Patent Law

Outside the Membrane

By Gary Odom and Jordan Kuhn

Amgen and Ariad got into a tussle over 6,410,516. Ariad started with a DJ action, asserting invalidity and noninfringement. Amgen counterclaimed infringement. '516 claims reducing a specific protein's activity (NF-kB). The claim construction crux was whether the claimed activity occurred outside a cell, inside, or it didn't matter. But of course it mattered.

Amgen et al v. Ariad et al (CAFC 2009-1023) non-precedential

The '516 patent proposes several classes of molecules potentially capable of reducing NF-kB activity, such as specific inhibitors, dominantly interfering molecules, and decoy molecules... These classes of molecules are meant to act inside the cell... In contrast, the accused drug--Amgen's Enbrel--acts outside the cell. Enbrel acts by binding to free TNF-a outside the cell, thus interfering with the TNF-a's ability to reach the receptors on the cell and induce NF-kB activity... The prior art also contains example agents that act outside the cell. For example, antibiotics act by killing bacteria, which consequentially reduces the amount of TNF-a released by macrophages in response to the bacterial infection. The use of decoy molecules, Enbrel, or antibiotics all may ultimately result in a decrease of NF-kB activity, but the question remains what is included in the properly interpreted scope of "reducing NF-kB activity in cells."

The district court agreed with Amgen that the asserted claims are limited to actions that reduce NF-kB activity wherein those actions occur within the cell.

Amgen prevailed in the district court by arguing that the outer boundary of the asserted claims' scope is the cell membrane. The district court agreed with Amgen that agents that act outside the cell do not infringe, but that agents that act inside the cell may.

Ariad tried to fudge where the boundary might be.

Rather, Ariad would place the boundary at some indefinite place outside of the cell such that accused drugs such as Enbrel are captured but certain prior art drugs, such as antibiotics, are left out of the claim scope.

Case law over the cell call -

"Claim terms should generally be given their ordinary and customary meaning and . . . such meaning is one 'that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.'" ICU Med., Inc. v. Alaris Med. Sys., 558 F.3d 1368, 1374 (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc)). "[T]he person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Phillips, 415 F.3d at 1313; see id. at 1317 ("It is therefore entirely appropriate for a court, when conducting claim construction, to rely heavily on the written description for guidance as to the meaning of the claims."). Furthermore, "the prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

The specification was dispositive.

The specification of the '516 patent divides external influences (e.g., TNF-a) and intracellular transducers (e.g., NF-kB). That division is at the cell membrane, and the claim language "reducing NF-kB activity in cells" is consistent with this division.

Thus, the specification assumes the existence of an external influence whose effect can be modified by acting within the cell. In contrast, Enbrel acts to stop the external influence (TNF-a) from reaching the cell.

Arguments made during reexamination "further reinforced the division between actions taken inside and outside of the cells."

Affirmed. Not even close.

Full post as published by The Patent Prospector on June 03, 2009 (boomark / email).