BIOSIMILAR IPR (INTER PARTES REVIEW) CONSTRUED CLAIM TERM GLOSSARY

            In any proceeding before the U.S. Patent Office, including an IPR (Inter Partes Review), claim terms in an unexpired patent are interpreted according to their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b).  Under that standard, claim terms are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure.  This “broadest reasonable construction” standard in an IPR proceeding is presumably broader than the “ordinary meaning” standard used by a district court.  In view of the different standard that is used by the PTAB to construe claims, I put together the following glossary of construed claim terms from biosimilar IPR proceedings.[1]  Overall, the construction of claim terms by the PTAB seems reasonable and in line with what would be expected from the narrower “ordinary meaning” standard.

Biosimilar IPR Glossary

·                     “about” - No need to construct at this stage of proceeding.

IPR2015-01792, Paper No. 14, at 7.

·                     “a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα) antibody, or an antigen-binding portion thereof, . . . wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7” – “the broadest reasonable interpretation of the entire phrase allows for either an antibody comprising the light chain variable region and the heavy chain variable region D2E7, or one or more fragments of D2E7 that retain the ability to specifically bind TNFα.”

IPR2015-01514, Paper No. 9, at 9-10.

·                     “a human patient who experiences an inadequate response to a TNFα-inhibitor” in the preamble recites the essence of the invention and is limiting.

IPR2015-00417, Paper No. 11, at 8. 

·                     “all of the domains of the constant region of a human IgG immunoglobulin heavy chain other than the first domain of said constant region” means “‘-hinge-C_H2-C_H3’ region of a human IgG immunoglobulin heavy chain.”

IPR2015-01792, Paper 14, at 7.

·                     “A method of reducing signs and symptoms in a patient with moderately to severely active rheumatoid arthritis” in the preamble is not limiting.

IPR2016-00189, Paper No. 8, at 9.

·                     “A method of reducing signs and symptoms in a patient with moderately to severely active rheumatoid arthritis” is not limiting beyond specifying the patient to whom the anti-TNFα antibody is administered.

IPR2016-00188, Paper No. 8, at 6.

·                     “[a] method for treating rheumatoid arthritis” in the preamble is not limiting.

IPR2016-00172, Paper No. 9, at 8.

·                     “antigen-binding portion" must include the light chain variable region and the heavy chain variable region of D2E7 but need not include the complete light chain and heavy chain variable regions of D2E7.  Note: The petitioner’s position that the term “encompasses an antibody fragment that can be as small as one CDR (5 to 17 amino acids)” was rejected by the PTAB.

IPR2015-01514, Paper No. 9, at 9.  See also IPR2015-01517.

·                     “chemotherapy consisting of CVP therapy” – “The ‘consisting of’ language used in connection with the CVP therapy limits the chemotherapeutic portion of the claimed regimen to only the CVP treatment, to the exclusion of other agents.”

IPR2015-00418, Paper No. 14, at 5.

·                     “CVP therapy to which the patient responds, followed by rituximab maintenance therapy” means “administration of CVP therapy, to which the patient responds according to the criteria set forth in the ’172 patent.”[2]

IPR2015-00418, Paper No. 14, at 6.

·                     “for a time period sufficient to treat the rheumatoid arthritis” means “for a time period sufficient to reduce the signs, symptoms, and/or progression of RA.”

IPR2016-00172, Paper No. 9, at 10.

·                     “40 mg dosage unit form” - “encompasses a syringe filled with 40 mg of D2E7.”  IPR2016-00188, Paper No. 8, at 7.

·                     “for a time period sufficient to treat the rheumatoid arthritis” – “we do not need to interpret expressly the claim term . . . except to note  . . . that the claim term does not require a particular level of efficacy.”  Note: The PTAB did not adopt Patent Owner’s construction of “for a time period sufficient to reduce significantly the signs and symptoms of rheumatoid arthritis.” 

IPR2016-00408, Paper No. 9, at 7; See also IPR2016-00409.

·                     “stable” as used in the preamble is limiting and means “formulation would need to be stable for storage and use.”  Note: Petitioner’s position that “stable” bears no patentable weight, solely on the basis that “stable” appears only in preamble language was rejected.

IPR2015-01514, Paper No. 9, at 7. See also IPR2015-01517.

·                      “TNF receptor” -  “[S]hould be given its ordinary meaning, but we are not persuaded that this claim limitation needs an express construction at this stage of the proceeding.”

IPR2015-01792, Paper 14, at 5.

---

[1] The claim constructions are taken from the PTAB’s decision to deny or to institute an IPR proceeding.  The PTAB’s “views on claim construction shall not be deemed final until the record is complete, [the PTAB has] finished [its] review of the complete record, and rendered [its] Final Decision.  IPR2015-00417, Paper No. 11, at 10. 

[2] Patent No. 8,329,172 “provides specific criteria for a complete response (CR) and a partial response (PR) and distinguishing such patients from ‘non-responders’. The CVP must be followed at some time by the rituximab maintenance therapy, with no disease relapse occurring between the patient’s response to the CVP therapy and the maintenance therapy.”  Id.