How are patents to "a second medical use" enforced?

Question

As I understand it, the EPO allows claims to a second medical use of a known substance. These claims are not the same as the formerly used "Swiss-type claims" that were drawn to the use and were therefore method claims.

An example in the EPO rules is:

"Product X for use in the treatment of cancer*

If a substance is previous known, what makes a bottle of it infringe a claim that has to do with an intended use? Sitting on a shelf it is the same substance that was long known. Would it be the labeling of the bottle?, the advertisements of its maker/bottler? I understand that methods of treatment are not patentable in the EPO (unlike in the U.S.). But this seems like form over substance since the intended use is not manifest until the unpatentable use is about to occur.

To the thinking of a practitioner of U.S. patent law it is very illogical for a known substance to be patentable with no physical change.

Answer 1

European Patents may indeed protect products for a second medical use. The Guidelines explicitly state "known products" for second (or further) medical use. The patent is granted depending on whether the further medical use is inventive over the prior art, because obviously the product itself is not. The reason behind all this is that protection of second medical uses fosters investigation of new ways of treating diseases without having to invent a new compound.

Whoever invents a compound can protect the compound itself if it has some use and is inventive, but can also protect the compound "for medical use" without specifying which disease it cures, thereby having protection for all medical uses. Said claim will be allowable only if it is shown that the compound cures some disease, otherwise the applicant is not entitled to the protection for medical use, so another applicant could take the known compound and protect it "for medical use" should the latter applicant show that it cures a disease. Then, other medical uses of the compound that are deemed inventive can also be protected.

Concerning the actual question, there are no uniform criteria between the Contracting States of the EPC when it comes to enforcement and infringement of second medical use claims. Several good explanations about these legal questions can be found in this article from Finnegan (I am in no way related to Finnegan) that summarizes the attempts of UK Courts to shed some light on the matter. One of the conclusions if not the main conclusion is as follows: "The Court recognised an obligation on a manufacturer to take active steps if it is to enter a market where it stands to benefit from the patentee’s patented invention. In order to avoid infringement, the manufacturer must show that it has taken all reasonable steps in its power to prevent its drug from being used in accordance with the patent."

The labeling and advertisements of the company commercializing the product are very important in the enforcement of the European Patent as you suspected, George White. It would seem in light of the article that this is not enough though, and some additional steps are expected from the company to avoid infringement of a European Patent for a second medical use.

Answer 2

EDIT: Second medical use patents are enforced as products for a give use. So the alleged infringer must have intention the product is used in a certain way to be found liable. What follows is a possibly-off-topic-but-hopefully-useful discussion of how intention might be considered in a second medical use situation. Note that the original question specifically asked about labeling and marketing. So this might seem off topic but actually gets to the heart of what the question is about, even if that's not apparent at first glance.

Excellent question. As pointed out, this has been the subject of some interesting court cases in recent years.

The interplay with the regulation of medicines is important here. In most (perhaps all?) countries a compound cannot be sold as being for the treatment of a disease (i.e., as a medicine) without an appropriate marketing authorization (MA) from the relevant regulator. The MA is for a particular condition or limited set of conditions. This allows you to put on the label (a.k.a., the SmPC or patient information leaflet) what the compound is for, medicinally, and to talk about it as a medicine in your marketing materials, etc.

If you come to know that the compound can be used in a new medical use, then you can't just start selling it for that use. You'd have to have an appropriate MA to update the label to include the new condition, or the regulator would come down on you like a tonne of bricks. If you have the right MA and you advertise the compound as being for the new medical use, then it's pretty clear what your intentions are. The holder of a second medical use patent covering the new use would therefore be able to say that you were selling the compound for the use in their patent: you've pretty much been forced to admit it to avoid heat from the regulator.

But you'd still be free to sell the compound for the use in your original MA, i.e., for the treatment of the old condition. You just can't say it's for treatment of the new condition. You might even manufacture the same product with multiple different versions of the label for different territories, which might be as simple as a sticker that goes on the boxes/bottles that are shipped to a territory where the second medical use is patented. This process is called skinny labeling or label carve-out.

However, where this gets complicated is that although you might never say your product is for the new use, it's possible that doctors will prescribe your product for the new use anyway. This is called off-label prescribing and is a routine thing doctors do.

SECOND EDIT: What if the alleged infringer knows that its product is being used off-label. What if they tacitly encourage it? Are they liable now? This is a complex infringement question that has been reviewed by courts across Europe.

So the position that some courts in Europe have reached is that the manufacturer has to do something to avoid off-label use in order to avoid infringement. Exactly what will depend on the territory.

It should be noted that the Finnegan article linked to in an earlier answer is a little out of date as the UK Supreme Court has since issued a decision on this topic (summary here).

Answer 3

Yes, during evaluation of infringement of a medical use patents in US or Europe the courts consider only what is present in the PIL(PATENT INFORMATION LEAFLET). It would not look beyond lable, the basis is that the regulatory agencies had reviewed and approved the drug for the indication and any use out side the PIL would attract a flag from regulatory agencies ( eg: Purdue pharma promotion of opioids).

The product can be marked even though there is a patent for new medical use. Statue had proved FDA To approve a product that doesn't have all indications i.e., a product x for an indication Y can be marked, even when there is patent for indication Z.

There are many instances where FDA has authorised generics for one indication when the brand drug has more than one indication. The recent case I would suggest is the case of NORVASC ( PFIZER VS TEVA) this case gives you understanding of lable carving/ skinny lable.