The National Law Review is pleased to bring you information about the ABA’s Upcoming Spring 2012 CLE National Institutes:
Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.
The National Law Review is pleased to bring you information about the ABA’s Upcoming Spring 2012 CLE National Institutes:
Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.
Recently an article by Richard G. Gervase, Jr. and Daniel W. Clarke, Ph.D. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding Biotech Patents recently appeared in The National Law Review:
On March 20, 2012, the United States Supreme Court handed down a groundbreaking decision in the field of biotechnology; however, the repercussions of this decision will be felt throughout the patent community. In a highly anticipated decision, the Court reversed the United States Court of Appeals for the Federal Circuit in Mayo Collaborative Services and Mayo Clinic Rochester v. Prometheus Laboratories, Inc., unanimously finding that process claims directed to optimizing the dosage of a drug for treatment of an immune-mediated gastrointestinal disorder are invalid because they effectively claim no more than an underlying law of nature.
The two patents at issue are exclusively licensed to Prometheus, who sells diagnostic tests that employ the patented processes. At first, Mayo bought and used these diagnostic tests; however, in 2004, Mayo decided to use and sell a slightly different diagnostic test. Prometheus responded by bringing an infringement action in the United States District Court for the Southern District of California, which found that although Mayo infringed a claim of a Prometheus-licensed patent, the asserted claims were invalid for being drawn to non-statutory subject matter. The District Court reasoned that the patents claimed “natural laws or natural phenomena,” which are not entitled to patent protection. Specifically, the District Court opined that the correlations between metabolite levels and the toxicity and efficacy of drug dosages are patent-ineligible laws of nature. The Federal Circuit reversed, and held that the claims were directed to patent-eligible subject matter because they “transform an article into a different state or thing,” and the transformation was “central to the purpose of the claimed process.” The Federal Circuit subsequently reaffirmed this decision on remand from the Supreme Court for reconsideration in view ofBilski v. Kappos.
The question presented to the Supreme Court in Mayo v. Prometheus was “whether the claimed processes have transformed unpatentable natural laws into patent-eligible applications of those laws.” The Court recognized that the threshold inquiry to determine whether a claim is directed to patent-eligible subject matter is governed by 35 U.S.C. § 101, which provides “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
The representative claim analyzed by the Court was directed to methods of calibrating the optimal dosage of a thiopurine drug by administering the drug, and determining the level of subsequent metabolites, where certain metabolite levels correlate with certain results. The Court relied on case precedent, including Diamond v. Diehr and Gottschalk v. Benson, for the proposition that the meaning of “process” in § 101 has been limited to exclude fundamental principles, such as “laws of nature, natural phenomena, and abstract ideas,” but noted that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” The Court concluded that the claims were not patent eligible, reasoning that the claims were merely instructions to apply a natural law, i.e., a natural correlation.
Specifically, the Court stated that the additional steps of “administering” and “determining,” along with the “wherein” clauses, “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.”
Although the Court recognized that in determining whether additional claim steps are routine or conventional, a § 102 novelty inquiry and a § 101 statutory subject matter inquiry “might sometimes overlap,” Justice Breyer repeatedly emphasized that from a policy perspective, a patent should not preempt natural correlations, thereby improperly inhibiting future innovation. The Court also warned that a non-statutory law of nature cannot be transformed into subject matter that is eligible for patent protection by mere clever claim drafting that amounts to no more than “insignificant post-solution activity.”
How the Supreme Court’s decision will impact medical diagnostic patents and patent applications in the future remains to be seen. We note that the Court declined to opine on the desirability of increased protection for diagnostic correlations, inviting Congress to develop “more finely tailored rules” for patent eligibility should the legislature disagree with the Court’s conclusion.
©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
An article regarding ObamaCare written by Wendell Potter of the Center for Public Integrity recently appeared in The National Law Review:
Remember those words from the health care reform debate of two years ago? I’m confident we’ll be seeing them on protest signs in Washington again this week as the Supreme Court hears arguments on the constitutionality of the Affordable Care Act. And we’ll see them again when the protest campaigns shift into high gear this summer.
One of the rules of effective communications is to keep it simple. In attacking something you don’t like, use as few words as possible, and make sure those words pack an emotional wallop. That’s why lies about “death panels” and a “government takeover” of health care have been so potent. Unfortunately for those advocating reform, it’s far more challenging to explain and defend a law as complicated as the Affordable Care Act.
Maybe, then, supporters of the law should co-opt the “hands off” slogan and make it their own. That would require adding just a few more words here and there to make clear what would be lost if the law is repealed, gutted or declared unconstitutional.
The Affordable Care Act is closing the despised and even deadly “doughnut hole” in the Medicare prescription drug program, which was designed in 2003 largely by lobbyists for insurance and pharmaceutical companies who were more interested in protecting their companies’ profits than helping seniors stay alive. The way the law was cobbled together, Medicare beneficiaries get prescription drug coverage only up to a certain amount. When they reach that limit, they fall into the “doughnut hole” and have to pay about $4,000 out of their own pockets for their prescriptions before coverage resumes. As a consequence, many people stop taking their medications because they don’t have the money to pay for them. And many of them die. The Affordable Care Act has already shrunk that gap and will close it completely in 2020.
Before the Affordable Care Act, insurance companies routinely refused to insure children who were born with disabilities or who developed life-threatening illnesses like diabetes or cancer. It was perfectly legal for them to refuse to sell coverage to anyone — even children— who had what insurers call a “pre-existing condition.” The reform law already requires insurers to cover all kids, regardless of health status. It will apply to the rest of us in 2014.
Insurers have long had a policy of kicking young adults off their parents’ policies when they turn 23. Many of these young folks don’t have the money to buy coverage on their own—and a lot of them can’t buy it at all because of, you guessed it, pre-existing conditions. That’s why young people comprise the biggest segment of the uninsured population. Because the Affordable Care Act allows parents to keep dependents on their policies until they turn 26, an estimated 2.5 million young people had become insured again as of the end of last year.
Millions of Americans fall into the ranks of the uninsured every year when they get laid off. That’s one reason the number of people without coverage swelled to 50 million during the recession. Many of them can’t afford to buy insurance on their own and many of them have—you guessed right again—pre-existing conditions and can’t buy it at any price. Starting in 2014, not only will the Affordable Care Act prohibit insurers from refusing to sell coverage to people of any age because of their medical history, it will also provide subsidies to low-income individuals and families to help them buy insurance.
To avoid paying claims, insurers for years have cancelled the coverage of policyholders when they got sick. A former nurse in Texas testified before Congress in 2009 about getting a cancellation notice from her insurer the day before she was to have a mastectomy because she had failed to note on her application for coverage that she had been treated for acne. The Affordable Care Act makes it illegal for insurers to cancel policies for any reason other than fraud or failure to pay premiums.
“Hands off my health care!” Maybe we ought to think that through a little bit more before we take to the streets with those words on our placards. Insurers who profited from the way things used to be will laugh all the way to the bank if you start waving those signs, but you and people you love might live to regret it. On the plus side, at least for the special interests, you probably won’t live as long.
Signs from a Tea Party protest in St. Paul, Minn.Flickr Creative Commons/Fibonacci Blue
Reprinted by Permission © 2012, The Center for Public Integrity®
Recently The National Law Review published a paper by the Labor and Employment Law Department of Barnes & Thornburg LLP regarding the ADA Requirements for Pools and Spas:
On March 20, 2012, the U.S. Department of Justice (the Department) announced an immediate 60-day postponement of the effective date for the accessibility requirements for pools and spas subject to either Title II (state and local government programs) or Title III (places of public accommodation). These requirements will now take effect on May 21, 2012.
The Department also is contemplating further extending the effective date, and simultaneously issued a Notice of Proposed Rulemaking (NPRM) soliciting public comment as to whether the effective date of the pool and spa requirements should be postponed until Sept. 17, 2012, 180 days from the original effective date. The Department indicated that it was taking this action in order to allow pool owners and operators additional time to address certain misunderstandings regarding these requirements and their application to existing pools and spas.
On Sept. 15, 2010, the Department adopted the 2010 ADA Standards for Accessible Design (2010 Standards), which took effect on March 15, 2012. The 2010 Standards contain requirements for accessible means of entry into and exit from swimming pools and spas as follows:
On Jan. 31, 2012, the Department issued technical guidance with respect to these requirements, in particular the manner in which they pertain to existing pools and spas. See “ADA 2010 Revised Requirements: Accessible Pools – Means of Entry and Exit,” available athttp://www.ada.gov/pools_2010.htm ). Use of pool lifts generally is the most convenient method for providing access to existing pools and spas. In its technical guidance and in subsequent correspondence further explaining the pool requirements, the Department indicated that under Title II (state and local government programs), access could be provided through the use of portable pool lifts. Under Title III, however, the Department indicated the pool lift must be fixed, or at least capable of being affixed to the pool deck or apron when in use; use of portable lifts is permitted only if provision of a fixed lift is not readily achievable. This difference stems from the fact that unlike Title III, which requires the removal of physical barriers to access where readily achievable, Title II permits state and local programs to provide access to existing facilities via alternative methods, including the purchase of equipment, in lieu of making structural modifications. Whether covered under Title II or Title III, however, newly constructed pools must comply with the 2010 Standards, and altered pools must comply to the maximum extent feasible.
In its technical guidance, the Department also indicated that pool lifts must be in place during the hours the pool or spa is open. Where a facility has multiple pools or spas that are required to be accessible, a pool lift cannot be shared among the pools and spas, unless providing multiple lifts creates an undue burden.
Following issuance of the technical guidance, certain pool owners and operators expressed concern over its substance and urged the Department to permit the use of portable lifts under Title III and to permit pool lifts to be shared among pools. They also raised safety concerns regarding the Department’s position that pool lifts must be in place during the hours the pool or spa is open.
In issuing its NPRM to further extend the effective date of the pool and spa requirements, the Department emphasized that it will not revisit the merits of the accessibility requirements for pools and spas. Public comments on the issue of whether the effective date of these requirements should be further extended to Sept. 17, 2012 must be submitted no later than April 4, 2012.
© 2012 BARNES & THORNBURG LLP
The National Law Review published an article by the Labor & Employment Group of Schiff Hardin LLP regarding ADA Claims:
An Illinois federal court recently decided that it could be unreasonable for an employer to require an employee take a mental health exam as a condition of keeping his job, and allowed a former employee’s claim to proceed to trial. Sanders v. Illinois Dept. of Central Management Services, 2012 WL549325 (C.D.Ill. Feb. 21, 2012).
The Illinois Department of Central Management Services (the “Department”) employed Michael Sanders as a data processing technician. In 2005, Mr. Sanders was disciplined with suspension for various infractions including not following procedures, leaving his work station and sending an email to his supervisor, Victor Puckett, accusing him of being racist and needing mental health treatment. Thereafter, on August 26, 2005, Mr. Sanders accused Mr. Puckett of screaming, cursing and threatening to throw him out the window during a work dispute, which Mr. Puckett disputed. Mr. Sanders was disciplined for the August 26 incident. On September 9, 2005, the union representative at the pre-disciplinary hearing relating to the August 26 incident notified the Department that Mr. Sanders had threatened to harm Mr. Puckett (which Mr. Sanders disputed).
Thereafter, the Department placed Mr. Sanders on administrative leave and directed him to undergo an independent psychological evaluation, but Mr. Sanders did not attend any of the three appointments made for him. The Department initially terminated Mr. Sanders on November 23, 2005 for not undergoing the psychological exam, but voluntarily reinstated him and placed him on administrative leave effective February 1, 2006. During his leave, the Department made additional appointments for him to undergo an independent psychological evaluation, but Mr. Sanders did not attend any of them.
In January, 2007, the Office of Executive Inspector General (“OEIG”) determined that there was no evidence that Mr. Sanders violated Department rules during the August 26, 2005 incident. The Department scheduled another appointment for an independent psychological evaluation on September 5, 2007. Mr. Sanders sent two memos to the doctor who was to examine him, threatening to take legal action, disciplinary action and contact the media if the doctor did not cancel the appointment.
Mr. Sanders was discharged for refusing to undergo the independent psychological examination. He appealed his termination to the Illinois Civil Service Commission. The Commission found that it was not reasonable for the Department to require Mr. Sanders to submit to an independent psychological examination, and the Department’s decision to discharge Mr. Sanders was unsupported, based on a number of factors including that the Department had not interviewed Mr. Sanders to obtain his version of events relating to the alleged incidents, and also that, according to the Commission, there was no “credible evidence” that Mr. Sanders had threatened Mr. Puckett. The Department’s appeals of that decision to the Commission and the circuit court were denied.
Thereafter, Mr. Sanders filed suit against the Department in Illinois federal court alleging violation of the Americans with Disabilities Act (“ADA”). The court allowed Mr. Sanders’ suit to proceed to trial on the question of whether Mr. Sanders’ discharge for refusal to undergo a psychological examination violated the ADA. The court noted that an employer’s demand that an employee submit to a medical exam may be permissible if the employer has a reasonable belief that the employee’s ability to perform essential job functions is impaired by, or the employee poses a direct threat due to, a medical condition. Here, however, the court focused on the OEIG’s finding that there was no evidence that Mr. Sanders violated the Department’s rules during the August 26, 2005 incident, and held that a jury should decide if it was reasonable for the Department to continue to schedule the psychological exams for Mr. Sanders after the OEIG’s determination. The court also noted that what may be reasonable in some employment settings, such as law enforcement or school personnel, may not be reasonable in others.
The case is significant because the district court in this case joined a number of federal circuit courts that allow a non-disabled individual to bring suit under the ADA, including the U.S. Courts of Appeal for the Ninth and Tenth Circuits. The Seventh Circuit has not ruled on the issue. Here, the court did not even consider the question of whether the plaintiff was a qualified individual with a disability under the ADA.
The case reinforces that any request for a physical or mental examination must be carefully examined for necessity and job-relatedness. It also highlights the importance of conducting thorough investigations into alleged instances of misconduct before taking any employment actions.
© 2012 Schiff Hardin LLP
The National Law Review is pleased to bring you information on the Launching & Sustaining Accountable Care Organizations Conference will be a two-day, industry focused event specific to CEOs, COOs, CFOs, CMOs, Vice presidents and Directors with responsibilities in Accountable Care Organizations, Managed Care and Network Management from Hospitals, Physician Groups, Health Systems and Academic Medical Centers.
By attending this event, industry leaders will share best practices, strategies and tools on incorporating cost-sharing measures in a changing healthcare landscape to strengthen the business model and ensure long-term success.
Attending This Event Will Enable You to:
1. Understand the initial outcomes and lessons learned from launching ACOs, with a focus on how to sustain these partnerships in the future
2. Hear from the early adopters of ACOs or similar cost-reducing partnerships and understand their initial operational and implementation challenges.
3. Learn about the final regulations regarding ACOs and their impact on those who want to initiate the formation process
4. Gain a clear understanding of regulatory issues and accreditation processes
5. Conquering initial hurdles for establishing an ACO
6. Gain knowledge from newly-formed ACOs
7. Ensure longevity by establishing a robust long-term plan
The National Law Review is pleased to bring you information on the Launching & Sustaining Accountable Care Organizations Conference will be a two-day, industry focused event specific to CEOs, COOs, CFOs, CMOs, Vice presidents and Directors with responsibilities in Accountable Care Organizations, Managed Care and Network Management from Hospitals, Physician Groups, Health Systems and Academic Medical Centers.
By attending this event, industry leaders will share best practices, strategies and tools on incorporating cost-sharing measures in a changing healthcare landscape to strengthen the business model and ensure long-term success.
Attending This Event Will Enable You to:
1. Understand the initial outcomes and lessons learned from launching ACOs, with a focus on how to sustain these partnerships in the future
2. Hear from the early adopters of ACOs or similar cost-reducing partnerships and understand their initial operational and implementation challenges.
3. Learn about the final regulations regarding ACOs and their impact on those who want to initiate the formation process
4. Gain a clear understanding of regulatory issues and accreditation processes
5. Conquering initial hurdles for establishing an ACO
6. Gain knowledge from newly-formed ACOs
7. Ensure longevity by establishing a robust long-term plan
The National Law Review is pleased to bring you information on the Launching & Sustaining Accountable Care Organizations Conference will be a two-day, industry focused event specific to CEOs, COOs, CFOs, CMOs, Vice presidents and Directors with responsibilities in Accountable Care Organizations, Managed Care and Network Management from Hospitals, Physician Groups, Health Systems and Academic Medical Centers.
By attending this event, industry leaders will share best practices, strategies and tools on incorporating cost-sharing measures in a changing healthcare landscape to strengthen the business model and ensure long-term success.
Attending This Event Will Enable You to:
1. Understand the initial outcomes and lessons learned from launching ACOs, with a focus on how to sustain these partnerships in the future
2. Hear from the early adopters of ACOs or similar cost-reducing partnerships and understand their initial operational and implementation challenges.
3. Learn about the final regulations regarding ACOs and their impact on those who want to initiate the formation process
4. Gain a clear understanding of regulatory issues and accreditation processes
5. Conquering initial hurdles for establishing an ACO
6. Gain knowledge from newly-formed ACOs
7. Ensure longevity by establishing a robust long-term plan
The National Law Review is pleased to bring you information on the Launching & Sustaining Accountable Care Organizations Conference will be a two-day, industry focused event specific to CEOs, COOs, CFOs, CMOs, Vice presidents and Directors with responsibilities in Accountable Care Organizations, Managed Care and Network Management from Hospitals, Physician Groups, Health Systems and Academic Medical Centers.
By attending this event, industry leaders will share best practices, strategies and tools on incorporating cost-sharing measures in a changing healthcare landscape to strengthen the business model and ensure long-term success.
Attending This Event Will Enable You to:
1. Understand the initial outcomes and lessons learned from launching ACOs, with a focus on how to sustain these partnerships in the future
2. Hear from the early adopters of ACOs or similar cost-reducing partnerships and understand their initial operational and implementation challenges.
3. Learn about the final regulations regarding ACOs and their impact on those who want to initiate the formation process
4. Gain a clear understanding of regulatory issues and accreditation processes
5. Conquering initial hurdles for establishing an ACO
6. Gain knowledge from newly-formed ACOs
7. Ensure longevity by establishing a robust long-term plan
