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.

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.

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.

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?

Dyslexia Gene eneG aixelsyD

By Jake Meyer

The other day I while doing some patent law related research, I stumbled across a patent in the U.S. Patent and Trademark's patent database on a gene linked to dyslexia—U.S. Patent No. 7,355,022.  Dyslexia has been defined as a learning disability.  It can manifest itself in many different ways, but usually appears as some type of difficulty with reading and/or writing. 

After I found the patent on a dyslexia gene, I started to think about the types of inventions a company licensing this patent might be.  After a gene is "discovered," lab tests for the gene can be developed.  These genetic tests could be used to determine if someone has this dyslexia gene and therefore a predisposition to dyslexia.  Tests could also be used to preselect embryos to help ensure a child might be born without dyslexia.  Or perhaps in the future genetic therapies or a cure to dyslexia could be found. 

"Generic" Versions of Expensive Biologic Drugs Would Benefit Consumers

GUEST BLOGGER Pat Bickley

Competition from generic drugs has substantially reduced the prices of many prescription drugs.  However, under current law, the FDA can only apply the expedited testing of a generic designation to certain classes of drugs, generally those that are chemically synthesized, small-molecule products.  Larger and more complex drugs, such as biologics, are not allowed to receive generic designations. Biologics are protein-based and produced in living cells.  They also tend to be much more expensive.  Annual costs can be as high as $48,000 for the breast cancer drug Herceptin and $20,000 for the rheumatoid arthritis drug Remicade.  Manufacturers of biologics, such as Amgen and Genentech, justify these costs as necessary to recoup their substantial investments in developing and gaining approval for the drug.

"Cheese Please, and No More Exercise Wheels"

By Jake Meyer

We've all talked to animals before, but never have the animals talked back.  Recent research makes the possibility of a day when the family dog calls your name, and tells you to sit and shake hands a little more probable.  Researchers at the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany have placed a human language gene in a strain of mice.

Although there are undoubtedly numerous genes that enable human speech, the replacement of the mice's FOXP2 gene with a human version of the gene had some surprising effects.  The mice with the human FOXP2 gene grew nerve cells with a more complex structure in the basal ganglia--a region of the brain used in language in humans.  The mice also had a new "voice."  When baby mice are separated from their mothers they make ultrasonic whistles.  But in the mice with the human gene, the whistle was a lower pitch.

Wheels of Justice Grind Slowly for Havasupai Tribe

By Julie Burger

In a remote section of the Grand Canyon about 450 members of the Havasupai Tribe live on tribal lands where they have lived for hundreds of years.  Another 200 members of the Tribe live away from Supai, the village area.  In March of 1990, researchers from Arizona State University ("ASU") (Drs. Theresa Markow and John Martin) presented the Havasupai Tribal Council with a proposed diabetes study, saying that they would like to collect and use tribe members' blood for diabetes studies.  The researchers met several times with the Tribal Council, but according to allegations, never revealed they intended to perform research other than diabetes research.  With the Council's approval, blood samples were collected from members of the Tribe, including children and vulnerable people.  Researchers additionally took handprints from members.  English is not the tribal members' primary language and many members do not even speak English as a second language.

The researchers did not stop at diabetes research.  They also performed additional research on the samples for schizophrenia, inbreeding, and population migration, and shared the samples with researchers at other institutions.  After discovering the additional research, the Havasupai filed state court complaints on behalf of individual Tribal members and on behalf of the Tribe against ASU and the researchers in 2004.  The Havasupai maintain that the schizophrenia and inbreeding research was stigmatizing and that they would not have consented to the migration research because it conflicts with their religious origin theory.  A member of the Tribe points out that "[the researchers] challenged our identity and our origins with our own blood and without telling us what they were doing."

Association for Molecular Pathology v. United States Patent and Trademark Office: Meet the Plaintiffs

By Jake Meyer

Earlier this week, a lawsuit organized by the American Civil Liberties Union was filed challenging the validity and constitutionality of patents on the BRCA1 and BRCA2 breast cancer genes owned by Myriad Genetics.  The plaintiffs in this case include: women who wish to have testing for the BRCA1 and BRCA2 genes; researchers who have the capabilities to offer testing for these genes but are unable to because of Myriad's patents on the BRCA1 and BRCA2 genes; medical organizations; and women's health organizations.

The presence of the certain mutations in the BRCA1 or BRCA2 genes is associated with a predisposition to breast or ovarian cancer.  Women who have these mutations are much more likely to develop these cancers and men who have the mutation can pass the mutation to their daughter.  Women who learn they have these mutations will often opt for drastic surgeries, such as a mastectomy or oopherectomy (removal of the ovaries) to avoid a battle with breast or ovarian cancer.  However, Myriad Genetics owns patents that cover both the BRCA1 and BRCA2 gene sequences and mutations of the genes, which grant Myriad a monopoly over the gene sequences (for an example of one of Myriad's patents click here). Myriad is the only company that offers genetic testing for BRCA1 and BRCA2 in the U.S. and therefore women cannot get second opinions before making decisions about major surgery.  Also, since Myriad has a monopoly on testing, it can charge whatever it wishes for the testing – currently the test costs over $3,000.  Many insurance plans don't cover this testing and many people can't afford the out of pocket cost of the test – so testing isn't available to them.  Further, according to a 2006 study, Myriad's test can miss certain mutations that help cause the disease.