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October 30, 2010

Putting Genes On

In May 2009, the ACLU and PUBPAT filed suit to overturn DNA patents: claims to both isolated DNA and methods of isolating DNA. In March 2010, NY Southern District Judge Sweet soured on isolated DNA as unpatentable subject matter under 35 U.S.C. §101. Billions at stake, hopping-hot corporate toads and "pity the patient" poobahs have pummeled the CAFC with amici briefs, for what is referred to as the Myriad matter - Myriad Genetics is the owner of the target patents. Now the Department of Justice (DOJ) has weighed in, against the patent office, which granted the target patents.

The anti-patent position, per the DOJ: "The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth."

The ACLU estimates that around 20% "of all human genes have been patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma, and many other illnesses."

In its amicus brief, the pro-corporate Intellectual Property Association (IPO) argued lack of standing, as there was no "actual controversy."

More substantially, the IPO argued that DNA is patentable as a "composition of matter" and "manufacture" in light of Diamond v. Chakrabarty.

The Court fashioned a straightforward test of whether a manufacture or composition of matter was patent-eligible: it must demonstrate the hand of man, something that is "a product of human ingenuity 'having a distinctive name, character [and] use.'" Chakrabarty, 447 U.S. at 309-10 (citing Hartranft v. Wiegmann, 121 U.S. 609, 615 (1887)). The Court distinguished Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), in this regard, where the patentee had discovered only "some handiwork of nature" and thus had discovered something that was not patent-eligible. This is the proper standard for patent- ineligibility. Anything that evinces the hand of man is patent-eligible, according to the Court.

The DOJ argued that "isolated but otherwise unmodified genomic DNA is not a human-made invention."

Hal Wegner on the DOJ getting down with the Funk (i.e., citing Funk Brothers to support its anti-patent position).

A critical underpinning for the decision below is the false concept that Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), has a holding keyed to patent-eligibility under 35 USC § 101, which was perpetuated in Bilski v. Kappos, 130 S. Ct. 3218 (2010). Nothing could be further from the truth. The mistake is perhaps understandable, given the statement by the Supreme Court in Bilski that names "three specific exceptions to § 101's broad patent-eligibility principles", citing in particular Funk v. Kalo. See Bilski , 130 S. Ct. at 3225 (citing Funk v. Kalo, 333 U.S. at 130).

Appellant in its principal brief in Myriad has, however, correctly understood and explained the critical distinction that shows that Funk v. Kalo was focused upon patentability under what today is 35 USC § 103, and not patent-eligibility.

If outlawed, the IPO tallies over 30,000 DNA patents that would meet the grim reaper, a low patent body count by KSR massacre standards.

The IPO then argued a scary strawman slippery slope: if isolated DNA is banned, the courts just won't know where to stop: biologic drugs that "have improved medical treatments, reduced suffering, and saved the lives of many Americans" would be able to do so without having to pay the pretty penny for the patent protection racket. But then, argues the IPO, without the racket, no ball.

Biologics, like other drugs, are cost- and investment-intensive to develop and commercialize, and may in fact be more expensive to develop than conventional therapeutic drugs. Development of a single biologic drug product can take up to 12 years and cost over $1 billion to bring to market.

Patent protection is necessary to support this level of investment and risk, and its absence can be expected to severely inhibit further development of biologic drugs.

However the CAFC opines, the Supreme Court will doubtlessly wrestle with DNA as patentable subject matter, though that's likely late in the decade.

Posted by Patent Hawk at October 30, 2010 3:47 PM | § 101

Comments

Assuming standing, am I the only patent attorney that thinks that the DOJ's line is actually the correct one on 101? If all you're doing is isolating a DNA sequence that is already present in nature and using it for the same purpose it was intended, then there's no patentable subject matter.

And if that's all those 30k patents claim (I doubt it), then I have no problem with the carnage.

Posted by: mmm at November 1, 2010 6:19 AM

I agree, mmm. I've always wondered why anyone considered such activity to be patentable.

Posted by: Defector at November 1, 2010 8:29 AM

What with the DOJ's brief arguing that isolated genes are unpatentable, Myriad's chances of success on the merits of its case seem increasingly remote. I know some patent law practitioners reading this blog may hate hearing it, but I think that this is the right position. In any case, I hope this issue still goes up to the SCOTUS and the Court grants cert, because I'm looking forward to reading that opinion.

Posted by: patent litigation at November 1, 2010 10:13 PM

mmm wrote:
"
If all you're doing is isolating a DNA sequence that is already present in nature and using it for the same purpose it was intended, then there's no patentable subject matter."
YOU ARE CONFUSING 101 WITH 103.

Posted by: anonymousAgent at November 1, 2010 10:54 PM