Federal Circuit Reverses District Court in Gene Patent Case

As expected, the Federal Circuit reversed the district court’s determination that Myriad’s gene patents are not patentable, Association for Molecular Pathology v. Myriad Genetics, Inc.  The court did rule that many of the method claims are directed to abstract mental ideas and are thus not patentable.

The three judges on the panel each wrote a separate opinion relating his or her views of the case.  Judge Lourie wrote the opinion of the court.  Judge Moore wrote a lengthy concurring opinion, and Judge Bryson concurred in all parts of the court’s opinion except the portion about isolated genes.  He would hold isolated genes to not be patentable subject matter.

Standing

First, the Federal Circuit held that, of all the plaintiffs in the case, only Dr. Harry Ostrer has standing to challenge the patents-in-suit.  Only Dr. Ostrer has indicated that he seeks to undertake specific activities that might fall within the patent claims.  The other plaintiffs merely indicate more hypothetical “some day” intentions to do so.  This is not adequate to confer standing on them to challenge the patents.

Interestingly, only two days ago, plaintiff’s counsel submitted a letter to the court indicating that Dr. Ostrer was leaving his current position at NYU to join a new lab that does not offer, and is not qualified to offer, genetic testing.  Since standing must be maintained throughout litigation, it would seem that this letter would effectively end the case as no other plaintiffs meet the standing requirement.  The court did not address this development in its opinion.

HT:  Hal Wegner

Isolated DNA Molecules

Next, the court addressed whether isolated DNA molecules are patentable subject matter.  After analyzing several Supreme Court decisions, including Chakrabarty and Funk Brothers, the court concluded as follows.

The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature. Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given “markedly different,” or “distinctive,” characteristics.

The court then concluded that the isolated DNA claimed in this case do have markedly different chemical identity and nature from DNA found in the human body.  The court distinguished isolating DNA from purifying it.  Purifying merely removes impurities, but results in an identical molecule.  Isolated DNA, by contrast, has been cleaved from a much larger DNA molecule, resulting in a distinct chemical entity.

In so holding, the court rejected the government’s view that isolated DNA should not be patentable, pejoratively referring to the government’s position as advocating a “magic microscope” test. 

The court also briefly addressed the other hypotheticals raised in various amicus briefs, such as elemental lithium, mining minerals from the earth, atomic particles like electrons, and organs like kidneys.  None of these results in a compound having a distinct chemical identity.  The court dismissed arguments about the claims’ breadth by noting that only the issue of patent eligibility was before the court, not the adequacy of the description.  The PTO has granted patents like these for many years.  Any change in policy should come from Congress, not the courts.

Judge Moore wrote a separate opinion concurring in the court’s judgment.  She goes into much more scientific detail on the various types of DNA and genes in the case as she concludes that isolated DNA has markedly different characteristics and utility than DNA in the body.  Her opinion seems to have been written almost entirely as a rebuttal to Judge Bryson’s opinion dissenting on this issue.

She also cautions courts against adding further judicial exceptions to the law of patentable subject matter.  She cites a number of very old patents claiming isolated molecules and compounds.  The settled expectations of the biotechnology industry must be given deference.

Judge Bryson argues that the only changes to the isolated DNA from those occuring in the body are incidental to their removal from their natural environment.  He does agree with the court that cDNA molecules do not occur naturally in the body and are eligible for patenting. 

Methods of Comparing or Analyzing Sequences

Next, the court turned to the patent eligibility of the method claims in the case.  The court held that the claims to “comparing” or “analyzing” two gene sequences are directed to abstract mental processes and are therefore not patent eligible.

The court distinguished these claims from those at issue in Prometheus because the claims in that case required a transformation step.  The comparison in this case is the result of mere inspection alone.

Method of Screening Potential Cancer Therapeutics

The court held that this claim is directed to patentable subject matter because it includes the step of “growing” the cells prior to their comparison.  This growth results in a transformation of the cells.  Other manipulations are also involved.  Thus, the claim is not directed to abstract ideas.

Summary

It will be interesting to see what happens on the standing issue.  The court made clear that only Dr. Ostrer has standing to bring this case.  Therefore, once he no longer has standing, the case should end.  The remaining plaintiffs are asking the court to provide an advisory opinion.  This, federal courts cannot do.

If the standing issue does not end the case, however, the plaintiffs will undoubtedly petition the Supreme Court to review this case.  That was their goal all along.  I can’t see what they would gain by requesting en banc review.  I would expect a cert. petition to be filed soon.

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6 Responses to “Federal Circuit Reverses District Court in Gene Patent Case”

  1. trademarkapplication2011 Says:

    Here is a similar story

    Biotech companies got a break today when a U.S. appeals court handed down a long-awaited ruling on gene patents in a case prompted by a suit involving Myriad Genetics of Salt Lake City. In a split decision (2-1), the court ruled broadly that genes can be patented. This was contrary to a lower court’s decision last year, which found that genes cannot be patented because they are “products of nature.” (The dissenting appeals judge sided with the lower court.) At the same time, five of Myriad’s specific patent claims were thrown out for being too abstract.

  2. Pharma & Biotech Global Week in Review 3 August 2011 from IP Think Tank Says:

    [...] Office (Orange Book Blog) (IP Watch) (KEI) (Patent Docs) (Patent Docs) (IP Spotlight) (Patently-O) (Inventive Step) (Patentology) (Patent Law Practice Center) (IPBiz) (Out-Law) (PharmaPatents) (Maier & Maier) [...]

  3. Federal Circuit Rules Beauregard Claims are Unpatentable « INVENTIVE STEP Says:

    [...] On the computer-readable media claim, the Federal Circuit overruled a great deal of precedent and is in conflict with a great deal more, including some that it attempted to distinguish.  The opinion calls into question literally tens of thousands of issued patents that were patentable under prior court precedent.  Some are even suggesting that this case could have implications for further review of Myriad. [...]

  4. Patentable Subject Matter at the Supreme Court « INVENTIVE STEP Says:

    [...] the district court held that Myriad’s patent to isolated genes were not patent eligible, the Federal Circuit reversed.  The court did hold that several claims to methods of comparing and analyzing gene sequences were [...]

  5. Reaction to Prometheus « INVENTIVE STEP Says:

    [...] order in the Myriad gene patent case.  The Court Granted the petition for certiorari, Vacated the Federal Circuit opinion, and Remanded the case back to that court for a further decision in light of the Supreme [...]

  6. Federal Circuit Holds Isolated Genes to be Patentable Subject Matter – Again « INVENTIVE STEP Says:

    [...] to check the date on this opinion because it is so similar to the earlier–now vacated–decision from July 2011.  Despite the Supreme Court’s admonition to reconsider its holding in light of [...]

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