On Crohn's disease and the patent case being heard next week in the Supreme Court

Next week the United States Supreme Court will hear argument in a patent case styled Mayo Collaborative Services v. Prometheus Laboratories, Inc., for which the SCOTUSblog has this link to the many briefs.

The patents at issue involve blood testing after administration of a drug called azathioprine, which I have taken off and on for some years. Azathioprine is an immune suppressant used as an anti-rejection drug for people who receive organ transplants. It is also prescribed for Crohn's disease and ulcerative colitis, which are thought to be disorders of the immune system.

It is an alarming thing to sit and read the label as I used to do sometimes and think about whether you want to take that pill. Some people who take azathioprine for Crohn's disease get one form of cancer or another and die. For some patients, it works no better than placebos on their moderate to severe Crohn's disease. The challenge with this powerful medicine is how to figure out how to give enough without giving too much to achieve the good effects and avoid the bad. Not everyone requires the same dosage to achieve the same level of metabolites in their blood.

A group of researchers "developed a database of pediatric patients with
inflammatory bowel disease who had received thiopurine treatment," applied standard laboratory techniques to measure the thiopurine metabolite levels in their blood, and observed some correlations between particular values and whether the patients did better or worse. The appellee Prometheus learned of this research, licensed it from the inventors and the hospital for whom they worked, filed patent applications, and marketed a blood test product that would measure whether the metabolite levels for GI patients taking azathioprine were within the optimal range of values.

The Mayo Clinic used this product for years, then decided that it could make and sell its own product to do a better job of evaluating thiopurine metabolite levels. Prometheus sued for patent infringement, and the case made its way to the high court.

The question presented, according to the appellant Mayo, is:

"Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the patent effectively preempts use of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve 'transformations' of body chemistry."

In other words, the Court will decide whether Prometheus can patent what amounts to nothing more than a lab test to see whether the level of thiopurine metabolites is within the range of therapeutic values shown by the research.

On the face of it, the patent seems preposterous. When only ordinary testing techniques are involved, why should any company be able to claim exclusive ownership of the idea of testing for any level of some chemicals in the blood, based on research that shows some particular level is best for patient health? Yet such patents are evidently common, and defended as Prometheus sought to do in its brief, as necessary to fund the type of research that lead to the conclusions about the therapeutic levels of the thiopurine metabolites - even though the specific research in this case was not done for commercial purposes.

More on tie-breaking in the Virginia Senate

The Washington Post reports here and the Washington Times reports here that Democrats in the Virginia Senate will file suit for a determination of the powers of the Lieutenant Governor to break tie votes on the organization of the Senate.

Worth reading

This piece in the Baltimore Sun asks whether recent criminal cases show that the Fourth Circuit has become more "liberal."

Following the Supreme Court's decision to take up the cases, a series of articles appeared over the weekend denouncing the ethics of Supreme Court justices in anticipation that they will vote to overturn the Affordable Care Act, including here, here, here, and here.

Some U.Va. students are trying to get the University to stop using coal to heat its buildings, according to this story in the Charlottesville paper. The article did not say whether they think the coal money that went into the Carl Smith Center should also be sent back.

The executive director of Lenowisco was quoted in this article suggesting that the Santa Train perpetuates negative stereotypes of Southwest Virginians as people who cannot afford to buy their own candy and gifts.

Who can defend Proposition 8?

In Perry v. Brown, the California Supreme Court held today that the proponents of Proposition 8, the referendum that amended the California constitution to prohibit same-sex marriage, have standing to appeal the federal judgment that the state constitutional amendment violated the United States Constitution, where California officials including the new governor have refused to try to defend the amendment. The decision clears the way for the Ninth Circuit to decide the constitutional issue on the merits.

The amendment at issue added section 7.5 to the California constitution, which provides: "Only marriage between a man and a woman is valid or recognized in California."

The California decision is interesting in its contrast with the Fourth Circuit decision in the health care case, where Virginia officials were held to have no standing to challenge the federal law.

In the photograph are Governor Brown and former Mayor Newsom, both opponents of Proposition 8.

Which ties can the Lieutenant Governor break?

The Virginia Constitution provides that "[t]he Lieutenant Governor shall be President of the Senate but shall have no vote except in case of an equal division." Va. Const. Art. 5, section 14.

Starting next year, the Virginia Senate will be split 20-20, when it votes along party lines. There has been reporting in the blogs and other media that the Republicans are refusing to "share power" in the organization of the Senate, such as the representation on committees.

In 1996 Va. Op. Atty. Gen. 31, 1980-1981 Op. Va. Att'y Gen. 97, and 1979-1980 Op. Va. Att'y Gen. 178, the Attorney General has offered opinions about which ties the Lieutenant Governor can and cannot break.

In the 1996 opinion, the Attorney General concluded that the Lieutenant Governor could not provide the tie-breaking vote on matters subject to the provisions of Article XII, section 1: "Any amendment or amendments to this Constitution may be proposed in the Senate or House of Delegates, and if the same shall be agreed to by a majority of the members elected to each of the two houses, such proposed amendment or amendments shall be entered on their journals, the name of each member and how he voted to be recorded, and referred to the General Assembly at its first regular session held after the next general election of members of the House of Delegates. If at such regular session or any subsequent special session of that General Assembly the proposed amendment or amendments shall be agreed to by a majority of all the members elected to each house, then it shall be the duty of the General Assembly to submit such proposed amendment or amendments to the voters qualified to vote in elections by the people, in such manner as it shall prescribe and not sooner than ninety days after final passage by the General Assembly."

In the later 1980 opinion, the Attorney General concluded that the Lieutenant Governor could not provide the tie-breaking vote on matters subject to this provision of Article IV, section 11: "No bill which creates or establishes a new office, or which creates, continues, or revives a debt or charge, or which makes, continues, or revives any appropriation of public or trust money or property, or which releases, discharges, or commutes any claim or demand of the Commonwealth, or which imposes, continues, or revives a tax, shall be passed except by the affirmative vote of a majority of all the members elected to each house, the name of each member voting and how he voted to be recorded in the journal."

Similar language regarding the votes of the "members elected to each house" appears in Article IV, section 6, pertaining to legislative sessions; Article V, section 6, pertaining to overriding vetoes; Article VI, section 7 pertaining to the selection of judges; Article VII, section 1, pertaining to special acts for localities; Article IX, section 1, pertaining to changing the number of State Corporation Commissioners; Article X, section 9, pertaining to state debt; and Article XII, section 2, pertaining to constitutional conventions.

The earlier 1980 opinion concluded that there was no similar limitation that would prohibit the Lieutenant Governor from voting to break a tie vote on the ratification of an amendment to the United States Constitution, but held that the Rules of the Senate might control whether the Lieutenant Governor got to vote.

The organization of the General Assembly is controlled by Article IV, section 7, which provides: "The House of Delegates shall choose its own Speaker; and, in the absence of the Lieutenant Governor, or when he shall exercise the office of Governor, the Senate shall choose from its own body a president pro tempore. Each house shall select its officers and settle its rules of procedure. The houses may jointly provide for legislative continuity between sessions occurring during the term for which members of the House of Delegates are elected. Each house may direct writs of election for supplying vacancies which may occur during a session of the General Assembly. If vacancies exist while the General Assembly is not in session, such writs may be issued by the Governor under such regulations as may be prescribed by law. Each house shall judge of the election, qualification, and returns of its members, may punish them for disorderly behavior, and, with the concurrence of two-thirds of its elected membership, may expel a member." Nothing in this provision on its face would appear to limit votes to "members elected to each house" in the same way as Article IV, section 11, or Article XII, section 1.

What has changed in pest control since 1989?

The Virginia Supreme Court would seem to have gotten it wrong in one of its two decisions dealing with the non-compete clause used by a pest control company, having reached the opposite conclusion in 2011 from what it held in 1989.

Justice McClanahan, in her dissent, observed that such a fundamental shift in so short a time is an offense against the Rule of Law.

I recall having an oral argument before the late Judge Richard Williams of the Eastern District some years ago, in my only (and somewhat terrifying) appearance before him, and when he asked me about some old precedent that I tried to dismiss as too old, he laughed and said, "so you're saying the Age of Enlightenment set in sometime after that decision, and you know better now than the Supreme Court did back then?"

The Home Paramount firm, the employer in both cases, has branched out beyond termites and will also take care of those stinkbugs, according to their website.

The online business entity records of all 50 states on one page

I was working on a project where I wanted to see what a corporation on the other side said in its corporate filings with the various states, and found this page, with links to the equivalent of the Virginia State Corporation Commission for all of the states.

And, it struck me that the SCC's online presence was sort of middle of the road compared to the other states - some of them make you pay to see much of anything, some have more detailed information, Virginia is better than most in that now you can download annual reports in PDF without getting a password or sending in a check.

Some states require the corporation to provide the names and addresses of its officers and directors. This information might be useful as evidence when there is a dispute of fact over a corporation's "principal place of business" for purposes of diversity jurisdiction. Under the Supreme Court's 2010 decision in Hertz Corp. v. King, the issue is reduced to where are the high level officers. Or so I have concluded from such opinions as Central West Virginia Energy Co. v. Mountain State Carbon, LLC, where the Fourth Circuit applying Hertz held that a company that mostly operated in Wheeling, West Virginia, and was even called "Wheeling" nevertheless had its principal place of business not in Wheeling but in another state.

I am a fan of Virginia's current State Corporation Commission, as the current Commissioners include Judy Jagdmann, and also interested by the facts that it was the only progressive product of Virginia's 1901 Constitutional Convention and that one of the early Commissioners was William Rhea, the original judge of the Corporation Court for the City of Bristol.