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.

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.

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.

The Supremes Unanimously Split DNA In The Myriad Genetics Case

Earlier today the Supreme Court announced its ruling in the case Association for Molecular Pathology vs. Myriad Genetics, Inc.  (Remember, I am not a lawyer.)  The case involves patents on genes (BRCA1 and BRCA2) that correlate with higher incidence of breast cancer and a genetic test that focuses on those genes.

SCOTUSBlog has collected a lot of coverage and analysis on the case, and I recommend you spend some time there.  I need to do the same before writing a lot about the case, if I end up finding something that doesn’t get covered elsewhere.  Again, I am not a lawyer.

The Court ruled 9-0 to affirm part of the case and reverse part of it.  What the court upheld was the ability to patent cDNA (complementary DNA), which is DNA synthesized or cloned from messenger RNA.  While cDNA is produced naturally, it is common to develop it in the lab to help express proteins and perform other functions.  The Court appears to conclude that the level of process to produce cDNA makes the end result distinct enough from ‘natural’ DNA to be eligible for patent protection, to not be a ‘product of nature’.  In the context of the Myriad Genetics tests, what remains legally patented are the right to synthetically create cDNA of the two BRCA genes.

By comparison, the Chakrabarty case (referenced on page 12 of the opinion), which opened up the possibility of patenting various forms and/or pieces of life, four plasmids were added to a bacterium that enabled the organism to break down components of crude oil.  If you care to analogize to a science fiction example, the Supreme Court would have ruled that Data, the android from Star Trek: The Next Generation, was patentable, even though Starfleet’s Judge Advocate General determined him to be alive (second season episode The Measure of a Man”).  It’s not the strongest analogy, as Data lacks biological components (I welcome better examples).

What was reversed were the patent claims addressing isolated sequences of the BRCA1 and BRCA2 genes.   Continue reading

Seed Patents Survive In The Supreme Court; Signs Unclear For Similar Patents

As should be noted for all court case analysis, I am not a lawyer.

On Monday the Supreme Court issued its opinion in Bowman v. Monsanto, a case involving a farmer (Bowman) attempting to use seeds that were descended from Monsanto-engineered seeds.  Monsanto believes that its intellectual property covers not only the original seeds and any of their descendants.  Bowman argued that the patents do not cover seeds replicated from the patented seeds.  The doctrine of patent exhaustion typically means that the intellectual property rights cover only the first sale of a product (this preserves the possibility of used markets in a variety of goods).

The Court ruled unanimously in favor of Monsanto.  Instead of considering what Bowman did as resale, the Court considered the replanting and harvesting of Monsanto-engineered seeds as copying, which does not fall under the protection of patent exhaustion.  When Monsanto sells the seeds originally, the licensing agreement that must be signed permits selling the resulting seeds as a commodity, and while Bowman purchased the seeds from a grain elevator, he used them for a different purpose, thus violating the license.

The Court makes a point of stating it is limiting its ruling to this particular kind of ‘self-replicating product’

“Our holding today is limited — addressing the situation before us, rather than every one involving a self-replicating product. We recognize that such inventions are becoming ever more prevalent, complex, and diverse. In another case, the article’s self-replication might occur outside the purchaser’s control. Or it might be a necessary but incidental step in using the item for another purpose.”

While the opinion specifically mentions software programs, I can see the possibility that gene patents could be considered as self-replicating products.  How that argument might fare legally is unclear to me.  I can see it being interpreted as like making copies, but since the associated uses of the gene patents like the Myriad case is not in discrete products like seeds, I’d resist making such a clear parallel.  We should see how the Court looks at this very soon.

BRCA Patents Are Working Through The Courts Down Under

The Supreme Court will soon hear a case concerning Myriad Genetics and its patents of genes associated with breast cancer.  The main issue is whether or not the patenting of this genetic material for the purposes of lab tests is valid.

At least one other country is dealing with the same question through its courts.  Australia’s Federal Court ruled on Friday (H/T The Conversation) that the Australian patent for the BRCA1 gene is valid.  In short, that there was sufficient work done to create within the patented material an ‘artificial state of affairs’ that made the work patentable.  The Judge in the case did not consider it an easy decision.

“The real problem lies in knowing, or rather not knowing, what degree of human intervention is necessary before it can be concluded that the requisite artificial state of affairs exists. It is an especially difficult problem in the present case, not so much because the authorities provide no clear solution to it, but because the problem has an almost metaphysical dimension to it.”

Remember folks, I Am Not A Lawyer, and I’m not Australian.  The rest of the judgment provides useful Australian legislative history, suggesting that the country’s Parliament has considered, and may still, refine the requirements for patents related to genetic material.  As this is the first judicial action on the matter, the judgment is somewhat conservative – judicially speaking.  Recognizing that the legislature may yet act to change the legal landscape, the judge in this case seems disinclined to write new law – which is usually the case.

The Federal Court “shares first instance jurisdiction with the Supreme Courts of the States and Territories in the complex area of intellectual property (copyright, patents, trademarks, designs and circuit layouts).”  So the case started with this court, and there are possibilities for appeal.  The Applicants (plaintiffs) have until March 8 to file an appeal.  I would not be surprised if they did.

Supreme Court Wants To Hear More Cases Involving Genes

This blog has spent some time on the Myriad Genetics case, which should come before the Supreme Court in late March.  It focuses on patents connected to genetic testing.  Another genetics case is coming to the court, this one agricultural in nature (H/T Science – full article behind paywall).

Monsanto has developed a series of agricultural products that are pesticide-resistant.  Per their brand name, these seeds are “Roundup Ready” and can handle being sprayed by the Roundup pesticide.  The case coming to the Supreme Court comes from a matter involving the use of the progeny of these “Roundup Ready” seeds.  Bowman has purchased and used Roundup Ready soybean seeds and complied with Monsanto requirements for their use.  However, he also purchased and planted commodity seeds, many of which are the offspring of soybeans grown by Roundup Ready seeds.  The major question before the court concerns whether or not the patents on Roundup Ready soybean seeds apply to seeds that are produced by crops grown by the ‘original’ seeds.

Per SCOTUSBlog, Bowman vs. Monsanto Co. will have oral arguments on February 19.

Supreme Court Decides To Hear Gene Patents Case

The last time this blog addressed the Myriad Genetics case, involving the patenting of two genes that show a strong correlation with breast cancer, an appellate court had reconsidered the case at the direction of the Supreme Court.  The order was a mixed bag, upholding the companies claims on the gene patents, but not on the testing method for cancer risk.

This latest ruling was appealed back to the Supreme Court, which earlier today agreed to hear the case (again) (H/T The New York Times).  The Court will only hear one aspect of the certiorari petition – the question of whether human genes are patentable.  The dispute centers, at least in part, on whether isolating the genes makes them sufficiently different from those in the body in order to be patentable.

The granting of certiorari does not include a date for oral arguments.  They could happen anytime during the current term, which runs until late June.  SCOTUSBlog, a reliable source for Supreme Court activities, suggests arguments will be heard in March.

Myriad Genetics Case Moves Sideways

Remember, I am not a lawyer (IANAL), and I am not a compensated judicial prognosticator.  I was wrong in my last post about the Myriad Genetics case.  The appeals court issued a order today, which is hardly the fall.

Quick refresher – the Myriad Genetics case concerns the patents connected to two genes that have strong connections with breast cancer – BRCA1 and BRCA2.  Myriad Genetics holds patents on those genes and on genetic tests connected to those genes.  The case was previously awaiting argument before the Supreme Court when a separate case, Mayo v. Prometheus, was decided by the Court.  Because the decision in that case was closely related to Myriad Genetics, the Supreme Court asked the lower court to reconsider the matter in light of the Mayo v. Prometheus decision.

The order does not come down clearly on one side or the other with respect to the parties in the case.  The order affirms the district court decision invalidating the patent claims on testing methods (it considers the methods to cover only patent-ineligible abstract steps).  It reverses the lower court’s decision invalidating the patent claims on the isolated sequences of DNA that comprise the breast cancer genes.

Further analysis of the order emphasizes that I am not a lawyer.  It also suggests that the Mayo case had little to do with this decision, independent of useful background.  From page 42:

“While Mayo and earlier decisions concerning method claim patentability provide valuable insights and illuminate broad, foundational principles, the Supreme Court’s decisions in Chakrabarty and Funk Brothers set out the primary framework for deciding the patent eligibility of compositions of matter, including isolated DNA molecules.”

A fair amount of the debate over patentability of the BRCA genes in this case has resolved around the interpretation of Section 101 of federal patent law (35 USC Section 101).  The court in this case argues that the isolated strands of DNA are sufficiently distinct from the same sequences in their natural state to make them patentable.  Other courts have disagreed on this point.  I’m also not a biologist, so I would point you towards legal blogs to dive deeper into the law (I’ll likely re-tweet relevant links on the blog’s Twitter feed).

My read of the appellate court decision is that they consider the District Court decision to invalidate the claims over DNA sequences an overreach.  That court essentially created new law that they were not entitled to do.  But the appellate court considers the test claims invalid because they are little more than a simple comparison.

The order includes two separate decisions, a concurring opinion from one judge (essentially taking a different angle, and incorporating more of the Mayo case, to arrive at a comparably similar decision), and a partial dissent from another.

I think the dissent could be important, as it makes a claim concerning genome sequencing that, if accurate, is worth following.  In the dissent, the judge considers the extraction of gene sequences to be insufficient to make them new genes, and therefore patentable (FWIW, I’m of the same opinion).  The dissent outlines an interpretation of the patent claim for these sequences that could cover a multitude of different molecules created by filling in the gaps listed in the patent claim.

I am assuming that at least one of the two sides in the case will appeal.  Whether the Supreme Court will hear it is unclear to me.  Once it enlightens us, I’ll post it here.

Weekend Updates: Apollo, Myriad Genetics, Rare Earth Minerals,

A few short notes updating topics familiar to these pages.

First, it’s the 43rd anniversary of the Apollo 11 Moon Landing.  As best as I can tell, for once Discovery Channel does not feel the need to repeat the MythBusters episode where they busted several “fake moon landing” myths.

The court case involving the Myriad Genetics tests for genes linked to breast cancer had oral arguments earlier today.  The company has patented the two genes for which they conduct the tests.  Currently at the Court of Appeals for the Federal Circuit, the case was remanded (kicked back downstairs) by the Supreme Court in March.  I wasn’t at the court, but it is interesting to see that James D. Watson, who helped determine the structure of DNA (and was asked about patenting DNA back then), weighed in with an amicus brief.  In the brief Watson outlines three main arguments:

  • The uniqueness and potential of human genes makes patenting them an unnecessary impediment to benefit everyone.  They are more than simple chemical compounds.
  • The goal of the Human Genome Project was to benefit everyone, and patenting genes would run counter to that goal.
  • The applications of genes – not the genes themselves – are the proper targets for commercialization.  To that end, if the court feels it necessary to permit patenting of genes, they should be accompanied by compulsory licenses for research purposes.  The discovery of additional genes requires unimpeded access to genetic information.

The court will not likely rule before the fall.

The House managed to pass a bill connected to rare earth minerals.  H.R. 4402 is now with the Senate, where it waits action from the Energy and Natural Resources Committee.  This bill is relatively limited, focusing on the regulatory processes connected to permits and environmental assessments, as well as associated court actions.  As best as I can tell, no other rare earth mineral bill introduced in this Congress has gotten passed by either chamber. And while this bill has, I don’t expect it to become law, at least this year.