Patent Docs

Berkeley Files Substantive Motion No. 2 to be Accorded Benefit to Earlier Priority Application in Interference

By Kevin E. Noonan --

On October 14th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC") filed its Substantive Motion No. 1 to be awarded priority benefit to their earlier priority applications: USSN 61/652,086, filed May 25, 2012 (P1); USSN 61/716,256, filed October 19, 2012 (P2); USSN 61/757,640, filed January 28, 2013 (P3); USSN 13/842,859, filed March 15, 2013; USSN 14/685,504, filed April 13, 2015; or USSN 15/138,604, filed April 26, 2016, in Interference No. 106,115 against Senior Party the Broad Institute, Harvard University, and the Massachusetts Institute of Technology.

CVC sets forth in detail the disclosure in its earlier priority applications for at least one embodiment falling within the scope of Count 1 of this interference.  The brief recites the "ground-breaking" nature of their work, stating that the earliest priority document (P1) disclosed "the minimal components required to generate a functional CRISPR-Cas9 DNA-cleavage complex—Cas9, crRNA, and tracrRNA."  In addition, CVC argues that this priority document "disclosed, for the first time, that complexes of Cas9 and a double- or single-molecule DNA-targeting RNA . . . are useful for targeted DNA cleavage and described numerous applications of this gene-editing technology, including modifying target DNA in eukaryotic cells," noting the many accolades bestowed upon CVC's inventors by the scientific community.  CVC further argues that "[t]he CVC inventors immediately understood that the CRISPR-Cas9 DNA-cleavage complex could be used in a variety of different cellular and noncellular settings."  The brief recites (prophetic) Example 1 in the P1 specification, and the (albeit prophetic) application of CRISPR technology to fish, human, and fruit fly cells.

The brief is careful to note that any failure of the P1 specification to show actual reduction to practice is not required to satisfy the requirement for entitlement benefit.  CVC also cautions the Board against any attempt by the Broad to "erroneously to link the issues in this motion to the PTAB's termination of Interference No. 106,048 due to no interference-in-fact," stating that "the legal and factual issues raised here are fundamentally different from those decided in the prior '048 proceeding" based on the PTAB's own prior statements of the grounds for its no interference-in-fact determination.  Rather, according to CVC:

[A person of ordinary skill in the art] reading P1 in light of the state of the art at the time of filing would have understood that the application describes and enables at least one embodiment within the scope of the count.  Moreover, post-filing-date publications report successfully practicing CVC's claimed invention in eukaryotes using the very methods and components that P1 describes.  The Board should therefore accord CVC the benefit of its first provisional application.

What follows is a succinct statement of the Precise Relief Requests (pursuant to PTAB rules) and support in the P1 specification for this relief, recited in the alternative with the other priority documents recited in CVC's request for relief.  The standard, undisputed by the parties, is that to be accorded benefit of priority a prior application must show constructive reduction to practice (CRTP) regarding at least one embodiment falling within the scope of the count, citing Falkner v. Inglis, 448 F.3d 1357, 1362 (Fed. Cir. 2006).  After setting out the legal grounds for CRTP, the brief then applies these rubrics to the disclosure in P1 for subject matter falling within the scope of the interference Count (which CVC argues satisfies these requirements).  Along the way the brief also suggests that "Broad will doubtlessly rely on cherry-picked quotes about whether or not the inventors or experts knew CRISPR would work in eukaryotic cells before testing it," rejecting these anticipated arguments on the ground that CTRP is grounded on what is disclosed in the specification citing Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc); Frazer v. Schlegel, F.3d 1283, 1288 (Fed. Cir. 2007); and Centrak, Inc. v. Sonitor Tech., Inc., 915 F.3d 1360, 1369 (Fed. Cir. 2019).  The relevant P1 disclosure for CVC is that CRISPR is functional "when removed from its natural prokaryotic cellular milieu, which is highly relevant here because it establishes CVC's possession of the necessary and sufficient components for a functional CRISPR-Cas9 DNA-cleavage complex regardless of its environment" (emphasis in brief).

The argument is illustrated by Figures from the P1 application:

And explicit disclosure compared with the elements of the interference Count:

The brief then sets forth specific disclosure related to the elements of the Count (also provided in Appendix 3 entitled "Exemplary Evidence of Constructive Reduction to Practice of Count 1 in the P1 '068 Application"), and CVC further asserts that "[t]he inventors fully grasped the broad utility of such a method as aptly illustrated by the many types of 'target cells of interest' suitable for the methods described in P1, including a variety of eukaryotic cells (elements [1]-[2]) such as a fish, human, and fruit fly cell," noting that "[t]hese features are not merely recited in P1, but diagrammed, discussed, and specifically exemplified showing the inventors' possession" based on express disclosure cited with particularity in the brief (including specifically the prophetic use of CRISPR in fish cells).  CVC presents explicit argument relating to what the skilled worker would understand CVC possessed and would be able to accomplish without undue experimentation with regard to the CRTP requirement for being accorded benefit.  Finally, in this regard, the brief asserts that post-filing evidence (much of it by third parties) further supports a conclusion of constructive reduction to practice in the P1 disclosure:

Within a year of CVC publishing that Cas9 and a [single guide RNA] such as chimera A (or a double-molecule RNA) formed a functional DNA-cleavage complex (Ex. 3202), other researchers used materially the same components and methods disclosed in P1 to practice the fish cell embodiment—objectively confirming that P1 enables making and using the fish cell of E1.  While the studies described below published after P1's May 25, 2012 filing date, post-priority date evidence "may show, for example, that practicing the invention did not require undue experimentation," citing Amgen, Inc. v. Sanofi, 872 F.3d 1367, 1379 (Fed. Cir. 2017); In re Wands, 858 F.2d 731, 739 (Fed. Cir. 1988); In re Hogan, 559 F.2d 595, 605 (Fed. Cir. 1977).

CVC supports its allegations of what the skilled person would understand from the disclosure in the P1 specification by declaration testimony an expert, Dr. Peterson (who eventually will be subject to cross-examination by the Broad in this interference).  Specifically, Dr. Peterson attests extensively to the applicability of CRISPR as set forth in P1 to use in human cells, which CVC asserts is also shown by third-party success in applying CRISPR to human cells, and fruit fly cells.  Thus, CVC asserts "[i]n sum, the great weight of evidence compels a finding that P1 describes and enables each of the fish (E1), human (E2), and fruit fly (E3) cell methods, any one of which, on its own provides a CRTP of Count 1."

The brief then turns on the distinction between what was required for the Broad to prevail (as it did) in the earlier interference and in this one:

Broad's previously asserted arguments wrongly impose a reasonable expectation of success standard (obviousness) on §112, first paragraph, which contains no such standard.  Obviousness "turns on . . . whether the claimed invention would have been obvious in view of the prior art."  Allergan, Inc. v. Sandoz, Inc., 796 F.3d 1293, 1310 (Fed. Cir. 2015) (emphasis in original).  "In contrast, the enablement inquiry turns on whether the skilled artisan, after reading the specification, would be able to make and use the claimed invention without undue experimentation."  Id. (emphasis in original).  Similarly, "[t]he standard for satisfying the written description requirement is whether the disclosure 'allow(s) one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.'"  Alcon, 745 F.3d at 1190 (emphasis added; citation omitted); see also, Ariad, 598 F.3d at 1351.  Any argument to the contrary erroneously conflates obviousness with written description and enablement.

Finally, the brief argues in the alternative that the other applications CVC asserts for priority contain the P1 disclosure relied upon for priority in this brief, and thus for the same reasons (set forth in brief for each reference) CVC is entitled to priority to these applications, based on the "continuous chain" of priority in these CVC applications.

Solicitor General Files Brief in Berkheimer v. HP

By Michael Borella --

Berkheimer v. HP Inc. was decided by the Federal Circuit in February 2018 and stands for -- in the words of Judge Moore of that Court -- "the unremarkable proposition that whether a claim element or combination of elements would have been well-understood, routine, and conventional to a skilled artisan in the relevant field at a particular point in time is a question of fact."  The Supreme Court's patent-eligibility opinions in Mayo Collaborative Srvs. v. Prometheus Labs, Inc. and Alice Corp. v. CLS Bank Int'l had not been perfectly clear on this issue, and the Federal Circuit appeared to have taken both sides at various times.  Berkheimer settled the issue, for a while at least.

HP petitioned the Supreme Court for certiorari in September 2018.  In January of this year, the Court requested that the Solicitor General file a brief expressing the views of the United States in this matter.  That brief finally arrived last week.  In short, the Solicitor General is of the opinion that the overall lack of clarity regarding the fundamental issues surrounding patent-eligibility under 35 U.S.C. § 101 makes addressing the points of Berkheimer premature.

As background, the Supreme Court's Alice decision set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101.  One must first decide whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But generic computer implementation of an otherwise abstract process does not qualify as "significantly more," nor will elements that are well-understood, routine, and conventional lift the claim over the § 101 hurdle.

While the Supreme Court did not specify whether the well-understood, routine, and conventional determination was to be carried out as a matter of law, fact, or a hybrid of both, its earlier Mayo Collaborative Srvs. v. Prometheus Labs, Inc. decision strongly suggested that the § 101 inquiry may overlap with fact-sensitive inquiries such as novelty under § 102 in at least some situations.  However, the Federal circuit has stated, in OIP Techs., Inc. v. Amazon.com, Inc. that "[p]atent eligibility under 35 U.S.C. § 101 is an issue of law reviewed de novo."  But in other cases, different panels have implied that facts may be considered.

This came to a head in Berkheimer, where Judge Moore wrote:

The question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact.  Any fact . . . that is pertinent to the invalidity conclusion must be proven by clear and convincing evidence.  Like indefiniteness, enablement, or obviousness, whether a claim recites patent eligible subject matter is a question of law which may contain underlying facts.  (Emphasis added.)

The outcome of the Court's factual analysis was that some of Berkheimer's dependent claims recite "limitations directed to the arguably unconventional inventive concept described in the specification" and therefore the case was remanded to the District Court for fact finding.  Notably, Berkheimer did not win on the merits, but instead managed to get the District Court's invalidation of some of his claims reversed modulo further review.

In its petition, HP's question presented was "[w]hether patent-eligibility is a question of law for the court based on the scope of the claims or a question of fact for the jury based on the state of the art at the time of the patent."  This question is somewhat deceptive, as the Federal Circuit explicitly stated that some patent-eligibility decisions can be made as a point of law, but others may require fact finding when the parties are in dispute over whether a claim element is well-understood, routine and conventional.  HP's attempt to make this non-binary decision into a black-or-white issue does not reflect the nuances of the opinion.

Nonetheless, the Solicitor General begins his discussion with a blunt statement:  "this Court's recent decisions have fostered uncertainty concerning those substantive Section 101 standards."  This uncertainty lies mainly in the "the scope of the exceptions and the proper methodology for determining whether a particular patent implicates them."

Berkheimer being largely a procedural case would not be the appropriate vehicle for addressing the more fundamental substantive questions, in the Solicitor General's view.  Indeed, "the allocation of decision-making authority between judge and jury . . . is deeply intertwined with the underlying legal standards that govern patent-eligibility."  Thus, the Solicitor General opines that HP's question "would be difficult to answer in any cogent manner while uncertainty about the substance of the Section 101 inquiry persists."  He further notes that Berkheimer's focus on step two of Alice is of limited use for purposes of clarifying § 101 since the uncertainty arises under both steps.

Indeed, any outcome of a Supreme Court ruling in Berkheimer could be rendered moot if the Court later rules on a more substantive § 101 case.  The Solicitor General appears to be taking the position that there is little point to apply a Berkheimer band-aid when patent-eligibility actually needs major surgery.

The Solicitor General further observes that both parties are suggesting the Court use this case to address the larger § 101 issues.  Yet, there is "significant disagreement about what the claimed invention actually comprises" in the disputed patent.  The Solicitor General writes:

The district court appeared to view Berkheimer's patent as simply identifying features that it would be desirable for a software system to possess—one-to-many editing, increased efficiency, and reduced redundancy and storage costs—rather than as claiming a specific method for achieving those features and the corresponding benefits.  In contrast, the court of appeals appeared to conclude that the claims at issue could be read as identifying a particular method that will achieve the desired results, and it declined to determine which view of the patent is correct in the case's current summary-judgment posture.

This implies that there is a potential problem with whether the patent conforms to the § 112(a) written description requirement.  Particularly, the Solicitor General states that "[i]t would be difficult to provide meaningful clarity about Section 101's boundaries without first knowing whether and to what extent the invention represents a particular practical implementation of broader principles of software design to achieve the stated objective, or merely posits one possible way one might attempt to do so."  In other words, if the scope of the invention is unclear, the Alice test is that much more difficult to apply.

The Solicitor General goes on to contend that this lack of clarity "may be exacerbated in the software-system context, in which this case arises."  He even suggests that the Supreme Court is especially unequipped to address § 101 issues in software technologies, and that the software focus of Berkheimer would frustrate the Court's ability to clarify the larger principles underlying patent eligibility.

In accordance with these points, the Solicitor General concludes with the recommendation that "[r]ather than attempt to resolve broader questions of Section 101's substantive scope in the face of those difficulties, the Court should await an appropriate case that properly presents those broader questions without similar obstacles."

It should not be surprising, given the brashness of the Trump administration, that the executive branch would take two clear swipes at the judiciary:  "You screwed up the law" and "you are not qualified to fix it."  Despite the merits to both of these points, being a fly on the wall during the Court's conference on this case would likely prove interesting.  But the important outcome here is that the government is arguing to let one of the very few patent-friendly § 101 decisions from the Federal Circuit stand.

Solicitor General Recommends That Supreme Court Deny Certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals

By Donald Zuhn --

On Friday, the United States filed its brief in response to the March 18, 2019 order of the Supreme Court inviting the Solicitor General to express the views of the United States on the petition for certiorari filed by Petitioners Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International Ltd. in Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc.  The Solicitor General concluded that "[i]n the view of the United States, the petition for a writ of certiorari should be denied," stating that the case was "not an optimal vehicle for bringing greater clarity [to the Court's recent § 101 precedents] because the court of appeals majority arrived at the correct result."

The brief begins by explaining that the case concerns claims for methods of using human-made drugs to treat medical conditions.  The dispute between the parties began when Vanda sued Hikma (at the time known as West-Ward Pharmaceuticals International Ltd.) for infringement of U.S. Patent No. 8,586,610, which relates to methods of treating patients suffering from schizophrenia with iloperidone.  Representative claim 1 of the '610 patent recites:

1.  A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:
    determining whether the patient is a CYP2D6 poor metabolizer by:
        obtaining or having obtained a biological sample from the patient; and
        performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
    if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
    if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,
    wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.

As the brief explains, the '610 patent describes that some patients have a variation (genotype) of a particular gene (CYP2D6) that results in poor metabolization of iloperidone, which in turn can lead to a dangerous heart condition called QTc prolongation.

The District Court determined that Hikma's proposed products would infringe Vanda's patent, rejecting Hikma's argument that the '610 patent claimed a patent-ineligible natural law.  The Federal Circuit affirmed, with the majority (Judges Lourie and Hughes) concluding at step one of its Mayo/Alice analysis that the claims of the '610 patent are patent-eligible because they are not directed to a patent-ineligible natural law, but rather are "directed to a novel method of treating a disease."  As explained in the Solicitor General's brief, "[t]he majority explained that, although '[t]he inventors recognized the relationships between iloperidone' and genetically linked side effects, they had not claimed the relationship itself, but instead had 'claimed an application of that relationship' that requires the administration of a specific dosage, 'depending on the result of a genotyping assay.'"  The brief also explained that Chief Judge Prost, writing in dissent, "stated that, '[w]hatever weight can be ascribed to' Mayo's suggestion that 'a new way of using an existing drug' may be patent-eligible, lower courts 'remain beholden' to what she described as Mayo's contrary 'holding.'"  Following the Federal Circuit's denial of rehearing en banc, the Hikma filed a Petition for a Writ of Certiorari, offering the following Question Presented:

Whether methods of using drugs to treat medical conditions are patent-eligible processes under Section 101.

In summarizing the position of the United States, the Solicitor states that:

The court of appeals correctly held that the relevant claims of Vanda's patent constitute patent-eligible subject matter under 35 U.S.C. 101.  Those claims encompass methods of medical treatment.  Historically, such methods were well understood to be patent-eligible.

The decision below, however, implicates important and recurring questions on which the Court's recent Section 101 decisions have fostered substantial uncertainty.  In particular, Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), has sent conflicting signals.  Language in that opinion indicates that the Court did not intend to overturn the well-settled understanding that method-of-medical treatment claims typically are patent-eligible.  But the decision's logic arguably implies the opposite.  The disagreement between the majority and dissenting opinions below reflects that internal inconsistency.

Although Mayo is the most immediate source of confusion, the uncertainty ultimately stems from the broader framework articulated in the Court's recent Section 101 decisions.  The Court's reconceptualization in Bilski v. Kappos, 561 U.S. 593 (2010), of inherent, long-recognized limitations on Section 101's affirmative scope as freestanding, atextual "exceptions," id. at 601, has given rise to an array of difficult questions.  The confusion created by this Court's recent Section 101 precedents warrants review in an appropriate case.

This case, however, is not an optimal vehicle for bringing greater clarity because the court of appeals majority arrived at the correct result.  In cases involving medical-diagnostic methods, by contrast, the Federal Circuit's recent decisions suggest that the court might well have reached different outcomes if it were not bound by the Mayo framework.  The Court should await a case in which lower courts' confusion about the proper application of Section 101 and this Court's precedents makes a practical difference.

The latter half of the brief is spent fleshing out the summary above.

While acknowledging the historical understanding that a method of using a drug to treat a medical condition constitutes patent-eligible subject matter, the brief notes that "the Court's recent Section 101 decisions leave the proper analysis of such claims unclear."  In support of that historical understanding of patent eligibility, the brief points to the "tens of thousands of patents that included at least one method-of-treatment claim" that the U.S. Patent and Trademark Office has issued since enactment of the 1952 Patent Act (although it should be noted that a similar argument failed to sway the Court in Association for Molecular Pathology v. Myriad Genetics, Inc.) and Congress' enactment of the Hatch-Waxman Act in 1984, which the brief suggests contains "provisions [that] assume that claims for methods of medical treatment, including methods that involve the administration of drugs to patients, are potentially patent-eligible."

As for the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the brief states that:

The Mayo Court . . . appeared to take as its premise that methods of medical treatment are patent-eligible.  Nevertheless, as evidenced by the dissenting opinion below, it is arguably unclear how the longstanding and entirely correct rule that method-of-treatment claims are patent-eligible can be reconciled with mechanical application of Mayo's two-step framework.

The brief argues that the Mayo Court's application of "a new and capacious understanding of patent-ineligible 'laws of nature'" was significant in two respects.  First, the brief asserts that the Mayo Court departed from the prior distinction under § 101 between products of nature and human-made inventions by describing as "laws of nature" biological responses of the human body to conditions that arise solely from human intervention.  Second, the brief contends that the Mayo Court defined the natural law it identified at an extremely high level of specificity, noting that "[w]hen highly specific relationships of that sort are treated as laws of nature, it becomes more difficult for a patent applicant to show that its invention goes substantially beyond an instruction to 'apply the law.'"  With respect to the difficulty of applying Mayo's two-step framework, the brief points out that:

[I]f mechanical application of Mayo's approach leads to the conclusion that the metabolizing of a drug, as in Mayo, is an "entirely natural process[ ]"—merely illustrating a natural law that "exists in principle apart from any human action," 566 U.S. at 77—the same would arguably be true of the biological reactions involved in Vanda's process.  And if the precise mathematical correlations in Mayo qualify for this purpose as "laws of nature," ibid., the same would arguably be true of the highly particularized relationships on which Vanda's treatment method is premised.

And the brief continues:

Indeed, it is arguably unclear whether even a method of treating disease with a newly created drug would be deemed patent-eligible under a mechanical application of Mayo's two-part test.  The proposition that a specified dosage of a new drug has therapeutic benefits for a particular class of patients would seem to constitute a "law of nature" under Mayo's expansive conception of that term.  And once that therapeutic benefit has been identified, an instruction to administer the drug in the specified dosage to the relevant patients might be viewed as nothing more than routine and conventional activity.  The patent-eligibility of such method-of-treatment claims has long been settled, and the Mayo Court did not suggest that it intended such an avulsive effect on established practices.  The potential for rote application of the Mayo two-step framework to call into question such bedrock understandings of the patent system, in a way that the Mayo Court clearly did not envision, suggests that the Mayo framework warrants reconsideration [emphasis in brief].

As for the Federal Circuit's handling of the case, the brief contends that the majority and dissenting opinions "illustrate the conflicting strands within the Mayo opinion."  The brief also suggests that "[t]he current uncertainty as to the proper application of the Mayo framework has considerable practical consequences for various types of medical innovations," with some commentators "liken[ing] Mayo's analysis to an elusive 'I-know-it-when-I-see-it' standard."  The brief also argues that the USPTO's ability to provide direction to its examining corps and administrative patent judges "is constrained by the lack of clarity in judicial precedent."

According to the Solicitor General's brief, "[t]he present difficulties in applying Section 101 ultimately derive in substantial part from the Bilski Court's reconceptualization of the limits on Section 101's coverage as freestanding 'exceptions,' 561 U.S. at 601, rather than as context-sensitive interpretations of the provision’s terms."  The brief states that:

[T]he Bilski Court . . . recast decades of precedent recognizing internal limits on Section 101's reach as "exceptions" that the Court acknowledged "are not required by" Section 101's language.  Id. at 601.  That approach decoupled the Section 101 analysis from the statutory text and context, necessitating an alternative methodology for ascertaining the scope of the exceptions and identifying claims that implicate them.

Mayo and later decisions demonstrate the difficulty of that task.  Mayo "set forth a framework" that Alice distilled to two "step[s]."  Alice, 573 U.S. at 217.  First, courts must ask "whether the claims at issue are directed to one of th[e] patent-ineligible concepts."  Ibid.  Second, "[i]f so," courts must "ask, 'what else is there in the claims,'" while effectively disregarding activities that are "'well-understood, routine, [and] conventional.'"  Id. at 217, 225 (quoting Mayo, 566 U.S. at 73, 78) (brackets omitted).  Both steps have proven problematic.

The brief argues that the Supreme Court's instruction that courts inquire at the first step of the Mayo/Alice analysis whether a patent is "directed at" a law of nature, natural phenomenon, or abstract idea "provides little guidance," and contends that "[t]he second step is similarly ambiguous."  Citing the Court's decision in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, the brief notes that:

Within a single post-Mayo opinion, the Court variously articulated that step as a query regarding "what else is there in the claims"; an examination of "whether the additional elements transform the nature of the claim into a patent-eligible application"; "a search for an inventive concept"; an inquiry into any "additional features to ensure that the claim is more than a drafting effort designed to monopolize" the abstract idea or natural law; a review of whether the claims do "more than simply stating the abstract idea while adding the words 'apply it'"; an evaluation of whether a patent does more than merely "limit the use of an abstract idea to a particular technological environment"; and a determination whether additional features are "well-understood, routine, conventional activit[ies]" previously known to the industry.

In addition to the ambiguity of the second step of the Mayo/Alice framework, the brief argues that the second step "causes the Section 101 inquiry to overlap with the application of other Patent Act provisions," adding that "to the extent Mayo's approach screens out routine activity and considers only those discrete steps that are independently new, it replaces the traditional statutory focus on the invention 'as a whole,' . . . with a more demanding test."

Despite the problems with the Mayo/Alice two-step framework, the brief ultimately concludes that:

This case . . . is not an optimal vehicle to address the confusion stemming from this Court's recent Section 101 decisions.  Despite that uncertainty, the court of appeals majority reached the correct result in concluding that the method of medical treatment claimed in Vanda's patent is patent-eligible subject matter.

Instead, the brief suggests that the Court "should provide additional guidance in a case where the current confusion has a material effect on the outcome of the Section 101 analysis," offering as one example a case involving the patent eligibility of medical-diagnostic methods, and pointing in particular to Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC.  The brief notes that in contrast with Vanda, where rehearing was denied by the Federal Circuit without dissent, "the Federal Circuit's recent order denying rehearing en banc in Athena was accompanied by multiple separate opinions articulating different understandings of Mayo and seeking clarification from this Court."  The brief argues that the eight opinions in the Athena order "provide substantial grounds for inferring that, if the Federal Circuit were not bound by the current Section 101 framework, that court might have reached different outcomes in Athena itself and in other diagnostic-method cases."

The Solicitor General concludes the brief by recommending that the petition for a writ of certiorari in Vanda be denied, and proposing as an alternative that the petition be held pending the Court's decision in Athena, in the event the Court grants the petition for certiorari in that case.

IPO Webinar on Significant Patent Cases for 2019

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Patent Case Law Year in Review" on December 9, 2019, from 2:00 to 3:00 pm (ET).  Samantha Aguayo of the Intellectual Property Owners Association will moderate a panel consisting of Paul Berghoff of McDonnell Boehnen Hulbert Berghoff LLP and Gregory Castanias of Jones Day, who will provide a roundup of this year's most significant patent cases, including Helsinn v. Teva, Return Mail v. US Postal Service, and others involving issues such as UPSTO inter partes review decisions and patent eligibility under 35 U.S.C. § 101.  The panel will also provide key takeaways from these decisions and comment on patent cases to watch in the coming year.

The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

Trump Administration Considering Reduction in Biologics Exclusivity Period

By Donald Zuhn --

On Monday, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and Innovation Act (BPCIA) to ten years.  According to The Wall Street Journal, the Trump administration is considering the change in order to persuade Democrats to support the U.S.-Mexico-Canada Agreement (USMCA), a replacement for the North American Free Trade Agreement (NAFTA), that the administration negotiated last year.  The USMCA would establish at least a 10-year data exclusivity period for biologic drugs, which would double the exclusivity period in Mexico and increase the exclusivity period in Canada by two years.

As Patent Docs readers may recall, the data exclusivity period in the BPCIA (and prior biosimilars legislation packages) was a hotly contested topic of debate, with some supporting a 14-year period, the Obama administration preferring a 7-year period, and others calling for a 5-year period (see "Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term"; "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements"; "Senators Send Letter on Biosimilars to FDA"; "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not"; and "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements").

United States v. Gilead Sciences, Inc.

By Daniel Boehnen --

Last month, the United States government, acting on behalf of its Department of Health and Human Services (HHS), filed suit in Delaware against Gilead Sciences, Inc. and Gilead Sciences Ireland UC for infringing four patents covering inventions developed by scientists at the Centers for Disease Control and Prevention.  The patents all cover methods for a type of medical regimen known as "pre-exposure prophylaxis" (PrEP) for the prevention of HIV.  More specifically, each of the four patents'  claims recite:

• A process for protecting a primate host from a self-replicating infection by an immunodeficiency retrovirus comprising . . . .

• A process for inhibiting establishment of a human immunodeficiency virus self-replicating infection of human immunodeficiency virus infection in a human comprising . . . .

The lawsuit is highly noteworthy for many reasons.  It is very unusual -- not unheard of, but very unusual -- for the U.S. government, acting as a patent owner, to sue a company for patent infringement.  Second, the Complaint is extremely detailed in explaining the history of events leading to the invention as well as the history of interaction between HHS and Gilead leading to the filing of the Complaint.  Third, it does not take much reading between the lines to see that one of the government's goals is to make the PrEP regimen as readily available and cost effective in the U.S. as it already is in many European and other countries, with Gilead being alleged as a primary roadblock in that path.

Gilead is of course well-known for discovering Truvada® (a fixed dose combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC)) as well as Descovy® (a combination of FTC and tenofovir alafenamide fumarate (TAF)).  Truvada® and Descovy® are regularly used in treating active HIV infections with the goal of reducing the active virus load to undetectable levels.  The Complaint notes that Gilead's patents on these products expire in 2021.

The Complaint explains that the CDC developed innovative pre-clinical models that proved to be keys in testing and proving the CDC scientists' concepts in the claimed inventions.

Still further, the Complaint goes to significant length to explain that Gilead provided absolutely no support in developing the inventions, aside from providing certain drug compounds under an MTA.  Indeed, the Complaint addresses and squarely shoots down Gilead's public statement claiming credit for the development of the PrEP regimine.

The Complaint notes the significant benefits achieved by Truvada® and Descovy® for treating established HIV infections, but focuses on the efforts that were being made in the 1990s and 2000s to discover a way to prevent HIV infection from becoming established.  In particular, the Complaint provides a great summary of the substantial -- yet unsuccessful -- R&D that had been and was being undertaken to develop a vaccine and/or post-exposure prophylaxis treatment of HIV prior to the invention, as well as the reasons why PrEP was then-deemed unachievable.  In this respect, the Complaint is like a great survey article on the history of HIV treatment research, but the document is written in a much more readable manner than most survey articles.

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 30th.

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 30th.

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 30th.