Patent Docs

Patent Public Advisory Committee to Meet on Wednesday, March 3, 2010

March 2, 2010

By
Sarah Fendrick —

The U.S. Patent and Trademark Office posted a notice on its
website announcing that the next meeting of the Patent Public Advisory
Committee (PPAC) will be held on Wednesday, March 3, 2010. A webcast of the meeting can be accessed here. Those interested in
conferencing in by phone (as listening participants only) should call 1-800-369-2139 and use the passcode: USPTO25. The
proposed meeting agenda includes:

• Call to Order (11:00 – 11:05 am) — Damon Matteo, Acting
Chairman

* Introductions (11:05
– 11:10 am) — Damon Matteo, Chairman

* USPTO Draft Strategic Plan (11:10
– 11:40 am) — Sharon Barner, Deputy Under
Secretary and Deputy Director of USPTO

• Policy: Wyeth v. Kappos Implications (11:40
am
– 12:10 pm) — Bob Bahr,
Acting Associate Commissioner for Patent Examination Policy; Ray Chen,
Solicitor; Esther Kepplinger, PPAC
Wyeth Sub-Committee Lead

• Quality: PPAC Quality Sub-Committee Brief Update (12:10 – 12:15 pm) — Marc Adler, PPAC Quality Sub-Committee Lead; Bob Bahr, Acting
Associate Commissioner for Patent Examination Policy

• Efficiency Gain Plan & Operations Update (12:15
– 1:00 pm) — Peggy Focarino, Deputy
Commissioner for Patents

• Break (1:00 – 1:30 pm)

• Financial Update & 2011
President's Budget (1:30 – 2:00 pm) — Karen
Strohecker, Acting Chief Financial Officer

• "Intersection"
Discussion: Finance & Strategy (2:00 – 2:30 pm) — Sharon Barner, Deputy Under Secretary and Deputy Director of
USPTO; Robert Stoll, Commissioner
for Patents; Karen Strohecker,
Acting Chief Financial Officer; Damon Matteo, Chairman

• Ad Hoc Follow-Ups/Catch-Up (2:30
– 2:45 pm) — Speaker TBD

• Next Steps Discussion: Agenda Follow-Up and
New Topics (2:45
– 2:55 pm) — Damon Matteo,
Chairman

• Closing Remarks & Adjourn (2:55 – 3:00 pm) — Damon Matteo,
Chairman
District Court Judge Provides Another Reminder of Dysfunctional State of the Federal Circuit’s Claim Construction Jurisprudence

March 1, 2010

Trading Technologies Int'l. Inc. v. eSpeed Inc. (Fed.
Cir. 2010)

By Kevin E.
Noonan —

In an otherwise
unremarkable affirmance of jury verdicts and district court decisions on claim
construction, the nascent Chief Judge of the Federal Circuit, Randall Rader,
and District Court Judge Ron Clark (E.D Tex.) sitting by designation, provided
remarkably similar views on the negative consequences of the de novo review standard for claim
construction enunciated 13 years ago by the en
banc court in Cybor Corp. v. FAS
Technologies, Inc. That standard,
whereby the appellate court gives no deference to the underlying factual
determinations made by the district court in construing claims, is widely
recognized as resulting in less than optimal administration or development of
U.S. patent jurisprudence.

In the majority
opinion, written by Judge Rader (at left), the panel reviews the development of the
standard by the Federal Circuit stemming from the Supreme Court's decision in Markman v. Westview Instruments, Inc. "The Supreme Court recognized that claim
construction 'falls somewhere between a pristine legal standard and a simple
historical fact,' Id. at 388 (quoting Miller v. Fenton, 474 U.S. 104, 114
(1985))" said the CAFC. In
addition, the opinion noted that the Supreme Court characterized claim
construction as "not a purely legal matter," but "found 'sufficient
reason to treat construction of terms of art like many other responsibilities
that we cede to a judge in the normal course of trial, notwithstanding its
evidentiary underpinnings.' Id. at 390." Nevertheless, however, the Federal Circuit "interpreted
Markman as holding that claim construction was solely a question of law,
which this court should review without deference," citing Cybor Corp. v. FAS Technologies, Inc.,
138 F.3d 1448, 1451 (Fed. Cir. 1998) (en banc). The opinion restates the question presented to the Supreme
Court in Markman as involving whether
a litigant had a Seventh Amendment right to a jury determination of claim scope
as the "the meaning of any disputed term of art about which expert
testimony is offered." The
opinion states that the Federal Circuit, in responding to Markman, understood the Supreme Court to have determined whether
claim construction was a matter of fact or law, and rejected the view that "the
Court endorsed a silent, third option — that claim construction may involve
subsidiary or underlying questions of fact," that may permit some deference to be given to factual
determinations made by the district court judge.

The opinion
then dissects the Supreme Court's Markman
opinion with regard to the "factual components of claim construction:"

• "[C]onstruing
a term of art following receipt of evidence" is "a mongrel practice." Id. at 378.
• Claim
construction "falls somewhere between a pristine legal standard and a
simple historical fact." Id. at 388.
• "We
accordingly think there is sufficient reason to treat construction of terms of
art like many other responsibilities that we cede to a judge in the normal
course of trial, notwithstanding its evidentiary underpinnings." Id. at
390.

"These references in the Supreme Court opinion,"
according to Judge Rader, "leaves this court stranded between the language
in the Court's decision and the language in this court's Cybor decision."

Turning
to the case before it, the panel reviewed the factual findings made by the District Court, including the "technical background of the invention,"
the meaning of the claim terms at issue as understood by the "ordinary
artisan," and the way that artisan would "interpret the patent applicant's
statements made to the PTO examiner during [patent] prosecution." "In sum," the court opined, "claim
construction involves many technical, scientific, and timing issues that
require full examination of the evidence and factual resolution of any disputes
before setting the meaning of the disputed terms." However,

[d]espite the Supreme Court's emphasis on the trial court's central role for
claim construction, including the evaluation of expert testimony, this court
may not give any deference to the trial court's factual decisions underlying
its claim construction. This court's prior en banc decision requires a review
of the district court's claim construction without the slightest iota of
deference. See Cybor, 138 F.3d at 1451.

With that
introduction, the opinion reviewed and affirmed the District Court's claim
construction.

Judge Clark
provided a district court's perspective in a separate concurring opinion. While agreeing with the result, Judge
Clark states his purpose in writing separately was "to respectfully suggest that the
current de novo standard of review for claim construction may result in the
unintended consequences of discouraging settlement, encouraging appeals, and,
in some cases, multiplying the proceedings." The task of construing a claim frequently requires a
district court to determine "crucial facts" and may depend on the weight
given conflicting evidence and sometimes evaluating the credibility of expert
testimony. The standard of review,
according to Judge Clark, "sets one of the important benchmarks against
which competent counsel evaluates decisions regarding settlement and appeal,"
uniquely addressing consequences of the Federal Circuit's de novo review standard on litigation behavior (rather than merely
litigation strategy).

The Judge
sets forth two "practical" results of this standard, neither of which
"furthers the goal of the 'just, speedy, and inexpensive determination of
every action and proceeding.' Fed. R. Civ. P. 1." The first of these is
that settlement becomes more difficult to negotiate, and appeal "almost
compelled," when it is even "debatable" that a client's position
on claim construction is valid. The Judge says it is "a natural reaction" to believe that the
Federal Circuit, having generally more experience with patent cases, will
better understand the facts underlying a party's claim construction arguments,
and under the court's "own authoritative rule" will review claim
construction "without regard to any determination the lower court has
made." "What public
policy," Judge Clark asks, "is advanced by a rule requiring the
determination of underlying facts by more than one court?"

A second
consequence of the Court's refusal to give any deference to the district court
in claim construction (albeit less common according to Judge Clark) is that a
party may "present [its] case with an eye towards appeal rather than the
verdict." This may occur, for
example, when "[s]killed counsel" recognize that her client "may
not be well received by a jury," and hence may be motivated to introduce
error into claim construction at the district court or limit the extent of
argument she presents to the district court during claim construction. This would permit a litigant to present
the "most sharply focused argument" on appeal rather than in the
district court. These tactics,
constituting some measure of gaming the system and introducing inefficiencies
to that system, would be "less inviting if the district court's claim
construction was officially accorded some measure of deference," even only
if applied to the relatively rare cases where reference to extrinsic evidence
was required.

These
sentiments are reminiscent of the dissenting
opinion of District Court Judge Vaughn R. Walker, Chief Judge, U.S. District
Court for the Northern District of California, sitting by designation, in Medegen
MMS, Inc. v. ICU Medical Inc. (Fed, Cir. 2008) (see "Claim Construction at the Federal Circuit: A District Court Judge's View"). In that case, Judge Walker pointed out rather more sharply than Judge Clark the
"conundrum" faced by district courts arising from the "twin
axioms" of claim construction: "[o]n the one hand, claims 'must
be read in view of the specification'," citing Markman, while "[o]n
the other hand, it is improper to read a limitation from the specification into
the claims," citing Arlington Indus. Inc. v. Bridgeport Fittings, Inc. Judge Walker reminded the Court
that these axioms "themselves seldom provide an answer, but instead merely
frame the question to be resolved." While recognizing the sound
policy reasons for a patent drafter to be required to include "all claim
limitations in the claims of a patent," he also admonished that "patents
must be read as well as written." Citing Phillips, he
asserted that this analysis must be performed with due consideration of a term's
"ordinary and customary meaning" informed by the "context of the
entire patent, including the specification."

Both Judge
Walker's dissent and Judge Clark's concurrence remind the Federal Circuit of the
essential paradox of its practice under Cybor:
by giving no deference to factual determinations by district courts in
claim construction, the Federal Circuit must substitute its judgment for that
of trial court judges more accustomed to make factual determinations "not
well suited to appellate review."

In his dissent
from the en banc opinion in Cybor, Judge Rader performed a rough
calculus on the fate of district court claim construction determinations at the
Federal Circuit in 1997. He found
that the Court reversed claim construction 53% of the time (27% reversed
completely, 26% reversed-in-part). Current academic research suggests that Federal Circuit reversal rates
of district court claim construction has "improved" to 30-40%. This
may reflect the vagaries of district court claim construction determinations,
being done by courts having various levels of experience in patent cases. On the other hand, each panel of the
Federal Circuit resolves claim construction issues idiosyncratically
(depending, as it must, on the particular terms that must be construed in each
case and the intrinsic evidence available to the Court in each case). While there may be some degree of
consistency that arises from having the Federal Circuit make the final
decision on claim construction, there are also inconsistencies and
inefficiencies produced by the Court's review standard, as set forth by Judge's
Walker and Clark. Judge Lourie has
suggested a middle ground, that rather than giving any formal deference to
district court claim construction the CAFC should exercise judicial restraint
from reversing the district court unless there is "strong conviction of
error." Phillips v. AWH Corp. It may be time for the Federal Circuit to consider again this option.
Court Report

March 1, 2010

By Sherri
Oslick —

About
Court
Report: Each week we will report briefly on recently filed
biotech and pharma cases.

Simonian v. Merck & Co., Inc. et al.
1:10-cv-01297; filed February 25, 2010 in the
Northern District of Illinois

• Plaintiff: Thomas A Simonian
• Defendants: Merck & Co., Inc.;
Schering-Plough Healthcare Products, Inc.

False marking based on Merck's marking of its
Claritin-D and Dr. Scholl's Double Air Pillo Insoles products indicating that
these products are covered by U.S. Patent Nos. 4,863,931 ("Antihistaminic Fluoro
Substituted Benzocycloheptapyridines," issued September 5, 1989) and
4,642,912 ("Shoe Insole," issued February 17, 1987), which are
expired. View the complaint here.

Simonian v. Novartis Pharmaceuticals Corp.
1:10-cv-01308; filed February 25, 2010 in the
Northern District of Illinois

False marking based on Novartis' marking of its
Hypo Tears® products indicating that these products are covered by U.S. Patent
No. 4,409,205 ("Ophthalmic Solution," issued October 11, 1983), which
is expired. View the complaint here.

Simonian v. Novartis Animal Health US, Inc.
1:10-cv-01267; filed February 24, 2010 in the
Northern District of Illinois

False marking based on Novartis'
marking of its Interceptor® products indicating that these products are covered
by U.S. Patent No. 4,547,520 ("5-Oxime Derivatives of Milbemycins and Veterinary
and Agricultural use Thereof," issued October 15, 1985), which is
expired. View the complaint here.

Simonian v. Novartis Consumer Health, Inc.
1:10-cv-01268; filed February 24, 2010 in the
Northern District of Illinois

False marking based on Novartis' marking of its
Prevacid® products indicating that these products are covered by U.S. Patent
No. 4,628,098 ("2-[2-pyridylmethylthio-(sulfinyl)]benzimidazoles,"
issued December 9, 1986), which is expired. View the complaint here.

Public Patent Foundation, Inc. v. Novartis Consumer Health,
Inc.
1:10-cv-01553; filed February 24, 2010 in the
Southern District of New York

False marking based on Novartis' marking of its
Prevacid® products indicating that these products are covered by U.S. Patent
No. 4,628,098 ("2-[2-pyridylmethylthio-(sulfinyl)]benzimidazoles,"
issued December 9, 1986), which is expired. View the complaint here.

O'Neill v. Roche Diagnostics Corp.
1:10-cv-01205; filed February 23, 2010 in the
Northern District of Illinois

False marking based on Roche's marking of its
ACCU-CHEK® products indicating that these products are covered by U.S. Patent
Nos. 4,891,319 ("Protection of Proteins and the Like," issued January
2, 1990), 4,924,879 ("Blood Lancet Device," issued May 15, 1990), and
4,999,582 ("Biosensor Electrode Excitation Circuit," issued March 12,
1991), which are expired. View the
complaint here.

Simonian v. Pfizer, Inc.
1:10-cv-01193; filed February 23, 2010 in the
Northern District of Illinois

False marking based on Pfizer's marking of its
Advil® products indicating that these products are covered by U.S. Patent No.
5,071,643 ("Solvent System Enhancing the Solubility of Pharmaceuticals for
Encapsulation," issued December 10, 1991), which is expired. View the complaint here.

Simonian v. Merial L.L.C. et al.
1:10-cv-01216; filed February 23, 2010 in the
Northern District of Illinois

• Plaintiff: Thomas A Simonian
• Defendants: Merial L.L.C.; Merial, Inc.

False marking based on Merial's marking of its
Heartguard Heartworm Canine Medication products indicating that these products
are covered by U.S. Patent No. 4,199,569 ("Selective Hydrogenation Products
of C-076 Compounds and Derivatives Thereof," issued April 22, 1980), which
is expired. View the complaint here.

Hollander v. Ranbaxy Laboratories Inc.
2:10-cv-00793; filed February 23, 2010 in the
Eastern District of Pennsylvania

False marking based on Novartis' marking of its
Ultravate® products indicating that these products are covered by U.S. Patent
No. 4,619,921 ("Polyhalogeno-Steroids," issued October 28, 1986),
which is expired. View the
complaint here.
In re Chapman (Fed. Cir. 2010)

February 28, 2010

The Standard of Reviewing Obviousness Determinations
from the USPTO

    By Kevin E. Noonan —

The Federal Circuit vacated and remanded a Board of
Patent Appeals and Interferences determination that the claims in U.S. Application No. 09/719,045 were obvious on Thursday, in deciding In re Chapman. The CAFC's decision addressed not only the proper
obviousness standard that the Board must apply, but also revisited the proper
standard of review the Federal Circuit applies regarding factual determinations by the Office
according to the Supreme Court's instructions in Dickinson v. Zurko.

The Chapman application is a U.S. national phase of
an International Application first filed in Great Britain. The following claim is representative:

1. A
divalent antibody fragment comprising
    (a) two
antibody heavy chains and
    (b) at least
one polymer molecule effective for increasing the circulating half-life of said
fragment in covalent linkage,
    (c) each
heavy chain being covalently linked to the other by at least one non-disulphide
interchain bridge linking the sulphur atom of a cysteine residue in one chain
to the sulphur atom of a cysteine residue in the other chain, said cysteine
residues being located outside of the variable region domain of each chain, characterized
in that the at least one non-disulphide interchain bridge contains the at least
one covalently linked polymer molecule.

As the CAFC
explained, the invention was directed towards making a derivative of an
antibody comprising two heavy chains linked to one another using a polymer
attached at each end to a sulfur atom comprising a cysteine residue in each of
the different heavy chain molecules, and that the cysteine residues in each
heavy chain came from outside the variable region domain (i.e., where the specificity
of antibody binding is structurally determined).

Importantly
for the Court's understanding of the underlying technology, the government
explained that there was a need in the art for antibody fragments, since
antibodies were frequently too large and had extended half-lives that could be
deleterious to a patient. Advantages of antibody fragments, according to the Court, were that they
had better serum clearance rates and more rapid distribution throughout the
body. The Court noted that
enzymatic digestion was known to produce antibody fragments effectively. The Court also noted that one species
(F(ab')2) produced by digestion (with pepsin) was "dumbbell
shaped" and that it was divalent (having two antigen binding sites) as
required by the claims.

With regard
to the teachings of the specification supporting the Chapman claims, the Court
said that Chapman's specification taught combining two separate Fab' fragments
(having removed the light claims) "using an interchain bridge that
contains at least one covalently linked polymer." Thus, the linkage between two heavy
chain molecules is mediated by the polymer rather than the disulfide bridges
used in the native molecule. One
of the advantages of using a polymer rather than a disulfide bridge is that it
increases the circulating half-life of the antibody fragment, according to the Court, to a half-life "that is intermediate between that of an individual
fragment and a whole antibody."

The prior
art asserted by the Office included U.S. Patent No. 6,025,158 (the Gonzales
reference), which the Court said "describes linking antibody fragments to
a polymer to increase an antibody's circulating half-life for therapeutic
purposes." One polymer known
in the art, polyethylene glycol (PEG), when attached to the sulfur atom in the cysteine residue in the hinge region of the molecule "reduced clearance
compared to the parental Fab' molecule"; the reference also describes
dumbbell-shaped embodiments "made up of two antibody fragments linked by a
polymer and the preparation of such conjugates," including Fab, Fab', Fab'-SH, F(ab')2, scFv, and
Fv as choice for the antibody portion of
the conjugate and PEG as the polymer linking them. Included in the description of the '158 patent were methods
for linking antibody fragments and the polymer without using a disulphilde bond
in some embodiments (albeit using sulfur atoms in cysteine residues as the
point of PEG attachment, specifically cysteine residues in the hinge region).

The Examiner
applied the Gonzales reference for anticipation under 35 U.S.C. § 102(e), or in
the alternative, combined Gonzales with U.S. Patent No. 5,436,154 to
Barbanti (teaching antibody therapy) in rejecting the claims under 35 U.S.C.
§ 103. The Board affirmed as to the
obviousness rejection, reversing the anticipation rejection on the ground that "too
much in the way of mental gymnastics would have been necessary for persons of
ordinary skill to have 'at once envisage[d]' the claimed antibody structure
among the different structures described in the Gonzalez patent. . . . [P]icking and choosing would have been necessary to have arrived at the
antibody structure of claim 1." The Federal Circuit noted several findings of fact made by the Board in affirming
the Examiner's rejections. These
included:

• Antibody
fragments disclosed in the Gonzales reference include monovalent Fab fragments,
monovalent Fab' fragments having one or more cysteine residues in the constant
region, or F(ab')2 fragments having a disulfide bond between
cysteine residues in the hinge region.

• The
Gonzales reference disclosed conjugates wherein the F(ab')2 fragment
is conjugated to the polymer at a cysteine that would otherwise comprise the
disulfide bond between the two fragments. However, Gonzales describes the polymer as being linked to a cysteine in
the light chain or the heavy chain, and that the cysteine in the other chain
that would otherwise for a disulfide bond with the cysteine bonded to the
polymer is changed to prevent a disulfide bond from forming.

• Gonzales
in other embodiments describes a polymer that links two antibody fragments in a
"dumbbell-shaped structure," using a polymer having multiple
functional groups "permitting the direct attachment . . . of two or more
antibody fragments to the polymer backbone."

The Board
agreed with the examiner that the Gonzales reference had disclosed "linking
two antibody fragments with a polymer to form a 'dumbbell-shaped'
structure," and had expressly taught "a Fab molecule with a PEG
linked to the hinge cysteine of the heavy chain." "The only issue," according
to the Board, was "whether persons of skill in the art would have had
reason to join the [Fab'] fragments together using a polymer linked to the
hinge cysteine residue." The
Board concluded that the preference disclosed in the Gonzales reference for
linking the polymer to the hinge region would have "led the skilled
artisan to utilize the claimed hinge cysteine," based in part on the
advantages disclosed in the Gonzales reference regarding such linkages (i.e.,
producing "reduced clearance" from the bloodstream). Especially important for the
Board's decision was that, in its view, the Gonzales reference taught "a
complete working example" of attaching a polymer to a hinge region
cysteine residue. The combination
of this teaching, and the "dumbbell" structure disclosed in the
Gonzales reference, "would have suggested to the ordinary skilled person
that such Fab' fragments could be readily linked polymer to polymer using a
bifunctional linker, as explicitly stated by Gonzalez when characterizing the
dumbbell-shaped antibody structure."

In the
Federal Circuit opinion, by Judge Dyk joined by Judges Gajarsa and Clevenger,
the Court began with the standard of review: no deference for legal conclusions, and substantial evidence
for factual findings. The opinion
notes that both parties agree that whether the obviousness rejection was
correctly maintained depends on whether the Office had correctly interpreted
the teachings of the Gonzales reference. In this regard, the Court refused to reverse the Board's determination
as a matter of law, instead remanding to the Board "to correct certain
errors in the Board's decision." The Court rejected applicants' argument that the Gonzales reference
teaches away from the claimed invention, based on the multiplicity of positions
for polymer attachment, in view of the express preference for attachment at the
hinge region. The Court also noted
that the reference was directed towards solving the same problem as the claimed
invention — increasing the half-life of the antibody in circulation.

Applicants'
most persuasive argument was directed to three of the Board's factual findings,
which both applicants and the government agreed were erroneous. The difference in the parties position
was that the Office argued that the errors were harmless, and the opinion
hinged on the Court's assessment of the harm caused by these errors, applying
the same "harmless error" rule that it applies to factual
determinations from district courts, citing In re Watts, 354 F.3d 1362
(Fed. Cir. 2004) (citing In re McDaniel, 293 F.3d 1379 (Fed. Cir.
2002) and Gechter v. Davidson, 116 F.3d 1454 (Fed. Cir. 1997)), an
approach the opinion asserted was affirmed by the Supreme Court in Shinseki v.
Sanders, 129 S. Ct. 1696, 1706 (2009).

Specifically,
the Board erred in finding that:

• Gonzales
taught a "dumbbell-shaped" structure comprising two monovalent Fab'
fragments lined via a polymer. The
government agreed that the Board "conflated" two correct statements
on the record from the Examiner to arrive at an incorrect conclusion. The Court found that this error was
harmless, because the Board did not rely on "any such explicit disclosure"
in the Gonzales reference

• "Gonzalez
describes a divalent antibody in which the polymer is linked between light and
heavy chains and only one cysteine residue is present." The Examiner stated that "Gonzalez
describes conjugates containing an 'F(ab')2 antibody
fragment in which the polymer is attached between the disulphide bridge that
would ordinarily link the light and heavy chains.'" The government conceded at oral
argument that applicants were correct, that the Gonzales reference in fact
disclosed that:

[T]he conjugate contains a F(ab')2 antibody fragment attached to no more than about 2 polymer
molecules, wherein every polymer molecule is attached to a cysteine residue in
the light or heavy chain of the antibody fragment that would ordinarily form
the disulfide bridge linking the light and heavy chains, wherein the disulfide
bridge is avoided by substituting another amino acid, such a serine, for the
corresponding cysteine residue in the opposite chain.

• Finally,
applicants argued (and the government agreed) that Gonzales taught that there
were up to six antibody fragments that could be conjugated to a polymer (F(ab),
F(ab'), F(ab')-SH, F(ab')2, scFv, and
Fv) and not just Fab, Fab' or F(ab')2 fragments.

The Court
found that both of the latter references were not harmless because "they
increased the likelihood that [applicants were] denied a patent on grounds of
obviousness." The Board's
obviousness finding being based on "a misunderstanding" of the
Gonzales reference "called into question" its legal determination of
obviousness, according to the Federal Circuit. Specifically, if the Board misinterpreted the Gonzales
reference regarding whether it contained a teaching of using a polymer to link
the light and heavy chains in an F(ab')2 fragment,
then applicants' invention of using a polymer to link two F(ab')2 fragments together "may be less obvious" in the Court's
opinion. Similarly, with regard to
the number of possible fragments that could be conjugated, "if the Board
did not appreciate the full scope of antibody fragments disclosed in Gonzalez,
we cannot be confident about its ultimate conclusion that the selection of one
of them to form Chapman's molecule is obvious, as it appears that there are
more possibilities from which to choose." Thus, "[b]ecause we cannot say with confidence
that the Board would have reached the same conclusion in the absence of these
errors, we are persuaded they are indeed harmful."

Interestingly,
despite the Court's clear understanding that the Board had made several
prejudicial errors in making its obviousness determination, rather than
reversing the Board outright the Court remanded to permit the Board to "revisit"
its obviousness assessment, in view of a correct understanding of the Gonzales
reference. "The Board is in
no way precluded from, and indeed may be correct in, finding the claims to be
obvious, particularly in the light of Gonzalez's disclosure of joining two
antibody fragments together with a polymer to make a dumbbell-shaped structure," wherein the Court thus exhibited a high level of deference to how the Board makes
its factual findings.

In re Chapman (Fed. Cir. 2010)
Panel: Circuit Judges Gajarsa, Clevenger, and Dyk
Opinion by Circuit Judge Dyk
Court Report

February 28, 2010

By Sherri
Oslick —

About
Court
Report: Each week we will report briefly on recently filed
biotech and pharma cases.

Watson Laboratories, Inc. vs Teva Women's Health, Inc.
3:10-cv-00115; filed February 25, 2010 in the
District Court of Nevada

Declaratory judgment of invalidity and
non-infringement of U.S. Patent No. 7,615,545 ("Oral Contraceptives to
Prevent Pregnancy and Diminish Premenstrual Symptomatology," issued
November 10, 2009) based on Watson's filing of an ANDA to manufacture a generic
version of Teva Women's Health's (formerly Duramed) Seasonique®
(levonorgestrel/ethinyl estradiol, used as oral contraception). View the complaint here.

Bio-Reference Laboratories, Inc. v. Assistance Publique –
Hopitaux De Paris et al.
1:10-cv-00292; filed February 24, 2010 in the
District Court of the District of Columbia

• Plaintiff: Bio-Reference Laboratories, Inc.
• Defendants: Assistance Publique – Hopitaux De
Paris; Institut National De La Sante Et De La Recherche Medicale (INSERM);
Institut Gustave Roussy; Universite De Versailles – St. Quentin En Yvelines;
Universite Paris – SUD

Declaratory judgment of invalidity and
non-infringement of U.S. Patent No. 7,429,456 ("Identification of a JAK2
Mutation in Polycythemia Vera," issued September
20, 2008) based on Bio-Reference's JAK2 diagnostic testing. View the complaint here.

Graceway Pharmaceuticals, LLC et al. v. Perrigo Co. et al.
2:10-cv-00937; filed February 23, 2010 in the
District Court of New Jersey

• Plaintiffs: Graceway Pharmaceuticals, LLC; 3M
Innovative Properties Co.
• Defendants: Perrigo Co.; Perrigno Israel
Pharmaceuticals Ltd.; Nycomed U.S. Inc.

Infringement of U.S. Patent No. 7,655,672 ("Immune
Response Modifier Formulations Containing Oleic Acid and Methods," issued
February 2, 2010) following a Paragraph IV certification as part of Perrigo's
filing of an ANDA to manufacture a generic version of Graceway's Aldara®
(imiquimod cream, used for the topical treatment actinic keratoses, superficial
basal cell carcinoma, and external genital and perianal warts). View the complaint here.

Millennium Pharmaceuticals Inc. et al. v. Teva Parenteral
Medicines Inc. et al.
1:10-cv-00137; filed February 19, 2010 in the
District Court of Delaware

• Plaintiffs: Millennium Pharmaceuticals Inc.;
Schering Corp.
• Defendants: Teva Parenteral Medicines Inc.; Teva
Pharamceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 5,747,447 ("Stable
Polypeptide Composition," issued May 5, 1998) and 5,968,902 ("Platelet
Aggregation Inhibitors," issued October 19, 1999), licensed to Schering
Corp., following a Paragraph IV certification as part of Teva's filing of an
ANDA to manufacture a generic version of Schering's Integrilin® (eptifibatide
injection, used to treat acute coronary syndrome). View the complaint here.

Endo Pharmaceuticals Inc. et al. v. Watson Laboratories Inc. et
al.

1:10-cv-00138; filed February 19, 2010 in the
District Court of Delaware

• Plaintiffs: Endo Pharmaceuticals Inc.; Teikoku
Pharma USA Inc.; Teikoku Seiyaku Co Ltd.
• Defendants: Watson Laboratories Inc.; Watson
Pharmaceuticals Inc.; Watson Pharma Inc.

Infringement of U.S. Patent No. 5,827,529 ("External
Preparation for Application to the Skin Containing Lidocaine," issued
October 27, 1998), licensed to Endo, following a Paragraph IV certification as
part of Watson's filing of an ANDA to manufacture a generic version of Endo's Lidoderm®
(lidocaine patch, used to treat after-shingles pain). View the complaint here.

Galderma Laboratories LP et al. v. Taro Pharmaceuticals USA Inc. et al.
4:10-cv-00114; filed February 19, 2010 in the
Northern District of Texas

• Plaintiffs: Galderma Laboratories LP; Galderma
SA
• Defendants: Taro Pharmaceuticals USA Inc.; Tara
Pharmaceutical Industries Ltd.

Infringement of U.S. Patent No. 6,106,848 ("Topically
Applicable O/W Emulsions Having High Glycol Content and At Least One
Biologically Active Agent," issued August 22, 2000) following a Paragraph
IV certification as part of Taro's filing of an ANDA to manufacture a generic
version of Galderma's Clobex® (clobetasol propionate lotion, used for the
treatment of moderate to severe plaque psoriasis). View the complaint here.

Cephalon, Inc. et al. v. Sandoz, Inc.
1:10-cv-00351; filed February 18, 2010 in the
District Court of Colorado

• Plaintiffs: Cephalon, Inc.; Cima Labs, Inc.
• Defendant: Sandoz, Inc.

Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual
Buccal Effervescent," issued March 13, 2001) and 6,974,590 (same title,
issued December 13, 2005) following a Paragraph IV
certification as part of Sandoz's filing of an ANDA to manufacture a generic
version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat
breakthrough pain in adult patients with cancer). View the complaint here.

Boehringer Ingelheim Pharma GMBH & Co. KG et al. v. Kappos
1:10-cv-00253; filed February 18, 2010 in the
District Court of the District of Columbia

• Plaintiffs: Boehringer Ingelheim Pharma GMBH
& Co. KG; Boehringer Ingelheim International GMBH; Boehringer Ingelheim
Pharmaceuticals, Inc.
• Defendant: David Kappos

Review and correction of the patent term adjustment
calculation made by the U.S. Patent and Trademark Office for U.S. Patent No.
7,579,449 ("Glucopyranosyl-Substituted Phenyl Derivatives, Medicaments
Containing Such Compounds, and Their Use and Process for Their Manufacture,"
issued August 25, 2009). View the
complaint here.

Biovail Laboratories International SRL v. Watson
Pharmaceuticals Inc. et al.
1:10-cv-00133; filed February 18, 2010 in the
District Court of Delaware

• Plaintiff: Biovail Laboratories International SRL
• Defendants: Watson Pharmaceuticals Inc.; Watson
Laboratories Inc. – Florida; Watson Pharma Inc.

Biovail Laboratories International SRL v. Watson
Pharmaceuticals Inc. et al.
1:10-cv-20526; filed February 19, 2010 in the
Southern District of Florida

• Plaintiff: Biovail Laboratories International SRL
• Defendants: Watson Pharmaceuticals Inc.; Watson
Laboratories, Inc. – Florida; Watson Pharma, Inc.

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent Nos. 7,569,610 ("Modified Release Formulations of a Bupropion Salt,"
issued August 4, 2009), 7,572,935 (same title, issued August 11, 2009),
7,649,019 (same title, issued January 19, 2010), 7,563,823 (same title, issued
June 21, 2009), and 7,553,992 (same title, issued June 30, 2009) following a
Paragraph IV certification as part of Waton's filing of an ANDA to manufacture
a generic version of Biovail's Aplenzin ER (bupropion, used to treat depression). View the Delaware complaint here.

Shionogi Pharma Inc. et al. v. Mylan Inc. et al.
1:10-cv-00135; filed February 18, 2010 in the
District Court of Delaware

• Plaintiffs: Shionogi Pharma Inc.; Andrx Corp.;
Andrx Pharmaceuticals Inc. (also known as Watson Laboratories Inc. – Florida);
Andrx Pharmaceuticals LLC; Andrx Laboratories (NJ) Inc.; Andrx EU Ltd.; Andrx
Labs LLC
• Defendants: Mylan Inc.; Mylan Pharmaceuticals
Inc.

Infringement of U.S. Patent Nos. 6,099,859 ("Controlled
Release Oral Tablet Having a Unitary Core," issued August 8, 2000) and
6,866,866 ("Controlled Release Metformin Compositions," issued March
15, 2005), both licensed to Shionogi, following a Paragraph IV certification as
part of Mylan's filing of an ANDA to manufacture a generic version of Shionogi's
Fortamet® (extended release metformin hydrochloride, used to treat Type 2
diabetes). View the complaint here.

Takeda Pharmaceutical Co. et al. v. Aurobindo
Pharma Ltd. et al.
1:10-cv-01339; filed February 18, 2010 in the
Southern District of New York

• Plaintiffs: Takeda Pharmaceutical Co.; Takeda Pharmaceutical North America, Inc.; Takeda Global Research and
Development Center, Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo
Pharma USA Inc.

Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical
Composition," issued October 12, 1999), 6,166,043 (same title, issued
December 26, 2000), and 6,172,090 (same title, issued January 9, 2001)
following a Paragraph IV certification as part of Aurobindo's filing of an ANDA
to manufacture a generic version of Takeda's Actoplus MET® (pioglitazone
hydrochloride and metformin, used to treat type II diabetes). View the complaint here.

Arius Two, Inc. v. Kappos
1:10-cv-00225; filed February 16, 2010 in the
District Court of the District of Columbia

Review and correction of the patent term adjustment
calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,579,019
("Pharmaceutical Carrier Device Suitable for Delivery of Pharmaceutical Compounds
to Mucosal Surfaces," issued August 25, 2009). View the complaint here.

Cephalon, Inc. v. Kappos
1:10-cv-00235; filed February 12, 2010 in the
District Court of the District of Columbia

Review and correction of the patent term adjustment
calculation made by the U.S. Patent and Trademark Office for U.S. Patent No.
7,576,206 ("Proteasome Inhibitors and Methods of Using the Same,"
issued August 18, 2009). View the
complaint here.

Idera Pharmaceuticals, Inc. v. Kappos
1:10-cv-00166; filed January 29, 2010 in the
District Court of the District of Columbia

Review and correction of
the patent term adjustment calculation made by the U.S. Patent and Trademark
Office for U.S. Patent No. 7,517,862 "Synergistic Treatment of Cancer
Using Immunomers in Conjunction with Therapeutic Agents," issued August 4,
2009). View the complaint here.
Conference & CLE Calendar

February 28, 2010

March
1-2, 2010 – 4th
Annual Patent Law Institute (Practising
Law Institute) – New York, NY

March
2, 2010 – Biotechnology/Chemical/Pharmaceutical
(BCP) Customer Partnership Meeting (U.S.
Patent and Trademark Office) – 10:00 am – 4:00 pm (EST)

March
2-4, 2010 – 6th
Annual Biosimilars Conference (Visiongain) – Boston,
MA

March
3, 2010 – "What? Our
Latest Stem Cell Discovery Has Already Been Patented?" (Patent
Buddy & Sunlight Research) – 12:00
–
12:45 PM (CST)

March
5, 2010 – Fifth
Annual
Symposium: "New Rules for a New Day" (Northwestern
Journal
of Technology & Intellectual Property) – Chicago, IL

March
9, 2010 – "Patent
Infringement
Claims, Opinions of Counsel and Attorney-Client Privilege: Best
Practices for Opinion Letters after Seagate
and Qualcomm" (Technology
Transfer
Tactics & Strafford) – 1:00
– 2:30 PM (EST)

March 17-18, 2010 – 18th
Forum on Biotech Patenting (C5) – Munich,
Germany

March 18-19, 2010 – 4th
Summit on Biosimilars and
Follow-on Biologics*** (Center for
Business Intelligence) – Washington, DC

March
22-23, 2010 – 4th
Annual Patent Law Institute (Practising
Law Institute) – San Francisco,
CA

March 24-25, 2010 – FDA
Boot Camp*** (American Conference
Institute) – New York, NY

March
30,
2010 – "The
Bilski Decision: Expert Strategies to Manage Its Impact on
University IP" (Technology
Transfer Tactics) – 1:00 – 2:30 PM (EST)

April
7, 2010 – First
Annual Board
Conference (U.S.
Patent and Trademark Office Board
of Patent
Appeals and Interferences) – Alexandria,
VA

April
7-10, 2010 – 25th
Annual
Intellectual Property Law Conference (American
Bar
Association Section of Intellectual Property Law) – Arlington,
VA

April
11-17, 2010 – Advanced
Patent Courses (Patent
Resources
Group) – Bonita
Springs, FL

April 27-28, 2010 – 4th
Annual Paragraph IV Disputes*** (American Conference
Institute) – New York, NY

April
29,
2010 – 26th
Annual Joint Patent Practice Seminar (Connecticut,
New
Jersey, New York, and Philadelphia Intellectual Property Law
Associations) – New York, NY

***Patent Docs is a media partner of this conference or CLE
Northwestern JTIP Fifth Annual Symposium

February 26, 2010

The Northwestern
Journal of Technology & Intellectual Property will be holding its Fifth
Annual Symposium on March 5, 2010 on the Chicago Campus of Northwestern
University. The Symposium,
entitled "New Rules for a New Day," will consist of the following
sessions:

• The Patenting of
Social Interactions: Bilski Before
the Supreme Court – a panel discussion on the Bilski case, what is at stake, and the Supreme Court's options
featuring Professor Matthew Sag of the DePaul University College of Law;
Professor Joshua Sarnoff of the Washington College of Law at American University;
Professor Jonathan Masur of the University of Chicago Law School; and Daniel
Williams, a Partner at McDonnell Boehnen Hulbert & Berghoff LLP;

• Sharon Barner,
Deputy Under Secretary and Deputy Director of the U.S. Patent and Trademark
Office will provide the luncheon keynote on "Strategies for the USPTO:
Ensuring America's Innovation Future";

• Trademark and
Copyright in the Days of Internet: The Google Influence – a panel discussion on
the ramifications of the Google Books and Google AdWords cases and the
protection of IP in the fluid landscape of the internet featuring Michael
Baniak, a Partner at McDonnell Boehnen Hulbert & Berghoff LLP and Professor
Matthew Sag of the DePaul University College of Law;

• Who Defines the
Law? USPTO Rule Making Authority – a panel discussion on recent court
challenges to the USPTO's rulemaking and interpreting power, including the Cooper Technologies, Tafas, and Wyeth cases featuring Professor James Speta of the Northwestern
University School of Law; Patent Docs author Donald Zuhn, a Partner at
McDonnell Boehnen Hulbert & Berghoff LLP; Nicholas Zovko of Knobbe Martens
Olson & Bear LLP; and Professor Jonathan
Masur of the University of Chicago
Law School; and

• Redefining
"Free": A Look at Open Source Software Management — a panel
discussion on the pitfalls and issues that arise when open source code is
included in a deal featuring John Hines,
a Partner at Reed Smith LLP; Jon Christiansen of EscrowTech International Inc.;
Alfred Hanna, a Partner at Reed Smith LLP; and Joseph Herndon, a Partner at
McDonnell Boehnen Hulbert & Berghoff LLP.

Additional
information about the Symposium, including a schedule, list of speakers, and
directions can be found at the Symposium's website. A cocktail reception will take place in
Lowden Hall at the Northwestern University School of Law following the
Symposium. Registration for the
Symposium is free (CLE credit will be available to attendees for a fee of
$200).
Webinar on Stem Cell Patents

February 26, 2010

Patent
Buddy and Sunlight Research will be offering a webinar entitled "What? Our
Latest Stem Cell Discovery Has Already Been Patented?" on March 3, 2010 from 12:00 –
12:45 PM (CST). Dr. Robin Chadwick
of Schwegman, Lundberg & Woessner, P.A. will provide a presentation on stem
cell patent claims coverage. The
webinar will reveal the industry leader's patent claims coverage and areas of
opportunity.

The
webinar is free for Patent Buddy members.
Those interested in registering for the webinar, can do so here.
Webinar on Opinions of Counsel

February 26, 2010

Technology
Transfer Tactics and Strafford will be offering a webinar entitled "Patent
Infringement Claims, Opinions of Counsel and Attorney-Client Privilege: Best
Practices for Opinion Letters after Seagate
and Qualcomm"
on March 9, 2010 from 1:00 – 2:30 PM (EST). Sanford Warren Jr. of Akin Gump Strauss Hauer & Feld,
Richard Hung of Morrison & Foerster; and Mark Wine of Orrick Herrington
& Sutcliffe will discuss opinion of counsel letters used in patent
infringement suits, the impact of recent federal court decisions, and
attorney-client privilege issues.
The panel will review the following questions:

•
What is the practical impact of the recent Federal Circuit decisions on
utilizing opinions of counsel?
•
How does Seagate's "objective recklessness" standard impact legal
advice on proactive clearance analysis for product planning and strategic
portfolio development?
•
How can counsel reconcile the seemingly contradictory decisions in Seagate and Qualcomm?
•
Under what circumstances should corporate counsel seek outside opinions of
counsel to protect their company from infringement claims?

The
registration fee for the webinar is $297 ($362 for registration and CLE
processing). Those interested in
registering for the audioconference, can do so here.
Chairman Leahy Announces “Tentative Agreement in Principle” on Patent Reform Bill

February 25, 2010

By
Donald Zuhn —

During
an Executive Business Meeting of the Senate Judiciary Committee held earlier
today, Chairman Patrick Leahy (D-VT) informed attendees and online viewers
that the Committee had reached a "tentative agreement in principle"
regarding patent reform legislation.
Chairman Leahy (at right) noted that the agreement preserves the "core of the
compromise" struck in Committee last spring that permitted the Senate bill
(S. 515) to be voted out of Committee (see
"Senate 'Patent Reform' Bill (S. 515) Voted out of Judiciary Committee").

In
a meeting that was somewhat shortened by the President's Bipartisan Meeting on
Health Reform, Chairman Leahy thanked Senator Jeff Sessions (R-AL), the
Committee's Ranking Member, for working with him on the patent reform bill,
which Chairman Leahy called "a top priority" of the Committee. He also thanked Senators Dianne
Feinstein (D-CA), Arlen Spector (D-PA), John Cornyn (R-TX), Amy Klobuchar
(D-MN), and Orrin Hatch (R-UT) for their efforts in moving the legislation
forward. In addition, Chairman Leahy noted that
the Committee had, at the suggestion of Senator Jon Kyl (R-AZ), consulted with
the U.S. Patent and Trademark Office and USPTO Director David Kappos in revising the legislation.

Chairman
Leahy noted that the Committee would release details regarding the bill
"in the coming days" and after consultation with House
legislators. He mentioned that he
had been meeting with members of the House majority and minority leadership to
discuss the Senate bill in an effort to prevent the legislation from becoming a
"partisan issue."
Chairman Leahy then conceded the floor to Senator Sessions, who called
the Senate bill a "step forward." Senator Sessions said he thought the Committee had addressed
all of the "problems," and was "pretty close to having it
right." He added that he
looked forward "to doing something significant in a bipartisan way."

In
a press release posted on Chairman Leahy's website,
a transcript of the Chairman's remarks regarding patent reform at today's meeting was provided.

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