We are all painfully aware of broad patents that claim methods of affecting a biological activity, and the difficulty these patents give when clearing pharmaceutical products. The Federal Circuit's decision to strike down the University of Rochester's COX-2 patent, which broadly claimed "administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment," for lack of written description, was a watershed moment reversing the Patent Office's tendency to grant these patents. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004). In that case, the Federal Circuit held that the patent was invalid for lack of written description because the specification did not describe any compounds that actually inhibited the PGHS-2 gene product.
Patent attorneys have adapted their drafting strategies in response to the COX-2 decision, and now describe huge genre of compounds in the specification capable of performing the recited function. Confronted with these huge genre, the argument with the Examiner now most often boils down to enablement, and whether the claim is sufficiently enabled throughout its scope based on the well-worn Wands factors.
In Ex Parte Rajinder Singh et al., 2017 Pat. App. LEXIS 3129, the Examiner and the Board took a different approach to the issue, and based the rejection on the specification's definition of "therapeutically effective amount." Claim 1 recited a method of inhibiting JAK activity in a cell, and specifically claimed:
A method for inhibiting JAK activity in a cell, comprising contacting the cell with a therapeutically effective amount of a compound having a formula I a tautomer, N-oxide, or salt thereof, wherein: [a genre of compounds was recited]
Even though the specification described thousands of compounds capable of inhibiting JAK activity, this was not enough to enable the claim because, according to the Board, the claim covered the treatment of any disease cited in the specification that was treatable by JAK inihibtion, and the claim did not adeqautely enable treatment of all these diseases. Even though the claim did not recite any diseases, the Board read a disease requirement into the claim based on the requirement for a "therapeutically effective amount," and the definition of "therapeutically effective amount" in the specification. According to the Board:
The Specification explains that the term "'therapeutically effective amount' refer[s] to an amount of a compound sufficient to treat a specified disorder or disease or one or more of its symptoms and/or to prevent the occurrence of the disease or disorder"
The Board's reliance on a "therapeutically effective amount" to bootstrap all of the diseases from the specification into the claims was certainly creative, and possibly justified by the Board's authority to give claims their broadest reasonable interpretation. However, to us it reflects more the Patent Office's antipathy toward mechansim of action claims. But this antipathy is not all bad news. After all, if reference is not enabling, it also does not qualify as prior art! See MPEP 2121. More on this in subsequent posts.