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.