USPTO Asks out of Gene Patenting Case (Again)

    By Kevin E. Noonan --

Several weeks ago, U.S. District Court Judge Robert W. Sweet denied the U.S. Patent and Trademark Office's motion to dismiss the ACLU-sponsored lawsuit aiming for a human gene patenting ban (see "BRCA Patent Suit to Continue in Southern District of New York").  Just before Christmas, the Office filed another motion with the District Court, for judgment on the pleadings (as well as opposition to Plaintiffs' summary judgment motion).

The brief, by Preet Bharara, U.S. Attorney for the Southern District of New York and Ross E. Morrison, Assistant U.S. Attorney, is broadly based on jurisprudential principles of avoiding a constitutional issue when possible, citing Allstate Ins. Co. v. Serio, 261 F.3d 143, 149-150 (2d Cir. 2001), and Spector Motor Serv. Inc. v. McLaughlin, 323 U.S. 101 (1944) ("'If there is one doctrine more deeply rooted than any other in the process of constitutional adjudication, it is that we ought not to pass on questions of constitutionality . . . unless such adjudication is unavoidable.'")

Accordingly, the brief argues, Plaintiffs' remedy is to prevail against the other defendants on the grounds that the patents-in-suit are invalid.  The Office asserts that the Patent Act gives plaintiffs' a statutory basis for challenging the patents-in-suit, on the grounds that the claims do not recite patent-eligible subject matter under § 101.  Thus, the brief argues, should the District Court find that the Myriad patents were improperly granted under 35 U.S.C. § 101 (as being subject matter not eligible for patenting), there will be no need to address the constitutional aspects of the patent-eligibility issue.  Moreover, the Office contends it cannot be haled into court for granting a patent in contravention of the Patent Act, citing Syntex (USA), Inc. v. U.S. Patent and Trademark Office, 882 F.2d 1570, 1572-1574 (Fed. Cir. 1989).

The office then argues that for the District Court to reach the constitutional issues raised in the complaint, it must first decide that the Patent Office properly applied the relevant provisions of the Patent Act, and thus that the Patent Act itself, not just the Office's implementation of it, is unconstitutional.  With that, the brief turns to the substantive constitutional questions raised in the lawsuit, identifying two:

1.  That granting gene patents are contrary to Article I, section 8, clause 8 (termed "the IP Clause" in the brief); and

2.  That granting gene patents violates the First Amendment.

With regard to the IP Clause argument, the brief points out plaintiffs' unfamiliarity with, or ignorance of, the meaning of the Constitutional language reciting the copyright and patent clause.  Plaintiffs allege in their summary judgment brief that the claims "impede rather than promote the progress of science."  But the language of the Constitution that mentions "science" does not refer to patents but rather to copyrights, since in the 18th Century the term "science" was associated with "learning or knowledge," and what we think of as technology (what is eligible for patenting) was termed "the Useful Arts."  Thus, the brief contends that allegations that the Patent Act does not promote "science" are "not relevant" to the patent system, citing Graham v. John Deere Co., 383 U.S. 1, 5 (1966) (the brief also cites Eldred v. Ashcroft, 537 U.S. 186, 192-92 (2003), which concerned a challenge to revisions to the Copyright Act).

The Office also argues that it is "far from clear" that the preamble to the IP Clause limits the power of Congress in establishing the patent laws.  The brief cites the Eldred case for this proposition, as well as the Supreme Court's Second Amendment decision (District of Columbia v. Heller, 128 S. Ct. 2783, 2789 (2008)), where the Court held that, outside a "clarifying function, a prefatory clause does not limit or expand the scope of the operative clause" in the Second Amendment.

Continuing, the brief further argues that there are limits to the extent of review the District Court can give to the constitutional question even if it were to reach it, saying it is well established that "Congress has the power to establish a patent system as it [sees] fit."  This is essentially an argument for deference, the brief citing in support Graham as well as Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (1989).  While this power of Congress may not be "absolute," the brief contends that at most Congress' implementation of the IP Clause is subject to rational basis review, again citing Eldred:  "[u]nder that standard," the brief asserts, "courts 'accord great deference to Congress's policy determinations,' and judicial review 'is limited to whether Congress's actions were 'a rational exercise in the legislative authority conferred by the [Patent] Clause,'" citing Figueroa v. United States, 466 F.3d 1023 (Fed. Cir. 2006).

Answering its own question in this regard, the Office contends that there is no doubt that Congress had "a rational basis to believe that a statutory scheme that established broad categories of subject matter eligible for patenting . . . would promote innovation and research."  Further, whether the patents-in-suit were properly granted does not implicate the constitutionality of the Patent Act:  "[t]he fact that some patents issued under the patent system can be argued not to 'promote progress' has no bearing on the question of whether the system as a whole has a rational basis" and is "simply not relevant," citing Eldred ("In sum, we find that the [Copyright Term Extension Act] is a rational enactment; we are not at liberty to second-guess congressional determinations and policy judgments of this order, however debatable or arguably unwise they may be.")

The proper question in this regard, the Office contends, is whether permitting patents on compositions of matter and processes have a rational relationship to "Congress's legitimate objectives under the IP Clause."  Here, the brief asserts, there are "multiple plausible bases" upon which Congress could have enacted § 101.  These include that "[c]hoosing broad categories of subject matter ensured that the Patent Act would not have to be repeatedly amended to accommodate new and emerging technologies," citing Diamond v. Chakrabarty for the proposition that the Supreme Court had "specifically found that broad statutory categories fulfill the constitutional goal."  Even limiting the question to the gene patents at issue, the brief argues that Congress had a rational basis for permitting patenting in "a field of technology [that] can be expected to stimulate investment, research and innovation within this area, all to the benefit of the national economy," citing the House of Representative report on the Hatch-Waxman Act.

The brief also cites numerous academic sources for the proposition that biotechnology required intensive investment and thus patent protection to promote such investment.  The brief then cites the benefits of disclosure as a rational basis for patenting, because "other researchers learn what has been patented, and therefore are able to focus their research dollars on areas that have yet to be explored."  "Under rational basis review, the task of performing the 'careful balance between the need to promote innovation and the recognition that imitation and refinement through imitation are both necessary to invention itself and the very lifeblood of a competitive economy,' must be left to Congress," the Office asserts, citing Bonito Boats, 489 U.S. at 146.

Finally, the brief reminds the District Court that Congress had recently considered, and did not deign to pass, a bill prohibiting gene patenting, asserting that this constitutes a suggestion "that courts should tread lightly in this area."

Regarding the First Amendment argument, the brief contends that the First Amendment does not provide a substantive limitation on Congress' authority to enact patent laws.  Indeed, the Office argues that the Patent Act actually supports the concerns motivating the First Amendment, since it "promote[s] the dissemination of knowledge."  Citing Kewanee Oil Co. v. Bicron, 416 U.S. 470 (1974) for support, the brief asserts that:

[T]he Patent Act promotes free speech and general dissemination of information because it grants a temporary exclusive right to an invention in exchange for disclosure of information that might otherwise have remained secret.  By making the information about the invention available, it creates the possibility for stimulating further research in a related area as well as for one who wants to practice the invention to seek a license.  If the information were kept secret -- potentially in perpetuity, depending on the nature of the technology -- no such opportunity would arise.

The brief then contends that patents are fully compatible with free speech rights, noting that Congress enacted the first Patent Act "in close proximity" to adoption of the First Amendment.  Indeed, the Office argues, the Framers did not seem to believe there was any "tension" between the IP Clause and the First Amendment, "given the proximity in time between the establishment of the patent system and the ratification of the First Amendment."

The Office also argues that any purported impact on free speech is not unique to the patents-in-suit.  The brief mentions in particular Morse's patent on the telegraph and Bell's patent on the telephone as patents impacting "free" speech, specifically by charging a fee for speech:  "[i]n each case, individuals wishing to use these devices to communicate their thoughts or to gain access to new knowledge could do so only subject to the rights of the patentholder."  In a footnote, the brief makes this point more forcefully:

"Nothing in the First Amendment requires that the exercise of First Amendment rights be cost-free.  Those who wish to publish must pay for the equipment and labor (or internet access) required for publication; indeed, even parade demonstrators may be required to pay to exercise their First Amendment right to march," citing Cox v. New Hampshire, 312 U.S. 569, 576-77 (1941) and, more generally, Eric Neisser, Charging for Free Speech: User Fees and Insurance in the Marketplace of Ideas, 74 Geo. L.J. 257 (1985).

Even the portion of the statutes providing for remedies for infringement could, the brief asserts, "be said to regulate speech and thus, according to plaintiffs' theory, to violate the First Amendment."  Any "incidental limitation" of unfettered speech is just "a temporary burden on the public that Congress has deemed necessary to encourage invention and disclosure of inventions that inure to the public benefit," the brief contends, and it characterizes such limitation as ones on conduct, not speech, thus not implicating the First Amendment.  Making the point more strongly, the Office argues that "[t]here are few restrictions on action which could not be clothed by ingenious argument in the garb of decreased data flow.  For example, the prohibition on unauthorized entry into the White House diminishes the citizen's opportunities to gather information he might find relevant to his opinion of the way the country is being run, but that does not make entry into the White House a First Amendment right.  The right to speak and publish does not carry with it the unrestrained right to gather information," citing Zemel v. Rusk, 381 U.S. 1, 16-17 (1965).

The brief's conclusion is that:

[T]he free-speech interests here -- if any -- are subordinate to the interest in a working patent system that provides complete remedies to patentholders.  The question is not whether any given patent might inhibit more speech than it promotes, but rather whether in establishing a patent system that awarded such a patent, Congress somehow violated the First Amendment.  Because Congress did not, plaintiffs' First Amendment claim should be dismissed.

The Office then goes on the offensive in this regard, stating that the Supreme Court has held the patent statutes to "promote free speech interests," notably by Supreme Court decisions precluding information and abstract ideas from being patent-eligible (citing Gottschalk v. Benson).  Using Eldred as an illustration, the brief illustrates the infirmities of plaintiffs' First Amendment case:  the plaintiffs in Eldred raised similar First Amendment allegations against the 1998 Copyright Term Extension Act, and the Supreme Court held that the Copyright Act and the First Amendment were compatible on historical grounds (closeness in time of adoption).

The brief also rebuts the argument that patenting genes is the same as patenting information, citing Amgen Inc. v. Chugai Pharmacutical Co. ("A gene is a chemical compound"), and reminding the District Court that chemical compounds have been patent-eligible subject matter since the first Patent Act.  "[P]laintiffs attempt to blur the line between genes, which are chemical compounds, and genetic sequences, which are human-created representations that identify one of the gene's properties:  the arrangement of nucleic acids in the gene.  . . .  Plaintiffs fail to cite -- nor is the USPTO aware of -- any case law supporting the notion that a chemical (or machine or any other physical structure) that is capable of conveying information no longer qualifies for patent protection based on the fact that it has informational content."  This distinction between chemistry and information is accommodated by the Office, according to the brief, citing specifically the Utility Guidelines (wherein the Office does not grant patents on the nucleotide sequence but on the chemical), and that use of the sequence per se is not patent infringement.  Regarding Plaintiffs' argument that genes can be represented by "a series of letters" and hence comprise information, the brief also reminds the court that "[a]ll chemicals can be described in letter and number format."

The brief provides a good example of the constitutional and jurisprudential deficiencies in the Plaintiffs' arguments.  The risk, of course, is that Judge Sweet will grant the Office's motion, thus removing any incentive for the Office to weigh in on the substantive question raised in Plaintiffs' summary judgment brief -- that the patents on the BRCA1 and BRCA2 genes were improperly granted.  No matter what decision the parties receive from the Judge, the case will be appealed and eventually reach a petition for certiorari.  At that point, it is likely that the Solicitor General will set out the Administration's position on the patent-eligibility of isolated human DNA.  But it could be helpful to have the Office's arguments before the case gets to that point.

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

• "Gene Patenting: Australian Potpourri," December 28, 2009
• "Science Progress Article Examines Impact of Gene Patents on Research," December 21, 2009
• "Gene Patenting Debate Continues - Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "The Tragedy of a Bad Idea," August 25, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009
• "BIO IP Policy Briefing," May 11, 2009
• "Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
• "The Effects of Intellectual Property Protection on Agricultural Research: Patents Are Not The Problem," February 3, 2009
• "Newsweek Joins the Anti-patent Bandwagon," January 26, 2009

Comments

[EG]

Kevin,

The PTO's memorandum in support of its motion meticulously (and accurately) points out the absurdity of the ACLU's position on the constitutional claims. If only Judge Sweet would listen and simply dismiss this nonsensical lawsuit.

[Bob Cook-Deegan]

It is clear that the plaintiffs have raised constitutional issues, but it is equally clear those are not the only issues that concern the USPTO. The case could also turn on claims structure, and intricacies such as the meaning of "isolated" DNA, the breadth of claims, and the structure of claims that the examiner has scored as "dependent," but are actually expansions that have been granted in some of these BRCA patents and many others pertinent to DNA diagnostics. Those issues are about examination practice at USPTO as well as prosecution and claim structured by patent applicants.

Citing the Syntex case about re-examination may not be very persuasive in this case, which is not about re-examination. Judge Sweet is likely to notice that difference. And the assertions that patent claims are only about chemicals and not information are on thin ice, given the combination of structural claims and method claims that in effect bar any way to derive the information. This may be good law or bad, but it is certainly not a settled matter, and this is, to my knowledge, the first case that has gotten before a judge that bears on diagnostic use, which is basically about extracting information from DNA samples (as opposed to using DNA molecules to make a valuable therapeutic).

Seems likely that Myriad will have some patent claims at the end of the day, but those claims might be considerably narrower in scope than the ones granted by the USPTO, if the European opposition process is any guide.

[Skeptical]

Why would the European opposition process be any type of guide in a US application/US Constitutional setting?

[Kevin E. Noonan]

Dear Bob:

The ACLU may have raised constitutional questions, but I think the PTO’s point is that’s rather like Mortimer raising demons in Act III, scene i of Henry IV, Part I. Whether the issues are properly raised remains to be seen – the Office doesn’t think so, and it may be that the Supreme Court thinks this challenge is more like Eldred than not.

At the risk of once again repeating myself, no matter what the merits of the case against the patent-eligibility of genetic diagnostic claims, that isn’t what the ACLU et al. are asking for – they want all gene patenting claims to be banned. We can’t talk about the case without recognizing that, as a strategic and publicity matter the ACLU chose to “go for it” rather than taking a more limited approach.

Of course, your point about the deficiencies of the claims at issue on patentability – rather than patent-eligibility – grounds is also the Office’s point, and their brief does not get to the merits of those issues. Indeed, the Office’s position is that the plaintiffs only reach their constitutional issues if the court decides that the claims were properly granted under the various sections of the patent statute. Thus the “Catch-22” in the Office’s argument.

I think the Syntex case was merely cited for the proposition that private litigants cannot hale the Office into court based on whether a particular patent is properly granted or not – the remedy is against the patentee, not the Office. And I doubt very much that the Judge will notice or take the government to task for the quote.

Also, I wouldn’t look to the EPO as a guide – different law, different standards (and when it comes to biotech, different outcomes).

Thanks for the comment.

[6]

"Thus the “Catch-22” in the Office’s argument."

That's not really a "catch-22" :( I know why you're saying it is, and I know they want it to be. But it isn't one since even if it was "properly" issued under the patent act, that doesn't necessarily mean a portion of the patent act isn't unconstitutional as the office applied it and is still applying it. It might also force an interpretation of the patent act that would leave the act valid, but the court would order it be interpreted differently than the office has been. As such, the PTO shouldn't get off scott free at this point.

[Kevin E. Noonan]

Dear 6:

I meant a procedural Catch 22 (which was what the original Catch 22 was). There are two possibilities: either the Office properly granted the patents under the relevant portions of the statute (101, 102, 103, 112, i.e. based on patentability) or it did not. If not, then the court should stop right there, according to the PTO, because there is a principle in US law that a court should avoid constitutional issues if possible. However, if the court finds that the PTO granted the patents properly under the statute, then it can look to the constitutional issues - that the PTO has granted a patent that does not qualify for patent-eligibility, either because DNA isn't patent-eligible subject matter or because the patents impinge a citizen's free speech rights under the First Amendment.

Now, it's easy to mix these up because the Supreme Court talks about whether something is patentable when they are considering whether it is patent-eligible. But the Office's point is sound with regard to review: since the patent-eligibility question impacts the Constitution, the court should avoid reaching it if it can.

Which is the Catch-22. In order for the plaintiffs to reach the constitutional issues (which is what they want, because they are not content with invalidating just these patents), the Office says the court has to find that the claimed subject matter is patentable - not something the ACLU wants to happen.

Thanks for the comment.

[6]

"I meant a procedural Catch 22 (which was what the original Catch 22 was). There are two possibilities: either the Office properly granted the patents under the relevant portions of the statute (101, 102, 103, 112, i.e. based on patentability) or it did not. If not, then the court should stop right there, according to the PTO, because there is a principle in US law that a court should avoid constitutional issues if possible. However, if the court finds that the PTO granted the patents properly under the statute, then it can look to the constitutional issues - that the PTO has granted a patent that does not qualify for patent-eligibility, either because DNA isn't patent-eligible subject matter or because the patents impinge a citizen's free speech rights under the First Amendment."

You left out the part about the constitutional basis of the patent act tho Kev. But let's ignore that for now.

Yes, I understand what you're saying, but I don't see that as proper since the court has been presented now with both issues and they are both legitimate. The hearing on the constitutional issue shouldn't be a different hearing than on the patent act one.

See, you seem to be acting like the consideration of the issues should progress from one to the next in "separate phases" if you will, and that seems a bit bogus. The court can consider both issues all at once, one trial, but only reach the constitutional issue in its decision if the other doesn't pan out.

I'm sure there's probably something I'm missing, but that just seems stu pid to let them off now only to have to drag them back in later. Especially having seen cases with this similar issue where the court wanted to avoid the issue of the constitutional challenge.

One of the cases I've seen was especially relevant since the court threw out the old interpretation of a law so that the guy got off and the case was then dismissed, or he was ruled not guilty, and then the constitutional challenge was never ruled upon in the decision. Still it was heard at oral arguments in the trial. Then of course the VA legislature corrected the law to mean what it should have said in the first place the next year, and I got hauled in on the same issue. I should have fought that case, but I kept missing the court date or the date to reply to get a court date. Which I also found stu pid. They're going to make me reply in writing to EVEN GET MY DAY IN COURT? W T F? Just how much nonsense do I have to go through to make an argument? I don't reply in "(hand) writing" to anything. Frakin snail mail. I don't have envelopes, stamps, good paper, or any of the rest of that nonsense.

All you old people make the legal system too difficult and unweildy for the people, especially people of my generation.

On the other hand, when I do subject myself to considerable bothersome activity to fight the system it goes pretty well. At least you guys did get that part right.

It only took me 4 hrs of trying to look up the statute I was accused of breaking to find the one sentence I needed to read and print to have the case well taken care of in one instance.

ONLY 4 HOURS. ONE SENTENCE.

Kev if you ever get into public office I want you to get this nonsense under control. You should go for it, there's nobody else hardly running. Who knows? You might take pres.

"Which is the Catch-22. In order for the plaintiffs to reach the constitutional issues (which is what they want, because they are not content with invalidating just these patents), the Office says the court has to find that the claimed subject matter is patentable - not something the ACLU wants to happen."

But that doesn't mean the office should be let out of the trial. The court is still going to reach the issue in its decision if the first one falls through. These guys must have some bogus "procedure" rule that I'm not privy to. Because like I said, in the other cases I've seen, they argued the constitutional ground at the same trial and the court would have considered it in the same opinion if it needed to.

[Kevin E. Noonan]

Sorry, 6, for not getting back to you sooner.

The Office is saying, look judge, before you get to the part of the complaint that implicates us you need to decide that we (the PTO) properly applied the statutes and the law in granting the patents in the first place. But even if you decide that we have, the constitutional arguments plaintiffs have made are wrong and we (the PTO) deserve judgment as a matter of law.

Most of the brief is taken up with (the PTO's) arguments that plaintiffs are wrong in claiming that patenting genes is outside the scope of Art. I, sec. 8, cl. 8 and also wrong that there is any First Amendment violation. Assuming the PTO is correct, there is no reason for the court to keep them in the case, because in the only part of the case that implicates the PTO plaintiffs deserve to lose.

Now, you may disagree with the substance of these arguments, and if the judge disagrees he will deny the motion. But if the PTO is correct then there is no reason for them to remain in the case. Again, a purely procedural issue based on the underlying law.

Thanks for the comment. I would be interest in any insight you may have about what Examiners think should hap

[6]

Oh a JMOL, I gotcha kev, thanks man.

What I think is that some of the issued claims are alright and there is certainly no constitutional issue, but there are some claims which I'm not too sure about. Probably more of a job for 101 or 103 than anything though. I also think that most people don't even understand the claims well enough to comment. Myself being pretty much included in the later catagory. You guys explaining what was going on in a different thread was helpful, but I just don't think I'm seeing how all the pieces fit. Specifically, how the arguments against the claims fit into what is happening in the science. And the science is probably still shaky for me.

However, whatever happens in the case, something needs to be done about not being able to get a 2nd opinion outside of the patent holding company, whether it be the patent holding company licensing it to someone so they can do the test or whatever other solution happens.

[Sean]

If the definitions of "Science" and "Arts" have changed (essentially flipped) since the Patent Act was drafted, the current 35 USC needs to be modified for modern times. The Patent Act, the Constitution, and the Bible are all arbitrary documents (to begin with) that need to be modified with the times.

I solemnly believe this issue of DNA/gene patents should not be settled on precedence, because DNA is different from what's precedence - is a chemical, but is not. Could be "man-made" i.e. isolated, but is not really man-made. 35 USC needs to be completely re-hauled at least for biotechnology patents.

My two cents.