“Obamacare” Survives – Including Path to Generic Biologicals

Recently featured in The National Law Review“Obamacare” Survives – Including Path to Generic Biologicals, an article by Warren Woessner of  Schwegman, Lundberg & Woessner, P.A.:

Biotech patent attorneys rejoice – no matter if you represent generic companies or NDA holders,  the 5-4 decision of the Supreme Court upholding the “individual mandate” – not under the commerce clause, but as an appropriate use of Congress’ power to tax – means that all the CLE charges you incurred to attend seminars on the future of generic biologics was not wasted. (A copy of the decision and dissents is available at the end of this post.) If the “Patient Protection and Affordable Care Act” had been voided in its entirety, the path to generic biologics that was included in the Act in some detail would have vanished (Title IV, subtitle A).  I summarized the features of the Act in my post of March 26, 2010 and posted an alert on March 29, 2012.

I am not versed enough in regulatory law to opine on how, or if, the FDA would have continued to promulgate regulations and hold hearings on this touchy subject, but given that bureaucracies seldom opt for more work without direction from Congress, my guess is that the current process would have simply gone into limbo. I welcome your opinions on the way forward, but amidst the furious debate about whether the Act would waste or save the taxpayers’ dollars, it cannot be denied that generic versions of older biologicals would save patients a lot of money.

scotus_opinion_on_ACA_from_msnbc.com

© 2012 Schwegman, Lundberg & Woessner, P.A.

Illuminating the “Invisible Branch” – the Supreme Court

The National Law Review recently featured an article by Health Government Relations Team of Drinker Biddle & Reath LLP regarding the Supreme Court:

While Congress’ deliberations over policy dominate the news, the Supreme Court often flies under the radar of the American people, unless there is a major case before it. Many Americans are not well-versed in the Supreme Court’s dealings; in fact, a Pew Research Center political knowledge survey found that in July 2010 only 28% of Americans polled could correctly identify John Roberts as the Chief Justice of the Court. As much of the health policy world’s attention is focused on the Supreme Court due to the Affordable Care Act case (Department of Health and Human Services, et al. v. Florida, et al.), below is a refresher on Supreme Court procedure and why there will be months of silence from the Court between the oral arguments and the announcement of the Court’s decision.

First, a few Supreme Court basics. The Supreme Court’s term begins on the first Monday in October and lasts for a year. The Court is typically in recess from late June or early July until the end of the term in October. The current term began on Monday, October 3, 2011, and will be wrapping up business for this term over the next two months. The next term will begin on Monday, October 1, 2012.

Each week when the Court is in session, the Justices hold a conference. Only the Justices are allowed in the room, and as a testament to the collegiality of the Court, each conference begins with each Justice shaking hands with every other Justice. During conferences, the Justices review petitions for certiorari or, in other words, decide which cases the Court will hear. The Justices then review the cases heard previously that week. Each Justice, beginning with the Chief Justice and going in order of seniority (who has been on the court the longest), is given time to state his or her views and raise any questions without interruption. Each Justice, in seniority order, then casts a preliminary vote on the case. In the case of the health reform arguments, which were heard March 26-28, the Justices met in conference to discuss the case and cast their votes on Friday, March 30.

So, if the votes have been cast and an outcome decided, why has there been no announcement of a decision yet? What has been going on since March 30?

After the votes are cast, the Court must then produce documents that state the Court’s reasoning for deciding a certain way. If the Chief Justice is in the majority (generally an opinion five or more Justices join), he or she assigns who will write the opinion. If the Chief Justice dissents from the majority opinion, the senior-most associate Justice in the majority assigns the opinion. The Chief Justice or most senior Justice may choose to write the opinion him or her self. Likewise, the most senior Justice in the minority assigns who will write the dissenting opinion. Dissenting opinions carry no legal weight or precedent, but might lay groundwork for future cases. Additionally, any Justice may write a concurring opinion, and anyone can write a separate dissenting opinion should they agree with the ruling but for a different rationale. In the case of a tie vote, which might happen if there is a vacant seat or if a Justice recuses themselves from the case, the decision of the lower court stands. In this situation, the case is not considered to be binding precedent.

Once the opinions have been drafted, they are circulated to all the other Justices for comments and recommended changes. If a Justice in the majority agrees with the outcome expressed but disagrees with the argument in the drafted opinion, they may write their own concurring opinion or, at anytime before the Court’s opinion is handed down, they may switch their vote. In some controversial cases, the outcome of the case has actually reversed from what the original outcome would have been, due to Justices flipping their vote. Then once the draft has been revised, the opinion is signed by the author. Other Justices who are in agreement then “sign on” to the opinion, and the verdict is subsequently made public.

In regard to the timing of decision announcements, there are no rules other than it must be released by the last day of term (before the Court goes into recess in June or July). Unanimous or less contentious decisions generally take less time than cases on more controversial subjects. Given the weight and attention given to the health reform cases, a decision is not expected until late in the term, with most people predicting an announcement coming June 21st, 25th or 28th.

©2012 Drinker Biddle & Reath LLP

High Court: Police Tracking of Suspect Via GPS Requires Warrant

Recently found in The National Law Review an article by Rachel Hirsch of Ifrah Law regarding a recent High Court Decision Requiring a Warrant:

Last November, we discussed the U.S. Supreme Court’s oral argument in United States v. Jones, which posed the question of whether police need to obtain a warrant before attaching a GPS device to a suspect’s vehicle during a criminal investigation.

We noted that in this case, 21st-century technology had come face to face with the constitutional requirements of the Fourth Amendment. We were hoping that the high court would uphold the U.S. Court of Appeals for the D.C. Circuit and hold that this action is a search that requires a warrant, but we took a pass on predicting what the Court would actually do.

On January 23, 2012, the Court decided the case – unanimously against the government and in favor of defendant Antoine Jones. The decision is fairly gratifying for those of us who believe it desirable to curb prosecutors’ power by imposing restrictions upon it, including, where appropriate, the requirement of a judge-issued warrant.

It turns out that both the advocates of the original-intent approach to constitutional interpretation, epitomized here and in general by Justice Antonin Scalia, and those who prefer the doctrine of the “living Constitution,” led here by Justice Samuel Alito, agree that the use of a GPS device by the government constitutes a search and requires a warrant.

Scalia, writing for a majority of the Justices, observed that prosecutors had intruded upon Jones’ property in way that would have been a “trespass” under common law.

Prosecutors “physically occupied private property for the purpose of obtaining information,” Scalia wrote. “We have no doubt that such a physical intrusion would have been considered a ‘search’ within the meaning of the Fourth Amendment when it was adopted.” And for Scalia, that fact alone was enough to decide the case.

Alito, joined by three Justices who concurred in the result, used quite a different line of reasoning and sharply criticized Scalia’s majority opinion, saying that ironically, it relied upon 18th-century tort law to decide a case involving 21st-century technology.

“This holding, in my judgment, is unwise,” Alito wrote. “It strains the language of the Fourth Amendment; it has little if any support in current Fourth Amendment case law; and it is highly artificial.”

Instead, Alito wrote, he “would analyze the question presented in this case by asking whether [Jones’] reasonable expectations of privacy were violated by the long-term monitoring of the movements of the vehicle he drove.” Alito observed that for decades, the Court has invoked the concept of “reasonable expectations of privacy” in a number of cases to define the nature of a “search” under the Fourth Amendment and to expand the definition of “search” to actions that do not involve a trespass to someone’s property.

Even though Alito is often identified with the pro-prosecution, conservative wing of the Court, he took the defendant’s side in this case. As our blog post last November noted, at oral argument Alito expressed concern about how easy it is these days “to amass an enormous amount of information about people” by the use of today’s technology.

Alito’s opinion followed similar lines. In the absence of legislation about police use of GPS tracking, he wrote, “The best that we can do in this case is to apply existing Fourth Amendment doctrine and to ask whether the use of GPS tracking in a particular case involved a degree of intrusion that a reasonable person would not have anticipated.”

This is good news for constitutional rights and for defendants. Whatever approach one takes to the Fourth Amendment, it’s clear that prosecutors can’t attach a GPS to a suspect’s car without a warrant.

© 2012 Ifrah PLLC