Back When We Last Checked In On The Myriad

The Supreme Court ruled on the Myriad Genetics case last summer.  Since the case was decided, the company has been engaged in litigation with companies that started offering testing for the subject genes after the ruling.  Robert Cook-Deegan has summarized the post-decision for those of us, like me, who thought the Supreme COurt ruling ended things.  He’s also outlined some possible reasons for why Myriad Genetics launched a patent offensive in the wake of a decision that would seem – at least to a layman like me – to have foreclosed the company’s control over two genes.

Six companies have been sued by Myriad, with one settlement so far.  The cases have been consolidated and are currently working through a Federal District court in Utah.  Hearings were held in September and October.  On March 10, the judge in the case denied a motion for a preliminary injunction filed by Myriad.  This means that the company wanted the judge to stop competition on the medical tests of the BRCA1 and BRCA2 genes while the lawsuit went through the judicial process.  Usually these injunctions are granted because the side requesting relief could be reasonably seen to prevail on the merits of its case.  That doesn’t automatically mean that Myriad would lose, but it suggests that the company’s case is far from obvious.

It’s worth noting that these cases, as Cook-Deegan describes them, could be more complicated than the underlying case that opened up this competition over genetic testing.  Among the possible wrinkles include government involvement, because underlying research relied on research funds from the National Institutes of Health.  Of course, the path of litigation is tough to predict.  As one company has already settled, it’s possible none of this comes to trial.  Or not.

While we’re on the subject of the BRCA genes, it’s interesting to note this development reported earlier today.  BRCA1, besides controlling the development of proteins that can help prevent DNA damage, could control brain development.  As the research is only at the mice level, it will be a while before Myriad Genetics or other companies may be able to take advantage of their breast cancer work on BRCA in a new context.

Texas Innovates In How To Deal With Science In The Courts

The Innocence Project is focused on exonerating wrongfully convicted individuals, mainly through the use of DNA evidence.  In many instances, at the time the people were convicted, DNA evidence was not sufficiently mature in order to demonstrate a person’s innocence.  For better or for worse, there is not a simple way in which criminal convictions based on inaccurate (or updated) scientific methodology can be overturned.

Texas (yep, that Texas) has passed a law that could make the process easier.  Signed last June (and effective since September 1), the law addresses the right to habeas corpus (literally, you may have the body) in the context of new and/or changed scientific evidence.  Convicted individuals can apply for relief from the court if there is relevant scientific evidence now available that was either not reasonably ascertainable at the time of trial, or conflicts with evidence asserted by the state at trial.

Since the law went into effect, three cases have used the law to obtain release for the convicted individuals (pending procedures to prove innocence per Texas law), or a hearing for a new trial.  And that’s in six months.

There is certainly the opportunity for abuse.  The law does not define what is meant by relevant scientific evidence, leaving that to the courts to determine.  That the law is referred to in some reports as the ‘junk science’ bill is problematic, because not all instances where the law could be used cover instances of inaccurate, misleading or just plain wrong scientific claims.  It also covers instances where new scientific theories or refinements in analysis and measurement could warrant reopening a case to demonstrate someone’s innocence.  What the law does is reinforce the validity of scientific knowledge (or at least changes in same) to provide cause to reopen criminal cases.

Whether Stem Cells Can Be Patentable May Be The Least Of Commercial Challenges

Two recent actions involving the Food and Drug Administration (FDA) suggest to me that the matter of whether stem cell patents are valid may not be so critical.

The D.C. Circuit Court of Appeals ruled last week that the FDA has jurisdiction over stem cells cultured for therapeutic use (H/T The Scientist).  This decision upheld a lower court ruling that considered the act of culturing the cells more than ‘minimal manipulation,’ and therefore subject to FDA drug oversight regulations.

(IANAL, but I think this decision could be used to strengthen the case that stem cell patents – at least for cultures of said cells – would be valid.  After all, if there was more than minimal manipulation, wouldn’t that be sufficiently transformative to make the cultures no longer products of nature?  Again – I Am Not A Lawyer.)

Aside from the legal matters, there appears to be a big regulatory mismatch that will hinder commercialization of stem cell treatments.  In the February 6 edition of Cell Stem Cell researchers note (H/T The Scientist) that differing regulations between the National Institutes of Health (NIH) and the FDA may reduce the number of stem cell lines that could be used in clinical practice.

FDA regulations require that stem cell donors be screened for various diseases (so that treatments derived from those cells cannot infect others).  NIH regulations – not focused on commercial applications of stem cell research – do not have this requirement.  Now it is possible, as the article from The Scientist notes, for the FDA to allow some treatments to be approved without such a screening, but some alternative measure will likely be needed to mitigate the risk of infection.

Stem Cell Patents Getting Additional Scrutiny Post-Myriad

While recent Supreme Court activity (like the Myriad case) focused on the validity of gene patents, other biotechnology patents have been the object of scrutiny.

Consumer Watchdog asked the U.S. Patent and Trademark Office (USPTO) to review the patent it granted the University of Wisconsin-Madison in 2006 related to in vitro cultures of human embryonic stem cell lines.  The USPTO agreed to review the patent, but ultimately upheld the patent after several reviews and appeals.  In July 2013 Consumer Watchdog filed a brief with the U.S. Circuit Court of Appeals to have the patent invalidated.  (February 9 – Edited To Add – I had posted about the matter back in 2010 as it worked its way through appeal(s))

As with many patent cases, there are a number of different arguments that can be made for deciding the case.  But one of the arguments in the brief draws comparisons with the Supreme Courts arguments in the Myriad and related cases.  Specifically Consumer Watchdog is arguing that like the isolated gene sequences, the stem cell cultures are isolated products of nature and should not be eligible for patent protection.

Now, the Court of Appeals may opt to let the USPTO’s decision stand.  It will hear the case (it requested all parties submit briefs by January 16), and decide to validate or invalidate the patent based on any other claims put forth in the argument.  There are any number of procedural questions (in the courts or at the USPTO) that could stop the case cold.  And should the case make it through the Court of Appeals, a visit to the Supremes could certainly happen.

New Ohio Execution Drug Protocol Appears Less Effective

Earlier today the State of Ohio executed its first prisoner under a new drug protocol.  Due to an inability to obtain supplies of the usual drug, pentobarbital, Ohio opted for a combination of midazolam and hydromorphone.  The first drug is a sedative and the second is a painkiller (in smaller doses).  This is the first time a prisoner has been executed under this protocol in the United States.

As news reports attest, the execution took longer than it would under the previous drug protocol.  It took more than 20 minutes for the condemned man to die, and witnesses report that there was about 10 minutes of gasping and irregular breathing.  Rarely in lethal injection executions is there any activity beyond the first moments.

This will likely give additional incentive for death penalty opponents to argue that various drug combinations constitute cruel and unusual punishment and should therefore be banned from executions.  It will likely make states more insistent on obtaining drugs like pentobarbital that won’t prompt such reactions.  However, states will not be able to effectively test these drugs outside of executions (which are hardly ideal experimental conditions), so at best states will be able to minimize such instances, rather than eliminate them.

National Commission on Forensic Science Meets Next Month

Last week the Department of Justice and the National Institute of Standards and Technology (NIST) announced the members of the newly formed National Commission on Forensic Science.  The Commission will hold its first meeting next month in Washington, D.C.

Members were selected from a pool of over 300 applicants, and are intended to represent a diversity of perspectives in law enforcement, research, and forensic laboratories.  The commission will focus on studies and recommendations to improve quality assurance in forensic science and forensic science laboratories.  Its recommendations to the Justice Department will include how best to manage the interactions between forensic sciences and the judicial system.  The Justice Department will coordinate Commission activities with NIST, and officials from both agencies will serve as co-chairs and co-vice chairs of the Commission.

At the moment there is no Commission website.  Normally the FACA Database would be the place to look for advisory committee information when there is no dedicated website.  However, I cannot access it as of this writing.  Hopefully this will be resolved in advance of the Commission’s first meeting in early February.

Lawsuits ‘R’ Us: 23andMe & Goldieblox

Two technology-oriented lawsuits of note for your weekend reading:

Besides the issues the Food and Drug Administration has with genetic sequencing firm 23andMe, the company has a lawsuit on its hands.  It’s a class action lawsuit filed in federal court.  Much like the FDA’s concerns, the class action focuses on how 23andMe represents the health screening tests it provide(d).  What I missed during the initial reporting is that there are two aspects to how the company markets its health screenings, both of which are suspect in the absence of rigorous proof of the validity of its tests.  Not only would consumers rely on the results for assessing their genetic health, but researchers using the company’s health databases depend on the reliability of that data.  If the company could not satisfy the FDA on the reliability of its tests, how can its customers depend on its data?

Apparently a letter of apology wasn’t enough to get GoldieBlox off the hook for how it used a Beastie Boys tune in a promotional video.  That GoldieBlox pre-emptively sued to establish a right to fair use certainly didn’t help.  The band has countersued the company, alleging systematic infringement of intellectual property – and not just their own.  In their Answer, the band asserts the following (page 7): Continue reading

Google Books Ruled Fair Use; Likely To Be Appealed

I had fallen off posting about the Google Books settlement process a few years ago.  But recently there was some serious action.  The federal judge who had been monitoring the settlement process (before rejecting it) ruled recently that the Google Books effort does not violate copyright law.

The major legal issue behind Google Books, which makes books available for search (with limitations), is whether or not making this content available online without compensating authors violated their copyright interests.  Part of the reason that the judge ruled no is that Google Books will only return clips of books if the service does not have permission from the authors.  (The ruling provides more details about how Google Books works.)  Additionally, the service was found not to be a replacement for the original works, but a service for finding and locating copies of the works.

The ruling follows a lengthy effort to try and settle the case, which was initiated by the Authors Guild and other parties concerned with infringement of their copyright interests.  The settlement efforts attempted to set up a system to find and then compensate the authors of so-called ‘orphan works’ – works for which the rights holders have been difficult to find.  Those efforts failed, which led to the ruling today.  The plaintiffs in the case will likely appeal.

Florida Continues To Use New Drug For Executions

On Tuesday Florida executed its second condemned man with the use of midazolam in its three-drug protocol.  The drug is still the subject of a lawsuit by death row inmates because of concerns midazolam (intended as an anesthetic) may leave prisoners in extreme pain as their lives are ended.  The reasoning is that such pain would violate the Eighth Amendment prohibition against cruel and unusual punishment.

Florida has turned to midazolam because of restrictions on other drugs have limited supplies.  Ohio was scheduled to use midazolam for the first time in an execution on the 14th, but the inmate requested that his organs be donated.  This prompted the governor to stay the execution pending an examination of how inmates could donate their organs post-execution.

But, as might be expected, Texas continues to execute with only small adjustments.  They are not using midazolam, but their reliance on compounding pharmacies and heightened secrecy surrounding how its drugs are acquired have prompted a lawsuit.  Missouri, which had delayed an execution due to concerns over how it obtained propofol, will move forward with that execution later this month.  It will use pentobarbital, but there are similar concerns over how it obtains its drugs.

If there is to be action from these court cases around compounding pharmacies, it will be over possible violations of existing state laws around public information and/or state procurement of resources.  Courts have not been sympathetic to concerns over how effectively drugs have been tested.  There will be more opportunities to check this hypothesis as states continue to execute prisoners.

Another Year, Another Genetics Test Patent Challenged In Court

Not that it was really expected, but recent action in the courts suggests that the Myriad Genetics case has not settled the legal standing of patents on testing of genetic sequences.

The new matter involves two companies in a lawsuit over the patenting of a genetic test for Down Syndrome (H/T ScienceInsider).  On the 30th, a Federal judge in California invalidated the patent licensed by Sequenom since 2011.  The test Sequenom developed and patented is new and different, utilizing a different technique and demonstrating marked increases in efficiency compared to other methods.  They were sued by Ariosa Diagnostics for a declaration that a test Ariosa developed did not infringe on Sequenom’s patent.

The judge’s order, which granted Ariosa’s motion for summary judgment (and rejected Sequenom’s motion), focuses on whether various claims of the underlying patent address eligible subject matter.  Specifically, whether or not patenting the uses of paternally-derived cell-free fetal DNA in the test constitutes the patenting of something novel and therefore patent-worthy.  The judge was persuaded that the test constituted the application of conventional techniques to a new natural phenomenon, and did not pass the patent-worthy threshold.  Relying on the decisions in both the Myriad case and the other recent medical test patenting case, Mayo v. Prometheus, the court found that the only inventive part of the patent was the use of cell-free fetal DNA, and thus not patentable.

This case is only at the District Court level, and Sequenom has stated it will appeal the decision.  Ariosa is pleased with the decision, and given the tenor of its press release, would likely meet Sequenom’s ‘vigorous’ defense with vigor of its own.  A visit to the Supreme Court in 2016 or so is plausible.