Inherent anticipation. Patent Law day at Michigan State.
A blog (duecourse.blogspot.com) carries a discussion of "Patent Law Day" at Michigan State University. I don't see too much other discussion of this event (held on Sept. 13, 2004) but do see a notice about that the inaugural issue of the Michigan State Intellectual Property Review contains selected presentations from this conference.
One item of the blog that caught my eye concerned inherent anticipation:
-->
Benjamin Hsing, of Kaye Scholer, discussed inherent anticipation. It is very hard to invalidate a patent by anticipation. Previously, there was a split in case law regarding the standard for anticipation. Both lines of cases said the limitation must be “necessarily present” in the prior art. However, one line of case also required that the limitation be “recognized by a person skilled in the art.” The Shilling case resolved the split, and recognition is not part of the test.
Suppose that a patent covers a drug that produces result Y. Say, drug causes reaction X before producing effect Y. Nobody recognized reaction X. Can you patent a drug that causes reaction X? Or, is it anticipated? The court says: recognition is not part of the test. However, recognition is proof of inherent anticipation. Intent is also important. If you use the patented drug to produce result Z, it does not infringe on the patent.
<--
The case in question is not the "Schilling" case but is Schering v. Geneva concerning Claritin (loratadine) and an attempt in US Patent 4,659,716 to obtain protection to a metabolite of loratidine, desloratadine (DCL) (marketed as Clarinex). The Federal Circuit recited the general rule on inherent anticipation that a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in that reference.
It is not clear that there was a split of authority on the point that the limitation be “recognized by a person skilled in the art.” The real issue may have been WHEN the limitation had to be recognized, and Schering makes clear that the limitation did not have to be recognized at the time of filing of the application (here, for the '716 patent). The patent opponent still needs to show that the limitation was inherent at the time of the filing and that this limitation is known to one of ordinary skill at the time of the litigation. [someone had to show that desloratine IS an inevitable product of the metabolism of loratadine]
I had written in Endnote 12 of "There's Always Something There to Remind You," Intellectual Property Today, May 2003:
Note In re Seaborg, 328 F.2d 996 (CCPA 1964). Applicant argued that a small amount of an unknown, unconcentrated isotope would have been undetectable, and the CCPA concurred. However, what result if a new analytical method were subsequently developed which made that small amount detectable? Contemplate text from L. B. Ebert, “Inherent difficulties,” Int. Prop. Today, Nov. 1999: To illustrate one issue in the interpretation of Continental Can, consider the discovery of buckyballs. In 1984, workers at Exxon disclosed the existence of C60, with the formula as determined by mass spectrometric measurement n6 and a way to make said C60. (J. Chem. Phys., 1984, 81, 3322). They did not disclose the correct structure of C60; Professors Smalley and Kroto proposed the structure of C60 to be that of a truncated icosahedron in 1985. This was not known to be correct until after the work of Huffman and Kratschmer in 1990. Now, assuming that the synthesis of Exxon always led to C60 with the icosahedral structure, would a patent claim to C60 in 1990 (with the truncated icosahedral structure) be inherently anticipated by the Exxon work in 1984, even though no one knew the structure in 1984, and in fact could not have proved the structure until 1990? Assuming that one of ordinary skill would recognize the inherent property, albeit at a later date, one might think there would be inherent anticipation. (Of course, a 1990 claim to merely C60 would be explicitly anticipated by the written description and enablement of the 1984 reference.)
From a commercial standpoint, the "big deal" about the Schering case concerned whether or not metabolites could be patented. The Federal Circuit noted generally that this conclusion regarding inherent anticipation does not preclude all patent protection for metabolites of known drugs. However, such metabolites [prodrugs] must be claimed in a way that is both new and non-obvious. Bare compound claims that include within their scope the recited compounds as chemical species in any surroundings, including within the human body, may not be novel under 35 USC 102, even if they have not been recognized. As Schering holds, these broad compound claims are inherently anticipated by a prior art disclosure of a process that causes a drug to metabolize into the claimed compound.
***Also of note
-->Sharon Barner, of Foley & Lardner, considered recent decisions related to the patent disclosure requirements. The Festo decision has created an increase of litigation over the description requirement of section 112.<--
I wasn't sure that the Festo decision, as opposed to perhaps Eli Lilly or Enzo or University of Rochester, was responsible for most 112 "written description" issues.
****
-->
The Hon. Cohn, Senior District Judge, United States District Court, for the Eastern District of Michigan, began by listing some challenges in American patent litigation. The complexity of patent suits tests the patience and capacity of a District Court judge (this was a joke, but it makes a point). In patent cases, there is a 33% reversal rate on appeal, and very complicated decisions are often committed to unsophisticated jury (or judge). There is a very high degree of uncertainty about outcome of patent suit. However, most action in patent cases is in the pre-trial, because most cases settle. Trials are becoming uncommon in the American legal system, especially for patent cases. <--
COMMENT: At one point, it seemed that legal academics pegged the reversal rate above 33%. A number of 33% has been mentioned for reversal SPECIFICALLY on claim construction issues.
In the April 2002 issue of Intellectual Property Today , Endnote 11 of "Deciding Cases the Old Fashioned Way", recites
--IP Worldwide, p. 30 (March 2002), citing to Kimberly Moore for a true rate of reversal of about 50% (Harvard's Journal of Law and Technology) and to Christian Chu for a rate of 47.3% (Berkeley Technology Law Journal). Also, Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1441, 1473 (Rader concurring)--
In the November 2002 Bulletin of the IP section of the ABA, Mark Banner reported of Moore's 2001 article: The article reviewed in exhaustive detail the holdings of the Federal Circuit on claim construction issues. It concluded that there was a 33% reversal rate on claim construction issues, and that where district courts were reversed on claim construction, the Federal Circuit either reversed or remanded the decision 81% of the time. Implicit in the analysis was the conclusion that such a reversal rate was too high for the legal and business community to have confidence in the predictability of outcome in patent infringement cases. [“Are District Court Judges Equipped to Resolve Patent Cases?”, 15 Harv. J. L. & Tech. 1 (2001), republished in 12 Fed. Cir. Bar. Journal 1 (2002).]
from footnote 194 of Glynn S. Lunney, Jr, Patent Law, the Federal Circuit, and the Supreme Court: A Quiet Revolution, 11 S. Ct. Econ. Rev. 1 (2004):
Both Christian Chu and Kimberly Moore have documented the high reversal rates involving claim construction. See Christian A. Chu, Empirical Analysis of the Federal Circuit's Claim Construction Trends, 16 Berkeley Tech LJ 1075, 1097-1100 (2001) (noting that despite the changes to the infringement inquiry, "the promises of pre-trial predictability and expedient patent litigation seem to remain a tantalizing dream"); Moore, 15 Harv J L & Tech at 14 (cited in note 192) ("This means that more than one in four appealed patent cases involving claim construction result in overturning the judgment reached by the district court solely for claim construction reasons.").
from footnote 26 of article by Rai, 17 Berkeley Tech. L.J. 877 (2002):
See Christian Chu, Empirical Analysis of the Federal Circuit's Claim Construction Trends, 16 Berkeley Tech. L.J. 1075, 1104 (2001) (giving figure of 44%); Kimberly A. Moore, Are District Court Judges Equipped to Resolve Patent Cases?, 15 Harv. J.L. Tech. 1, 11 (2001) (giving figure of 33%). The discrepancy between the Moore and Chu findings likely emerges from two factors. First, while Moore's study encompasses cases decided between April 1996 and December 2000, Chu's study encompasses cases decided between January 1998 and April 2000. In addition, while Moore's includes within her population of cases Rule 36 summary affirmances, Chu excludes these affirmances. Chu's study also draws interesting conclusions regarding the Federal Circuit's review of patent cases more generally. He determines that, excluding summary affirmances, the overall reversal rate was 47.3%. Id. at 1098. Including summary affirmances, the overall reversal rate was 36.6%. Id. at 1100.
Also, from article by Judge Holderman, 2002 U. Ill. J.L. Tech. & Pol'y 425:
Nationwide, there are about 2,500 patent infringement cases filed in the U.S. District Courts each year. In fact, in the year 2000, there were exactly 2,484 filed, n25 and in 2001, there were 2,520 filed. n26 However, there are over 300,000 other types of cases, both civil and criminal, filed each year. In fact, the nationwide number of total district court filings in 2000 was 322,262 n27 and in 2001 was 313,615. n28 Patent cases are less than 1% of the nationwide caseload of our district judges.
****Also
-->Also, Judge Cohn pointed out that two books were recently published about reforming our patent system (Patents in the knowledge based economy & Patent system for the 21’st century). It is suggested that we also look at other studies commissioned by the FTC in 1936, 1943, 1966, 1992. Looking at these 5 reports might suggest the progress we have made in the past century.
Finally, Judge Cohn looked at four of the recommendations made in the books.
1. Post grant review procedure of opposition – suggests this could run into problems due to the 7th amendment right to jury trial.
2. Validity should have a Preponderance of Evidence Standard – This will probably be accomplished by an upcoming Federal Circuit decision.
3. The legal standards for obviousness should be tightened. – This will probably be accomplished by upcoming Federal Circuit decisions.
4. Redefine willfulness to be just actual written notice, or obvious copying. – This probably requires legislation, but will shorten the length of patent trials.
A final practice point: Judge Cohn does not like attorneys trying to hustle the judiciary with fancy PowerPoint presentations.
<--
Of 1., I don't believe I've heard that objection before. If the opposition is part of the PTO administrative process, what jury right attaches?
Of 2., what upcoming Federal Circuit decision will change the evidence standard? Same query for 3.
Of 4., Knorr-Bremse has altered presumptions about willfulness.
***Also
-->
Maria C.H. Lin, spoke about China’s patent system. To put China into context, one must remember that China is a socialist state, China had no patent laws just 25 years ago, and China only joined the WTO in 2001. China is different from US patent law in some major ways. For example, there is a 2 year statute of limitations for patent damages. Also, there is a defense of innocent infringement in China. Finally, the feared compulsory licensing provision exists, but has never been used.
The Chinese translation of English patents is controlling, which can cause problems. Chinese patents use Jepson claim format. U.S. practitioners must remember to deposit microorganisms on the filing date to receive a patent in China. China also provides “utility model” patents which are filed without examination and a source of possible danger. The legal profession is still being privatized, and the Chinese culture has some conflicts with patent ownership. Finally, China is influenced by the U.S. Federal Court of Appeals (which can be seen as good or bad).<--
One item of the blog that caught my eye concerned inherent anticipation:
-->
Benjamin Hsing, of Kaye Scholer, discussed inherent anticipation. It is very hard to invalidate a patent by anticipation. Previously, there was a split in case law regarding the standard for anticipation. Both lines of cases said the limitation must be “necessarily present” in the prior art. However, one line of case also required that the limitation be “recognized by a person skilled in the art.” The Shilling case resolved the split, and recognition is not part of the test.
Suppose that a patent covers a drug that produces result Y. Say, drug causes reaction X before producing effect Y. Nobody recognized reaction X. Can you patent a drug that causes reaction X? Or, is it anticipated? The court says: recognition is not part of the test. However, recognition is proof of inherent anticipation. Intent is also important. If you use the patented drug to produce result Z, it does not infringe on the patent.
<--
The case in question is not the "Schilling" case but is Schering v. Geneva concerning Claritin (loratadine) and an attempt in US Patent 4,659,716 to obtain protection to a metabolite of loratidine, desloratadine (DCL) (marketed as Clarinex). The Federal Circuit recited the general rule on inherent anticipation that a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in that reference.
It is not clear that there was a split of authority on the point that the limitation be “recognized by a person skilled in the art.” The real issue may have been WHEN the limitation had to be recognized, and Schering makes clear that the limitation did not have to be recognized at the time of filing of the application (here, for the '716 patent). The patent opponent still needs to show that the limitation was inherent at the time of the filing and that this limitation is known to one of ordinary skill at the time of the litigation. [someone had to show that desloratine IS an inevitable product of the metabolism of loratadine]
I had written in Endnote 12 of "There's Always Something There to Remind You," Intellectual Property Today, May 2003:
Note In re Seaborg, 328 F.2d 996 (CCPA 1964). Applicant argued that a small amount of an unknown, unconcentrated isotope would have been undetectable, and the CCPA concurred. However, what result if a new analytical method were subsequently developed which made that small amount detectable? Contemplate text from L. B. Ebert, “Inherent difficulties,” Int. Prop. Today, Nov. 1999: To illustrate one issue in the interpretation of Continental Can, consider the discovery of buckyballs. In 1984, workers at Exxon disclosed the existence of C60, with the formula as determined by mass spectrometric measurement n6 and a way to make said C60. (J. Chem. Phys., 1984, 81, 3322). They did not disclose the correct structure of C60; Professors Smalley and Kroto proposed the structure of C60 to be that of a truncated icosahedron in 1985. This was not known to be correct until after the work of Huffman and Kratschmer in 1990. Now, assuming that the synthesis of Exxon always led to C60 with the icosahedral structure, would a patent claim to C60 in 1990 (with the truncated icosahedral structure) be inherently anticipated by the Exxon work in 1984, even though no one knew the structure in 1984, and in fact could not have proved the structure until 1990? Assuming that one of ordinary skill would recognize the inherent property, albeit at a later date, one might think there would be inherent anticipation. (Of course, a 1990 claim to merely C60 would be explicitly anticipated by the written description and enablement of the 1984 reference.)
From a commercial standpoint, the "big deal" about the Schering case concerned whether or not metabolites could be patented. The Federal Circuit noted generally that this conclusion regarding inherent anticipation does not preclude all patent protection for metabolites of known drugs. However, such metabolites [prodrugs] must be claimed in a way that is both new and non-obvious. Bare compound claims that include within their scope the recited compounds as chemical species in any surroundings, including within the human body, may not be novel under 35 USC 102, even if they have not been recognized. As Schering holds, these broad compound claims are inherently anticipated by a prior art disclosure of a process that causes a drug to metabolize into the claimed compound.
***Also of note
-->Sharon Barner, of Foley & Lardner, considered recent decisions related to the patent disclosure requirements. The Festo decision has created an increase of litigation over the description requirement of section 112.<--
I wasn't sure that the Festo decision, as opposed to perhaps Eli Lilly or Enzo or University of Rochester, was responsible for most 112 "written description" issues.
****
-->
The Hon. Cohn, Senior District Judge, United States District Court, for the Eastern District of Michigan, began by listing some challenges in American patent litigation. The complexity of patent suits tests the patience and capacity of a District Court judge (this was a joke, but it makes a point). In patent cases, there is a 33% reversal rate on appeal, and very complicated decisions are often committed to unsophisticated jury (or judge). There is a very high degree of uncertainty about outcome of patent suit. However, most action in patent cases is in the pre-trial, because most cases settle. Trials are becoming uncommon in the American legal system, especially for patent cases. <--
COMMENT: At one point, it seemed that legal academics pegged the reversal rate above 33%. A number of 33% has been mentioned for reversal SPECIFICALLY on claim construction issues.
In the April 2002 issue of Intellectual Property Today , Endnote 11 of "Deciding Cases the Old Fashioned Way", recites
--IP Worldwide, p. 30 (March 2002), citing to Kimberly Moore for a true rate of reversal of about 50% (Harvard's Journal of Law and Technology) and to Christian Chu for a rate of 47.3% (Berkeley Technology Law Journal). Also, Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1441, 1473 (Rader concurring)--
In the November 2002 Bulletin of the IP section of the ABA, Mark Banner reported of Moore's 2001 article: The article reviewed in exhaustive detail the holdings of the Federal Circuit on claim construction issues. It concluded that there was a 33% reversal rate on claim construction issues, and that where district courts were reversed on claim construction, the Federal Circuit either reversed or remanded the decision 81% of the time. Implicit in the analysis was the conclusion that such a reversal rate was too high for the legal and business community to have confidence in the predictability of outcome in patent infringement cases. [“Are District Court Judges Equipped to Resolve Patent Cases?”, 15 Harv. J. L. & Tech. 1 (2001), republished in 12 Fed. Cir. Bar. Journal 1 (2002).]
from footnote 194 of Glynn S. Lunney, Jr, Patent Law, the Federal Circuit, and the Supreme Court: A Quiet Revolution, 11 S. Ct. Econ. Rev. 1 (2004):
Both Christian Chu and Kimberly Moore have documented the high reversal rates involving claim construction. See Christian A. Chu, Empirical Analysis of the Federal Circuit's Claim Construction Trends, 16 Berkeley Tech LJ 1075, 1097-1100 (2001) (noting that despite the changes to the infringement inquiry, "the promises of pre-trial predictability and expedient patent litigation seem to remain a tantalizing dream"); Moore, 15 Harv J L & Tech at 14 (cited in note 192) ("This means that more than one in four appealed patent cases involving claim construction result in overturning the judgment reached by the district court solely for claim construction reasons.").
from footnote 26 of article by Rai, 17 Berkeley Tech. L.J. 877 (2002):
See Christian Chu, Empirical Analysis of the Federal Circuit's Claim Construction Trends, 16 Berkeley Tech. L.J. 1075, 1104 (2001) (giving figure of 44%); Kimberly A. Moore, Are District Court Judges Equipped to Resolve Patent Cases?, 15 Harv. J.L. Tech. 1, 11 (2001) (giving figure of 33%). The discrepancy between the Moore and Chu findings likely emerges from two factors. First, while Moore's study encompasses cases decided between April 1996 and December 2000, Chu's study encompasses cases decided between January 1998 and April 2000. In addition, while Moore's includes within her population of cases Rule 36 summary affirmances, Chu excludes these affirmances. Chu's study also draws interesting conclusions regarding the Federal Circuit's review of patent cases more generally. He determines that, excluding summary affirmances, the overall reversal rate was 47.3%. Id. at 1098. Including summary affirmances, the overall reversal rate was 36.6%. Id. at 1100.
Also, from article by Judge Holderman, 2002 U. Ill. J.L. Tech. & Pol'y 425:
Nationwide, there are about 2,500 patent infringement cases filed in the U.S. District Courts each year. In fact, in the year 2000, there were exactly 2,484 filed, n25 and in 2001, there were 2,520 filed. n26 However, there are over 300,000 other types of cases, both civil and criminal, filed each year. In fact, the nationwide number of total district court filings in 2000 was 322,262 n27 and in 2001 was 313,615. n28 Patent cases are less than 1% of the nationwide caseload of our district judges.
****Also
-->Also, Judge Cohn pointed out that two books were recently published about reforming our patent system (Patents in the knowledge based economy & Patent system for the 21’st century). It is suggested that we also look at other studies commissioned by the FTC in 1936, 1943, 1966, 1992. Looking at these 5 reports might suggest the progress we have made in the past century.
Finally, Judge Cohn looked at four of the recommendations made in the books.
1. Post grant review procedure of opposition – suggests this could run into problems due to the 7th amendment right to jury trial.
2. Validity should have a Preponderance of Evidence Standard – This will probably be accomplished by an upcoming Federal Circuit decision.
3. The legal standards for obviousness should be tightened. – This will probably be accomplished by upcoming Federal Circuit decisions.
4. Redefine willfulness to be just actual written notice, or obvious copying. – This probably requires legislation, but will shorten the length of patent trials.
A final practice point: Judge Cohn does not like attorneys trying to hustle the judiciary with fancy PowerPoint presentations.
<--
Of 1., I don't believe I've heard that objection before. If the opposition is part of the PTO administrative process, what jury right attaches?
Of 2., what upcoming Federal Circuit decision will change the evidence standard? Same query for 3.
Of 4., Knorr-Bremse has altered presumptions about willfulness.
***Also
-->
Maria C.H. Lin, spoke about China’s patent system. To put China into context, one must remember that China is a socialist state, China had no patent laws just 25 years ago, and China only joined the WTO in 2001. China is different from US patent law in some major ways. For example, there is a 2 year statute of limitations for patent damages. Also, there is a defense of innocent infringement in China. Finally, the feared compulsory licensing provision exists, but has never been used.
The Chinese translation of English patents is controlling, which can cause problems. Chinese patents use Jepson claim format. U.S. practitioners must remember to deposit microorganisms on the filing date to receive a patent in China. China also provides “utility model” patents which are filed without examination and a source of possible danger. The legal profession is still being privatized, and the Chinese culture has some conflicts with patent ownership. Finally, China is influenced by the U.S. Federal Court of Appeals (which can be seen as good or bad).<--
posted by Lawrence B. Ebert at 8:28 AM
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