Gene patents: Sup.Ct. provides a guide

Some time ago, I posted about a case about patenting genes.  In Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013), Myriad was trying to patent genes.  Their argument, in summary, was that because they isolated a gene, they had the right to patent it.  The question is really whether it is a product of nature or manmade.  Here, the Supreme Court stated some DNA genes could not be patented, while another was.

The decision explained under what circumstances DNA can be patented and cannot be patented.  The DNA (BRCA1 and BRCA2) in this case involved genes which can involve mutations that increase the likelihood of breast cancer.  Regarding these genes, the Supreme Court ruled against the patent because it held that merely isolating the DNA gene does not make the DNA segment patent eligible.

The Supreme Court explained that Myriad isolated the gene and identified its precise location and genetic sequence.  Myriad did not create or alter the genetic information encoded in the genes (BRCA1 and BRCA2).  In addition, the Supreme Court noted that a new nonnatural occurring molecule is not created by isolating the DNA.  The patent focused on the information contained in the genetic sequence.  If another where to use the process, the same molecules in the genetic sequence would be seen.

However, the case also discussed a different synthetic gene, which the Supreme Court ruled could be patented.  Myriad created cDNA molecule by removing the introns from the DNA sequence.  The creation of cDNA resulted in a exons-only molecule.

 

Exons-only molecules are not naturally occurring.  Both parties agreed that cDNA differs from natural DNA in that the non-coding regions have been removed.  Even though the nucleotide sequence of cDNA is dictated by nature, the Supreme Court held:

the lab technician unquestionably creates something new when cDNA is made.  cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA form which it was derived.  As a result, cDNA is not a “product from nature” and is patent eligible under s101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA.  In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

(italics added).  Consequently, the Supreme Court held that cDNA was patentable.

So what does this mean?  When genes are not altered or created, the gene is not patentable.  When a company isolates the DNA to figure out where it is in the gene and its sequence, the company is not creating a new DNA or altering the DNA.

So how can a gene be altered or created?  When the technician is creating a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring.

via Details on Association for Molecular Pathology v. Myriad Genetics, Inc. : SCOTUSblog.

Sup. Ct. allows Class Action Arbitration under FAA

In Oxford Health Plans LLC v. Sutter, No. 12-125 (2013), the Supreme Court ruled that an arbitrator can require a class action arbitration.

The gist of the case is that Sutter, a pediatrician, had a fee-for-services contract, which required arbitration for all contractual disputes.  When Oxford failed to promptly pay him and other physicians, Sutter filed a class action in New Jersey.  After filing, the court compelled arbitration.  The arbitrator concluded that the contract called for class action arbitration.  Sutter appealed to higher courts, but these appeals were denied.

The Supreme Court explained its decision as follows.  First, the parties agreed to go to arbitration in their contract.  Second, an arbitrator looks at the contract, makes a decision based on the contractual language, and this decision is binding.  Thirdly, and most importantly, the Supreme Court explained that judicial review is limited to whether the arbitrator interpreted the contract, not whether the court agreed with the decision.  Consequently, because the arbitrator considered the contract, the arbitrator’s decision stands.  They only way to vacate an arbitral decision is when an arbitrator strayed from his task of interpreting the contract.  In other words, not when he performed his task poorly.

As a note: In prior decisions (Steelworkers Trilogy/Misco) in the labor context under the Labor Management Relations Act (LMRA), the Supreme Court had ruled that a contractual language had to explicitly allow class actions in the arbitration clause.  Here, the arbitration clause did not do so.

This raises the question of how the Federal Arbitration Act (FAA) reconciles with LMRA arbitrations when they are both present.  In this case, only the FAA was involved.

via Workplace Prof Blog: SCOTUS OKs Class Arbitration.

ACLU challenges NSA surveillance

On June 11th, the ACLU filed a lawsuit challenging the NSA’s surveillance program.  The ACLU lawsuit alleges that the program violates the First Amendment rights or free speech and association, the right to privacy under the Fourth Amendment, and that the surveillance program exceeds the authority provided by the Patriot Act.

ACLU, a customer of Verizon, made the following comments:

This dragnet program is surely one of the largest surveillance efforts ever launched by a democratic government against its own citizens.

It is the equivalent of requiring every American to file a daily report with the government of every location they visited, every person they talked to on the phone, the time of each call, and the length of every conversation.  The program goes far beyond even the permissible limits set by the Patriot Act and represents a gross infringement of the freedom of association and the right to privacy.

The complaint can be accessed here.

via ACLU Files Lawsuit Challenging Constitutionality of NSA Phone Spying Program | American Civil Liberties Union.

Is a Fourth Branch in the horizon?

The Washington Post has a very interesting article, which highlights the increased deferment of cases to government agencies.  Instead of going through the court system, many cases are increasingly going through administrative agencies instead.

The question posed here is whether the right for court accessibility being challenged?  The Washington Post raises its concerns:

The growing dominance of the federal government over the states has obscured more fundamental changes within the federal government itself: It is just not bigger, it is dangerously off kilter.  Our carefully constructed system of checks and balances is being negated by the rise of a fourth branch, an administrative state of sprawling departments and agencies that govern with increasing autonomy and decreasing transparency.

The Washington Post reports that the vast majority of laws governing the United States are not passed by Congress but are issued as regulations.  A study found that in 2007, Congress enacted 138 public laws, while federal agencies finalized 2,926 rules, including 61 major regulations.

The Washington Post also reports that a citizen is 10 times more likely to be tried by an agency instead of an actual court.  While federal judges conduct roughly 95,000 adjudicatory proceedings (including trials), federal agencies complete more than 939,000.

However, there are several items the Washington Post fails to mention.  The increasingly use of administrative agencies does not only fall upon the agency.

Take for example the individual’s decision to file a charge/claim.  Going through administrative agencies is more cost-effective.  Lawsuits in court have become more expensive.  Technology, electronic evidence, growth in documents and companies, among others, lead to a higher volume of issues and motions that increase the cost of litigation.  Given both alternatives, it makes sense that an individual might choose to go through an administrative agency.

For example, an individual going through the EEOC for a discrimination charge does not have to pay anything.  While an individual going through the court system may have to pay attorney fees and might be responsible for attorney fees.

 

 

Saying that, however, the issue of transparency and timing is highly concerning.  Administrative decisions are not public.  In addition, the length of an administrative decision might take several years.

via The rise of the fourth branch of government – The Washington Post.

Minn. Sup. Ct. reins in expungement power

Minnesota Lawyer (subscription required) has an interesting article regarding expungement of adult and juvenile cases.

In this decision, the Minn. Sup. Ct. declined to recognize a court’s inherent authority to order expungement of executive branch records of an adult’s criminal history (State v. M.D.T.).  When explaining prior precedent, the court differentiated State v. C.A., where the language was dicta and the case did not involve executive records.

The Minn. Sup. Ct. also narrowly construed a juvenile’s statutory expungement remedy in companion cases (In the Matter of the Welfare of: J.J.P.).  Here, the court held that the authority of the court under Minn. Stat. sec. 260B.198 is limited to the order adjudicating the juvenile delinquent.

VA modifies Mental Health benefits

Courthouse News has this update on VA benefits regulations:

The Department of Veterans Affairs has modified eligibility rules so veterans with mental illness may receive treatment while waiting for confirmation of their service, according to a revised regulation.

The VA has revised its rules to allow for tentative eligibility approvals for VA health care for those who served in the military after Sept. 7, 1980. Applicants must still meet the minimum service requirement under federal code and tentative approvals are contingent on whether they have filed for VA health care within six months after their discharge under conditions “other than dishonorable,” the agency said in its action.

Effective June 13, veterans may receive medical treatment before their psychosis or “mental illness other than psychosis” has been confirmed to be service-connected, the rule says.

The VA said the rule change makes sense considering most veterans are able to connect their medical condition to military service, and early treatment could improve their chances of a positive outcome.

“The immediate medical treatment will, in turn, enable the veteran to manage his or her medical condition more effectively,” the agency said in its action.

The agency also removed the six-month minimum service time to be eligible for the mental health benefits. The minimum was originally set by a Congress concerned about some service members who would enlist with the sole intention of obtaining eligibility for veterans’ benefits, but then would bring about their own early discharge, the agency explained in its action.

The agency said that the rule has been changed “in consideration of the fact that very few, if any, veterans will be seeking tentative eligibility determinations within six months of discharge for a period of service that began over 32 years ago. The amount of time that a veteran, who entered active duty after Sept. 7, 1980, must serve on active duty to be eligible for VA benefits is governed by another U.S. code.

In addition, mental health care has been extended to “non-enrolled” veterans, or veterans who receive their care from private hospitals instead of the VA, and copayment obligations have been removed.

via Courthouse News Service.

New Homeowners Bill of Rights

Governor Dayton will soon be signing a new bill that includes new protections for homeowners facing foreclosures.  This new law is known as the Homeowners Bill of Rights.

Some of the ways that it protects homeowners are as follows:

• Loan servicers are required to communicate all options to homeowners.
• Loan servicers are required to offer loan modifications to all eligible homeowners.
• “Dual tracking” is banned.  Dual tracking is when servicers foreclose without a clear yes or no on loan modification.
• Servicers are required to assist homeowners in submitting documentation regarding the foreclosure process.
• Homeowners are allowed to take the servicer to court to stop a foreclosure if the servicer fails to comply with any aspect of the law.

 

Federal Agents Indicted in Immigration Scams

Seeking immigration or legal advice sometimes comes with the risk that the person you are talking to is committing fraud.

The most public cases of these frauds are known as ”Notario Fraud” or “Immigration Consultants Fraud.”  Notarios or immigration consultants use false advertising and fraudulent contracts.  They hold themselves as qualified to help immigrants to obtain lawful status or perform other legal functions.  (You can read more about Fight Notario Fraud at the ABA).

Now, federal agents were indicted in an immigration fraud scheme led by a L.A. attorney.  The indictment alleges two conspiracies against the US involving bribery and fraud, seven counts of bribery, as well as making false statements and misuse of government seals.

The U.S. Attorney stated in a statement,

The conspiracy was allegedly orchestrated by a Los Angeles attorney who paid bribes as high as $10,000 to officials with several agencies in the Department of Homeland Security to help secure immigration benefits for aliens he was representing.

The indictment claims alleged that Kwan Man “John” Lee bribed public officials to get immigration benefits for clients who paid him, at times, more than $50,000.  Lee was charged in a previous criminal complaint and is not a defendant in the indictment.

via Courthouse News Service.

Senators’ committee will advise on new U.S. attorney

Minnesota Lawyer Blog brings to our attention that a new advisory committee has been formed to recommend a new U.S. Attorney.

The current U.S. Attorney B. Todd Jones has been nominated to serve as the permanent director of the Bureau of Alcohol, Tobacco, and Firearms (ATF) and his confirmation hearing is expected to be held soon, the release states.

Judge Timothy O’Malley of the Minnesota Office of Administrative Hearings and the former head of Minnesota’s Bureau of Criminal Apprehension will chair the committee, which will also include Annamarie Daley, a Minneapolis attorney in private practice; former U.S. Attorney Thomas Heffelfinger; Stearns County Attorney Janelle Kendall; Donald Lewis, Dean of Hamline Law School; retired St. Louis County Judge Carol Person; and Chief Thomas Smith of the St. Paul Police Department.

The committee will review letters of interest, conduct interviews, and offer guidance to Klobuchar and Franken.  In the press release, Klobuchar stated that the candidate should be a seasoned, respected attorney who is fair-minded, able to work productively with local, state and federal law enforcement agencies, and who is committed to seeing that justice is done under the law and for the people of Minnesota.

Those wishing to be considered for the position of U.S. Attorney should submit letters of interest by June 3, 2013 to: Judge Timothy O’Malley, U.S. Attorney Advisory Committee, c/o Caroline Holland, Office of Senator Amy Klobuchar, 1200 Washington Avenue South, Suite 250, Minneapolis, MN 55415.  Letters may also be e-mailed to caroline_holland@judiciary-dem.senate.gov.

via Senators’ committee will advise on new U.S. attorney – MinnLawyer Blog.

EEOC’s First GINA Suit Settlement

The first settlement between the EEOC and an employer over GINA is important because it brings attention to this relatively new law.  EEOC charges alleging GINA violations have increased each year.  Consequently, it is important for employers to ensure their policies and procedures are compliant with GINA procedures.

The Genetic Information Nondiscrimination Act (GINA) went into effect in 2009.  Some of GINA’s regulations are as follows.

• It is illegal for employers to discriminate against employees or applicants based on their genetic information.
• Employers cannot request or obtain genetic information, which includes any information about an employee or an applicant’s family history.
• GINA also applies to third parties.  So, employers cannot request or obtain family medical history, even through a third-party medical provider or examiner.
• There are exceptions for voluntary health risk assessments.  However, if the employee is receiving an incentive for completion of the Health Risk Assessment, the employer must make clear that an employee need not answer any of the questions about family medical history in order to obtain the incentive.

On May 7, 2013, the U.S. Equal Employment Opportunity Commission (“EEOC”) reached a milestone of sorts as it filed – and then settled – its first complaint ever alleging genetic discrimination under the Genetic Information Nondiscrimination Act of 2008 (“GINA”).

The EEOC filed suit in Oklahoma federal court against Fabricut Inc., one of the world’s largest distributors of decorative fabrics, alleging that Fabricut violated GINA and the Americans With Disabilities Act (“ADA”) by unlawfully asking a job applicant for her family medical history in a pre-employment, post-job offer medical examination, and allegedly rescinding her job offer based on the belief that she had carpal tunnel syndrome.

The EEOC and Fabricut reached a settlement, which is the first settlement in a GINA case.  In the consent decree, Fabricut agreed to pay $50,000 but did not admit to violating GINA or the ADA.

via EEOC’s First GINA Suit Serves As Reminder of Pre-Employment Exam Pitfall | Proskauer Rose LLP – JDSupra.