Supreme Court Issues Decision in AMP v. Myriad

Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

By Donald Zuhn --

In a much anticipated decision, the Supreme Court issued its opinion this morning in Association for Molecular Pathology v. Myriad Genetics, Inc.  In an opinion by Justice Thomas, joined by Chief Justice Roberts, Justices Kennedy, Ginsburg, Breyer, Alito, Sotomayor, and Kagan, and Justice Scalia concurring in part, the Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but determined that cDNA is patent eligible because it is not naturally occurring.

Noting that "[i]t is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," the Court acknowledged that "[t]o be sure, [Myriad] found an important and useful gene," but indicated that "separating that gene from its surrounding genetic material is not an act of invention."  Justice Thomas also stated that Myriad's claims were not "saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule" because "Myr­iad's claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemi­cal changes that result from the isolation of a particular section of DNA."

The Court, however, also determined that "cDNA does not present the same obstacles to patentabil­ity as naturally occurring, isolated DNA segments."  In particular, Justice Thomas explained that "cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived," and therefore, "cDNA is not a 'product of nature' and is patent eligible under §101." Justice Thomas did provide one caveat, however, noting that "insofar as very short series of DNA may have no intervening introns to remove when creating cDNA," under such circumstance, "a short strand of cDNA may be indistinguishable from natural DNA."

Importantly, the opinion concludes by stating that "[i]t is important to note what is not implicated by this decision."  In addition to noting that the case did not involve an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes or new applications of knowledge about the BRCA1 and BRCA2 genes, the Court also indicated that it did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.  Instead, the Court indicated that it was "merely hold[ing] that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material."

Patent Docs will provide additional analysis of the opinion in a subsequent post.

Comments

[Mary]

The reasoning would appear to imply that isolated polypeptides that are identical to endogenous sequences are now no longer patentable. So this would mean that claims to isolated polypeptide sequences covering human proteins that are in therapeutic use, are no longer valid. Can you address this issue?

[Shrivan]

Good question, Mary. Dr. Zuhn has his own opinions, I'm sure, and hopefully he'll share them with everyone. As for me, I can't see that it's entirely clear that a newly discovered "isolated" protein would necesarily become ineligible simply because it occurs naturally. The holding in Myriad seems to rely very heavily on the breadth of Myriad's claims and their perceived impact on basic research and fundamental applications. If, for example, one identified a gene associated with a disease, then isolated that gene, recombinantly expressed the protein, purified it to nearly 100% purity, and demonstrated some useful result achieved with that protein, it still seems that an eligible claim to that specific, highly purified protein composition could be obtained (by distinguishing it from the much more broadly claimed subject matter at issue in the Myriad case).

I also note that in the last portion of the Opinion, the Court seems to have tried to keep the door wide open to the patenting of specifically claimed new compositions that incorporate the ineligible gene (as opposed to broadly claiming any and all such compositions with the same "information content"). In that way, a claim to methods of making the recombinant protein and compositions for making the recombinant protein (e.g., recombinant cells or vectors) would remain eligible and could provide adequate protection for the new protein invention/discovery.

This view could be viewed as "too optimistic" by some. Your mileage may vary, as they saying goes. ;)

[Mary]

Thanks for your comments Shrivan. I'd like to be optimistic too, but the reasoning that an isolated gene is a product of nature notwithstanding the cleavage of its covalent bonds joining it to the remainder of the chromosome, seem to apply directed to an isolated protein. The opinion states that "extensive effort alone is insufficient to satisfy 101's demainds." There generally is some difference between a naturally occurring human protein and its expressed counterpart, even where the amino acids are identical, due to glycosylation differences (post translational modifications). I wonder patent eligibility is going to require claims to amino acid sequences with specific post translational modifications? I look forward to further discussion on this matter.

[Dan Feigelson]

I hear you Mary, but never try to confuse SCOTUS with the facts.

Hard to predict the impact of this decision on the biotech field. As Kevin has pointed out several times, the days of the PTO granting patents with broad gene claims are long gone, so this decision may have little impact on future R&D.

Or it may have a huge impact - as a chemist I too have a hard time distinguishing cDNA from isolated DNA for 101 purposes, so if they can say that legally there is a distinction, who knows where this decision may lead (your question regarding proteins is spot-on), not withstanding Thomas' statements about what the decision is "not about", and we may find this decision heralds the death knell for biotech.

I hope for the sake of the [insert your preferred plural description] on the Supreme Court that in the future none of their relatives end up suffering from a disease for which there would have been a cure, but for their folly in Myriad.

[Mary]

Yes, I agree, they managed to kill diagnostics claims off with Prometheus. I've had all sorts of small companies/academic inventors see their dreams of licensing or developing tests based on biomarkers get really set back. The only entity that seems to be able to get claims would be pharma who simply tack on a biomarker limitation to a treatment claim for a drug they already own. I think isolated DNA as nonpatentable subject matter isn't that big of a deal, given that nobody really patents genes anyways anymore, but I am quite concerned about the implications for native protein therapeutics. However, seems that the tide is shifted a lot there too, with the polypeptide claims being directed to modified proteins (aa modifications) both for art reasons and due to the fact that unmodified unPEGylated protein drugs are not good drugs.

[Moocow]

Mary, a protein that's obtained in a recombinant expression system differs from the natural protein in its glycosylation pattern no more or less than an "isolated" DNA differs from chromosomal DNA in its methylation pattern and other epigenetic modifications. You're putting your finger on a major problem with the opinion: Myriad inserted human sequences into BACs and other cloning vectors and thereby obtained quantities of "isolated DNA." If "isolated DNA" that's been cleaved out of a a BAC is not patent-eligible, then how can a human protein that was expressed in a host cell be patentable? And what about an antibiotic that is purified straight from a fungus?

[John L]

The Supremes exhibit an astonishing ignorance of biology and fundamental patent law. Setting aside the fact that they went way beyond the question presented for cert (Are human genes patentable?) - they say “Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes….”

Really? Maybe somebody should have shown them 35 USC section 154, which is the right to exclude others, not the right to do it yourself. Seems pedantic but even a junior attorney would know better. Please, nobody ask them for a freedom to operate opinion.

[Skeptical]

John L,

I am not sure that you understand why "the exclusive right to isolate..." could not be given in a patent to anyone.

That reason is what the Court provided.

Without passing judgment on the notion of Product of Nature, do you understand what that exception aims to do?

[Albert Hall]

Thomas's reasoning about the cDNA is strange to me. Generally, cDNA is just copied from the mRNA (that a cell makes for protein production). The mRNA has the introns spliced out therefore, of course, so does the cDNA. There is really nothing new about the cDNA. It's just a translation. It's sort of like an author losing copyright protection for a book if it appears in a different language...

[Shrivan]

a protein that's obtained in a recombinant expression system differs from the natural protein in its glycosylation pattern no more or less than an "isolated" DNA differs from chromosomal DNA in its methylation pattern and other epigenetic modifications.

True enough. There could be no difference at all between the claimed "isolated" molecule and the natural molecule. It depends on how the "isolated" protein or DNA in question was obtained and, perhaps more importantly, on the definition given to the term "isolated" (either by the applicant or by a court construing the claim).

[Igor Faynshteyn, Esq.]

This is not a big deal, but the link to "opinion", mentioned in the first paragraph, does not work.

[Donald Zuhn]

Igor:

Thanks for alerting us to the broken link. The Supreme Court changed its link to the opinion.

Don