February, 02 2010, 09:14am EDT

ACLU And PUBPAT Argue Today That Patents On Breast Cancer Genes Are Unconstitutional And Invalid
First Hearing In Federal Court About The Patentability Of Human Genes
NEW YORK
In
the first hearing in federal court about the patentability of human
genes, the American Civil Liberties Union and the Public Patent
Foundation (PUBPAT), a not-for-profit organization affiliated with
Benjamin N. Cardozo School of Law, asked the court today to rule that
patents on two human genes associated with breast and ovarian cancer
are unconstitutional and invalid. The groups charge that the patents
stifle diagnostic testing and research that could lead to cures and
that they limit women's options regarding their medical care.
"Allowing patents on genetic
material imposes real and severe limits on scientific research,
learning and the free flow of information," said Chris Hansen, an
attorney with the ACLU.
The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al.,
was filed on May 12, 2009 in the U.S. District Court for the Southern
District of New York on behalf of breast cancer and women's health
groups, individual women and scientific associations representing
approximately 150,000 researchers, pathologists and laboratory
professionals. The lawsuit was filed against the U.S. Patent and
Trademark Office, as well as Myriad Genetics and the University of Utah
Research Foundation, which hold the patents on the genes, BRCA1 and
BRCA2. The lawsuit charges that patents on human genes violate the
First Amendment and patent law because genes are "products of nature"
and therefore can't be patented.
"Patenting human genes is like patenting e=mc2, blood or air," said Hansen.
"The patent system was designed to
reward and encourage human ingenuity. But genes are naturally-occurring
parts of our bodies, not inventions," said Daniel B. Ravicher,
Executive Director of PUBPAT and co-counsel in the lawsuit. "Patents on
human genes should never have been granted in the first place. Genes
are identified, not invented."
Mutations along the BRCA genes are
responsible for most cases of hereditary breast and ovarian cancers.
Many women with a history of breast and ovarian cancer in their
families opt to undergo genetic testing to determine if they have the
mutations on their BRCA genes that put them at increased risk for these
diseases. This information is critical in helping these women decide on
a plan of treatment or prevention, including increased surveillance or
preventive mastectomies or ovary removal.
The patents granted to Myriad give
the company the exclusive right to perform diagnostic tests on the
BRCA1 and BRCA2 genes and to prevent any researcher from even looking
at the genes without first getting permission from Myriad. Myriad's
monopoly on the BRCA genes makes it impossible for women to access
alternate tests or get a second opinion about their results and allows
Myriad to charge a high rate for their tests.
Because the ACLU's lawsuit
challenges the whole notion of gene patenting, its outcome could have
far reaching effects beyond the patents on the BRCA genes.
Approximately 20 percent of all human genes are patented, including
genes associated with Alzheimer's disease, muscular dystrophy, colon
cancer, asthma and many other illnesses.
"The patents on the BRCA genes
restrict women's access to genetic testing and interfere with their
medical care," said Sandra Park, staff attorney with the ACLU Women's
Rights Project. "We hope that at the conclusion of this lawsuit, the
court declares the patents unconstitutional and invalid."
Several major organizations,
including the American Medical Association, the March of Dimes and the
American Society for Human Genetics, filed friend-of-the-court briefs
in support of the ACLU and PUBPAT's case. Prominent medical researchers
and academics, including Nobel Prize winners Joseph Stiglitz and Sir
John Sulston, have also stated their support.
Today's argument is on the ACLU's
motion for summary judgment, asking the court to rule in favor of the
ACLU's clients without a trial, and on the defendants' cross motions.
Attorneys on the case include Hansen
and Aden Fine of the ACLU First Amendment Working Group; Park and
Lenora Lapidus of the ACLU Women's Rights Project; and Ravicher and
Sabrina Hassan of PUBPAT. Tania Simoncelli, the ACLU's science advisor,
provides expert guidance on the case.
More information about the case,
including an ACLU video featuring breast cancer patients, legal
documents and plaintiff and supporter statements and declarations can
be found online at: www.aclu.org/brca
The American Civil Liberties Union was founded in 1920 and is our nation's guardian of liberty. The ACLU works in the courts, legislatures and communities to defend and preserve the individual rights and liberties guaranteed to all people in this country by the Constitution and laws of the United States.
(212) 549-2666LATEST NEWS
'Appalling': Biden Administration Declines to Force Big Pharma to Cut Price of Prostate Cancer Drug
"This decision effectively rubber-stamps continued Big Pharma abuse," said one Democratic lawmaker.
Mar 21, 2023
Patient advocates on Tuesday blasted the Biden administration's refusal to compel the manufacturer of a lifesaving prostate cancer drug developed completely with public funds to lower its nearly $190,000 annual price tag.
In 2021, prostate cancer patient Eric Sawyer petitioned U.S. Health and Human Services (HHS) Secretary Xavier Becerra to grant march-in rights—under which the government can grant patent licenses to companies other than a drug's manufacturer—for enzalutamide, which is sold under the brand name Xtandi by Pfizer and Japanese pharmaceutical giant Astellas.
The drug's development was 100% taxpayer-funded. Yet a one-year supply of Xtandi currently costs $189,800 in the United States, or up to five times more than its price in other countries.
HHS' National Institutes of Health (NIH) said Tuesday that it "does not believe that use of the march-in authority would be an effective means of lowering the price of the drug."
"What the Biden administration is saying is that charging U.S. residents three to six times more than any other high-income country is reasonable."
The agency added that it "will pursue a whole-of-government approach informed by public input to ensure the use of march-in authority is consistent with the policy and objective of the Bayh-Dole Act," a reference to legislation meant to promote the commercialization and public availability of government-funded inventions.
James Love, director of the Washington, D.C.-based advocacy group Knowledge Ecology International, called the administration's rejection "appalling."
"What the Biden administration is saying is that charging U.S. residents three to six times more than any other high-income country is reasonable," he wrote.
U.S. Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-Vt.) said in a statement that he is "extremely disappointed that the Biden administration denied a petition by prostate cancer patients to substantially reduce the price of Xtandi."
"This is a drug that was invented with taxpayer dollars by scientists at UCLA and can be purchased in Canada for one-fifth the U.S. price," Sanders added. "The Japanese drugmaker Astellas, which made $1 billion in profits in 2021, has raised the price of this drug by more than 75%... How many prostate cancer patients will die because they cannot afford this unacceptable price?"
Rep. Lloyd Doggett (D-Texas), the ranking member of the House Ways and Means Health Subcommittee, said in a statement:
Today's decision is a blow to prostate cancer patients, their families, and taxpayers. Developed with U.S. taxpayer research dollars, Xtandi costs American patients $180,000 a year—as much as six times as much as patients in other countries. This excessive price gouging cost taxpayers $2 billion to cover Medicare beneficiaries' treatment in 2020 alone. The Biden administration has missed yet another opportunity to do something meaningful to lower prescription drug costs and protect taxpayer investments.
The administration's position "protects monopolists over taxpayers and patients, despite clear statutory authority and reasonableness to intervene," Doggett added. "This decision effectively rubber-stamps continued Big Pharma abuse."
In a move that Public Citizen president Robert Weissman called "pathetic," HHS and the Department of Commerce announced Tuesday that they would "pursue a whole-of-government approach to review... march-in authority as laid out in the Bayh-Dole Act" by forming an interagency working group.
The group "will develop a framework for implementation of the march-in provision that clearly articulates guiding criteria and processes for making determinations where different factors, including price, may be a consideration in agencies' assessments."
In a statement, Becerra said that the administration is "committed to increasing access to healthcare and lowering costs."
"March-in authority is a powerful tool designed to ensure that the benefits of the American taxpayers' investment in research and development are reasonably accessible to the public," he added. "We look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public, and better define how HHS could effectively utilize our authority moving forward."
Keep ReadingShow Less
Senate Dems Urge Treasury Chief to Crack Down on Rich Tax Dodgers
"The Treasury Department can and should exercise the full extent of its regulatory authority to limit this blatant abuse of our tax system by the ultrawealthy."
Mar 21, 2023
Four U.S senators this week called on Treasury Secretary Janet Yellen to use her existing authority to go after American billionaires and multimillionaires who "use trusts to shift wealth to their heirs tax-free, dodging federal estate and gift taxes."
"They are doing this in the open: Their wealth managers are bragging about how their tax dodging tricks will be more effective in the current economy," stressed Sens. Elizabeth Warren (D-Mass.), Chris Van Hollen (D-Md.), Bernie Sanders (I-Vt.), and Sheldon Whitehouse (D-R.I.).
"While we look forward to continuing to partner with you on legislative solutions," the senators wrote to Yellen, "the Treasury Department can and should exercise the full extent of its regulatory authority to limit this blatant abuse of our tax system by the ultrawealthy."
Their letter to the Treasury leader, dated Monday and first reported by CBS MoneyWatch Tuesday, highlights that "only the wealthiest American families" are asked to pay transfer taxes such as the estate tax, gift tax, and generation-skipping transfer (GST) tax.
As the letter lays out:
Tax avoidance through grantor trusts starts with the ultrawealthy putting assets into a trust with the intention of transferring them to heirs. Grantor trusts are trusts where the grantor retains control over the assets, and the structures of some of these grantor trusts allow the transfer of massive sums tax-free. Tax planning via grantor trusts, including grantor retained annuity trusts (GRATs), is a kind of shell game, with a wealthy person and their wealth managers able to pass assets back and forth in ways that effectively pass wealth to heirs while minimizing tax liability.
Some of the wealthiest families further compound this tax avoidance with perpetual dynasty trusts, which can be used to shield assets from transfer tax liability indefinitely. For example, aggressive valuation discounts can artificially reduce the value of assets transferred into a trust below the GST tax exemption threshold, after which the assets can grow in perpetuity within a trust exempt from transfer tax.
"The ultrawealthy at the top of the socioeconomic ladder live by different rules than the rest of America, especially when it comes to our tax system," the letter charges. "As the richest Americans celebrate and take advantage of these favorable tax opportunities, middle-class families struggle with inflation and Republicans threaten austerity measures and the end of Social Security and Medicare."
To help force the richest Americans to "pay their fair share" in taxes, the senators are calling on Treasury to revoke a pair of tax code rulings from the Internal Revenue Service (IRS); require GRATs to have a minimum remainder value; reissue family limited partnership regulations; clarify that intentionally defective grantor trusts (IDGTs) are not entitled to stepped-up basis; and put out clarifying regulations on certain valuation rules for estate and gift taxes.
The senators also sent a series of questions—about potential administrative action, how much is estimated to be held in grantor trusts, and how much could be raised from cracking down on abuse—and requested a response from Treasury by April 3.
Their letter comes after President Joe Biden earlier this month introduced a budget blueprint for fiscal year 2024 that would hike taxes on the rich—proposed policies praised by progressive experts and advocates as "fair, popular, and long overdue."
Yellen last week appeared before the Senate Finance Committee—of which Warren and Whitehouse are members—to testify about the administration's proposal. She said in part that "our proposed budget builds on our economic progress by making smart, fiscally responsible investments. These investments would be more than fully paid for by requiring corporations and the wealthiest to pay their fair share."
Keep ReadingShow Less
Biden DOL Praised for Historic Suit Over Using Debt Threat to Stop Workers From Quitting
The department's "action against predatory stay-or-pay contracts sends a monumental message to employers: Obey the law or face repercussions," said the head of Towards Justice.
Mar 21, 2023
Workers' rights advocates are applauding the Biden administration this week for filing a historic lawsuit against a Brooklyn-based healthcare staffing agency for coercive contracts that allegedly violate federal labor law.
Biden's Department of Labor (DOL) says in a complaint filed against Advanced Care Staffing (ACS) and CEO Sam Klein in the U.S. District Court for the Eastern District of New York that "in flagrant disregard" of the Fair Labor Standards Act (FLSA), the company "has entered into contracts purporting to require employees to complete at least three years of full-time work for ACS in order to retain their wages."
"The contracts warn employees that if they leave ACS's employ before three years' time, they will face ACS and its lawyers in an arbitration behind closed doors, where ACS will demand that employees kick back much of their hard-earned wages—including wages to which they are entitled under federal law," the complaint continues.
"Under this scheme, the pay that ACS promises its employees may be converted into nothing more than a loan that employees must repay with interest and fees, leaving some employees with no compensation at all, much less the wages required by the FLSA," the document adds. "The FLSA prohibits an employer from holding employees' wages hostage, allowing employees to keep their wages free and clear only if employees remain in the service of their employer."
The DOL, led by acting Secretary Julie Su, aims not only to end this "unlawful conduct" but also "to recover unpaid wages and liquidated damages due to the former employees from whom ACS has already initiated arbitrations, and to restrain defendants from withholding unpaid wages from their former employees."
Solicitor of Labor Seema Nanda reiterated in a statement Monday that "federal law forbids employers from clawing back wages earned by employees, for employers' own benefit."
"Employers cannot use workers as insurance policies to unconditionally guarantee future profit streams. Nor can employers use arbitration agreements to shield unlawful practices," Nanda said. "The Department of Labor will do everything in its power to make sure employees are being paid their hard-earned wages, and to safeguard them from these types of exploitative practices."
Bloomberg last September reported on Benzor Shem Vidal, a nurse who immigrated to the U.S. from the Philippines and took legal action against ACS for forcing him to work in "brutal and dangerous conditions," including simultaneously caring for 40 patients.
As Bloomberg detailed:
Under Vidal's contract, Advanced Care Staffing could sue him in arbitration for damages if he quit within three years of starting work—and make him pay the legal costs, according to the complaint in federal court in Brooklyn. The conditions were so onerous that they violate human trafficking laws meant to protect people from being exploited for labor, Vidal said.
"Mr. Vidal believed it was impossible for him to provide adequate care to patients but was also terrified to resign," his lawyers wrote. "He knew that his contract with Advanced Care Staffing purported to allow the company to pursue legal action against him, with potentially ruinous financial consequences, if he decided to terminate his employment."
Advanced Care Staffing did not immediately respond to an inquiry. The company has placed thousands of employees at facilities in New York and surrounding states, according to its website.
The DOL complaint lays out his experience over several pages and concludes that "defendants have a policy and practice of entering into contracts with employees with identical or substantially similar contract provisions to the 2022 contract with Vidal."
Celebrating the new case against ACS, Towards Justice executive director David Seligman declared Tuesday that "DOL's action against predatory stay-or-pay contracts sends a monumental message to employers: Obey the law or face repercussions."
"A fundamental premise of our labor laws is that employers pay workers, and not the other way around," said Seligman. "This lawsuit builds on a multiagency effort from the Biden administration to curb coercive contracts that rob workers of bargaining power. We look forward to what's next."
As Seligman noted in a series of tweets, other actions include the Consumer Financial Protection Bureau (CFPB) last June launching an inquiry into practices and products that may leave workers indebted to their employers, and the Federal Trade Commission (FTC) in January proposing a ban on noncompete clauses.
After noting that the DOL is taking on the ACS case as a minimum wage fight, Seligman said another important aspect is the department's allegation that the company's "arbitration requirements violate federal law too, not just because the employer is attempting to shield unlawful practices but also because the arbitration requirement itself shifts costs onto workers."
The DOL complaint states that ACS's arbitration and contract demands "have an impermissible chilling effect on their employees' ability to effectively vindicate their federal statutory rights, including the protection to be free from an unsafe or hazardous workplace, and to obtain unpaid wages due."
Student Borrower Protection Center senior policy adviser Chris Hicks on Tuesday stressed that such problems stretch far beyond one company, saying that "whether it's training repayment agreement provisions (TRAPs) or stay-or-pay contracts, employers are using debt as a tool of coercion to force workers to stay in low-paying, unsafe jobs."
Hicks also highlighted that "the Biden administration has been strengthening its whole-of-government approach to ensure workers are able to fully and freely exercise their rights—including their right to depart without the looming threat of debt."
Keep ReadingShow Less
Most Popular
SUPPORT OUR WORK.
We are independent, non-profit, advertising-free and 100%
reader supported.
reader supported.