AIPLA Submits Amicus Brief in AMP v. USPTO

By Kevin E. Noonan --

The American Intellectual Property Law Association (AIPLA) filed an amicus brief in the Myriad case (Association of Molecular Pathology v. U.S. Patent and Trademark Office), in support of neither party but advocating reversal.  While making many of the arguments made by Myriad and other amici, the brief contains at least one definitive (albeit prescient) rebuttal of the arguments made by the Justice Department in its ill-advised brief (see "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief").

The brief presents the questions of 1) whether "purified, isolated DNA" ("transformed in structure and function from native DNA at great cost through significant human effort that identified them as being associated with an increased risk of certain cancers") should be deemed patent-ineligible as a "product of nature"; 2) whether genetic diagnostic method claims should be deemed patent-ineligible as being "nothing more than scientific principles or abstract mental steps"; and 3) whether "potential customers and their related associations" have standing to bring a declaratory judgment action of patent invalidity that would permit third party providers to sell "potentially infringing goods and services that the potential customers may wish to purchase?"  Before answering these questions, the brief sets forth several policy reasons why they should all be answered in the negative.  These include the benefits to the U.S. populace and economy provided by strong patent protection, and the historical understanding of the value of patents in American history (citing Jefferson and Lincoln).  The brief relates these historical antecedents with the current controversy by pointing out that the patent system has provided strong economic incentives to biotechnology and the development of treatments for diseases like cancer, "that have eluded effective treatments for generations, despite the dedicated effort of the medical, scientific, and other interested communities."  These interests, the brief argues, were ignored by the District Court, in a decision that "threatens more than just the members of the biotechnology industry whose business depends on purified/isolated DNA molecule patents."  The outcome is contrary to the Constitutional mandate, AIPLA argues, which is sufficient reason for the Federal Circuit to reverse.

Citing Bilski v. Kappos, the brief argues that Congress "has envisioned Section 101 as broad, flexible, and adaptable to new technologies and advances in knowledge," a stance extending from Jefferson at the beginning of the Republic through Diamond v. Chakrabarty, to today.  The beneficiary, AIPLA agues, has been the public, both from the invention itself (be it a "'better mousetrap' or a breakthrough in advanced medical science") as well as the general economic benefits of prosperity through a patent's role in "inspiring entrepreneurship, putting investment capital in the hands of innovators, and stimulating employment."  Patents make innovation "contagious," the brief argues, by dint of the required disclosure of the claimed invention, the "quid pro quo" that makes the disclosure available to competing innovators, "who can then use the patent disclosure to push the frontiers of science even further."  And the brief mentions the oft-forgotten (or disregarded) feature of patents that they expire, so that thereafter "all are free to enjoy, commercialize, and improve the claimed inventions."  In contrast to these advantages, the brief argues that the District Court's decision would have a "profound negative impact" on biotechnology if not reversed.  The brief uses to support this contention the powerful example of the effects on the stock market of some ill-considered words by a White House spokesman in 2000, that the U.S. and Great Britain would act to limit patent protection for the fruits of the Human Genome Project, which caused the stocks in "two relevant [genomics] companies" to plummet by 25-30%.  The District Court's decision represents a "step backward" based, in part, on the "visceral reaction" against corporate ownership of "one's personal genetic makeup" -- something that gene patenting does not provide, they are quick to point out.

AIPLA's argument focuses on the utility of isolated DNA as a tool for "allow[ing] health care practitioners to identify individuals at significant risk of breast and ovarian cancer, tailor existing treatment options to ensure the highest likelihood of therapeutic success, and develop new anti-cancer treatments specifically designed to combat these devastating diseases."  These are "real-world" benefits that the patent laws were intended to promote, argues the brief.  Importantly, patent policies consistent with the Constitution are "blind to the raw materials from which significant technological advances spring."  Isolated DNA does not fall within the "few narrow exceptions" to patent-eligibility (laws of nature, natural phenomena and abstract ideas).  (The brief cites the precautionary injunction from Bilski that "[t]hose exceptions do not 'give[] the Judiciary carte blanche to impose other limitations that are inconsistent with the text and the statute's purpose and design.'")  The brief cites precedent -- adrenaline and prostaglandins -- for the principle that "naturally-occurring biological substances" that have been isolated and purified "to give them different characteristics and uses" is sufficient for such "natural products" to be eligible for patenting.  Insofar as there is a "products of nature" exception, the brief cites In re Bergy (and Judge Giles Sutherland Rich) for the principle that it is limited to "something preexisting and merely plucked from the earth and claimed as such."  Provided that the "product of nature" is rendered different from the natural product as it exists in nature "in some structural and functional manner as a result of human effort and ingenuity" it is patent-eligible, according to the AIPLA's reading of the relevant case law.

Under this standard, isolated and purified DNA molecules are patent-eligible according to the brief.  As claimed, they are "new chemical compounds that do not exist in nature and have been adapted for new uses as diagnostic tools and probes."  The brief grounds this argument in the new utility of the isolated DNA, therein "[a]rmed with knowledge resulting from the use of the claimed purified/isolated DNA molecules in the claimed methods, cancer patients can determine whether or not to undergo certain medical procedures, and healthy individuals can opt for preventative techniques that may ward off the onset of cancer," supporting this analysis by Judge Rich's statements in Bergy that the bacterial cultures were required for the practice of the indisputably patent-eligible methods for producing lincomycin.  The brief then cites the District Court opinion that there was "[u]ndisputed evidence" that the isolated DNA was a chemical compound that was structurally and functionally different from DNA as it exists as a component of a chromosome.  Accordingly, AIPLA argues, these differences were enough to impart patent-eligibility on isolated human DNA.

The brief particularly points out that the District Court focused on the similarities between isolated DNA and DNA in its unisolated state in a chromosome of the "essential characteristics" (the infamous "physical embodiment of [genetic] information" standard) rather than the differences between isolated and native DNA.  There is "no legal basis" for thus "arbitrarily and categorically excluding such DNA-derived invention" from patent-eligibility.  The brief argues that the "shared essential characteristics" test cannot stand, since there will always be some similarities between a product derived from nature and the "natural product," and thus that patent-eligibility would always fail by focusing on the similarities rather than the differences:  "it therefore becomes all too easy to focus on one shared characteristic, while ignoring all the other differences, even salient, fundamental differences."  And of course it is all too easy to "cherry-pick" these properties, rather than consider the claims "as a whole" (the proper standard).  The brief argues that the District Court "selectively assign[ed] dispositive importance to one shared characteristic of the claimed purified/isolated DNA molecules and discount[ed] all the differences" in arriving at its decision, an analytical process rejected by the Bergy Court (which precedent is binding on the Federal Circuit unless and until overturned by the en banc Court).

The brief also argues that the District Court improperly granted summary judgment, since the question of whether isolated DNA was "transformed from their natural state to possess a different structure and new function" was a genuine issue of material fact when "all reasonable inferences [are decided] in favor of the non-movant Myriad."

Turning to the method claims, the brief argues that the District Court misapplied Bilski, particularly in view of the Supreme Court's clarification as to the role of the "machine-or-transformation" test in deciding patent eligibility of method claims.  The question is whether Myriad's claims completely preempt an abstract idea, and AIPLA argues they do not.  Rather, the method claims at issue are "applications[s] of a law of nature" consistent with the Supreme Court's holding in Diamond v. Diehr, "utiliz[ing natural processes] in a series of specific steps" that constitute patent-eligible subject matter, citing Prometheus Labs, Inc. v. Mayo Collaborative Servs.  In addition, the brief asserts that the method claims "inextricably" depend on the isolated DNA which require "substantial physical and chemical transformations" that would satisfy the Bilski test.  The brief sets forth the steps required to practice the method claims of U.S. Patent Nos. 5,710,001; 5,709,999; 5,753,441; and 6,033,857, which include "the transformative steps of drawing blood or removing a tissue sample from a subject, extracting BRCA DNA or RNA from the biological sample, and detecting alterations in the subject's BRCA nucleotide sequence in order to analyze the BRCA DNA, RNA or cDNA made from an mRNA of the sample."  Regarding the extent of transformation, "the extraction process radically alters the structure and function of the native DNA, creating a new chemical compound that does not exist in nature."  Even the comparison steps are transformative:  "such comparisons cannot be made by the naked eye but instead require sophisticated biotechnological methods of sequencing nucleic acids and/or detecting alterations that involve chemical or physical transformation."  The case for patent-eligibility of the screening method claim of U.S. Patent No. 5,747,282 is even easier to make, wherein the brief recites that "administration of a potential cancer therapeutic to a cell that contains an altered BRCA gene involves both the insertion of that gene into a cell and the biological effect of the test agent on cell growth."  Thus, even under the Federal Circuit's more restrictive "machine or transformation" test, the brief argues, Myriad's method claims are patent-eligible because they do not merely recite "only [] the abstract mental process of 'comparing' or 'analyzing' gene sequences" as the District Court had erroneously determined.

The brief then makes several policy arguments why the Federal Circuit should reverse the District Court's decision.  These include the principle that courts should not lightly "adopt[] changes that disrupt the settled expectations of the inventing community," citing Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 28 (1997).  Congress is the proper venue for plaintiffs to effect changes in the Patent Law, not the courts, because "[f]undamental alterations in these rules risk destroying the legitimate expectations of inventors in their property.  Id."  "To change so substantially the rules of the game now could very well subvert the various balances the PTO sought to strike when issuing the numerous patents which have not yet expired and which would be affected by our decision," citing Festo.

It is here that the brief presciently provides the most succinct answer to the DOJ's wrong-headed foray into the unfamiliar waters of patent law.  It arises in Footnote 19, which discusses President Clinton's attempts to forestall the highly negative effects of White House remarks that patent protection would not be available for the products of the Human Genome Project:

In a widely publicized comment, President Clinton noted that the people "with the skills and the experience to draw the line in the right place" were in a position to formulate criteria for patent-eligibility of gene-based inventions.  BIO Praises Clinton Reassurances Regarding Gene Patents and PTO Leadership, BIOTECH Patent News (Apr. 1, 2000), available at http://www.allbusiness.comltechnology 538104-1.html.  Indeed, the government agency specifically charged with that task, the Patent Office, has in fact already drawn that line in the right place, in its Utility Examination Guidelines.

It bears repeating:  "the government agency specifically charged with that task, the Patent Office, has already in fact drawn that line in the right place."  This argument, while not specifically developed in the brief, adds yet another reason to reverse the District Court:  failure to find that the Office's grant of "gene patents" was arbitrary and capricious agency action, thereby not entitled to Chevron deference in the exercise of its particular area of expertise.

Similarly, the brief argues that it is Congress, not the courts, that is the proper venue for arguing the "moral and ethical policy considerations" underlying the plaintiffs' challenge to patenting isolated DNA.  "[W]hile important," these issues "go beyond the social objective set forth [in the Patent Clause of the Constitution]" they argue.  This principle is even more applicable in instances, such as here, where Congress has spoken, broadly, on the scope of patent-eligible subject matter:  in such instances, "the courts should not arbitrarily narrow the scope of the patent laws based on their own balancing of ethical and moral considerations."  Here, the AIPLA argues that the District Court raised the concerns of "certain segments of the public who claim they might be adversely affected by the patents' existence" over the "rewards to society as a whole from encouraging progress in science and technology" that results from "the limited exclusionary power of patents."  The brief dismisses plaintiffs' complaint that the patents increase costs of patented diagnostic tests as being "a natural -- indeed, even intended -- consequence of the Framers' decision to provide patents on inventions and discoveries."  To allow such considerations to determine patent eligibility fails to recognize that the patented inventions here are what made the diagnostic tests possible in the first place, the brief argues, reminding the Court that "there has never been a 'medical treatment/diagnostics' exception in the statute," and insofar as Congress has intended to remedy disparities in health care availability, it has enacted laws (Hatch-Waxman and the Biologics Price Competition and Innovation Act are cited) to address these concerns.  (And, the brief notes, Congress did not "abrogate or limit[] the rights of innovators in biotechnological medical advances" in the latter Act.)  Simply put:

Addressing the alleged economic or social impact of Myriad's patents in the context of a patent challenge brought by patients and researchers is to engage in a moral and ethical inquiry that is not the proper subject of the patent statute, but is a matter for the public forum provided by Congress.

Finally, the brief argues that the "customer" plaintiffs (the individual breast cancer patients and their organizations) lacked standing and should have been dismissed from the lawsuit.  Under the "all the circumstances" test of Genentech, Inc. v. MedImmune, Inc., these plaintiffs did not allege actions of sufficient reality and immediacy to bring a declaratory judgment action against Myriad.  None of Myriad's activities were directed to any of these plaintiffs.  At best, their asserted desire to "purchase" the potentially infringing services that the other plaintiffs may provide would make them "at best only potential inducers of infringement," which status is insufficient to confer standing, citing Prasco, LLC v. Medicis Pharm. Corp.  The brief also cites as insufficient the District Court's finding that these plaintiffs "may very well understand the precise nature of, and be prepared to take advantage of, the services of a potential infringer were the latter not prevented from offering those services by a third party's assertion of its patent rights" as satisfying the standing requirement that a party had "undertaken 'meaningful preparation to conduct potentially infringing activity'" under the test enunciated in Cat Tech LLC v. TubeMaster, Inc., 528 F.3d 871, 880 (Fed., Cir. 2008).  "[M]ere contemplation" is not enough, the brief argues because it is "simply too tenuous" a basis for this finding.  Considered with the parties' allegations reversed, the brief argues it is "doubtful" that Myriad would be able to succeed in an action against the consumer plaintiffs for inducing infringement under the facts alleged, arguing that "potential purchasers of non-existent products do not have proper declaratory judgment standing," citing Ours Tech., Inc. v. Data Drive Thru, Inc., 645 F. Supp. 2d 830, 840 (N.D. Cal. 2009).  And while the consumer party plaintiffs "have a worthy and commendable interest in the outcome of this case," Federal Circuit precedent "has long held that the public interest merits of the patentability issues raised in this case do not confer jurisdictional standing," citing Indium Corp. of Am. V. Semi-Alloys Inc., 781 F.2d 879, 884 (Fed. Cir. 1985).

The brief ends with a cogent explication of the dangers presented by the District Court's decision:

In its attempt to be sensitive to the social implications of this case, the District Court impermissibly expanded its declaratory judgment jurisdiction to cover an "advisory opinion" for anyone merely expressing the desire to purchase a patented product or utilize a patent method, including non-existent products and services.  However, this decision, if affirmed, presents a very real concern for other federal courts and patent holders.  The dramatic expansion of federal declaratory judgment jurisdiction to those without a real and immediate interest in the litigation will open all patents to challenge by anyone asserting a "public" interest.  This has never been permitted by the controlling authorities and could not have been the intent of Congress in permitting declaratory judgment actions.

Briefing Update:  Patent Docs has learned of one additional amicus brief that has been filed in this appeal:

• Gilead Sciences, Inc. and BioGenerator, in support of Defendants-Appellants and urging reversal (brief)

We thank our readers for bringing this brief 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:

• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "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

[EG]

Kevin,

One argument I haven't seen in Myriad's or the amicus briefs would be based on what steps were required by Myriad to "isolate" the BRCA 1 & 2 sequences. I'm willing to bet that "mother nature" can't or doesn't do those steps. If "mother nature" can't duplicate the steps required to "isolate" the BRCA 1 & 2 sequences, then how can those sequences be a "product of nature"?

[patent litigation]

Although some gene patent proponents argue that it's about legal precedent and reliance, I honestly think that this is one of those issues that is largely about one's politics and policy. Whether or not human genes are legally patentable is a question rather like the "if a tree falls in the forest" hypo. I've noticed that most biotech proponents, in particular, base their pro-patenting contentions on policy arguments, rather than on legal ones -- perhaps because there is no real legal answer. That being the case, although I'd like to read a Supreme Court opinion deciding this issue, perhaps this is really one for Congress to deal with.
http://smallbusiness.aol.com/2010/05/10/how-to-file-a-patent/

[EG]

Kevin,

Let me qualify my comment. The Myriad and AIPLA briefs do point out generally the steps required to get the claimed "isolated" the BRCA 1 & 2 sequences. Even so, an explicit run down of those steps, perhaps using a flowchart might get the point across more clearly that "mother nature" didn't do and can't do what Myriad did.