IPO Files Amicus Brief in AMP v. USPTO

By Donald Zuhn --

In an amicus brief filed last Friday with the Federal Circuit in Association of Molecular Pathology v. U.S. Patent and Trademark Office, the Intellectual Property Owners Association (IPO) sets forth the organization's views regarding "two issues of vital importance to the proper functioning of the patent system."  In response to the first issue of how immediate and substantial a controversy must be in order to create declaratory jurisdiction standing sufficient to challenge the validity of a patent, the IPO contends that an actual controversy of sufficient immediacy and reality is required, that such controversy was not present in the instant case, and therefore that the plaintiffs lacked standing in the instant case to bring a declaratory judgment action for invalidity.  With respect to the second issue of whether isolated DNA qualifies as patentable subject matter under 35 U.S.C. § 101, the IPO asserts that it does.  (For the sake of full disclosure, it should be noted that the IPO amicus brief was co-authored by Patent Docs author Kevin Noonan.)

On the issue of standing, the IPO begins by citing Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1339 (Fed. Cir. 2008), for the proposition that "a case or controversy must be based on a real and immediate injury or threat of future injury that is caused by the [patentee]."  The brief next compares the facts in Association of Molecular Pathology with those in Prasco and SanDisk Corp. v. STMicroelectronics, Inc., 480 F.3d 1372 (Fed. Cir. 2007), noting that:

In contrast to the patentee in SanDisk, Myriad has not taken any affirmative action toward the plaintiffs that would create an actual controversy of sufficient immediacy and reality to warrant declaratory judgment jurisdiction.  Like the plaintiffs in Prasco, there is no evidence that Myriad either (i) had any plans to assert its patents against any of the plaintiffs or (ii) had any knowledge that any of the plaintiffs were even considering engaging in any type of infringing activity with respect to the claims at issue.

Addressing cease-and-desist letters sent by Myriad to two of the plaintiffs (Dr. Ostrer and Dr. Kazazian) on May 21, 1998; May 29, 1998; and August 26, 1998, the IPO argues that "these decade-old letters should not be considered to be sufficiently immediate to show a justiciable controversy, particularly when there is no evidence that Myriad has taken any other actions against these two plaintiffs in at least 10 years."  As for the researcher, non-researcher, and organization plaintiffs, the IPO concludes that each group "expressed at most a vague and unsubstantiated notion of being ready to engage in some undefined conduct that may or may not infringe Myriad’s patents at some undetermined time in the future."

The brief contends that the District Court's decision expands declaratory judgment jurisdiction such that "literally anyone might ask any federal court to invalidate any claim of any unexpired patent."  Under the District Court's approach to declaratory judgment jurisdiction:

[A]ny corporation, association or individual might attack almost any patent as a form of protest or to seek leverage against the patentholder.  Indeed, the present case appears to be just such a form of social protest against the principle of gene patents, based on nothing more than an unsubstantiated intent or desire to be free of the commercial constraint of well-established patent rights.

On the issue of the patent-eligibility of isolated DNA, the IPO notes that in Diamond v. Chakrabarty, 447 U.S. 303 (1980), "[t]he [Supreme] 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.'"  Describing the process by which DNA is "ioslated," the brief explains that:

In isolating the claimed DNA, an inventor typically identifies a cell that expresses a gene, obtains the mRNA from the cell and enzymatically converts it into DNA before it can be isolated.  The enzymatic conversion is performed by a viral enzyme called reverse transcriptase that is absent from cells that have not been infected by a virus that produces the enzyme.  Significantly, DNA copies of mRNAs encoding isolated human DNA do not exist without human intervention, i.e., prior to their synthesis by a researcher.

In view of this process, the IPO contends that claims to isolated human DNA satisfy the Chakrabarty requirement that patent-eligible subject matter show the hand of man.

The IPO argues that the District Court's decision, which concerns human DNA, "applies with equal force to isolated DNA from other organisms," and warns that "[b]anning patenting of isolated DNA from all known organisms would have widespread and deleterious effects on human health, nutrition, and progress."  The IPO also notes that patents on isolated human DNA support the development of biologics, and that "[i]f the district court’s decision that patents on isolated human DNA are directed to patent-ineligible 'natural products,' then biologics perforce would be patent-ineligible as well."  The brief also outlines how the District Court's decision, if affirmed, would adversely impact the personalized medicine industry by removing patents needed to promote investment and development.  Finally, the brief contends that "[a]bsent patent protection [for isolated human DNA and patents on diagnostic uses of genetic information], and under the circumstances of multigenic causation (or at least association) of common diseases, the impetus will be to develop and protect this nascent technology using, inter alia, trade secret protection."  The brief concludes that:

If the standard for patentable subject matter applied by the District Court were adopted, it could render broad categories of important inventions patent-ineligible, including most biologic drugs, antibodies, antibiotics, hormones, metabolites, proteins, and genetically-modified organisms and food.  This in turn would have a devastating effect on the viability of large portions of the biotechnology, pharmaceutical and other industries, industries that are built upon the availability of valid and enforceable patent protection for the fruits of their costly and risky research efforts.

Briefing Update:  Patent Docs has learned of three additional amicus briefs that were filed by last Friday's deadline:

• American Intellectual Property Law Association (AIPLA), in support of reversal, but in support of neither party (brief)
• Christopher M. Holman and Robert Cook-Deegan, in support of neither party (brief)
• Rosetta Genomics, Ltd., Rosetta Genetics, Inc., and George Mason University, in support of Defendants-Appellants, supporting reversal (brief)

We thank our readers for bringing these additional briefs to our attention and note that we are interested in securing copies of any other amicus briefs that may be filed in this appeal.

For additional information regarding this and other related topics, please see:

• "AMP v. USPTO -- Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010

Comments

[Skeptical]

Will Standing trump Eligibility, or will the court take up the Supreme Court's invitation in Bilski and use this opportunity to better define that subject?

Good job Dr. Noonan, you've laid out the law nicely.

[gasstationwithoutpumps]

I believe that the current patenting of DNA does not use the correct criteria in distinguishing between works of nature and manipulated DNA, and that the amicus brief errs in still allowing cDNA (which is just a transcription of naturally occuring RNA sequences) to be patentable.

More on my blog at http://gasstationwithoutpumps.wordpress.com/2010/10/31/patentability-of-dna/

[6]

In other news, people loled at the IPO's brief.

Also, Kev, why get so worked up? If you guys need protection for your little molecules, why not just go ask congress for a molecule patent statute? I'm sure they'll be happy to oblige.

[Kevin E. Noonan]

Dear Gas:

You are certainly entitled to your opinion. I agree that the distinctions raised by the DOJ are inapt, but of course I come to the conclusion that isolate DNA is also patent-eligible.

Thanks for the comment.

[Kevin E. Noonan]

Dear 6:

Always happy to amuse you and your peeps.

Not to worry about me, though - I'm not worked up at all. By the way, Congress has already passed a law that protects my "little molecules" - it's called Section 101.

Always nice conversing with you. Did you decide on that California job yet?

[David Koepsell]

so, Kevin, if gaseous, isolated O2 is also patent-eligible, as you seem to have remarked here or elsewhere, is there anything that fails under the Diehr and Chakrabarty standards? What do you think an abstract idea, law of nature, or physical phenomenon is, exactly? Can you give an example? Why isn't the isolation of genes accomplished via transcription in nature?

[Kevin E. Noonan]

Dear David:

Now, let's get things in context. My point is that purified oxygen, as produced by Priestley, should have satisfied the requirements for a composition of matter in the 18th Century. This is based on the then-prevaling belief that combustion was dependent on the quantity of phlogiston in combustable substances. I am not arguing that oxygen is patentable today (and of course the argument is hypothetical because Priestley isolated oxygen before there was a Patent Act, or a USA, for that matter).

Plenty of things fall within the proscription of Diehr and Chakrabarty (keeping in mind that methods and tangible articles have different standards). Per Judge Dyk, a leaf isn't patentable, nor is a stone, or water, or most things in the natural world as they exist in the natural world. (That past phrase should be in italics.) The reason is simple - they do not show the "hand of man" and have not been changed in any way from their natural state. Bear in mind that none of these things is either a law of nature, a natural phenomenon or an abstract idea; I use Judge Rich's calculus on patent eligibility rather than the absence of teachings from the Supreme Court on this point.

Finally, genes are not isolated via transcription. In addition, what nature produces is a single-stranded RNA molecule that is unstable, unisolated and useless for making proteins outside the cell. I think those biological, chemical and physical differences are enough to distinguish mRNA from isolated cDNA (and I don't think mRNA infringes claims to cDNA, so if you want to practice the invention by isolating lots of mRNA and trying to get a cell to express it, be my guest).

Thanks for the comment. I assume no baby yet, or you would have more pressing things to do than chat with me. Good luck.

[David Koepsell]

Thanks, Kevin, I see clearly now where we differ. I see the leaf, stone, and other things in the natural world as directly analogous to the gene, as each could be isolated through human intention from their "natural state." I also abide by Diehr and Chakrabarty's guidance and see each of these as natural phenomena. My point about genes is that the process of transcription indicates that the isolation of the gene occurs via the placement of the promoter and stop codons... the information itself isolates the gene from the rest of the genome. Transcription relies upon this natural isolation.

So tell me what you think constitutes a real natural law, physical phenomena, or abstract idea. I am really curious, or do you think these are useless categories that we should ignore?

We are waiting on tenterhooks, and following this debate is a good distraction.

best,
David

[Skeptical]

David,

I do not understand what you mean by your statement of "as each could be isolated through human intention from their 'natural state.'" I think that you are redefining "isolating" to mean a mere separation without more. "Isolating" in the instant claim context is decidedly different. You then seem to hold a completely different meaning of "isolating" with the codons that has nothing at all to do with the separation from the rest of the molecular chain.

That's a lot of effort to piece together definitions and examples to fit your position while ignoring what is actually happening here.

[Kevin E. Noonan]

David:

I don't see how placement of promoters, etc. Constitues isolation. Demarcation, maybe.

Natural law is gravity. Patentable use would be machines that use gravitational force to translate into something else - hydroelectric dams come to mind.

Natural phenomenon is wind. Patentable use would be a windmill - I'm sure you know what those are. :)

Abstract idea is the gene theory of disease. Isolated DNA a patentable use (sorry, I couldn't resist).

Glad to provide a diversion. Can't wait for the Facebook pictures.

Best, Kevin

[David Koepsell]

Kevin, it seems to me that you distinguish between natural and unnatural demarcations, and are willing to grant inventiveness to unnatural demarcations even if they end up being identical to natural ones. So the examples I have frequently used are natural vs. Fiat borders around landmarks (my recurring example is the Devil's Tower), or perhaps the junction between a leaf and a branch. In the one instance, a leaf fals from a tree, no human intention, thus no patent-eligible artifact. In another instance, a human snaps the leaf from off the tree, so I assume that to you is human involvement sufficient for inventiveness. In the one instance, photosynthesis isolates an O2 molecule from CO2, thus, not patent-eligible, in another instance, a human devises a way to isolate the very same molecule from mercuric oxide, or maybe by electrolysis from water, and so now suddenly the same molecule is patent-eligible. The boundaries in each of these cases ore-exist human intention. The underlying objects in each case are identical, but for you, as soon as the slightest bit of human intention is involved, an otherwise natural object, defined by natural boundaries, becomes patent eligible. This seems to conflates a process and a product, and unnecessarily populated the world with objects. Suddenly, there are, for instance, mercuric-oxide-liberated O2 molecules vs. Water-liberated- O2 molecules. This sort of lack of ontological sparsity is maddeningly strange to me.

Oh, and I got a sweet new camera, so the Facebook pics of the child will be awesome, let us hope.

[David Koepsell]

By the way, one other puzzling thing... When does an idea become abstract. The gene theory of disease is certainly abstract. The idea of Canavans disease is also abstract (as it is a tup, not a token). A particular instance of Canavans disease is not abstract. My point is, the term abstract applies, technically, to all ideas since all types are necessarily abstract and all instances necessarily concrete. If we agree that all abstract ideas are not patent-eligible, then we should agree that the type represented by the token in the claims that patent Canavans disease are not patent-eligible.

Just a thought.

[EG]

David,

We've had this debate before. The problem you're having is apply "philosophical theory" to practical reality.

The "isolated" DNA sequences claimed by Myriad aren't made by "mother nature" and cannot be made by "mother nature." Tell me how "mother nature" does, for example, PCR required to get these "isolated" DNA sequences? As Kevin points out "genes are not isolated via transcription" which is "mother nature's" process. Put differently, we aren't simply picking up rocks or plucking leaves when we "isolate" these DNA sequences.

More significantly, these "isolated" DNA sequences don't operate like when these sequences are present in the native DNA. In fact, the properties of these "isolated" DNA sequences are very different from the native DNA. Read the Myriad, AIPLA and BIO briefs, and you'll find out why this "isolated" DNA has very different properties.

I also agree with Kevin that "isolated" oxygen is different from oxygen in air, and we're lucky that it is (I also happen to be an undergraduate chemist). Can you imagine how flammable our world would be if we didn't have that ~80% nitrogen in the air!

BTW, best wishes on the new addition to come. As a parent of two boys, it's an exciting time.

[David Koepsell]

Hi Eric, yes I know we have debated it before, and I was once a lone voice in the wilderness, and now courts and the DoJ are making my arguments. Perhaps we are all stupid, deceived, etc., or perhaps we have a point. My point is that the sequences that are identified, of not modified, belong to the class of objects excluded by Diehr and Chakrabarty, as would O2. Usefullness is not enough, there are parts of the universe, what I have called commons-by-necessity, that cannot ethically be monopolized. I argue that the sequences that Myriad and numerous others identified belong to that class of objects. Under your view, even laws of nature and physical phenomena, like O2, even though molecularly identical to O2 produced by photosynthesis, becomes a new thing if produced by man. This overpopulated the world illogically, and unnecessarily. Give Myriad the method claims, if new and non-obvious, but not for a new product since the product is a physical phenomenon pre-existing human intention.

And thanks for the mazel tovs, we are still waiting now a week past the due date and eager and anxious.
David

[EG]

David,

Thanks for the reply. I didn't figure we would agree on this.

You view this issue from a philosophical and ethical standpoint, while I view this issue strictly from a legal and especially IP law standpoint. From an IP law standpoint, "isolated" DNA, as well as oxygen extracted from air, are not "natural phenomena"; only human intervention can create these entities, which under Chakrabarty, means these are patent-eligible (but not necessarily patentable).

I understand your point of view and you certainly understand mine. That means we're simply going to have to "agree to disagree." Also, I would be very surprised if the Federal Circuit agrees with Sweet or you (with the exception of Judge Dyk).

Peace.