Patent Docs

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

December 8, 2019

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

December 7, 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

December 3, 2019

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.

December 1, 2019

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

November 28, 2019

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving. Publication of Patent Docs will resume on November 30th.
Pharma Tech Solutions, Inc. v. Lifescan, Inc. (Fed. Cir. 2019)

November 27, 2019

By Kevin E. Noonan —

"Everything you say can be held against you" is a trope in crime shows from the U.S., Australia, New Zealand, the UK, and Ireland (stated in various ways), and a recent decision by the Federal Circuit regarding preclusion of infringement under the doctrine of equivalents by prosecution history estoppel is an excellent example of the same principle in patent law.

The lawsuit that gave rise to the Court's decision in Pharma Tech Solutions, Inc. v. Lifescan, Inc. involved Pharma Tech's assertion of U.S. Patent Nos. 6,153,069 and 6,413,411, which were directed to blood glucose monitoring systems. As explained in the opinion:

To test blood glucose, an individual typically draws blood by pricking a finger, placing the blood on the end of a test strip, and placing the test strip into a meter. The test strip contains a pair of electrodes, including a working electrode and a second electrode. The working electrode is coated with an enzyme that oxidizes glucose in the blood sample. Following an incubation period, the meter (1) applies a known electric potential across the electrodes, creating a diffusion limiting electric current (referred to as the "Cottrell current") through the sample; and (2) measures Cottrell current. A proportional relationship exists between the measured current and blood glucose concentration. Based on this proportional relationship, a microprocessor in the meter converts the measured electric current to a blood glucose level and then reports the blood glucose level to the user.

The distinction from prior art monitoring systems embodied in the claims is illustrated by the italicized portion of claim 1 of the '069 patent:

1. An apparatus for measuring compounds in a sample fluid, comprising:
    a) a housing having an access opening therethrough;
    b) a sample cell receivable into said access opening of said housing, said sample cell being composed of;
        (i) a first electrode which acts as a working electrode;
        (ii) a second electrode which acts to fix the system potential and provide opposing current flow with respect to said first electrode, said second electrode being made of the same electrically conducting material as said first electrode, and being operatively associated with said first electrode, the ratio of the surface area of said second electrode to the surface area of said first electrode being 1:1 or less;
        (iii) at least one non-conducting layer member having an opening therethrough, said at least one non-conducting layer member being disposed in contact with at least one of said first and second electrodes and being sealed against at least one of said first and second electrodes to form a known electrode area within said opening such that said opening forms a well to receive the sample fluid and to allow a user of said apparatus to place the sample fluid in said known electrode area in contact with said first electrode and said second electrode;
    c) means for applying an electrical potential to both said first electrode and said second electrode;
    d) means for creating an electrical circuit between said first electrode and said second electrode through the sample fluid;
    e) means for measuring a first Cottrell current reading through the sample fluid at a first predetermined time after the electrical potential is applied and for obtaining at least one additional Cottrell current reading through the sample fluid, the at least one additional Cottrell current reading occurring at a second predetermined time following the first predetermined time;
    f) microprocessor means for converting the first Cottrell current reading into a first analyte concentration measurement using a calibration slope and an intercept specific for the first Cottrell current measurement, for converting the at least one additional Cottrell current reading into an additional analyte concentration using a calibration slope and an intercept specific for the at least one additional Cottrell current measurement, and for comparing the first analyte concentration measurement with the at least one additional concentration measurement to confirm that they are within a prescribed percentage of each other; and
    g) means for visually displaying the results of said analyte concentration measurements.

Thus, rather than measuring the induced Cottrell current readings and comparing them, the microprocessor converts these current readings to glucose concentrations and compares them.

Lifescan's accursed infringing article, sold as the OneTouch® Ultra® system, operates by measuring current produced in the presence of blood on the test strip in two working electrodes during a five-second "countdown period," and then conducts a "Current Difference Test" (as a control that the values are within proscribed limits), followed by calculating total final current (that is then correlated with blood glucose concentration). As stated in the opinion:

It is undisputed that Lifescan's meters neither convert multiple Cottrell current readings to analyte concentration measurements nor compare multiple analyte concentration measurements. Pharma Tech agrees that the accused products therefore do not literally infringe the claim. But Pharma Tech asserts that "an analyte measurement can be expressed as a current at a given time or as a concentration" and, thus, the accused device infringes under the doctrine of equivalents.

The opinion sets forth certain aspects of the prosecution history, wherein the italicized portion of the claim set forth above was added by amendment in response to rejection over certain prior art references (specifically U.S. Patent No. 5,385,846 (Kuhn), U.S. Patent No. 5,288,636 (Pollmann), and U.S. Patent No. 5,108,564 (Szuminsky)). These amendments were accompanied by argument, wherein the applicant relied on the feature of converting the Cottrell current readings to analyte (i.e., blood glucose) concentrations which were then compared with one another. These amendments were not completely availing for patentability, because the Examiner asserted two additional prior art references (U.S. Patent No. 5,508,171 (Walling) and U.S. Patent No. 5,243,516 (White)) for obviousness, which the applicant distinguished based on the "converting" and "comparing" language introduced into the claims in the previously presented amendment. After somewhat protracted argument along these lines, the applicant was finally able to have the '069 patent grant; the '411 patent granted shortly thereafter.

The District Court granted Life Scan summary judgment that prosecution history estoppel prevented Pharma Tech from showing infringement under the doctrine of equivalents (Pharma Tech dismissed its literal infringement claims). In doing so, the Court held that both amendment-based and argument-based estoppel arose by Pharma Tech's amendments and arguments, and rejected plaintiff's argument that estoppel did not arise because the amendments and arguments were only tangentially related to patentability, pursuant to Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1369 (Fed. Cir. 2003). This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Stoll, joined by Judges Moore and Reyna. The opinion sets forth the parameters of "amendment-based" estoppel (that the amendment was narrowing for purposes of establishing patentability over the prior art) and "argument-based" estoppel (surrender of claim scope by arguments made to the Patent Office), finding both species of estoppel on the record before it. Under Festo, a presumption arises when an applicant submits a narrowing amendment to overcome a rejection for unpatentability. That presumption can be overcome one of three ways, according to the Court: "(1) the equivalent was "unforeseeable at the time of the application"; (2) "the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question"; or (3) "there may be some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question," citing Festo at 740-1. Here, Pharma Tech argued tangentiality, unsuccessfully.

With regard to argument-based estoppel, "the prosecution history must evince a clear and unmistakable surrender of subject matter" according to the opinion, citing Conoco, Inc. v. Energy & Envtl. Int'l, L.C., 460 F.3d 1349, 1364 (Fed. Cir. 2006) (quoting Deering Precision Instruments, L.L.C. v. Vector Distribution Sys., Inc., 347 F.3d 1314, 1326 (Fed. Cir. 2003)). The Court set forth the policy bases for this estoppel, stating that "[c]lear assertions made during prosecution in support of patentability, whether or not actually required to secure allowance of the claim, may also create an estoppel . . . because [t]he relevant inquiry is whether a competitor would reasonably believe that the applicant had surrendered the relevant subject matter," citing PODS, Inc. v. Porta Stor, Inc., 484 F.3d 1359, 1368 (Fed. Cir. 2007).

The Federal Circuit held that both types of estoppel precluded Pharma Tech from a finding of infringement under the doctrine of equivalents. Regarding amendment-based estoppel, the opinion states that, prior to amendment Pharma Tech's claim "was broad enough to cover any bioelectrical blood glucose monitoring system" and afterwards, the claim was limited to systems that converted Cottrell current readings to analyte concentrations that were compared to one another. Accordingly, "[t]he applicants thus presumptively surrendered any bioelectrical blood glucose monitoring systems that do not convert a plurality of current readings into analyte concentration measurements and compare the resulting analyte concentration measurements." The "equivalent" asserted by Pharma Tech to ensnare Lifescan's accused infringing article — "the functionality of a system that (a) measures current at two different times, (b) compares the current[s] to ensure they are within a prescribed percentage and (c) converts the current readings into a glucose concentration" — "falls squarely within the territory between the original claim and the amended claim" in the panel's view. In order for Pharma Tech to overcome the presumption that the amendments estopped them from (successfully) asserting this equivalent, its burden was to show that the amendment was only tangentially related to patentability. Pharma Tech failed to make this showing, according to the opinion, because "the inventors clearly and unambiguously distinguished their invention over the prior art based on the converting and comparing limitations added by [their] amendment." The opinion cites the "consistent[] assert[ions]" (expressly cited in the opinion) by the patent applicant that their amendment overcame the asserted prior art in support for their conclusion regarding amendment-based estoppel. And to Pharma Tech's argument that their amendment (under the Court's reading) surrendered more claim scope than necessary to establish patentability, the opinion states that this doesn't establish tangentiality, citing Int'l Rectifier Corp. v. IXYS Corp., 515 F.3d 1353, 1359 (Fed. Cir. 2008) (quoting Schwarz Pharma, Inc. v. Paddock Labs., Inc., 504 F.3d 1371, 1377 (Fed. Cir. 2007)) that "'[t]he fact that the inventors may have thought after the fact that they could have relied on other distinctions in order to defend their claims is irrelevant' to discerning the objective reason for their amendment."

As for argument-based estoppel, the opinion states that Pharma Tech failed to show that the facts before the panel were sufficiently analogous to cases where the estoppel was not found to absolve these claims from this species of estoppel. Specifically, the opinion rejects Pharma Tech's attempted reliance on Insituform Technologies, Inc. v. CAT Contracting, Inc., 385 F.3d 1360 (Fed. Cir. 2004). In that case, the Federal Circuit was able to find that there was "no indication in the prosecution history of any relationship between the narrowing amendment" and the asserted equivalent. Here, in contrast, the Court found ample evidence that the amendments and arguments had more than a tangential relationship to patentability. Similarly, the panel distinguished these facts from the situations arising in recent Federal Circuit decisions regarding the scope of estoppel, including Eli Lilly & Co. v. Hospira, Inc., 933 F.3d 1320, 1332 (Fed. Cir. 2019) and Ajinomoto Co. v. Int'l Trade Comm'n, 932 F.3d 1342, 1355 (Fed. Cir. 2019).

The outcome here illustrates the difficulty (if not impossibility) of predicting future design-around efforts by others, and how prudent prosecution practices include maintaining pending applications to give a patentee the flexibility to pursue claims that will be literally infringed by even the most clever competitors.

Pharma Tech Solutions, Inc. v. Lifescan, Inc. (Fed. Cir. 2019)
Panel: Circuit Judges Moore, Reyna, and Stoll
Opinion by Circuit Judge Stoll
Merck Sharp & Dohme Corp. v. Wyeth LLC (Fed. Cir. 2019)

November 26, 2019

By Donald Zuhn —

Today, in Merck Sharp & Dohme Corp. v. Wyeth LLC, the Federal Circuit vacated and remanded two final written decisions by the U.S. Patent and Trademark Office Patent Trial and Appeal Board finding claim 18 of U.S. Patent No. 8,562,999 to be nonobvious. The '999 patent, which is directed to formulations for stabilizing polysaccharide-protein conjugate vaccines, is assigned to Wyeth LLC.

Polysaccharide-protein conjugate vaccines are derived from capsular polysaccharides present on the surface of certain disease-causing bacteria. These capsular polysaccharides can be used by the human immune system to detect different serotypes (or strains) of a bacterial species. Polysaccharide vaccines can be monovalent (comprising a single serotype) or multivalent (comprising multiple serotypes). Because such capsular polysaccharides may have low immunogenicity, it is desirable to enhance the effectiveness of vaccines comprising such polysaccharides by conjugating the polysaccharides to a carrier protein with high immunogenicity. As the '999 patent explains, however, polysaccharide-protein conjugate vaccines aggregate when exposed to silicone oil, which is commonly used as a lubricant in vaccine storage containers. The '999 patent describes a formulation that inhibits silicone-induced aggregation by suspending the polysaccharide-protein conjugate in a mixture of a pH-buffered saline solution and an aluminum salt. Claim 1 of the '999 patent (the sole independent claim) recites:

1. A formulation comprising (i) a pH buffered saline solution, wherein the buffer has a pKa of about 3.5 to about 7.5, (ii) an aluminum salt and (iii) one or more polysaccharide-protein conjugates, wherein the formulation is comprised in a siliconized container means and inhibits aggregation induced by the siliconized container means.

Claim 18 of the '999 patent recites:

18. The formulation of claim 1, wherein the one or more polysaccharide-protein conjugate comprises an S. pneumoniae serotype 4 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6B polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 9V polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 14 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 18C polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 19F polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 23F polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 1 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 3 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 5 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6A polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 7F polysaccharide conjugated to a CRM197 polypeptide and an S. pneumoniae serotype 19A polysaccharide conjugated to a CRM197 polypeptide.

Thus, claim 18 is directed to a formulation comprising thirteen different S. pneumoniae serotype polysaccharides conjugated to a CRM197 polypeptide.

Merck Sharp & Dohme Corp. petitioned for inter partes review of claims 1–6, 10, 11, 14, and 17–20 of the '999 patent. The Board instituted review of all challenged claims in two parallel proceedings: IPR2017-00378, in which claim 1 was challenged as obvious in view of International Publication No. WO 03/009869 ("Chiron"); Smith, Siliconization of Parenteral Drug Packaging Components (1988) ("Smith"); and International Publication No. WO 2004/071439 ("Elan"), and IPR2017-00380, in which claim 1 was challenged as obvious in view of Chiron and Annex I of the European Medicines Agency's European Public Assessment Report for Prevenar ("Prevenar"). In each proceeding, Merck challenged claim 18 as obvious in view of the above references in combination with Peña et al., 24 Pediatrika 47 (2004) ("Peña"), which discloses a study involving a 13-valent conjugate, but does not disclose conjugating the polysaccharides with the CRM197 protein as recited in claim 18. In both proceedings, the Board found all of the challenged claims except claim 18 to be unpatentable as obvious.

Merck appealed the Board's decisions as to claim 18, arguing that the Board failed to provide a reasoned basis for upholding claim 18. As discussed in the Federal Circuit's opinion, "[t]he Board's decision rests on its finding that the study discussed in Peña did not show that 'a formulation comprising each of the thirteen known serotypes conjugated to a CRM197 [protein] . . . was even considered, tried and successful.'" However, the Court notes that:

Standing alone, this finding is insufficient to support a lack of motivation or a reasonable expectation of success. Obviousness, unlike anticipation, does not require a prior art successful formulation. See Par Pharm., 773 F.3d at 1198. Here, there was conflicting evidence as to motivation and reasonable expectation of success—evidence not discussed by the Board.

That conflicting evidence included the testimony of Merck's expert, who testified that a skilled artisan would have found it obvious to select the thirteen conjugates recited in Peña, each conjugated to CRM197, for a polysaccharide-protein conjugate vaccine, and Wyeth's expert, who testified that Peña would not have lead a skilled artisan to conclude that the 7-valent conjugate vaccine of Prevenar could be expanded to the 13-valent pneumococcal polysaccharide single-carrier CRM197 conjugate vaccine of claim 18 with a reasonable expectation of success. According to the panel, the parties' differences concerned whether a skilled artisan would have been dissuaded from using a single carrier protein, such as CRM197, for a 13-valent pneumococcal polysaccharide conjugate vaccine due to "immune interference," a phenomenon that may result in decreased immunogenicity in multivalent vaccines with a sole carrier protein.

Although Merck argued that the immune interference issue is irrelevant, the Court disagreed, stating that "this issue is relevant to whether a skilled artisan would have been motivated to conjugate the 13 serotypes with CRM197 as a sole carrier protein." In vacating and remanding the Board's decisions, the panel indicated that "the Board simply did not address the evidence as to whether someone skilled in the art would have been motivated to combine the 13 serotypes into a CRM197 conjugate or whether the potential loss of immunogenicity would have dissuaded someone skilled in the art from making such a combination," and concluded that "the Board’s decision is too cryptic to survive judicial review." The Federal Circuit therefore vacated the Board's obviousness findings with respect to claim 18, and remanded for further consideration of the parties' arguments and evidence as to the motivation to combine, reasonable expectation of success, and other issues such as secondary considerations.

Merck Sharp & Dohme Corp. v. Wyeth LLC (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Dyk and Wallach
Opinion by Circuit Judge Dyk
CRISPR Housekeeping

November 25, 2019

By Kevin E. Noonan —

Part of every interference are a variety of housekeeping matters which, while not dispositive, are important to recognize for their effects (or potential effects) on the proceedings. Some are simple matters: for example, on October 28th, the Board granted the Broad's request for authorization to file a Reply to CVC's (the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier) opposition to the Broad's Substantive Motion No. 1 (which the Broad filed on November 4th), and CVC filed its revised protective order on November 7th, pursuant to the Board's earlier authorization.

More recently, the Board issued an Order denying CVC relief requested on two grounds. First, CVC requested authorization to file a sur-reply to Broad's reply to CVC's opposition to Broad's Motion No. 1. The Board denied this motion for now, saying that it could reconsider after it had had the opportunity to review the Broad's motion, CVC's Opposition, and the Broad's Reply. This result logically followed from the grounds CVC asserted in support of its sur-reply request, including that the Broad in its reply had mischaracterized CVC's arguments in its Opposition.

The Board also denied CVC's request for a conference call to compel Broad to produce a witness for cross-examination. The Order referred to the opportunity for CVC to file a Motion to Exclude Evidence at Time Period 5, which would dispose of the matter. In noting this opportunity, the Board certainly sent a message to the Broad that the testimony of this witness could be put in jeopardy should it continue to resist.

Also on the issue of depositions, the Board on November 22nd issued an Order mediating a dispute between the parties on the amount of time each party will get for deposition. The witnesses for each party are as follows:

Broad witnesses, relied upon for Motion Nos. 2, 3, and 4:

• Seeger        161 pg declaration (Exhibit 3401)
• Beaker        48 pg declaration (Ex. 3403)

CVC witness, relied upon for Motions 1 and 2:

• Peterson        first declaration 169 pg (Ex. 4036)
                        second declaration 153 pg (Ex. 4189)

The parties agreed that the Broad will make each witness available for seven hours of deposition, for a total of fourteen hours. The Broad wanted twelve hours to depose CVC's witness and CVC objected, requesting the Board grant the Broad seven hours equal to the time each of the Broad's witnesses would sit for deposition. The Board ordered that each party would have the same amount of time for deposition without regard to the number of witnesses. The Board's reasoning was that the Broad was not responsible for CVC's choice to put forth one witness and, for seemingly practical reasons, the number of pages for CVC's lone declarant exceeded by about 100 pages the combined declarations of the Broad's two witnesses.

Finally, for now, on November 20th CVC provided an updated Notice of Related Proceedings, informing the Board and the Broad of the following newly granted patents (as well as additional pending applications), none of which are involved in this interference:

10,301,651 (USSN 14/685,504); 10,227,611 (USSN 14/042,782); 10,407,697 (USSN 15/435,233); allowance of USSN 15/803,424; 10,385,360 (USSN 15/925,544); 10,421,980 (USSN 16/033,002); 10,415,061 (USSN 16/033,005); 10,308,961 (USSN 16/033,016); 10,358,658 (USSN 16/201,836); 10,337,029 (USSN 16/201,848); 10,351,878 (USSN 16/201,855); 10,400,253 (USSN 16/276,343); 10,428,352 (USSN 16/276,348); 10,443,076 (USSN 16/276,356); 10,487,341 (USSN 16/277,090); allowance of USSN 16/380,758; allowance of USSN 16/380,781; AND allowance of USSN 16/382,093.
CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 4

November 24, 2019

By Kevin E. Noonan —

On October 14th, Senior Party the Broad Institute (joined by Harvard University and MIT) filed several authorized motions in Interference No. 106,115, including Substantive Motion No. 2 and No. 3, against Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC." In its Motion No. 4, the Broad asks the U.S. Patent and Trademark Office Patent Trial and Appeal Board for priority to U.S. Provisional Application No. 61/736,527 to Zhang (termed "Zhang B1" in the motion), pursuant to 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) and Standing Order ¶ 208.4.1.

The brief begins by setting forth the standard for obtaining the relief requested: "a party need only show a constructive reduction to practice—an enabled written description—of a single species within the count," citing Hunt v. Treppschuh, 523 F.2d 1386, 1389 (CCPA 1975); Weil v. Fritz, 572 F.2d 856, 865 n.16 (CCPA 1978); and Falkner v. Inglis, 448 F.3d 1357, 1362 (Fed. Cir. 2006). For completeness, the brief sets forth the standard for constructive reduction to practice under 37 C.F.R. § 41.201. According to the Broad, Zhang B1 "provides working examples and embodiments that meet each and every limitation of both halves of Count 1" and thus evinces to the skilled worker possession of an embodiment within the scope of the Count.

The brief includes a schematic of the relationship between Zhang B1 and the multiple patents and applications claiming priority thereto:

These priority relationships are claimed in each link in the priority chain, according to the Broad, with reference to more than a dozen facts set forth in the Appendix of material facts. While admitting that the priority claim is set forth in each in "boilerplate language" (perhaps anticipating CVC's objection), the brief asserts that "[t]he PTAB has held that such 'boilerplate language' . . . broadly stating without further qualification that the earlier-filed patents are 'incorporated by reference,' is sufficient in view of Federal Circuit precedent to incorporate the disclosure of at least the [earlier filed] patent into each later-filed patent," citing Symantec Corp. v Finjan, Inc., 2016 WL 1081973 (IPR2015-01897 (PTAB February 26, 2016)) (citing Harari v Lee, 656 F. 3d 1331, 1335 (Fed. Cir. 2011). Further support is asserted by the Broad because Example 1 from Zhang B1 is explicitly disclosed in Broad's involved U.S. Patent Nos. 8,771,945; 8,795,965; 8,871,445; 8,889,356; 8,932,814; 8,945,839; 8,906,616 and 9,840,713, as well as the Broad's involved U.S. Patent Application No. 14/704,551. Other patents in the priority chain incorporate Zhang B1 by reference. The brief then asserts that the priority claim in each case complied with the requirements of 35 U.S.C. § 120.

Turning to Example 1 of Zhang B1, the brief sets forth the argument for Zhang B1 satisfying the requirements for constructive reduction to practice, including the level of one of ordinary skill in the art and how Example 1 would be understood by such a person (in detail). According to the Broad, "Zhang B1 sufficiently teaches, describes and enables each embodiment such that [a person having ordinary skill in the art would be able to use each embodiment successfully, without undue experimentation, and hence provides systems, cells, and methods falling within the scope of Count 1." The brief characterizes as "the Broad half of the Count" the alternative recited in the Broad patent used as the exemplar of the Count and recites with reference to the specification the disclosure in Zhang B1 disclosing these elements. The brief supports these explications of the Zhang B1 disclosure with expert affidavit testimony. The brief then sets forth disclosure in Zhang B1 of the elements defined by the "CVC half of the Count," the alternative recited in the CVC application used as the exemplar of the Count.

The brief then turns to enablement, focused on the "working examples" of CRISPR-Cas9 set forth in Zhang B1, including disclosure of utility in eukaryotic cells for the disclosed technology.

Accordingly, the brief asks the Board to grant priority to Zhang B1, giving the Broad a presumptive priority date of December 12, 2012.
Conference & CLE Calendar

November 24, 2019

December 2, 2019 – "Cross-Border Trends, Tactics and Strategic Insights: What European and U.S. Lawyers Should Each Know About Litigating Abroad" (Practising Law Institute) – London

December 5, 2019 – Intellectual Property Law Educational Program (Clyde & Co and McDonnell Boehnen Hulbert & Berghoff LLP) – 6:15 pm to 7:00 pm, London

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