By Kevin E. Noonan —

One of the more unusual aspects of the Supreme Court's Bilski v. Kappos decision was its direction, towards the end of the majority opinion, that the Federal Circuit develop its case law on what would constitute an "abstract idea" for purposes of patent eligibility.  After a decade of using the appellate court as its favorite whipping boy, the Court (for the first time since Warner-Jenkinson Co. v. Hilton Davis Chemical Co.) left the task in the hands of the Federal Circuit in deference to "that court's sound judgment in this area of its special expertise."  Given how the Federal Circuit exercised its prerogatives in the peripatetic peregrinations of Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., the Supreme Court's reticence to repeat the experience may be understandable.

An example of how the Federal Circuit will exercise this prerogative is found in the court's decision in Research Corporation Technologies, Inc. v. Microsoft Corp., a case involving claims to computer methods for producing pixilated gray-scale images.  While the details of the claims at issue are beyond the scope of the topics usually discussed herein, the principles enunciated by the Federal Circuit, and the analysis performed in arriving at its decision are informative.  Briefly, the District Court found two claims of the patents-in-suit to be invalid under 35 U.S.C. § 101 as being directed to an abstract idea:

1.  A method for the halftoning of gray scale images by utilizing a pixel-by-pixel comparison of the image against a blue noise mask in which the blue noise mask is comprised of a random non-deterministic, non-white noise single valued function which is designed to produce visually pleasing dot profiles when thresholded at any level of said gray scale images.

U.S. Patent No. 5,111,310 ("'310 patent")

11.  A method for the halftoning of color images, comprising the steps of utilizing, in turn, a pixel- by-pixel comparison of each of a plurality of color planes of said color image against a blue noise mask in which the blue noise mask is comprised of a random non-deterministic, non-white noise single valued function which is designed to provide visually pleasing dot profiles when thresholded at any level of said color images, wherein a plurality of blue noise masks are separately utilized to perform said pixel-by-pixel comparison and in which at least one of said blue noise masks is independent and uncorrelated with the other blue noise masks.

U.S. Patent No. 5,341,228 ("'228 patent")

The Federal Circuit reversed, in an opinion by Judge Rader joined by Judges Newman and Plager.  The panel began its analysis by starting with the language of the statute, as interpreted by the Supreme Court in Bilski, as defining "broad statutory categories" further characterized by "the broadening double 'any' exhortation."  Again citing Bilski, the panel references the statutory definition of "process" (35 U.S.C. § 100(b) as well as Diamond v. Diehr, 450 U.S. 175 (1981), and Diamond v. Chakrabarty, 447 U.S. 303 (1980), for the proposition that "Congress plainly contemplated that the patent laws would be given wide scope," Chakrabarty, 447 U.S. at 308, and that "courts 'should not read into the patent laws limitations and conditions which the legislature has not expressed.'"  Diehr, 450 U.S. at 182 (quoting Chakrabarty, 447 U.S. at 308).  Noting the three exceptions to patent eligibility ("laws of nature, physical phenomena and abstract ideas") the panel quickly rejected the first two exceptions as not applying to the invalidated method claims.  Thus, the question before the panel was whether the claims recited an abstract idea, and whether they were thus patent-ineligible.  Also, the opinion cites Bilski for the proposition that "section 101 does not permit a court to reject subject matter categorically because it finds that a claim is not worthy of a patent" in derogation of the substantive patent law provisions ("a patentability analysis related to prior art, adequate disclosure, or the other conditions and requirements of Title 35").

Turning to the claims at issue, the panel first finds that the claims are recited as a "process" which is one of the categories of statutory subject matter.  Thus, the issue is whether the claims fall within the scope of the "abstract idea" exception.  And the panel is keenly aware that the Supreme Court has not provided it with "a rigid formula or definition for abstractness" and that it writes on this aspect within the Supreme Court's instruction:  "the Supreme Court invited this court to develop 'other limiting criteria that further the purposes of the Patent Act and are not inconsistent with its text.'"  Bilski at 3231.  Accordingly, the panel treads lightly:

With that guidance, this court also will not presume to define "abstract" beyond the recognition that this disqualifying characteristic should exhibit itself so manifestly as to override the broad statutory categories of eligible subject matter and the statutory context that directs primary attention on the patentability criteria of the rest of the Patent Act.

"In that context, this court perceives nothing abstract in the subject matter of the processes claimed in the '310 and '228 patents," the panel opined.  The basis for this decision is that the inventive methods are "functional and palpable applications in the field of computer technology."  The Court points to claims that recite tangible (i.e., not abstract) limitations including "high contrast film," "a film printer," "a memory," and "printer and display devices" as evidence that the recited method is not abstract.  "Indeed, this court notes that inventions with specific applications or improvements to technologies in the marketplace are not likely to be so abstract that they override the statutory language and framework of the Patent Act."

As it has done previously (most notably in its en banc Bilski decision), the Federal Circuit turns to express direction from the Supreme Court to anchor its bases for arriving at this conclusion:

In determining the eligibility of respondents' claimed process for patent protection under section 101, their claims must be considered as a whole.  It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis.  This is particularly true in a process claim because a new combination of steps may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.  Diehr at 188.

(Ironically, this analytical standard was ignored most notoriously by Justice Breyer in his dissent from dismissal of the Laboratory Corp. v. Metabolite Labs., Inc. ("LabCorp") case.)

The Federal Circuit also seems to direct the issue away from § 101 and to § 112: even if a claim is not "so manifestly abstract as to override the statutory language of section 101," § 112 precludes patentability for failure to contain "sufficient concrete disclosure to warrant a patent."  Section 112 "provides powerful tools to weed out claims that may present a vague or indefinite disclosure of the invention," even for claims reciting a process "sufficient to pass the coarse eligibility filter."

Application of these considerations to pending appeals on a number of cases relating to diagnostic method claims will be the subject of a future post.

By Donald Zuhn —

In one of nine amicus briefs filed in late October in the Association of Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") case, amici Rosetta Genomics Ltd., Rosetta Genetics, Inc., and George Mason University focus solely on the patentability of Myriad's isolated DNA claims, and conclude that "isolated DNA composition claims, such as the ones at issue in this case, correspond to patentable subject matter under 35 U.S.C. § 101" (see brief).  Amici begin by noting that the Myriad case has "generated significant public comment regarding so called 'gene patents.'" and that "[t]he ACLU and Plaintiffs-Appellees have welcomed, and in fact encouraged, the public attention and resulting controversy."  The brief argues that Plaintiffs-Appellees' "simplistic viewpoint" of seeking judicial abolition of gene patents as a way of resolving public policy questions "mischaracterizes and misunderstands what motivates scientific innovation, and ignores the high cost and risks of failure associated with placing any medical product into the hands of doctors and patients."  The brief addresses two issues:  how the judicial abolition of gene patents will deter and not stimulate innovation, and why isolated DNA claims constitute patentable subject matter under § 101.

With regard to the first issue, amici argue that "[c]ontrary to Plaintiffs-Appellees short-sighted view, abolishing patents on genetic inventions will have more of a dampening effect on research and development ('R&D') in relevant medical fields than any patent right could ever have."  According to the brief, absent the funding incentive provided by patents for "'translating' a specific innovation into a viable benefit for patients, . . . the entire U.S. system for developing biomedical therapies for patient use will become unworkable, as it necessarily will lead to a significant financial loss for any initial innovator."  Amici argue that "[t]his significant loss will occur, not in small part, due to the fact that other non-innovating for-profit entities will have every incentive to piggyback and freeload off the significant effort and investment of original innovators."  Without gene patents, the brief predicts a world in which "[b]iotech/pharma companies, who are otherwise solely responsible for getting products to doctors and patients, will have neither the finances nor the potential of future returns needed to attract necessary investment to support continued efforts to innovate."

While amici note that the District Court acknowledged the "deep disagreement" regarding the impact of gene patents on innovation, the brief also notes that the Court "[n]evertheless . . . apparently summarily assumes that gene patents negatively impact scientific knowledge and innovation in biotech and biomedical fields."  To support this assumption, the Court refers to two studies offered by Plaintiffs-Appellees:  the Murray study and the Cho study.  Amici contend, however, that "[t]he district court does not consider nor critique whether the methodology used in the Murray study actually provides relevant information," and "the Cho study reports the perceptions of certain basic researchers regarding the impact of patents on their research, but does not explore the validity of those perceptions" (emphasis in original).  Amici argue that "[o]ne should not dictate patent policy based on perceptions that are not grounded in legal reality," adding that both studies "fail[] to illuminate whether gene patents actually increase or decrease public knowledge and innovation."  With respect to the impact on innovation of the patents at issue in the case, amici convincingly point out that:

Over 18,000 scientists have conducted research on the BRCA1 and BRCA2 genes, and have published more than 7,000 papers on those genes since Myriad's patents issued.  Such scientists include eight Plaintiffs-Appellees and their declarants in this case, who have themselves published over 48 scientific papers on the BRCA1 and BRCA2 genes.

Moving to the brief's second issue — why isolated DNA claims constitute patentable subject matter under § 101 — amici note that the District Court's decision "heavily relies on the notion that DNA are 'physical carriers of information.'"  Notwithstanding the District Court's creation "for the first time [of] a new and devastatingly sweeping interpretation of the law, [that is] in direct contradiction to Supreme Court precedent," amici suggest that "[m]any other naturally-occurring molecules manifest 'a physical embodiment of information."  As but one example, amici propose an amino acid sequence of a protein, which determines the protein's three-dimensional structure and biological properties.

Turning to Judge Dyk's concurring-in-part and dissenting-in-part opinion in Intervet Inc. v. Merial Ltd., which questions whether isolated DNA claims are patentable under § 101, amici believe the opinion is noteworthy because it provides one Judge's thoughts on the issue and indicates which cases Judge Dyk believes are most relevant (i.e., Diamond v. Chakrabarty, 447 U.S. 303 (1980), and Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)).  Amici contend that "[t]he science at hand makes it abundantly clear that an isolated DNA composition 'is qualitatively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty.'"  In particular, the brief states that "[l]ike the man-made bacteria in Chakrabarty, 'isolated DNA' differs chemically in size and composition from anything that naturally exists in nature," and "[c]ontrary to Plaintiffs-Appellees' scientifically erroneous assertions to the district court, the human body does not have a mechanism for isolating DNA, and consequently, isolated DNA is not found in the body."  In addition, amici argue that "[i]solated DNA do not merely 'serve the ends nature originally provided,'" but rather have "a vast number of other uses and properties, [which] are unique to isolated DNA and cannot be duplicated with naturally-occurring DNA."  The brief lists the use of isolated DNA to make purified proteins by recombinant means, as primers to synthesize DNA in PCR, to create transgenic animals, and in the diagnosis of disease as a few of these other uses.

In support of their argument that isolated DNA claims constitute patentable subject matter under § 101, amici note that the "[o]ver nearly twenty years, the USPTO has issued tens of thousands of patents directed to isolated nucleic acids."  The brief indicates that in the past 17 years, 23,710 patents have been issued that have claims reciting "(isolated or purified) and (nucleotide or DNA or RNA or 'nucleic acid' or 'SEQ ID NO')," and 35,504 patents have been issued that have claims reciting "SEQ ID NO."  Despite this large number of patents, the brief states that an ALLFEDS search for decisions including the terms "(patent) and (isolated or purified) and (nucleotide or DNA or RNA or "nucleic acid" or "SEQ ID NO")" identified only 204 cases.  Thus, amici argue that their data appear to confirm a Nature editiorial that "[r]eports of researchers being blocked from access to patented DNA sequences or being sued for infringement are extremely rare."  Amici also point to Congress' failure to pass H.R. 977 as supportive of their position (see "Science Progress Article Examines Impact of Gene Patents on Research" and "The Continuing Threat to Human Gene Patenting").  Lastly, the brief discusses Judge Learned Hand's determination in Parke-Davis & Co. v. HK. Mulford & Co., 189 F. 95 (S.D.N.Y. 1911), that claims directed to purified adrenaline were patentable, stating that:

"[The inventor] was the first to make it available for any use by removing it from the other gland-tissue.  . . .  It became for every practical purpose a new thing commercially and therapeutically.  That was a good ground for a patent.

Amici suggest that similarly, "it was not until identification and purification of the BRCA1 and BRCA2 genes that the isolated nucleotide sequences could be used in a variety of highly important and beneficial methods including disease diagnosis."

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

• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," October 3, 2010
• "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

By Kevin E. Noonan —

Two academic amici — Robert Cook-Deegan (at right), Research Professor and Director, Center for Public Genomics at Duke University, and Christopher Holman, Ph.D. (Molecular Biology) (below left), Associate Professor of Law, University of Missouri – Kansas City School of Law — filed a brief in the AMP v. USPTO (Myriad) appeal that rebuts many of the distorted (albeit emotionally effective) arguments made by plaintiffs and their supporters (specifically, the ACLU and PubPat) against patent-eligibility for human genes.  While disavowing any interest in the brief by either party or any other amicus, they state their purpose in filing the brief as:

Our sole interest in this case is maintenance and development of a sensible patent system that accomplishes the constitutional goal of "promot[ing] the Progress of Science and useful Arts," particularly in the area of genetic diagnostic testing, and more generally in biotechnology and life sciences.

While that certainly may have been their intention, in the execution of the brief, this pair of academics debunks most of the public policy rhetoric advanced by the ACLU and PubPat to support their anti-gene patenting agenda.

They begin their argument by pointing out the risks occasioned by plaintiffs' invocation of the "recently re-invigorated patent eligibility doctrine" that they assert "threatens to wreak substantial collateral damage on future innovation in genetic diagnostic testing, personalized medicine, and biotechnology in general."  They concede that "plaintiffs have identified numerous potential concerns with gene patents in the context of some types of genetic diagnostic testing."  They then state plainly and forthrightly the fundamental flaw in the argument:  that "there is insufficient evidence that harms attributable to patents on genes justify broad, subject matter-based invalidation of all patents made of or based on DNA."  Calling patent-ineligibility a "blunt doctrinal instrument," the brief notes that "DNA patents have created incentives critical in attracting the substantial investment necessary to fuel the discovery and development of life-saving products produced by the biotechnology industry," the policy point never acknowledged by plaintiffs or their supporters.  There are "other tools more appropriate to the task" of regulating the impact of patenting genes on diagnostics and other areas of genetic medicine, and thus the brief argues the District Court's decision should be reversed.

Amici argue that the problem with plaintiffs' zealous attack on gene patents in response to "what they perceive to be a significant public health concern," however justified by "Myriad's patent enforcement and business practices," is that the strategy, and asked-for remedy would invalidate "a host of patents claiming gene-based inventions, often referred to as 'gene patents' and indeed many other technologies based on making and analyzing DNA."  It is the broad scope of this remedy that threatens the "substantial negative implications for future developments in genetics and biotechnology."  The brief reminds the Court that it has "substantial discretion under applicable Supreme Court precedent to interpret and implement the patent eligibility doctrine in a manner that fosters innovation," with amici citing the U.S. Patent and Trademark Office's Guidelines for implementing the Supreme Court's decision on patent-eligibility of process claims in Bilski v. Kappos (75 Fed. Reg. 43922) for the principle that "issues of claim validity are better addressed using more targeted and well-established doctrines of patent law" (i.e., "compliance with the requirements of §§ 102, 103, and 112" rather than § 101 "except in the most extreme cases").

The argument is supported by a thorough analysis of the facts relating to the effects, good and bad, of gene patents on biotechnology, genetics, and medicine.  The brief notes that gene patents have been granted for more than thirty years and form "the core intellectual property platform for companies dedicated to translating the fruits of biomedical research into life-saving therapeutic and diagnostic agents."  This has not been the experience in the European Union, the brief notes, and while different countries in Europe permit varying degrees of scope and enforcement of claims to isolated human DNA, the Biotechnology Directive (1998) requires EPC member states to grant patents on human DNA.  This includes claims to the BRCA genes at issue in this lawsuit, which were found valid despite being subjected to opposition proceedings in the European Patent Office.  Paradoxically in view of the differing histories of gene patents in Europe and the U.S., many of the claims held valid in Europe would be invalid under the District Court's patent-eligibility requirements.

The brief also addresses the idea that gene patent holders enforce (or threaten to enforce) their patents against medical doctors or clinical labs.  Citing Professor Holman's study of gene patent litigation (see "Science Article Should Help Allay Gene Patenting Fears"), the brief states the study's conclusion:  that litigation based on gene patents has arisen between innovator biotechnology companies and direct competitors in the marketplace for a biologic drug.  In this way, the brief notes, gene patents in biotechnology are akin to drug patents in the pharmaceutical industry.  This analogy is supported by reports from the Congressional Office of Technology Assessment (OTA) and the Federal Trade Commission that gene patents "have provided the 'fuel' for the 'R&D engine' bringing biologic drugs to patients."  The specific example cited in the brief is erythropoietin, which is protected by Amgen "primarily" using its gene patent protection; these claims are "almost identical to some of the composition of matter claims invalidated" by the District Court (and by implication, Amgen would have been unable to bring EPO to market in the absence of these patents).

The brief cites Heller and Eisenberg's "landmark" paper (Heller & Eisenberg, 1998, "Can Patents Deter Innovation? The Anticommons in Biomedical Research," Science 280: 698-701)) warning of a "tragedy of the anticommons" as being a major source of the fear that gene patents would harm medical research.  But as all other honest commentators have acknowledged, study after study has shown that the feared tragedy has not arisen, "at least in noncommercial, academic research."  In support of this point, the brief cites Professor Holman's study, as well as papers by Walsh et al., "Effects of Research Tool Patents and Licensing on Biomedical Innovation," in Patents in the Knowledge-Based Economy 285-340 (Wesley M. Cohen & Stephen A. Merrill eds., 2003), and could have cited many more, including Walsh et al., 2003, "Science and the Law: Working Through the Patent Problem," Science 299: 1020); Straus, 2002, Genetic Inventions, Intellectual Property Rights and Licensing Practices); Nicol et al., 2003, Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry, Centre for Law & Genetics, Occasional Paper 6 and Nagaoka, 2006, "An Empirical Analysis of Patenting and Licensing Practice of Research Tools from Three Perspectives," presented in OECD Conference in Research Use of Patented Inventions, Madrid).

Importantly, the brief also addresses the fear of a "patent thicket" in the "gene chip" industry, exemplified by Affymetrix (one of the few biotechnology companies that opposes gene patenting, at least in part due to the feared negative effect gene patents and their "thickets" could have), as discussed in Barton, "Emerging Patent Issues in Genomic Diagnostics," Nature Biotechnology 24: 939 (2006).  These feared outcomes have also not manifested themselves, the brief states, again citing Professor Holman's research showing that "hybridization array technology has never been the subject of a patent infringement lawsuit involving a gene patent" (emphasis in original).  The brief argues that this may be a consequence of the low probability that a court would enjoin production of a gene chip "serving an important public health function" and that the royalties available to a gene patent holder having rights to a small number of gene sequences on a chip comprising thousands of sequences would be too "modest" to support litigation.  "Most concerns about the negative impact of gene patents are based on an assumption that patents are always enforced, but experience with hybridization arrays illustrates that there are practical constraints on injudicious patent enforcement," amici assert.  Unstated is that these assumptions are generally made by individuals with little experience in patent litigation or biotechnology.

Turning to genetic diagnostic testing, the brief cites the SACGHS report ("Revised Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests") for the "potential for a substantial negative impact of gene patents on genetic diagnostic testing" (emphasis in brief) but ultimately concluding that there was "no conclusive evidence" that gene patents have had the purported "net negative impact on the availability of genetic testing services."

The brief cautions against "conflating" two types of restrictions on access to these tests:  restrictions on competition from other commercial diagnostic labs and restrictions on the ability of patients to obtain a particular test on a particular (patented) gene.  Myriad is cited as an example of this distinction:  while its enforcement policies have prevented competing companies from access to the U.S. market (the first type of restriction), "there is no clear evidence that this has resulted in less patients being tested in the US" (the second type of restriction).  The brief cites efforts Myriad has made to facilitate reimbursement by insurance companies as well as "promoting awareness of BRCA testing," and the paradox that the SACGHS study discussed whether BRCA testing was being over utilized.  This lack of effect of gene patents on genetic testing access was a general finding:

[O]ne surprising finding from the case studies was that the per-unit price of the full-sequence BRCA test, which often is cited as being priced very high, was actually quite comparable to the price of other full-sequence test done by polymerase chain reaction (PCR), at both nonprofit and for-profit testing laboratories.

In practice, Professor Holman's study found that lawsuits involving genetic diagnostic testing patents have been few and have settled "quickly," and no court has been asked to consider the validity of genetic diagnostic method claims, either for invalidity under the substantive patent law sections or patent-ineligibility until the District Court below.  As a consequence, the brief argues, affirming the District Court's basis for invalidating gene patents instead of applying "less sweeping patent challenges" would be "premature."

The brief argues extensively that "other doctrines of patentability and claim interpretation" would be better tools to use in limiting any negative effects of gene patents than patent ineligibility.  The brief notes that many of the arguments raised below against the Myriad BRCA gene patents (that their existence was "well-known," that isolation of the genes was "inevitable," that BRCA gene genetic testing would have become available "without Myriad's contribution" and that Myriad was not the first to identify the BRCA gene sequence) are matters of substantive patent law, not patent eligibility.  The brief argues that using these statutory patentability standards is advantageous (at least in comparison with patent-eligibility) because they can be used to distinguish what is new and non-obvious (and thus deserving patent protection) from what is not (although this analysis avoids the plaintiffs' principal contention that genes fail the threshold requirement of patent eligibility).

As for the contention that Myriad's claims are overbroad, the brief concedes that some of them may be (Kepler et al., "Metastasizing patent claims on BRCA1"; see "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims"), but amici argue that proper claim construction is the appropriate tool for preventing these claims from being successfully asserted against activities outside their proper scope.  This also applies to the scope of claims to full-length genes (like the invalidated claims to the BRCA genes here) that are unlikely to be infringed by diagnostic sequencing (citing Cook-Deegan et al., "Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: comparing breast and ovarian cancers with colon cancers," Genetics In Medicine 12: S15-S38 (2010)).  The brief also cites successful instances of "designing around" gene patents for biologic drugs (Genzyme Corp. v. Transkaryotic Therapies, Inc., 346 F.3d 1094 (Fed. Cir. 2003), Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), Novo Nordisk of North America, Inc. v. Genentech, Inc., 77 F.3d 1364 (Fed. Cir. 1996), Biogen, Inc. v. Berlex Laboratories, Inc., 318 F.3d 1132 (Fed. Cir. 2003), Schering Corp. v. Amgen Inc., 222 F.3d 1347 (Fed. Cir. 2000)) in support of its argument that a finding of patent-ineligibility is not necessary to avoid any disadvantages or threats to innovation produced by gene patents, and cites Regents of University of California v. DakoCytomation (517 F.3d 1364 (Fed. Cir. 2008)) as an example of BRCA testing that could be practiced using reagents (peptide nucleic acids) that would not infringe Myriad's claims.  Even the much-argued term "isolated" may not be enough to confer broad scope on gene patent claims to "isolated" nucleic acids, amici argue, since such claims have never been litigated and may well receive a narrower interpretation than commonly imagined (since the more broadly the term is asserted the more vulnerable it becomes to validity challenges).

In sum, "[p]roperly drafted and interpreted, gene patent claims should not have the broad inhibitory effect on access and innovation asserted by the critics.  The remedy to unduly broad scope is invalidation based on insufficient enablement or inadequate written description, not a blanket prohibition on the patenting of anything made of or based on DNA."

Finally, the brief argues that insofar as the "current anxiety surrounding gene patents in general, and Myriad's patents in particular, centers around their potential negative impact on genetic diagnostic testing and research," and this anxiety is a consequence of Myriad's business practices (insofar as they may be), there are more appropriate remedies directed specifically at these practices that are better suited to the task than a broad gene patenting ban.  One of these is a limitation on infringement liability for individuals using patented genetic technologies for research or genetic testing uses (as suggested by the SACGHS report).  The brief also cites the never-enacted Genomic Research and Diagnostic Accessibility Act of 2002, H.R. 3967, 107th Cong. (2002) that would have eliminated liability for such activities, analogous to current patent law provisions (35 U.S.C. § 287(c)) that preclude liability for the practice of patented surgical procedures and other "medical activities."  Other possibilities include compulsory licensing, use of "march-in" rights under the Bayh-Dole Act, and practice by state-affiliated institutions protected by sovereign immunity (although the brief characterizes them as "extreme" and "not [apparently] justified at the present time").  Citing restrictions on Myriad's business and enforcement policies abroad, the brief state that a more appropriate remedy may be "awakening US agencies and institutions from their stupor rather than foregoing the patent incentive for all inventions based on DNA."

The brief concludes with a discussion of the potential "unintended consequences" of a broad gene patenting ban on such areas as pharmacogenomics and personalized medicine, calling gene patents "critical to securing the funding necessary to bring these products to market" based on amicus briefs filed in the District Court by BayBio, Genetic Alliance, and the Biotechnology Industry Organization.  Also potentially at risk are biologic drugs, the brief argues, in view of the historic role of gene patents in "providing market exclusivity for biologic innovators in the past."  The brief also makes the distinction between diagnostic testing based on the BRCA gene patents and other single-gene based tests, and the "next generation of genetic testing technologies" that are likely to involve "a large number of genes" with "more complex patterns of genetic variation" as has been discussed elsewhere (see "Like Peas in a Pod").  Finally, the brief suggests that greater regulation by the FDA could minimize the "harm" caused by gene patents.  Any of these alternatives would be preferable to the de facto gene-patenting ban created by the District Court's decision.

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

• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," October 3, 2010
• "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

By Donald Zuhn —

Earlier this month, the Federal Circuit, in Mikkilineni v. Stoll, affirmed a decision of the District Court for the Eastern District of Virginia dismissing Mikkilineni's challenge of the U.S. Patent and Trademark Office's Interim Patent Subject Matter Eligibility Examination Instructions ("Interim Guidelines").

Plaintiff-Appellant M. R. Mikkilineni filed an application claiming "a method to fall-asleep by learning to use the process-algorithm in the brain [to] transform brain-neurons into a different[]physical state and produce melatonin and serotonin . . . without the use of drugs."  Mikkilineni's claims were rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter, the Examiner explaining that the rejection was mandated under the Office's Interim Guidelines.  One day after responding to the Examiner's non-final rejection, Mikkilineni filed suit against the Commissioner of Patents, alleging that the Patent Office violated 5 U.S.C. § 553(b)-(c) of the Administrative Procedure Act ("APA") by failing to provide notice and an opportunity to comment with respect to the Interim Guidelines.  The District Court granted the Patent Office's motion to dismiss under Federal Rules of Civil Procedure 12(b)(1) and (6).

On appeal, Mikkilineni argued that the Interim Guidelines constituted substantive rules that were improperly promulgated without notice and comment rulemaking, and that the Office improperly rejected his application.  In an opinion issued per curiam, the panel noted that under § 553 of the APA, "substantive" rules require notice and comment and "interpretative" rules do not.  The panel also noted that "[a] rule is 'substantive' where it causes a change in existing law or policy that affects individual rights and obligations and 'interpretive' where it 'merely clarifies or explains existing law or regulations.'"  While Mikkilineni contended that the Interim Guidelines were substantive rules because they substantively deprived him of his rights by requiring the Examiner to reject his claims under § 101, the panel found this argument to be without merit, explaining that the Office's notice requesting comments regarding the Interim Guidelines stated that the Interim Guidelines were interpretive guidance based on the Office's current understanding of the law, "do not constitute substantive rule making and hence do not have the force and effect of law," and that "[r]ejections are and will continue to be based upon the substantive law."  The panel therefore concluded that the Interim Guidelines are interpretive, rather than substantive, and were thus exempt from the notice and comment requirements of § 553 of the APA.  (Interestingly, the panel did not rely on the fact that the Patent Office appears to have subjected the Interim Guidelines to notice and comment rulemaking.)

With regard to Mikkilineni's second argument (that the Patent Office improperly rejected his application), the panel observed that the District Court's dismissal was proper because the Court did not have jurisdiction to review the Examiner's non-final rejection.  The panel noted that when Mikkilineni receives a final rejection from the Office, he can appeal the rejection to the Board, and only after receiving a Board decision affirming that final rejection will he be able to seek judicial review.

Mikkilineni v. Stoll (Fed. Cir. 2010)
Nonprecedential disposition
Panel: Circuit Judges Gajarsa, Linn, and Dyk
Per curiam opinion