On the Edges of Science and Law

Motion to Dismiss Denied in Breast Cancer Case: The USPTO is a Defendant in a Case Challenging the Constitutionality of Patents Granted by the USPTO

 By Jake Meyer

November 1, 2009, Judge Sweet of the United States District Court in the Southern District of New York issued an opinion in Association for Molecular Pathology v. United States Patent and Trademark Office.  The plaintiffs in the case, which were previously blogged about here, challenge the constitutionality and validity of patents on the BRCA1 and BRCA2 breast cancer genes owned by Myriad.  The defendants -- the U.S. Patent and Trademark Office (USPTO), Myriad Genetics, and the Directors of the Utah Research Foundation -- moved to dismiss the case for standing and jurisdictional issues.  Judge Sweet denied all motions to dismiss, finding there was both standing and jurisdiction.

The inclusion of the USPTO as a defendant in this case is unique to this case, as the USPTO has never been a party to a lawsuit in which the constitutionality of patents issued by the USPTO were brought into question.  The USPTO moved to dismiss for lack of subject matter jurisdiction (the USPTO also moved to dismiss for lack of standing) arguing that it had a comprehensive statutory scheme in place to redress violations of the Patent Act.  However, the cases the USPTO cited involved claims that alleged statutory violations that the Patent Act provided a remedy for.  Judge Sweet found that there was no comparable statutory scheme that provided remedies for constitutional violations.  Judge Sweet found that there was subject matter jurisdiction over the USPTO citing the novel circumstances of the action, the absence of any remedy provided in the Patent Act, and the importance of the constitutional rights asserted by the plaintiffs.

The Story of a Sperm with a Bad Heart

  By Keith Syverson

A study published in last week's issue of the Journal of the American Medical Association (JAMA) raises concerns about regulation of sperm banks.  The study describes the case of a 23-year-old man in good health who donated sperm to a U.S. sperm bank almost a hundred times over a two year period.  The sperm bank followed protocols standard in the industry at the time of the donation: doctors gave the donor a comprehensive medical evaluation including a complete personal and family medical history in addition to laboratory testing for communicable diseases. Several years later, a woman inseminated with the donor's sperm gave birth to a child diagnosed with Hypertrophic Cardiomyopathy (HCM) -- a heart disease characterized by the thickening of the heart muscle.  The sperm bank notified the donor and all other recipients of his sperm that their children were at risk for HCM.  Twenty-two children were born using the donor's sperm in addition to two children born to the donor's wife.  Five children showed evidence of HCM including one two and a half year old child who died waiting for a heart transplant.

This case study underscores the need for more stringent testing protocols for gamete donation.  The American Society for Reproductive Medicine has published recommendations on genetic screening for gamete donors, but compliance with these guidelines is voluntary.  Studies have shown that most gamete donor agencies do not follow these protocols.  For sperm banks, only half of programs surveyed performed a chromosome analysis and about a quarter of egg donor agencies reported that they do not screen egg donors.  Moreover, the authors of the JAMA article note that it is a surprise that the sperm bank was able to contact the donor and everyone who received the sperm because this is uncommon in the industry.

Blood Glucose Monitors: A Sleek 21st Century Look With Nixon Era Accuracy

 GUEST BLOGGER Ed Kraus

It is essential that people with diabetes have accurate tools with which they can effectively manage their disease on a day-to-day basis.  And, despite all the recent technological and scientific advances in diabetes management, it appears that home blood glucose monitors—one of the most commonly used and critical tools for the management of glucose levels—are not keeping pace with the times.  

In a July 2009 New York Times article, Gardiner Harris wrote that the Food and Drug Administration (FDA) is considering tightening its accuracy standards for home blood glucose monitors (BGMs).  The article highlights the fact that the FDA has long followed international standards set by the International Organization for Standardization (ISO) which allow for BGMs to be manufactured with an error rate of up to 20%.  While an error rate of 20% may have seemed acceptable or reasonable 10 years ago, given our present-day technology and our current understanding of the clear health benefits of tight control of glucose levels, it is simply indefensible.

To understand why this error rate is unacceptable, it is helpful to consider what a 20% error rate for a BGM actually means for an individual with diabetes.  Let's take the example of an individual who checks her glucose level and gets a reading of 156 when, in fact, her blood glucose is only 130.  With a reading of 156, she might administer a correction dose of insulin to lower her glucose to a level within her target range.  However, had the BGM accurately displayed her glucose level as 130, she would not have taken any insulin.  This unnecessary dose of insulin could then cause her glucose levels to go too low -- meaning below the low end of her target range -- and cause her to suffer from hypoglycemia.  Alternatively, if her blood glucose level was actually 160 but the BGM gave a reading of 128, she might not administer any insulin -- because she might falsely believe that her glucose level is within her target range.  Failing to administer insulin when it is needed could lead her to becoming hyperglycemic which, over time, can cause serious health complications. 

As it turns out, in response to concerns from the American Association of Clinical Endocrinologists regarding BGMs' accuracy, in June 2009, the FDA pressed the ISO to tighten its standards.  In addition, the FDA has indicated that if the ISO does not act, the FDA will take the initiative itself by requiring higher performance standards for BGMs sold in the United States.  However, as of September 2009, the FDA has yet to do so; rather, it appears that the FDA is still merely commenting on its plans to make changes in some way or another.

It is interesting to consider why there have not been any major improvements in the accuracy of BGMs in the past decade.  BGM manufacturers have improved the technology, aesthetics, and convenience of BGMs since their introduction in the 1970s, but manufacturers have not improved the accuracy of glucose level readings -- arguably the single most important feature of a BGM.  As FDA Commissioner Margaret Hamburg has indicated, this is the result of manufacturers' contentment with meeting the international standard set by the ISO.  But this response begs the question: Why have market forces led BGM manufacturers to improve certain aspects of their products, but not accuracy? After all, most people with diabetes purchase and use BGMs with the goal of closely managing and monitoring their glucose levels, which in turn enables them to minimize the risks of long-term, diabetes-related complications.  Perhaps BGM manufacturers have taken advantage of the fact that individuals easily notice the aesthetic difference between certain BGMs, but that most BGM users likely were never (or still aren't) aware of the 20% error rate allowed by the FDA?

Whatever the reason for the market's failure to promote the development of more accurate BGMs, the solution is clear.  Whether by pressuring the ISO or creating its own higher standards for domestic BGM approval, the FDA should act quickly and decisively to put an end to the current tolerance of a 20% error rate for BGMs. 

Ed Kraus is an Associate Clinical Professor at Chicago-Kent College of Law.  Professor Kraus focuses part of his practice on representing and advocating for individuals with diabetes in education, employment and insurance matters.

I.B.M. Seeking to Make Sequencing of Personal Genome Available for the Low Low Price of $1,000 (Plus Millions in Royalties to Patent Holders)

By Jake Meyer

I.B.M. recently announced its plans to join the race to sequence the genome for $1,000.  I.B.M. joins seventeen other companies in the race to sequence the gene.  Currently the cost to sequence the human genome ranges between $5,000 and $50,000, but these companies are yet to successfully sequence the entire genome of an individual.  I.B.M. hopes to ultimately bring the price as low as $100 to sequence an individual's entire genome.  The goal is to build a machine that can sequence an individual's genome – three billion base pairs – in several hours.  This will provide the genetic information needed by an individual for personalized diagnostic and treatment uses. 

I.B.M. is using its expertise in semiconductor manufacturing, computing, and material science to design a gene sequencer with increased speed and accuracy.  I.B.M.'s sequencer revolves around a nanoscale electric device.  The device uses an electric field to pull the DNA strand through a 3 nanometer hole in a surface, at which point the electric field holds the DNA in place for a fraction of a second while the order of the nucleotide bases (adenine, guanine, cytosine, or thymine) is determined.  After the nucleotide bases are determined, the DNA strand is pulled further through the hole and the order of the next nucleotide bases are determined.