Patent Docs

Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021)

By Kevin E. Noonan --

As is well-known, Congress established the Federal Circuit as a circuit court of appeals to harmonize U.S. patent law in an environment where regional Circuit Courts had developed their own judicial interpretations of the patent statute.  As a consequence, it was often to a party's benefit to choose to litigate in a Circuit where the law was favorable to their case.  The resulting disharmony was occasionally and variably corrected by the Supreme Court, but Congress perceived the High Court's capacity or concentration on patent law to be insufficient to the country's needs for consistent application in this area of the law.  For a generation, the Federal Circuit was able, with little interference from the Supreme  Court, to create the harmony Congress mandated, assisted by judges who understood the law and the precedential roots thereof (as well as understanding Congress's mandate and the need to doctrinal consistency).  Recently, however, the Court seems to have morphed (along with the composition of the judges) into a soi-disant court of equity, more concerned with doing what at least two judges on any particular panel have been convinced to believe is "the right thing" (for the parties or the law) than with ruling consistently with the Court's precedent.  And that tendency (which could be termed "equity creep") explains in part the Court majority's decision in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. and Judge O'Malley's vigorous and cogent dissent.

To briefly recapitulate proceedings before the District Court, the case arose over Mylan's attempt to get regulatory approval and come to market with a generic equivalent of Biogen's Tecfidera® (dimethyl/monomethyl fumarate) multiple sclerosis drug.  Biogen asserted Orange Book-listed U.S. Patent Nos. 6,509,376; 7,320,999; 7,619,001; 7,803,840; 8,399,514; and 8,759,393, but the parties dismissed their causes of action on all patents except the '514 patent, where Biogen asserted claims 1-4, 6, 8-13, and 15-16; claim 1 is representative:

1.  A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.

(Wherein the italicized limitation was the entirety of the basis for the District Court's decision and the Federal Circuit majority's affirmance.)

While this litigation was proceeding, Mylan successfully petitioned the Patent Trial and Appeal Board to institute an inter partes review proceeding, on the grounds that the asserted claims of the '514 patent were obvious.  The Board issued a Final Written Decision that Mylan had not shown obviousness by a preponderance of the evidence, and the District Court held that Mylan was collaterally estopped from asserting obviousness as a basis for invalidating the '514 patent in this litigation.  Accordingly, the only ground Mylan pursued before the District Court was that the specification of the '514 patent did not satisfy the written description requirement of 35 U.S.C. § 112(a).

Mylan's arguments on its written description defense were grounded on certain characteristics of the '514 specification and its prosecution history.  The '514 patent specification reflected Biogen's more general research goal of finding treatments for neurological disorders, including but not limited to multiple sclerosis (MS).  Mylan noted that the original named inventor, Dr. Lukashev, was not a clinician but rather a research scientist investigating the mechanism of action of the claimed compound.  Specifically, the research underlying the '514 patent disclosure showed that DMF could activate a particular metabolic pathway (the Nrf2 pathway).  One important consequence of this inventor's testimony is that he "denied that his research could be extrapolated to a clinical dose of DMF; it 'was never the focus of [his] work to inform the clinical dosing of [DMF].'"  Dr. Lukashev was the only named inventor on the earliest applications from which the '514 patent claimed priority.

As originally filed, the claims of the application that matured into the '514 patent did not recite methods of treatment but rather were drawn to methods for identifying compounds that affected the Nrf2 pathway.  However, in April 2011, Biogen received the results of a Phase III clinical study showing that a 480mg/day dose of DMF was effective in treating MS.  Apparently in response, Biogen replaced the then-pending claims with claims that eventually issued, changed the title of the application, and added as an inventor the scientist who posited that this dosage would be particularly effective as an MS treatment; significantly to the written description calculus, Biogen did not supplement its specification in doing so, which permitted it to rely on a February 8, 2007 earliest priority date.

Mylan's position was simple:  the invention described in the specification filed in 2007 "bears no resemblance to the invention claimed in 2011."  Mylan supported this assertion with two arguments.  First, Mylan argued that "a POSA [person of skill in the art] would not have expected the claimed invention—a 480mg/day dose of DMF (BID)—to effectively treat MS" and "that nothing in the specification of the '514 Patent teaches otherwise."  Second, Mylan argued that "when viewed as an integrated whole, the combination of selectively-plucked disclosures in the specification of the '514 Patent fails to sufficiently describe the claimed invention—a method of treating MS with a therapeutically effective amount of DMF, i.e., 480mg/day of DMF (BID)."  According to Mylan, the reason for this situation is that "Biogen grafted the '514 claims onto a specification written to cover an entirely different set of inventions, conceived of by an entirely different inventor, and filed more than four years before Biogen's 2011 Phase III trial results demonstrated the effectiveness of the 480[mg/day] dose."

The District Court held that the '514 specification failed to satisfy the written description requirement because it did not show that the inventors possessed the invention on its earliest claimed priority date.  The Court noted that in the '514 specification only the first of its 30 columns focused on MS and that only one of the five methods expressly disclosed in the '514 specification was directed to treating a neurological disease by administering to the subject in need thereof at least one compound that is partially structurally similar to DMF (or a closely related compound, monomethylfumate).  The District Court understood even this method to "broadly describe[] treating neurological diseases with a therapeutically effective amount of DMF; MS is merely one such disease 'among a slew of competing possibilities,'" citing Novozymes A/S v. DuPont Nutrition Biosciences APS by analogy in support of the inadequacy of the '514 patent disclosure.  As further indicia of the lack of necessary specificity of the '514 patent disclosure, the District Court cited "an exhaustive list of 'diseases suitable for the [five] methods described' in the '514 Patent."  In view of this listing of a "plethora of neurological diseases," the Court held that there were no blaze marks that would teach the skilled worker to treat MS with DMF at this dosage.  The Court particularly rejected Biogen's contention that the specification would teach the POSA that the '480 mg/day dosage was the preferred dosage, crediting Mylan's expert Dr. Greenberg's testimony to the contrary in this regard.  The Court focused on the fact that the specification mentioned the 480 mg/day dosage only once, as part of a preferred range ("from about 480 to about 720mg/day").  The Court found "neither credible no persuasive" Biogen's argument that a POSA would understand that using the lowest effective dose of the narrowest range was preferred.  The Court found it more consistent with what was known at the time the application was filed that dosages of 720 mg/day were effective in treating MS, and 120 and 360 mg/day were ineffective.  And in the "battle of the experts," the Court was unpersuaded by Biogen's expert (whose credibility Mylan impeached on cross-examination, according to the Court) and was clearly persuaded by Mylan's expert.

From the evidence presented at trial, the District Court found that "[i]n sum, Biogen has attempted to satisfy the written description requirement of § 112 by selectively plucking specific words from the specification that correspond to each element of the claimed invention."  Citing Nuvo Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy's Labs. Inc., Enzo Biochem, Inc. v. Gen–Probe Inc., and Novozymes A/S v. DuPont Nutrition Biosciences APS, the Court stated that "the Federal Circuit has clearly rejected" the approach Biogen has taken.  Biogen appealed.

The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Judge Hughes, with Judge O'Malley (the only Federal Circuit judge who had also been a district court judge) dissenting.  A good portion of the majority opinion is devoted to an explication of the scientific background of MS, the procedural mechanics of Hatch-Waxman litigation, and a primer on the Court's written description jurisprudence.  The majority is cognizant (and applies partly in justification) of the high burden Biogen has to show clear error by the District Court over the factual issues underlying its determination that the '514 patent does not satisfy the written description requirement.  But in explicating its reasons for affirmance, the majority indicates it believes that Biogen did what the District Court determined, "attempted to satisfy the written description requirement of § 112 by selectively plucking specific words from the specification that correspond to each element of the claimed invention."

In this vein, the opinion states that the specification "casts a wide net for a myriad of neurological disorders, including neuro-degenerative diseases such as amyotrophic lateral sclerosis (ALS), Parkinson's disease, Alzheimer's disease, and Huntington's disease; demyelinating neurological diseases, such as various forms of MS and at least twenty-eight other disorders related to demyelination; polyneuritis; and mitochondrial disorders with demyelination" (Judge O'Malley terms this type of disclosure "laundry list").  The Court further enunciates a repeated enumeration of how many times the specification mentions MS, DMF, and the 480 mg/day dose (tellingly, exactly once, where once for the majority is clearly not enough), saying "consistent with the disclosure's original title concerning Nrf2 screening, the totality of the specification focuses primarily on drug discovery," the majority noting in conjunction with this statement that "[i]ndeed, the invention's title was only amended to "Treatment for Multiple Sclerosis" in 2011 after Biogen acquired Phase III clinical data for the use of DMF480 in treating MS."

Focusing on Example 4 (which the majority and dissent, as well as the District Court, recognized is the portion of the specification most closely related to using DMF to treat MS), the majority opinion sets forth the one paragraph of the specification that "teach[es] potential dosage levels for DMF monotherapy":

Effective doses will also vary, as recognized by those skilled in the art, dependent on route of administration, excipient usage, and the possibility of co-usage with other therapeutic treatments including use of other therapeutic agents.  For example, an effective dose of DMF or MM[F] to be administered to a subject orally can be from about 0.1 g to 1 g per pay, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day; or from about 480 mg to about 720 mg per day; or about 720 mg per day).  For example, the 720 mg per day may be administered in separate administrations of 2, 3, 4, or 6 equal doses [emphasis in opinion].

In this context the panel majority further recognizes "two crucial aspects of the invention":

First, the above paragraph features the one and only reference to DMF480 in the entire specification, which puts the DMF480 dose that the '514 Patent claims at the bottom end of the spectrum of a DMF 480–720 mg/day range.  Second, the specification defines the term "effective" within a therapeutic, rather than drug-discovery, context.  Thus, according to the specification, the terms "'therapeutically effective dose' and 'therapeutically effective amount' refer to that amount of a compound which results in at least one of prevention or delay of onset or amelioration of symptoms of a neurological disorder in a subject or an attainment of a desired biological outcome, such as reduced neurodegeneration (e.g., de-myelination, axonal loss, and neuronal death) or reduced inflammation of the cells of the CNS" [emphasis in opinion].

(The second aspect the majority finds "crucial" is an important, factual source of Judge O'Malley's disagreement with her brethren and the District Court.)

The majority opinion is replete with instances showing the influence of the history of the development of the claimed invention (and their implied suspicions about its origins) had on their opinion (including, inter alia, mention of Biogen adding as an inventor the clinical scientist who advocated for the 480 mg/day dose and his exclusion in the application originally filed in favor of a laboratory, not clinical, scientist who was involved in developing methods for identifying compounds that acted on biological basis for MS, the Nrf2 pathway).  Also important for the majority are the facts that by naming this scientist as an inventor they were able to "claim a priority date of February 8, 2007, despite filing wholly new claims alongside the [inventorship] amendments."

On the law, the majority is willing to concede that "assuming that a skilled artisan would understand the disclosure to be unambiguously focused on MS despite its inclusion among approximately three-dozen neurological disorders—a determination we need not reach in this case—the specification may arguably provide adequate information to convey to a skilled artisan that the invention supports method-of-treatment claims directed to MS and, perhaps, that the use of DMF may be therapeutically linked to MS treatment" (although in a footnote the majority note that the only method directed to the claimed invention "is devoid of any specific reference to MS").

But the apparently important point for the majority is the disclosure in the specification of dosage amount.  Here, the majority agrees with the District Court (or is unwilling to find clear error in its determination) that "[t]he DMF480 dose is listed only once in the entire specification."  From this (and the more extensive disclosure of ranges of DNF dosages and 720 mg/day dosage in particular) the majority opine that "the specification's focus on basic research and broad DMF-dosage ranges show that the inventors did not possess a therapeutically effective DMF480 dose at the time of filing in 2007."  This assessment was supported, according to the majority, by Dr. Lukashev's testimony regarding the extent to which (i.e., none) his research could be used to arrive at the 480 mg/day dose (despite the majority's recognition that Dr. Lukashev was not a clinical scientist).

According to the majority, "[w]hat matters for purposes of the inquiry in this case is whether, at the time of filing the disclosure—well before the Phase III study even commenced—a skilled artisan could deduce simply from reading the specification that DMF480 would be a therapeutically effective treatment for MS.  As to this point, the specification's focus on drug discovery and basic research further buttresses the district court's conclusion that the specification lacks an adequate written description to support the DMF480 claims."

As set forth above, it is a fact that the application resulting in the '514 patent was filed before the clinical trials that established that the 480 mg/day dose was clinically effective at ameliorating the symptoms of MS.  It is also the case that the original focus of the claims was not directed to this dose (indeed, those claims were directed to methods for finding a therapeutically effective dose), and this temporal disjunction inter alia (vide infra) created the impression at the District Court and perhaps for the majority that Biogen was not entitled to claims reciting this dose.

At the end of the opinion the majority broaches the issue upon which Judge O'Malley bases her dissent:

Based on the record, including at least the specification's definition of a "therapeutically effective dose" and the witness and expert testimony, the district court did not find it necessary to distinguish between therapeutic effects and clinical efficacy with respect to its patentability determination, instead electing to consider both under the specification's definition of "therapeutically effective dose."  We determine that such a finding was not clearly erroneous.

This is where Judge O'Malley believes the majority and the District Court got off on the wrong foot as a "threshold error" that the majority dismisses in error.  The District Court's error (an "original sin" in the dissent) was its decision to hold Biogen judicially estopped from making a distinction between clinical efficacy and therapeutic effects, based on positions that party took in the inter partes review instituted by Mylan on obviousness (where Biogen prevailed; in a companion, nonprecedential opinion the Court affirmed the PTAB decision without analysis in view of their precedential decision here) regarding whether a POSA would have had a reasonable expectation of success in achieving the claimed invention.

The basis for that error was, according to Judge O'Malley, not appreciating that:

Clinical efficacy involves the type of scientific rigor associated with Phase III clinical trials: the investigative DMF480 dose must produce superior clinical endpoints to the standard of care for MS, Rebif®. Therapeutic effects, by contrast, "do not require efficacy on clinical endpoints or superior efficacy to existing drugs."  Id.  It, instead, "refer[s] to the amount of [DMF480] which results in . . . prevention or delay of onset or amelioration of symptoms of a neurological disorder" like MS [citations to the record omitted].

This distinction is important because failing to appreciate it, by the District Court and the majority, was the basis, in Judge O'Malley's view, of the determination that "the '514 patent lacked written description support because 'a person of ordinary skill in the art would not have a reasonable expectation that the 480 mg/day [DMF] dose would provide statistically significant and clinically meaningful effectiveness for treating MS.'"  But this is the case, as Biogen argued and Judge O'Malley agreed, only if the "claims required clinical efficacy" when instead they only covered therapeutic effects," i.e., a different albeit related property.  In addition to imposing judicial estopped in these circumstances being an abuse of discretion by the trial court under 4th Circuit law (in a two-sentence footnote in its opinion), Judge O'Malley takes recourse in Biogen's post-trial briefing for the nature of this error as a matter of fact.  For her dissent, Judge O'Malley argues that this error led to the District Court's next error, finding that the '514 patent claims were not supported by an adequate written description.  Because, according to Judge O'Malley, "the district court's refusal to acknowledge the difference between therapeutic and clinical effects evinces a fundamental misunderstanding of what is claimed" (emphasis in dissenting opinion).  Judge O'Malley supports her view with an explication of what the '514 specification says and how the specification uses the term "therapeutic efficacy," and how this definition is tied to just the type of "research" applications that seems to have disquieted the majority.  But both Biogen and Judge O'Malley have a point:  the written description begins and ends with the question, "a written description of what"? and that "what" is the claimed invention as the invention is claimed, i.e., the claim language (which, Judge O'Malley reminds us and the majority defines an invention as a "bedrock principle of patent law," citing Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc)).

According to Judge O'Malley, this conflation of therapeutic and clinical efficacy led the District Court, and the Federal Circuit majority, to improperly apply the Court's Nuvo Pharms. (Ireland) Designated Activity Co. v. Dr. Reddy's Lab'ys Inc., 923 F.3d 1368, 1377, 1381 (Fed. Cir. 2019), precedent.  Judge O'Malley states that "[t]he district court's reliance on Nuvo to conclude that Mylan could use Biogen's own obviousness defenses against it in the written description context is, therefore, legally erroneous" and this erroneous reading of Federal Circuit precedent was not something on which the Court needed to defer, its review of the District Court in this regard being de novo.

Judge O'Malley reaches a critical issue (otherwise unmentioned) when she discusses the question of whether Biogen provided sufficient "blaze marks" in its specification regarding the specific 480 mg/day dosage (which the District Court and the majority determined it did not), using the colorful imagery from In re Ruschig, 379 F.2d 990, 994–995 (C.C.P.A. 1967).  But this analytical tool "is not used in every case concerning written description," Judge O'Malley reminds us, but " instead[] provides a useful framework to analyze whether written description has been met in cases involving patents containing laundry list disclosures," citing Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996).  Judge O'Malley's identification of the majority's error is relegated to a footnote (no. 4):

The majority's decision affirming the district court partially rests on the fact that the '514 patent only mentions the claimed DMF480 dose once.  . . .  But the majority cites no case law (and I know of none) for the proposition that the written description requirement demands that a patentee recite a claim element repeatedly to pass written description muster.  The majority does not, and cannot, deny that the claimed DMF480 dose is expressly disclosed.  To the extent the majority's opinion may be read to establish a requirement that a claim element must be disclosed multiple times, I dissent from that holding as well.

This is not a case where blaze marks are needed, according to Judge O'Malley, who states "[the specification] does not provide a laundry list disclosure of therapeutically effective doses" but rather provides "one range with the exact DMF 480 dose that is claimed" (emphasis in dissenting opinion) and thus blaze marks should not be required or an issue in deciding satisfaction of the written description requirement.

This portion of Judge O'Malley's dissent raises the issue in a way not otherwise addressed expressly in either opinion, but one that seems relevant to the Court's precedent and consideration of it in this case.  It has long been the case that claims must not need in haec verba support in the specification.  See, e.g., Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc).  This decision, for the first time, may be one where claims that unambiguously have in haec verba support have been found not to satisfy the written description requirement.  As with many of the Court's precedents, the current Court seems to show in its opinions a slow, disquieting tendency to have them spread from the doctrinal boundaries to encompass more and more circumstances that, in past precedent would have been inconceivable.  This is an embodiment of a specialized patent court that it is not easy to appreciate Congress did not intend to create.

Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021)
Panel: Circuit Judges O'Malley, Reyna, and Hughes
Opinion by Circuit Judge Reyna; dissenting opinion by Circuit Judge O'Malley

Mylan Pharmaceuticals Inc. v. Biogen MA Inc. (Fed Cir. 2021)
Nonprecedential disposition
Panel: Circuit Judges O'Malley, Reyna, and Hughes
Opinion by Circuit Judge Reyna

Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A. (Fed. Cir. 2021)

By Kevin E. Noonan --

The Leahy-Smith America Invents Act prescribed two very different post-grant review proceedings in U.S. patent law.  The first, post-grant review (PGR), had some analogies with European opposition practice, in that petitions for PGR could be filed no later than nine months after the patent had granted and any ground of patentability was available as the basis for challenge (see 35 U.S.C. § 321 et seq.).  The other proceeding, inter partes review (IPR), was available throughout an unexpired patent term but the subject matter of challenge was limited to anticipation under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103 (see 35 U.S.C. § 311 et seq.).  However, Section 112 issues can be considered in an IPR as a part of construing the claims when questions of priority are raised, and this was the basis for the Patent Trial and Appeal Board (PTAB) to find invalid all but one of the challenged claims in Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A.

Dr. Reddy's petitioned for inter partes review (IPR) of U.S. Patent No. 9,687,454 on the grounds that all claims were anticipated by U.S. Patent Publication 2011/0033541 to Myers.  The claims are directed to therapeutic agent-containing films that can be orally dissolved as an administration route for various medicines.  The '454 patent is the latest in a series of related applications, the earliest (U.S. Patent Application 12/537,571) dating to 2009.  At issue in this IPR was whether the challenged claims were entitled to this earliest filing date, which antedated the publication of the '541 application asserted by Dr. Reddy's for anticipation.

The opinion sets forth claims 1, 7, 8, and 12 as representative of the issues before the Board.

Claim 1:

1.  An oral, self-supporting, mucoadhesive film comprising:
    (a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;
    (b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof;
    (c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and
    (d) an acidic buffer;
    wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa;
    wherein the weight ratio of (b):(c) is about 4:1;
    wherein the weight ratio of (d):(b) is from 2:1 to 1:5;
and
    wherein application of the film on the sublingual mucosa or the buccal mucosa results in differing absorption between buprenorphine and naloxone, with a buprenorphine Cmax from about 0.624 ng/ml to about 5.638 ng/ml and a buprenorphine AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone Cmax from about 41.04 pg/ml to about 323.75 pg/ml and a naloxone AUC from about 102.88 hr*pg/ml to about 812.00 hr*pg/ml.

7.  The film of claim 1, wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water-soluble polymeric matrix.

8.  The film of claim 7, wherein the film comprises about 48.2 wt % of the water-soluble polymeric matrix.

12.  The film of claim 1, wherein the weight ratio of (d):(b) is from about 1:1 to 1:5; wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5; and wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water-soluble polymeric matrix.

(emphasis in each instance in the opinion).  As is evident from the emphasized limitations, the distinction between claim 8 and the other claims is that this claim has a particularly specified composition of the water-soluble polymeric matrix making up the film while the other claims have a broader range of values for this parameter.

The Board considered whether the written description in the '571 priority specification had support for these features.  The Board found express disclosure for the "about 48.2 wt %" limitation in the '571 specification (albeit as the result of calculation by the skilled artisan); the Tables containing these data were reciprocated in the Federal Circuit opinion.  (While express disclosure of a claimed range can readily satisfy the written description requirement, inherent disclosure of such ranges by example is also in some cases adequate for written description purposes; see Union Oil of Cal. v. Atl. Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000)).  The ranges of water-soluble polymer in the films recited by the other claims did not find support in the '571 specification, according to the Board.  Moreover, the Board did not find Indivior's expert witness testimony to be credible on this issue.  Finally, the Board held that a person of ordinary skill in the art "would have been led away" from these ranges based on the '571 disclosure that "[t]he film may contain any desired level of self-supporting film forming polymer."  Accordingly, the Board held that the challenged claims of the '454 patent were not entitled to the priority date of the '571 application and thus claims 1-5, 7, and 9-14 were invalid for being anticipated by the teachings of the prior art '541 application while claim 8 was not anticipated.  Both parties appealed the Board's judgment.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judge Dyk and joined in part by Judge Linn, who dissented in part.  Regarding Indivior's appeal of the Board's invalidation of claims 1-5, 7, and 9-14, the panel majority agreed with the Board that the portions of the '571 specification Indivior attempted to rely upon did not disclose, expressly or inherently, the ranges recited in claims 1-5, 7, or 9-14.  Instead, there are instances in the disclosure that are "only specific, particular examples" but they are not ranges according to the opinion.  The panel majority expressly rejected Indivior's argument that written description is adequate when the skilled worker would need to "pluck[] out the polymer components and create[] a range from the percentage totals" which the opinion states "amounts to cobbling together numbers after the fact."  And "[a] written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention" because "a patent is not a hunting license," citing (with some irony) Brenner v. Manson, 383 U.S. 519, 536 (1966).  The Federal Circuit illustrated the doctrinal difficulties of applying the written description requirement consistently by rejecting Indivior's resort to its case law by stating "written description cases are intensively fact-oriented, and the cases vary, just as ranges vary."

Because Indivior did not dispute that the '541 application would anticipate claims 1-5, 7, and 9-14 if the '454 patent was not entitled to the priority date of the '721 application, the Court affirmed the Board's decision that these claims were invalid for being anticipated.

Turning to Dr. Reddy's cross-appeal, the panel understood the argument to be that the skilled worker "would not have immediately discerned that the '571 application discloses a polymer component comprising 48.2 wt % of a film because the tables do not state the total polymer weight of various formulations."  The panel agreed with Dr. Reddy's that the 48.2 wt% is not expressly disclosed but deferred to the Board's fact-finding as being supported by substantial evidence.  To the possibility that this decision be perceived as being contrary if not contradictory to the Court's decision affirming invalidity of the other claims in the '454 patent, the opinion states that "given that claim 8 does not recite a range, but only a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components, we accept that there is substantial evidence to support the Board's decision concerning claim 8" and accordingly affirmed.

Judge Linn's dissent illustrated the difficulties of analyzing compliance with the written description requirement.  Citing some of the same caselaw Indivior unsuccessfully relied upon, including Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019), and In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976), Judge Linn contended the majority was incorrect in failing to find written description support in the '571 specification for the '454 patent's claims 1-5, 7, and 9-14, saying the panel majority had "applie[d] an overly demanding standard for written description for ranges" contrary to this precedent.  His dissent then performs the Judge's assessment of the '571 disclosure and comes to a conclusion opposite from the panel majority.  In Judge Linn's assessment, the reason for this difference with the panel majority is that Judges Lourie and Dyk took statements in the specification out of context and considered the specification to contain "inconsistent language" that Judge Linn is at a loss to perceive.  Indeed, Judge Linn chides the panel majority for doing just what the majority opinion states should not be done, applying "strict rules" to show possession of the claimed range(s).  Judge Linn also states that in his analysis the Tables set forth in the '571 application (and reproduced in the opinion) disclose the 48.2 wt% and 58.6 wt% in the recited ranges and required no "cobbling together numbers after the fact" as the majority had asserted in support of their decision.  Finally, Judge Linn found the Wertheim and Nalpropion opinions to be "directly on point" and support his opinion that the '571 specification provided an adequate written opinion of the challenged claims of the '454 patent.

Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A. (Fed. Cir. 2021)
Panel: Circuit Judges Lourie, Linn, and Dyk
Opinion by Circuit Judge Lourie; opinion concurring in part and dissenting in part by Circuit Judge Linn

Conference & CLE Calendar

November 30, 2021 - "Trends in Patent Prosecution: Don’t Get Left Behind" (LexisNexis and IPWatchdog) - 2:00 pm (ET)

December 2, 2021 - "The Intersection of Intellectual Property and International Arbitration: Quantum and Valuation (Part 1)" (Lexology, iam, GAR, and Charles Rivers Associates) - 8:00 am to 9:30 am (CST)

December 3, 2021 - "PTAB Review: Effects of Arthrex and Potential Future Reforms" (Federal Circuit Bar Association PTAB/TTAB Committee) - 12:00 pm to 1:00 pm (ET)

Webinar on Trends in Patent Prosecution

LexisNexis and IPWatchdog will be offering a webinar entitled "Trends in Patent Prosecution: Don’t Get Left Behind" on November 30, 2021 at 2:00 pm (ET).  Roberta Young of Seyfarth Shaw LLP, Aparna Nemlekar of Fox Rothschild LLP, Megan McLoughlin of LexisNexis Intellectual Property Solutions, and Gene Quinn of IPWatchdog, Inc. will focus on trends in patent eligibility (35 U.S.C. § 101) and claim language (35 U.S.C. § 112), providing examples from both the life sciences and high-tech sectors and walking through amendments made during prosecution and through allowance, looking at language added to overcome examiner rejections.  The panel will also discuss claiming strategies, drafting strategies, and an uptick in § 112(a) and (b) rejections, and what this means for prosecution budgets and strategies for streamlining prosecution in light of current trends.  The panel will address the following topics:

• Accurately predict and better manage expectations around cost and time of prosecution
• Adjust your prosecution strategy based on USPTO examiner type
• Easily access the patent prosecution analytics you rely on directly in the USPTO PAIR website
• Overturn examiner's specific rejections with carefully curated ex parte appeals data

There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

Happy Thanksgiving from Patent Docs

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 28th.

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 28th.

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 28th.

ToolGen Files Motion to Exclude Evidence, Broad Opposes, and ToolGen Replies in Interference No. 106,126

By Kevin E. Noonan --

On October 1st, Senior Party ToolGen Inc. filed its Motion to Exclude certain evidence presented by Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") in Interference No. 106,126.  Broad filed its Opposition to ToolGen's motion on October 8th, and ToolGen filed its Reply on October 15th.

ToolGen's bases for excluding evidence including Broad's purported "best proofs" on priority were that they have not been authenticated and are thus inadmissible under FRE 901.  Specifically, ToolGen raised these objections against Broad Exhibits 2526, 2530, 2533, 2535, 2536, 2563, 2565, 2566, 2581, 2582, and 2599.  Some of these objections involve the date of the exhibit (e.g., Exh. 2526) which is dated after the relevant time period concerning conception and reduction to practice of the claimed invention (i.e., CRISPR achieved in eukaryotic cells).  Others relate to lack of "dates, labels, or other identifying marks" (e.g., Exh. 2530, which purports to be "an image of an electrophoresis gel that Broad alleges shows a dual-molecule RNA configuration that was 'used to target, cleave, and edit an endogenous "NTF3" genomic target in eukaryotic cells in October–November 2011'").  ToolGen raised objections on similar grounds against Exhs. 2535, 2536, and 2563, which ToolGen asserted "are unannotated images completely devoid of identifying features" that "could be generic images from anywhere; none contain labels, captions, or descriptions that would allow a person of ordinary skill in the art ('POSA') to understand the alleged experiment, let alone assess whether the exhibit is what Broad claims it to be" (which are "successful single and dual-molecule systems").  Finally, ToolGen asserted that none of these exhibits were authenticated by Broad's expert witness, Dr. Seeger who "[did] not profess to have any knowledge of the aforementioned exhibits."

ToolGen's second basis for its Motion to Exclude is related to Exhibit Nos. 2708, 2710, 2716, 2734, 2751, 2770, 2771, 2772, 2773, 2775, 2777, 2780, 2781, 2782, 2784, 2829, 2830, 2842, and 2845, introduced in support of Broad's Substantive Motion No. 1, and also Exhibit Nos. 2704, 2705, and 2793 introduced in support of Broad's Substantive Preliminary Motion No. 3, and was that they were hearsay and inadmissible under FRE 801 and 802.  These Exhibits all contain out-of-court statements offered for the truth of the matter asserted, specifically "to prove that Broad's experiments allegedly showed successful reduction to practice of Broad's Proposed Count 2."

ToolGen's third ground for its Motion to Exclude is related to Exhibits published after December 12, 2012, as being irrelevant under FRE 401 and 403 for not providing information about the state of the art at the time the application was filed.  In particular, Exh. 2217, relied upon by Broad expert Dr. Seeger and allegedly pertaining to the definition of guide RNA, was relied upon in opining on obviousness and thus should be excluded ToolGen maintained.  ToolGen raised similar objections against Exhibits 2201, 2226, 2231, 2232, 2654, and 2683 (for the relationship as independent inventions between SaCas9 and chimeric Cas-9) and Exhibits 2226, 2231, 2232, 2454, 2683, and 2653.

ToolGen further objected to "certain testimony of Broad's expert Dr. Seeger (i.e., Ex. 2454, ¶¶166–168, 233–243, 255–57) under FRE 702 and 703" as being irrelevant under FRE 403 and improper under FRE 702 and 703.  The latter objection was based on ToolGen's assertions that the evidence is based on "inadmissible exhibits of the type upon which an expert would not ordinarily [or reasonably] rely."  ToolGen made a similar objection to the declaration of Broad's expert, Dr. Seeger (Exh. 2454) as it has on other exhibits, that it (and they) relies on evidence dated after the relevant time period (the dates of the priority applications in the interference).  This disjuncture in time period makes the expert's analysis run afoul of FRE 702 and 703 to the extent that the expert opined on the understanding of one skilled in the art using evidence from post-filing exhibits ToolGen asserts, citing as an example Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008).  These same principles apply here, ToolGen contended, with regard to the expert's assessment of the disclosure of Broad's P1 priority application (61/736,527, filed December 12, 2012) and the meaning to be ascribed to the term "guide RNA," during which the expert relied on Exh. 2217 which post-dates this filing date.  ToolGen cited additional instances of this improper reliance, and asked that the Board exclude the expert's testimony tainted thereby.

ToolGen also criticized Dr. Seeger for relying on "unauthenticated and hearsay[-containing]" exhibits, specifically Exh. 2526 regarding Broad Inventor Zhang's completion of a tracrRNA vector which is "devoid of any identifying features" and is "unsponsored by any witness with personal knowledge."

Finally, ToolGen asserted as hearsay several e-mails (Exh. 2704, 2705, 2708, 2750, and 2793) relied upon by Dr. Seeger in his declaration (Exh. 2454). Because "[e]ach of the . . . emails consists of out-of-court statements offered for the supposed truth of the matter asserted—[that] Broad's experiments allegedly showing successful reduction to practice of dual-molecule CRISPR-Cas9 in a eukaryotic system and that certain claims are separately patentable inventions," ToolGen contended that these e-mails are hearsay and Dr. Seeger's reliance on them should be excluded under FRE 801 and 802.

In its Opposition Broad argued generally that the evidence ToolGen objected to regarding FRE 901 was merely a proffer ("a demonstration of what Broad later intends to prove at the priority phase should the Count be changed") and should not be excluded (because a tribunal can consider such evidence within its sound discretion).  Broad asserted that:

ToolGen's motion is based on a misunderstanding of what it means to make a proffer in connection with a motion to change the count.  The PTAB is clear that—consistent with traditional procedure—a proffer in connection with a motion to change the count need not be based on admissible evidence, as it is not an attempt to introduce testimony or documents.  Rather, a proffer is a demonstration of what a party intends to show at a later point, and thus, it may include unauthenticated or hearsay evidence.  To hold otherwise would require a party making a proffer of its best proofs essentially to put forth its priority case, including subjecting authenticating and testifying witnesses to cross-examination before the priority phase.  This is not consistent with the law or PTAB practice: "[i]n general submission of a document together with a representation by counsel of what the document shows is a sufficient proffer," citing Byrn v. Aronhime, Patent Interference 105,384 (McK), Paper 64, at 11:24-26 (P.T.A.B. Sept. 20, 2006).

Failing that, Broad argued substantively that ToolGen has not met its burden to show inadmissibility under FRE 901(b)(4) because the test for authentication is that indicia thereof ("appearance, contents, substance, internal patterns, or other distinctive characteristics") should be considered as a whole.  And with regard to ToolGen's hearsay arguments Broad countered by contending that ToolGen was wrong because the challenged documents are "not offered for the truth of the matters asserted, but rather as proof of what they say."

Regarding ToolGen's relevancy contentions, Broad argued that "Federal Circuit precedent is clear that post-filing information, such as testing that shows unexpected results or evidence of commercial success, can be relevant" (which is certainly true but is much less clear that Broad addressed the application of the rule advanced by ToolGen), citing Knoll Pharm. Co., Inc. v. Teva Pharm. USA, Inc., 367 F.3d 1381, 1385 (Fed. Cir. 2004), and Sanofi-Aventis Deutschland GmbH v. Glenmark Pharm. Inc., USA, 748 F.3d 1354, 1360 (Fed. Cir. 2014), as examples (but perhaps because circumstances like commercial success by their very nature must be evidence "after the fact" of conception and reduction to practice of the invention).

Finally, Broad argued that the declaration of its expert, Dr Seeger, is admissible and faults ToolGen for failing to depose him.  Broad also argued that the predicate for ToolGen's objection to Dr. Seeger's declaration, the admissibility of evidence he relied upon based on ToolGen's relevancy and hearsay objections, dooms its arguments that Dr. Seeger's declaration is not admissible.  Even if this is not the case, Broad reminds the panel that "it is well established that an expert can rely on inadmissible or hearsay evidence if it is the type of material on which experts would reasonably rely," citing FRE 703.

The remainder of Broad's Opposition is a point-by-point refutation, by page and line number according to interference rules, of ToolGen's allegations and assertions in its Motion.

In its Reply, ToolGen responds to Broad's allegations that it misunderstands the nature of a proffer by arguing that, regardless of the standard for the Board to consider evidence in a proffer a proponent of the proffer "must show sufficiency of its proffer in its substantive Motion 1, not here" (i.e., not in its Opposition to ToolGen's motion to exclude) and "Broad may not offer evidence into the record under the guise of a proffer, thereby bypassing the evidentiary rules."  ToolGen notes that Broad's expert, Dr. Seeger, had not cited nor described ten of the objected-to citations.

ToolGen also maintains that Broad "misunderstands" how its hearsay evidence is used and is thus is properly deemed to be inadmissible when, as here, it is being introduced as evidence. ToolGen notes that "[b]elying its position, Broad offers the content of challenged hearsay exhibits as material facts in Broad Motion 1," which suggests that this evidence is being used to establish its truth (and not as "proof of what they say"), citing examples of this type of use ("stating as a fact that Zhang 'engineered and tested dual-molecule RNA CRISPR systems in eukaryotic cells'").

With regard to Dr. Seeger's declaration, ToolGen maintains that what is improper, and properly the subject of its Motion to Exclude, is the use of post-filing exhibits to support his averments.  This is because this evidence "provide[s] no insight into how a skilled artisan would understand claim terms at the relevant filing date (emphasis in brief), providing examples and citing Brookhill-Wilk, LLC. v. Intuitive Surgical, Inc., 334 F.3d 1294, 1299 (Fed. Cir. 2003).

And finally, ToolGen characterizes Dr. Seeger's declaration as being a "mere conduit for hearsay" and inadmissible for that reason.  ToolGen admits that FRE 703 permits an expert to rely on the hearsay comprising Exhibits 2704, 2705, 2708, 2750, and 2793, but ToolGen maintains "FRE 703 does not permit an expert or party to evade hearsay rules by simply incorporating inadmissible out-of-court statements into the record via the expert's testimony," citing Wi-Lan Inc., v. Sharp Electronics Corp., 992 F.3d 1366, 1375 (Fed. Cir. 2021).  ToolGen asserts that "Dr. Seeger does exactly this" by summarizing the contents of various exhibits comprising such hearsay.

The Board will render its decision prior to Final Hearing in this Interference.  Broad has not filed a motion to exclude evidence in this interference.

USPTO News Briefs

By Donald Zuhn --

USPTO Delays Fee for Failure to File Applications in DOCX Format

In a notice published in the Federal Register earlier today (86 Fed. Reg. 66192), the U.S. Patent and Trademark Office announced that it was delaying the effective date for assessment of the fee for filing patent applications that are not in the DOCX format.  The new fee, which was announced by the Office on August 3, 2020, was set to take effect on January 1, 2022, but will now become effective on January 1, 2023.  The fee is set forth in 37 C.F.R. § 1.16(u), which requires an additional charge of $400 for large entities, $200 for small entities, and $100 for micro entities, for any application filed under 35 U.S.C. § 111 for an original patent (except for design, plant, or provisional applications), where the specification, claims, and/or abstract does not conform to the USPTO requirements for submission in DOCX format.

The Office notes that two pilot programs have been conducted for filing applications in DOCX format:  the eMod Text Pilot Program, which was conducted between August 2016 and September 2017, and the Patent Center Text Pilot Program, which was conducted from June 2018 to April 2020.  Although all applicants have been able to file applications in DOCX format in Patent Center since April 2020, the Office's notice indicates that the delay in assessing the new fee will enable the Office to provide enhanced testing of its information technology systems as more users file in DOCX and give applicants more time to adjust to filing patent applications in DOCX format.  Despite delaying the effective date of the new fee, the Office strongly encourages applicants to begin filing patent applications in DOCX format or file test submissions through the Patent Center training mode before the new effective date.  Additional information regarding the filing of application documents in DOCX format can be found here.


USPTO Provides Reminder Regarding Proper Presentation of Prophetic and Working Examples

In a notice published in the Federal Register earlier this year (86 Fed. Reg. 35074), the U.S. Patent and Trademark Office reminded applicants that "patent applications must properly present examples in a manner that clearly distinguishes between prophetic examples that describe predicted experimental results and working examples that report actual experimental results."  The Office notes that "[t]he distinction must be clear to satisfy the written description and enablement requirements and comply with the applicant's duty of disclosure."

The Office's notice points out that prophetic examples are typically used in a patent application to describe reasonably expected future or anticipated results, and working examples correspond to work performed or experiments conducted that yielded actual results.  The notice also indicates that prophetic examples should not be described using the past tense, cautioning that improper use of past tense could raise an inequitable conduct issue:

[P]rophetic examples should not be described using the past tense.  Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d. 1354, 1367 (Fed. Cir. 2003) (improperly identifying a prophetic example in the past tense validly raises an inequitable conduct issue based on the intent of the inventors in drafting the example in the past tense, when the example, in fact, is prophetic).  Knowingly asserting in a patent application that a certain result "was run" or an experiment "was conducted" when, in fact, the experiment was not conducted or the result was not obtained is fraud.

Instead of using past tense, the Office notes that prophetic examples may be written in future or present tense.  The Office also suggests that "[i]t is a best practice to label examples as prophetic or otherwise separate them from working examples to avoid ambiguities."


USPTO Establishes Email Address for PCT Inquiries

In a Notice issued earlier this month, the U.S. Patent and Trademark Office announced that it was establishing an email address (PCTHelp@uspto.gov) for stakeholders to submit inquiries regarding the Patent Cooperation Treaty (PCT), including procedures applicable to international applications filed under the PCT and U.S. national stage applications submitted under 35 U.S.C. § 371.  The Office notes that the new address, which will be available beginning on January 1, 2022, is intended to improve the overall customer service experience for those needing information regarding the PCT and international and national stage applications in the USPTO.  The Office also notes that the email address is not intended for case-specific or time-sensitive inquiries, which should continue to be directed by telephone to the existing PCT Help Desk.  According to the Notice, the new email address will permit those faced with substantial time differences to submit queries outside of USPTO business hours and should help improve response times for the PCT Help Desk by taking some inquiries out of the Help Desk's queue.  The PCT Help Desk, which was established in 1993, has received an average of 23,000 calls annually over the last three fiscal years.


USPTO Increases Annual Limit on Accepted Track One Requests

In a notice published in the Federal Register in September (86 Fed. Reg. 52988), the U.S. Patent and Trademark Office announced that it was increasing the limit of the number of prioritized examination (Track One) requests that may be accepted in a fiscal year to 15,000.  The notice points out that the number of accepted requests that was originally specified in the America Invents Act was 10,000, which was increased in 2019 to 12,000 accepted requests.  The notice also indicates that quality metrics used by the Office continue to reveal no loss in examination quality for applications given prioritized examination, and further, that the number of applications accepted for prioritized examination continues to constitute a small fraction of the total number of patent examinations completed in a fiscal year (approximately 640,000 applications and requests for continued examination).


USPTO Updates Requirements for Examination for Registration to Practice in Patent Cases

In a notice published in the Federal Register in September (86 Fed. Reg. 52652), the U.S. Patent and Trademark Office announced the implementation of updates to the General Requirements Bulletin for Admission to the Examination for Registration to Practice in Patent Cases Before the United States Patent and Trademark Office ("GRB").  The notice indicates that there are three categories of technical and scientific qualifications that permit applicants to sit for the registration examination:  Category A for specified bachelor's degrees, Category B for other bachelor's degrees with technical and scientific training, and Category C for practical engineering or scientific experience.  The updates include the addition of certain Category B degrees to the list of Category A degrees, the acceptance of advanced degrees (i.e., master's and doctor of philosophy degrees) under Category A, and the acceptance of a combination of core sciences with a lab component under Category B.  Additional information regarding the specific changes can be found in the Office's notice.