Takeda Chemical Industries Ltd v Patent Office

This appeal by Takeda Chemical Industries is from a decision of Mr Walker acting on behalf of the Comptroller of Patents. He refused six requests for the grant of a supplementary protection certificate. Before Mr Walker were three issues. He decided two of them adversely to Takeda and found it unnecessary to resolve the third. Takeda appealed from that decision. When the appeal first came before this court, Laddie J, with the agreement of the parties, thought it would be better if the third issue were actually resolved. So the matter was remitted for that to be done. Subsequently Mr Walker resolved that third issue by a decision of 31^st May 2002. That resolution was essentially in Takeda’s favour. It is common ground that no issue arises between the parties on this appeal arising out of that second decision.

The case turns on the application of the SPC Regulation (EEC/1768/92). I do not propose to read out more of this than I need to. Mr Walker’s decision helpfully sets out every part of it which could have application to this case. The broad idea behind the Regulation is well known. It is to give patentees “adequate effective protection” in cases where their patent for a medicinal product would provide inadequate remuneration because of delays in marketing authorisation.

I turn to what happened here. Takeda have two patents, EP 174,726 and EP 382,489. ‘726 was filed on 31^st July 1985; ‘489 on 6^th February 1990. So ‘726 expires on 31^st July 2005 and ‘489 expires on 6^th February 2010. Although the claims of both patents are wider, for present purposes they can be treated as concerned solely with the compound lansoprazole. The first patent is for lansoprazole itself; the second is in “Swiss” form: “use of lansoprazole for the manufacture of a medicament for preventing or treating infectious diseases caused by [a bacterium called H.pylori].” The use of lansoprazole disclosed in the first patent is for the treatment of acid related disorders of the upper gastro-intestinal tract. The second patent was based upon the further discovery that the compound could be used for the eradication of H.pylori. Because the compound was known by then, the patentees had to use the intellectually-questionable-but-now-well-established Swiss form claim. The second patent goes out of its way to point out that lansoprazole has particular advantages in killing this organism compared with more general antibiotics because they have their well known side effects, for instance upsetting the gut. Further research by the patentees showed that, in patients, lansoprazole is effective in eliminating H.pylori when used in combination with three particular antibiotics - clarithromycin, amoxycillin and metronidazole. The use of lansoprazole along with any two of those three antibiotics has proved effective.

The patentee’s clinical trials led to a marketing authorisation (“MA” or “product licence”) on 23^rd February 1994 for the marketing of lansoprazole under the trademark ‘Zoton’. That MA was granted in accordance with Directive 65/65/EEC. It only referred to the use of lansoprazole for the treatment of the upper gastro-intestinal tract. That MA was given nearly nine years from the date of filing of the first patent. So Takeda applied for an SPC. It was granted under number GB94/011 and was based on patent number ‘726. It will expire on 10^th December 2005 (that date is, under the SPC rules, determined by a slightly earlier French MA 11^th December 1990).

When the further research showing that lansoprazole was effective against H.pylori when taken with antibiotics had been done, Takeda applied to the Medicines Control Agency for a further product licence for the new indication. In the event the MCA amended the existing product licence so as to include, as an indication for the use of lansoprazole, the treatment of H.pylori when in combination with certain antibiotics. It is this variation of the product licence which was the foundation of Takeda’s applications the subject of this appeal. Understandably, not knowing precisely what the legal position was they covered themselves by making six applications. These were for lansoprazole with any two of the antibiotics I have mentioned (ie. three possibilities) based upon either ‘726 or ‘489 (so six in all). So far as what I have to decide is concerned, nothing turns on this. Actually if an SPC is granted based upon ‘489 it would expire on 27^th February 2011, whereas if an SPC is granted based upon ‘726 it would expire on 30^th July 2010. There may be a difference in the scope of protection depending upon which patent is the basic patent for the purposes of the SPC. But fortunately I do not have to go into that.

I can now turn to set the issues I have to decide. Article 3 of the Regulation sets the conditions for obtaining an SPC. They are:

“Medicinal product” means any substance or combination of substances presented for treating or preventing disease in human beings …;

“Product” means the active ingredient or combination of active ingredients of a medicinal product;

“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, which is designated by its holder for the purpose of the procedure for the grant of a certificate.

Mr Alexander, for Takeda, submits that the combination of lansoprazole with an antibiotic, if sold, would infringe the patent (and for this purpose it matters not which). So, the combination is protected by a basic patent which is in force. So, Takeda comply with condition 3(a). Moreover, he submits definition (b) specifically contemplates that “product” may be a combination of active ingredients. So it is clear that condition 3(a) contemplates protection of a combination.

Mr Walker reasoned this way:

“A patent protects no more and no less than the invention as construed by reference to the claims in accordance with Section 125 [of the Patents Act 1977]. Thus, where there is a combination of things and only one of those things is identifiable with the invention of a patent, unauthorised use of the combination will result in the one thing infringing the patent. However the patent protects just this one thing. The other things making up the combination have no bearing whatsoever on the question of infringement because they are not identifiable with the invention and so are not protected by the patent.

If I apply this view to the Regulation, I can only conclude that the product which is the subject of the certificate must be identifiable with the invention of the designated basic patent.”

Having analysed the patents he then went on to say this:

“As I have already stated, these patents neither disclose nor suggest that the subject pyridine derivatives may be combined with any other active ingredient, in particular with specific antibiotics. Against this background I do not see that a combination of lansoprazole plus two of of clarithromycin, amoxycillin and metronidazole can be identified with the invention of either patent.”

On that basis he dismissed Mr Alexander’s arguments.

Mr Birss, for the Comptroller, submits Mr Alexander’s argument is flawed. I agree. The so-called “combination” of lansoprazole and an antibiotic would only infringe because of the presence of the lansoprazole. In truth, the combination is not as such “protected by a basic patent in force”. What is protected is only the lansoprazole element of that combination. It is sleight-of-hand to say that the combination is protected by the patent. The sleight-of-hand is exposed when one realises that any patent in Mr Alexander’s sense protects the product of the patent with anything else in the world. But the patent is not of course for any such “combination”.

I think the position is absolutely clear. I am not surprised to find that the Swedish courts think so too. A/B Hassle sought an SPC for a combination of two active ingredients. Only one of these was covered by a patent. The Swedish Patent Office, the Patent Appeal Court and the Supreme Administrative Court unanimously concluded that there was no compliance with Article 3(a). (Case number 3248-1996).

The Swedish courts thought the point was acte claire and refused to make a reference to the Court of Justice. I think so too. The SPC system is to provide supplementary protection to that provided by the patent - to extend the relevant part of the patent monopoly. It is not a system for providing protection for different monopolies. Here Takeda’s monopoly is in lansoprazole. The monopoly which they seek is a combination of lansoprazole and an antibiotic. The fact that that combination might infringe the monopoly given by the patent simply because one component infringes is irrelevant. Accordingly I uphold Mr Walker’s decision in relation to Article 3(a).

I turn to the Article 3(b) point. Was there a valid authorisation to place the product on the market as a medicinal product? Mr Alexander submits that the varied product licence for lansoprazole constitutes such an authorisation. He submits that the licence permits the use of lansoprazole with an antibiotic and so constitutes an authorisation for that combination. I do not agree. The licence, both in its original form and its varied form, is for lansoprazole as such. It is that chemical compound which has a marketing authorisation. The product or products to be used for indications are not what is licensed. Putting it another way, it is not this product licence which permits the marketing of the antibiotic component. That would have to have its own marketing authorisation.

Mr Birss submits that there could be a marketing authorisation for a combination. Indeed, he points to a later product licence obtained by Takeda on 4^th January 1999. This is indeed for a combination of lansoprazole and two specified antibiotics. The three compounds are specified as the active ingredients of the product licence. Because that product licence is for the combination, Mr Birss accepted that that would satisfy Article 3(b). He further accepted that should this appeal succeed on the Article 3(a) point but fail on the Article 3(b) point, that Takeda should be given an opportunity of basing an application for an SPC on this further combination product licence, provided an application is made in time. I am concerned only with the current applications which, to my mind, plainly do not satisfy Article 3(b). And in the view I have taken about Article 3(a) the further opportunity does not arise.

In the result the appeal fails on both points.