USA Trends and Developments Contributed by: Ed Haug, Andrew Wasson and Wan Chieh (Jenny) Lee, Haug Partners LLP
not disrupt prior enablement case law, including the longstanding Wands factors. In another non-precedential opinion, In re Pen, the Federal Circuit provided a further glimpse at the potential expanded applicability of Amgen to broad claims beyond antibody technologies (In re Pen, 2024 US App LEXIS 14235 (Fed Cir 2024)). The claims at issue in Pen were directed to a chemical composition, a polycylic metallole heteroatom rich conductive long chain polymer, having a particular chemical structure containing n number of repeating units, each unit containing a number of R groups where “R is any substitu - ent, and x is the number of R substituents.” In rejecting the claims at issue, the USPTO exam - iner applied the Wands factors and discussed reasons why a skilled artisan would not be able to make and use the claimed invention with - out undue experimentation. This rejection was upheld by the Board and affirmed by the Fed - eral Circuit. The Federal Circuit relied on Amgen to explain that “[i]n short, the more you claim, the more you must explain”, and affirmed the Board’s rejection of the pending claims for lack of enablement. Most recently, the Federal Circuit affirmed the district court’s determination of enablement for claims to a pharmaceutical composition com - prising a combination of valsartan and sacubitril or sacubitrilat (Novartis Pharms. Corp. v Torrent Pharma Inc, 2025 US App. LEXIS 486 (Fed Cir 2015)). Some recent district court decisions also shed some light on distinctions from Amgen that support a finding of enablement. For example, in Regeneron Pharma v Mylan Pharma, the district court held that claims for an ophthalmic formu - lation of a vascular endothelial growth factor (VEGF) antagonist was sufficiently enabled by the description provided in the patent specifi - cation (Regeneron Pharm., Inc. v Mylan Pharm.
Inc., 714 F.Supp.3d 652 (N.D.W.Va. 2023)). The district court distinguished the facts of this case from Amgen because “[h]ere, in contrast, the claims are directed to formulations of a specific protein at a specific concentration – not “an entire kingdom” of proteins.” The claims recite specific structures, and the specification provides exam - ples and lists of excipients and amounts to use. The district court relied on expert testimony and applied the Wands factors to reach the conclu - sion that “the Defendants have failed to demon - strate by clear and convincing evidence that the asserted claims of the Product Patent are invalid for lack of enablement.” More recently, in Supernus Pharma v Torrent Pharma, the district court applied the Wands factors and held that claims directed to sus - tained release formulations of topiramate “which is released immediately and continuously upon administration from the formulation” and where the extended release component “exhibits a maximum plasma concentration of topiramate in vivo at 16 or more hours after a single initial dose” met the enablement requirement (Super - nus Pharms., Inc. v Torrent Pharms. Ltd., 2024 US Dist LEXIS 49856 (DNJ 2024)). In upholding validity of the claims, the district court distin - guished this case from Amgen in two meaningful ways: (i) the claims do not encompass an entire genus of release-controlled coatings regardless of physical characteristics or chemical proper - ties; and (ii) expert testimony indicating that it would have been routine to adjust the coating precisely to achieve a desired release rate once a first in-vitro dissolution test has been con - ducted. In view of the developing post-Amgen case law, patentees should anticipate invalidity chal - lenges alleging lack of enablement and prepare litigation strategy in advance. Such preparation
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