On the Edges of Science and Law

Motherhood Divided: What Should Happen When a Clinic Gives a Woman the Wrong Embryo?

By Lori Andrews

When Carolyn Savage learned she was pregnant through in vitro fertilization, she and her husband Sean rejoiced.  A few weeks later, though, they received devastating news.  The clinic had implanted the wrong embryo in her.  Rather than carrying their own genetic child, Carolyn was carrying the embryo of another couple.

While some women might have chosen to terminate a pregnancy, the Savages' own moral beliefs precluded that option.  So instead, they selflessly went forward with the pregnancy, agreeing to turn the baby over after birth to the child’s genetic parents.  The one thing Carolyn Savage requested was a moment for her and Sean to be alone with the baby.  She said, "We want a moment to say hello and goodbye."

In an interview on the Today Show, Carolyn's absolute emotional pain comes through.  Whatever abstract legal ideas currently exist about the weight given to genetic bonds over gestational bonds, Carolyn had already begun a nine-month relationship with this child.  And, to make matters worse, she will not be able to carry another child.  If she and her husband want to procreate further, they will have to hire a surrogate mother to carry their remaining embryos.

Prometheus Labs, Inc. v. Mayo – Administering a Drug is Transformative

 By Jake Meyer

Recently the Federal Circuit ruled on the case Prometheus Labs, Inc. v. Mayo, a case involving 35 U.S.C. §101 subject matter.  Prometheus came before the Federal Circuit as an appeal from a decision from the United States District Court for the Southern District of California to grant summary judgment of invalidity of Prometheus’s patents (U.S. Patents 6,355,623 and 6,680,302) finding that the claims were directed to non-statutory subject matter.   The case was a little unusual in that it was decided by two Federal Circuit judges, Michel and Lourie, and District Court Judge -- Judge Clark of the United States District Court for the Eastern District of Texas.  The patents claim methods for calibrating the proper dosage of thiopurine drugs, which are used for treating autoimmune diseases.  Since the patents are directed to a process and the case involves a subject matter inquiry, the Federal Circuit was able to revisit In re Bilski (a case now before the Supreme Court) and apply the test for subject matter eligibility of a process the Federal Circuit laid out in Bilski.

Thiopurine drugs are used to treat inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis.  Thiopurine drugs include 6-mercaptopurine (6-MP), and azathiopurine, which upon administration to the patient converts to 6-MP.  The body breaks down 6-MP into different metabolites, such as 6-methyl-mercaptopurine (6-MMP) and 6-thioguanine (6-TG).  Prometheus’s patents involve the measurement of these metabolites.  For example, claim 1 of patent 6,355,623 is representative of the claims in the Prometheus:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8.times.10.sup.8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Patent Infringement Case May Be Damaging to Microsoft and My Preferred Word Processor

By Jake Meyer

Microsoft is currently involved in a patent infringement case involving its word processor program Microsoft Word.  The outcome of this case could determine the fate of Microsoft's most well-known software.  In fact, this very blog post was composed on Microsoft Word.

Microsoft's Word program allegedly infringes Canadian software developer i4i's U.S. Patent No. 5,787,449.  The asserted claim (claim 14) of this patent is directed to "markup languages" for computers.  A markup language inserts "tags" that indicate how a text should be displayed between the tags.  XML, HTML, and SGML are all examples of markup languages.  Microsoft’s brief to the Federal Circuit gives an example of markup language. "For example, <Para> is a computer markup code that indicates the start of a paragraph and </Para> indicates the end of a paragraph."  Claim 14 claims this markup language as a method for producing a "map of metacodes":

A method for producing a first map of metacodes and their addresses of use in association with mapped content and stored in distinct map storage means, the method comprising: providing the mapped content to mapped content storage means; providing a menu of metacodes; compiling a map of the metacodes in the distinct storage means, by locating, detecting and addressing the metacodes; and providing the document as the content of the document and the metacode map of the document.

"What if our perception of normal exposure is skewed?": Analyzing the Science of BPA

by Sarah Blenner

Bisphenol A (BPA) is an estrogen mimicking chemical commonly used to create both polycarbonate plastics and the resin lining of cans.  This chemical can be found in plastic food and beverage containers, cans, dental sealants, household products, cell phones, computers, and medical devices.  Hundreds of studies link the synthetic hormone, BPA, to a variety of adverse health conditions, including, breast cancer, prostate cancer, ADHD, autism, obesity, insulin resistance, type 2 diabetes, liver enzyme abnormalities, early onset of puberty, and cardiovascular disease.

In a study conducted by the CDC, scientists found that BPA was present in 93% of Americans tested, signifying the high prevalence of BPA exposure in the American population.  One participant of the "Is It In Us?" study, which measured the presence of toxic chemicals, such as BPA, in the blood and urine of participants, was relieved to know that her results were no different than the results of most of the other participants.  But then she thought: "what if our perception of normal exposure […] is skewed?" 

Last May, Chicago became the third jurisdiction in the United States to successfully pass legislation regarding Bisphenol A when it banned the sale of baby bottles and other empty food and liquid receptacles intended for the use by children under the age of three.  Prior to Chicago City Council's passage of the BPA Free Kids Ordinance, the State of Minnesota and Suffolk County New York passed legislation regulating BPA.  In June, Connecticut became the fourth jurisdiction in the United States to address the health risks of BPA through legislation, when it passed an "Act Concerning Banning Bisphenol-A in Children's Products and Food Products."  According to the Public Act, beginning October 1, 2011, the sale of infant formula, baby food, and reusable food or beverage containers that contain the chemical Bisphenol A will be banned. 

Will Patent Court Police the Boundaries of the Statute?: Federal Circuit to Look at Written Description Requirement

 By Jake Meyer

A panel of Federal Circuit judges previously heard the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 2007 WL 2712087 (Fed. Cir. 2009) and held that Ariad failed to provide adequate written description for its claims to methods of the regulation of the expression of certain genes.  The Federal Circuit has granted a request to hear the case Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., en banc and in doing so will interpret a section of the Patent Act.  The questions before the Federal Circuit en banc are now:

1. Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from enablement?
2. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?