Source: https://www.patentdocs.org/followon_biologics/page/2/
Timestamp: 2019-05-25 09:05:04
Document Index: 138408919

Matched Legal Cases: ['§ 262', '§ 262', '§ 262', '§ 271', '§ 262', '§ 262', '§ 262', '§ 271', '§ 262']

Posted at 11:59 PM in Biosimilars, Supreme Court | Permalink | Comments (3)
Biosimilars Update -- Pfizer's Proposed Epogen®/Procrit® Biosimilar Recommended for Approval
On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen Inc.'s Epogen/Procrit (epoetin alfa). According to a press release from Pfizer, the committee "recommended approval of the Company's proposed epoetin alfa biosimilar across all indications." Pfizer had sought approval for treatment of anemia due to Chronic Kidney Disease (CKD), for treatment of anemia due to zidovudine in HIV-infective patients, for treatment of anemia in patients with non-myeloid malignancies, and to reduce the need for allogenic RBC transfusions among patients with perioperative hemoglobin. If ultimately approved, Retacrit would become the sixth biosimilar in the U.S. And if the experience with the previous five biosimilars is any indication, the FDA should be expected to approve the present application in the next couple of months. Retacrit would also be the second biosimilar for Pfizer, which began selling Celltrion's biosimilar INFLECTRA® in late 2016. As Pfizer's representative Diem Nguyen said in the press release: "Following the approval and launch of INFLECTRA® (infliximab-dyyb) in 2016, this positive recommendation -- a first for a proposed ESA [erythropoiesis-stimulating agent] biosimilar -- marks an important milestone for Pfizer's U.S. biosimilars portfolio."
The Retacrit application would also represent the longest delay between submission and approval. BLA 125545 was originally submitted in December 2014, and according to a Complaint filed by Amgen in September 2015, the application was accepted sometime on or before February 23, 2015. But on October 27, 2015, Pfizer announced that it had received a complete response letter (CRL) from the FDA that required more evidence to support approval. According to Pfizer's FDA Advisory Committee Briefing Document, the CRL "requested additional data and sensitivity analysis to align with the most current FDA expectations and to ensure the robustness of the data demonstrating biosimilarity of Epoetin Hospira to the Epogen/Procrit reference product." This included information in the categories of: manufacturing process, analytical, clinical pharmacology, clinical efficacy, and clinical immunogenicity. In response, Pfizer obtained the additional scientific evidence, which it summarized in the following figure that it said "establishes the biosimilarity of Epoetin Hospira to the Epogen/Procrit reference product."
Marketing of the drug will likely be delayed because of the requirement to give the 180-day notice of commercial marketing. In anticipation, though, Amgen filed a motion for preliminary injunction on May 26, 2017, because (as it alleged in the original underlying Complaint (at paragraph 66)): "Hospira has indicated that it intends to violate the statute by categorically refusing to provide Amgen with a legally operative notice of commercial marking under 42 U.S.C. § 262(l)(8)(A)." Of course, according to the Federal Circuit's Amgen v. Sandoz ruling, Hospira cannot give notice until after the FDA has approved the product. But this requirement may change this month when the Supreme Court issues its decision in the Sandoz v. Amgen case. The Delaware Court also denied Amgen's request for discovery related to Hospira's manufacturing process that was not supplied during the patent dance. The appeal from that decision was heard by the Federal Circuit in April 2017, and an opinion is expected within the next few months.
As a reminder, both this author and Kevin Noonan will be attending the American Conference Institute's 8th Annual Summit on Biosimilars next week, June 12-14, 2017 in New York, NY. Dr. Noonan is co-chair of the conference and will be on a panel reviewing the first 18 months of biosimilars (and looking ahead). If you are attending, please say hello. As a reminder, Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD17, but hurry because registration is closing soon.
Posted at 11:35 PM in Biosimilars, Federal Circuit | Permalink | Comments (2)
Earlier today, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. Sandoz was represented by Deanne E. Maynard, and Amgen was represented by Seth P. Waxman. In addition, Anthony A. Yang presented the position of the United States. The Court considered two issues: (1) whether a biosimilar applicant is required to provide the reference product sponsor ("RPS") with its abbreviated biologics license application ("aBLA") and related manufacturing information in order to take advantage of the abbreviated approval process, and (2) whether the 180-day notice of commercial marketing can be given before FDA approval. In addition, Amgen had originally included causes of action under California state law because Sandoz refused to participate in the patent dance. Justice Gorsuch, in his first oral argument related to patent law as a Supreme Court Justice, brought up the issue of preemption and state law. In this first post related to the oral argument, we will address the first of these issues related to the so-called patent dance, and review the issue regarding preemption.
The majority of the oral argument dealt with the question about the Notice-of-Commercial marketing provision. We will address that section in an upcoming post. Nevertheless, there was enough discussion about the patent dance that it is possible to glean some insights into the thoughts of the Justices. As a reminder, the patent dance kicks off with the disclosure of the biosimilar application, as well as the process of manufacture, by the subsection (k) applicant. The statute at subsection (l)(2) reads:
42 U.S.C. § 262(l)(2) (emphasis added). However, the BPCIA appears to include a remedy should the biosimilar applicant not disclose the requisite information:
42 U.S.C. § 262(l)(9)(C). Moreover, the section of the patent statute dealing with patent infringement actions also suggests a remedy for such a failure to disclose:
35 U.S.C. § 271 (e)(2)(c)(ii).
Sandoz was questioned about how the reference product sponsor will be able to know with certainty just which patents are being infringed if the biosimilar application does not disclose the requisite information. For example, Justice Sotomayor challenged Sandoz, asking:
[C]ould the company with the product file a declaratory judgement action when they don't know what you're going to do? Do they have a good-faith basis for believing you're going to infringe if they don't have the application to look at until they get discovery?
Counsel for Sandoz responded in the affirmative, pointing out that "by definition, a biosimilar is highly similar to the reference product sponsor's product." When Chief Justice Roberts pushed back on this point, noting that "by definition, the biosimilar is similar; it's not identical," counsel responded:
But the question is whether or not you have a good-faith basis to sue. And given the standard of highly [sic] similarity and the kind of similarities there have to be, if the sponsor has any patent that covers its product, this product itself or any uses of the product, it would have a good-faith basis to sue, which is exactly what Amgen did here.
She explained that Congress created this statutory artificial act of infringement for this very reason. With no significant follow-up questions, it is possible that the Justices were satisfied with this response.
With respect to Amgen's position, one of the factors it is required to overcome is that the BPCIA appears to include a remedy when a biosimilar applicant refuses to "dance." For example, Justice Gorsuch questioned counsel for Amgen by asking:
But the question still remains under . . . (l)(9)(c), what the remedy is. And we've heard from the other side that the exclusive remedy is a declaratory judgement action. And how can we possibly decide what (2)(A) means without taking a peek at (9)(c) as to what remedies are permitted.
Importantly, Justice Gorsuch was willing to "spot" Amgen the assumption that "shall" means shall. But, as he put it:
[I]t's hard to divorce a right from its remedy, isn't it, and to understand the contours of the right. And if (2)(A) gives you a certain right to information, we usually understand the right in the context of the remedy provided.
Counsel for Amgen responded to this issue by alleging that (9)(C) was not meant to provide a remedy to the reference product sponsor, but rather it was meant to specify who cannot bring a declaratory judgement action, specifically the biosimilar applicant:
9(C) says if you don't provide that (2)(A) information, you, the applicant, can't ever file for a declaratory judgement action, but (9)(C) doesn't remedy the sponsor's harm . . . 9(C) simply confirms what is -- what should be obvious, which is if it isn't provided, the sponsor is left to his background rights to -- to litigate the declaratory judgment action.
However, the Justices did not seem convinced. As such, it would appear as though the Supreme Court is likely to come to the same conclusion as the Federal Circuit -- that even though "shall" normally means "shall," because the statute specifies the remedy, the biosimilar applicant is free to accept the consequence for not satisfying this requirement.
After Sandoz refused to provide its aBLA, Amgen filed suit in the U.S. District Court for the Northern District of California. Interestingly, a number of the allegations fell under California state law. For example, the first cause of action in the complaint alleged that the Sandoz action of filing its BLA and planning for launching its biosimilar drug product was a violation of California's state law of unfair competition. Specifically, Amgen alleged, in part, that the use of the abbreviated biosimilars pathway without complying with the statutory requirements of the BPCIA was a direct cause of economic injury. Amgen also asserted a cause of action for conversion based on the use of Amgen's information related to safety, purity, and potency. If Sandoz does not adhere to the patent exchange provisions of the BPCIA, Amgen argued, it should not be entitled to rely on the efforts of the reference product sponsor.
The parties did not raise the state law and preemption issue because the Federal Circuit decision rested solely on Federal law. Nevertheless, Justice Gorsuch brought it up during the argument by the assistant to the Solicitor General. Specifically, he was concerned that if (l)(9)(C) was viewed as the exclusive remedy, "what happens when we have a claim under State law that no one's argued is preempted?" Chief Justice Roberts echoed the concern:
Nevertheless, the assistant to the Solicitor General pointed out that there would be no issue, as there would be "no State law claim, because your state law claim is predicated on violating the Federal law."
Justice Sotomayor also expressed concern regarding this issue during Amgen's argument. Specifically, she questioned counsel for Amgen:
What you're not telling me is, it's no longer a choice . . . because State law can force them . . . through you seeking injunctions to participate unwillingly.
In fact, she pointed out that every time a biosimilar application refused to participate in the patent dance, the reference product sponsor could:
[J]ust run to court and say, my State law remedy is force them to take the next step. Give me the application, then identify, then do this. You're going to -- there's no longer a choice.
Counsel for Amgen tried to avoid the subject by pointing out that the state law was not preempted, but that it was not appropriate to address it at this time. He started by citing the Bates v. Dow Agroscience, which he had argued, but the Court ruled against his client in that case holding that because Texas made it a violation to fail to comply with a Federal statute, the plaintiff was entitled to a state law remedy. This was true, even though Congress did not provide for a remedy in the statute. He ultimately concluded that, even though the result would be unsatisfactory, the Court should not be deciding that issue at this time. Correspondingly, it will be interesting to see if the Court addresses the preemption issue when it issues its decision by the end of June.
Posted at 11:59 PM in Biosimilars, Supreme Court | Permalink | Comments (1)
Posted at 10:43 PM in Biosimilars, Supreme Court | Permalink | Comments (1)
On Wednesday, April 26, the Supreme Court will hear oral arguments in the Sandoz Inc. v. Amgen Inc. case. This case involves the interpretation of the Biologics Price Competition and Innovation Act ("BPCIA"), which will be the Court's first opportunity to consider this statute enacted in 2010 to facilitate the entry of biosimilar drug products into the marketplace. However, even though the purpose of the statute is commonly understood, the language of the BPCIA is far from clear, so much so that Judge Lourie described it as "a riddle wrapped in a mystery inside of an enigma." As a case in point, the Amgen v. Sandoz decision authored by Judge Lourie contained two dissenting opinions (at least in part). Patent Docs began following this case from the very beginning; at the time the FDA accepted its first aBLA from Sandoz to market a biosimilar version of NEUPOGEN® (see "Finally, A Biosimilar Application Has Been Accepted By The FDA"). Now, almost three years later, the Supreme Court will be considering two issues that have plagued this case from Judge Seeborg's early rulings in the Northern District of California to the Federal Circuit's highly fractured conclusions: (1) whether the biosimilar applicant is required to provide the reference product sponsor ("RPS") with its abbreviated biologics license application ("aBLA") and related manufacturing information in order to take advantage of the abbreviated approval process, and (2) whether the 180-day notice of commercial marketing can be given before FDA approval. In this preview post, we will review the first of these issues.
This case stems from two appeals from the aforementioned Federal Circuit opinion: Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195), which were subsequently consolidated. Amgen did not initially appeal the decision related to aBLA-disclosure provision, but instead filed a conditional cross-petition asking the Court to review that issue in the event it granted the Sandoz petition for writ of certiorari on the notice-of-commercial marketing issue. Specifically, the question posed by Amgen was:
Not surprisingly, this case has garnered a significant amount of amicus interest from pharmaceutical companies that market biologic therapeutics, biosimilar manufacturers, trade organizations, and academics. The Solicitor General's office filed a brief for the United States in support of Sandoz. In addition, eight other amici filed briefs in support of the petitioner, although many did not address Amgen's question (and those that did gave it little attention). On the other hand, there were five amicus briefs filed in support of Amgen, including three submitted by pharmaceutical companies: Abbvie Inc, Genentech, Inc, and Janssen Biotech Inc. (all of which are reference product sponsors dealing with aBLAs filed against their products); one submitted by the Biotechnology Innovation Organization (BIO); and one submitted by eleven Professors. For the record, the brief of the eleven Professors was filed by Patent Docs author Kevin E. Noonan, Ph.D. as counsel of record, along with other attorneys at McDonnell Boehnen Hulbert & Berghoff LLP.
To understand the question presented by Amgen, it is important to understand the so-called "patent dance." The patent resolution section of the BPCIA consists of a series of exchanges between the biosimilar applicant and the RPS that most likely culminates in litigation that potentially proceeds in two phases. This procedure begins with the FDA's acceptance of the aBLA, after which the biosimilar applicant is to provide the application and other information describing the process(es) used to manufacture the biosimilar product. The patent dance consists of a cascade of information exchanges regarding the patents that the parties believe could reasonably be asserted against the biosimilar drug product were it to be marketed before patent expiration. The parties negotiate a first set of identified patents that will be asserted in a first round of litigation. The remaining identified patents (if any) are held in reserve until the biosimilar applicant provides notice that it intends to market the biosimilar product, at which time the RPS can seek a preliminary injunction with respect to the second-phase patents. If the biosimilar applicant fails to complete any action required by the BPCIA, the RPS is permitted by the BPCIA to immediately bring a declaratory judgement action.
The information disclosure provision of the BPCIA can be found at § 262(l)(2)(A), and reads: "[the aBLA applicant] shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application . . . ." The Federal Circuit held that even though the statute uses the word "shall," in the context of the BPCIA, "shall" does not mean "must." Importantly, the statute contains an optional remedy: if a biosimilar "applicant fails to provide the application and information required under paragraph (2)(A), the reference product sponsor . . . may bring an action . . . for a declaration of infringement, validity, or enforceability of any patent that claims the biologic product or a use of the biological product." 42 U.S.C. § 262(l)(9)(C). In essence, the statute expressly provides the remedy to address the precise "non-disclosure" path that Sandoz chose. As such, failure to disclose was found to not be a violation of the BPCIA.
Amgen has asserted that such a conclusion is contrary to the purpose of the BPCIA. In other words, without the knowledge of the nature of the biosimilar drug product and the methods of manufacturing it, the RPS must essentially guess which patents it should assert. This uncertainty may ultimately prevent a reference product sponsor from being able to assert any of its patents in federal court prior to the launch of the biosimilar drug. Nevertheless, Sandoz has pointed out that Congress did not include a provision linking the FDA approval process to the patent resolution procedures. Thus, there is nothing in the statute that would appear to prevent the FDA from approving an aBLA even if the applicant did not participate in the patent dance.
BIO's Amicus Brief
The Federal Circuit focused on the text of the statute, specifically the inclusion of the remedy should the aBLA applicant fail to disclose its application. For the Supreme Court to reverse on this issue, they will likely need to be convinced that such an interpretation of "shall" is contrary to the legislative history of the BPCIA. BIO submitted a brief in support of Amgen that highlighted the background and history of the statute, recounting the efforts of the various interested parties to arrive at a compromise solution. As BIO put it, the Federal Circuit's "construction was contrary to the plain meaning of the text, the purpose of the legislation, and the intent of Congress."
With regard to the text, BIO stressed that "shall" means "shall" -- in other words, the "shall" connotes a requirement (citing the Supreme Court's recent case of Kingomware Techs Inc. v. United States case from 2016). In fact, the very next section of the statute, § 262(l)(2)(B) demonstrates that Congress understood the difference between "shall" and the word "may" (which implies discretion): "[The aBLA application] may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor." Moreover, BIO pointed out that the BPCIA was fashioned after the Hatch-Waxman act for dealing with small molecule generics. Without the disclosure obligation, though, the patent-dispute-resolution scheme of the BPCIA scheme falls apart. "Not only is the information disclosure requirement critical to the identification of relevant patents, it is also vital to the sponsor's ability to assert them."
The BIO brief is probably at its most effective, however, when it explains why the history of the legislation "bolsters" this conclusion. For example, the brief explained that the Senate "HELP" committee, consisting of Sens. Hatch, Enzi, Kennedy, and Clinton, worked for approximately three years to devise a bill that ultimately became the BPCIA. This committee "concluded that a mandatory patent-dispute-resolution procedure would best effectuate the goals of the legislation while balancing competing interests of stakeholders." This was because biosimilar manufacturers were always able to (and are still able to) file a full BLA to get a biological generic on the market. But by taking advantage of the abbreviated FDA approval pathway of the BPCIA, it must "accept both the benefits and the burdens." The Federal Circuit's decision, therefore, upset this balance, allowing an aBLA applicant to get all of the benefits and none of the burdens.
The Amicus Brief of the Eleven Professors
The eleven professors, for their part, focused on the real-world implications of the Federal Circuit's construction of the BPCIA. Beginning with an explanation of the innovations brought about by the biopharmaceutical industry, the brief highlighted the advances that have come about thanks to the biotechnology revolution. The United States has been at the forefront of those advances, for example, the U.S. was responsible for "originating more than half of all worldwide biopharmaceutical introductions from 1982 to 2003" (citing Henry Grabowski, Follow-on Biologics: Data Exclusivity and the Balance Between Innovation and Competition, 7 Nature Rev. Drug Discovery 479, 483 (2008)). Nevertheless, obtaining such drugs can take around ten to twelve years at a cost more than $2.5 billion. Expenses related to the manufacturing process range from building the required complex facilities to the actual development and validation of the process. Moreover, biologic drugs are risky because they, unlike small molecules, present a risk of immunogenicity that can render the medicine ineffective or cause the treatment to become life-threatening. It is because of this, according to the brief, that patent protection is essential. And the Federal Circuit's decision disrupts the balance established by the BPCIA, thereby eroding the reference product sponsors' patent protection.
The eleven professors also countered the arguments posited by Sandoz by casting the Sandoz actions as an end-around the compromise reached by Congress. In other words, they were attempting to obtain an outcome through the courts that they otherwise were not able to obtain from Congress. For example, the parent company of Sandoz, Novartis, repeatedly opposed any version of the statute that combined the biosimilar regulatory pathway with the patent resolution process. This went against other representatives of the generics industry who generally agreed that resolution of the patent issues prior to biosimilar approval was desirable. Congress nevertheless rejected the Novartis approach. The eleven professors concluded by arguing that "Novartis/Sandoz should take its case back to Congress rather than asking this Court for relief that the company failed to secure from the legislature."
Posted at 11:59 PM in Biosimilars, Supreme Court | Permalink | Comments (0)
• "Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen," December 12, 2016
• "Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States," June 21, 2016
• "Amgen files Declaratory Judgment Action against Sandoz over NEULASTA® Biosimilar," March 7, 2016
• "Sandoz Petitions for Certiorari over 180-day Notice Provision in BPCIA," February 17, 2016
• "Patent Trolls Beware! -- Supreme Court to Review Patent Venue Statute," December 14, 2016
• "In re TC Heartland (Fed. Cir. 2016)," May 5, 2016
• "The VENUE Act -- A Last-Ditch Attempt at Patent Reform?" March 28, 2016
• "Halo Electronics, Inc. v. Pulse Electronics, Inc. and Stryker Corp. v. Zimmer, Inc. (2016)," June 13, 2016
• "Trolls v. Pirates: Supreme Court Oral Argument Reviewing Enhanced Damages," February 23, 2016
• "Kayak Software Corp. v. International Business Machines Corp. (PTAB 2016)," December 27, 2016
• "Unwired Planet, LLC v. Google Inc. (Fed. Cir. 2016)," November 21, 2016
• "Plaid Technologies Inc. v. Yodlee, Inc. (PTAB 2016)," September 29, 2016
• "BMC Software, Inc. v. zIT Consulting GmbH (PTAB 2016)," September 28, 2016
• "HP Inc. v. Big Baboon, Inc. (PTAB 2016)," July 20, 2016
• "Corelogic, Inc. v. Boundary Solutions, Inc. (PTAB 2016)," June 2, 2016
• "AT&T Mobility LLC v. Intellectual Ventures II LLC (PTAB 2016)," May 24, 2016
• "Qualtrics, LLC v. OpinionLab, Inc. (PTAB 2016)," April 26, 2016
• "Motorola Mobility, LLC, v. Intellectual Ventures I, LLC (PTAB 2016)," March 31, 2016
• "Square, Inc. v. Protegrity Corp. (PTAB 2016)," March 24, 2016
• "Blue Calypso, LLC v. Groupon, Inc. (Fed. Cir. 2016)," March 6, 2016
Posted at 11:59 PM in Biosimilars, Damages, Federal Circuit, Patentable Subject Matter, Post-Grant Proceedings, Supreme Court | Permalink | Comments (0)
• "Amgen Inc. v. Apotex Inc. (Fed. Cir. 2016)," July 11, 2016
• "Does the "Notice of Commercial Marketing" Provision in the BPCIA Stand Alone? -- Amgen v. Apotex Case Preview," March 2, 2016
• "PTAB Update -- Patent Office Proposes Rule Amendment to Recognize Patent Agent-Client Privilege," October 26, 2016
• "In re Queen's University at Kingston (Fed. Cir. 2016)," March 16, 2016
• "In re NuVasive, Inc. (Fed. Cir. 2016)," December 8, 2016
• "Cutsforth Inc. v. MotivePower, Inc.," January 31, 2016
Posted at 11:19 PM in Biosimilars, District Court, Federal Circuit, Obviousness, Patent Trial and Appeal Board, Patentable Subject Matter, Post-Grant Proceedings | Permalink | Comments (0)
After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories. For 2016, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants. Today, we count down stories #20 to #16, and then in the coming week, we will work our way towards the top stories of 2016. As with our other lists (2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2016" on January 18, 2017 from 10:00 am to 11:15 am (CT). Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.
20. Mailing of Corrected Restriction Requirement Did Not Reset PTA Clock
In February, the Federal Circuit affirmed the finding by the District Court for the Eastern District of Virginia that the U.S. Patent and Trademark Office properly calculated the Patent Term Adjustment of Pfizer's U.S. Patent No. 8,153,768. In calculating the PTA, the USPTO denied Pfizer 197 days between the time the Examiner issued a first restriction requirement and then, after the applicant noted that the Examiner had omitted claims 75, 76, and 103-106, issued a corrected restriction requirement. Noting that the applicant "could have taken direction for the[] classification [of the six omitted claims] from the fact that their respective independent claims were each included in the initial restriction requirement," the panel majority sided with the District Court and USPTO. Writing in dissent, Judge Newman countered that "[t]he panel majority erroneously holds that term adjustment is not available because the applicant, not the PTO, spotted the PTO's error," stating that "[w]hether the examiner's actions 'were outside the normal 'give-and-take process' of patent prosecution,' should not turn on who recognized the error."
• "Pfizer, Inc. v. Lee (Fed. Cir. 2016)," February 15, 2016
19. USPTO Continues Efforts to Enhance Patent Quality
In 2015, the U.S. Patent and Trademark Office announced the launch of a comprehensive and enhanced patent quality initiative, indicating that its efforts would be aimed at improving patent operations and procedures, enhancing the customer experience, and improving existing quality metrics. In 2016, the Office continued its efforts to improve patent quality through the Office's Enhanced Patent Quality Initiative. In response to an invitation to stakeholders to submit patent quality-related topics that could be used as case studies, the Office selected six topics for the case study pilot program in May. In April, the Office announced that it was in the process of designing new patent quality metrics for use in FY2017 and requested comments from stakeholders regarding the new metrics. The Office also held a Patent Quality Community Symposium at its headquarters in Alexandria, VA in April, and offered several webinars in its patent quality chat webinar series. In November, the Office issued a request for public feedback regarding its reevaluation of examination time goals, and announced that it would be holding five roundtables on examination time goals (the last of which will be held on January 11 in San Jose, CA).
• "USPTO Seeks Comments and Will Hold Roundtables on Examination Time," November 3, 2016
• "USPTO Selects Topics for Quality Case Study Pilot Program," May 31, 2016
• "USPTO Holds Patent Quality Symposium," May 4, 2016
• "USPTO Seeks Comments on New Patent Quality Metrics," May 1, 2016
• "IPO Responds to USPTO Call for Case Study Topics," March 15, 2016
18. CRISPR Patent Battle Begins
CRISPR (an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats), which is part of a system for altering chromosomal sequences in situ in a cell in combination with a bacterially derived protein called Cas9, was hailed as a "Breakthrough of the Year" for 2015. CRISPR provides a mechanism for inserting or deleting specific DNA sequences using CRISPR-associate targeting RNAs and the Cas9 RNA-guided DNA endonuclease enzyme. Given the commercial potential of this method, patenting is an obvious concern and, as it turned out, more than one group of inventors has filed patent applications on the reagents, methods, and cells produced or used to produce CRISPR modifications. Because these applications were filed prior to March 16, 2013, the dispute regarding who was the first to invent will be resolved in an interference. On January 11, 2016, the USPTO declared Interference No. 106,048, naming Feng Zhang and his colleagues, the named inventor of the Broad Institute/MIT's patents, as the Junior Party, and Jennifer Doudna and her colleagues at UC/Berkeley as Senior Party. Oral argument in the interference was held last month, so the dispute could reach a resolution in 2017 and make a return trip to our list of top stories next year.
• "The Patient Side of the CRISPR Patent Battle," December 19, 2016
17. AbbVie Engages Amgen in BPCIA Dispute over HUMIRA®
Earlier this year, we noted that Amgen has been the reference product sponsor for many biosimilar applications, and as a result has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price Competition and Innovation Act ("BPCIA"). It was therefore noteworthy that Amgen once again became involved in a BPCIA litigation -- but this time as the aBLA filer. In August, AbbVie sued Amgen pursuant to the BPCIA and 35 U.S.C. § 271(e)(2)(C) because Amgen submitted an application to the FDA to market a biosimilar version of adalimumab, AbbVie's anti-TNFα therapeutic antibody, HUMIRA®. Prior to the filing of AbbVie's complaint, it was not known whether the parties had been engaging in the BPCIA's "patent dance," because the process consists of various disclosures and exchanges, none of which are meant to be publicly available. In September, the FDA approved Amgen's application to market Amjevita (adalimumab-atto) -- which marked the fourth biosimilar approved by the FDA pursuant to the BPCIA. Notwithstanding the approval, Amgen indicated in its counterclaims and answer to AbbVie's complaint that it would not begin commercial marketing of its biosimilar before at least one of the patents identified by AbbVie had expired on December 31, 2016.
• "FDA Approves Amjevita -- Amgen's HUMIRA® Biosimilar," September 25, 2016
• "AbbVie v. Amgen: The Litigation Phase for a HUMIRA® Biosimilar Begins," August 9, 2016
16. Defend Trade Secrets Act Signed into Law
In May, President Obama signed the Defend Trade Secrets Act of 2016 ("DTSA") into law, creating a new Federal cause of action for misappropriation of trade secrets. The new law is a significant expansion of Federal intellectual property law, and brings with it significant benefits -- but also new responsibilities -- for intellectual property owners and employers. And in this era of narrowed subject matter eligibility for patenting, the DTSA may provide enough of an incentive for intellectual property owners to keep more information as trade secrets. Prior to the enactment of the DTSA, trade secret owners could protect their rights under state law or a patchwork of Federal laws that provided criminal and civil sanctions for interstate trade secret misappropriation or misuse of computerized data, such as the Economic Espionage Act ("EEA") and the Computer Fraud and Abuse Act ("CFAA"). The DTSA includes three key provisions that intellectual property owners should know about: (1) the Federal civil cause of action for misappropriation of trade secrets; (2) an ex parte seizure provision that can be invoked in extraordinary circumstances; and (3) whistleblower protections that preempt criminal and civil liability under either Federal or state law, and place certain new obligations upon employers.
• "President Obama Signs Defend Trade Secrets Act," May 11, 2016
• "Defend Trade Secrets Act Passes House, Moves to President for Signature," April 27, 2016
• "House Judiciary Committee Unanimously Reports Defend Trade Secrets Act of 2016," April 20, 2016
Posted at 11:50 PM in Biosimilars, Federal Circuit, Inventorship, Patent Office Rules & Procedures, Trade Secrets | Permalink | Comments (0)
Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen
The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The first was whether the requirement in the law that the biosimilar applicant (BA) disclose its biosimilar application (aBLA) and other information to the reference product sponsor (RPS) was mandatory (as it appeared by Congress' use of the term "shall" in that provision of the statute); it is not according to the Court's decision. The second was whether the 180-day notice provisions of the statute permits a BA to give notice of commercial marketing prior to FDA approval of the aBLA; according to the Federal Circuit's decision the BA cannot provide such "early" notice. Sandoz petitioned for certiorari (and Respondent Amgen conditionally cross-petitioned), and the Supreme Court asked the Solicitor General for the government's views on whether or not to grant cert. Last week, Acting Solicitor General Ian Heath Gershengorn provided those views.
The SG recommended that the Court grant both cert petitions, counseling that the Court should overturn the Federal Circuit's determination that a BA cannot provide notice of commercial marketing under the statute prior to FDA approval, but to affirm the Federal Circuit's decision that the disclosure provisions of the statute are not mandatory. These recommendations are expressly policy-driven; the SG states that the reason the Court should hear the parties is based on the importance of biologic drugs and their cost:
"[B]iologic medicines are among the most important pharmaceuticals available today" and "are also among the most expensive, with costs often exceeding tens of thousands of dollars per year," citing FTC, Follow-On Biologics Workshop, Tr. 8 (Feb. 4, 2014), http://www.ftc.gov/system/files/documents/public_events/171301/140204biologicstranscript.pdf (statement of FTC Chairwoman Edith Ramirez). In 2013, biologics accounted for approximately $80 billion in spending in the United States, constituting approximately 25% of all pharmaceutical expenditures. FTC, Public Workshop: Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition, 78 Fed. Reg. 68,841 (Nov. 15, 2013).
And as a matter of statutory interpretation, the SG's brief states that "[t]he BPCIA represents a carefully calibrated legislative effort to promote innovation and competition in this important field, and the questions presented address core questions governing how the BPCIA operates."
The SG's brief sets out it conclusions succinctly:
The SG's analysis is expressly textual (if not hypertextual). The brief frames the notice provisions as a gatekeeper for initiation of a second round of patent infringement litigation, wherein said notice triggers the "stay" imposed on such litigation the SG says is part of the statutory scheme. Specifically:
The SG advocates that the statute provides that the RPS "may seek a preliminary injunction to enjoin such marketing '[a]fter receiving the notice * * * and before [the] date of the first commercial marketing,'" citing § 262(l)(8)(B). In practice, however, should the BA (as Sandoz did in this case) give the required notice when the FDA accepts the aBLA for review, the RPS can either file suit (and seek a preliminary injunction immediately; as in this case, in the absence of anything other than the notice upon which to base its motion), or risk waiting for the FDA to approve the biosimilar (burdening the RPS with a surveillance responsibility not recited in the statute).
The brief provides this basis for its reading of the statute:
This passage illustrates the overarching concern expressed by the brief, that biosimilar market entry could be delayed even if there was no basis for a delay, i.e., that the RPS did not have a patent that would preclude market entry.
Importantly, not only does the SG argue that notice of commercial marketing can be given before FDA approval, but the brief argues that injunctive relief is not available as a remedy after such notice is given. This is based on the principle that the right to an injunction must be conferred by statute, and the BPCIA does not do so (supposedly this proscription lies outside the scope of a preliminary injunction motion in the anticipated second round of litigation provided by the statute).
This means the BA will be able to market immediately upon approval, and the only recourse for an RPS is to file suit and apply for a TRO -- because unlike under the Hatch-Waxman Act there is no automatic stay upon filing suit under the provisions of the BPCIA. Alternatively, if as in this case the notice is given at the same time that the FDA accepts the aBLA for review, the RPS would need to initiate both Phase 1 and Phase 2 of the litigation at the same time.
With regard to the patent dance, the SG takes an interesting position: the Federal Circuit construed the statute incorrectly, but arrived at the correct conclusion:
The government agrees that the Federal Circuit misconceived the relevant inquiry [concerning whether the disclosure provisions are mandatory]. But Section 262(l)(2)(A) may properly be understood as imposing a mandatory condition for invoking Subsection (l)'s patent-dispute framework without concluding that an injunction is available to compel compliance with that condition. Even if the term 'shall' is understood as mandatory, the only consequences for failing to satisfy that condition are those expressly set forth by Congress in the BPCIA. That conclusion flows logically from essentially the same reasons discussed . . . in connection with [notice provisions] Section 262(l)(8)(A).
The SG also agrees with the Federal Circuit majority that the RPS has alternatives to protect its interests:
And as petitioner explains, a [reference product] sponsor can, after conducting a diligent investigation, file an infringement suit as contemplated by the BPCIA based on any patent it reasonably believes has been infringed, and it may seek additional information regarding that patent claim through discovery.
These recommendations are significant, because the Supreme Court asks the government for its views under those circumstances inter alia where there are important policy considerations at stake. What these recommendations have in common is a reading of the statute that materially disadvantages the RPS in favor of the BA. According to the government, the BA can "opt out" of the patent dance at any time, and the statutory remedy is immediate suit. But depending on the timing of the BA's opt out, the RPS may have but a brief time to decide whether and where to bring suit, and on what basis. At this stage of the process the balance of information is firmly in favor of the BA; the BA has all the information (from regulatory filings and patent disclosures) the RPS may use against her. On the other hand, the RPS may know little about how the BA will produce its biosimilar and the similarities and differences (structural, pharmacological, etc.) between the biosimilar and the reference product, considerations important in making these decisions regarding suit against the BA.
Deciding the questions before it as the SG recommends, the Supreme Court can permanently enshrine these disparities into the law (unless and until Congress intervenes, if it deigns to do so). While this may promote cheaper biosimilar drugs in the near term, an overemphasis on cost to the detriment of development may have unintended consequences. Principal among these is that these drugs may be produced elsewhere in countries having different drug development dynamics than in this country. (Europe's reticence to provide patent protection for biotechnology for almost twenty years left the field clear for U.S. biotechnology companies to prosper without European company competition.) But this eventuality doesn't mean biologic drugs will be cheaper in the U.S. (the "Congressional intent" expressly relied upon in the SG's brief). Such countries, having a deep reservoir of internal and international demand will be able to charge what the traffic will bear in the U.S., particularly if these misguided policies have driven U.S. producers from the market (compare for example the consumer electronic industries in the 1980's; with American companies like Philips, and RCA, and GE having been driven out of the market by cheap foreign competition, new technologies were initially controlled by Sony, and Mitsubishi, and Samsung). None of these outcomes is beneficial to keeping the American status quo, much less making it great. And while it is unlikely to be the case that Congress intended to shift the balance against RPS's to this degree, if the Court takes the government's recommendations it may take the eventuality that the country suffers the consequences set forth above for Congress to realize that the golden-egged goose has been well and thoroughly cooked.