More on Merck v. Integra
from Stanton J. Lovenworth, Dewey Ballantine LLP at http://www.bio-itworld.com/staff/steve_withrow/expert-comment/view:
The Supreme Court was careful not to decide whether or not Merck’s activities qualified for Section 271(e)(1)’s safe harbor. Rather, the Court held that the Federal Circuit applied the wrong standard in reviewing Merck’s activities. According to the Court, the central inquiry in applying Section 271(e)(1) is whether or not use of the RGD peptide was “reasonably related to the development and submission of information” to the FDA. The Federal Circuit erred, the Court suggests, by focusing too much on the distinction between pre-clinical and clinical research. As the Court pointed out, the language of 271(e)(1) does not distinguish between clinical and pre-clinical research. Furthermore, because the FDA requires both clinical and pre-clinical research during the course of approving a drug, 271(e)(1) must be read to permit both kinds of research.
[LBE note: recall the Supreme Court did not find that the CAFC had applied a clinical/preclinical distinction.]
The Court held that the appropriate standard focuses on the extent to which Merck’s research was “reasonably related” to an FDA filing, which the Court delineated with a two-step test: “As least where a drugmaker has a reasonable basis for believing that a patented compound may … produce a particular physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is ‘reasonably related’ to the ‘development and submission of information under … Federal law.’”
[LBE note: observe that the Supreme Court did not comment upon the word "solely" in the text of 271(e)(1). HOWEVER, if Integra prevails on remand, there is a way to implicitly bring the concept of solely back into the test.]
In remanding the case for further proceedings, the Court left open a number of questions. First, the Court’s standard suggests a fairly bright line between when a researcher does and does not have “a reasonable basis for believing that a patented compound” will work. But what level of confidence does a researcher require to satisfy this standard? Would an educated guess or conjecture suffice? There is a lot at stake in arriving at the correct answer.
Second, although dicta suggest a wide berth allowing uses of patented compounds studies which, “if successful, would be appropriate to include in a submission to the FDA,” it does not discuss treatment of studies that have overlapping applications, such as the development of derivative compounds. Indeed, although the Court exhaustively discusses 271(e)(1)’s “reasonably related” language, it does not discuss the import of the word “solely” in 271(e)(1)’s proscription that the use of patented inventions must be “… solely for uses reasonably related to the development and submission of information” to the FDA.
Finally, the Court’s focus on “patented compounds,” despite 271(e)(1)’s express reference to “patented invention[s],” casts uncertainty as to whether the Court anticipates a separate “reasonably related” standard for inventions that are not compounds. This concern is highlighted in the case of so-called “research tools,” which are used in the discovery and/or development of a compound, but will not be referenced in any FDA application. Although the Court explicitly states that it “need not – and do[es] not – express a view about whether, or to what extent, §271(e)(1) exempts form infringement the use of ‘research tools’ in the development of information for regulatory purposes,” there is nothing in the text of 271(e)(1) or the Court’s opinion that rationalizes treating research tools any differently than “patented compounds” or any other “patented invention.” Consequently, the decision is less than sanguine news for licensors of research tools who sought a clear statement exempting their use from 271(e)(1)’s ambit.
[LBE note: the claimed invention of a research tool (for research using the claimed invention ONLY as a research tool) would never be submitted to the FDA, nor be information desired or even contemplated by the FDA.]
**
Integra learned that Merck had been sponsoring the research from
scientific papers written by Scripps scientists. Although Integra did not object to the use of its patented technology for research purposes only (and indeed had previously provided these peptides to Scripps scientists [LBE query: after the Supreme Court decision, how likely are the Integras of the world to share samples?]), Integra took the position that sponsored research that was part of Merck's commercial drug development program required a license.
[Mauricio A. Flores and Cathryn Campbell, Legal Times, p. 66, June 20, 2005]
Of the text: Properly construed, section 271(e)(1) leaves adequate space for experimentation and failure on the road to regulatory approval: At least where a drugmaker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if successful,
would be appropriate to include in a submission to the FDA, that use is "reasonably related" to the "development and submission of information under . . . Federal law."
The net effect of the Supreme Court decision will be that patent holders will have to tightly control research that establishes a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect.
UPDATE on Merck v. Integra, 3 October 2005
One wonders how much of the following philosophy was evident in the Supreme Court's decision.
From the Boston Globe on Stephen Breyer:
. ''I think an approach to interpreting statutes, or interpreting the Constitution," Breyer said, ''that certainly looks to text, certainly looks to history, certainly looks to tradition and precedent -- but that also emphasizes heavily the purpose of this particular provision and the consequences as viewed in terms of the purposes, is more likely to get at what this law is about, what area of human life it is seeking to affect and how. That's what I think the essence of law is."
''I don't like the notion of there being two things, the law and life," Breyer said. ''I prefer a metaphor where law is part of life, law grows out of life, law is rules, practices, standards, approaches, formal and less formal behavior that people in a community create so they can live together fruitfully. That's what law is."
In the particular case of Merck v. Integra, it is doubtful that the Congress in 1984 contemplated the type of activity being done by Merck KGaA. It is almost certain that they did not contemplate patents on "research tools."
The Supreme Court was careful not to decide whether or not Merck’s activities qualified for Section 271(e)(1)’s safe harbor. Rather, the Court held that the Federal Circuit applied the wrong standard in reviewing Merck’s activities. According to the Court, the central inquiry in applying Section 271(e)(1) is whether or not use of the RGD peptide was “reasonably related to the development and submission of information” to the FDA. The Federal Circuit erred, the Court suggests, by focusing too much on the distinction between pre-clinical and clinical research. As the Court pointed out, the language of 271(e)(1) does not distinguish between clinical and pre-clinical research. Furthermore, because the FDA requires both clinical and pre-clinical research during the course of approving a drug, 271(e)(1) must be read to permit both kinds of research.
[LBE note: recall the Supreme Court did not find that the CAFC had applied a clinical/preclinical distinction.]
The Court held that the appropriate standard focuses on the extent to which Merck’s research was “reasonably related” to an FDA filing, which the Court delineated with a two-step test: “As least where a drugmaker has a reasonable basis for believing that a patented compound may … produce a particular physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is ‘reasonably related’ to the ‘development and submission of information under … Federal law.’”
[LBE note: observe that the Supreme Court did not comment upon the word "solely" in the text of 271(e)(1). HOWEVER, if Integra prevails on remand, there is a way to implicitly bring the concept of solely back into the test.]
In remanding the case for further proceedings, the Court left open a number of questions. First, the Court’s standard suggests a fairly bright line between when a researcher does and does not have “a reasonable basis for believing that a patented compound” will work. But what level of confidence does a researcher require to satisfy this standard? Would an educated guess or conjecture suffice? There is a lot at stake in arriving at the correct answer.
Second, although dicta suggest a wide berth allowing uses of patented compounds studies which, “if successful, would be appropriate to include in a submission to the FDA,” it does not discuss treatment of studies that have overlapping applications, such as the development of derivative compounds. Indeed, although the Court exhaustively discusses 271(e)(1)’s “reasonably related” language, it does not discuss the import of the word “solely” in 271(e)(1)’s proscription that the use of patented inventions must be “… solely for uses reasonably related to the development and submission of information” to the FDA.
Finally, the Court’s focus on “patented compounds,” despite 271(e)(1)’s express reference to “patented invention[s],” casts uncertainty as to whether the Court anticipates a separate “reasonably related” standard for inventions that are not compounds. This concern is highlighted in the case of so-called “research tools,” which are used in the discovery and/or development of a compound, but will not be referenced in any FDA application. Although the Court explicitly states that it “need not – and do[es] not – express a view about whether, or to what extent, §271(e)(1) exempts form infringement the use of ‘research tools’ in the development of information for regulatory purposes,” there is nothing in the text of 271(e)(1) or the Court’s opinion that rationalizes treating research tools any differently than “patented compounds” or any other “patented invention.” Consequently, the decision is less than sanguine news for licensors of research tools who sought a clear statement exempting their use from 271(e)(1)’s ambit.
[LBE note: the claimed invention of a research tool (for research using the claimed invention ONLY as a research tool) would never be submitted to the FDA, nor be information desired or even contemplated by the FDA.]
**
Integra learned that Merck had been sponsoring the research from
scientific papers written by Scripps scientists. Although Integra did not object to the use of its patented technology for research purposes only (and indeed had previously provided these peptides to Scripps scientists [LBE query: after the Supreme Court decision, how likely are the Integras of the world to share samples?]), Integra took the position that sponsored research that was part of Merck's commercial drug development program required a license.
[Mauricio A. Flores and Cathryn Campbell, Legal Times, p. 66, June 20, 2005]
Of the text: Properly construed, section 271(e)(1) leaves adequate space for experimentation and failure on the road to regulatory approval: At least where a drugmaker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if successful,
would be appropriate to include in a submission to the FDA, that use is "reasonably related" to the "development and submission of information under . . . Federal law."
The net effect of the Supreme Court decision will be that patent holders will have to tightly control research that establishes a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect.
UPDATE on Merck v. Integra, 3 October 2005
One wonders how much of the following philosophy was evident in the Supreme Court's decision.
From the Boston Globe on Stephen Breyer:
. ''I think an approach to interpreting statutes, or interpreting the Constitution," Breyer said, ''that certainly looks to text, certainly looks to history, certainly looks to tradition and precedent -- but that also emphasizes heavily the purpose of this particular provision and the consequences as viewed in terms of the purposes, is more likely to get at what this law is about, what area of human life it is seeking to affect and how. That's what I think the essence of law is."
''I don't like the notion of there being two things, the law and life," Breyer said. ''I prefer a metaphor where law is part of life, law grows out of life, law is rules, practices, standards, approaches, formal and less formal behavior that people in a community create so they can live together fruitfully. That's what law is."
In the particular case of Merck v. Integra, it is doubtful that the Congress in 1984 contemplated the type of activity being done by Merck KGaA. It is almost certain that they did not contemplate patents on "research tools."
posted by Lawrence B. Ebert at 5:14 PM
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