Friday, March 25, 2022

ImmunoGen prevails in 145 action. Errors?

This case involves a civil action to obtain a patent under 35 U.S.C. § 145. Appellee [sic: ?] ImmunoGen, Inc.’s (“ImmunoGen”) U.S. Application No. 14/509,809 (“the ’809 Application”) describes methods of administering the immunoconjugate mirvetuximab for the treatment of cancer. After the Patent Trial and Appeal Board (“Board”) of the United States Patent and Trademark Office (“USPTO”) affirmed the examiner’s rejection of the pending claims for obviousness and obviousness-type double patenting, ImmunoGen filed its § 145 suit in the Eastern District of Virginia. The district court determined on summary judgment that the claims of the ’809 Application are “fatally indefinite and fatally obvious” as a matter of law. ImmunoGen, Inc. v. Iancu, 523 F. Supp. 3d 773, 799 (E.D. Va. 2021). ImmunoGen appeals from the summary judgment. We have jurisdiction under 28 U.S.C. § 1295(a)(1). In its analysis, the district court resolved numerous factual disputes against non-movant [sic: ?] ImmunoGen, an error that is fatal to its ultimate ruling. We therefore vacate the grant of summary judgment and remand for proceedings consistent with this opinion.

Of note

Although mirvetuximab showed promise as a cancer treatment, Phase 1 clinical trials revealed it can have severe ocular side effects when administered at a dose of 7 mg per kg of the patient’s total body weight (“TBW”). ImmunoGen determined that a dose of 6 mg per kg of the patient’s adjusted ideal body weight (“AIBW”) successfully maintains exposure of the drug at the therapeutically effective level while keeping it below the ocular toxicity threshold. It is undisputed that AIBW dosing had not previously been used for mirvetuximab, let alone any other immunoconjugate.

Of the law:

Summary judgment is appropriate when, drawing all justifiable inferences in favor of the non-moving party, there exists no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. See Fed. R. Civ. P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48 (1986). We review a district court’s summary judgment determination under the law of the regional circuit, see Syngenta Crop Prot., LLC v. Willowood, LLC, 944 F.3d 1344, 1355 (Fed. Cir. 2019), which, here, is the Fourth Circuit. “The Fourth Circuit reviews the grant of a motion for summary judgment de novo, viewing all evidence in the light most favorable to the non-moving party.” Id. (citing cases). Indefiniteness and obviousness are both issues of law that may rely on underlying factual findings, such as the knowledge, level, or understanding of those skilled in the art. See BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017) (indefiniteness); Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1342 (Fed. Cir. 2015) (same); Acorda Therapeutics, Inc. v. Roxane Lab’ys, Inc., 903 F.3d 1310, 1328 (Fed. Cir. 2018) (obviousness). Obviousness may also rely on factual findings regarding motivation to combine, reasonable expectation of success, and secondary considerations of nonobviousness. Acorda, 903 F.3d at 1328.

An argument NOT made by the Board

Although neither the examiner nor the Board rejected the claims of the ’809 Application for indefiniteness, the USPTO (as permitted by statute) argued in the § 145 action that the term “AIBW” is indefinite. The district court agreed, concluding that the ’809 Application fails to define IBW or AIBW in such a way that a skilled artisan would be informed, with reasonable certainty, as to the scope of the invention.3 ImmunoGen, 523 F. Supp. 3d at 787, 799.

From footnote 5

The district court incorrectly concluded that Example 4 plays no role in the indefiniteness inquiry. See, e.g., Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373 (Fed. Cir. 2014) (“We recognize that a patent which defines a claim phrase through examples may satisfy the definiteness requirement.”); Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1336 (Fed. Cir. 2010) (holding that the phrase “not interfering substantially” is sufficiently definite because a skilled artisan could use “the examples in the specification to determine whether interference with hybridization is substantial”).

For each of these examples, the district court erred in concluding that there is no disputed question of material fact. This error repeats across its other factual findings, including those relating to motivation to combine, reasonable expectation of success, and secondary considerations.

CONCLUSION For the reasons stated above, we hold that the district court erred in granting summary judgment. We therefore vacate the district court’s determination that the pending claims of the ’809 Application are indefinite and would have been obvious, and remand for proceedings consistent with this opinion.


Post a Comment

<< Home