosed by implication a range of SO₃ concentrations from 1 to 99%. He then submitted, founding himself on the EPO case law which I have referred to above, that the broad range deprived claim 1 of 614 of novelty because the skilled person would seriously contemplate working within the 20-33% range claimed.

I think this argument fails at the first hurdle. On no view does the Danish application disclose a range of SO₃ concentrations. It is simply silent on the concentration of SO₃ used. One simply cannot convert an absence of disclosure into the disclosure of a range of concentrations. It is not implicit that the Danish application is referring to a range from 1 to 99% either.

It is therefore not necessary for me to decide whether to follow the EPO case law on which Mr Turner relies, particularly as the point does not arise directly. Decisions of an expert tribunal such as the Technical Board of Appeal of the EPO are entitled to respect. On the other hand the court is not bound to follow such a decision. In Actavis v Merck [2008] EWCA Civ 444 Jacob LJ likened the EPO to a commodore leading a fleet of ships in a convoy. But he said:

“In the unlikely event that we are convinced that the commodore is steering the convoy towards the rocks we can steer our ship away.”

A patent will be invalid on the ground called “obviousness” if the invention is obvious to a person skilled in the art having regard to any matter which formed part of the state of the art: Sections 72(1)(a), 1(1)(b) and 3 of the Act, which enact Article 56 of the EPC.

The structured analysis adopted in Pozzoli v BDMO [2007] FSR 37, is a helpful guide to the fact finding tribunal, but is not to be regarded as a substitute for the statutory test. The structured approach is as follows:

“(1)

(a) Identify the notional "person skilled in the art";

(b)

Identify the relevant common general knowledge of that person;

Kitchin J concisely summarised the law in Generics v Lundbeck [2007] RPC 32 at [72] subsequently approved by the Court of Appeal in that case and the House of Lords in Conor v Angiotech [2008] R.P.C. 28 at [42]:

“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.” Over the Forney papers

I have identified the person skilled in the art and the common general knowledge above. The inventive concept of claim 1 is the process for making 5-cbx identified in that claim, as I have construed it. I consider this claim first of all. The differences between the Forney papers and claim 1 are (a) to the extent that it is not made absolutely explicit, the use of an unpressurised open reactor; (b) the use of such a reactor in combination with the 20-33% oleum solvent described in Forney 2.

Because lack of novelty was thought still to be in issue, much of the cross examination was conducted on the basis of the individual papers. By the end of the trial it was clear that whether the skilled person started from Forney 1 or from Forney 2, he or she would end up with both papers. That is because anyone sufficiently interested in the Note in Forney 1 would chase up the fuller paper, and anyone interested in Forney 2 would note and follow up the cross-reference to Forney 1. Mr Lykiardopoulos submitted that the evidence also established that the skilled person would at least do a patent name search with the name Forney, and would come across the Forney patent. I think that conclusion is justified as well.

The overall picture presented by the Forney work is that the chemical reaction of terephthalic acid with formaldehyde in an SO₃-containing medium is a robust reaction over a wide range of reaction conditions. Forney demonstrates a preference for 100% SO_3, but makes it clear that the reaction will give comparably good results with 30% oleum and 30% SO₃ in dimethylsulphate.

The evidence established that the skilled person would start by repeating Forney 1’s preparative example. This would involve using Sulfan B, i.e. stabilised 100% SO₃ at atmospheric pressure. There is no suggestion that the skilled person would fail to achieve Forney’s results.

The skilled person would naturally turn to think about whether the reagents described by Forney were the best for his purposes. Dr Scott agreed with Mr Ward that it would be natural to consider alternatives which were less hazardous than 100% SO₃.

Once the skilled person considers the use of an alternative reagent the evidence establishes to my satisfaction that oleum is a natural choice. Firstly, it is, to a degree, less hazardous than 100% SO₃. Secondly, it did not seem to me from the evidence that there was much of a choice of “SO₃-containing media” that would occur to the skilled person as being suitable. Oleum is certainly the one that would first come to mind. Thirdly, there is a broad hint in Forney 1 that Forney himself had done experiments in oleum: contrast the third paragraph with the by-product experiment. Fourthly, the skilled person would know that the reaction in 100% SO₃ will produce sulphuric acid: each molecule of water eliminated in the reaction will react with a molecule of SO₃ to form sulphuric acid. The medium is therefore SO₃ in sulphuric acid in any event. Finally Forney 2 makes it clear that the reaction has been tried in 30% oleum and achieved a similar conversion to that achieved with 100% SO₃, albeit both in sealed tubes.

It seems to me, therefore, that the skilled person would have every incentive to try oleum in the place of liquid SO₃. The real questions are what sort of oleum (i.e. what SO₃ content) would the skilled person use and whether he would use an open and unpressurised reactor.

Mr Lykiardopoulos submitted that the skilled person would not naturally choose an SO₃ concentration in the patented range, for a number of reasons. Firstly, he submitted that Forney warns against “dilute oleum” which the skilled person would understand as encompassing 20-33% oleum. He relied on some answers given by Dr Scott and Mr Ward about the ranges of oleum that they would have on their shelf. So Mr Ward said that 20-30% was the “lower range” as indeed it was. Dr Scott’s answer was that the lowest available form was about 20%. Secondly, Mr Lykiardopoulos submitted that the Figure 1 graph in Forney 2, coupled with the statement about maximum conversion at 60 mol% would point the skilled person towards higher concentrations of SO₃. Thirdly he points to the fact that SO₃ is said to be “critical to the reaction.”

I do not accept these submissions. In the context, which includes Forney 1, the skilled person would understand the reference to dilute oleum as being to oleum containing less than 20% SO₃. Above this level the product is produced in excellent yield, a conclusion confirmed by the 30% oleum results in Forney 2. The answers relied upon from Mr Ward and Dr Scott were the only ones they could have given, but were divorced from the context of the Forney papers. There is no indication in the Forney papers that by-product formation is a problem at 30% concentration, which is used extensively in Forney 2. There is no “warning” against 30% SO₃.

The reference to the conversion reaching a maximum at 60% also needs to be read in context. Firstly - a fairly minor point - the mol% translates to 55% by weight in the case of oleum. Secondly it must be remembered, as Mr Ward points out, that the comment is made in relation to Figure 1, which only records conversion after one hour. Table II shows that 95% conversion can be achieved in 30% oleum after two hours, which is similar to the results for 100% SO₃ both with and without pressure.

Finally the statement that SO₃ is “critical to the reaction” would not be understood as telling the skilled reader that he should adopt a high concentration of SO₃. The

Armed with a proper understanding of the papers the skilled person would naturally reach for the sort of oleum he is likely to have at his disposal, which is likely to be in the 20-30% range. Although he might try to obtain a more concentrated oleum, that would not detract from the fact that a 30% oleum was a natural choice.

There remains the question as to whether the skilled person would try 30% oleum in an open and unpressurised reactor. There is no specific experimental write-up of such a reaction in any of the Forney documents. Lundbeck’s case was that it was obvious to use unpressurised reactions if one could, and the statement about the wide range of conditions for the reaction in the third paragraph of Forney 1 would encourage one to believe that one could.

Dr Moses’s main answer to this was that, although the skilled person might wish to try to do the reaction with oleum in an open and unpressurised reactor, he would not be confident about the results. His view was that there would be doubt about whether the SO₃ would boil away. If enough of it boiled away the SO₃ concentration might fall below 20% and lead to by-product formation.

There is, however, no substance in the concern about the SO₃ concentration falling below 20%. Mr Ward explained that there was no reason why the skilled person would not do the preparative reaction in a round bottomed flask using a reflux condenser. In cross examination Dr Moses said this:

“If I was heating a reaction and trying to keep the reagent concentration above 20%, whatever 20% refers to, I would consider doing it in a sealed vessel. I may consider doing it in an open vessel if I put a condenser on it. I would not know the outcome. I would not be able to reasonably predict whether the SO₃ concentration would drop below 20%. I cannot say that claim 1 is therefore obvious.”

I think that, in this passage and elsewhere, Dr Moses was saying that he would not be sure about the precise result. His statement about the final question of obviousness must be read in that light. He did not really have any quarrel with the suggestion that an open reactor was a sensible way to proceed.

I think all that would be involved would be the sort of routine process investigation that a skilled industrial process chemist would be obliged to perform as part of his job. The skilled person is not going to use a pressurised reactor if the reaction proceeds satisfactorily under atmospheric pressure. It is true, as Dr Moses emphasised regularly, that one would not be certain, or sure, of what the results would be. As he said, if that were the case, one would not have to run the test. But I gained the impression that the uncertainty with which he was concerned was about how good the conversion would be. He did not advance any coherent reason why the reaction

I should add that Mr Lykiardopoulos sought to characterise the necessary testing as a research project. He reminded me of what I said in Teva v Merck [2010] FSR 17 at [88]-[98] namely that the court should proceed “with caution” when faced with an obviousness attack based on the suggestion that the skilled person would embark on a research program in the course of which he would discover that a product was effective.

I do not think that this is that type of obviousness case at all. Mr Ward explained that in the following exchange:

“Q. He cannot predict the outcome, but he is doing this in order to cover all bases, basically. He picks the papers up and he does a full range of experiments.

A.

I would not quite agree that you cannot predict the outcome because I think Forney gives him a very powerful pointer, saying that he can do this over a wide range of conditions. He starts these things with the expectation that he is going to get a lot of positive results rather than a whole host of negative ones.”

Mr Lykiardoupoulos also pointed to the fact that the patent teaches at [0007] that the invention “allows” the synthesis of 5-cbx with “high yield and purity and easily controllable in the industrial scale”. He submits that it would not be obvious that a process which used 20-33% oleum in an open, unpressurised reactor would achieve these good results.

I think this submission seeks an answer to the wrong question, because it incorrectly characterises the inventive concept of the claim. Firstly, to bring the good results into the claim, it is necessary for the results to be obtainable across the breadth of the claim: Brugger v Medic-Aid [1996] RPC 635 at 656-657. There is, however, no limitation in the claim about either yield or purity. On the construction of the claim which I have adopted, the claim is infringed whenever the prescribed conditions are used to make 5-cbx, even if the process is not taken to completion, or low purity product is obtained. It follows that it is not legitimate to use the results which the invention “allows” to formulate the question for the purposes of determining inventive step.

Secondly, the relative terms “high yield and purity and easily controllable conditions” are nowhere defined. The evidence does not enable me to conclude that these parameters for the claimed process are any better or worse than those obtained using 100% SO₃. In the opposition proceedings in the European Patent Office, Infosint relied on some experiments which purported to show improvements, but they elected not to rely on such material here.

The result is that one cannot approach obviousness on the basis that the claimed process is better, or even as good as Forney’s preferred SO₃ process. It is simply another set of process conditions for performing the same reaction.

I have come to the conclusion, therefore, that the skilled industrial process chemist, starting from the Forney work, would arrive at the use of 20-30% oleum in an open and unpressurised reactor without invention. Claim 1 is therefore invalid for obviousness. I would have reached the same conclusion were Forney 1 the only citation to be considered.

I have been able to reach this conclusion without relying on the work at Lundbeck before the priority date. In view of the unsatisfactory way in which that material was put before the court, I do not think it would be safe to place reliance on it in the way that Lundbeck would wish. Mr Turner suggested that I could, nevertheless, place reliance on some answers given by Dr Scott, commenting on the work by Lundbeck. He said that I could do so notwithstanding the inaccuracy of the account which was put to him. I think it would be wrong to do so. The material was put to Dr Scott on the footing that this was what Lundbeck had done, and it was reasonable for them to have proceeded in that way. It was hard for Dr Scott to answer that it was not reasonable. He was not given the opportunity of answering the question in the light of a proper explanation of what had happened. Moreover, part of what drove Lundbeck forward was Mr Nielsen’s mistaken belief that the preparative example in Forney 1 was oleum, when it was not. It is difficult to place much weight on the work once that mistake had been made. Finally, if the newly disclosed material is indeed the whole of the work which Mr Nielsen did, it seems to have started with a dehydrating agent which is neither oleum nor SO₃. This is not consistent with the way in which the experts were agreed the skilled person would proceed, namely by trying what is disclosed first. I do not think there is anything on which either party can rely in the history. I have disregarded it. Claim 22

The inventive concept of claim 22 is the use of the claim 1 process in a process of making citalopram. Lundbeck advance two cases of obviousness of claim 22. The first is that the skilled person seeking to make use of the process of making citalopram disclosed in 513 would need a method for making the disclosed intermediate, 5-cbx. He would be led to perform a search for methods of making 5-cbx, which would uncover the Forney work, with the obvious consequence that he would use the claimed process to make the intermediate, and the rest of 513 to make citalopram. I call this “the searching argument”.

Lundbeck’s alternative case is that claim 22 is a mere aggregation of features. Forney renders obvious the process of claim 1 for making 5-cbx; 513 discloses a process of converting 5-cbx into citalopram. To take these two process steps and perform them in sequence is not an invention: it is a mere aggregation of process steps. I call this “the aggregation argument”.

It is common ground that all 513 discloses about the way to make 5-cbx is that it:

“is commercially available and may be prepared by well known procedures (Tirouflet, J.; Bull. Soc. Sci. Bretagne 26, 1959, 35).”

So far as the evidence goes, 5-cbx was not commercially available, and the reference, Tirouflet, does not disclose a method of making 5-cbx. It follows that the skilled person who wishes to put 513 into effect must find a way of making 5-cbx.

The Beilstein Handbook of Organic Chemistry is the standard reference for the preparation of organic compounds. It was first published in 1881, set up by a German chemist of that name. It is a practical reference source in the sense that it records what chemists have actually made. As Mr Ward put it, “you can be sure that entries in Beilstein are useful”. It is now available on-line, but in 2000 the bound volumes would also have been readily available. A search against the formal chemical name for 5-cbx would have uncovered Forney 1 with the indication “(Prep)” which means that the paper gives a preparative method.

The Dictionary of Organic Compounds is also a standard reference work which the skilled person would be likely to consult. It was first published in 1934. An entry for “Phthalide-5-carboxylic acid” (5-cbx) in the 1996 edition identifies Forney 1 and gives an indication that it provides a synthesis.

For completeness, Mr Ward did a search through Chemical Abstracts. This is a much larger database which catalogues almost every publication in the area of chemistry. In my judgment, the skilled person would be more likely to consult Beilstein and/or the Dictionary of Organic Compounds before resorting to Chemical Abstracts.

On the basis of these materials, Lundbeck submit that the skilled person would obviously and inevitably find and read Forney 1. I think that is correct.

Infosint answers this case in the following way. The evidence showed that, in addition to Forney, the Beilstein search, whether done manually or on-line, would have turned up a number of other papers. These were not placed before the court, and, for all one knows, might have led the skilled person in other directions.

Attractively though this argument was presented by Mr Lykiardopoulos, I am not persuaded by it. Firstly, if there were any material in these other documents which would have rendered Forney’s synthesis less attractive, then I would have expected this material to be put to Lundbeck’s expert. After all, Mr Ward had made clear that he would find Forney 1 and what he would do on finding it. Secondly, it is difficult to see what these other publications could say which would detract from Forney’s plain instruction that he has a robust process for making 5-cbx. The fact that there might be other suggestions would not be sufficient to prevent Forney from being at least one obvious process to use.

Accordingly, in my judgment, the skilled person starting from 513 would be led to the other Forney materials and to a process within claim 1 for making 5-cbx. Claim 22 is therefore obvious over 513 and Forney.

It is not therefore necessary for me to deal with the aggregation argument. Mr Turner recognised that it was a more difficult argument both in law and on the facts. It can sometimes be the case that connecting two known processes together in series can be obvious: see the sausage machine case Williams v Nye (1890) 7 RPC 602. The EPO Guidelines for Examination has a similar principle which it expresses in the following way:

“Obvious and consequently non-inventive combination of features:

The invention consists merely in the juxtaposition or association of known devices or processes functioning in their normal way and not producing any non-obvious working interrelationship.

Example: Machine producing sausages consists of known mincing machine and that known filling machine disposed sideby-side.” (original emphasis)

Equally one can have a claim which identifies two separate and distinct solutions to two separate and distinct problems as in Sabaf SPA v MFI Furniture Centres Limited [2004] UKHL 45; [2005] RPC 10. There is no need in those circumstances to show that there was some obvious motive to combine the solutions, if no special advantage flows from the combination. But it is not necessary on the facts of this case to explore these considerations further. For the reasons I have identified in dealing with the searching argument, there was no invention in the present case in combining the teaching of 513 with that of Forney, and it was obvious to do so.

A patent will be invalid for insufficiency (section 72(1)(c) of the Act; Article 123(2) of the EPC) if:

“the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art.”

A number of cases have addressed the problem of whether it is enough, where a claim covers a class of products or processes, for the specification of the patent to teach only one, or some but not all, of those products and processes. In Lundbeck v Generics [2009] UKHL 12; [2009] RPC 13, the House of Lords held that, in the case of a claim to a single chemical compound (in that case escitalopram), it was necessary only to disclose one way of making it. Lord Neuberger emphasised that statements of general principle in relation to inventions with many embodiments, in which class he included the judgment of the House of Lords in the earlier case of Biogen Inc v Medeva [1997] RPC 1, might be irrelevant to a case which consists of a single chemical compound.

In Biogen Lord Hoffmann explained the principle in the following terms, at 48 line 42:

“… the specification must enable the invention to be performed to the full extent of the monopoly claimed. If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms. The patentee need not show that he has proved his application in every individual instance. On the other hand, if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them."

In the later case of Kirin-Amgen v Hoechst Marion Roussel Ltd [2004] UKHL 46; [2005] RPC 9, Lord Hoffmann explained what was meant by a principle of general application in this context:

“In my opinion there is nothing difficult or mysterious about it. It simply means an element of the claim which is stated in general terms. Such a claim is sufficiently enabled if one can reasonably expect the invention to work with anything which falls within the general term."

Lundbeck attack claim 22 of the 614 patent on the basis of insufficiency only if claim 22 is not invalid for obviousness. The points on insufficiency do not therefore arise. I will deal with them shortly, in case it turns out that my decision on obviousness of claim 22 is wrong.

Lundbeck’s pleaded case is:

“(a)

the Patent discloses a process for producing [5-cbx] and not a process extending to the production of citalopram

(b)

in the alternative, insofar as the Patent discloses how to make citalopram from 5-cbx, it does so only by reference to a method described in International Patent Application WO 000243431 and in Italian Patent Application

IT1999MI0001724 and not by any other methods. For this reason claim 22 is objectionable insofar as it extends to other ways of making citalopram from 5-cbx.”

Lundbeck elaborated the first point in the following way. Claim 22 is what Lundbeck call a “reach-through” claim. This is intended to convey the notion that the inventive concept of the claim lies in how to make 5-cbx, not in how to make citalopram from 5-cbx. Lundbeck point out that although the addition of the step of making citalopram narrows the claim in some respects, it enables Infosint to complain of the importation of citalopram made from 5-cbx abroad, when this would not have been possible if the patent only had claims to a process for making 5-cbx. Lundbeck submits that the monopoly in these circumstances extends beyond the contribution to the art.

I cannot accept this submission. The technical contribution of claim 22 is making citalopram via 5-cbx made by the process of claim 1. So a monopoly which prevents dealings in citalopram made in that way does not extend beyond the contribution. Points made about the consequent scope of protection have nothing to do with insufficiency.

The objection pleaded in sub-paragraph (b) relies on passages in the judgment Lord Hoffmann in Biogen as subsequently explained by the House of Lords in Lundbeck v Generics. Lundbeck rely on the fact that a process claim needs to be sufficient across its entire breadth. The 614 patent discloses only some ways of making citalopram from 5-cbx, not all the ways.

Claim 22 is a claim to the general principle of using 5-cbx made by the claim 1 process to make citalopram. Insofar as it relates to making citalopram from 5-cbx it is claimed in entirely general terms. One could reasonably expect the invention to work with any process which produced citalopram from 5-cbx. As such it would have been enabled provided it taught one method by which to make citalopram from 5-cbx. There is no suggestion that the skilled person would have encountered any difficulty in doing so.

From a date before the priority date both LUPUK and LUMSAS (Lundbeck’s facilities in the UK and Denmark respectively) were operating a process for making 5-cbx. Thereafter other companies, identified below in the way they were referred to at trial, became involved in making 5-cbx for Lundbeck. All of the 5-cbx is now made in India. I deal with each process below.

This was operated in Denmark from 1986 to April 2003, i.e. both before and after the priority date. The reaction mixture is supposed to be heated to 115-145^oC for 17-21 hours. This is a one-pot process: all the reactants are heated up in the same open and unpressurised reactor. Whilst there was some debate in the evidence about individual batches, Infosint accepts that Lundbeck have a defence under section 64 (see below) in relation to the operation of this process up to July 2003. It is therefore not necessary to discuss it further. LUPUK low temperature process

This process was operated in the UK from 1995 to July 2003, again both before and after the priority date. As with the LUMSAS low temperature process, it is accepted that section 64 applies.

This was a two-pot process, introduced in an attempt to avoid the 614 patent. The oleum and terephthalic acid were first heated to 150°C before paraformaldehyde was slowly added, keeping the temperature at about 150°C and maintaining the temperature at about 150°C thereafter.

The difference between a one-pot and a two-pot process is no longer relied on as avoiding infringement. Infosint now accepts, however, that Lundbeck have a defence in relation to these processes on the ground that the temperature exceeds 150^oC. There is therefore no infringement here either.

The temperature here was within the claimed range but the pressure was 1.4 to 1.7 bar above atmospheric. These are undoubtedly pressurised conditions. On the view which I have taken of construction there is no infringement.

This was a multi-pot process. A mixture of terephthalic acid in oleum is first heated up to the reaction temperature before a mixture of paraformaldehyde in oleum is slowly added. Additional SO₃ is then distilled over into the mixture from a third vessel. Lundbeck accept for the purposes of these proceedings that at least one batch falls within the claims. There is therefore infringement. There is an issue about whether section 64 applies to this process.

These processes were operated at Lundbeck’s plant in Italy. The reactor was operated at 0.2 to 0.4 bar above atmospheric.

As originally implemented in 2001, the process used 66% oleum. It is common ground that this high oleum process did not infringe.

Later, LUPI used an oleum concentration within the claimed range. Dr Scott accepted that the reaction was being run under pressure, but maintained that the reaction was technically equivalent because the extra pressure had no effect on the reaction. He had not, however, done any analysis to determine whether the additional pressure might have a minor effect on impurities or yield. As I have construed the claim, pressurised reaction conditions are not covered. There is therefore no infringement.

This process is also run at 1.5 to 1.7 bar over atmospheric. The conclusion is the same as for Siegfried and LUPI: pressurised conditions do not infringe.

There are two Ramdev processes, one run at 140-145^oC (up to 26^th October 2009) and the other at 147-152^oC (thereafter). Both are two-pot processes.

The first process infringes the claims, subject only to the section 64 defence.

The batch records for the post-26^th October 2009 process reveal:

There is therefore no evidence of any infringement of the claims by these processes.

This is a two pot process. The batch record at Trial Bundle H tab 8 shows the process is supposed to run at 145^oC but was measured once at 148.1^oC, just before the reaction ended. I consider that, on the balance of probabilities, 5-cbx is being made at temperatures within the claimed range. It seems overwhelmingly likely given the intended temperature and the 148.1^oC reading, that in practice the temperature would fluctuate above and below the 145^oC mark. 5-cbx is accordingly likely to be made within the claimed range.

This is run at above 145^oC and is two-pot. Trial Bundle I tab 10 reveals a process where the temperature varied with time between 146 and 147^oC. The batch record at Trial Bundle H tab 9 reveals slightly higher temperatures. This one is very close to the line, but I think it is just outside the temperature range specified. It does not infringe. Section 64

Section 64 of the Act provides:

“(1)

Where a patent is granted for an invention, a person who in the United Kingdom before the priority date of the invention –

(a)

does in good faith an act which would constitute an infringement of the patent if it were in force, or

(b)

makes in good faith effective and serious preparations to do such an act,

has the right to continue to do the act or, as the case may be, to do the act, notwithstanding the grant of the patent; but this right does not extend to granting a licence to another person to do the act.

(2)

If the act was done, or the preparations were made, in the course of a business, the person entitled to the right conferred by subsection (1) may–

(a)

authorise the doing of that act by any partners of his for the time being in that business, and

(b)

assign that right, or transmit it on death (or in the case of a body corporate on its dissolution), to any person who acquires that part of the business in the course of which the act was done or the preparations were made.

(3)

Where a product is disposed of to another in exercise of the rights conferred by subsection (1) or (2), that other and any person claiming through him may deal with the product in the same way as if it had been disposed of by the registered proprietor of the patent."

In Lubrizol Corp. v Esso Petroleum [1997] RPC 195, Jacob J (as he then was) noted an apparent difference in judicial opinion on the scope of the defence that had arisen between the decision of Aldous J (as he then was) in Helitune v. Stewart Hughes [1991] FSR 171 at 205-206 and Mr Laddie QC sitting as a Deputy Judge of the Patents Court (as he then was) in Lubrizol v. Esso (No.1) [1992] RPC 281 at 295. Aldous J had appeared to suggest that s.64 provided a general licence under the patent. On appeal in Lubrizol Corp. v Esso Petroleum [1998] RPC 727 at page 770, Aldous LJ explained the approach as follows:

LUMSAS and LUPUK were operating the processes I have described as their low temperature process from dates before the priority date of the 614 patent. They continued to operate substantially the same processes thereafter until the temperature was changed to the non-infringing high temperature process. I have already recorded the fact that it is common ground that they had a section 64 defence in respect of the importation of citalopram made by those processes. There are really only two issues left on the facts. The first is whether importation of product made from 5-cbx made by the two-pot processes which would otherwise come within the scope of the claims is within the scope of the right given by section 64. The second is whether the importation of the enantiomer, escitalopram, is within that right.

The two-pot process was introduced by Lundbeck in an attempt, now acknowledged to be inadequate, to avoid the claims of the 614 patent. Mr Turner submitted, firstly, that it was not necessary to enquire into how the citalopram was made before it was imported. The act of importation of citalopram before the priority date gave the right to import citalopram after the priority date even if made by a different process. He says that this is the right approach because the act which gives the rise to the right under section 64 is the act in the United Kingdom – importation of citalopram.

Whilst the language of section 64 does not sit entirely happily with the case of infringing importation of the direct product of a process, I am unpersuaded by Mr Turner’s submission. The prior act which section 64 refers to is an act which would infringe the patent if it were in force. It makes no sense to characterise this as “importation of citalopram”. The only act which infringes is the importation of citalopram made by a claim 22 process. Section 64 therefore gives a right to continue to import citalopram made by a claim 22 process, not a right to import citalopram however made.

Mr Turner next submits that the two-pot process does not make any difference, because it is substantially the same commercial process as the one-pot process.

Mr Trickett was responsible for introducing the two-pot process at LUPUK. He did so under instructions to change the process for patent infringement reasons. He accepted in cross-examination that making the changes was like starting again. The new process (this is what Mr Trickett called it) involved extra equipment, new timings, a pre-heating step and new pipework. Dr Scott described the new process as “operationally different”.

In my judgment Lundbeck are not entitled to a section 64 defence in relation to the importation of citalopram made by two-pot processes. Such processes are not substantially the same as what was done before. To the extent that those processes use the claimed process parameters, they infringe the claims. Escitalopram

It is not suggested by Lundbeck that they imported or made serious and effective preparations to import escitalopram by the process of claim 22 before the priority date. The section 64 defence to the importation of escitalopram is based on the importation of racemic citalopram.

I do not think there is any difficulty here. The importation of escitalopram is not substantially the same act as the importation of citalopram. As Professor Davies’ evidence makes clear, although escitalopram is contained within racemic citalopram, the two materials have different properties, and are different articles of commerce as a result.

There was a further point mooted about whether Lundbeck could resume production according to the LUMSAS or LUPUK low temperature processes, which they stopped using in 2003, and still rely on section 64. It does not seem to me that it arises directly, and I therefore do not need to deal with it.

Lundbeck say that Section 68 of the Act provides them with a partial defence. The point does not arise because the patent is invalid, and for that reason not infringed. Nevertheless I will deal with the point in case I am wrong on validity.

Section 68 has been amended. In the section as set out below, the words in square brackets were removed and the words in bold added by the Intellectual Property (Enforcement, etc) Regulations 2006 (SI 2006/1028) coming into force on April 29 2006.

“68.

Where by virtue of a transaction, instrument or event to which section 33 above applies a person becomes the proprietor or one of the proprietors ... of a patent and the patent is subsequently infringed [, the court ... shall not award him damages or order that he be given an account of profits in respect of such an infringement occurring] before the transaction, instrument or event is registered, in proceedings for such an infringement, the court ... shall not award him costs or expenses unless –

(a)

the transaction, instrument or event is registered within the period of six months beginning with its date; or

(b)

the court ... is satisfied that it was not practicable to register the transaction, instrument or event before the end of that period and that it was registered as soon as practicable thereafter.”

In Siemens v Thorn [2008] RPC 4 Mann J held that the unamended version of section 68 applies to acts of infringement committed before the section was amended. Although the Court of Appeal allowed an appeal on the non-registration point, the issue of whether or not the amendments to section 68 were retrospective was not the subject of any appeal – see the Court of Appeal’s judgment at [2008] EWCA Civ 1161 at [79]. Infosint did not invite me to differ from Mann J, but reserved an argument that he was wrong for a higher court.

The position is therefore that, if the point is a good one, Infosint would not, if the patent had been infringed, have recovered damages or an account of profits for infringements before April 29 2006, and not recover costs thereafter.

Section 32(1) requires the Comptroller to maintain the register of patents. Section 32 defines “register” (as a noun) as “the register of patents” and (as a verb) as “to register particulars, or enter notice, of that thing in the register and, in relation to a person, means to enter his name in the register”. Cognate expressions, in which one would include the word “registered” used in section 68, are expressly required to be construed accordingly.

Section 33, which is cross-referred to in section 68, is a section which sets out certain effects of registration. For present purposes it is sufficient to note that it is a section which applies by section 33(3)(a) to the assignment of a patent or application for a patent, or a right in it.

By Implementing Regulations pursuant to the EPC it is provided that:

“22(1). The transfer of a European patent application shall be recorded in the European Patent Register at the request of an interested party, upon production of documents providing evidence of such transfer.

85.

Rule 22 shall apply to any transfer of the European patent made during the opposition period or during opposition proceedings.”

The provisions of the Act which govern the relationship between the European and national phases include:

“78.-(1) Subject to the provisions of this Act, an application for a European patent (UK) having a date of filing under the European Patent Convention shall be treated for the purposes of the provisions of this Act to which this section applies as an application for a patent under this Act having that date as its date of filing and having the other incidents listed in subsection (3) below, but subject to the modifications mentioned in the following provisions of this section.”

Section 78(2) provides that the section applies to sections 30 to 33 of the Act. Section 78(3)(f) includes as one of the incidents referred to in subsection (1):

“(f)

registration of the application in the register of European patents shall be treated as registration under this Act.”

Accordingly, although Section 78(3)(f) is not absolutely clear on the point, it would appear that if the applicant succeeds in registering an assignment of an application for a European patent (UK) on the register kept by the European Patent Office, then that will be treated as valid registration under the Act. There is, however, no corresponding provision dealing with the assignment of the European patent. Although the EPO will, by virtue of Rule 85, register such an assignment, there is no provision deeming such registration to be registration under the Act.

The scope of the defence afforded by section 68(b) was explained by the Court of Appeal in Molnlycke v Procter & Gamble [1994] RPC 49 at 139 in the judgment of Sir Donald Nicholls VC:

“It is relevant to consider the nature of the responsibility or obligation imposed and its meaning must depend on the conduct or actions which the person on whom the obligation is placed would ordinarily be expected to take to comply with that obligation. The purpose of the registration requirements of the Patents Act 1977 is to make the subject matter of the application and details of relevant transactions available to the public…

In this context "practicable" means that the applicant for registration must take all the steps which the reasonable applicant acting on competent advice would take in the circumstances to secure registration."

In that case an application to register an assignment had been made but not acted on by the Patent Office because of a settled practice of the Office not to register assignments when there were revocation proceedings pending. There was no statutory basis for such a practice. The Court held that a competent agent could properly take the view that she had done all she reasonably could in the circumstances to obtain registration.

The application for the 614 patent was filed by Norpharma on 18^th January 2000. In February 2002 Infosint was granted an option to purchase a portfolio of patent applications and rights, including the application for the patent in suit. On 18^th March 2002 Infosint stated that they intended to exercise the option and would pay the consideration to Norpharma by 25^th March.

The patent in suit was granted on 19^th June 2002. By an assignment dated 22^nd July 2002 Norpharma purported to assign the application for the patent in suit to Infosint.

On 29^th July 2002 Dragotti wrote to patent attorneys in the UK. It was apparent from the letter that the patent had been granted and that it had been assigned from Norpharma to Infosint. The letter also informed the UK attorneys that the recordal of the assignment had been requested at the EPO. The purpose of the letter was to ask the UK attorneys to attend to the “formalities for recordal” of the case in the UK. On 5^th August 2002 the UK attorneys wrote to the UK Patent Office giving the reference number of the granted patent and heading the letter “Infosint SA”. However, the letter only expressly requested the entry of the UK attorneys as the address for service in respect of the Patent. It did not expressly request alteration of the name of the proprietor. Infosint was however recorded as the proprietor in the books and records of the UK agents.

On 7^th August 2002, Dragotti forwarded the EPO acknowledgment concerning the registration of the assignment. This was not, so far as the correspondence shows, forwarded on to the Patent Office here.

A similar procedure adopted with agents in the Irish Republic resulted in the Irish register being amended to record Infosint as proprietors.

When the 614 patent entered the national phase in the UK it remained in the name Norpharma. Consequently, in the present proceedings Norpharma were named as defendant.

In consequence of the commencement of these proceedings, eight years later, on 17^th May 2010, Infosint requested registration at the UKIPO of the 22^nd July 2002 assignment. The assignment was registered at the UKIPO on 9^th June 2010.

It is plain on these facts that the registration of the assignment at the UKIPO did not happen within six months of the date of the assignment. Infosint have two answers to this:

On the first point Mr Lykiardopoulos argues that registration of the assignment at the EPO under Rule 85 counts as registration under the Act. So the assignment was registered within 6 months of its date. I am unable to accept this argument.

The “transaction, instrument or event” with which this case is concerned is the assignment dated 22^nd July 2002. It is true that, according to its terms, it is an assignment of the application, not the patent. But by the time it came to be executed the patent had been granted. The assignment thereby operated to convey the title to the patent on that date. It makes no sense to regard it as an assignment of the application, which had by then ceased to exist.

It was therefore the assignment of the patent which had to be registered, and which was registered at the EPO. There is no provision which deems such registration to be registration under the Act (unlike section 78(3)(f)). So the assignment needed to be registered here as well. That did not occur.

Mr Lykiardopoulos submits that this result does not give effect to the purpose of the provision, which is to put the public on notice of the assignment. He submits that this purpose is satisfied if the assignment is registered at the EPO. I do not agree. Once the patent is granted, it is a bundle of national rights, each separately assignable. It is therefore to the individual national registers that the public are required to look. The public should not be expected to check the EPO register to see whether by any chance an assignment of the patent was registered in the opposition period under rule 85 and then not registered here.

I turn therefore to whether section 68(b) provides an answer. The burden of Mr Zanetti’s evidence was that, in the usual course, he would have expected the inventors

Mr Lykiardopoulos submits that Infosint have done all that was practicable by instructing its agents in this way. He focused on the words of Sir Donald Nicholls VC in Molnlycke and submitted that, whatever might have been done by the applicants’ agents, the applicants had taken all the steps which the reasonable applicant acting on competent advice would take in the circumstances to secure registration.

I do not accept that Infosint can avail itself of section 68(b). The defence is only available if it is not practicable to register the assignment. As Molnlycke shows, the section requires an investigation of what was done by the applicant and his agents, not just the applicant alone. The fact that the patentee’s agent has not succeeded in registering the assignment despite being instructed to do so does not mean that it was not practicable to register the assignment. It would be an odd conclusion if the effect of the section depended on whether the patentee used an employee or an agent to effect registration. Yet on Mr Lykiardopoulos’ argument it would make all the difference: in the one case it would be practicable and in the other case it would not.

The facts demonstrate that it plainly was practicable to register the assignment, as the registration which was achieved in Ireland shows. It was practicable to register it here as well. The section 68 defence succeeds.

My conclusions are that the 614 patent is invalid. If it had been valid the patent would have been infringed by some of the processes relied on. If there had been infringement, the remedies in damages and costs would have been limited by section 68.

In slightly more detail: