Medicine And Medically Related Inventions

In general, the standards for PCT applications apply equally to EPO applications. One major difference is that PCT allows incorporation by reference (as does the United States ), but the EPO does not. During prosecution the EPO examiner requires the applicant to select from the reference whatever material should be inserted into the application, and then insert that material. From time to time that really put the patent attorney on the spot, because references usually use very different terminology from the current application, and incorporation of the text from a large reference, or even a significant amount of material from a relatively short reference, can lead to all sorts of apparent inconsistencies in the application.

The biggest difference from my perspective is that the EPO generally limits the claims to examples that are enabled in the Specification. Thus, whereas a U.S. patent claim may recite a chemical composition in which an R group can be any of H, OH, lower alkane, lower alkyne, and so forth, the EPO may well limit the applicant to H, OH, and the three or four specific alkanes for which the Specification included synthetic schemes. Specifications geared towards EPO should therefore contain many more examples, which of course is fairly difficult to accomplish if the applicant has never even made the claimed compounds.

Another major distinction is that the EPO will not allow claims to methods of treating humans. Article 52(4) EPC expressly excludes from patentability any method of treating humans or animals by surgery or therapy and diagnostic methods practiced on humans or animals. In general, the law reflects a policy decision that physicians and veterinarians should not be hindered in their practices by the patent system . For example, use of a laser to modify a corneal implant was unpatentable, in part because it would likely be performed by a physician .

On the other hand the exclusion is narrowly construed such that a claimed method that has little or no impact on the way a physician practices medicine is likely to fall outside the scope of Section 4(2) . Indeed, the reality is that most medical inventions can still be claimed, provided an applicant uses specialized claiming formats such as the so-called "Swiss type" (i.e., "second medical use") type claims . Instead of claiming administering a given drug to treat a disease, the patent attorney simply begins the claim with the magic words:

"The use of <<a substance or composition>> for the preparation of a pharmaceutical composition for the treatment of <<a disease>>, wherein...."

Why this is legal is anyone's guess. My thought is that the Europeans don't want to be left out of the development of critical areas of medicine because of their patent system. In typical lawyer doubletalk, however, the distinction rests on a "nice" distinction that only an attorney could love{fn} T 775/97, not published in OJ EPO. {/fn}.

"… the reason why claims in the second format of claims (‘Swiss type claims') qualify as representing an ‘industrial' activity outside the scope of the exclusion from patentability under Article 52(4) EPC is simply the fact that the mere manufacturing of a product, irrespective of whether that product is (also) a ‘medicament' because of its capacity to produce certain effects on or in the human or animal body when administered to it, does not necessitate or comprise any action on an individual human or animal body and, therefore, does not constitute a treatment of such body by surgery or therapy".

One excellent source for deciphering what is and is not patentable with respect to medical inventions is provided by the British Patent Office for medical and biotech inventions.