Ariad Pharm v Eli Lilly 560 F.3d 1366 (Fed. Cir., 2009).
SUMMARY
Ariad Pharmaceuticals sued Eli Lilly for infringing patent claims for a method for reducing the activity of a transcription factor named NF-KB. At a jury hearing, Lilly denied infringement on the grounds that the patent was invalid for anticipation, lack of enablement, and lack of written description. A separate bench trial was held on Lilly’s affirmative defenses of inequitable conduct and prosecution laches. Ariad prevailed at both the jury hearing and bench trial. Lilly appealed all rulings except prosecution laches. On appeal, the Federal Circuit found Ariad’s patent invalid for lack of a written description without addressing other issues. The district court ruling regarding inequitable conduct was affirmed.
PROCEDURAL HISTORY
Ariad Pharmaceuticals, along with the original assignees and inventor, sued Lilly in U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 6,410,’516 (‘516) for a method of gene regulation on June 25, 2002. Lilly filed motions for re-examination of the patent on April 4, 2005. Lilly’s motion for a stay was denied, as was a renewed motion for a stay on January 17, 2006. A fourteen day trial was undertaken in April 2006.
The jury found that Lilly had infringed on four claims under ‘516 and that the claims were not invalid for anticipation, lack of enablement or lack of written description. The court denied Lilly’s motions, at the close of the case and following the verdict, for summary judgment as a matter of law (JMOL) due to anticipation, lack of enablement, or lack of written description without opinion. A separate bench trial ruled that ‘516 was not unenforceable due to unpatentable subject matter, inequitable conduct or prosecution laches. Lilly appealed all rulings except the ruling re prosecution laches.
FACTS
Ariad Pharmaceuticals licensed ‘516, which claims methods for modifying the activity of a transcription factor named NF-KB, from Harvard and the Massachusetts Institute of Technology, the assignees of ‘516. At the time that ‘516 was issued, Lilly was producing and selling two medications for use in humans that Ariad alleged utilized the methods described in ‘516; Evista and Xigris.
Transcription factors are intracellular proteins are part of are the mechanisms that control gene function. Genes, in turn, are part of the mechanisms that control cells and the production of cell products. Specific transcription factors, such as NF-KB, then, help regulate cell function, by regulating gene’s that regulate cell production of specific cell products, such as proteins.
NF-KB lies dormant in cells until it is activated by various stimuli in the cell’s environment. The stimuli that activate NF-KB are typically things that might be harmful to the cell. Once activated NF-KB can prompt genes to produce proteins for cell protection, such as cytokines, which are part of the inflammatory and immune response that cells produce. In addition to providing a means for protecting the cell from threats, such as infection, the inflammatory response produces symptoms, such as swelling, redness, pain and fever that may have adverse effects if unregulated or excessive. The inventors of ‘516 realized that a method for artificially controlling NF-KB activity could potentially control such untoward symptoms. They asserted claims for four such methods. These claims were rewritten by the court to include the claims that they depended on.
The claims are summarized below keeping emphasis from the decision and the original language kept by the court from the claims (underlined in claims 80, 95, 144, and 145 below):
In eukaryotic cells:
80. A method for modifying the effects of external influences that modify NF-KB mediated
intracellular signaling by reducing NF-KB activity in the cell wherein reducing NF-KB activity comprises reducing binding of NF-KB to NF-KB recognition sites on genes which are transcriptionally regulated by NF-KB.
95. A method for reducing the expression of genes activated by extracellular influences that induce NF-KB mediated intracellular signaling, comprising reducing NF-KB activity in the cells such that the expressions of said genes is reduced, carried out on human cells.
In mammalian cells:
144. A method for reducing bacterial lipopolysaccharide-induced expression of cytokines, comprising reducing NF-KB activity so as to reduce lipopolysaccharide-induced expression of cytokines in said cells, wherein reducing NF-KB activity comprises reducing binding of NF-KB to NF-KB recognition sites on genes which are transcriptionally regulated by NF-KB.
145. A method for reducing bacterial lipopolysaccharide-induced expression of cytokines, comprising reducing NF-KB activity so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in said cells, carried out on human cells.
The district court interpreted “reducing NF-KB activityâ€, used as emphasized by the court in each claim above, to mean “decreasing the function of NF-KB to act as an intracellular messenger that regulates transcription of particular genes in response to certain stimuli.†Without objection by either party.
The parties dispute of the effective filing date, April 21, 1989 v. November 13, 1991, was resolved by a jury, through use of a special verdict form, to be April 21, 1989.
ISSUES
1. Was there a preponderance of evidence that process claims 80, 95, 144, and 145 from ‘516 had; 1) not been enabled, 2) lacked a written description, and 3) been anticipated, under U.S.C.S. 35 sections 112, and 102?
2. Was there clear and convincing evidence that Lilly’s prosecution of the claims involved inequitable conduct?
DECISION
1. No, “The jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description, and thus hold the asserted claims invalid.†supra at 1376. “Because we hold claims 80, 95, 144, and 145. . .invalid for lack of written description, we need not address infringement or the other validity issues on appeal.†Id. At 1381.
2. No, “There is simply no evidence of what Lilly contends is “purposeful concealment†no matter how material the errors might be. Id. At 1379. . .Because Lilly failed to establish the “threshold level of intent to deceive. . .by clear and convincing evidence,†the. . .’516 patent was not unenforceable due to inequitable conduct. Id. At 1380.
HOLDINGS
The court found ‘561 invalid for lack of an adequate written description under U.S.C.S. 35 § 112 noting, “To satisfy the written description requirement, ‘the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’†Carnegie Mellon Univ. v. Hoffman-La Roche Inc., 541 F3d 1115, 1122 (Fed. Cir. 2008). The court emphasized that the written description “serves both to satisfy the inventor's obligation to disclose the technological knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir 2005). The court went on to point out that this requirement was true for both process claims and composition claims, "regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods." Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2005).
The court noted that the adequacy of description depends on the context of the claimed invention and that it had previously articulated a variety of factors to be used in evaluating the adequacy of description relative to context. These factors include "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue." Capon, 418 F.3d 1349, 1358. The court held that written description analysis occurs “as of the filing date sought.†Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991).
In analyzing Lilly’s affirmative defense of inequitable conduct the court found that this defense required “evidence that the applicant (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) intended to deceive the USPTO.†Cargill, Inc. V. Canbra Foods, Ltd., 476 F3d 1359, 1364-65 (Fed. Cir. 2007). "Further, at least a threshold level of each element — i.e., both materiality and intent to deceive-- must be proven by clear and convincing evidence.†Star Scientific, Inc., v. R.J. Reynolds Tobacco Co., 537 F3d 1357, 1365 (Fed. Cir. 2008). "If a threshold level of intent to deceive or materiality is not established by clear and convincing evidence, the district court does not have any discretion to exercise and cannot hold a patent unenforceable, regardless of the relative equities or how it might balance them." Id. The court noted that clear and convincing evidence of deceptive intent could not rest on the materiality of errors, but required clear and convincing evidence of "culpable" conduct. Halliburton Co. v. Schlumberger Tech. Corp., 925 F.2d 1435, 1443 (Fed. Cir. 1991).
ANALYSIS
The court found ‘516 invalid because the 1989 written description of the broad claims being contested failed to teach a PHOSITA their implementation. In particular, the court found that written description, as it existed at time of filing, failed to disclose specific examples of what a NF-KB inhibitor was or how NF-KB inhibition could be achieved.
Expert testimony that the inventors were in possession of the knowledge that they claimed was found to be conclusory and non-dispositive of this issue. Figure 43, the DNA sequence for a NF-KB inhibitor that was submitted after the filing date, was found to be both too late to be legally relevant and inaccurate. Although this evidence was found to be legally irrelevant, with regard to the adequacy of the written description, because it post-dated the filing date, the court did take note of it to the extent that the uncorrected submission of this inaccurate information suggested the inventor lacked possession of the knowledge it claimed.
The significance of this decision is unclear because it has been vacated and is awaiting rehearing as of November 4, 2009. If affirmed, it emphasizes the need for detail and specificity in the written description that is commiserate with the breath of the patent’s claims. From another perspective, or concomitantly, it emphasizes that it is important to give careful consideration to the breadth of claims. Sometimes less is more. In this case, narrower process claims may have required concomitantly less detail and specificity in the written description.
On a technical level, the confusion re filing dates and the errors in the supporting material submitted were straightforward issues that adversely impacted the plaintiff’s case despite the favorable decision of regarding inequitable conduct. The confusion re filing dates was critical in two respects; 1) it impacted the PHOSITAS’ reading of the claims; i.e., a 1991 PHOSITA may not have needed as much information as a 1989 PHOSITA and, 2) much of the evidence that Ariad submitted to support its claims was held to be post-dated. Lastly, the errors in the material submitted were judged by the court as evidence that the inventor was not in possession of the knowledge that it claimed. All good reminders that ‘the devil is in the details’.
W. Harry Horner WVU Class of 2011
SUMMARY
Ariad Pharmaceuticals sued Eli Lilly for infringing patent claims for a method for reducing the activity of a transcription factor named NF-KB. At a jury hearing, Lilly denied infringement on the grounds that the patent was invalid for anticipation, lack of enablement, and lack of written description. A separate bench trial was held on Lilly’s affirmative defenses of inequitable conduct and prosecution laches. Ariad prevailed at both the jury hearing and bench trial. Lilly appealed all rulings except prosecution laches. On appeal, the Federal Circuit found Ariad’s patent invalid for lack of a written description without addressing other issues. The district court ruling regarding inequitable conduct was affirmed.
PROCEDURAL HISTORY
Ariad Pharmaceuticals, along with the original assignees and inventor, sued Lilly in U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 6,410,’516 (‘516) for a method of gene regulation on June 25, 2002. Lilly filed motions for re-examination of the patent on April 4, 2005. Lilly’s motion for a stay was denied, as was a renewed motion for a stay on January 17, 2006. A fourteen day trial was undertaken in April 2006.
The jury found that Lilly had infringed on four claims under ‘516 and that the claims were not invalid for anticipation, lack of enablement or lack of written description. The court denied Lilly’s motions, at the close of the case and following the verdict, for summary judgment as a matter of law (JMOL) due to anticipation, lack of enablement, or lack of written description without opinion. A separate bench trial ruled that ‘516 was not unenforceable due to unpatentable subject matter, inequitable conduct or prosecution laches. Lilly appealed all rulings except the ruling re prosecution laches.
FACTS
Ariad Pharmaceuticals licensed ‘516, which claims methods for modifying the activity of a transcription factor named NF-KB, from Harvard and the Massachusetts Institute of Technology, the assignees of ‘516. At the time that ‘516 was issued, Lilly was producing and selling two medications for use in humans that Ariad alleged utilized the methods described in ‘516; Evista and Xigris.
Transcription factors are intracellular proteins are part of are the mechanisms that control gene function. Genes, in turn, are part of the mechanisms that control cells and the production of cell products. Specific transcription factors, such as NF-KB, then, help regulate cell function, by regulating gene’s that regulate cell production of specific cell products, such as proteins.
NF-KB lies dormant in cells until it is activated by various stimuli in the cell’s environment. The stimuli that activate NF-KB are typically things that might be harmful to the cell. Once activated NF-KB can prompt genes to produce proteins for cell protection, such as cytokines, which are part of the inflammatory and immune response that cells produce. In addition to providing a means for protecting the cell from threats, such as infection, the inflammatory response produces symptoms, such as swelling, redness, pain and fever that may have adverse effects if unregulated or excessive. The inventors of ‘516 realized that a method for artificially controlling NF-KB activity could potentially control such untoward symptoms. They asserted claims for four such methods. These claims were rewritten by the court to include the claims that they depended on.
The claims are summarized below keeping emphasis from the decision and the original language kept by the court from the claims (underlined in claims 80, 95, 144, and 145 below):
In eukaryotic cells:
80. A method for modifying the effects of external influences that modify NF-KB mediated
intracellular signaling by reducing NF-KB activity in the cell wherein reducing NF-KB activity comprises reducing binding of NF-KB to NF-KB recognition sites on genes which are transcriptionally regulated by NF-KB.
95. A method for reducing the expression of genes activated by extracellular influences that induce NF-KB mediated intracellular signaling, comprising reducing NF-KB activity in the cells such that the expressions of said genes is reduced, carried out on human cells.
In mammalian cells:
144. A method for reducing bacterial lipopolysaccharide-induced expression of cytokines, comprising reducing NF-KB activity so as to reduce lipopolysaccharide-induced expression of cytokines in said cells, wherein reducing NF-KB activity comprises reducing binding of NF-KB to NF-KB recognition sites on genes which are transcriptionally regulated by NF-KB.
145. A method for reducing bacterial lipopolysaccharide-induced expression of cytokines, comprising reducing NF-KB activity so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in said cells, carried out on human cells.
The district court interpreted “reducing NF-KB activityâ€, used as emphasized by the court in each claim above, to mean “decreasing the function of NF-KB to act as an intracellular messenger that regulates transcription of particular genes in response to certain stimuli.†Without objection by either party.
The parties dispute of the effective filing date, April 21, 1989 v. November 13, 1991, was resolved by a jury, through use of a special verdict form, to be April 21, 1989.
ISSUES
1. Was there a preponderance of evidence that process claims 80, 95, 144, and 145 from ‘516 had; 1) not been enabled, 2) lacked a written description, and 3) been anticipated, under U.S.C.S. 35 sections 112, and 102?
2. Was there clear and convincing evidence that Lilly’s prosecution of the claims involved inequitable conduct?
DECISION
1. No, “The jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description, and thus hold the asserted claims invalid.†supra at 1376. “Because we hold claims 80, 95, 144, and 145. . .invalid for lack of written description, we need not address infringement or the other validity issues on appeal.†Id. At 1381.
2. No, “There is simply no evidence of what Lilly contends is “purposeful concealment†no matter how material the errors might be. Id. At 1379. . .Because Lilly failed to establish the “threshold level of intent to deceive. . .by clear and convincing evidence,†the. . .’516 patent was not unenforceable due to inequitable conduct. Id. At 1380.
HOLDINGS
The court found ‘561 invalid for lack of an adequate written description under U.S.C.S. 35 § 112 noting, “To satisfy the written description requirement, ‘the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’†Carnegie Mellon Univ. v. Hoffman-La Roche Inc., 541 F3d 1115, 1122 (Fed. Cir. 2008). The court emphasized that the written description “serves both to satisfy the inventor's obligation to disclose the technological knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir 2005). The court went on to point out that this requirement was true for both process claims and composition claims, "regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods." Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2005).
The court noted that the adequacy of description depends on the context of the claimed invention and that it had previously articulated a variety of factors to be used in evaluating the adequacy of description relative to context. These factors include "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue." Capon, 418 F.3d 1349, 1358. The court held that written description analysis occurs “as of the filing date sought.†Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991).
In analyzing Lilly’s affirmative defense of inequitable conduct the court found that this defense required “evidence that the applicant (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) intended to deceive the USPTO.†Cargill, Inc. V. Canbra Foods, Ltd., 476 F3d 1359, 1364-65 (Fed. Cir. 2007). "Further, at least a threshold level of each element — i.e., both materiality and intent to deceive-- must be proven by clear and convincing evidence.†Star Scientific, Inc., v. R.J. Reynolds Tobacco Co., 537 F3d 1357, 1365 (Fed. Cir. 2008). "If a threshold level of intent to deceive or materiality is not established by clear and convincing evidence, the district court does not have any discretion to exercise and cannot hold a patent unenforceable, regardless of the relative equities or how it might balance them." Id. The court noted that clear and convincing evidence of deceptive intent could not rest on the materiality of errors, but required clear and convincing evidence of "culpable" conduct. Halliburton Co. v. Schlumberger Tech. Corp., 925 F.2d 1435, 1443 (Fed. Cir. 1991).
ANALYSIS
The court found ‘516 invalid because the 1989 written description of the broad claims being contested failed to teach a PHOSITA their implementation. In particular, the court found that written description, as it existed at time of filing, failed to disclose specific examples of what a NF-KB inhibitor was or how NF-KB inhibition could be achieved.
Expert testimony that the inventors were in possession of the knowledge that they claimed was found to be conclusory and non-dispositive of this issue. Figure 43, the DNA sequence for a NF-KB inhibitor that was submitted after the filing date, was found to be both too late to be legally relevant and inaccurate. Although this evidence was found to be legally irrelevant, with regard to the adequacy of the written description, because it post-dated the filing date, the court did take note of it to the extent that the uncorrected submission of this inaccurate information suggested the inventor lacked possession of the knowledge it claimed.
The significance of this decision is unclear because it has been vacated and is awaiting rehearing as of November 4, 2009. If affirmed, it emphasizes the need for detail and specificity in the written description that is commiserate with the breath of the patent’s claims. From another perspective, or concomitantly, it emphasizes that it is important to give careful consideration to the breadth of claims. Sometimes less is more. In this case, narrower process claims may have required concomitantly less detail and specificity in the written description.
On a technical level, the confusion re filing dates and the errors in the supporting material submitted were straightforward issues that adversely impacted the plaintiff’s case despite the favorable decision of regarding inequitable conduct. The confusion re filing dates was critical in two respects; 1) it impacted the PHOSITAS’ reading of the claims; i.e., a 1991 PHOSITA may not have needed as much information as a 1989 PHOSITA and, 2) much of the evidence that Ariad submitted to support its claims was held to be post-dated. Lastly, the errors in the material submitted were judged by the court as evidence that the inventor was not in possession of the knowledge that it claimed. All good reminders that ‘the devil is in the details’.
W. Harry Horner WVU Class of 2011