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Thursday, 9 November 2006

BAXTER AND ABBOTT BATTLE OVER RESEARCH DATA; BACK TO THE CUPBOARD FOR MEDICINE USERS?


Baxter and Abbott battle over research data

Another round in the battle of Baxter Healthcare Corporation and another v Abbott Laboratories and another has been fought out in the Patents Court for England and Wales, before Mr Justice Pumfrey who gave his ruling on Monday. This time the battle, noted briefly on the LexisNexis Butterworth service, was over disclosure of research data.

Right: er, not THAT sort of Baxter Healthcare ...

Briefly stated, Abbott and Baxter make sevoflurane-based anaesthetic products, administered using an anaesthetic vaporiser. Baxter went to court, seeking revocation of Abbott's patent and also - to be on the safe side - seeking a declaration of non-infringement. In this particular judicial spat, Abbott applied for disclosure of some documents recording tests that Baxter had made on a batch of its own product, arguing (i) that disclosure of the documents was relevant to the question of the declaration of non-infringement, and (ii) that it would assist Abbott in deciding whether or not to resist Baxter's application for the declaration of non-infringement.

Pumfrey J dismissed the application. In the first place, he said, while in principle the documents sought were disclosable if relevant, Abbott hadn't actually identified how or why they were relevant. Secondly, an order of disclosure would be disproportionate and inconvenient in relation to any benefit that could be got from it.

Left: ... and not THAT sort of Abbot.

The IPKat notes with approval the judge's observation that disclosure orders shouln't be made in respect of ongoing experiments: that could lead to disputable and uncertain results being introduced into heavy patent proceedings without any way of knowing the correct degree of weight to be attached to them. Nor was it fair on scientists if they were at risk of being exposed to the extra burden of disclosing interim research results. Merpel says, that's all very well - but what ever happened to the subtle art of using disclosure as a means of fishing for juicy information concerning your competitor's research?


Back to the cupboard for medicine users?

An Advocate General's Opinion from the European Court of Justice on which the IPKat has so far failed to comment was given on 26 October in Case C-412/05 P Alcon Inc v OHIM, Biofarma SA.

In 1998 Alcon Inc applied to register the word TRAVATAN as a Community trade mark for phthalmic pharmaceutical preparations. Biofarma opposed, alleging a likelihood of confusion and citing its earlier Italian word mark TRIVASTAN for “pharmaceutical, veterinary and hygiene products; dietary products for infants or patients; plasters; materials for dressings; tooth fillings and dental impressions; disinfectants; herbicides and pesticides”. After Biofarma was put to proof of use of its earlier mark, proof was furnished for a “peripheral vasodilator intended to treat peripheral and cerebral vascular disturbance and vascular disorders of the eye and ear”. The Opposition Division agreed that there was a likelihood of confusion and refused the application, in a decision upheld both by the Board of Appeal and the Court of First Instance. Alcon appealed on various grounds, particularly challenging the notion that in respect of pharma products such as those in question, which were available in part on prescription, the relevant consumer should be taken to be the public at large rather than healthcare professionals.

Advocate General Juliane Kokott has advised the ECJ to dismiss Alcon's appeal. On the issue of who should be the relevant public for the purpose of testing if confusion was likely, she had this to say:

"43. Alcon contests the inclusion of end users in the relevant public. Since the products require a prescription, solely the doctor makes the decision as to their acquisition. Therefore only the perception of healthcare professionals is relevant. Another OHIM Board of Appeal, the Court of First Instance and the Court of Justice have already so decided.

44. The Office and Biofarma, on the other hand, take the view that the perception of patients matters too. The Office stresses that when patients are confronted by a mark, they are not to be misled as to the origin of the goods designated. Their perception is irrelevant only if their being confronted with the mark can be ruled out. Biofarma supplements this with the practical example of confusing two medicinal products in the medicine cabinet at home.

45. This limb relates, first, to a factual element, namely the determination as to the public addressed by the goods in question, and is inadmissible to that extent.

46. Second, at the same time it contests the interpretation of Article 8(1)(b) of Regulation 40/94 with regard to the definition of the relevant public. In addition, it implies that the reasoning for the findings of the Court of First Instance is insufficient, since reasons are not stated for the inclusion of end users despite submissions to the contrary. Both aspects concern points of law, and the limb is therefore admissible to this extent.

47. The Court of Justice focuses on the perception of the mark in the mind of the average consumer of the type of goods or services in question. In general, the perception of consumers or end users will play a decisive role as the aim of the whole commercialisation process is the purchase of the product by those persons. However, this is true only where the end user makes the decision on the purchase.

48. In the case of medicinal products available only on prescription, the choice between various products is made not upon acquisition but earlier, during the medical consultation. Medicinal products available only on prescription are, because of the risks attaching to them, subject to special control by doctors, and also by pharmacists. This justifies even restrictions on intra-Community trade and finds expression in the relevant secondary legislation. Under the first indent of Article 88(1) of Directive 2001/83 of the European Parliament and of the Council on the Community code relating to medicinal products for human use, Member States are to prohibit the advertising to the general public of medicinal products which are available on prescription only. In principle, therefore, the acquisition of medicinal products available only on prescription is to be decided upon by health professionals and not end consumers.

49. Even if regard is nevertheless in principle had to patients too, because – as submitted in particular by the Office at the hearing – they can influence a doctor’s prescription, in the case of medicinal products available only on prescription their influence has very little significance when compared with the doctor’s responsibility for the decision.

50. In particular, the possible influence exerted by patients cannot mean that the patient is regarded as the reasonably well informed and reasonably observant and circumspect consumer of those products. The average consumer must rather be determined by reference to the group that largely determines decisions on the acquisition of medicinal products available only on prescription, that is to say by reference to prescribing doctors.

51. The risk, pointed out by OHIM and Biofarma, of confusion on the part of a patient who, independently of prescription, is confronted with the mark, is also of little significance, under trade mark law at any rate. In the
Picasso judgment, the Court of Justice regarded the moment when the choice between the goods and marks is made as crucial for assessing the likelihood of confusion. Other points in time, at which confusion on the part of consumers might be more likely because they display a lesser level of attention, are by contrast of secondary importance.

52. Therefore, Alcon is correct in its argument that the relevant public for medicinal products available only on prescription is to be determined by reference to healthcare professionals, and not patients. Despite this submission, the Court of First Instance does not deal with the legal question of how the public under Article 8(1)(b) of Regulation 40/94 is to be defined, nor does it explain why, contrary to Alcon’s submission, it includes end users in the relevant public.

53. Consequently, at the very least the reasoning in the contested judgment is insufficient, both so far as the interpretation of Article 8(1)(b) of Regulation 40/94 is concerned and with regard to the specific inclusion of end users. If the Court of First Instance were in fact to be proceeding on the basis that, irrespective of the product at issue, it is always the average end user that matters, that would involve, in addition to the defective reasoning, an incorrect interpretation of Article 8(1)(b) of Regulation 40/94.

54. In the present case, however, inclusion of the end user can be upheld at least on other grounds. Here it is not two medicinal products available only on prescription that are to be compared but, on the one hand, the group of goods – ophthalmic pharmaceutical preparations – specified in the application and, on the other, the medicinal product available only on prescription that has been marketed under the trade mark TRIVASTAN. As Alcon acknowledged in response to a question put in the course of the oral procedure, on the Italian market not all ophthalmic pharmaceutical preparations are available only on prescription.

55. In the case of trade marks for medicinal products sold without a prescription, the perception of the end user is of very much greater importance. While it is true that these products may be acquired at the instigation of doctors, in many cases the end users decide by themselves on their purchase. Therefore they are also advertised to end users.

56. The perception of the end user is also of importance in particular for an examination, as must be conducted here, of the likelihood of confusion between, on the one hand, a group of goods including both medicinal products sold without a prescription and medicinal products available only on prescription and, on the other hand, a medicinal product available only on prescription. If the end user wants to purchase the product sold without a prescription but, as the result of confusion, asks for the product requiring a prescription, the pharmacy will refuse to sell the latter. If, on the other hand, because of confusion, he asks for the product sold without a prescription although he actually wanted the product available only on prescription for his ailment, it is possible that he will obtain a product that does not help him.
The IPKat is unhappy about this analysis, which effectively closes the door on the doctrine of post-sale confusion. While confusion at the point of sale is crucial, in the real world in which decisions are made as to what to purchase or use, confusion may occur at any time. The wording of the relevant legislation does not confine "likelihood of confusion" to the point of sale, so why should the courts? Merpel agrees: trade mark law often pays lip-service to the notion that it is a consumer protection measure - and here's an opportunity for it to show that this is true, by protecting ordinary humans against the risk of confusing their TRAVATAN with their TRIVASTAN in the medicine cabinet at home.

Dangers in medicine cabinets here and here

9 comments:

Anonymous said...

Sorry, can't agree with the IPKAT. Just what 'post sale confusion' is likely to arise in respect of a prescribed (personal) pharmaceutical.

Post sale confusion can be an issue (see Arsenal case) but each case is different, and the AG cannot be assumed to be laying down any legal principle.

Jeremy said...

Sorry you can't agree. Let's try again. When your consumer goes to the medicine cupboard and finds a number of products in it - even if all of them are prescribed personal pharmaceutical products - he or she may not have a clear recall as to which has been prescribed for what purpose, particularly if (i) the prescribing was done some time earlier, (ii) the cupboard contains various pharma products with brand names that skate as close to the INN as they date, (iii) the household contains more than one person, each of whom may have been prescribed products with slightly different names and (iv) the consumer is elderly, perhaps with poor eyesight or recall, or drowsy, tranquilised or in a state of tension.

The healthcare professional may have no problem distinguishing products at the point at which the decision to prescribe one is made. If only the consumer's lot were so easy!

Anonymous said...

Ah yes, I see your point. But is this kind of 'non trade- related' confusion properly the subject of trade mark law ?

In any event, I can't see how floating the issue really helps the appellants in this case - or have I missed something ?

I think my caution also holds good - beware the ECJ purporting to lay down legal principle. Invariably they are trying to do justice in a given case.

Anonymous said...

Jeremy,

I would be the first to accept that my knowledge of trade mark law is limited. However, the issue of confusion in the medicine cabinet would not appear, in my opinion, to be a trade mark isssue, i.e. one which affects the trade in the products. I cannot complain that I put salt on my cornflakes because it looked like sugar.

Ilanah said...

1. The medicine cupboard only becomes an issue if consumers ask doctors for medicine by name and the doctors agree to prescribe it OR if it's over the counter medicine.

2. Don't forget than in the Picasso case, the ECJ said that it hadn't intended to lay down a general rule on post-sale confusion in Arsenal.

Anonymous said...

In the result, Trivastan and Travatan are so similar that even doctors would confuse it, in particular since both relate to eye problems. In many other cases the situation is different. Would you confuse Alrex (eye drops) and Artex (heart pills), a parallel case quoted by the Advocate General? My doctor would not and even I would not when I go to my cupboard. I agree with the other authors that consumer protection is rather a task for EMEA than for trade mark offices. Trade marks exist to help to make a choice when buying the product. The one who takes the decision to buy a product on prescription is the doctor not the client. Moreover, pharmaceutical trade marks are so complicated (when the allude to ingredients) that when they are on prescription, the average consumere does not pay any attention when buying. He just hands over the prescription. Then he reads the instructions and maybe talks with the pharmacist. But he does not pay attention to the trade mark. End consumers have such a bad memory that already small similarities would be sufficient to come to a likelihood of confusion. Quickly, companies would run out of trade marks.

Ilanah said...

Accurate perception and retention of the TMs by end consumers can't be helped by the fact that the consumers will, by definition, have eye problems!

Anonymous said...

It would appear that Abbott are having problems with their sevoflurane patents. In the US, the Court of Appeal held all claims of US 5,990,176 to be invalid. See:

http://www.patenthawk.com/rulings/06-1021.pdf

EdT

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