Can a gene’s DNA be patented?

In the 1990s Myriad Genetics, collaborating with investigators at the University of Utah Research Foundation and other institutions and companies around the world, isolated the BRCA 1 and BRCA 2 genes, which are linked to both breast and ovarian cancer. In 1997 the U.S. Patent Office, ruling that the isolated DNA of these genes were discrete chemical compounds, granted a patent on the BRCA 1 gene and certain mutations to Myriad and its collaborators. The office later granted similar protection for the BRCA 2 gene. Over a decade later a science expert employed by the American Civil Liberties Union (ACLU) who was looking into health and medical issues reported that patents were being granted for genes. Impossible, replied Chris Hansen, J.D., an ACLU attorney. They must be patenting the methodology to isolate the genes. No, the researcher assured him, they’re patenting genes, and about 20 percent of known human genes are under patent. “That’s just wrong,” Hansen replied. “Let’s sue somebody.” Visit http://yalemedicine.yale.edu/winter2012/news/chronicle/119700 to read the full article. You can also click the above light blue link to be redirected. Read more!

Supreme Court Bounces Myriad BRCA Gene Patent Case Back to Appeals Court for Review

Article from GenomeWeb.com

The US Supreme Court is sending the most high-profile gene patenting case to date, focusing on Myriad Genetics' breast and ovarian cancer tests, back to a lower court for reconsideration in light of its decision last week to invalidate patents held by Prometheus Laboratories.

The decision to remand the case back to the US Court of Appeals for the Federal Circuit, which last year decided that patents Myriad has licensed and used related to the isolated gene sequences in the BRCA 1 and BRCA2 genes are valid, means that the Prometheus decision could influence or impact the case, though the effect of that case is unclear, as it centerd on different types of claims than the Myriad litigation.

The case against Myriad was brought by the Public Patent Foundation, American Civil Liberties Union, the Association for Molecular Pathology, and others who filed the suit in 2009 claiming that patents cannot cover natural phenomena and that Myriad's patents, and others like them, will hinder genetics research and keep some people from receiving the personalized medicine tests and second opinions.Myriad has held that its patents have not hindered science, that is has not impeded research, that the pricing of its BRACAnalysis tests are not prohibitive, and that most insurers cover them. Additionally, the company also says that there are other options for people seeking second opinions.

Those assertions may not mean much if the Supreme Court at some point decides that isolated DNA is not patentable, but the CAFC in its ruling in August 2011 decided that Myriad's patents covering isolated DNA are eligible under Section 101 of the US Patent Act.

That decision in part overturned an earlier ruling from the Federal District Court for the Southern District of New York, which decided that isolated DNA was not much different from gene sequences found in nature and therefore is not patentable.

"While, this case should not have any direct impact to Myriad and its operations because of our extensive patent estate, it has great importance to the medical, pharmaceutical, biotechnology and other commercial industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection," Myriad Genetics President and CEO Peter Meldrum said today in a statement.

"Thus, we are prepared to vigorously defend the patent claims granted to Myriad by the U.S. Patent and Trademark Office and believe that we will be successful," he said.

The plaintiffs, led by ACLU and PUBPAT, have suggested that the Prometheus decision could impact the CAFC's second look at the Myriad case, and are holding to their core argument about the special status of genes in the natural world.

“In light of recent rulings from the court that mere laws of nature cannot be patented, we hope that the lower court will come to the correct conclusion this time around,” Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project, said today in a statement. “It’s inconceivable that a company can own a patent on something as naturally occurring as DNA.”

“Nobody ‘invents’ genes, so no one should be able to claim ownership of them,” added Daniel Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. “We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. That cannot, and should not, be patented.”

Paul Rivard, a shareholder at the intellectual property-focused law firm Banner and Witcoff, told GenomeWeb Daily News today that the Supreme Court decided to bounce the Myriad case back to the CAFC because of the Prometheus ruling.

That case involved patents related to the proper dosing of thiopurine drugs for autoimmune diseases by correlating dosage levels with the levels of certain metabolites in a patient's blood. In its unanimous decision, the Supreme Court said that these patents are invalid because they describe laws of nature and "add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity."

"It is unclear exactly how the Prometheus ruling will guide the Federal Circuit on remand, particularly given that Myriad involves both composition-of-matter and process claims, whereas Prometheus involved only process [or method] claims," Rivard told GWDN in an e-mail. "Historically, composition-of-matter claims receive less scrutiny than do process claims with respect to subject matter eligibility."

Rivard said that despite the differences in the two cases, the CAFC will have to address the questions raised by the Prometheus decision.

"Given that [the Myriad case] involves a number of different types of claims (isolated DNA, cDNA, fragments, etc.), it is possible the Federal Circuit may reach different conclusions for different types of claims," Rivard said.

Goldman Sachs today said it is maintaining its 'neutral' rating of Myriad's shares in light of the Supreme Court's decision to send the case back to the lower court for review.

The investment bank said the case's "legal overhang is likely to persist for the foreseeable future and now includes the added twist of the Prometheus ruling as a factor to consider."

Myriad's shares rose 4 percent to $23.58 in late afternoon trading today on the Nasdaq.

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"The Human Genome: Poems on the book of life"

Hey, that’s my gene! No it’s not, it’s mine. No, it’s not. Yes it is. How can it be yours?! You didn’t invent it! Neither did you. Did so. Did not. Big fat liar… Your genes are on fire. - from Gillian K. Ferguson "The Human Genome: Poems on the book of life" Read more!

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SUPREME COURT POSTPONES DECISION ON GENE-PATENTING CASE

From the National Society of Genetic Counselors

The Supreme Court has delayed a decision on whether to hear a gene patenting case that could affect the entire biotech industry. Because it had been scheduled for a conference discussion by the justices earlier this month, a decision about whether to consider the case was expected on Tuesday. But the Court did not accept or reject the case, suggesting that the justices will want to discuss it again.

Here's the National Society of Genetic Counselor's position statement on gene patenting:

HUMAN GENE PATENTING: The National Society of Genetic Counselors (NSGC) supports an individual's access to medical technology and services. NSGC believes that patent holders granting exclusive licenses on human nucleic acid sequences will hinder the development and cost-effectiveness of genetic testing, particularly when the analysis of multiple genes or the entire genome is necessary to assess the risk or existence of disease.

The NSGC supports government policy that encourages open and unfettered access to human nucleic acid sequences to promote the development of personalized medicine services that will benefit the public. Read more!

We Need Your Help - Take back YOUR Genes!

Dear Friends,

As many of you know, the BRCA genes are under patent and this has created a corporate monopoly, driven up the cost of testing, and had a huge impact on clinical care and research for hereditary breast, ovarian and pancreatic cancer. We need your help.

Please take the time to watch the video at https://www.aclu.org/take-back-our-genes. If you believe in this campaign, visit the slide show, print out your own sign (at the bottom of the page) and submit a picture of yourself holding the signto the ACLU. Please share this e-mail with your friends, family members and colleagues who are interested in cancer research and treatment, bioethics, and women's rights. If you are on Facebook or Twitter, please post the video and pass on. You can also post your picture with the “I Take Back My Genes” sign as your profile picture. Recruit friends and family members who are into social networking to help you. If you have friends and family members in high school or college, ask them to serve as Ambassadors at their schools to spread the word.

Now is our chance to be heard. Please help us Take Back Our Genes.

Ellen Matloff

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Today the ACLU is launching a public education campaign to illustrate the harms of gene patenting. In 2009, twenty medical professional associations, geneticists, genetic counselors, patients, and breast and women’s health groups, represented by the ACLU and the Public Patent Foundation (PUBPAT), filed a lawsuit challenging patents on two human genes associated with hereditary breast and ovarian cancer. Recently a divided appeals court ruled that companies may patent the genes, reversing a trial court’s invalidation of the patents. We have petitioned the Supreme Court to hear an appeal of the case.

The campaign - “Taking Back Our Genes” – is designed to showcase (through photos and stories) the impact of gene patenting on people’s lives. You can view the slideshow, video (featuring ovarian cancer patient Kathleen Maxian and genetic counselor Ellen Matloff), and blog. Please help us collect stories by sharing widely with relevant contacts, listservs, and social media networks.

Please help us spread the word. You can help in a number of ways:

·Send an email about the campaign to relevant contacts, listservs or member lists asking people to share their story and photo with us at: https://www.aclu.org/take-back-our-genes

·Leverage your social media networks! If you are active on Twitter please share links to the campaign using the hashtag. #TakingBackOurGenes

·Share on Facebook and ask your friends and followers to join the campaign.

·Cross post our blog on the topic.

_________________________________ Read more!

Testimony from FORCE: The Patenting of the BRCA Genes has Negatively Impacted Our Community

We believe that the exclusive gene patents of the BRCA 1 and BRCA 2 genes held by Myriad Laboratories has had a detrimental impact on the community we serve.

We requested that as the USPTO studies the impact of gene patenting on genetic diagnostic tests, they consider a number of important issues. We feel that the patenting of BRCA 1 and BRCA 2 has negatively affected the community we serve and has added to the already disproportionate cancer burden that our constituency shoulders. FORCE commented specifically on the impact exclusive licensing has on the areas of clinical care and research:

Gene patenting stifles research

We believe that the BRCA gene patent has had a profound impact by delaying and slowing the development of targeted cancer therapies for people with BRCA mutations. PARP inhibitors are a class of drugs that were developed based on scientists’ knowledge of how hereditary cancers develop in people with BRCA mutations. The drugs showed activity and early studies were promising in several types of hereditary cancers including breast, ovarian, and prostate. PARP inhibitor research has been ongoing since 2005, and today, 7 years later, the drugs have yet to gain FDA approval. After meeting with the FDA, we were told that for targeted therapies that benefit a distinct population, (such as people with a BRCA mutation) to receive FDA approval, they require that any companion laboratory test identifying a target population must be FDA approved as well. BRACAnalysis—Myriad’s test for BRCA mutations is NOT FDA approved. Myriad is a CLIA-approved laboratory; they were never required to receive FDA approval in order to market their test, and it doesn’t appear that they have plans to seek FDA approval. Because Myriad holds the patent on the gene, no other lab can develop an FDA-approved test to identify BRCA mutation carriers. As a result, drug companies have opened up registration studies for the wider breast and ovarian cancer populations—comprised mostly of people who do not carry BRCA mutations. The two largest registrations didn't meet primary end-points, likely due to the broader study population chosen, which ultimately has derailed development and approval of these agents.

BIC (Breast Information Core) is a large international consortium organized by the National Human Genome Research Institute (NHGRI), which is part of the National Institutes of Health. BIC’s goal is to provide critical research to determine gene changes that may be cancer-causing vs. those which aren’t. Around 2004, Myriad stopped contributing data to the BIC database. About 7% of BRCA tests return with an inconclusive result and data from BIC is used to help better classify these variants to determine if they are cancer-causing. According to a 2010 article in the Genomics Law Report, the company [Myriad] quietly stopped contributing data [to BIC] in favor of building its own database to retain a competitive advantage over other gene testing companies once their patent runs out. According to the article’s authors, “Among other things, such a strategy would run contrary—at least in spirit—to a policy against extending patent monopolies beyond their terms.” “In addition, the hoarding of immensely important clinical data does not seem likely ‘to promote the Progress of Science and useful Arts.’”

Exclusive licensing has negative impact on test interpretation

Myriad no longer contributing to the BIC database has impeded research on the interpretation of a type of test known as a Variant of Uncertain Significance (VUS). Once the patent does expire, the fact that Myriad no longer contributes mutation information to the BIC consortium will limit other laboratories’ ability to interpret certain test results. In effect, this will extend Myriad’s monopoly on testing. Based on a 2010 article from the New York Times it appears that withholding this data may provide a competitive benefit to Myriad over other laboratories after their patent expires at the cost of critical information that could help provide information to families that have inconclusive genetic test results right now.

Excessive costs of testing impacts clinical care

There is now evidence-based information demonstrating that identifying those who have the highest risk for breast and ovarian cancer can lower breast, ovarian, and all-cause mortality through genetic testing and surgical prevention. The cost of prevention, both in dollars and human lives, is less than the cost of treating cancer once it is diagnosed. Yet, people are being denied access to critical health information due to the excessive cost of BRCA testing. Financial assistance for BRCA testing is limited, especially for people who have any type of health insurance, including Medicaid. Thus, if a health insurance company denies coverage for BRCA testing, patients often are faced with paying 100% of the costs out-of-pocket, or forgoing this valuable diagnostic test altogether.

With patent exclusivity and a monopoly on the test, Myriad has increased the cost of their test even as the cost of genetic technology and gene sequencing has gone down. The full-sequencing BRCA testing costs about $3500, making it cost-prohibitive for many people. Further, Myriad charges an additional $750 for expanded testing known as BART to look for mutations known as large rearrangements in some people who test negative with full BRCA sequencing.

Due to the exorbitant cost of testing, some payers (most recently Tricare, which insures over 9 million members of the Armed Forces, including active duty service members, retirees, spouses and dependents) are no longer covering BRCA testing for their patients.

In 2010, the Secretary’s Advisory Committee on Genetics Health and Society submitted a report to Secretary of Health Sebelius on the topic of gene patenting. SACGHS studied the issues extensively, and has expertise in regards to genetic testing, research and related costs. We encouraged the USPTO to adopt, or at the very least, to cite the SACGHS recommendations when reporting to Congress on the results of these hearings. Additionally, we suggested that it might be prudent to place a moratorium on the issuance of gene patents until their impact has been studied in greater depth.

References

How Will Myriad Respond to the Next Generation of BRCA Testing? Genomics Law Report. March 2011.

Despite Gene Patent Victory, Myriad Genetics Faces Challenges. Andrew Pollack. New York Times, August, 2011. Read more!

Supreme Court Decides Today if they will take the BRCA Patent Case

As Myriad Genetic Laboratories nears its one millionth predictive genetic test for hereditary breast and ovarian cancer, the cost of the test has more than doubled, and the company’s 15-year patent monopoly is being challenged by critics who contend it is stymieing other potentially life-saving screening.

In addition, more than 140 researchers, doctors and clinicians affiliated with the Yale Cancer Center and from institutions all over the country, have written an open letter to Myriad raising concerns that the so-called BRAC Analysis test does not detect “a significant proportion of BRCA1 and BRCA 2 mutations” and therefore is not truly “comprehensive.”

They say an additional analysis, known as BART (BRAC Analysis Rearrangement Test), is necessary, but not always accessible—especially for Hispanics, who show in Myriad testing to be at high risk for the large-rearrangement mutations. The BART test, also licensed by Myriad, costs $700 and is not widely approved for insurance coverage.

“As you know, most insurance companies do not cover the extra BART Analysis and most patients do not have this important testing,” the Yale group wrote. “This means we are missing BRCA mutations in many patients, which is costing lives.” The Yale group said Myriad never responded to the letter.

An excerpt from www.newhavenindependent.org. Click on the above light blue link to be directed to the full article. Read more!

BRCA Gene: Should Parents Communicate Risk?

Karen Kramer's children were 9, 14 and 16 when she told them she'd tested positive for a harmful BRCA gene mutation, putting her at much higher risk of developing breast and ovarian cancer. The news had serious implications for her health and theirs, but Kramer said she never once considered keeping it a secret.

According to new research, Kramer's decision to discuss her results is far from uncommon.

It suggests that in spite of debate about the advantages and disadvantages of early communication of genetic risk to children, the majority of parents who undergo testing for BRCA, or the "breast cancer gene," share their results with their children -- even if those children are relatively young.

Click on the above light blue link to be directed to the entire article Read more!

Male patients are denied Medicaid insurance for breast cancer treatment, because they are not women

Click the above light blue link to read more at ACLU.org Read more!