Raising Countless Eyebrows, Walmart Files Patent for Autonomous Bee Drones

Why Aren’t There More Cancer Vaccines?

Blame America’s lousy patent system.

Six years from now, when my daughter turns 11, she will get a three-part human papillomavirus vaccine that will reduce her chances of getting cervical cancer by around 70 percent. Currently a little over half of American girls get the HPV vaccine, a public health intervention that will prevent tens of thousands of cancers. It’s one of modern medicine’s few success stories in finding a means of preventing cancer.

Maybe the reason we have so few cancer vaccines is that they’re harder to develop than treatments for patients who already have cancer, which are more common. But in an as yetunpublished study, economists Eric Budish and Heidi Williams teamed up with patent lawyerBen Roin to argue that the scarcity of preventive measures and relative abundance of late stage cancer treatments can also be blamed on the distorting effects that the U.S. patent system has on medical research.

The duration of patent protection in the U.S. is 20 years. All drug innovations get patented at the time of discovery, but late-stage cancer treatments will work their way through the clinical trials required for FDA approval much more quickly, since the effect on patient survival will be apparent within a couple of years. That means fewer years of the patent clock ticking without revenues coming in. For a preventive treatment like the HPV vaccine, the 20 years of patent protection will be long expired before any clinical trial can show whether lives are being saved, which in turn makes vaccines far less alluring investments for biotech companies. It’s yet another indication of America’s patent system’s desperate need for a makeover.

To appreciate what’s wrong with the American system of granting fixed-length, 20-year patents, you first need to understand why we grant patents—and make them expire—in the first place. A patent gives an inventor ownership over her intellectual property, in much the same way a homeowner holds title to her house. This affords the inventor a period of exclusive rights to profit financially from the fruits of her innovation. Without this protection, who would go through the time and trouble of inventing anything in the first place, when someone could just take the idea and run with it?

At the same time, this license to exploit an idea for private gain needs to be balanced against the social benefits that come with universal access to new knowledge. After a patent expires, other innovators can build on earlier breakthroughs and competitors can market similar products without worrying about licensing contracts, patent litigation, or other headaches. The need to encourage invention and to let ideas be free leads to the compromise of giving patent protection for a limited period of time. Thanks to patent protection, we have biotech companies that spend billions developing next-generation drugs, and thanks to patents’ limited lifespans, we have generic manufacturers waiting to rush in with lower prices as soon as the patent ends.

patent terms distort R&D is simple. In most cases, inventors need to file for patents early on in the process, before they even enter trials, lest word get out and competitors beat them to the patent office. Consider a drug that takes two years to bring to market. Given our 20-year patent term, the drug’s manufacturer would get 18 years of patent protection after the drug goes on sale. Now consider a drug that takes 18 years to bring to market. Its manufacturer would get only two years of protection once it hits the market. For drugs that take more than 20 years to develop, there won’t be any post R&D patent protection at all.

The heart of the new study shows how these incentives have affected biomedical research in America over the past few decades, with a focus on cancer. Why cancer? Obviously, given the suffering caused by the disease, we care a lot about anything that might be holding back the development of better treatments. And if you’re interested in the connection between time to commercialization and biotech investments, cancer affords an additional set of advantages. The lag between invention and going to market is dictated primarily by the length of trials required for Food and Drug Administration approval, and trial length, in turn, is determined by patients’ survival rates. Generally, to get approval for a new cancer drug you need to show that patients live longer. It doesn’t take long to determine whether a new treatment adds months of life in the case of metastatic cancers (those that have spread throughout the body): 90 percent of patients with such cancers are dead in less than five years. But it can take more than a decade to see whether survival is affected for localized cancers that remain confined to a single organ. And for treatments aimed at cancerprevention—the holy grail of cancer research—it could take multiple decades to prove a treatment’s efficacy.

Using records from the National Cancer Institute, the authors link data on survival rates by cancer type (e.g., prostate) and stage (i.e., local versus regional versus metastasized) to clinical trial data on treatments targeted at a particular stage-type (e.g., metastatic prostate). They find that there are many more trials for deadlier cancers, a pattern that persists after they account for other considerations such as the frequency with which a cancer occurs or the type of individual (gender and age) most likely affected by it. Their calculations indicate that a 10 percentage point increase in the five-year survival rate of a given cancer type leads to an 8.7 percent decrease in R&D investment, an enormous effect when you consider the fact that metastatic cancers have an average five-year survival rate of 10 percent, versus 70 percent for localized cancers.

It’s not exactly wrong to devote resources to improving the prospects of metastatic cancer patients—theirs is the deadliest type. But as the saying goes, an ounce of prevention is worth a pound of cure: We’d be saving more years of life if we had more research on early-stage treatment and vaccines that prevented people from facing metastatic cancers to begin with. The authors provide some rough (and highly speculative) calculations for how many lives might have been saved with a better-designed patent system, and come up with a figure of 890,000 life-years saved for patients diagnosed in 2003 alone.

There are exceptions to the rule that late-stage cancers attract more research resources, but many of these exceptions only serve to reinforce the study’s findings. For example, there are a lot of clinical trials for treatment of breast cancers of every stage. Call it the Betty FordSusan Komen effect—the breast cancer awareness movement has been enormously effective at raising money for research. But within breast cancer types, the general pattern of more trials for metastatic than localized cancers still holds.

Given the study’s findings, you wouldn’t expect any cancer prevention drugs to have been developed. In fact, there are six such FDA-approved treatments. But these were either developed with public money, meaning profits weren’t a consideration, or gained FDA approval using so-called “surrogate endpoint” trials, where a treatment’s effectiveness is determined by a biological marker other than death. That turns out to have been the case for the HPV vaccine. Gardasil, developed by Merck, was approved on the basis of the presence of “atypical cervical cells” rather than patient survival, so the trial lasted only around four years. In fact, for leukemia and other cancers of the blood, where a treatment’s efficacy can be shown based on the surrogate endpoint of white blood cell counts, the negative relationship between cancer survival rate and number of trials disappears, as one might expect given that survival time doesn’t affect trial length.

Removing this distortion to research incentives would seem to be straightforward: Allow biotech companies to apply for patents at the time of invention, but only start the patent clock ticking after clinical trials are completed. But even if the authors’ theory is well-reasoned, legislative practice is quite another matter. Kevin Sharer, CEO of biotech giant Amgen from 2000 to 2012, sums up the prospects of any major patent reform as a “150 foot putt”—in other words, impossible. Many competing factions would surely see any attempt to change patent law as an opportunity to twist the rules in their favor, making intellectual property reform another casualty of Capitol Hill gridlock.

There has been some progress in changing the way the patent system adversely affects research. The FDA can, for example, grant a drug “market exclusivity,” which allows the original inventor the exclusive right to market a drug in the United States for a period of time following regulatory approval.Legislation was passed in 2010 that should strengthen the power of those arrangements: Some classes of drugs are now given 12 years of market exclusivity, which puts short- and long-trial drugs on a more equal footing. (This is in addition to a patent extension of 50 percent of the time a treatment spends in trial, for up to an additional five years, as a result of the 1984 Hatch–Waxman Act, which evidently didn’t have much of an impact on cancer research at least.) But only about a third of new inventions are covered by the new market exclusivity rules. For the bulk of new discoveries—so-called small molecule drugs—the patent system remains the same as it’s been since the early ’80s. (And very short trial drugs will still end up with longer market protections. For example, a three-year trial drug like Abiraterone, a prostate cancer treatment, could still get 17 years of exclusivity.)

The authors of the new study argue that the law should go even further and actually give long-trial drugs more protection than short-trial drugs following approval, instead of less (and also potentially cut back protection for short-trial drugs). Their argument has two parts: First, drugs with short trial times also tend to have lower development costs, so they’d get done even without the extra protection. Second, since drugs with long trial times tend to focus on prevention or early-stage treatment, they may have higher societal payoffs than drugs that spend just a few years in development.

Yet such legal innovation would surely have unanticipated consequences: For every well-meaning rule change, creative legal teams would develop new and unexpected ways of gaming the system. It’s for this reason that ex-Amgen CEO Sharer says that the rule-makers had better “shine a laser beam” on the particular disease classes where they hope to encourage innovations. Sharer points to the Orphan Drug Act of 1983, which gave seven years of market exclusivity, along with tax incentives, for drugs that treat rare diseases that would go uninvestigated without greater incentives.

It’s likely that many industries besides biotech suffer from the same distortionary effects of the 20-year patent rule—biotech is hardly unique in the long lag between discovery and commercialization. And other areas of research may not have the workaround of extending protection through regulators like the FDA. So if you consider the implications of this new study more broadly, it’s yet another argument that American legislators need to find the political will for a long-overdue overhaul of the patent system, and a responsibility to do it in such a way that logic and reason do defeat the lobbying assault that would accompany it. American business isn’t exactly renowned for forward thinking, with executives rarely looking beyond the next quarter’s earnings. The last thing they need is an ill-designed patent system to further encourage their short-sightedness.


Gene Patents and Personalized Cancer Care: Impact of the Myriad Case on Clinical Oncology.

Genomic discoveries have transformed the practice of oncology and cancer prevention. Diagnostic and therapeutic advances based on cancer genomics developed during a time when it was possible to patent genes. A case before the Supreme Court,Association for Molecular Pathology v Myriad Genetics, Inc seeks to overturn patents on isolated genes. Although the outcomes are uncertain, it is suggested here that the Supreme Court decision will have few immediate effects on oncology practice or research but may have more significant long-term impact. The Federal Circuit court has already rejected Myriad’s broad diagnostic methods claims, and this is not affected by the Supreme Court decision. Isolated DNA patents were already becoming obsolete on scientific grounds, in an era when human DNA sequence is public knowledge and because modern methods of next-generation sequencing need not involve isolated DNA. The Association for Molecular Pathology v Myriad Supreme Court decision will have limited impact on new drug development, as new drug patents usually involve cellular methods. A nuanced Supreme Court decision acknowledging the scientific distinction between synthetic cDNA and genomic DNA will further mitigate any adverse impact. A Supreme Court decision to include or exclude all types of DNA from patent eligibility could impact future incentives for genomic discovery as well as the future delivery of medical care. Whatever the outcome of this important case, it is important that judicial and legislative actions in this area maximize genomic discovery while also ensuring patients’ access to personalized cancer care.

Source: JCO

Gene Patenting — The Supreme Court Finally Speaks.

Are human genes patentable? On June 13, the Supreme Court gave its long-awaited answer — a unanimous “no.” The case, Association for Molecular Pathology v. Myriad Genetics, 1 has generated enormous interest among medical institutions, industry organizations, patient advocacy groups, and scientists. “ Life’s instructions,” James Watson asserted in one of 49 amicus curiae briefs, “ought not be controlled by legal monopolies created at the whim of Congress or the courts.” For some, the gene patents were symbols of a shrinking public domain and an overreaching patent system that traded too much monopolistic power for too little innovation. For others, the challenge to the patented genes amounted to an attack on the intellectual-property protections that fuel private investment in biomedical discovery.

Although ethical and policy arguments were a major feature of the debate surrounding the case, the decision focused squarely on the definitions of two codes: the genetic code and the patent code. All nine Justices of the Court agreed that the segments of DNA that make up human genes are not patentable subject matter under section 101 of the Patent Act2 because they are products of nature. However, the Court held, molecules that are reverse-transcribed from messenger RNA (mRNA) to eliminate intron sequences — so-called complementary DNA (cDNA) — are eligible for patents. The decisive sentence of Justice Clarence Thomas’s ruling crisply stated that, “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”

The decision joins a suite of recent Supreme Court cases that are reshaping patent law, with important implications for innovation in the life sciences. Here we review the Myriad Genetics case and the reasoning of the Court and discuss the implications for health care and the biotechnology industry. Patient advocates and industry groups alike can find something to celebrate in this Supreme Court decision: although it will open up competition in the genetic testing arena and drive down prices, it leaves undisturbed most of the intellectual-property rights on which the biotechnology industry depends.


The human genes at issue in the Myriad Genetics case are BRCA1 and BRCA2. In federally funded research dating back to the 1980s, Mary-Claire King and others identified a region of chromosome 17 that must contain a gene mutated in families with many cases of breast cancer. That gene became known as BRCA1, and it turned out to also predispose women to ovarian cancer.

King’s 1990 report of genetic linkage for a “breast-cancer gene”3 set off an intense race to clone and sequence it. A team led by Mark Skolnick of the University of Utah won that race4; Skolnick was also a cofounder of Myriad Genetics. In 1994, Michael Stratton and others mapped another locus in chromosome 13,5 which precipitated another furious race to identify and clone what became known as BRCA2. That race ended in a near tie,6 with the Stratton group publishing in Nature 7 just a day after Myriad filed a patent application,8-10 having gotten wind of the Stratton work.11

Myriad sought patent protection for methods of detecting and comparing DNA sequence variations and for the isolated DNA molecules. The claims on DNA molecules included cDNA and genomic DNA, sometimes both in the same claim. The Supreme Court parsed these elements in its decision .Types of Patents Issued to Myriad Genetics Relating toBRCA.). Applications by Myriad for BRCA1 and BRCA2 were broken into separate patents, covering different aspects of the work. These patents undergirded the commercialization of its BRACAnalysis test for predisposition to breast cancer, which Myriad first made available in 1996. Myriad filed subsequent patents and acquired rights to other BRCA patents by out-of-court settlements and now states that it has 24 patents containing over 500 claims relating to this field.12

The American Civil Liberties Union (ACLU) and the Public Patent Foundation, representing more than 20 plaintiffs, filed suit against Myriad in May 2009 in federal court for the southern district of New York. The litigation arose in large part because, in the intervening decade, a steady drumbeat of criticism had grown against the business practices of Myriad and against patents on genes in general. Objections raised by public health advocates included the restriction set by Myriad on certain uses of its genes in the context of research, its refusal to allow independent confirmatory testing of ambiguous initial results,13 and the high price of its genetic test (up to $4,000).14Advances in sequencing technology had made it possible for patients to have dozens of genes sequenced for less than what Myriad charged for BRCA1 and BRCA2 testing.15 Fueling advocates’ arguments were surveys showing that gene patents reduced access to testing16,17 and research showing that legal restrictions on gene sequences reduced product development by up to 20 to 30%, as compared with diagnostic products arising from freely available sequences.18

Inventors must satisfy several statutory criteria in the Patent Act to obtain patent protection, but theMyriad case focused on just one: whether the claimed inventions met the basic definition of patentable subject matter. That is, did they constitute inventions at all? The Patent Act defines the scope of patentable subject matter as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”2 The Supreme Court has previously established that “Anything under the sun that is made by man” is eligible for a patent19but has read into the patent statute an important implicit caveat that laws of nature, natural phenomena, and abstract ideas belong in the public domain.

In March 2010, Judge Robert Sweet of the southern district of New York issued a summary judgment order in the Myriad case, invoking long-standing Supreme Court doctrines to conclude that this caveat excluded DNA from patentability.20 He invalidated all 15 claims challenged in seven of the Myriad patents. The next year, a divided panel of the Court of Appeals for the Federal Circuit tempered the district court holding. The three-judge panel unanimously affirmed Judge Sweet’s determination that Myriad could not patent its method of testing for cancer risk by comparing a patient’s isolated BRCA1 and BRCA2 sequences to the reference sequences. By contrast, the panel upheld the method claim for the use of BRCA1 and BRCA2 in screening potential therapeutic agents against cancer and held that cDNA could be patented.

Most controversially, the Federal Circuit split 2 to 1 on whether DNA molecules corresponding to sequences found in cells were patentable because they were described in the patent claim as “isolated.”21 The two judges in the majority reached their conclusion that isolated DNA is eligible for patents in different ways. Judge Alan Lourie reasoned that the act of severing covalent bonds in the process of isolating the DNA created a new molecule, and Judge Kimberly Moore argued that not only fragmentation but also the demonstrable utility of isolated DNA sequences, as compared with native DNA, was the basis for patent eligibility.22 Judge William Bryson wrote a vigorous dissent arguing that isolated molecules were not eligible for patents because they were not different enough from their natural counterparts.

The Supreme Court reviewed the decision of the Federal Circuit court in 2011 but sent the case back for reconsideration in light of a newly issued Supreme Court decision invalidating a patent on a method of diagnostic testing.23 The Federal Circuit court judges did not substantively change their opinions in 2012, reiterating the same logic and coming to the same 2-to-1 split.24 On November 30, 2012, the Supreme Court agreed to hear arguments on one question only: Are human genes patentable?


To answer this question, the Supreme Court returned to the opaque and oft-contested boundary line between human inventions and discoveries of naturally occurring phenomena. Writing for a unanimous Court, Justice Thomas cited the long history of the Court of drawing a distinction between compositions of matter that are made by humans and those that are naturally occurring.Major Supreme Court Decisions Defining the Boundary between Inventions and Products of Nature.). The relevant doctrine, however, has been “vague and malleable,” in the words of Justice Felix Frankfurter in a seminal 1948 case.25 Cases have lacked clarity and consistency during the past hundred years, with the criterion that inventions must involve the application of human ingenuity seemingly established in different ways.

In considering patents on DNA sequences, Justice Thomas struck a balance between the long-standing principle that discoveries of natural phenomena are not patentable and the competing notion that “all inventions at some level . . . apply laws of nature, natural phenomena, or abstract ideas” by drawing a line between genomic DNA and cDNA. The isolated DNA sequences were not the proper subject of patents, he wrote, because they were not markedly different from the sequences found in nature. Indeed, they derived their diagnostic usefulness from having the identical sequence. Justice Thomas distinguished between the claims of Myriad and those at issue in the landmark 1980 case of Diamond v. Chakrabarty, which ushered in the modern explosion in biotechnology patents. In that case, a bacterium was genetically engineered to contain four naturally occurring plasmids, each of which was useful in breaking down oil. The inventor inserted the plasmids into the DNA of the microbe, giving rise to an organism not found in nature. No similar transformation of a product of nature was present in the claims of Myriad covering the isolated DNA sequences.

The cDNA claims, the Court held, were another matter. Because cDNA is reverse-engineered by scientists from mRNA to include only the protein-coding exons, it is different from any naturally occurring genetic material. It thus falls on the invention side of the line between discovery and invention. To then earn a patent, a sequence of cDNA would have to meet the remainder of the criteria required in the Patent Act of all inventions, including novelty, utility, and nonobviousness, although these considerations were not at issue in the Myriad case.

The parties challenging the cDNA patent claims argued that cDNA is a product of nature because it represents the naturally determined stretch of nucleotides that codes for the mRNA. Its information is what matters, they asserted, and that is the same as naturally occurring DNA. However, the Court focused on the human ingenuity involved in reverse-transcribing the sequence as a separate nucleotide array. The fact that some DNA sequences mimicking cDNA may occur by chance in nature was deemed insufficient to undercut its patentability.

Myriad represents the third in a series of decisions since 2010 in which the Supreme Court has redefined the boundaries of its three main exclusions from patentability — laws of nature, natural phenomena, and abstract ideas. In each of these categories, the Supreme Court has ultimately shown a more restrictive stance on patent eligibility than the Patent and Trademark Office.

The first case, Bilski v. Kappos, involved an abstract idea. In striking down a patent on an investment strategy, the Court announced that it supported a “high enough bar” on patenting abstract ideas that would not “put a chill on creative endeavor and dynamic change.”26 The patent was invalidated because it “would preempt use of this approach in all fields,” over a vigorous dissent from Justice John Paul Stevens, who agreed with the outcome but wanted to set down an even more formal rule excluding business methods from patent eligibility.

Next in 2012 came Mayo v. Prometheus, in which the Court unanimously invalidated patent claims on a method of adjusting the dose of thiopurine antiinflammatory drugs on the basis of metabolite levels.23 In that decision, the Court expressed concern “that patent law not inhibit further discovery by improperly tying up the future use of laws of nature,” which in that case was the correlation between doses of a drug and its physiological effects.27

Myriad extends this judicial anxiety to the context of DNA molecule claims. In concluding that “[g]roundbreaking, innovative, or even brilliant” discoveries of such natural phenomena are not patentable, the Court stressed the social cost: it “would `tie up’ the use of such tools and thereby `inhibit future innovation premised upon them.’”


Advocacy groups have heralded the Myriad decision as a huge win for patients. “VICTORY!,” the ACLU declared, “Our genes belong to us!”28 The invalidation of genomic DNA claims — and the earlier refusal by the appellate court to allow patents on methods of detecting BRCA1 and BRCA 2mutations — permits other companies to market their own genetic tests. Indeed, within days of theMyriad ruling, at least five competitors had announced that they would enter the market.29,30

Myriad has responded to this new competition with further infringement litigation.31 Patent claims by Myriad covering other methods and other “synthetic” DNA sequences such as primers and probes have not been challenged, and the Supreme Court specifically noted that they might indeed cover patentable subject matter. With the prospects for such infringement claims uncertain, however, Myriad may also seek to capitalize on its proprietary library of BRCA mutations, which provides a competitive advantage in interpreting rare mutations. The last deposit of data on BRCA variations by Myriad into the federal Breast Cancer Information Core database occurred in 2004, and a group of coauthors, including some from Myriad, published a manuscript listing 118 additional mutations in 2006.32 Since then, Myriad has not made public other BRCA variations that it received while holding its monopoly on testing. Recently, a physician-led grassroots effort has been organized to obtain data on rare variants directly from patients and their providers and publicly disseminate it, which could undermine this competitive advantage.33,34

Ultimately, the end of the Myriad monopoly should improve access to genetic testing and rapid turnaround of results by driving down the price — DNA Traits, for example, will charge less than $1,000 — and expanding capacity for analyzing samples. When the case was brought, one crucial concern was whether the claims in question blocked analysis by means of whole-genome sequencing. Myriad argued that its patents on isolated DNA involved sequestering BRCA sequences from others in the genome and that whole-genome sequencing would not infringe such patents. The ACLU pointed out, however, that the plain meaning of the claims would indeed cover molecules created during whole-genome sequencing. Given the outcome of the case (and in light of the oral arguments presented by Myriad before the Court), institutions offering whole-genome sequencing should no longer fear lawsuits from parties holding patents on isolated DNA.35

Although the Myriad decision places in jeopardy thousands of patent claims, its effects on biotechnology companies and innovation will probably be modest. A recent analysis estimated that as many as 3535 unexpired patents on naturally occurring, human gene sequences may be affected,36 although the applicability of the decision will depend on the specifics of each individual patent claim. Furthermore, because nothing about the reasoning of the Supreme Court would prevent its holding from being applied to nonhuman genes, several thousand patent claims relating to other organisms may also be affected, with implications for a range of applications outside human medicine. However, the same study showed that patent claims on merely isolated DNA were already on the decline. Since 2005, companies have sought to patent naturally occurring gene sequences much less frequently than they did in the past, perhaps because the Patent and Trademark Office raised the bar for meeting another requirement for patenting an invention — showing that it has practical utility. Some companies also found it more difficult than expected to profit from these DNA sequences and abandoned their patents.35,37,38 As a result, after Myriad, we expect that companies developing DNA-based therapeutic agents will need to more clearly distinguish their inventions from the genome itself and specify the claimed uses so as to avoid questions about covering the naturally occurring sequences.

Claims on DNA that has been engineered, in contrast, have been on the rise — in both frequency and scientific importance36 — and will continue to enjoy protection after Myriad.35 Patents on synthetic DNA include those on vectors and engineered molecules that could be useful as therapeutic agents themselves (e.g., in gene transfer) or in the process of making therapeutic proteins for so-called biologic drugs. Since these technologies remain squarely within the bounds of patentability outlined by the Supreme Court, the effects on innovation emerging from these areas should be minimal.

The impact of the Myriad decision on innovation will also be muted by the fact that the holding itself was clearly limited by Justice Thomas to isolated DNA corresponding to sequences found in nature. However, it may affect patent applications on DNA-based therapeutic agents, such as (still experimental) DNA vaccines, which will now have to clarify how the active sequence is not merely isolated but has been transformed and has a specific utility. It could also spill over into other areas of medical research, such as the development of diagnostic testing for microbes, which have genomes lacking introns altogether.

Finally, Myriad is important as an expression of strident judicial opposition to patents on methods of making medical diagnoses. The method claims for detecting genetic sequence alterations were struck down unanimously by the Federal Circuit court, and the Supreme Court declined to take up the question on appeal. It will therefore be impossible for companies to mimic a business model of identifying a gene sequence and attempting to control the production of diagnostic tests from it. The combination of the Myriad and Mayo decisions greatly diminishes the prospects of Myriad or any other company claiming monopolies on genetic diagnostic tests alone, without a direct linkage to therapeutic agents or other molecular transformations. For example, companies seeking to develop multigene diagnostic or prognostic tests will have to try to claim some combination of methods of diagnosis and modification of the DNA molecules, rather than relying simply on patents covering the underlying isolated DNA. Whether this will reduce private investment in genetic diagnostic testing and necessitate supplemental public research funding remains to be seen.


The Myriad decision will be an important symbol for those who seek to foster scientific discovery by protecting and expanding the public domain. It also has symbolic resonance with the ideal that our common humanity cannot be owned. The Universal Declaration on the Human Genome and Human Rights declares the human genome to be “the heritage of humanity” and that “the human genome in its natural state shall not give rise to financial gains.”39 The Supreme Court quietly came to a similar conclusion, though with attention to preserving the incentives important for biomedical innovation.

It is interesting that although the Supreme Court decision concerns human genes, humanness had no bearing on the decision. Nor does the law allow courts to consider whether patenting human genes — or anything else — should be disallowed on grounds of morality. There is a disconnect, then, between the reasons the Supreme Court articulated for its decision and the rich set of ethical and policy concerns that have animated much of the public interest in the case.

Those powerful ideas may or may not have swayed the Court as it considered a vague and open-ended legal doctrine. If the questions raised during oral argument are any indication, however, the justices were primarily interested in innovation — both in preserving patent incentives for investing in research and in the blocking effects that patent rights can have on upstream discovery. Viewed in this light, the decision represents a careful balancing act.

Source: NEJM




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