The Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) claim construction (and inter partes review (IPR) decision invalidating claims for obviousness) in it recent Genentech, Inc. v. Iancu decision, and also had the occasion to review and affirm the Board's procedure-based denial of patent owner Genentech's motion to amend when Petitioner requested the Board to enter adverse judgment on one ground of IPR institution.

The IPR involved U.S. Patent Nos. 7,846,441 (claims 1-14) and U.S. Patent No. 7,892,549 (claims 1–17) and was brought (in separate petitions consolidated after institution) by Hospira, Samsung Bioepsis, Celltrion, and Pfizer.  The patents were directed to methods for treating disorders characterized by overexpression of Her2 (encoded by the erbB2 gene), which include breast cancer, by administering an anti-ErbB2 antibody (such as Herceptin) and a taxoid, in the absence of an anthracycline derivative (in the '441 patent claims) or in the presence of "a further growth-inhibitory agent" or "a further therapeutic agent."  Claim 1 of the '441 patent and claims 1 and 5 of the '549 patent are representative:

The '441 patent:

1.  A method for the treatment of a human patient with a malignant progressing tumor or cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an in-tact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an anthracycline derivative, to the human patient in an amount effective to extend the time to disease progression in said human patient, without increase in overall severe adverse events.

The '549 patent:

1.  A method for the treatment of a human patient with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient in an amount effective to extend the time to disease progression in the human patient, wherein the antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.

5.  A method for the treatment of a human patient with breast cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of a combination of an anti-ErbB2 antibody which binds epitope 4D5 within the ErbB2 extracellular domain sequence, a taxoid, and a further therapeutic agent, to the human patient.

(where the italicized limitations were relevant to the Board's decision).

The Board rendered Final Written Decisions finding all claims in these patents to be obvious.  The Board's decision was based on its construction of the phrases "an amount effective to extend the time to disease progression in the human patient" and "an effective amount" to be in the context of situations where there is no treatment.

The Federal Circuit affirmed, in an opinion by Judge Moore joined by Judges Lourie and Wallach.  The Federal Circuit noted that Genentech did not challenge the Board's obviousness determination, just the claim construction upon which it was based.  The panel reviewed the Board's claim construction de novo, under Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015), and focused on the prosecution history in its analysis, because neither the claim language nor the specification "clearly define[d]" the terms at issue before the Court.  The Examiner rejected the term "extend the time to disease progression" as being indefinite, without the specification providing "a standard for ascertaining the requisite degree," wherein "one of ordinary skill would not be reasonably apprised of the scope of the invention."  The opinion sets forth the "give and take" between the Examiner and applicant on this issue:

The Examiner:

Specifically, it is never set forth what the extension of time to disease progress is relative to, for example, is the extension of time to disease progress relative to untreated patients?  Patients who received antibody or taxoid alone?  Patients who received antibody and an anthracycline?

Applicant's response:

[T]he expressions "extend the time to disease progression" and "response rate" are clear from the specification (see, in particular, page 15, lines 15-17; and pages 42-43) and would be readily under-stood by a skilled oncologist.  Clearly, the combination of an anti-ErbB2 antibody and a taxoid is administered in an amount effective to extend the time to disease progression relative to an untreated patient.

The Board considered Genentech to have made an "express choice" in making this response, and that the Examiner allowed the claims of the '441 patent based on this response.  The Federal Circuit agreed with the Board's apprehension in this regard, saying that Genentech had "provided an unequivocal, direct response to the examiner's inquiry—that the term 'extend the time to disease progression' was compared to an untreated patient."  The construction Genentech advocated before the Board and on appeal was one the Examiner suggested and that Genentech rejected, according to the opinion.

On these facts, the panel found no error in how the Board had construed the claims.  Specifically, the panel held that "[t]he Board's construction of the term 'extend the time to disease progression' as requiring comparison to an untreated patient is consistent with the claims, specifications, and prosecution histories of the '441 and '549 patents."

The Federal Circuit also upheld the Board's decision not to grant Genentech's motion to amend, based on failure to show good cause.  The Board rejected Genentech's argument that it had a statutory right to amend under § 316(d)(1) and based its "good cause" requirement on 37 C.F.R. § 42.121(c).  In addition, because Petitioner had requested an adverse judgment on one of the grounds for institution under 37 C.F.R. § 42.73(b), the Board held (and the Federal Circuit agreed) the issue was mooted.  And the Court responded to Genentech's argument that the rules do not permit "partial" adverse judgment by relying on 37 C.F.R. § 42.5(b), which gives the Board discretion to "waive or suspend a requirement of part[] . . . 42." The Board's use of this discretion was consistent with the Supreme Court's statement in SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018), that "Congress chose to structure a process in which it's the petitioner, not the Director, who gets to define the contours of the proceeding."  The significance of these procedural issues was that Genentech had submitted a motion to amend in the remaining IPR ground and in the absence of any showing of prejudice (that the opinion states Genentech had not shown) the Board was within its discretion require a showing of good cause, and in its absence, to deny a further motion to amend.  And, on appeal, Genentech was unable to satisfy the stringent requirement of establishing an abuse of discretion by the Board.  ("The Board abuses its discretion if the decision: (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision."  Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d 1267, 1271 (Fed. Cir. 2017)).

Genentech, Inc. v. Iancu (Fed. Cir. 2020)
Panel: Circuit Judges Lourie, Moore, and Wallach
Opinion by Circuit Judge Moore