Amgen and Mircera and the CAFC decision
from the AP:
Thousand Oaks, Calif.-based Amgen ( AMGN - news - people ) said the Boston-based 1st U.S. Circuit Court of Appeals ruled that the Roche ( RHHBY.PK - news - people ) Group's rival product, Mircera, infringes on four Amgen patents. The patents relate to genetically engineered erythropoietin, a hormone that stimulates red blood cell production, and to the processes used for making it.
For those who understand patent law (unlike Associated Press), note that the appeal of the Amgen/Roche patent case was handled by the Washington, DC-based Court of Appeals for the Federal Circuit.
see AMGEN (plaintiff) vs. F. HOFFMAN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMAN-LA ROCHE INC. . The outcome of the case had elements that were unfavorable to Amgen and elements that were unfavorable to Roche:
We vacate the court’s grant of summary judgment and of JMOL to Amgen of no
invalidity for obviousness-type double patenting of claims 3, 7, and 8 of the ’933 patent;
claim 1 of the ’422 patent; and claim 7 of the ’349 patent. We therefore remand to the
district court for an obviousness-type double patenting analysis of those claims in light
of this opinion. We also vacate the court’s grant of JMOL to Roche of non-infringement
of claim 7 of the ’349 patent and remand to the district for a new trial on infringement of
that claim. We affirm the court’s judgment in all other respects.
In the case, the CAFC determined that the "safe from double-patenting harbor" of 35 USC 121 does
not apply to continuation applications: We are persuaded by the reasoning in Pfizer that the § 121
safe harbor provision does not protect continuation applications or patents descending from only continuation
applications. (...) See Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688
(Fed. Cir. 1990) (“To gain the benefits of Section 121 there outlined, [the patentee] must
have brought its case within the purview of the statute, i.e., it must have limited the
claims in its divisional application to the non-elected invention or inventions.” (emphasis
added)). We recognize that, unlike a continuation-in-part application, a continuation
application can satisfy the definition of a “divisional application” in MPEP § 201.06.
A Georgia Pacific case is mentioned in a footnote:
We note that, because the ’933 patent issued on August 20, 1996, which
was before the issuance of the ’698 patent on April 8, 1997, the ’698 patent presumably
cannot be used as an obviousness-type double patenting reference against the ’933
patent on remand. See Georgia-Pacific, 195 F.3d at 1326 (“Under obviousness-type
double patenting, a patent is invalid when it is merely an obvious variation of an
invention disclosed and claimed in an earlier patent by the same inventor.” (emphasis
added)).
The Takeda case [Takeda Pharmaceutical Co. v. Doll, 561 F.3d
1372 (Fed. Cir. 2009) ] was discussed:
Takeda presented the situation where a patent applicant sought to overcome a
double patenting rejection of a process patent over a product patent by presenting post-
invention evidence of alternative processes of making the product. 561 F.3d at 1375–
76. (...) The district court held that,
because viable, alternative processes for making the product existed in 2002 and 2005,
the process and product were patentably distinct, and, therefore, not invalid for
obviousness-type double patenting. Takeda, 511 F. Supp. 2d at 97. (...)The question on appeal to this court in Takeda was whether, when an issued
patent claims a product and discloses, but does not claim, a process for making that
product, the patentee, when later seeking a patent on the disclosed process, may
present evidence of post-invention, alternative processes that produce the patented
product, in order to show that the process and product are patentably distinct. 561 F.3d
at 1375–76.6 The answer was a qualified yes. We concluded that “the relevant time
frame for determining whether a product and process are ‘patentably distinct’ should be
at the filing date of the secondary application,” which is the later application for the
process. Id. at 1377.
The bottom line, Roche lost on its Takeda argument:
Consequently, we must reject Roche’s contention that it should be
able to show patentable indistinctiveness by relying on evidence up to the filing date of
“secondary application[s].” Therefore, on remand, Roche may not rely on developments
in the art subsequent to November 30, 1984,
The topic of "old product made by new process" arose:
It has long been the case that an old product is not patentable even if it is made
by a new process. See Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 373
(1938) (“Wabash”) (“[A] patentee who does not distinguish his product from what is old
except by reference, express or constructive, to the process by which he produced it,
cannot secure a monopoly on the product by whatever means produced.”); Cochrane v.
Badische Anilin & Soda Fabrik, 11 U.S. 293, 311 (1884) (“BASF”) (“While a new
process for producing [the product] was patentable, the product itself could not be
patented even though it was a product made [by an artificial process] for the first time.”);
SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1317 (Fed. Cir. 2006) (“It
has long been established that one cannot avoid anticipation by an earlier product
disclosure by claiming the same product . . . as produced by a particular process.”);
The topic of "product-by-process" arose:
In determining validity of a product-by-process claim, the focus is on the product
and not on the process of making it. See Atl. Thermoplastics Co. v. Faytex Corp., 970
F.2d 834, 841 (Fed. Cir. 1992) (explaining that, in BASF, the validity rule “focused on
the product with less regard for the process limits”); Brown, 459 F.2d at 535 (focusing
on the product claimed and not the process); Pilkington, 411 F.2d at 1348 (noting that
the product itself must be new).
Of infringement and invalidity, on "anticipates if earlier, infringes if later":
The impact of these different analyses is significant. For product-by-process
claims, that which anticipates if earlier does not necessarily infringe if later. That is
because a product in the prior art made by a different process can anticipate a product-
by-process claim, but an accused product made by a different process cannot infringe a
product-by-process claim. Similarly, that which infringes if later does not necessarily
anticipate if earlier. That is because an accused product may meet each limitation in a
claim, but not possess features imparted by a process limitation that might distinguish
the claimed invention from the prior art.
Based on our precedent, the court did not err in conducting its validity and
infringement analyses differently.
On indefiniteness:
Indefiniteness is a question of law. Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306,
1319 (Fed. Cir. 2008). Under 35 U.S.C. § 112, claims must “particularly point[ ] out and
distinctly claim[ ] the subject matter which the applicant regards as his invention.” If a
claim fails to reasonably apprise one skilled in the art of the boundaries of the claim
when read in light of the specification, then the claim is invalid under § 112 for
indefiniteness. See Miles Labs., Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir.
1993). (...) That does not mean, however, that an ordinarily skilled artisan at the time
of the invention would not have known the scope of human EPO in claim 1. See
Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624 (Fed. Cir. 1985)
(explaining that § 112 only requires the claim language to be “as precise as the subject
matter permits” (quotation marks omitted)).
On infringement:
Relying on A.B. Dick Co. v. Burroughs Corp., 713 F.2d
700, 703 (Fed. Cir. 1983), for the proposition that “one cannot avoid infringement merely
by adding elements,” the court rejected Roche’s argument that MIRCERA® does not
contain EPO because CERA is formed through pegylation.
(...)
Roche’s argument that human EPO no longer exists “as a matter of
chemistry” once it reacts with a PEG molecule is unpersuasive because the record
shows that the human EPO component exists in the final product and confers its
structural and functional properties onto MIRCERA®. The record therefore supports the
court’s conclusion, and the jury’s implicit conclusion,18 that the attachment of a PEG
molecule is the addition of an element, which cannot negate infringement, as opposed
to a fundamental chemical transformation, which might save MIRCERA® from
infringement. Amgen, 581 F. Supp. 2d at 203–04; see also Amstar Corp. v. Envirotech
Corp., 730 F.2d 1476, 1482 (Fed. Cir. 1984) (“Modification by mere addition of elements
. . . cannot negate infringement, without disregard of . . . long-established, hornbook law
. . . .”).
On materiality:
Materiality is context-dependent. See Biotech Biologische Naturverpackungen
GmbH & Co. v. Biocorp, Inc., 249 F.3d 1341, 1352 (Fed. Cir. 2001) (“Whether a change
in a product is material is a factual determination, and is properly for the trier of fact.”).
Doctrine of equivalents:
To support a finding of infringement under DOE, Amgen must have presented,
on a limitation-by-limitation basis, “particularized testimony and linking argument as to
the ‘insubstantiality of the differences’ between [the pharmaceutical composition in claim
12] and [MIRCERA®], or with respect to the function, way, result test.” Tex. Instruments
v. Cypress Semiconductor Corp., 90 F.3d 1558, 1567 (Fed. Cir. 1996).
Evidentiary issue:
Contrary to Roche’s assertions, Amgen was not required to have duplicated
Roche’s actual production process in order to prove infringement. See Johns Hopkins
Univ. v. CellPro, Inc., 152 F.3d 1342, 1349–50, 1356 (Fed. Cir. 1998) (affirming
infringement where patentee did not test the accused product, but relied on documents
produced by accused infringer). Neither was Amgen required to establish infringement
by offering RIA data into evidence. See Union Carbide Chems. & Plastics Tech. Corp.
v. Shell Oil Co., 425 F.3d 1366, 1374–75 (Fed. Cir. 2005) (affirming infringement where
patentee proved infringement of a limitation measured by the “comparison test” with
measurements from a different, but comparable test); cf. Genentech, Inc. v. Wellcome
Found. Ltd., 29 F.3d 1555, 1566 (Fed. Cir. 1994) (affirming non-infringement where
patentee relied on test different from that specified in the claims without establishing
tests were comparable).
See earlier IPBiz post:
http://ipbiz.blogspot.com/2008/10/amgen-whips-roche-in-mircera-case.html
**Also
anticipation without obviousness
Thousand Oaks, Calif.-based Amgen ( AMGN - news - people ) said the Boston-based 1st U.S. Circuit Court of Appeals ruled that the Roche ( RHHBY.PK - news - people ) Group's rival product, Mircera, infringes on four Amgen patents. The patents relate to genetically engineered erythropoietin, a hormone that stimulates red blood cell production, and to the processes used for making it.
For those who understand patent law (unlike Associated Press), note that the appeal of the Amgen/Roche patent case was handled by the Washington, DC-based Court of Appeals for the Federal Circuit.
see AMGEN (plaintiff) vs. F. HOFFMAN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMAN-LA ROCHE INC. . The outcome of the case had elements that were unfavorable to Amgen and elements that were unfavorable to Roche:
We vacate the court’s grant of summary judgment and of JMOL to Amgen of no
invalidity for obviousness-type double patenting of claims 3, 7, and 8 of the ’933 patent;
claim 1 of the ’422 patent; and claim 7 of the ’349 patent. We therefore remand to the
district court for an obviousness-type double patenting analysis of those claims in light
of this opinion. We also vacate the court’s grant of JMOL to Roche of non-infringement
of claim 7 of the ’349 patent and remand to the district for a new trial on infringement of
that claim. We affirm the court’s judgment in all other respects.
In the case, the CAFC determined that the "safe from double-patenting harbor" of 35 USC 121 does
not apply to continuation applications: We are persuaded by the reasoning in Pfizer that the § 121
safe harbor provision does not protect continuation applications or patents descending from only continuation
applications. (...) See Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688
(Fed. Cir. 1990) (“To gain the benefits of Section 121 there outlined, [the patentee] must
have brought its case within the purview of the statute, i.e., it must have limited the
claims in its divisional application to the non-elected invention or inventions.” (emphasis
added)). We recognize that, unlike a continuation-in-part application, a continuation
application can satisfy the definition of a “divisional application” in MPEP § 201.06.
A Georgia Pacific case is mentioned in a footnote:
We note that, because the ’933 patent issued on August 20, 1996, which
was before the issuance of the ’698 patent on April 8, 1997, the ’698 patent presumably
cannot be used as an obviousness-type double patenting reference against the ’933
patent on remand. See Georgia-Pacific, 195 F.3d at 1326 (“Under obviousness-type
double patenting, a patent is invalid when it is merely an obvious variation of an
invention disclosed and claimed in an earlier patent by the same inventor.” (emphasis
added)).
The Takeda case [Takeda Pharmaceutical Co. v. Doll, 561 F.3d
1372 (Fed. Cir. 2009) ] was discussed:
Takeda presented the situation where a patent applicant sought to overcome a
double patenting rejection of a process patent over a product patent by presenting post-
invention evidence of alternative processes of making the product. 561 F.3d at 1375–
76. (...) The district court held that,
because viable, alternative processes for making the product existed in 2002 and 2005,
the process and product were patentably distinct, and, therefore, not invalid for
obviousness-type double patenting. Takeda, 511 F. Supp. 2d at 97. (...)The question on appeal to this court in Takeda was whether, when an issued
patent claims a product and discloses, but does not claim, a process for making that
product, the patentee, when later seeking a patent on the disclosed process, may
present evidence of post-invention, alternative processes that produce the patented
product, in order to show that the process and product are patentably distinct. 561 F.3d
at 1375–76.6 The answer was a qualified yes. We concluded that “the relevant time
frame for determining whether a product and process are ‘patentably distinct’ should be
at the filing date of the secondary application,” which is the later application for the
process. Id. at 1377.
The bottom line, Roche lost on its Takeda argument:
Consequently, we must reject Roche’s contention that it should be
able to show patentable indistinctiveness by relying on evidence up to the filing date of
“secondary application[s].” Therefore, on remand, Roche may not rely on developments
in the art subsequent to November 30, 1984,
The topic of "old product made by new process" arose:
It has long been the case that an old product is not patentable even if it is made
by a new process. See Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 373
(1938) (“Wabash”) (“[A] patentee who does not distinguish his product from what is old
except by reference, express or constructive, to the process by which he produced it,
cannot secure a monopoly on the product by whatever means produced.”); Cochrane v.
Badische Anilin & Soda Fabrik, 11 U.S. 293, 311 (1884) (“BASF”) (“While a new
process for producing [the product] was patentable, the product itself could not be
patented even though it was a product made [by an artificial process] for the first time.”);
SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1317 (Fed. Cir. 2006) (“It
has long been established that one cannot avoid anticipation by an earlier product
disclosure by claiming the same product . . . as produced by a particular process.”);
The topic of "product-by-process" arose:
In determining validity of a product-by-process claim, the focus is on the product
and not on the process of making it. See Atl. Thermoplastics Co. v. Faytex Corp., 970
F.2d 834, 841 (Fed. Cir. 1992) (explaining that, in BASF, the validity rule “focused on
the product with less regard for the process limits”); Brown, 459 F.2d at 535 (focusing
on the product claimed and not the process); Pilkington, 411 F.2d at 1348 (noting that
the product itself must be new).
Of infringement and invalidity, on "anticipates if earlier, infringes if later":
The impact of these different analyses is significant. For product-by-process
claims, that which anticipates if earlier does not necessarily infringe if later. That is
because a product in the prior art made by a different process can anticipate a product-
by-process claim, but an accused product made by a different process cannot infringe a
product-by-process claim. Similarly, that which infringes if later does not necessarily
anticipate if earlier. That is because an accused product may meet each limitation in a
claim, but not possess features imparted by a process limitation that might distinguish
the claimed invention from the prior art.
Based on our precedent, the court did not err in conducting its validity and
infringement analyses differently.
On indefiniteness:
Indefiniteness is a question of law. Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306,
1319 (Fed. Cir. 2008). Under 35 U.S.C. § 112, claims must “particularly point[ ] out and
distinctly claim[ ] the subject matter which the applicant regards as his invention.” If a
claim fails to reasonably apprise one skilled in the art of the boundaries of the claim
when read in light of the specification, then the claim is invalid under § 112 for
indefiniteness. See Miles Labs., Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir.
1993). (...) That does not mean, however, that an ordinarily skilled artisan at the time
of the invention would not have known the scope of human EPO in claim 1. See
Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624 (Fed. Cir. 1985)
(explaining that § 112 only requires the claim language to be “as precise as the subject
matter permits” (quotation marks omitted)).
On infringement:
Relying on A.B. Dick Co. v. Burroughs Corp., 713 F.2d
700, 703 (Fed. Cir. 1983), for the proposition that “one cannot avoid infringement merely
by adding elements,” the court rejected Roche’s argument that MIRCERA® does not
contain EPO because CERA is formed through pegylation.
(...)
Roche’s argument that human EPO no longer exists “as a matter of
chemistry” once it reacts with a PEG molecule is unpersuasive because the record
shows that the human EPO component exists in the final product and confers its
structural and functional properties onto MIRCERA®. The record therefore supports the
court’s conclusion, and the jury’s implicit conclusion,18 that the attachment of a PEG
molecule is the addition of an element, which cannot negate infringement, as opposed
to a fundamental chemical transformation, which might save MIRCERA® from
infringement. Amgen, 581 F. Supp. 2d at 203–04; see also Amstar Corp. v. Envirotech
Corp., 730 F.2d 1476, 1482 (Fed. Cir. 1984) (“Modification by mere addition of elements
. . . cannot negate infringement, without disregard of . . . long-established, hornbook law
. . . .”).
On materiality:
Materiality is context-dependent. See Biotech Biologische Naturverpackungen
GmbH & Co. v. Biocorp, Inc., 249 F.3d 1341, 1352 (Fed. Cir. 2001) (“Whether a change
in a product is material is a factual determination, and is properly for the trier of fact.”).
Doctrine of equivalents:
To support a finding of infringement under DOE, Amgen must have presented,
on a limitation-by-limitation basis, “particularized testimony and linking argument as to
the ‘insubstantiality of the differences’ between [the pharmaceutical composition in claim
12] and [MIRCERA®], or with respect to the function, way, result test.” Tex. Instruments
v. Cypress Semiconductor Corp., 90 F.3d 1558, 1567 (Fed. Cir. 1996).
Evidentiary issue:
Contrary to Roche’s assertions, Amgen was not required to have duplicated
Roche’s actual production process in order to prove infringement. See Johns Hopkins
Univ. v. CellPro, Inc., 152 F.3d 1342, 1349–50, 1356 (Fed. Cir. 1998) (affirming
infringement where patentee did not test the accused product, but relied on documents
produced by accused infringer). Neither was Amgen required to establish infringement
by offering RIA data into evidence. See Union Carbide Chems. & Plastics Tech. Corp.
v. Shell Oil Co., 425 F.3d 1366, 1374–75 (Fed. Cir. 2005) (affirming infringement where
patentee proved infringement of a limitation measured by the “comparison test” with
measurements from a different, but comparable test); cf. Genentech, Inc. v. Wellcome
Found. Ltd., 29 F.3d 1555, 1566 (Fed. Cir. 1994) (affirming non-infringement where
patentee relied on test different from that specified in the claims without establishing
tests were comparable).
See earlier IPBiz post:
http://ipbiz.blogspot.com/2008/10/amgen-whips-roche-in-mircera-case.html
**Also
anticipation without obviousness
posted by Lawrence B. Ebert at 5:54 AM
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