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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`PROTIVA BIOTHERAPEUTICS, INC.,
`Patent Owner.
`
`
`___________________
`
`Case No. IPR2019-00554
`Patent No. 8,058,069
`___________________
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE
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`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`10822208
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`Case IPR2019-00554
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`I.
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`INTRODUCTION
`Petitioner ModernaTX, Inc.’s1 (“Moderna”) original expert in this
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`Patent No. 8,058,069
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`proceeding, Dr. Janoff, passed away shortly after his October 2019 deposition.
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`Petitioner engaged a new expert, Dr. Anchordoquy, to address arguments that
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`Patent Owner Protiva Biotherapeutics, Inc. (“Protiva”) submitted in its Patent
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`Owner Response (“POR”). Protiva now seeks to limit the record available for
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`the Board’s consideration through its baseless motion to exclude the entirety of
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`Dr. Anchordoquy’s opinions. Protiva’s motion, however, is both procedurally
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`improper and substantively incorrect.
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`To begin with, Protiva spends much of its motion improperly arguing
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`that (1) the Anchordoquy Reply Declaration (EX1020) goes beyond the bounds
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`of the arguments in the Petition (Mot. 3-5), and (2) impugning the credibility of
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`Drs. Janoff and Anchordoquy (id., 5-7). The Board’s rules are clear that a
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`motion to exclude should not “address arguments or evidence that a party
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`believes exceeds the proper scope of reply or sur-reply” or present “arguments
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`regarding weight” (i.e., credibility). Trial Practice Guide Update, 83 Fed. Reg.
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`39,989, 16 (Aug. 2018) (“TPG”).
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`Substantively, Protiva’s motion fares no better. For example, Dr.
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`Anchordoquy has over thirty years of experience with lipid carrier particles,
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`1 ModernaTX, Inc. was formerly known as Moderna Therapeutics, Inc.
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`Case IPR2019-00554
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`teaches doctoral level courses in lipid chemistry, and actually trained as a
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`Patent No. 8,058,069
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`doctoral candidate in his lab, one of the inventors on the cited prior art. Despite
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`this extensive knowledge base and experience, Protiva launches baseless
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`challenges against his credentials (Mot. 1-2).
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`Regarding Dr. Janoff, Protiva seeks to exclude redirect testimony from
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`his October 2019 deposition regarding the technical analysis underlying his
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`determination that Moderna has established a prima facie case of obviousness.
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`Protiva’s sole basis for exclusion is that the redirect questioning was allegedly
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`beyond the scope of cross-examination. Mot. 8-10. But, Protiva’s counsel
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`opened the door to such questioning by trying to get Dr. Janoff to agree that
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`there was no technical analysis underling his opinion—a proposition he flatly
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`rejected and then addressed on redirect.
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`II. EX1020 – REPLY DECLARATION OF DR. ANCHORDOQUY
`A.
`Protiva’s Motion Is Both Procedurally Improper And
`Substantively Baseless
`The Board’s rules state that a motion to exclude should not put forth
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`arguments that “the proper scope of reply or surreply” was exceeded by the
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`Reply or supporting evidence. TPG, 16. Protiva spends much of its motion
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`arguing that Dr. Anchordoquy’s declaration “introduce[s] argument that should
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`have been presented with the petition ….” Mot. 3-5. Given the Board’s
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`Patent No. 8,058,069
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`guidance, this is not a proper objection for a motion to exclude.2
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`Even if considered, Protiva’s assertions are demonstrably false. For
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`example, Protiva claims that issues related to routine optimization are new
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`because “Dr. Janoff, agreed on the inapplicability of routine optimization.”
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`Mot. 4. The Board has already rejected this false characterization of Dr.
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`Janoff’s opinions. See ID, 24-25, n.11. The Petition, e.g., pointed to “testing
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`relating to the 2:40 formulation that the Patent Owner identified as a prior art
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`formulation” as a starting point (Pet. 31; EX1008, ¶109) and argued, e.g., that
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`“determining the optimal proportion of cationic lipid for a given lipid
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`combination would be a simple matter of varying the proportion using prior art
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`methodologies” (Pet. 33; Ex. 1008, ¶112). Drs. Janoff and Anchordoquy thus
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`properly expanded on arguments in the Petition in response to Protiva’s POR.
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`While the rules state a petitioner cannot introduce new theories of
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`unpatentability, there is no prohibition against introducing new evidence on
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`2 Alternatively, the Board should reject Protiva’s motion as an improper
`end run around the page limits set for Protiva’s motion to strike and the word
`count for the sur-reply. Regarding Protiva’s motion to strike, Protiva requested
`permission to file a motion arguing that Moderna’s Reply raised “new theories
`and arguments.” Paper 25, 2. The Board authorized the motion and set a 5-page
`limit. Id., 3. Protiva used the full page limit. Paper 28, 5. By trying to expand
`on its arguments in its present motion, Protiva is violating the Board’s limit.
`Similarly, Protiva should have addressed issues regarding the credibility of
`Drs. Janoff and Anchordoquy in the substantive briefing.
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`reply that supports an existing theory of unpatentability and responds directly
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`Patent No. 8,058,069
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`to a patent owner’s faulty response arguments. See Genzyme Therapeutic
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`Prods. L.P. v. Biomarin Pharm. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016)
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`(“[T]he introduction of new evidence in the course of the trial is to be expected
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`in inter partes review trial proceedings”).
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`Protiva also points to statements from Dr. Janoff that the field is
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`immense, complex and unpredictable to argue against routine optimization.
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`Mot. 4-5. Dr. Janoff's reference to an “immense” range referred to the
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`“hundreds of cationic lipids known.” EX2033, 51:7-18. The field was
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`unpredictable because of that immense range of available lipid species. Id.,
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`60:5-15. But, when you have a defined, efficacious system like the 2:40
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`formulation tested in the prior art the unpredictability in the field is minimized.
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`Id.; see also EX1020, ¶56. Thus, Dr. Anchordoquy’s opinions on routine
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`optimization (id., ¶57) do not raise contradictory positions, but properly expand
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`on Dr. Janoff’s prior opinion (Ex. 1008, ¶112) that varying the lipid
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`component percentages using such a defined system as a starting point would
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`require mere routine optimization.
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`The Board's rules also state that a motion to exclude “is not a vehicle for
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`addressing the weight to be given evidence—arguments regarding weight
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`should appear only in the merits documents.” TPG, 16. Despite this limit,
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`Protiva makes improper credibility arguments regarding Dr. Anchordoquy’s
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`testimony. Mot. 5-6.
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`Such arguments are also substantively meritless. For example, Protiva
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`argues that Dr. Anchordoquy did not provide “underlying calculations for the
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`N/P ratios.” Mot. 5. But, Dr. Anchordoquy testified at deposition on how the
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`ratios were calculated. EX2043, 33:10-36:20. He also testified that the field
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`commonly used an approximation of the molecular weight per negative charge
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`for the nucleic acid. Id., 44:24-45:13. Tellingly, Protiva itself offered an N/P
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`calculation using the same methodology (EX2041) and has not argued that Dr.
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`Anchordoquy’s proffered N/P ratios are inaccurate (see Paper 30, 16-17).
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`Regarding Lin and Ahmad, Protiva argues that the references do not
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`support increasing the N/P ratio, because the charge ratio was held constant in
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`the testing in those references. Mot. 6. Dr. Anchordoquy’s declaration states
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`that a POSITA would understand from Lin and Ahmad that “for certain
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`cationic lipids, increasing the N/P ratio by elevating the cationic lipid
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`concentrations above 50 mol% enhanced transfection efficiency” based on
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`testing showing increases in charge density increased efficacy. EX1020, ¶89. A
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`POSITA would have been aware that one way to increase charge density is to
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`lower the amounts of the helper lipids (thereby increasing the cationic lipid
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`percentage) (the method used in Lin and Ahmad) and another way is to
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`increase the amount of cationic lipid (and thus the N/P ratio).3 Moreover, this
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`Patent No. 8,058,069
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`issue goes to weight and not admissibility. Protiva’s Other substantive factual
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`disagreements, like the trend in increasing cationic lipid levels (Mot. 6) are
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`similarly directed at weight, not admissibility.
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`B. Dr. Anchordoquy’s Level Of Skill Is Far Above What Is
`Required
`Dr. Anchordoquy has far more education and experience than is required
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`of a person of skill in the art. First, while is his doctorate dating from 1989 is in
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`“zoology” (EX1020, ¶9), the zoology program at UC Davis at the time
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`encompassed biophysics and he was in “a biophysics lab for the most part.”
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`EX2043, 77:10-79:21. For example, his doctoral thesis concerned liposomes.
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`EX1020, ¶9. In addition, he has been working with lipid carrier particles for
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`over 35 years (id., ¶9) and specifically with nucleic acid payloads for
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`therapeutic use since 1996 (id., ¶13). He is tenured faculty in the Department
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`of Pharmaceutical Sciences at the University of Colorado, where he teaches
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`lipid chemistry, including one course entitled “Liposome-based Drug
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`Delivery.” Id., ¶16. In fact, one of his past doctoral students is a named
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`inventor on the prior art at issue here. Id., ¶17.
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`3 Protiva also complains that Dr. Anchordoquy did not discuss the N/P
`ratio for patisiran. Contrary to Protiva’s assertions that this is the “optimized
`commercial product,” patisiran does not use the claimed target formulation and
`is of little, if any, relevance. EX1020, ¶¶139-141.
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`Patent No. 8,058,069
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`Protiva relies on mischaracterizations of Dr. Anchordoquy’s experience.
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`For example, Protiva argues that Dr. Anchodoquy is “not a lipid chemist”
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`(Mot. 1), but that is false—he teaches doctoral level course in lipid chemistry.
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`Protiva’s support for its disparagement of Dr. Anchordoquy’s expertise is that
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`his first patent dealt with an allegedly different lipid carrier particle technology.
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`Mot. 2. First, that is one of thirteen patent filings on his CV. EX1021. It is
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`evident from the titles alone that many of these filings deal with lipid carrier
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`particles. Id. (e.g., “Functionalized Nanoparticle Formulations For Oral Drug
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`Delivery;” “Lipoplexes Formulated for Catalytic Delivery,” “Stabilized
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`Nucleotide-Based Products”). Protiva also ignores his dozen of articles on
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`lipid-carrier systems, including over a dozen involving nucleic acid payloads
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`for therapeutic use, as well his awards, speaking engagements and teaching
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`experience relating to lipid-carrier particles.
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`III. EX2033 – DR. JANOFF’S TESTIMONY
`Protiva’s argument for seeking exclusion of Dr. Janoff’s redirect
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`testimony on the basis that it was beyond the scope of the cross-examination
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`(Mot. 7-8) is contradicted by the record. Dr. Janoff’s redirect testimony
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`addresses the overlapping ranges for the various lipid components in the prior
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`art. On direct, he was asked about his opinions that such ranges establish a
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`prima facie basis for obviousness. EX2033, 145:23-147:15. In this questioning,
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`counsel attempted to establish that Dr. Janoff’s opinion on prima facie
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`Patent No. 8,058,069
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`obviousness was an entirely legal construct without “technical analysis”:
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`Q. Looking at the same sentence where you state, “The
`disclosed ranges establish a prima facie case of obviousness,”
`the next part of that sentence states, “and the testing of the ‘069
`patent does not support alleged unexpected results.”
`Do you see that?
`A. I don't see it, but I heard it and I agree.
`Q. So the first part of that sentence is purely a legal matter, is
`that correct?
`MR. WELLS: Objection, form.
`A. I would say that a prima facie case of obviousness is a
`legal construct and it has to do with overlapping ranges.
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`Id., 145:23-146:15. The redirect simply asked how his opinions on prima facie
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`obviousness have to do with overlapping ranges, i.e., the supporting technical
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`analysis (as opposed to “legal matter” as insinuated by counsel for Protiva). As
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`stated to the Board: “they are directly responsive in establishing the technical
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`analysis supporting the prima facie determination that the expert made.” Id.,
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`160:19-24. Thus, the line of redirect questioning identified in Protiva’s motion
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`was not beyond the scope of Dr. Janoff’s cross-examination and it should not
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`be excluded.
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`IV. PROTIVA’S REMAINING GENERAL OBJECTIONS ALSO FAIL
`Protiva asks the Board to exclude all or portions of EX1020 and EX2033
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`Patent No. 8,058,069
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`under Fed. R. Evid. 401, 402, and 403. Mot. 1, 6. Pursuant to Fed. R. Evid.
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`401, “[e]vidence is relevant if: (a) it has any tendency to make a fact more or
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`less probable than it would be without the evidence; and (b) the fact is of
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`consequence in determining the action.” Protiva only offers conclusory
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`assertions that the opinions offered are irrelevant. See Mot. 1, 8. Moreover,
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`Protiva’s position is contradictory—Protiva admits the opinions relate to the
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`issue of routine optimization and an expectation of success related thereto. See
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`Mot. 5, 8.
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`For evidence to be excluded under Rule 403, the Petitioner must show
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`that its probative value is substantially outweighed by a danger of unwanted
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`consequences, such as undue delay, wasting time, or presenting cumulative
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`evidence. Fed. R. Evid. 403. Notably, an assertion of “untimeliness” is not
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`covered by Rule 403. Protiva fails to even attempt to explain how Dr.
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`Anchordoquy’s opinions could present a danger of “unfair prejudice, confusing
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`the issues, misleading the jury, undue delay, wasting time, or needlessly
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`presenting cumulative evidence” per Rule 403. See Mot. 1. Its motion should
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`be rejected on that basis alone. See Biomarin Pharm. Inc. v. Genzyme
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`Therapeutic Prods. Ltd. Partnership, IPR2013-00537, Paper 79 at 24-25
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`(P.T.A.B. Feb. 23, 2015) (denying motion to exclude reference under FRE 403
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`Patent No. 8,058,069
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`because the moving party “fail[ed] to identify specifically the portions of [the
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`reference] that it believe[d] to be prejudicial and confusing, or why [the Board]
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`would be unable to weigh this evidence without prejudice or confusion”).
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`Moreover, Protiva has not identified any prejudice it would suffer from
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`admitting these opinions, let alone explain how such prejudice would
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`substantially outweigh the probative value of the evidence. Nor could Protiva
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`do so—it has had the opportunity to depose both Drs. Anchodoquy and Janoff
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`and submit a sur-reply.
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`V. CONCLUSION
`For the foregoing reasons, Petitioner respectfully requests that the Board
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`deny Protiva’s motion to exclude EX1020 and portions of EX2033.
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`Dated: April 8, 2020
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`Respectfully,
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`/s/ C. Maclain Wells
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`Michael R. Fleming, Reg. No. 67,933
`C. Maclain Wells, Reg. No. 48,991
`IRELL & MANELLA LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, CA 90067-4276
`Telephone: (310) 277-1010
`Fax: (310) 203-7199
`Attorneys for Petitioner
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that, pursuant to 37 CFR § 42.6(e), a copy of
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`the foregoing PETITIONER’S OPPOSITION TO PATENT OWNER'S
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`MOTION TO EXCLUDE was served electronically via electronic mail on
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`counsel for the Patent Owner as follows:
`
`
`WILSON SONSINI GOODRICH & ROSATI
`Michael T. Rosato, Reg. No. 52,182
`mrosato@wsgr.com
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`Steven W. Parmelee, Reg. No. 31,990
`sparmelee@wsgr.com
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`Sonja R. Gerrard, Reg. No. 72,802
`sgerrard@wsgr.com
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`Lora M. Green, Reg. No. 43,541
`lgreen@wsgr.com
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`
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`By: /Susan M. Langworthy/
` Susan M. Langworthy
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`April 8, 2020
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