Questionable footnoting in the journal Science?
In discussing the Brauman report on the Hwang fraud, IPBiz alluded to a paper in the Dec. 1, 2006 issue of Science: "When Patents Threaten Science" by Lori Andrews, Jordan Paradise, Timothy Holbrook, and Danielle Bochneak. Science, Vol. 314. no. 5804, pp. 1395 - 1396.
Some quotes from the Dec. 1 Science paper are included below.
Science: Astonishingly, the Federal Circuit also held that physicians (or researchers) would infringe the patent merely by thinking about the relation between homocysteine and vitamin deficiency when they analyzed an alternative homocysteine test (5).
5. Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F. 3d 1354 (Fed. Cir. 2004).
What the CAFC actually said is the following -->
Direct Infringement
The jury found LabCorp liable for indirect infringement. The record must show the presence of direct infringement, however, to support the verdict of indirect infringement. Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 774 (Fed. Cir. 1993) ("Liability for either active inducement of infringement or for contributory infringement is dependent upon the existence of direct infringement."). Thus, this court must examine whether there is substantial evidence in the record of the physicians' direct infringement. In that respect, the parties hinge the direct infringement issue solely on whether the physicians perform the correlating step. Hence, we review the record for substantial evidence of that step.
Substantial evidence supports the jury's verdict. The record shows that physicians order assays and correlate the results of those assays, thereby directly infringing. LabCorp's Discipline Director, Dr. Peter Wentz, testified that the physicians receiving total homocysteine assays from LabCorp carry out the correlating step. Specifically, Dr. Wentz testified that "the correlating step . . . [is] a separate, distinct step that's performed by the physician who receives . . . our results." Inventor Dr. Sally Stabler also testified that it would be malpractice for a doctor to receive a total homocysteine assay without determining cobalamin/folate deficiency.
To support the verdict, the record does not need to contain direct evidence that every physician performed the "correlating" step. "It is hornbook law that direct evidence of a fact is not necessary. 'Circumstantial evidence is not only sufficient, but may also be more certain, satisfying and persuasive than direct evidence.'" Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1272 (Fed. Cir. 1986) (citing Michalic v. Cleveland Tankers, Inc., 364 U.S. 325, 330 (1960)). As discussed above, the record contains sufficient circumstantial evidence to permit the jury to imply that physicians directly infringe.
Science: The USPTO and lower courts are responsible for granting and enforcing patent rights that run contrary to U.S. Supreme Court precedent (22).
22. S. Merrill et al., Eds., A Patent System for the 21st Century (National Research Council, National Academies Press, Washington, DC, 2004), pp. 25-27.
What Merrill et al. said on pages 25-27 is a bit different. One will not find Merrill talking about the USPTO or lower courts on pages 25-27. Merrill barely talks about patents on discoveries. Merrill's focus is on research tool patents.
Of reference 22, page 25 has a section entitled Expanded Patenting of Research Tools and Discoveries
This section begins:
There is disagreement whether patents on discoveries and tools of research, an expanded domain of patenting,13 provide needed incentives to innovate or, because of difficulties and costs entailed in accessing the subjects of these patents, may impede the progress of scientific investigation.
Page 26 has the text:
The issue has recently reemerged in a new context—not whether failure to license or cross-license product patents is impeding further innovation but whether patents on some research tools and foundational discoveries have the potential to stymie further scientific research well upstream of commercial products (Nelson, 2003). The concern involves a rapidly expanded domain of patenting—inventions that are useful solely or primarily for further research. Previously, in most cases these techniques and discoveries became part of the public domain of scientific knowledge available without restriction for use by all investigators, especially where they were the products of publicly funded research at institutions of higher education. Open academic science thrived not on the basis of altruism but because the rewards for successful work are reputational and the benefits that go with prestige. That they are now being patented may be as much a function of changes in the innovation system as of the utilization of patents in new fields of technology.
(…)
Three different problematic circumstances have been hypothesized:
1. Access to patented foundational discoveries is denied, foreclosing research avenues to other investigators (Merges and Nelson, 1990).
Page 27:
The concern has focused primarily on the field of biotechnology, where there has been an increase in patents on a variety of inputs into the process of discovering a drug or other medical therapy or method of diagnosing disease as well as the tools of plant modification—genes and genetic sequences, drug targets and pathways, antibodies, and so forth.
For page 25, see
http://fermat.nap.edu/openbook.php?record_id=10976&page=25
http://newton.nap.edu/pdf/0309089107/pdf_image/25.pdf
For page 27 (pdf) see
http://newton.nap.edu/pdf/0309089107/pdf_image/27.pdf
Science: Patent applicants who seek to patent laws of nature often point to a Federal Circuit opinion, State Street Bank & Trust Co. v. Signature Financial Group, which suggests that a law of nature is patentable if it produces a "useful, concrete, and tangible result" (23).
23. State Street Bank & Trust Co. v. Signature Fin. Group 149 F. 3d 1368, 1373 (Fed. Cir. 1998), cert. denied 525 U.S. 1093 (1999).
What the CAFC said in State Street about a "law(s) of nature" is as follows:
The Supreme Court has identified three categories of subject matter that are unpatentable, namely "laws of nature, natural phenomena, and abstract ideas." Diehr, 450 U.S. at 185.
(...)
After Diehr and Chakrabarty, the Freeman-Walter-Abele test has little, if any, applicability to determining the presence of statutory subject matter. As we pointed out in Alappat, 33 F.3d at 1543, 31 USPQ2d at 1557, application of the test could be misleading, because a process, machine, manufacture, or composition of matter employing a law of nature, natural phenomenon, or abstract idea is patentable subject matter even though a law of nature, natural phenomenon, or abstract idea would not, by itself, be entitled to such protection.
(...)
Footnote 1. Indeed, although we do not make this determination here, the judicially created exceptions, i.e., abstract ideas, laws of nature, etc., should be applicable to all categories of statutory subject matter, as our own precedent suggests. See Alappat, 33 F.3d at 1542, 31 USPQ2d at 1556; see also In re Johnson, 502 F.2d 765, 183 USPQ 172 (CCPA 1974) (Rich, J., dissenting).
(...)
Footnote 6. See e.g. Parker v. Flook, 437 U.S. 584, 590 (1978) ("[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm."); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) ("He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law to a new and useful end."); Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86, 94 (1939) ("While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.").
(...)
Footnote 15. (...) See e.g. Parker v. Flook, 437 U.S. 584, 590 (1978) ("[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm."); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) ("He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law to a new and useful end."); Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86, 94 (1939) ("While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.").
Science: Scientists may not have paid sufficient attention to the privatization of common knowledge because, in the past, they felt that research activities did not require approval from patent holders. The 2002 Madey v. Duke decision put an end to such protection (24).
24. Madey v. Duke University, 307 F. 3d 1351, 1362 (Fed. Cir. 2002).
The Madey case said:
Madey argues, and we agree, that the district court had an overly broad conception of the very narrow and strictly limited experimental use defense. The district court stated that the experimental use defense inoculated uses that “were solely for research, academic, or experimental purposes,” and that the defense covered use that “is made for experimental, non‑profit purposes only.” Id. at 9. Both formulations are too broad and stand in sharp contrast to our admonitions in Embrex and Roche that the experimental use defense is very narrow and strictly limited. In Embrex, we followed the teachings of Roche and Pitcairn to hold that the defense was very narrow and limited to actions performed “for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.” Embrex, 216 F.3d at 1349, 55 USPQ2d at 1163. Further, use does not qualify for the experimental use defense when it is undertaken in the “guise of scientific inquiry” but has “definite, cognizable, and not insubstantial commercial purposes.” Id. (quoting Roche, 733 F.2d at 863, 221 USPQ2d at 941).
(...)
Our precedent clearly does not immunize use that is in any way commercial in nature. Similarly, our precedent does not immunize any conduct that is in keeping with the alleged infringer’s legitimate business, regardless of commercial implications. For example, major research universities, such as Duke, often sanction and fund research projects with arguably no commercial application whatsoever. However, these projects unmistakably further the institution’s legitimate business objectives, including educating and enlightening students and faculty participating in these projects. These projects also serve, for example, to increase the status of the institution and lure lucrative research grants, students and faculty.
In short, regardless of whether a particular institution or entity is engaged in an endeavor for commercial gain, so long as the act is in furtherance of the alleged infringer’s legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defense. Moreover, the profit or non-profit status of the user is not determinative.
[IPBiz separately notes that the Science authors completely ignored the Supreme Court decision in Merck v. Integra.]
*****
See also
Patents on Human Genes: An Analysis of Scope and Claims
Jordan Paradise, Lori Andrews, Timothy Holbrook
Science, Vol. 307. no. 5715, pp. 1566 - 1567
There is significant domestic and international opposition to gene patents based on the fact that gene patents deter medical research and health care, as well as the policy position that genes are an inherent product of nature. Yet, equally troubling is the fact that gene patents have been issued by the U.S. Patent & Trademark Office [USPTO]that are problematic with respect to existing federal patent law. The authors of this Policy Forum describe their study, which examined issued gene patents covering a variety of genetic diseases and described ways in which many claims fell short of USPTO patentability requirements.
*****
In passing IPBiz notes that Google does not index the IPBiz post on the Brauman report, which is
http://ipbiz.blogspot.com/2006/12/brauman-report-on-hwang-fraud-issues.html
but Google does index a post referencing the IPBiz post:
kinja.com/user/nip/default/all?p=118816603 - 47k
It is sheer stupidity to index a secondary reference but not a primary reference which is freely available.
Some quotes from the Dec. 1 Science paper are included below.
Science: Astonishingly, the Federal Circuit also held that physicians (or researchers) would infringe the patent merely by thinking about the relation between homocysteine and vitamin deficiency when they analyzed an alternative homocysteine test (5).
5. Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F. 3d 1354 (Fed. Cir. 2004).
What the CAFC actually said is the following -->
Direct Infringement
The jury found LabCorp liable for indirect infringement. The record must show the presence of direct infringement, however, to support the verdict of indirect infringement. Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 774 (Fed. Cir. 1993) ("Liability for either active inducement of infringement or for contributory infringement is dependent upon the existence of direct infringement."). Thus, this court must examine whether there is substantial evidence in the record of the physicians' direct infringement. In that respect, the parties hinge the direct infringement issue solely on whether the physicians perform the correlating step. Hence, we review the record for substantial evidence of that step.
Substantial evidence supports the jury's verdict. The record shows that physicians order assays and correlate the results of those assays, thereby directly infringing. LabCorp's Discipline Director, Dr. Peter Wentz, testified that the physicians receiving total homocysteine assays from LabCorp carry out the correlating step. Specifically, Dr. Wentz testified that "the correlating step . . . [is] a separate, distinct step that's performed by the physician who receives . . . our results." Inventor Dr. Sally Stabler also testified that it would be malpractice for a doctor to receive a total homocysteine assay without determining cobalamin/folate deficiency.
To support the verdict, the record does not need to contain direct evidence that every physician performed the "correlating" step. "It is hornbook law that direct evidence of a fact is not necessary. 'Circumstantial evidence is not only sufficient, but may also be more certain, satisfying and persuasive than direct evidence.'" Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1272 (Fed. Cir. 1986) (citing Michalic v. Cleveland Tankers, Inc., 364 U.S. 325, 330 (1960)). As discussed above, the record contains sufficient circumstantial evidence to permit the jury to imply that physicians directly infringe.
Science: The USPTO and lower courts are responsible for granting and enforcing patent rights that run contrary to U.S. Supreme Court precedent (22).
22. S. Merrill et al., Eds., A Patent System for the 21st Century (National Research Council, National Academies Press, Washington, DC, 2004), pp. 25-27.
What Merrill et al. said on pages 25-27 is a bit different. One will not find Merrill talking about the USPTO or lower courts on pages 25-27. Merrill barely talks about patents on discoveries. Merrill's focus is on research tool patents.
Of reference 22, page 25 has a section entitled Expanded Patenting of Research Tools and Discoveries
This section begins:
There is disagreement whether patents on discoveries and tools of research, an expanded domain of patenting,13 provide needed incentives to innovate or, because of difficulties and costs entailed in accessing the subjects of these patents, may impede the progress of scientific investigation.
Page 26 has the text:
The issue has recently reemerged in a new context—not whether failure to license or cross-license product patents is impeding further innovation but whether patents on some research tools and foundational discoveries have the potential to stymie further scientific research well upstream of commercial products (Nelson, 2003). The concern involves a rapidly expanded domain of patenting—inventions that are useful solely or primarily for further research. Previously, in most cases these techniques and discoveries became part of the public domain of scientific knowledge available without restriction for use by all investigators, especially where they were the products of publicly funded research at institutions of higher education. Open academic science thrived not on the basis of altruism but because the rewards for successful work are reputational and the benefits that go with prestige. That they are now being patented may be as much a function of changes in the innovation system as of the utilization of patents in new fields of technology.
(…)
Three different problematic circumstances have been hypothesized:
1. Access to patented foundational discoveries is denied, foreclosing research avenues to other investigators (Merges and Nelson, 1990).
Page 27:
The concern has focused primarily on the field of biotechnology, where there has been an increase in patents on a variety of inputs into the process of discovering a drug or other medical therapy or method of diagnosing disease as well as the tools of plant modification—genes and genetic sequences, drug targets and pathways, antibodies, and so forth.
For page 25, see
http://fermat.nap.edu/openbook.php?record_id=10976&page=25
http://newton.nap.edu/pdf/0309089107/pdf_image/25.pdf
For page 27 (pdf) see
http://newton.nap.edu/pdf/0309089107/pdf_image/27.pdf
Science: Patent applicants who seek to patent laws of nature often point to a Federal Circuit opinion, State Street Bank & Trust Co. v. Signature Financial Group, which suggests that a law of nature is patentable if it produces a "useful, concrete, and tangible result" (23).
23. State Street Bank & Trust Co. v. Signature Fin. Group 149 F. 3d 1368, 1373 (Fed. Cir. 1998), cert. denied 525 U.S. 1093 (1999).
What the CAFC said in State Street about a "law(s) of nature" is as follows:
The Supreme Court has identified three categories of subject matter that are unpatentable, namely "laws of nature, natural phenomena, and abstract ideas." Diehr, 450 U.S. at 185.
(...)
After Diehr and Chakrabarty, the Freeman-Walter-Abele test has little, if any, applicability to determining the presence of statutory subject matter. As we pointed out in Alappat, 33 F.3d at 1543, 31 USPQ2d at 1557, application of the test could be misleading, because a process, machine, manufacture, or composition of matter employing a law of nature, natural phenomenon, or abstract idea is patentable subject matter even though a law of nature, natural phenomenon, or abstract idea would not, by itself, be entitled to such protection.
(...)
Footnote 1. Indeed, although we do not make this determination here, the judicially created exceptions, i.e., abstract ideas, laws of nature, etc., should be applicable to all categories of statutory subject matter, as our own precedent suggests. See Alappat, 33 F.3d at 1542, 31 USPQ2d at 1556; see also In re Johnson, 502 F.2d 765, 183 USPQ 172 (CCPA 1974) (Rich, J., dissenting).
(...)
Footnote 6. See e.g. Parker v. Flook, 437 U.S. 584, 590 (1978) ("[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm."); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) ("He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law to a new and useful end."); Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86, 94 (1939) ("While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.").
(...)
Footnote 15. (...) See e.g. Parker v. Flook, 437 U.S. 584, 590 (1978) ("[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm."); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) ("He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law to a new and useful end."); Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86, 94 (1939) ("While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.").
Science: Scientists may not have paid sufficient attention to the privatization of common knowledge because, in the past, they felt that research activities did not require approval from patent holders. The 2002 Madey v. Duke decision put an end to such protection (24).
24. Madey v. Duke University, 307 F. 3d 1351, 1362 (Fed. Cir. 2002).
The Madey case said:
Madey argues, and we agree, that the district court had an overly broad conception of the very narrow and strictly limited experimental use defense. The district court stated that the experimental use defense inoculated uses that “were solely for research, academic, or experimental purposes,” and that the defense covered use that “is made for experimental, non‑profit purposes only.” Id. at 9. Both formulations are too broad and stand in sharp contrast to our admonitions in Embrex and Roche that the experimental use defense is very narrow and strictly limited. In Embrex, we followed the teachings of Roche and Pitcairn to hold that the defense was very narrow and limited to actions performed “for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.” Embrex, 216 F.3d at 1349, 55 USPQ2d at 1163. Further, use does not qualify for the experimental use defense when it is undertaken in the “guise of scientific inquiry” but has “definite, cognizable, and not insubstantial commercial purposes.” Id. (quoting Roche, 733 F.2d at 863, 221 USPQ2d at 941).
(...)
Our precedent clearly does not immunize use that is in any way commercial in nature. Similarly, our precedent does not immunize any conduct that is in keeping with the alleged infringer’s legitimate business, regardless of commercial implications. For example, major research universities, such as Duke, often sanction and fund research projects with arguably no commercial application whatsoever. However, these projects unmistakably further the institution’s legitimate business objectives, including educating and enlightening students and faculty participating in these projects. These projects also serve, for example, to increase the status of the institution and lure lucrative research grants, students and faculty.
In short, regardless of whether a particular institution or entity is engaged in an endeavor for commercial gain, so long as the act is in furtherance of the alleged infringer’s legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defense. Moreover, the profit or non-profit status of the user is not determinative.
[IPBiz separately notes that the Science authors completely ignored the Supreme Court decision in Merck v. Integra.]
*****
See also
Patents on Human Genes: An Analysis of Scope and Claims
Jordan Paradise, Lori Andrews, Timothy Holbrook
Science, Vol. 307. no. 5715, pp. 1566 - 1567
There is significant domestic and international opposition to gene patents based on the fact that gene patents deter medical research and health care, as well as the policy position that genes are an inherent product of nature. Yet, equally troubling is the fact that gene patents have been issued by the U.S. Patent & Trademark Office [USPTO]that are problematic with respect to existing federal patent law. The authors of this Policy Forum describe their study, which examined issued gene patents covering a variety of genetic diseases and described ways in which many claims fell short of USPTO patentability requirements.
*****
In passing IPBiz notes that Google does not index the IPBiz post on the Brauman report, which is
http://ipbiz.blogspot.com/2006/12/brauman-report-on-hwang-fraud-issues.html
but Google does index a post referencing the IPBiz post:
kinja.com/user/nip/default/all?p=118816603 - 47k
It is sheer stupidity to index a secondary reference but not a primary reference which is freely available.
posted by Lawrence B. Ebert at 6:45 PM
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