From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Wednesday, 1 February 2012

What's the use of contraception? Don't ask the EPO ...

Never mind all this patent stuff, says
the IPKat, this suit is the best form
of contraceptive. Wear this and you
should be quite safe ...
Having announced the appointment of Darren Smyth as this weblog's third guest Kat for the first half of 2012  (see Katnews 1, here), this Kat is doing Darren the favour of posting his first piece on his behalf.  From now on, Darren's doing it himself.

Darren's maiden blog contribution focuses on patents and, in particular, on the concept of the use claim:
"This temporary feline has been musing on the European Patent Office (EPO) Board of Appeal (BoA) decision T 1635/09, which was published in OJEPO 11/2011. Ostensibly it is about contraception, but at its heart is a more fundamental question – what is a use claim? 
Practitioners will be aware that the EPO regards claims to certain methods of contraception, namely those “applied in the private and personal sphere of a human being” as lacking in industrial applicability (T 74/93: however, this decision did emphasise that “a method of contraception is not excluded per se from patentability under the aspects of industrial application as stipulated in Article 57” of the European Patent Convention, but only because “in this particular case the method is intended for application by the woman herself”). 
On the other hand, a method of contraception is intrinsically not a method of medical treatment, because pregnancy is not a disease. However, if a claimed method of contraception encompasses prophylaxis against side-effects (for example side effects which may be attendant upon taking a contraceptive pill), then such a method claim does fall within the exclusion of patentability of methods of medical treatment (T 820/92). 
Against this background comes T 1635/09. The invention was concerned with a hormone-based low-dose contraceptive pill, in which a purpose of selecting a low dose of the hormones was to reduce the side effects. The part of the decision concerning the patentability of contraceptive methods is all square with T 820/92, so Headnote I states:
Use as an oral contraceptive of a composition in which the claimed concentrations of the hormone content are selected at such a low level as to prevent or reduce the likely pathological side-effects of such an oral contraceptive is a therapeutic method excluded from patentability under Article 53(c) EPC.
Unsurprisingly, the BoA also held that, in such a case, the therapeutic and non-therapeutic aspects of the use cannot be separated, so the exclusion from patentability cannot be overcome simply be specifying “non-therapeutic” in the claim (See headnote II). 
In contrast to the situation in T 74/93 and T 820/92, which were appeals from the Examining Division, the proprietor was in the unfortunate position that the EPO had granted the patent, which was under opposition, with the offending claims to “Use of ….. [a] ….. dosage form for contraception …”. So when the proprietor tried to change the claims to a Swiss-style form “Use of … to produce … [a] dosage form for contraception …”, it fell to be examined what was the effect of such a change of claim format, and, in particular, whether it constituted an extension of scope of protection under Article 123(3) EPC. 
From this analysis emerges the fascinating (but unfortunate for the proprietor) insight that all use claims are not at all equal. 
So what is a “use” claim? The EPO explicitly recognises “use” as one of the four permitted claim categories (product, process, apparatus, use) in Rule 43(2). However, the national infringement law of patents in European countries recognises only two categories of claim – product and process. So apparatus is a type of product and use is a type of process, right? Well, apparently not.  It turns out that some use claims are process claims, and some use claims are not process claims. How do you tell the difference? It all comes down to whether Article 64(2) EPC applies. Art 64(2) states:
If the subject‑matter of the European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process.
The BoA looked at the Enlarged Board of Appeal decisions that recognise Swiss-from use claims (G1/83) and second non-medical use claims (G 2/88), and found a major difference in the way that Art 64(2) would apply. On the one hand, G 2/88 held:
5.1 The Board has considered the effect of Article 64 (2) EPC upon the question whether an amendment involving a change from, for example, a compound claim to a claim to a use of such compound will cause extension of the protection conferred. In particular, it could be considered that such a "use" claim is notionally equivalent to a claim to a "process including the step of using the compound", and that the effect of Article 64(2) EPC is to extend protection to the "product" of such process (whatever it is); thus there would be extension of protection within the meaning of Article 123(3) EPC by reason of the change from a claim to one physical entity (the compound) to a different physical entity (the "product" of the process of using the compound).
In the Board´s view, in relation to such a change of category to a "use" claim, Article 64(2) EPC does not normally have such an effect, however, for the following reason. Article 64(2) EPC is not directed to a patent whose claimed subject-matter is the use of a product to achieve an effect (this being the normal subject of a use claim): it is directed to a European patent whose claimed technical subject-matter is a process of manufacture of a product; the Article provides that for such a patent, protection is conferred not only upon the claimed process of manufacture, but also upon the product resulting directly from the manufacture. 
Thus, provided that a use claim in reality defines the use of a particular physical entity to achieve an "effect", and does not define such a use to produce a "product", the use claim is not a process claim within the meaning of Article 64 (2) EPC.
Thus a “second non-medical use” claim, including a claim to use in contraception, is not a process claim to which Art 64(2) applies. 
On the other hand, G1/83 stated (emphasis from BoA in T1635/09):
It seems justifiable by analogy to derive the novelty for the process which forms the subject-matter of the type of use claim now being considered from the new therapeutic use of the medicament and this irrespective of the fact whether a pharmaceutical use of the medicament was already known or not.
So, according to the BoA in T1635/09, the EBA in G1/83 “deemed the Swiss-type claim to be a process of manufacture the novelty of which, however, exceptionally arises from the intended use of the manufactured product”. This type of use claim therefore was a process claim to which Art 64(2) would apply. 
With relentless and ruthless logic, therefore, the BoA concluded:
It follows from the above finding that the process of manufacture to which claim 1 of auxiliary request 23 [the Swiss-form claim], in view of its content, is directed goes beyond the scope of protection conferred by the use claims as granted: in the case of claims directed to a process of manufacture, the effect of Article 64(2) EPC is to extend protection to the "product" obtained by such process (whatever it might be), whereas a use claim does not encompass the manufacture of the pharmaceutical product (G 1/83, Reasons 11), with the result that its scope of protection does not extend to the directly resulting product. Consequently, the requirements of Article 123(3) EPC are not met.
So the change of claim category from use (not a process) claim to use (really a process) claim was held to enlarge the scope of protection, and was therefore not allowed. 
Having decided this, of course the BoA held an EPC 2000 claim in the form “dosage form … for contraception” likewise to offend Article 123(3) EPC. 
The final result (for these and some other reasons): patent revoked. 
It is quite unlikely that someone will again be in the position that the EPO has allowed an unallowable claim to a method of contraception. So practitioners will probably not be changing the way they go about their business. But for those who have wondered what a use claim is really about, this case finally gives some insight. Merpel thinks that it shows just how right the US patent law is not to recognise use claims at all".


Peter Smith said...

I'm still trying to understand the first part of the decision: "Use ... of a composition in which the claimed concentrations of [the effective ingredient] are selected at such a low level as to prevent or reduce the likely pathological side-effects of [the effective ingredient] is a therapeutic method excluded from patentability under Article 53(c) EPC."

To my mind it can't be a therapeutic treatment if what you are treating is a condition that the patient never had because you failed to give them the substance that would have caused it. By this logic you could conclude that chocolate containing no arsenic is a pharmaceutical because it has the effect of reducing arsenic poisoning.

Anonymous said...

It is minimisation of side-effects, hence is directed to minimisation of the pathological effects caused by the (already present) active ingredient.

I'd change your chocolate supplier if I was you.

Darren Smyth said...

Peter makes a good point. The decision contains many aspects that are interesting, of which I focussed only on some. On the Art 53(c) aspect, it is also clear from para 3.1 of the decision that statements in the description influenced the BoA, as well as an analysis of how the claimed invention differs from the prior art. Both of these are open to question, as in other circumstances the Art 53(c) analysis would be independent both of the patentee's statements and of the novelty/inventive step analysis.

ex-examiner said...

An examiner once told me that, in less enlightened days prior to the UK PA 1977, inventions for condoms were refused as a matter of policy under the royal prerogative and had to be claimed as "A child's balloon comprising...".

Anonymous said...

In the case of hormonal contraceptives which typically contain both a progestin and an estrogen, the hormonal activity has both a therapeutic application (a treatment for estrogen and/or progesterone deficiency related conditions) and also a contraceptive one.

Since the same hormonal activity underlies both the medical and contraceptive uses they are inseparable. T74/93 found that a method of contraception is not a method of treatment and as such is not excluded by Art.53(c) but rather than it is a private matter and as such is excluded from industrial application. However, this decision related to a barrier method of contraception, not a hormonal one.

I feel that a far more practical solution for hormonal contraceptives in general is to allow as novel a second medicinal indication claim under Art. 54(5) relating to a contraceptive hormonal indication as well as to a therapeutic hormonal indication. Pregnancy is certainly not a disease, but the hormonal effects which the contraceptive pill employs to prevent it are the same as those which underlie a broad range of other therapeutic uses.

If the interpretation given in T74/93 is applied to hormonal contraceptives, then an inventor who develops a hormonal application of a pharmaceutical known for a different activity, cannot claim a method of contraception because it is not industrially applicable and cannot claim a contraceptive indication in accordance with Art. 54(5) because it is not novel. This catch-22 situation can only be avoided by considering hormonal contraception to be a method according to Art. 53(c) and thus benefiting from the special novelty provided by Art. 54(5).

Darren Smyth said...

To Anon on Friday February 03 at 3:01, T74/93 makes clear that the "catch-22" situation that its analysis creates does not apply to contraceptive methods generally, but only in that individual circumstance where the method is particularly private in its application. It states that industrial applicability is not excluded for contraceptive methods as such, in a general manner. Therefore, there is no reason in principle why a method of hormonal contraception cannot simply be regarded as industrially applicable. I also note that in both T74/93 and T820/92 there were allowable composition/product claims, so there was in fact no "catch-22" in those factual situations.

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