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[Note: This post was updated to report on the execution of Jack Jones and to add additional information about the case of Marcel Williams, including the Supreme Court’s denial of his application for a stay of execution, the district court’s temporary stay, the lifting of that stay, and Williams’ execution.]
Less than 12 hours after a Texas death row inmate found apparently sympathetic ears for his plea that he was entitled to have assistance from his own psychiatrist at his trial, the Supreme Court turned down a request by an Arkansas inmate to put his execution, one of two scheduled for tonight at a prison in southeast Arkansas, on hold.
Inmate Jack Jones was scheduled to die at 7 pm local time for the brutal robbery, rape and strangulation of Mary Phillips. Jones argued that subjecting him to the state’s lethal injection protocol would violate the Eighth Amendment’s ban on cruel and unusual punishment because he suffers from diabetes and hypertension and has taken several medications for his chronic pain. The net effect of these chronic conditions, he contended, is that “he is likely to be either not rendered unconscious and thus suffer a painful death,” or he will “be left alive but brain damaged.” Justice Sonia Sotomayor was the only justice to dissent publicly from the court’s denial of a stay. Jones was pronounced dead at 7:20 pm local time.
Jones’ execution was one of eight originally scheduled over an 11-day period. The state had wanted to carry out all of the executions before the end of the month, when one of the three drugs that it uses in its lethal injection protocol is set to expire. Some of those inmates obtained stays of their executions, but the Supreme Court last week rejected a broader challenge by a group of inmates, including Jones, to the state’s protocol. On Friday morning, one of the eight inmates, Ledell Lee, was executed.
Another inmate, Marcel Williams, was scheduled to be executed at 8:15 pm local time tonight. Williams had also asked the Supreme Court to step in, but the justices denied his request as well, less than 30 minutes before his execution was scheduled to begin. Sotomayor was the only justice to publicly dissent from that order. Williams was sentenced to death for the 1994 kidnapping, rape and murder of Stacy Errickson, a 22-year-old mother and military spouse.
Like Jones, Williams suffered from a variety of chronic health conditions, including diabetes, hypertension, morbid obesity and sleep apnea. He too argued that executing him using the state’s lethal injection protocol would violate the Eighth Amendment; a physician who examined him attested that, if the current protocol is employed, “it is unlikely that the State will succeed in killing him.” The “more likely result,” the physician said, “will be that he is left with disabling, irreversible injuries.”
After the Supreme Court denied his request for a stay, Williams returned to a federal district court in Arkansas, where he again sought to postpone his execution, citing problems that occurred during the execution of Jack Jones earlier tonight. Among other things, Williams told the district court, medical staff at the prison spent 45 minutes trying to place a central line in Jones’ neck, but eventually gave up and inserted one elsewhere in Jones’ body. The district court granted a temporary stay, but lifted the stay at 9:22 pm local time. (h/t Chris Geidner for the district court documents) Officials began to administer the lethal-injection drugs at 10:16 pm local time, and Williams was pronounced dead at 10:33 pm.
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“This report discusses and assesses the War Powers Resolution and its application since enactment in 1973, providing detailed background on various cases in which it was used, as well as cases in which issues of its applicability were raised. It will be revised biannually. In the post-Cold War world, Presidents have continued to commit U.S. Armed Forces into potential hostilities, sometimes without a specific authorization from Congress. Thus the War Powers Resolution and its purposes continue to be a potential subject of controversy. On June 7, 1995, the House defeated, by a vote of 217-201, an amendment to repeal the central features of the War Powers Resolution that have been deemed unconstitutional by every President since the law’s enactment in 1973. In 1999, after the President committed U.S. military forces to action in Yugoslavia without congressional authorization, Representative Tom Campbell used expedited procedures under the Resolution to force a debate and votes on U.S. military action in Yugoslavia, and later sought, unsuccessfully, through a federal court suit to enforce presidential compliance with the terms of the War Powers Resolution. The War Powers Resolution P.L. 93-148 was passed over the veto of President Nixon on November 7, 1973, to provide procedures for Congress and the President to participate in decisions to send U.S. Armed Forces into hostilities. Section 4(a)(1) requires the President to report to Congress any introduction of U.S. forces into hostilities or imminent hostilities. When such a report is submitted, or is required to be submitted, Section 5(b) requires that the use of forces must be terminated within 60 to 90 days unless Congress authorizes such use or extends the time period. Section 3 requires that the “President in every possible instance shall consult with Congress before introducing” U.S. Armed Forces into hostilities or imminent hostilities. From 1975 through March 2017, Presidents have submitted 168 reports as the result of the War Powers Resolution, but only one, the 1975 Mayaguez seizure, cited Section 4(a)(1), which triggers the 60-day withdrawal requirement, and in this case the military action was completed and U.S. armed forces had disengaged from the area of conflict when the report was made. The reports submitted by the President since enactment of the War Powers Resolution cover a range of military activities, from embassy evacuations to full-scale combat military operations, such as the Persian Gulf conflict, and the 2003 war with Iraq, the intervention in Kosovo, and the anti-terrorism actions in Afghanistan. In some instances, U.S. Armed Forces have been used in hostile situations without formal reports to Congress under the War Powers Resolution. On one occasion, Congress exercised its authority to determine that the requirements of Section 4(a)(1) became operative on August 29, 1983, through passage of the Multinational Force in Lebanon Resolution (P.L. 98-119). In 1991 and 2002, Congress authorized, by law, the use of military force against Iraq. In several instances none of the President, Congress, or the courts has been willing to initiate the procedures of or enforce the directives in the War Powers Resolution.”
Alison Head and John Wihbey: Truth to Consequences “…Librarians are the facilitators and guides to the world of knowledge. Yet, many librarians lack the institutional power or budgets for truly scaling their training of information literacy skills — the fundamental competencies for finding, evaluating, and using information in the digital age. This skill set needs to become a cause not only on the margins — in the context of occasional high school civics and English classes — but as an issue front-and-center across civic life, from town halls and state legislatures to voting booths. As Lee Rainie, the Founding Director of Pew’s Internet and American Life has said, librarians are the epitome of nodes — trusted conduits to high quality information, active champions of an accessible government online, and an informed citizenry among all ages and classes…”
The Atlantic Council Report, April 2017 – “No one can be complacent about geopolitical risks these days. The shocks and surprises of the past few years show how easily assumptions about liberal markets, international relations, conflict, and democracy can be shaken. Geopolitical volatility has become a key driver of uncertainty, and will remain one over the next few years. The three risks with geopolitical consequences and interconnections examined in this study—protectionism, energy crisis, and water and food scarcities—are growing. While the threat of growing protectionism is a daily feature in the news, an energy crisis resulting from the worsening Middle East situation or the spread of water scarcity could also disrupt the world. Should any of these situations become full blown, the impacts would be nothing less than earth shattering for how the world governs or does business…Scenarios are a critical device for mapping the ways risks can balloon into full-scale crises. Scenarios can show how single risks can trigger scores of others. Nobody can ignore “large impact but small likelihood” scenarios. All too frequently, those “black swans” have indelibly recast the geopolitical landscape. It is important for companies, as well as governments, to understand the triggers, trends, and scenarios for which to look out, and to prepare for the possible consequences of any of those risks…”
Ted Hunt – Googling gives us answers—but deprives us of intelligence – “…Here are the problems that we must surmount if we are to continue creating and sharing tools to help amplify and advance knowledge, reasoning, critical thought, and creative thinking…”
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“The Ithaka S+R Library Survey 2016 examines strategy and leadership issues from the perspective of academic library deans and directors. This project aims to provide academic librarians and higher education leaders with information about chief librarians’ visions and the opportunities and challenges they face in leading their organizations. In fall 2016, we invited library deans and directors at not-for-profit four-year academic institutions across the United States to complete the survey, and we received 722 responses for a response rate of 49 percent Results from the Library Survey reinforce the distinct differences in academic library leaders’ strategic direction and priorities by institution type, as perceptions differ notably across Carnegie classifications. There are also a number of areas in which library leaders differ based on the number of years they have been in their positions – namely, in the challenges that they identify facing and in their perceptions of the role of the library as a starting point for research – and these differences have been highlighted in this report.”
Mapping Drug Overdoses Across the United States, Matthew Beckwith, Center for Data Innovation. “The New York Times has created a data visualization illustrating the severity of the overdose epidemic at the county level throughout the United States. Using data from the National Center for Health Statistics and the Centers for Disease Control and Prevention, the visualization allows users to observe and compare the rates of overdose deaths for people between the ages of 15 and 44. New England and the the Appalachian region are the most affected, with 50 percent of all deaths for people between 15 and 44 resulting from drug overdose in many counties. The epidemic is not evenly distributed across demographic lines, with whites in urban and suburban areas experiencing the highest mortality rates.”
Joe Kennedy, Harvard Business Review, April 17, 2017: “Innovation has always required a constant iteration of trial and error as companies use data about current performance to improve future performance. So it should come as no surprise that companies in the information age want to use ever more data to hone their products. But there is an emerging debate over the competitive implications of big data. Some observers argue that companies amassing too much data might inhibit competition, so antitrust regulators should preemptively take action to cut “big data” down to “medium data.” Others say there is nothing new here, and existing competition law is more than capable of dealing with any problems. Among those advocating for an expansion of antitrust reviews around data are law professor Maurice Stucke and antitrust attorney Allen Grunes, who voice three interrelated concerns in Big Data and Competition Policy. First, they argue that allowing companies to control large amounts of data raises barriers to entry for potential rivals that lack enough data to develop competitive products. By this logic, deals like Facebook’s acquisition of WhatsApp should be fought, because allowing a dominant company to acquire even more data will increase its market power. Second, proponents of this view assert that existing antitrust law is inadequate for the competitive threats stemming from large collections of data. One reason why is that much of traditional antitrust analysis focuses on the prices of goods and services, because companies with market power face incentives to limit supplies and charge more. With the profusion of “free” services, authorities may have a much tougher time adequately evaluating the implications of competition other than price, such as degradations in product quality or privacy protection. Finally, some who worry about big data from an antitrust perspective claim that consumer protection laws are inadequate, because privacy protections are themselves a function of how much competition companies face, so antitrust regulators must step in to protect privacy…”
“Watch the Museum’s Days of Remembrance ceremony in the US Capitol Rotunda featuring a keynote address by President Donald Trump. The president will be joined by Holocaust survivors, liberators, members of Congress, the diplomatic corps, and community leaders. #USHMM #HolocaustRemembrance”
Watch Live – Tuesday, April 25, 11 a.m. ET
See also via the BBC – “Six million Jews were murdered by the Nazis and their accomplices during World War Two. In many cases entire towns’ Jewish populations were wiped out, with no survivors to bear witness – part of the Nazis’ plan for the total annihilation of European Jewry. Since 1954, Israel’s Holocaust memorial, Yad Vashem (“A Memorial and a Name”), has been working to recover the names of all the victims, and to date has managed to identify some 4.7 million.
“Every name is very important to us,” says Dr Alexander Avram, director of Yad Vashem’s Hall of Names and the Central Database of Shoah [Holocaust] Victims’ Names. “Every new name we can add to our database is a victory against the Nazis, against the intent of the Nazis to wipe out the Jewish people. Every new name is a small victory against oblivion.”
The Atlantice – Will you pay more for those shoes before 7 p.m.? Would the price tag be different if you lived in the suburbs? Standard prices and simple discounts are giving way to far more exotic strategies, designed to extract every last dollar from the consumer.
“…the immense data trail you leave behind whenever you place something in your online shopping cart or swipe your rewards card at a store register, top economists and data scientists capable of turning this information into useful price strategies, and what one tech economist calls “the ability to experiment on a scale that’s unparalleled in the history of economics.” In mid-March, Amazon alone had 59 listings for economists on its job site, and a website dedicated to recruiting them.”
“The latest available case-by-case records from the federal courts show that as of the end of March 2017, 763 new civil immigration lawsuits have been filed in disputes involving immigration matters since January 20, 2017. Under President Trump, monthly filings in March were up 40.5 percent when compared with those of the same period in the previous year, and have more than doubled from levels of five years ago. According to the case-by-case court records analyzed by the Transactional Records Access Clearinghouse (TRAC) at Syracuse University, nearly half (47%) of these 763 suits were brought by individuals detained by Immigration and Customs Enforcement (ICE). These individuals sought release from their detention and/or a court order to prevent their deportation. Most of the remaining suits challenged government inaction. One third (33%) were mandamus actions to compel the federal government to act on visa or related applications. Another 8 percent sought a hearing or other action on naturalization applications. Four out of every ten of these new lawsuits were filed in just three federal districts – all centered in the greater New York City area. The federal district court in the Eastern District of New York (Brooklyn) had the largest number with 136 suits. In second place with 90 suits was the New Jersey federal district court. The federal court in the Southern District of New York (Manhattan) had the third highest number in the nation with 77. Nine out of every ten lawsuits in New Jersey were filed by ICE detainees seeking to be released from custody. In contrast, in the New York East judicial district, three out of four were seeking to compel action on a visa or naturalization application. Since President Trump assumed office, a total of 52 out of the 94 federal judicial districts had one or more new civil immigration lawsuits filed. To see the full report, including the number of post-Trump filings for each district, go to: http://trac.syr.edu/immigration/reports/467/“
Three decades ago, James McWilliams was convicted of the robbery, rape and murder of convenience store clerk Patricia Reynolds. An Alabama judge sentenced McWilliams to death, rejecting both his pleas to consult with an independent psychiatrist about psychiatric records that his attorney had recently received and his argument that he suffered from serious mental health issues. That denial of an independent expert, McWilliams’ attorney told the justices today, violated his client’s constitutional rights, established in a Supreme Court decision, Ake v. Oklahoma, issued just a few months after Reynolds’ murder. After an hour of oral argument this morning, the court’s four more liberal justices seemed to agree. And perhaps most critically for McWilliams, Justice Anthony Kennedy also seemed persuaded.
Under federal laws governing efforts by state prisoners like McWilliams to obtain relief from their convictions and sentences in federal courts, the right that they contend was violated must have been clearly established when their convictions became final in state court. Arguing for McWilliams, Stephen Bright emphasized that the court’s 1985 opinion in Ake had “clearly established” that a defendant is entitled to help from “an expert independent of the prosecution” when his mental health is a “significant factor” in the case.
Kennedy pressed Bright to explain exactly how the court should make that determination. If, at least for the sake of argument, Kennedy suggested, Ake was actually ambiguous on whether the defendant is entitled to help from an independent expert, but “over time, it became clear that” the expert should only be “consulting with the defense and not with the prosecution,” should the court say “that the basic right was clearly established, and that over time, we are simply making a refinement,” or would a ruling for McWilliams instead be “establishing a new right”?
Bright initially resisted, responding that the ruling was “quite clear.” But later on, he seemed to realize that Kennedy may have been throwing him a lifeline, and he assured the justices that “what really has happened here is refinement” of the principle first announced in Ake.
Chief Justice John Roberts was skeptical. McWilliams, Roberts observed, had pointed to several examples of how the right to an independent expert was clearly established in Ake, through the court’s descriptions of the kind of assistance an expert would provide. But some of those examples, Roberts suggested, did not “entail partisanship of any kind.” And a few minutes later, Roberts noted that a well-respected criminal law treatise had described the court’s decision in Ake as “deliberately ambiguous” on the question presented by McWilliams’ case.
And Justice Samuel Alito was dubious that, even if the state made an expert available to defendants like McWilliams, an expert “who is chosen by the court and paid by the court can ever” be truly “part of the defense team.” At most, Alito seemed to say, the expert would be a neutral expert.
The court’s newest justice, Neil Gorsuch, chimed in with what he viewed as another potential problem with the rule that McWilliams was advocating. If the court were to rule that a defendant has a right to a partisan expert, where should it draw the line in terms of other assistance for defendants? “Would we also have to apply the same rule in other kinds of medicine, perhaps? Forensic science?” And would it mean that the defendant is also entitled to a partisan lawyer, rather than just a competent one?
The court’s four more liberal justices tried to bypass some of these potential problems by shifting the focus of the conversation away from labels like “neutral,” “partisan” and “independent” to a more straightforward rule that, in their view, was grounded squarely in Ake. As Justice Stephen Breyer put it, “The defense has to have somebody who will conduct an appropriate examination, assist in evaluation, preparation, and presentation of the defense. So why do we have to say more than” that? In this case, Breyer continued, “it seems to me that this defendant certainly did not get that help.”
Justice Elena Kagan made a similar point, telling Alabama Solicitor General Andrew Brasher, who argued on behalf of the state, that the “theme” of the court’s decision in Ake was that “you have to give the indigent defendants, just as you give the wealthier defendant, the tools that they need to establish what they want to establish about mental health. And then that’s consistent with these words that are repeated in the holding and elsewhere” in Ake.
Bright echoed these ideas in his rebuttal, reminding the justices that “what we come back to at the end on this case, is the proper working of the adversary system. And this certainly doesn’t put the defense in an equal position with the prosecutor, not by a long shot, but it at least gives the defense a shot, at least gives them one competent mental health expert that they can talk to, understand what the issues are, present them as best they can.”
In what McWilliams could view as a positive sign, Justice Ruth Bader Ginsburg asked Bright whether, if his client were to prevail, he would get a new sentencing hearing. (The answer was yes.) If – as it appears – McWilliams can pick up a vote from Kennedy in addition to the four more liberal justices, that new hearing might not be too far away.
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On April 27 at 9 a.m., the Constitutional Accountability Center will host its fourth annual “Home Stretch at the Supreme Court” event. Speakers will include Deborah Archer, Brianne Gorod, Erin Murphy and Don Verrilli; Amy Howe will serve as moderator and Elizabeth Wydra will give opening remarks. More information about this event, which will be held at the National Press Club in Washington, is available at this link.
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Argument preview: The ACA returns to the Supreme Court (this time disguised as a hugely complex patent case)
On the last day of scheduled oral arguments in the term, the Affordable Care Act — the always controversial “Obamacare” statute — returns yet again to the Supreme Court, although many of the justices and their clerks will probably be wishing it weren’t so.
The consolidated patent cases Sandoz v. Amgen and Amgen v. Sandoz involve the complex interaction between the Patent Act and the Biologics Price Competition and Innovation Act, which is an approximately 17-page subchapter contained in the larger 906-page ACA. That larger statute has not been hailed for precise drafting or ease of application. This new litigation will certainly not improve the reputation of the statutory behemoth.
The cases arise out of (i) Sandoz’s petition for certiorari on two questions and (ii) a quite rare “conditional cross-petition for certiorari” filed by Amgen that presents a third question. In January, the court granted both the petition and the conditional cross-petition; consolidated the cases; set a special briefing schedule allowing longer briefs in less time than normal; and scheduled the case for the last day of arguments in the term.
This initial description only hints at the truly startling complexity of these consolidated cases. Together they are a giant Russian nesting doll, a matryoshka, of complication. Even though I have been teaching and writing about patent law for years, I find these consolidated cases daunting. I can only imagine what the poor law clerks assigned to work on them are thinking.
Let’s take apart the nesting doll. I’ll describe five layers of complexity and apologize in advance for not doing justice to any particular layer.
First, at the highest level of generality, these consolidated cases are another battle in a long-running policy war over the optimal level of patent protection for medicines, with the battle lines drawn as usual. The generic-drug company, Sandoz, seeks slightly less patent protection, which would lower drug costs and provide short-run benefits to consumers and health insurance companies. The research pharmaceutical company, Amgen, wants a bit more protection, which is likely to provide better medicines to treat cancer and other maladies, but only over the long run.
The best that can be hoped for is that the justices understand that the case is not one-sided at the policy level. The amicus briefs can help in this regard, but only if amici on both sides are taken seriously. An amicus brief by America’s Health Insurance Plans supports a bit less patent protection as a way to “control spiraling health care costs.” A professors’ amicus brief written by noted patent attorney Kevin Noonan (who is Justice Sonia Sotomayor’s ex-husband) reminds readers that “[i]nnovation in medicine over the last century is responsible for profound improvements in public health,” and that continued innovation in medicine “depends on the availability of meaningful patent protection.” Which brief is right? Both, of course; they are two sides of the same story. Patent protection increases costs today to improve lives tomorrow. It’s always been a controversial and difficult tradeoff.
Second, this case also involves complex technology – which is why the litigation involves not merely the general Patent Act but the interaction between that statute and the provisions in the ACA designed to regulate “biologics.”
Biologics are a class of bio-engineered drugs that are far more complex and hard to produce than the typical “small molecule” drugs patented in the 20th century. For example, just 50 atoms are contained in a molecule of loratadine, also known by the trade name “Claritin” (chemical formula: C22H23ClN2O2), which was patented in the 1980s and became a popular “blockbuster” drug in the 1990s. By contrast, the drug at issue in this litigation — filgrastim — contains several thousand atoms in each molecule (formula: C845H1343N223O243S9).
Typically (or at least typically in the 20th century), when the patent on a drug expires, generic companies can enter the market with exact copies of the previously patented drug. That happened in the 2002 for loratadine, and the drug’s price fell dramatically as ever more competitors entered the market. The sheer complexity of biologics makes them very difficult for generic drug companies to reproduce exactly. Often the best that can be done is to produce a “biosimilar,” which, as its name suggests, is not identical to the original biologic drug. The imprecision, however, creates a regulatory problem because the Food and Drug Administration must approve any new drug before it is sold.
The biologics provisions in the ACA were intended to streamline the FDA approval process for biosimilars and also to provide a clear and structured process for addressing the patent issues that were almost certain to arise as competitors tried to copy these drugs. Now, the very first time the provisions have been used, a three-judge panel for the U.S. Court of Appeals for the Federal Circuit split three ways, and this complex piece of Supreme Court litigation followed. So much for clarity and simplicity!
Third, having dealt with the basic policy choices and the underlying technology, we can now turn to the legal issues in the case. The new biologics statute includes two key structures. Subsection (k) (of 42 U.S.C. § 262) creates a process by which the FDA can license biosimilars for commercial marketing. Subsection (l) provides a process by which the applicant for a biosimilar license (i.e., the generic pharmaceutical company) can exchange information about patents with the company that first obtained FDA approval to market the original biologic drug (i.e., the research pharmaceutical company).
One of the very first requirements in that statutory “exchange of information” process is that the applicant for a biosimilar license – here Sandoz – “shall provide to the [research pharmaceutical company] a copy of the application submitted [to the agency] under subsection (k).” The word “shall” in the statute might suggest that Sandoz is required to provide a copy of its biosimilar application to Amgen, but the divided panel of the Federal Circuit ruled disclosure of the application optional based on two other statutory provisions that prescribe consequences when the “applicant fails to provide the application” to the research pharmaceutical company. Those two sections, the Federal Circuit reasoned, would be rendered “superfluous” if disclosure were mandatory.
The Federal Circuit thus inferred from Congress’ expression of some specific consequences for failure to disclose a biosimilar application an intent to exclude other additional remedies, such as injunctive relief compelling compliance with the requirement that the applicant “shall provide” the application. Such an inference parallels the reasoning underlying the controversial “expressio unius” canon of statutory construction – that the expression of one thing implies the exclusion of others.
That logic has been described as “one of the most fatuously simple of logical fallacies.” If I tell my students that I’ll fail anyone who cheats, I do not mean to foreclose the possibility of other, additional consequences, such as expulsion from the university. Perhaps the Federal Circuit’s inference is more plausible as applied to this particular statute, but there’s a lot of force to Amgen’s argument that the word “shall” bespeaks a mandatory, not optional, duty.
Fourth, the statute also requires that the biosimilar applicant (here Sandoz) “shall provide notice to [the research pharmaceutical company, here Amgen] not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” Sandoz sent the notice while its biosimilar application was still pending before the FDA so that, Sandoz hoped, the biosimilar could marketed as soon as the FDA licensed it.
The Federal Circuit, however, concluded that Sandoz had sent the notice too early. Relying on the structure of the statute, the Federal Circuit thought that the notice should logically have “to follow licensure, at which time the product, its therapeutic uses, and its manufacturing processes are fixed.” Thus, the court held that “notice, to be effective under this statute, must be given only after the product is licensed by the FDA.” That holding meant that Sandoz had to wait to introduce its licensed product until 180 days after the FDA’s approval, a delay to which Sandoz objected.
Here too, the Federal Circuit’s logic is open to question, though the issue is difficult due to poor statutory drafting. The Federal Circuit might be right in thinking it sensible to require the biosimilar applicant to send notice after the FDA licensure; the applicant could then inform the other company of the precise conditions of the FDA’s license. The statute, however, does not require that the applicant provide notice about the terms and conditions of the license or about the manufacturing processes approved by the FDA. Rather, the statute – quite incredibly – merely requires “notice” but nowhere expressly specifies what information should be included in the notice.
The title of the statutory sub-paragraph, “Notice of commercial marketing,” together with the requirement that the notice must precede the marketing by 180 days, suggests that the notice merely has to include (as Judge Raymond Chen argued in dissent below) a statement of the “intent to begin commercially marketing the biosimilar product.” And because such a notice merely recites intended actions expected to take place in the future, the statutory language could reasonably be interpreted as permitting the notice to be contingent on future events, such as expected issuance of an FDA license. That interpretation is also consistent with the structure of the sentence because, as Sandoz argues, the entire phrase “the date of the first commercial marketing of the biological product licensed under subsection (k)” appears only to define “a specific point in time” in the future at which time the product will be “licensed.”
Fifth, the last of the questions presented in the case is whether a court can enforce the 180-day notice requirement – however that is calculated – by enjoining the marketing of the drug until notice is given. Simply and generally stated, Sandoz is arguing that a line of Supreme Court cases restricting implied private rights of action should also restrict the equitable powers of federal courts. This issue, unlike the others in the case, could have an enormous impact on many other areas of federal law, including federal administrative law.
On this hugely important issue, the parties spend a significant amount of time debating a position articulated in a Federal Circuit biosimilars case decided about a year after the decision below in this litigation. (If you are wondering why the parties in this case are debating judicial reasoning expressed in a different case, the answer is that virtually nothing is easy or straightforward in this litigation.)
Writing for the court in that other case, Amgen Inc. v. Apotex Inc., Judge Richard Taranto relied on Supreme Court precedent to rule that the federal courts’ “equitable jurisdiction is not to be denied or limited in the absence of a clear and valid legislative command.” As Justice Neil Gorsuch’s former colleague on the U.S. Court of Appeals for the 10th Circuit, Judge Michael McConnell, explained in Simmat v. United States Bureau of Prisons, an express or implied private right of action is unnecessary for injunctive relief because “[e]quity … provides the basis for relief — the cause of action, so to speak — in appropriate cases within the court’s jurisdiction.”
As support for the view that equitable relief needs no additional statutory authorization, Judge McConnell cited one of my articles. Although that article discussed non-statutory equitable relief against government officers (an important issue in administrative law), such relief was traditionally available only because officers acting beyond their lawful authority were viewed as being non-governmental (and thus not protected by sovereign immunity). My article shows not only that I have academic views on this issue (views that readers are free to discount), but also that the general issue has implications far outside the bounds of patent law. That alone should make the court cautious about contravening long-standing tradition concerning federal court power to enjoin violations of federal law in the course of deciding this complex patent case.
* * *
In closing, I’ll offer one final point just to prove how complex the case is: Every question presented by the parties is moot with respect to this case!
Take, for example, the dispute over whether the ACA requires Sandoz to turn over its biosimilar application to Amgen. Is Amgen still waiting to get that application? No! Amgen sued Sandoz for patent infringement and got the application in discovery. Or consider the issues concerning when Sandoz should have given notice to Amgen and whether the courts can enjoin Sandoz for failing to give that notice. Those too are solidly in the rear-view mirror because the injunctive relief ordered below has now expired.
So why is this case still being litigated? Sandoz argues that the case is “capable of repetition yet evading review” – a supposedly narrow exception to mootness deployed most famously in Roe v. Wade.
Perhaps that exception can cover part of this case (though the parties’ briefing on mootness leaves much to be desired), but let’s hope that the justices are not too eager to decide every question possible. For example, if the Supreme Court rules that the Federal Circuit miscalculated the 180-day notice period, the fifth issue may well be moot, because Sandoz would not again be subject to the same action (i.e., an injunction holding its product off the market for 180 days after the issuance of a biosimilar’s FDA license).
As this case is about medicines and health care, the court would do well to remember the maxim often attributed to the Hippocratic Oath: “First do no harm.” That’s good advice, because the chances for unintended mischief here are great. It’s a hugely complex case involving the very first application of a new statute; it’s being argued on the last day of the last argument session of the term; it presents issues that most of the justices and their law clerks may not have considered often in the past; and finally it involves provisions of the notoriously complex and imperfectly drafted ACA. I expect, and hope, that the oral argument will show the justices being cautious lest they do harm.