Are Human Genes Patentable?

Efthimios Parasidis

The Supreme Court will consider the patentability of human genes when it reviews the Myriad case this term. As Bill of Health readers are likely to know, the Myriad case centers on Myriad’s patents on gene sequences for BRCA mutations that are associated with the propensity to develop breast or ovarian cancer.  Myriad does not claim ownership over the mutations as they exist in nature, but rather on isolated BRCA sequences that the company has “created”. The Myriad case will give the high Court another chance to clarify the scope of subject matter that is eligible for patent protection. The Court’s track record in this area is less than stellar.

As I have argued (here), the legal uncertainty at to the scope of patentability for claims that implicate products of nature is largely the result of the lack of a uniform framework for determining what areas are excluded from patent-eligible subject matter. More specifically, while patent law prohibits patent protection for inventions that equate to a law of nature, natural phenomenon, mental process, mathematical equation, or abstract idea (collectively referred to as the product of nature doctrine), no court has defined these terms adequately. Uncertainty is bad for business and bad for patients — the Court should seize upon this opportunity and offer clear guidance as to the contours of the product of nature doctrine.

With respect to gene sequences, the mere fact that a sequence is isolated is inconsequential.  Rather, courts should analyze the precise subject matter of the isolated gene sequence to determine if it differs substantially from its natural counterpart. I’ve created a three-part test to help make this determination:

  1. Does the isolated sequence exhibit characteristics or contain properties that are substantially different from the non-isolated sequence?
  2. Is the proximate cause of any difference between the isolated and non-isolated sequences the result of natural phenomenon that govern the properties of the sequence when isolated?
  3. Would a patent on the isolated sequence grant a property interest that extends to anything other than the isolated sequence?

If the answer to these questions is anything other than (1) yes, (2) no, (3) no, the claim must be invalidated pursuant to Section 101 of the patent act because the claim does not constitute patent-eligible subject matter. My article explains why…

Public Health & The First Amendment – AID v. Alliance for Open Society

The Supreme Court’s decision last week to grant cert in AID v. Alliance for Open Society International, demonstrates anew the importance of First Amendment jurisprudence to public health protection. In recent years, it has sometimes seemed as if the First Amendment has become the most significant legal obstacle to effective public health protection through law. In cases such as Lorillard Tobacco, Thompson v. Western States Medical Center (the compounding pharmacy case), and Sorrell v. IMS Health, Inc., the Supreme Court has found that First Amendment protections for commercial speech trump public health protection, a view that the D.C. Circuit seemed to endorse when it ruled last summer in R.J. Reynolds that the graphic warning labels required by the Tobacco Control Act violated the First Amendment Rights of cigarette companies.

Yet sometimes the First Amendment helps to advance the cause of public health, particularly by limiting the reach of laws that are designed to restrict an open and informed approach to sexual and reproductive. US AIDS offers one such example. In that case, plaintiff NGOs challenged a provision in the federal Leadership Act, 22 U.S.C. § 7631(f),  that required them to adopt a policy explicitly opposing prostitution in order to receive federal funds available to fight HIV/AIDs, tuberculosis, and malaria.  The plaintiffs argued that the Act constituted an unconstitutional condition and violated their First Amendment rights by compelling them to adopt the government’s viewpoint regarding prostitution. The Second Circuit, in an opinion by Judge Parker, concluded that the plaintiffs were likely to prevail on the merits and granted them a preliminary injunction.

Now the Supreme Court will reconsider the issue. Public health advocates are likely to weigh in and argue for the widest possible protection for their own advocacy.  In doing so, they might want to keep in mind the threat that the First Amendment poses for public health in other contexts, especially in commercial speech cases.  And they will certainly want to think about how they can convince courts to value public health when deciding First Amendment cases. Figuring out how to do that — how to develop a First Amendment jurisprudence that is respectful of public health – just may be the most pressing challenge facing public health lawyers today.

Guest Post on Animal Research: Animal Research Is an Ethical and Vital Tool to Fight Disease

[Ed. Note: A few weeks ago, we had a post comparing the protections offered to humans and animals used in research, and it prompted quite a stir.  We thought the issues merited more discussion from both sides, and therefore solicited blog posts from two divergent perspectives: Theodora Capaldo, President of the New England Anti-Vivisection Society and Tom Holder, founder of Speaking of Research.  Mr. Holder's post is below and Dr. Capaldo's post can be found here.  As always, we welcome discussion via the comment thread, but request that your comments be respectful and focused on the topic rather than the speaker.]

By Tom Holder

The Benefits

In the US alone there are over 95 million prescriptions every year for asthma medications, primarily inhalers. So what can over 25 million American asthma sufferers thank for making their lives manageable? The guinea pigs and frogs which allowed scientists to gain the underlying understanding about how chemical nerve transmitters helped to control the muscles in the airways, as well as create reliever inhalers with a long duration of action.

This is just one example of a long list of medical achievements made possible by animal research which include insulin (dogs and rabbits), polio vaccine (monkeys), anaesthetics (rabbits), blood transfusion (monkeys, dogs), antibiotics to cure tuberculosis (guinea pigs), asthma treatment (frogs and guinea pigs), meningitis vaccine (mice), deep brain stimulation (monkeys), penicillin (mice).

Herceptin, originally developed in mice, has had a significant impact on the survival rates for breast cancers. As a mouse antibody (now humanised) it would not have come about without the use of animal research. Mice, far and away the most common mammal used in scientific research, have also been used in conjunction with stem cell research to create a treatment for macular degeneration (one of the leading causes of blindness). This research, pioneered in mice, has now been used successfully to treat humans.

In a country where we eat 9 billion chickens and 150 million cattle, pigs and sheep every year, 25 million (approx.) animals (96% is estimated to be mice, rats, birds and fish) seems a small price to pay for medical progress.

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Guest Post on Animal Research: Inadequate laws don’t – but research alternatives will – protect animals in labs

[Ed. Note: A few weeks ago, we had a post comparing the protections offered to humans and animals used in research, and it prompted quite a stir.  We thought the issues merited more discussion from both sides, and therefore solicited blog posts from two divergent perspectives: Theodora Capaldo, President of the New England Anti-Vivisection Society and Tom Holder, founder of Speaking of Research.  Dr. Capaldo's post is below and Mr. Holder's post can be found here.  As always, we welcome discussion via the comment thread, but request that your comments be respectful and focused on the topic rather than the speaker.]

By Theodora Capaldo

When the New England Anti-Vivisection Society (NEAVS) launched Project R&R: Release & Restitution for Chimpanzees in U.S. Laboratories in 2006, 1,300 chimpanzees languished in U.S. laboratories. The campaign was a focused effort to end invasive and harmful research on the first non-human species in the U.S. Today, more and more chimpanzees are being transferred to sanctuary as momentum for the ethical and scientific cases against using them in biomedical research continues to grow. Though the Great Ape Protection and Cost Savings Act was one of many bills to not pass in the 112th Congress, policy is taking shape that reflects an end to holding and using chimpanzees in US labs. This month an NIH-convened council is expected to release its report on current and future chimpanzee use in NIH-supported research. The report will address how the NIH will realize its commitment to follow the Institute of Medicine (IOM) of the National Academy of Sciences’ recommendations from an expert paneled and lengthy assessment of the need for chimpanzees. The IOM report could not find any area of current biomedical research where the use of chimpanzees is critical and concluded that any possible future use must meet strict criteria. As to future need, the IOM noted that it could not conclude whether there would or would not be such future need.

Given the weight of scientific evidence, legislative and government support, and public opinion, chimpanzees who have been subjected to years of trauma, confinement, and research will one day soon have the chance to live the remainder of their lives in sanctuaries. They will be “released” and provided the “restitution” that only a sanctuary of high standards is capable of providing. The plight of chimpanzees in US labs highlights the suffering of all animals in laboratories. The scientific arguments highlight that even a species as closely related to humans as chimpanzees is a poor, limited, and even dangerous model by which to study human health and the inferiority of all animal research compared to modern methods. Chimpanzees are a keystone species by which myriad issues regarding the use of animals in research can be measured. Survivors in sanctuary bear witness to the degree of harm and suffering caused to them and are another indictment of the lack of effective laws and enforcement of those laws for animals in labs.

In short, there are no effective laws protecting animals in laboratories. The Animal Welfare Act (AWA), the only U.S. federal law governing animals’ “welfare,” provides minimal protections for less than 10% of animals used in laboratories. It excludes rats, mice, birds, fish, reptiles, amphibians, and farmed animals in research.

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On Behalf of John Robertson: May Guardians Terminate Treatment Without Judicial Review?

(Note, posting on behalf of John Robertson):

Legal questions about end-of-life decisions have moved on since the paradigm-setting battles in the 1980’s and 1990’s.  It is now clearly established that a competent person has the right to refuse needed medical treatment and to make binding advance directives about treatment if she becomes incompetent.  Physician-assisted suicide is a policy choice for states, not a constitutional right.  National debate now focuses on providing palliative care rather than high-tech interventions to prolong  fading life.  Cost reduction consistent with these values remain an omnipresent dilemma.

Sticky legal issues, however, remain, particularly with regard to the care of incompetent patients, as a Minnesota trial court recently reminded us (In re the Guardianship of Jeffers J. Tschumy, Hennepin County District Court, Fourth Judicial District, #27-GC-PR-07-496, October 18, 2012).   The question before the court was whether a broad grant of power to a guardian to make decisions about consenting or not consenting to medical treatment includes the power to have treatment terminated that will result in the ward’s death.  While allowing treatment to be withheld in that case, the court decided that only a judge, not the guardian on his own, could make that decision.  An appeal is now pending.

The court’s opinion catalogued the main arguments for each position before coming down on the side of judicial review.  Allowing the guardian to decide without court review was supported by the broad language of powers granted to guardians—to make decision about providing or withholding medical treatment—and the legislature’s failure to list termination of treatment as something that was explicitly denied the guardian (as it had done with certain other procedures).  It would also be quicker and less cumbersome, expensive, and burdensome  both for judges and family members to have guardians empowered to terminate treatment.

On the other side were the argument that the awesome power to end life was not specifically granted the guardian, and the fact that guardians are often appointed years before such decisions must be made.  At that time of appointment there is usually little thought of ending the life at some future time, and guardians so appointed may have not expertise or training in such matters.  The court concluded that until the legislature decided otherwise, a guardian would have to return to court for permission to end treatment that would result in the ward’s death.

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