What We May Learn from the Myriad Oral Argument

By Kevin E. Noonan --

The U.S. Supreme Court heard oral argument in Association for Molecular Pathology v. Myriad Genetics, Inc. on Monday, and many have commented on the Court's interrogation of the parties' representatives (and the government) and how those representatives responded to the Justices' questioning.  On balance, it seems fruitless to bemoan the apparent difficulties the Court has with these issues; to paraphrase the sponsor of the aspartame patent term extension (private) bill, "you go to patent law with the Supreme Court you have."  Equally unavailing are discussions of the ACLU's perfidity (in advancing arguments having little resemblance to the law or the facts), the government's duplicity (asserting that genomic DNA should not be patent-eligible after more than thirty years of granting, and continuing to grant, such patents), any perceived incompetence by Myriad's representatives (for being unable to do the near impossible in answering the Court's sometimes incoherent questions) or Myriad's irresponsibility (for continuing a suit on patents that do not protect its core business and putting at risk patents to others necessary for commercialization).

While assessing (or worse, trying to predict) the Court's take on the issue, there are a few aspects that are evident:

Bad analogies make bad law:  Isolated human DNA is not a tree (Justice Kagan); sap from a tree (Justice Breyer); a chocolate chip cookie (Justice Sotomayor); a baseball bat (Greg Castanias); or a liver or kidney (Chris Hanson).  Instead of dancing around the issues by waxing poetic with analogies, the Court might have (and at least Myriad should have given them an opportunity to) considered more realistic comparisons.  For example, it should not too much to ask the Court if any of the following are or should be patent-eligible:

• Isolated chemical compound from crude oil useful as a lubricant
• Isolated chemical compound from a plant useful as a drug
• Isolated antibiotic produced by bacteria
• Isolated protein from an animal useful to cure/ameliorate human disease
• Isolated cucumber gene that extends freshness
• Isolated human gene (erythropoietin)

The Goldilocks view of patent law:  Justice Breyer still believes it is the Court's role to make sure the amount of patenting is just right regarding the balance between too much (retarding innovation) and too little (providing insufficient incentives for commercialization).  And while colorful, colloquies such as the following:

It's important to keep products of nature free of the restrictions that patents there are, so when Captain Ferno goes to the Amazon and discovers 50 new types of plants, saps and medicines, discovers them, although that expedition was expensive, although nobody had found it before, he can't get a patent on the thing itself.  He gets a patent on the process, on the use of the thing, but not the thing itself.

Not only do not answer the question but obscure it.  It is also disquieting to hear that the Justice thinks that the "product of nature" prohibition is "horn-book law"; were that the case, the Court would not need to consider the question before it.

The Court remains cautious regarding its capacity to harm incentives for commercialization:  This concern was expressed by many members of the Court, not limited to those Justices (such as Justices Scalia or Alito) who might be expected to voice these sentiments.  Indeed, Justice Kennedy's questions regarding the effects of a negative decision might indicate that there are sufficient members of the Court who might be persuaded that the more prudent course would be to affirm.

The government's position has the best chance of prevailing:  Not surprisingly, the "compromise" position espoused by the government (that cDNA is patent-eligible, but genomic DNA is not) seemed to have significant traction with the Court, if only because (as it did at the Federal Circuit) the presence of the "hand of man" is most evident for these embodiments of isolated DNA claims.  (The question of whether cDNA is obvious, as discussed by some members of the Court, falls into the category of battles to be fought another day.)  The Court did not fail to appreciate the change in the government's position, with Justice Kagan dismissing the PTO's history of granting patents encompassing genomic DNA because the Office was "patent-happy" (this disparagement, while unfair is not surprising in view of the general drumbeat of a "broken patent system" over the past decade from various interest groups).

Patent-eligibility will depend on how subject matter is claimed:  This isn't new, but may take on renewed significance.  Many members of the Court seemed to think that "method" claims (of using or producing) isolated DNA would be sufficient, ignoring the experience of foreign patent systems that eschewed composition protection for pharmaceuticals, for example in favor of such method claims; these generally did not result in robust commercialization of such pharmaceutical products.  Paradoxically, of course, for isolated DNA, "use" claims may be the most important in the future, as the composition of matter claims to DNA per se will not survive into the next decade by the action of patent term limits to 20 years from filing and the publication of the fruits of the Human Genome Project between 1998-2001.  What may not be as clear (or, more troubling, may become crystal clear) is the fate of claims such as Claim 2 in this sequence:

1.  Penicillin.
2.  An isolated preparation of penicillin having a specific activity of x Units/mg.
3.  A pharmaceutical composition comprising a therapeutically effective amount of penicillin and an acceptable diluent, excipient or carrier.

Claim 1 is not patent-eligible today, as it reads on the molecule as it exists in nature, and Claim 3 should remain eligible regardless of the Court's decision in Myriad.  Whether Claim 2 remains patent-eligible will depend on how narrowly the Court bases its decision (in the event that It reverses any portion of the Federal Circuit's decision below) and the amount of dicta that accompanies such a decision.

Ironically, the ACLU may have provided the best rationale for the Court to render a decision that does not do violence to traditional concepts of patenting molecules found in nature, in the following response to Justice Alito's question:

JUSTICE ALITO: Suppose there is a substance, a -- a chemical, a molecule in the -- the leaf -- the leaves of a plant that grows in the Amazon, and it's discovered that this has tremendous medicinal purposes. Let's say it -- it treats breast cancer.

A new discovery, a new way -- a way is found, previously unknown, to extract that. You make a drug out of that. Your answer is that cannot be patent -- patented; it's not eligible for patenting,

MR. HANSEN: If there is no alteration, if we simply pick the leaf off of the tree and swallow it and it has some additional value, then I think it is not patentable. You might be able to get a method patent on it, you might be able to get a use patent on it, but you can't get a composition patent.

JUSTICE ALITO: But you're making -- you the hypotheticals easier than they're
 intended to be. It's not just the case of taking the leaf off the tree and chewing it.  Let's say if you do that, you'd have to eat the whole forest to get the [] value of this. But it's extracted and -- and reduced to a concentrated form. That's not patent -- that's not eligible?

MR. HANSEN: No, that may well be eligible, because you have now taken what was in nature and you've transformed it in two ways. First of all, you've made it substantially more concentrated than it was in nature; and second, you've given it a function. If it doesn't work in the diluted form but does work in a concentrated form, you've given it a new function. And the -- by both changing its nature and by giving it a new function, you may well have patent -­

JUSTICE ALITO: Well, when you concede that, then I'm not sure how you distinguish the isolated DNA here, because it has a different function.

Finally, the fate of claims to oligonucleotide claims is uncertain, although these claims raise other issues of patentability (not patent-eligibility) that may render them invalid if ever asserted against an accuse infringer.

The Court's decision is expected by the end of this term, some time in June.

Comments

[EG]

Kevin,

Very nice article. Glad you noted at the end the soliloquy between Justice Alito and Hansen. There's a real life example of that hypothetical: it's called Taxol. Or to put it differenlty, you could chew on the bark of the Pacific Yew tree to your heart's content, and not get any significant anti-cancer benefit from the Taxol contained therein.

[Skeptical]

Dr. Noonan states "Claim 1 is not patent-eligible today, as it reads on the molecule as it exists in nature..."

But does not state the legal basis for this.

Some will say that 102 is sufficient.
Some will say that this is a 101 issue.
But after Prometheus, no one should be saying that 102 does the work of 101.

Preventing patents on those items from nature's warehouse is not a prior art legal issue - thus 102 is not at play. Being known prior is not the driver of that philosophy (as simple 102 doctrine would then suffice).

That leaves [pun intended] 101. And since this decision was expressly remanded in view of Prometheus (and the Federal Cicrcuit gave barely even lip service to that critical driver), should anyone be surprised that the Court makes this 101 focus a central point in their decision?

[Karen Canady]

Thanks, Kevin, for clarifying the issues in a way that (quite frustratingly) has not happened much with this case. I think you pointed to the key argument for patent-eligibility and I hope that this view prevails:

MR. HANSEN: No, that may well be eligible, because you have now taken what was in nature and you've transformed it in two ways. First of all, you've made it substantially more concentrated than it was in nature; and second, you've given it a function. If it doesn't work in the diluted form but does work in a concentrated form, you've given it a new function. And the -- by both changing its nature and by giving it a new function, you may well have patent -

[Renee Marie Jones]

Wow. Absolutely NONE of your examples is legally patentable. I am sure you disagree, but that is because you care more about corporate profits than the law.

[Paul San Quentin]

@RMJ - The hypotheticals are provided to assess the specific question of subject matter eligibility - not whether they are "legally patentable" (whatever that might mean).

[6]

"Not only do not answer the question but obscure it. It is also disquieting to hear that the Justice thinks that the "product of nature" prohibition is "horn-book law"; were that the case, the Court would not need to consider the question before it."

You guys have me to thank for that *muah*.

[6]

"Claim 1 is not patent-eligible today, as it reads on the molecule as it exists in nature,"

As, strangely, the discoverer noted when he declined to patent it.

[Skeptical]

Normally I ignore the posts of Renee Marie Jones as they are typically mindless anti-patent squawking.

But in a sense, here there is a difference.

Looking closer at the claims 2 and 3, the "legally patentable" question is in fact NOT answered on its face.

By the way, I would take "legally patentable" to include both the concept of patent elibility and patentability, so I don't have too much of a qualm with that part of her reply as does Paul.

Claim 2 may not be patent eligible (or patentable for other reasons) on its face. What is missing is whether or not the specific activity is different enough from that which the product of nature has. In this sense, mere isolation may not confer enough for patentability, and is a direct result of the Court's Prometheus case.

As for claim 3, this too may fail, and again can be linked directly to the reasoning of Prometheus. The mere preamble labelling of "pharmaceutical composition" lends nothing to patentabililty (or patent eligibility), and the "diluent, excipient or carrier" portion is effectively equivalent to Prometheus' admonition that the Court's exceptions cannot be circumvented by attempting to limit the use of the item to a particular technological environment (here - the delivery mechanism, which like Prometheus is merely common and old in the art). Also like Proometheus, this is simply not sufficient to transform the nature of the claims. The "effective amount" postion falls to the same (possible) reasoning as in claim 2.

[Kevin E. Noonan]

Dear Skeptical:

I think Justice Breyer was careful to recognize an exception for a novel drug, and the hypothetical should be read to be at a time when penicillin was not known in the art. I doubt that the Court will ever say that a beneficial drug was not patent-eligible (see Justice Alito's concerns quoted in the post). And I agree that the specific activity is important per Mr. Hansen's response to the Justice.

Thanks for pointing out the need for clarification.

[Kevin E. Noonan]

Dear RMJ:

If you are not Professor Jones, my apologies to her. If you are, a few points. First, please justify your conclusions: after all, the Court is deciding the extent to which claims like the last one are patent-eligible, so a flat "not eligible" is, at best, anticipating the future.

And second, if you are teaching your students that ad hominem attack (however tempting) is an acceptable way to craft a legal argument you do them a disservice. "Renee, you ignorant slut" may be satisfying to say but is hardly persuasive legal argument.

[Skeptical]

Dr. Noonan, I do hope that Renee is of vintage to recognize the Saturday Night Live context.

[Kevin E. Noonan]

Thanks for noticing, Skep. Of course that was my reference, and I would never impugn the good Professor in that way in earnest (despite her willingness to impugn my motives).

[Riley]

Great insights on bad analogies. Thanks for the post!