PTAB

IPR2015-00754

Array Biopharma Inc v. Takeda Pharmaceutical Co Ltd

Key Events

Petition

petition Intelligence

Title: Nitrogen-Containing Heterocyclic Compound and Use of the Same
Brief Description: The ’454 patent discloses a genus of nitrogen-containing heterocyclic compounds, pharmaceutical compositions containing these compounds, and methods of their use as antagonists for tachykinin receptors.

Prior Art Relied Upon: EP ’721 (European Patent Application No. 1,623,721 A1).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that EP ’721 discloses a specific chemical species, identified as “Compound 3,” which falls entirely within the scope of the genus claimed in independent claim 1 of the ’454 patent. Specifically, Compound 3 contains a pyrrolidine ring that corresponds to the claimed “Ring A,” a 3-fluorophenyl group for “Ring B,” and a phenyl group for “Ring D,” along with other substituents that satisfy all limitations of claim 1. Petitioner further asserted that the dependent claims are also anticipated, as Compound 3’s structure meets the narrower limitations of claims 2-7. For the composition and method claims, Petitioner argued that EP ’721 explicitly teaches formulating its disclosed compounds into pharmaceutical compositions with acceptable carriers, thereby anticipating claim 12. Claims 13-17, which recite methods of use, were alleged to be inherently anticipated because administering Compound 3 as taught by EP ’721 would necessarily result in the claimed effects (e.g., antagonizing NK receptors), which are inherent properties of the compound.

Prior Art Relied Upon: KR ’645 (Korean Patent 838,645 B1).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner contended that KR ’645 discloses multiple compounds, including “Compound 20” and “Compound 22,” that are species within the genus of claim 1. This ground was presented to show anticipation by a compound with a different core structure than the one in EP ’721. While the compound from EP ’721 has a pyrrolidine ring, the compounds from KR ’645 contain a piperidine ring for “Ring A.” Since claim 1 of the ’454 patent recites either a piperidine or a pyrrolidine ring, Petitioner argued that the disclosure in KR ’645 provides a separate, independent basis for anticipation. Petitioner mapped the structural elements of the KR ’645 compounds to the limitations of claim 1 and its dependent claims. Similar to the first ground, Petitioner argued that KR ’645 anticipates composition claim 12 by teaching the formulation of its compounds into pharmaceutical dosage forms. The method claims 13-17 were argued to be inherently anticipated by the disclosure of administering these compounds to patients for therapeutic purposes.

Method Claim Preambles (Claims 13-17): Petitioner argued that the preambles reciting the intended purpose of the methods (e.g., “method of antagonizing an NK1 receptor” in claim 13 or “method for the treatment of vomiting, nausea…” in claim 17) should not be treated as limitations on the claims. The petition asserted that the body of each method claim defines a structurally complete invention—the act of administering a composition—and the preamble merely states an intended use or result. Therefore, Petitioner contended that the method claims rise and fall with the patentability of the underlying compound and composition claims. If the prior art discloses administering an identical compound, the method claims are anticipated, even if the prior art does not explicitly state the mechanism of action or intended result recited in the preamble.

Petitioner requested the institution of an inter partes review (IPR) and cancellation of claims 1-7 and 12-17 of the ’454 patent as unpatentable under 35 U.S.C. § 102.