Cases on "failure to disclose" by patent applicants
The topic of inequitable conduct by drug companies, highlighted in an April 2008 NYT piece by Robert Pear, shows up in the recent Aventis case, discussed in some detail by Patent Docs.
In the Aventis case, plaintiff-appellant Aventis was represented by Donald R. Dunner of Finnegan. Dunner and Aventis lost this case, which relates to Lovenox.
The inequitable conduct issue came up in declaration(s) by a non-inventor (Uzan) to assert unexpected properties to overcome an obviousness rejection. The CAFC decision contains the following sentence:
Specifically, Dr. Uzan reported, “For the claimed compound T½ was 4.36 ± 1.07. For the compound of [EP ’144], T½ was 3.33 ± 0.2,” and the statistical analysis showed that 4.36 and 3.33 were statistically significant.
Hmmm, not too well written. The court noted that the data for the EP '144 example did not mention the dosage used.
The CAFC also wrote:
Aventis argued, in its response, that EP ’144 does not suggest compounds
containing polysaccharides of the claimed MW in the claimed proportions and that the
examiner improperly relied on inherency to reject the claimed compounds over EP ’144.
The crux of the matter was: Amphastar averred that Dr. Uzan engaged in inequitable conduct
by failing to disclose that the half-life studies comparing the patented compound to the
EP ’144 compound were at different doses.
Aventis noted: Dr. Uzan informed the examiner that the half-life comparison was done
at different doses, those of skill in the art frequently compare half-lives at different
doses, and half-life is independent of dose. IPBiz notes that here, the half-life apparently DID depend on dose, so the later Aventis representation was false on these facts. The CAFC so noted: Further, this court did not
accept the explanation that the half-life data were dose independent because the
evidence clearly suggested otherwise.
An interesting aspect of this case is the different approach taken between the majority and the dissent as to the
high qualifications of Uzan. The majority's version is more plausible than Rader's in dissent: the court declined to find that Dr. Uzan’s failure to disclose the difference in doses could be justified based on inadvertence because it was not credible that a scientist with Dr. Uzan’s qualifications could have committed, and failed to correct
during a lengthy prosecution, such an egregious error, and there was a complete
absence of evidence suggesting negligence throughout prosecution.
In this "second time around," Aventis made a different argument:
Aventis offers a new justification for Dr.
Uzan’s failure to disclose the dosage information in his half-life comparisons.7
According to Aventis, Dr. Uzan’s half-life comparisons were intended to show a
difference in properties in response to the obviousness rejection under 35 U.S.C. § 103,
not to demonstrate a compositional difference to address the anticipation rejection
under 35 U.S.C. § 102, as the district court concluded. Aventis’s argument is premised
on the fact that while a half-life comparison must be done using equivalent doses to
establish a compositional difference, a half-life comparison may be done using different
doses if the purpose is to establish a difference in property.
The CAFC acknowledged that the district court made an error in the law: Although the court incorrectly suggested, in a footnote, that obviousness is subsumed
by inherency, we see this as merely a recognition by the court that the notion of
inherency was part and parcel of the examiner’s rejections.
As in the re-exam of the WARF patents on stem cells, In re Best, 562 F.2d 1252, 1255 (CCPA 1977) came up.
There is an interesting sub-theme of attorney error vs. scientist misrepresentation.
Judge Rader, in dissent, noted:
In this case, Dr. Uzan, Associate Director of Biological Research at Aventis,
assisted in the prosecution of the application that led to U.S. Patent No. 5,389,618
('618) covering a low molecular weight heparin mixture invented by Roger Debrie
(Debrie LMWH). Specifically, Dr. Uzan assembled data from various clinical studies
comparing the half-lives of the Debrie LMWH to a prior art LMWH invented by
Mardiguian (Mardiguian LMWH). Dr. Uzan submitted this data, from the Duchier study
and the Foquet study respectively, as example 6 of the patent. In submitting the data,
Dr. Uzan did not draw attention to the different doses in those studies.
The Aventis claim in question discussed molecular weight but NOT half-life:
A heterogeneous intimate admixture of sulfated heparinic polysaccharides,
such sulfated polysaccharides having a weight average molecular weight
less that that of heparin and said admixture comprising[3]
from 9% to 20% of polysaccharide chains having a molecular
weight less than 2,000 daltons
from 5% to 20% of polysaccharide chains having a molecular
weight greater than 8,000 daltons, and
from 60-86% of polysaccharide chains having a molecular weight of
between 2,000 and 8,000 daltons,
the ratio between the weight average molecular weight and the
number average molecular weight thereof ranging from 1.3 to 1.6,
said admixture (i) exhibiting a bioavailability and antithrombotic
activity greater than heparin and (ii) having an average molecular weight
of between approximately 3,500 and 5,500 daltons.
In an obviousness rejection, the issue is whether, with the prior art at hand, one of ordinary skill would be motivated to go to the claimed invention.
****
Another inventor omission case is Taltech v. Esquel, a failure to disclose best mode case.
Of the best mode issue, the CAFC wrote:
The district court found claim 18 invalid because the inventor failed to satisfy the
best mode requirement of 35 U.S.C. § 112 by not disclosing in the specification the
preferred use of Vilene SL33 as the adhesive when he knew it at the time of filing. We
have set out a two-pronged test for determining whether an inventor has met the best
mode requirement. “First, the factfinder must determine whether, at the time of filing the
application, the inventor possessed a best mode for practicing the invention.” Eli Lilly
and Co. v. Barr Labs., Inc., 251 F.3d 955, 963 (Fed. Cir. 2001) (citing Chemcast Corp.
v. Arco Indus. Corp., 913 F.2d 923, 927-28 (Fed. Cir. 1990)). This involves a subjective
inquiry whereby the factfinder focuses on the inventor’s state of mind at the time of
filing. Id. “Second, if the inventor possessed a best mode, the factfinder must
determine whether the written description disclosed the best mode such that one
reasonably skilled in the art could practice it.” Id. This involves an objective inquiry
focused on the scope of the claimed invention and the level of skill in the art. Id.
Of inequitable conduct, the CAFC cited Cargill:
To support a finding of inequitable conduct, there must be clear and convincing
evidence that the applicant made an affirmative misrepresentation of material fact, failed
to disclose material information, or submitted false material information, intending to
deceive the PTO. Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1363 (Fed. Cir.
2007).
*******
Relevant to a long ago discussion on the patenthawk blog, patent docs does NOT have a link to IPBiz. [Recall PatentHawk's memorable line: That posted blogroll listing on The Patent Prospector: a real sleaze move, huh? I noticed you wouldn't stoop so low on your blog to mention other bloggers in the patent community.] IPBiz notes that, at the time of PatentHawk's line, IPBiz had mentioned PatentHawk 53 times, and PatentHawk had mentioned IPBiz exactly one time. Is your argument sleazy, PatentHawk?
Separately, the new IP blog, effectiveip, does NOT have a link to IPBiz, but does have a link to "fire of genius," most recent post, April 27, 2008 and phosita, most recent post, april 07, 2008.
How useful are blogrolls?
In the Aventis case, plaintiff-appellant Aventis was represented by Donald R. Dunner of Finnegan. Dunner and Aventis lost this case, which relates to Lovenox.
The inequitable conduct issue came up in declaration(s) by a non-inventor (Uzan) to assert unexpected properties to overcome an obviousness rejection. The CAFC decision contains the following sentence:
Specifically, Dr. Uzan reported, “For the claimed compound T½ was 4.36 ± 1.07. For the compound of [EP ’144], T½ was 3.33 ± 0.2,” and the statistical analysis showed that 4.36 and 3.33 were statistically significant.
Hmmm, not too well written. The court noted that the data for the EP '144 example did not mention the dosage used.
The CAFC also wrote:
Aventis argued, in its response, that EP ’144 does not suggest compounds
containing polysaccharides of the claimed MW in the claimed proportions and that the
examiner improperly relied on inherency to reject the claimed compounds over EP ’144.
The crux of the matter was: Amphastar averred that Dr. Uzan engaged in inequitable conduct
by failing to disclose that the half-life studies comparing the patented compound to the
EP ’144 compound were at different doses.
Aventis noted: Dr. Uzan informed the examiner that the half-life comparison was done
at different doses, those of skill in the art frequently compare half-lives at different
doses, and half-life is independent of dose. IPBiz notes that here, the half-life apparently DID depend on dose, so the later Aventis representation was false on these facts. The CAFC so noted: Further, this court did not
accept the explanation that the half-life data were dose independent because the
evidence clearly suggested otherwise.
An interesting aspect of this case is the different approach taken between the majority and the dissent as to the
high qualifications of Uzan. The majority's version is more plausible than Rader's in dissent: the court declined to find that Dr. Uzan’s failure to disclose the difference in doses could be justified based on inadvertence because it was not credible that a scientist with Dr. Uzan’s qualifications could have committed, and failed to correct
during a lengthy prosecution, such an egregious error, and there was a complete
absence of evidence suggesting negligence throughout prosecution.
In this "second time around," Aventis made a different argument:
Aventis offers a new justification for Dr.
Uzan’s failure to disclose the dosage information in his half-life comparisons.7
According to Aventis, Dr. Uzan’s half-life comparisons were intended to show a
difference in properties in response to the obviousness rejection under 35 U.S.C. § 103,
not to demonstrate a compositional difference to address the anticipation rejection
under 35 U.S.C. § 102, as the district court concluded. Aventis’s argument is premised
on the fact that while a half-life comparison must be done using equivalent doses to
establish a compositional difference, a half-life comparison may be done using different
doses if the purpose is to establish a difference in property.
The CAFC acknowledged that the district court made an error in the law: Although the court incorrectly suggested, in a footnote, that obviousness is subsumed
by inherency, we see this as merely a recognition by the court that the notion of
inherency was part and parcel of the examiner’s rejections.
As in the re-exam of the WARF patents on stem cells, In re Best, 562 F.2d 1252, 1255 (CCPA 1977) came up.
There is an interesting sub-theme of attorney error vs. scientist misrepresentation.
Judge Rader, in dissent, noted:
In this case, Dr. Uzan, Associate Director of Biological Research at Aventis,
assisted in the prosecution of the application that led to U.S. Patent No. 5,389,618
('618) covering a low molecular weight heparin mixture invented by Roger Debrie
(Debrie LMWH). Specifically, Dr. Uzan assembled data from various clinical studies
comparing the half-lives of the Debrie LMWH to a prior art LMWH invented by
Mardiguian (Mardiguian LMWH). Dr. Uzan submitted this data, from the Duchier study
and the Foquet study respectively, as example 6 of the patent. In submitting the data,
Dr. Uzan did not draw attention to the different doses in those studies.
The Aventis claim in question discussed molecular weight but NOT half-life:
A heterogeneous intimate admixture of sulfated heparinic polysaccharides,
such sulfated polysaccharides having a weight average molecular weight
less that that of heparin and said admixture comprising[3]
from 9% to 20% of polysaccharide chains having a molecular
weight less than 2,000 daltons
from 5% to 20% of polysaccharide chains having a molecular
weight greater than 8,000 daltons, and
from 60-86% of polysaccharide chains having a molecular weight of
between 2,000 and 8,000 daltons,
the ratio between the weight average molecular weight and the
number average molecular weight thereof ranging from 1.3 to 1.6,
said admixture (i) exhibiting a bioavailability and antithrombotic
activity greater than heparin and (ii) having an average molecular weight
of between approximately 3,500 and 5,500 daltons.
In an obviousness rejection, the issue is whether, with the prior art at hand, one of ordinary skill would be motivated to go to the claimed invention.
****
Another inventor omission case is Taltech v. Esquel, a failure to disclose best mode case.
Of the best mode issue, the CAFC wrote:
The district court found claim 18 invalid because the inventor failed to satisfy the
best mode requirement of 35 U.S.C. § 112 by not disclosing in the specification the
preferred use of Vilene SL33 as the adhesive when he knew it at the time of filing. We
have set out a two-pronged test for determining whether an inventor has met the best
mode requirement. “First, the factfinder must determine whether, at the time of filing the
application, the inventor possessed a best mode for practicing the invention.” Eli Lilly
and Co. v. Barr Labs., Inc., 251 F.3d 955, 963 (Fed. Cir. 2001) (citing Chemcast Corp.
v. Arco Indus. Corp., 913 F.2d 923, 927-28 (Fed. Cir. 1990)). This involves a subjective
inquiry whereby the factfinder focuses on the inventor’s state of mind at the time of
filing. Id. “Second, if the inventor possessed a best mode, the factfinder must
determine whether the written description disclosed the best mode such that one
reasonably skilled in the art could practice it.” Id. This involves an objective inquiry
focused on the scope of the claimed invention and the level of skill in the art. Id.
Of inequitable conduct, the CAFC cited Cargill:
To support a finding of inequitable conduct, there must be clear and convincing
evidence that the applicant made an affirmative misrepresentation of material fact, failed
to disclose material information, or submitted false material information, intending to
deceive the PTO. Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1363 (Fed. Cir.
2007).
*******
Relevant to a long ago discussion on the patenthawk blog, patent docs does NOT have a link to IPBiz. [Recall PatentHawk's memorable line: That posted blogroll listing on The Patent Prospector: a real sleaze move, huh? I noticed you wouldn't stoop so low on your blog to mention other bloggers in the patent community.] IPBiz notes that, at the time of PatentHawk's line, IPBiz had mentioned PatentHawk 53 times, and PatentHawk had mentioned IPBiz exactly one time. Is your argument sleazy, PatentHawk?
Separately, the new IP blog, effectiveip, does NOT have a link to IPBiz, but does have a link to "fire of genius," most recent post, April 27, 2008 and phosita, most recent post, april 07, 2008.
How useful are blogrolls?
posted by Lawrence B. Ebert at 1:41 PM
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