U.S. Supreme Court Liberates Breast Cancer Gene

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By Lori Andrews

Today the U.S. Supreme Court held in Association for Molecular Pathology v. Myriad Genetics, Inc., that human genes were not patentable since they are products of nature and not inventions.  This decision is great news for patients, doctors, and scientific researchers.  Some biotechnology companies might grumble about the decision, but the decision will actually stimulate innovation by pharmaceutical companies and the new generation of biotech companies.

The case involved Myriad’s patents on the human breast cancer genes known as BRCA1 and BRCA2.  Those patents made your genes Myriad’s property once they were removed from your body.  Consequently, the company could control all uses of the genes, including any diagnostic testing or research.  The U.S. Supreme Court saw the absurdity of letting a company own your breast cancer genes.  Continue reading

Supreme Court to Hear Challenge to Patents on Human Genes

Blog Photo_Lori

By Lori Andrews

On April 15, the U.S. Supreme Court will hear the case Association of Molecular Pathology v. Myriad.  The question before the court is:  Are human genes patentable?

For 150 years, the Supreme Court has said that abstract ideas, laws of nature and products of nature are not patentable.  Such patents would run afoul of the progress clause of the Constitution and section 101 of the Patent Act.

In 1980, the Supreme Court in Diamond v. Chakrabarty held that genetically modified living organisms are patentable if they are markedly different than what occurs in nature.  That case reiterated that laws of nature like E = mc2 are not patentable, nor are products of nature such as plants from the wild or minerals from the ground.

Three decades after the Chakrabarty decision, the Supreme Court revisited the exception by taking a trilogy of cases.  In the first one, Bilski v. Kappos, the Court held that an abstract idea–hedging in trading energy futures–could not be patented.  In Mayo v. Prometheus, the Court held 9-0 that a law of nature–how the body responded to the administration of a drug–was not patentable.

In the Myriad case, the Court will be addressing the third part of the exception, dealing with products of nature.  It will address whether an “isolated” breast cancer gene is an unpatentable product of nature.  The patents at issue cover two isolated genes related to breast cancer, BRCA1 and BRCA2.  The patents define the isolated gene to include a gene sequence “removed from its naturally occurring environment.”  This claim gives Myriad the ability to control all uses of anyone’s breast cancer genes once they are removed from the body, giving Myriad the right to exert a monopoly over all BRCA1 and BRCA2 breast cancer gene testing and research.

What is a gene sequence?  It’s a series of chemical letters known as nucleic acid bases–designated by A, T, C, and G.  It is important because a single change in the letter–a typo in the sequence–can lead to a genetic disease.  To diagnose a genetic disease, a physician or laboratory compares the patient’s genetic sequence to a normal gene sequence to see if there are differences that predispose the patient to breast cancer.

The question the Supreme Court will ask, under the Chakrabarty case, is whether what Myriad patented is “markedly different” from the breast cancer genes in the body.  Myriad asserts that the isolated gene is a product of human ingenuity.  Myriad argues that it “successfully isolated the ‘BRCA’ molecules and disclosed their creation to the world. This momentous advancement required significant skill, insight, and invention on the part of Myriad’s inventors.”

Myriad also argues that isolation of the gene “depended on an enormous amount of human judgment, including how to define the beginning and end of what came to be called the BRCA1 and BRCA2 genes, and then creating isolated DNA molecules corresponding to those particular defined genes.”  Myriad also argues that by isolating the gene, it gave the gene new uses since genes in the body cannot be used for diagnosis.  It also created copies of the gene in the lab.

In contrast, the petitioners in the case argue that what Myriad patented is not markedly different from nature.  For Myriad’s gene sequence to work as a diagnostic tool, it must have the identical sequence to that of a breast cancer gene in nature.  The petitioners argue that once the unpatentable product of nature, the gene sequence, was discovered, Myriad used routine means to create copies of it and to undertake diagnostic comparisons to patients’ genes.  The Court is likely to look to a 1948 Supreme Court case, Funk Brothers Seed Co. v. Kalo Inoculant Co., in which the patent applicant combined six types of bacteria and the claimed invention was found to be an unpatentable product of nature because the bacteria “served the ends nature originally provided.”  The petitioners argue that here the isolated gene sequence merely serves the ends nature intended.

In addition to extensive briefing about whether there is sufficient human ingenuity involved to consider an isolated human gene to be a patentable invention, the affidavits and amicus briefs in the case gathered all existing data on whether gene patents encourage or discourage innovation.  Over 90 affidavits were filed, including those from Nobel Laureates.  Briefs from over 102 amicus groups were filed, including briefs from medical organizations such as the American Medical Association and patient advocacy groups such as the March of Dimes arguing for the invalidation of gene patents, and briefs from industry organizations such as the Biotechnology Industry Organization and intellectual property associations such as the American Intellectual Property Law Association arguing that gene patents are valid.  Also weighing in were prominent scientists, various companies and numerous law professors.

I filed an amicus brief in the case on behalf of medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, and American Society of Human Genetics, providing evidence that patents on genetic sequences interfere with health care and research.

Medical organizations are concerned because gene patents increase the cost of the diagnosis and treatment of genetic diseases.  For 20 years, a gene patent holder controls any use of “its” gene. The patent holder can charge whatever it wants for any test analyzing the patented gene–even if that test uses a technology that was not invented by the patent holder.  Myriad, which holds the patent on the BRCA1 and BRCA2 genes, charges over $3,000 for its genetic test for breast cancer.  One in four laboratories has stopped performing certain genetic tests because of patent restrictions or excessive royalty costs.

The ability of a patent holder to prevent health care providers from using a patented genetic sequence denies people crucial medical information.  Most drugs only work on a percentage of patients who use them.  An asthma inhaler might only work on seven of ten people to whom it is prescribed, causing the other three to suffer symptoms of asthma and pay for an inappropriate drug until the right medication can be found.  Genetic testing can help to distinguish those people for whom a drug will work from those people for whom it will not work, but, if the same entity holds the patents on the drugs and the gene sequences, it may prevent use of the gene sequence because the identification of people for whom the drug will not work will limit the market for the drug.

One company has filed for patent protection on a genetic sequence that could be tested to determine the effectiveness of its asthma drug in a prospective patient.  The company, however, has said that it will not develop the test–or let anyone else develop the test.  While such a test would be crucial to doctors in determining which patients would benefit from the use of the asthma inhaler and which patients would benefit from a different drug or treatment, it would also diminish the market for the drug because a trial use of the asthma inhaler would no longer be needed to know if it would be an effective treatment.

For more information, listen to my interview with Minnesota Public Radio on the subject or view the video of an interview with me on the OYEZ website.

Massachusetts Court Could Tell the CIA to Stop Using Flawed Software to Pilot Killer Drones

Jake Meyer by Jake Meyer

The U.S. is increasingly using unmanned aircraft known as drones to fight its wars and kill enemy targets.  These drones are controlled remotely by soldiers thousands of miles away from the action and armed with 100lb missiles — larger drones can be armed with 500lb bombs that are deadly in a radius of over 200 feet.  Concern has been raised about the use of these drones because drones strikes have resulted in civilian casualties.  Civilian casualties are counterproductive to the war effort in Afghanistan where a goal is “winning the hearts and minds” of the local population.  New America Foundation, a public think tank, has reported that 142 drone attacks in Pakistan killed between 1,013 and 1,362 people from 2004 to 2010 and up to a third of the casualties were civilians.  Now a company involved in a contract dispute in a Massachusetts court is alleging that the CIA is using software to guide its drones to targets that was rushed, illegally reverse engineered, and not properly designed for the CIA’s hardware — causing calculations made by the software to be off from 1 to 13 meters (over 40 feet).  The Massachusetts court is currently considering a motion for preliminary injunction and if the court were to grant the injunction, it could possibly force the CIA to stop using the miscalculating software and have more accurate software developed for its drones.

The case involves claims by the Netezza Corporation that Intelligent Integration Systems Inc. (IISI) was under contract to provide a version of IISI’s Geospatial software (an analytical software program that integrates spatial data with non-visual data) to Netezza for a new computer system called TwinFin.  The Massachussetts court dismissed the claims by Netezza in a summary judgment, but counterclaims made by IISI still remain to be ruled on.  IISI’s counterclaims allege that Netezza improperly acquired an IISI trade secret — the Geospatial software — through reverse engineering.  The software licensing agreement contains provisions that explicitly prohibit the reverse engineering of IISI’s Geospatial software and use of its proprietary information.  IISI also alleges that the reverse engineering of the software was to please its client, the CIA, as “Netezza’s own records also show that Netezza was motivated to take this action in order to save face with the CIA.” 

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Collaboration Among Alzheimer’s Researchers As A Model For Future Genetics Research

Jake Meyer by Jake Meyer

Researchers studying Alzheimer’s disease have been using an approach to learning about the disease rarely used in the life sciences – cooperation.  In 2003, the Alzheimer’s Disease Neuroimaging Initiative formed as a collaborative effort to find biomarkers that show the progression of Alzheimer’s disease in the brain.  Researchers from the National Institute of Health, Food and Drug Administration, the drug and medical imaging industries, and universities and non-profits have been sharing all of their data and making every finding freely accessible to the public.  The collaboration agreed that no one would either own the data or submit patent applications.  Now in 2010, the collaboration is starting to bear fruit.

The Alzheimer’s collaboration is significant for two reasons. First, the collaboration of Alzheimer’s disease research is yielding promising results for the understanding and treatment of the disease.  This collaborative approach looks to be effective – currently there are over 100 studies being conducted to test drugs that could slow the effects of the disease or cure it.  Second, this type of collaboration in the life sciences is rare, as the practice of allowing patents on the results of basic scientific research (such as human gene sequences and correlations between genetic mutations and disease) in the life sciences fields has created an incentive to not share results, but instead withhold data.  Dr. John Q. Trojanowski, an Alzheimer’s disease researcher at the University of Pennsylvania, describes how uncommon collaboration like this is in the life sciences: "It’s not science the way most of us have practiced it in our careers.  But we all realized that we would never get biomarkers unless all of us parked our egos and intellectual-property noses outside the door and agreed that all of our data would be public immediately." 

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Bilski v. Kappos: The Supreme Court Tells Us That Methods of Hedging Risk Are Not Patentable And Not Much Else

Jake Meyer by Jake Meyer

On June 28, 2010, the U.S. Supreme Court issued a decision in Bilski v. Kappos, a case the patent law community had been anxiously awaiting.  The oral argument took place on November 9, 2010 and the Court waited till the last possible moment to release the decision.  The case dealt with the most fundamental question of patent law, the first question a patent examiner asks: what is patentable subject matter?  The case could have had far reaching implications for many types of patents — from business methods, to software, to medical methods.  Instead the Supreme Court issued a narrow decision that largely left the law surrounding what is a patentable process unchanged.  By not setting forth a clear test for patentability of processes, however, the Court opened the door for even more patent challenges.

In In re Bilski, the Court of Appeals for the Federal Circuit, the court that hears the appeals of all patent cases, announced that the proper test to determine whether a process was patentable subject matter under 35 U.S.C. § 101, was the machine-or-transformation test, stating that a “process is surely patent-eligible under 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.”  The patent claims in Bilski were directed to a method of hedging risk in commodities trading.  The Federal Circuit found that Bilski’s claims were neither tied to a particular machine nor did they transform a particular article into a different state or thing.  Therefore, the claims in Bilski were not patentable.

On appeal, the Supreme Court affirmed the ruling of the Federal Circuit and found that the claims to hedging risk in commodities trading were not patentable because they were directed to an abstract idea.  But the larger question before the Court was one that the Court sidestepped:  what is the scope of the test for determining whether a process was directed to patentable subject matter.

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BRCA in the Outback: The Australian Gene Patent Challenge

DamonGuptaby Damon Gupta

The U.S. case challenging the validity of gene patents is moving to the next step in the U.S. legal system.  Myriad Genetics has filed a notice of their intent to appeal the Southern District of New York’s decision invalidating patent claims on the BRCA1 and BRCA2 gene sequences and methods of determining the existence of mutations associated with breast cancer, of which Myriad is the exclusive licensee.  The Court of Appeals for the Federal Circuit will be next in line to hear the case and determine whether to affirm or deny the lower court’s decision.

The validity of gene patents is also being challenged in Australia, and Myriad is a party to the lawsuit.  June 8, 2010, Rebecca Gilsenan, an attorney with the Maurice Blackburn law firm, filed a lawsuit pro-bono on behalf of applicants (plaintiffs), Cancer Voices Australian, an advocacy group for all cancer patients in Australia, and Yvonne D’Arcy, a Brisbane woman diagnosed with breast cancer who could not afford BRCA1 testing by the exclusive licensee of the challenged Australian gene patent.

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Spider Walkers: DNA Nanobots Indicate Cooperation Among Nanotechnology Researchers

Robert Enneser by Robert Ennesser

In 1676, Issac Newton wrote to rival researcher Robert Hooke, "[y]ou have added much in several ways, and . . . [i]f I have seen a little further it is by standing on the shoulders of giants."  Scientific and medical innovation occurs when the greatest numbers of researchers are able to use the best materials and methods available to develop new technologies and treatments.  Nanotechnology and genetics are two heavily patented areas with promising medical applications.  Unlike some current genetics companies that use patents to block researchers from studying their gene and developing new technologies, several recent nanotechnology studies are evidence that scholars across the country are working together and building off of each others' results. 

Two recent studies in Nature have illustrated how innovation builds from research findings of multiple groups.  Both studies make use of a technique known as "DNA origami"  DNA origami is the precise, nanoscale folding of a single strand of DNA on a synthetic scaffold.  DNA origami has been used to produce DNA in particular nanoscale structures, shapes, and patterns.  In the first study, a group of researchers led by biochemist Milan Stojanovic of Columbia University created molecular "robots" which move on top of a DNA origami pattern. Their robot "spider" is composed of a body and includes 3 legs which interact with a trail created by the researchers on the DNA origami pattern.  The body of the spider is made of a streptavidin molecule, a protein often used in biotechnology experiments which can be used to visualize nanoscale structures by attaching a molecule that fluoresces when excited by fluorescent light.  In the second study, a team of scientists led by Professor Nadrian Seeman at New York University created a DNA "assembly line" that can create 8 different arrangements of gold particles.  Seeman created a tiny robot "walker" composed of single-stranded DNA fragments with three "hands" that pick up and bind cargo and four "feet" that bind to a path on a DNA origami pattern.  Professor Seeman is regarded as the creator of DNA nanotechnology and was awarded the Kavli Prize in Nanoscience on June 4th, 2010.

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No Need for Intent to Decieve: Failure to Disclose Should Automatically Render a Patent Unenforceable

Jake Meyer by Jake Meyer

The U.S. Patent System provides incentives for inventors to disclose their inventions in exchange for a limited monopoly, but patent applicants do not always disclose all of the information necessary for an accurate assessment by the U.S. Patent and Trademark Office (USPTO) of whether the patent applicant is deserving of a limited monopoly.  The Federal Circuit (the court that hears all patent appeal cases) currently has an opportunity to insure more complete information is presented to the USPTO when determining whether it should grant a particular patent.

In order for an inventor to obtain a patent, 1) an invention must be useful – the invention must have a beneficial purpose; 2) an invention must be novel – it must be new and have not been previously described to the public elsewhere; and 3) an invention must be non-obvious – the invention must not be a combination of known components or techniques that would be obvious for a person skilled in that area of technology to try together.  When applying for a patent, the applicant must disclose to the USPTO any information related to the invention and relevant to the questions of whether the invention is novel, or whether the invention is obvious.  The applicant must include relevant articles, books, patents, and other materials describing the invention (all of which is known as prior art) in the patent application.

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S.D.N.Y. Holds That Patent Claims on Breast Cancer Genes Are Invalid

Jake Meyer by Jake Meyer

On March 29th, 2010, Judge Sweet of the United States District Court in the Southern District of New York declared that the challenged patent claims, owned by Myriad genetics, that cover the BRCA1 and BRCA2 breast cancer genes are invalid.  The full opinion is available here.  I had previously blogged about the plaintiffs in the case here, and I previously blogged about Judge Sweet’s denial of the defendant’s motion to dismiss here.  This was the first case to raise the argument that gene sequences and correlations between gene mutations and disease are unpatentable subject matter under 35 U.S.C. section 101.

There were two types of claims at issue in the case:  1) claims to “isolated” DNA containing the BRCA1 or BRCA2 sequence or certain segments of those sequences, and 2) claims to methods of comparing two BRCA1 or BRCA2 sequences to determine whether a mutation that predisposes a subject to cancer is present.  Judge Sweet found that both of these types of claims were invalid subject matter.

U.S. patent law does not allow for the patenting of products of nature.  As Judge Sweet recognizes this in his opinion there is a “judicially created ‘products of nature’ exception to patentable subject matter, i.e. ‘laws of nature, natural phenomenon, and abstract ideas.'”  Judge Sweet applied analysis from the 1980 Supreme Court case Diamond v. Chakrabarty to determine whether the product claims directed to “isolated” DNA were patentable.  The Supreme Court in Chakrabarty held that a genetically engineered bacterium was patentable because the “patentee had produced a new bacterium with markedly different characteristics from any found in nature.”  Sweet found that the requirement that an invention have “markedly different characteristics” from a product of nature to be patentable had been stated (although using different language) in earlier cases as well, such as in the Supreme Court case American Fruit Growers and in the Court of Customs and Patent Appeals case In re Merz.

Judge Sweet held that the “isolated” DNA was not “markedly different” than DNA inside the human body.  The analysis focused on the DNA’s unique role as both a physical molecule and as information.  While the “isolated” DNA was removed from the body, the information embodied by the DNA was not changed:

In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA “markedly different.”  This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form.  The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.

The second types of claims to methods of comparing two BRCA1 or BRCA2 sequences to determine whether a mutation that predisposes a subject to cancer is present were found invalid because they involved a law of nature and did not satisfy the Federal Circuit’s machine-or-transformation.  When a method claim makes use of a law of nature, the claimed method must either use a specific machine or apply a transformation to be patentable.  Judge Sweet found that the method did not include a transformation and since the claims did not include the use of a specific machine the method claims were directed to an unpatentable law of nature.

Thicket of Uncertainty in the Gene Patent Debate

Keith Syverson by Keith Syverson

In 1998, Michael Heller and Rebecca Eisenberg wrote that the proliferation of biotechnology patents created a tragedy of the anticommons where "people underuse scarce resources because too many owners can block each other."  This phenomenon is also referred to as a "patent thicket" where there are multiple different patents from different owners.  Over the past 12 years, many studies have been published evaluating the effect of intellectual property rights in medical research and diagnostic testing.  In October 2009, a group of European scientists led by Isabelle Huys investigated whether the proliferation of gene patents or patents on diagnostic methods created a patent thicket.  The article, Legal Uncertainty in the Area of Genetic Diagnostic Testing, concluded that there was no patent thicket with regard to claims that actually claim DNA sequences, but that there were enough different claims on diagnostic methods to create a chilling effect on medical diagnoses and restrict access to care.

The authors provide an empirical analysis of the nature, extent, and scope of patents relating to 22 of the most commonly tested for genetic diseases in Europe which include cystic fibrosis, breast cancer, and colon cancer.  They then compared the claims to the best practice guidelines in Europe and the United States for testing of susceptibility to these genetic disorders to determine if the patents had any effect on access to genetic testing in either country.  The authors concluded that there was not a "thicket" of patents covering only genes because most of these patents could be easily invented around.

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