Patent Docs

Court Report

March 21, 2010

By Sherri
Oslick —

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

Cephalon, Inc. et al. v. Lupin Ltd. et al.
1:10-cv-00661; filed March 17, 2010 in the District
Court of Maryland

• Plaintiffs: Cephalon, Inc.; Cephalon France
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals,
Inc.

Cephalon Inc. et al. v. Lupin Ltd. et al.
1:10-cv-00210; filed March 16, 2010 in the District
Court of Delaware

• Plaintiffs: Cephalon Inc.; Cephalon France
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals
Inc.

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent Nos. RE37,516 ("Acetamide Derivative Having Defined Particle Size,"
issued January 15, 2002) and 7,132,570 ("Method for the Production of
Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7,
2006) following a Paragraph IV certification as part of Lupin's filing of an
ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used
to improve wakefulness in patients with excessive sleepiness associated with
obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep
disorder). View the Delaware complaint here.

Eli Lilly and Company et al. v. Synthon Pharmaceuticals, Inc.
1:10-cv-00310; filed March 15, 2010 in the Southern
District of Indiana

• Plaintiffs: Eli Lilly and Company; Icos Corp.
• Defendants: Synthon Pharmaceuticals, Inc.

Eli Lilly and Company, et al. v. Synthon Pharmaceuticals, Inc.
1:10-cv-00210; filed March 15, 2010 in the Middle
District of North Carolina

• Plaintiffs: Eli Lilly and Company; Icos
Corp.
• Defendants: Synthon Pharmaceuticals, Inc.

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent Nos. 6,821,975 ("Beta-Carboline Drug Products," issued
November 23, 2004) and 7,182,958 ("β-Carboline Pharmaceutical
Compositions," issued February 27, 2007) following a Paragraph IV
certification as part of Synthon's filing of an ANDA to manufacture a generic
version of Lilly's Adcirca® (tadalafil, used to treat pulmonary arterial
hypertension). View the Indiana
complaint here.

Pfizer Inc. et al. v. Alphapharm Pty Ltd. et al.
1:10-cv-00204; filed March 12, 2010 in the District
Court of Delaware

• Plaintiffs: Pfizer Inc.; Warner-Lambert Co.
LLC; CP Pharmaceuticals International CV; Northwestern University
• Defendants: Alphapharm Pty Ltd.; Mylan
Pharmaceuticals Inc.

Infringement of U.S. Patent No. 6,197,819 ("Gamma
Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001)
following a Paragraph IV certification as part of Alphapharm's filing of an
ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to
treat fibromyalgia). View the
complaint here.

Abbott Laboratories et al. v. Impax Laboratories, Inc.
2:10-cv-01322; filed March 12, 2010 in the District
Court of New Jersey

• Plaintiffs: Abbott Laboratories; Fournier
Laboratories Ireland Ltd.
• Defendant: Impax Laboratories, Inc.

Infringement of U.S. Patent No. 7,259,186 ("Salts
of Fenofibric Acid and Pharmaceutical Formulations Thereof," issued August 21, 2007)
following a Paragraph IV certification as part of Impax's filing of an ANDA to
manufacture a generic version of Abbott's Trilipix® (choline fenofibrate
delayedrelease, used to treat increased triglyceride levels). View the complaint here.

Bristol-Myers Squibb Co. et al. v. Teva Pharamceuticals USA,
Inc.
1:10-cv-00198; filed March 11, 2010 in the District
Court of Delaware

• Plaintiffs: Bristol-Myers Squibb Co.; Novartis
Corp.; Novartis Pharma AG
• Defendant: Teva Pharamceuticals USA, Inc.

Infringement of U.S. Patent Nos. 5,849,911 ("Antivirally
Active Heterocyclic Azahexane Derivatives," issued December 15, 1998) and
6,087,383 ("Bisulfate Salt of HIV Protease Inhibitor," issued July
11, 2000), both licensed to BMS, following a Paragraph IV certification as part
of Teva's filing of an ANDA to manufacture a generic version of BMS' Reyataz®
(atazanavir bisulfate, used to treat HIV infection). View the complaint here.
BIO International Convention

March 21, 2010

The
Biotechnology Industry Organization (BIO) will be holding its annual BIO
International Convention on May 3-6, 2010 in Chicago, IL. Founded in 1993, BIO is a nonprofit
association seeking supportive biotechnology policies on behalf of more than
1,200 biotechnology companies, state and international affiliates, and related
organizations, as well as providing business development services for many
emerging biotech companies.
According to BIO, the BIO International Convention serves to educate the
public and policymakers about biotechnology, while fostering partnering
meetings and other business development activities to keep the biotech industry
growing.

A
complete list of the Convention's 125 Breakout Sessions can be obtained here
and descriptions of the Convention's three Super Sessions can be obtained here. Among the sessions that might be of
particular interest to Patent Docs readers are:

May
3, 2010

•
Leveraging IP to Spur Global Biotechnology Innovation, Investment and Jobs
(Super Session) — 2:00 – 3:30 pm — featuring U.S. Patent & Trademark
Office Director David Kappos
•
IP Issues Affecting Biomarker-Based Diagnostics — 2:00 pm – 3:30 pm
•
Biotech: The New Normal? (Super Session) — 4:00 – 5:00 pm
•
Follow-on Biologics: The Proposed Legislation and Its Impact on Your Patent
Portfolio — 4:00 – 5:30 pm

May
4, 2010

•
Patenting Genes: In Search of Calmer Waters — 8:00 – 9:00 am
•
How Health Care and Patent Reform May Affect Pipeline Development for Drugs,
Biologics and Devices — 8:00 – 9:00 am
•
Keys to Successful Technology Transfer in the Current Economic Climate — 8:00
– 9:00 am
•
Global Patent Strategy: Perspectives Of International Patent Leaders — 9:30 –
10:30 am
•
Bayh-Dole Nearing 30: Have Universities Under-, Over- or Well-Utilized the Act?
— 9:30 – 10:30 am
•
Burrill State-of-the-Industry Report (Super Session) — 2:00 – 3:30 pm
•
What You Need to Know About ITC Section 337 Investigations — 2:00 – 3:30 pm
•
Patents for Personalized Medicine Products — Considerations and Pitfalls for
the Unwary — 4:00 – 5:30 pm

May
5, 2010

•
Does Pre-Packaging Patents and IP Make Them More Attractive to Potential
Licensees? — 8:00 – 9:30 am
•
Preparing for a New Era of FDA Enforcement — 8:00 – 9:30 am
•
Post-Quanta Legal Issues and
Licensing Strategies — 2:00 – 3:30 pm
•
The 111th Congress: What Happened in the 1st Session and What's to Come — 4:00
– 5:30 pm
•
An International Dilemma: Integrating Development and Social Policy Objectives
Into Global Patent Law Standards — 4:00 – 5:30 pm

May
6, 2010

•
IP in Tough Economic Times: Pitfalls and Opportunities — 8:00 – 9:30 am —
panel includes Patent Docs author
Donald Zuhn
•
Effective Acadamia and Industry Interactions: The Role of Patents in Attracting
Industry Interest in This Economy — 8:00 – 9:30 am — panel includes Dr. Maria
Fotaki of the European Patent Office
•
Open Innovation: A New Vision for Research for the Developing World — 2:00 –
3:30 pm

As
part of the Convention, more than 2,200 biotech companies, organizations, and
institutions will participate in the BIO Exhibition. A list of exhibitors can be found here. Information regarding registration and
pricing can be obtained here. Patent
Docs Donald Zuhn, Kevin Noonan, Sherri Oslick, and Chris Singer will be
attending BIO as part of the MBHB contingent, and will be reporting on a number
of the sessions listed above.
BIO IPCC Spring Conference

March 21, 2010

The Biotechnology
Industry Organization (BIO) will be holding its Intellectual Property Counsels
Committee (IPCC) Spring Conference & Meeting on April 19-21, 2010 in New
Orleans, LA. The semi-annual IPCC
conference will once again be open to the public.

The conference will
offer presentations on the following topics:

Tuesday, April 20:

• Patent
pools: Navigating a course for
access to biotechnology innovations;
• Having your cake
and eating it, too — Conflicts between inherency and infringement analyses for
drug metabolites;
• Health care
reform: On the front lines;
• Biosimilars
legislation: A done deal or a deal
undone? — Part 1: Regulatory
policy; and
• Biosimilars
legislation: A done deal or a deal
undone? — Part 2: Patent
enforcement.

Wednesday, April
21:

• Living on
borrowed time: Adjustment,
extension, and supplementary protection of patent term;
• Patenting
polynucleotides and polypeptides; and
• Case law updates
from the U.S. and around the world.

In addition, there
will be a welcome reception on Monday, April 19 from 5:00 pm to 8:30 pm at the
New Orleans Cooking Experience, and a French Quarter Foot Rally and dinner
reception at Restaurant August from 4:30 pm to 9:30 pm on Tuesday, April 20, where U.S. Patent and Trademark Office Administrator for External Affairs Arti
Rai will be the dinner speaker.

A program agenda
for this conference, including a list of speakers and descriptions of the
presentations and events can be obtained here.

The registration
fee for the conference is $400.
Those interested in registering can do so here or by faxing a registration form to
1-202-488-0650. Additional
information can be found at the conference website.
Conference & CLE Calendar

March 21, 2010

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
14, 2010 – "Obviousness
Standard for Patents
Post-KSR: Strategies to Withstand USPTO
Obviousness Rejections and
Attacks on Patent Validity" (Strafford) – 1:00
– 2:30 PM (EST)

April
19-21, 2010 – Intellectual
Property Counsels
Committee (IPCC) Spring Conference & Meeting (Biotechnology
Industry
Organization) – New
Orleans,
LA

April
23-24, 2010 – 12th
Comprehensive PCT Seminar (Franklin Pierce Law Center &
World Intellectual Property
Organization) – Concord,
NH

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

April
27-28, 2010 – Corporate
IP Counsel Summit (World
Research
Group) – 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

May
3-6, 2010 – 2010 BIO International Convention (Biotechnology
Industry Organization) – Chicago, IL

May
24-25,
2010 – Hatch-Waxman
Boot Camp*** (American
Conference
Institute) – San
Diego, CA

***Patent Docs is a media partner of this conference or CLE
Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. (Fed. Cir. 2010)

March 17, 2010

Federal Circuit Transfers "Hot Potato" Diagnostic Method Case

By Kevin E. Noonan —

The Federal Circuit's majority decision in Laboratory Corp. of America Holdings ("LabCorp") v. Metabolite Laboratories, Inc., and Judge Dyk's
dissent, illustrate how often factual considerations, and different views of
the same facts, can influence if not determine a legal outcome. Here, the issue was the Federal Circuit's
jurisdiction to hear an appeal on a patent and know-how license from the same
parties who went before the Supreme Court three years ago on a patent question
relating to diagnostic assays for vitamin deficiencies. The Supreme Court's non-decision left intact
the Federal Circuit's underlying affirmance of an infringement judgment by the Colorado District Court. This case concerned LabCorp's declaratory judgment suit over
whether it had breached its licensing agreement with Metabolite rather than
addressing patent infringment per se. And that basis, and how the different
members of the panel viewed it, was outcome-determinative for both the majority
opinion (written by Judge Gajarsa and joined by Judge Moore) as well as Judge
Dyk in dissent.

The lawsuit involved a dispute over the terms of
the judgment entered in the original patent infringement/breach of contract
case. The license between the
parties encompassed both the patent (U.S. Patent No. 4,940,658) as well as "know-how"
developed by Metabolite under a license from the patent owner, Competitive
Technologies Inc. (CTI). LabCorp
licensed the homocysteine-based assay recited in Claim 13 of the '658 patent
until 1998, when it began using a competing test sold by Abbott Laboratories. This action led to the first lawsuit,
filed by Metabolite and claiming patent infringement and breach of
contract. That action led to a
jury verdict of infringement in favor of CTI and breach of contract for
Metabolite. Significantly for the
present decision, the jury found by Special Verdict that the license from
Metabolite had been terminated. The
case then famously went before the Federal Circuit, where the judgment was
affirmed, and to the Supreme Court, which granted certiorari, heard argument, and then decided that certiorari had been improvidently granted, Justices
Breyer, Souter, and Stevens dissenting.

The action below was a declaratory judgment under
diversity jurisdiction under 28 U.S.C. § 1332, by LabCorp that it did not breach
the License Agreement by post-judgment activities, including outsourcing the
homocysteine assay to a third party company that had a non-exclusive license
from CTI (and thus raised no patent infringement issues). Metabolite filed a counterclaim for
breach of contract and other state law claims. The District Court held on summary judgment that there was
no breach of contract since the contract had been adjudged to be terminated by
the jury in the first Metabolite case. In response to Metabolite's appeal of this decision to
the Federal Circuit, LabCorp moved for the CAFC to transfer the appeal to the
Tenth Circuit, based on an asserted lack of jurisdiction. "The issue of this court's jurisdiction
over Metabolite's appeal is now squarely before [the court]," according
to the opinion.

The Federal Circuit's majority opinion, by Judge Gajarsa and
joined by Judge Moore, first addressed the question of its own
jurisdiction. While based on
specific statutory provisions (28 U.S.C §§ 1295(a)(1) and 1338), the CAFC
assessed its jurisdiction under the two-prong test enunciated by the Supreme Court
in Christianson v. Colt Industries Operating Corp., 486 U.S. 800 (1988):

Under Christianson, "arising under"
jurisdiction "extend[s] only to those cases in which a well-pleaded
complaint establishes either that federal patent law creates the cause of
action or that the plaintiff's right to relief necessarily depends on
resolution of a substantial question of federal patent law, in that patent law
is a necessary element of one of the well-pleaded claims." Christianson, 486 U.S. at 808-09.

This test was refined, according to the opinion, by
the Court's decision in Grable & Sons Metal Products, Inc.,
v. Darue Engineering & Manufacturing, 545 U.S. 308, 314 (2005), which "refined the
Christianson two-part test for § 1338 jurisdiction by requiring a determination
of whether 'a state-law claim necessarily raise[s] a stated federal issue,
actually disputed and substantial, which a federal forum may entertain without
disturbing any congressionally approved balance of federal and state judicial
responsibilities.'" Grable, 545
U.S. at 314. Turning to the
requirements of the well-pleaded complaint rule, the Court said that "arising
under" jurisdiction was determined "from the plaintiff's statement of
his or her own claim 'unaided by anything alleged in anticipation or avoidance
of defenses which it is thought the defendant may interpose,'" Christianson, 486 U.S. at 809, and that
the Court looked "'not to the declaratory judgment complaint, but to the
action that the declaratory defendant would have brought,'" citing Speedco, Inc. v. Estes, 853 F.2d 909, 912
(Fed. Cir. 1988) and Cedars-Sinai Med.
Ctr. v. Watkins, 11 F.3d 1573, 1578 (Fed. Cir. 1993).

Applying
this law to these facts, the majority held that Metabolite did not bear its
burden of "demonstrating that its hypothetical claim depends on resolution
of a substantial question of federal patent law,'" citing Christianson, 486 U.S. at 808-09. The "hypothetical" claim
Metabolite would have brought in response to LabCorp's declaratory judgment
complaint "would have been a breach of contract claim," according to
the Court, and in order to prevail Metabolite would be required to "prove
the elements of breach of contract cause of action under New Jersey law." Metabolite claimed that in order to
prevail on its breach of contract claim, it had to establish that it was
entitled to royalties, and this required evidence of patent infringement. The majority disagreed, based on
the determination of patent infringement in the first Metabolite case. There was no "disputed question of
patent law central to the disposition of the breach of contract claim." This requirement for a substantial
question of patent law to be in dispute for the Federal Circuit to have
jurisdiction is consistent with Supreme Court precedent according to the
majority, citing Christianson and Empire Healthchoice Assurance, Inc. v.
McVeigh, 547 U.S. 677, 689-90 (2006). This was not such a case, in the majority's opinion,
because the infringement question was not in dispute (having been finally
adjudicated in the first Metabolite case). Thus, "[b]ecause the issue of patent law is
not disputed and substantial, we do not have jurisdiction over this appeal,"
citing Grable, 545 U.S. at 314-15.

In dissent
Judge Dyk disagreed, characterizing the question as involving "whether the
res judicata" effect of the Federal Circuit's earlier Metabolite decision required
treating the contract provisions as having been terminated. Judge Dyk supported his view that the
case should not be transferred with two lines of reasoning. First, a suit to determine the res judicata
effects of a prior judgment "arising under" the patent laws is itself a suit that arises under
patent law in his view. Second, in
Judge Dyk's view, a necessary predicate of deciding the contract question
raised a substantial question of patent law, i.e., what activity regarding patented technology fell within the
scope of the license. The parties'
contentions directly disputed the scope of the prior judgment, with LabCorp contending
that the license was terminated by that judgment and Metabolite maintaining that
the judgment did not terminate the license. In this context, Judge Dyk believed that the question
of the scope of the earlier judgment directly affected the question before the Court, because of the necessity for a contractual obligation in order for there
to be damages for breach of that obligation.

Considering
the res judicata effect of the District Court's prior judgment certainly "arises
under" federal law; the question was whether it arose under federal patent
law. And the dissent maintained that
this question required the Court to consider whether it should "'look
through' the prior judgment to determine whether it [was] predicated on an
action that 'arises under' federal patent law." Citing Semtek Int'l
Inc. v. Lockheed Martin Corp., 531 U.S. 497, 507-08 (2001) and Vaden v. Discover Bank, 129 S. Ct. 1262
(2009), Judge Dyk contended that such a "look through approach" was
appropriate here, and that the result was the conclusion that the issue "arose
under" federal patent law. In the alternative, Judge Dyk contended that the issue between the
parties when the complaint was filed involved a contract that made a patent
issue "determinative" (the royalties under the contract being tied to
net sales of "licensed assays" falling within the scope of licensed
patent claims), analogizing the facts here with U.S. Valves, Inc. v. Dray, 212 F.3d 1368 (Fed. Cir. 2000). Timing is also critical: "[a]t
the time the complaint was filed in this case, there was a substantial,
disputed issue of patent law, because the issue of whether the outsourced
homocysteine assays were in fact covered by the '658 patent claims was
contested by LabCorp." According to Judge Dyk, the fact that the patent issue "became"
undisputed during the course of the lawsuit was not sufficient to deprive the Court of jurisdiction. "[L]ater
concessions (such as those ultimately made in this case that the outsourced
assays were licensed assays) do not operate to defeat jurisdiction that
rightfully attached at the outset of the case," citing a plethora of
Supreme Court precedent: Dole Food Co. v.
Patrickson, 538 U.S. 468, 478 (2003); St.
Paul Mercury Indemnity Co. v. Red Cab Co., 303 U.S. 283, 289-90 (1938); Minneapolis & St. Louis R.R. Co. v.
Peoria & Pekin Union Ry. Co., 270 U.S. 580, 586 (1926); Anderson v. Watt, 138 U.S. 694, 702-03
(1891); and Mollan v. Torrance, 22
U.S. (9 Wheat.) 537, 539 (1824).

One
immediate consequence of the transfer is a greatly reduced risk that this case
will make it back to the Supreme Court on a patent question. This is good news in view of the stance
of at least some of the Justices regarding the patent-eligibility of (in)famous
Claim 13 of the '658 patent (see "The Relevance of In re Bilski to the Patentability of the Metabolite Claim"). In any event, the
Supreme Court is said by some to be poised to issue its decision on Bilski v. Kappos, which has the
potential to address fundamentally the way the courts assess
patent-eligibility of method claims. In addition, the Supreme Court is expected to send the Prometheus Laboratories, Inc. v. Mayo Collaborative Services case back to the Federal Circuit for
reconsideration in view of its decision in Bilski. Thus, the ultimate question of whether
diagnostic method claims like Metabolite's Claim 13 are patent-eligible will likely take some time
to be decided, and as a consequence uncertainty on this question will persist,
to no one's benefit.

Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc. (Fed. Cir. 2010)
Panel: Circuit Judges Gajarsa, Dyk, and Moore
Opinion by Circuit Judge Gajarsa, dissenting opinion by Circuit Judge Dyk
VentureDeal Report Shows 65% Increase in Fourth Quarter Biotech Venture Funding

March 16, 2010

By
Donald Zuhn —

Earlier
today, VentureDeal, a venture capital database offering
information on U.S. technology startup companies, venture capital firms, and company
financings, released its latest quarterly venture capital funding reports covering
the fourth quarter of 2009. The
VentureDeal reports track venture capital funding in 15 technology-based
sectors, with separate reports focusing on alternative energy, clean tech,
energy, and environmental sectors; biotechnology, pharmaceutical, and medical
device sectors; internet, digital media, ecommerce, and software sectors; and
telecom, wireless, mobile, and communications sectors.

The
biotechnology, pharmaceutical, and medical devices report, which can be obtained here,
shows that the three sectors took in $1.9 billion in venture capital financing
during the fourth quarter of 2009.
According to the report, this represented virtually no change when
compared with the third quarter results. However, while medical device and pharmaceutical venture funding dropped
by 20% and 29%, respectively, in the fourth quarter, the report noted that
biotech funding increased a "whopping" 65% during the quarter,
reversing a previous downward trend.
In addition, the biotech sector saw a 19% increase in the number of
companies funded in the fourth quarter.
In particular, 69 biotech companies secured $871 million last
quarter. In contrast, 78 medical device companies secured $752 million and 45 pharmaceutical
companies secured $460 million during the fourth quarter.

As
for the other sectors monitored by VentureDeal, the alternative energy, clean tech,
energy, and environmental sectors took in $232 million among 33 companies in
the fourth quarter, which constituted a 45% decrease in funding and a 6%
decrease in companies being funded; the internet, digital media, ecommerce, and
software sectors secured $1.8 billion among 286 companies, which marked a 38%
increase in funding and a 25% increase in companies being funded; and the telecom,
wireless, mobile, and communications sectors took in $231 million among 49
companies, which constituted a 17% decrease in funding and a 14% increase in
companies being funded.

The
funding totals in the VentureDeal reports were similar to totals presented in the
latest National Venture Capital Association (NVCA) MoneyTree Report on venture
funding, which was released in January (see
"NVCA Report Shows Slight Drop in 4Q Venture Funding and Sharp Decline for
2009"). While the VentureDeal reports indicate
that 560 companies secured $4.16 billion during the fourth quarter, the
NCVA report showed that there were 794 deals involving $5.0 billion in the
fourth quarter. The differences
between the two reports with regard to total venture funding may be due to the
difference in the number of sectors each organization monitors, as VentureDeal examines 15
sectors and the NVCA looks at 16 sectors. As for biotech funding, the NVCA report indicated that there were 108
deals involving $1.0 billion during the fourth quarter.
Ajinomoto Co. v. International Trade Commission (Fed. Cir. 2010)

March 15, 2010

    By Suresh Pillai —

Last week, the Federal Circuit affirmed a
determination by the International Trade Commission ("ITC") that: (1)
the asserted claims of U.S. Patent Nos. 5,827,698 and
6,040,160 were invalid for failure to comply with the best mode requirement, and (2) the '698
patent was unenforceable due to inequitable conduct. Both the '698 patent and the '160 patent are directed to
improved methods of producing L-lysine through the use of E. coli bacteria that have been genetically engineered specifically
for the purpose of producing lysine at levels far above those found in nature. Specifically, the patents are directed to methods that disrupt the natural
feedback inhibition and lysine degradation pathways within E. coli. Claim 15 of
the '698 patent, rewritten to include the claim from which it depends, recites:

15. A method for producing L-lysine, comprising:
    (a) cultivating an isolated microorganism belonging to the genus Escherichia,
wherein the microorganism containing a [mutant lysine decarboxylase] in a
liquid medium, thereby producing the L-lysine and accumulating the L-lysine in
the liquid medium, and
    (b) collecting the L-lysine produced and accumulated in step (a), wherein the
microorganism belongs to the species Escherichia
coli.

Asserted claim 15 of the '160 patent, rewritten to
include the claim from which it depends, recites:

15. A
method of producing L-lysine, comprising:
cultivating a bacterium belonging [to] the genus Escherichia which is
transformed with a DNA coding for a dihydrodipicolinate synthase originating
from a bacterium belonging to the genus Escherichia and having mutation to
desensitize feedback inhibition of L-lysine, wherein the mutation is selected
from the group consisting of [a mutation to replace the alanine residue at the
81st position and/or a mutation to replace the histidine residue at
the 118th position] in a suitable culture medium, producing and
accumulating L-lysine in the culture thereof, and collecting L-lysine from the
culture.

The panel opinion notes that that both patents
disclose certain E. coli strains for
practicing the claimed inventions. In contrast to the specification of the '698 patent, however, the
inventors actually induced two other undisclosed additional genetic alterations
before the addition of mutant Idc. Similarly, in the '160 patent specification,
the inventors described two host strains (B-399 and W3110 (tyrA)); however, the
inventors neglected to include strain AE-70, a strain characterized by the
inventors prior to the filing of the priority Japanese application as "their
best lysine producer."

On April 25, 2006, Ajinomoto filed its complaint
with the ITC, alleging that Global Bio-Chem Technology Group Company,
Ltd., Chanchun Dacheng Bio-Chem Engineering Development Co., Ltd., Chanchun Baocheng Bio-Chem Development Co., Ltd., Chanchun Dahe
Bio-Technology Development Co., Ltd., and Bio-Chem Technology (HK) Limited ("defendants")
violated section 337 of the Tariff Act of 1930 as amended, 19 U.S.C. § 1337,
through defendants' importation and sale of certain lysine feed products made
according to the disclosed methods of the '160 and '698 patents. The ITC launched an investigation. Before trial, defendants admitted
infringement of the patents-in-suit. However, the ITC ALJ's ruling found that
the patents were invalid for multiple violations of 35 U.S.C. § 112's best mode
requirement. The ALJ also
concluded that both patents were unenforceable due to inequitable conducted
related to the § 112 violations.

Having first defined the scope of the claims to
have encompassed the overall production of lysine (beyond just the specific
disclosed genetic mutations), the ALJ concluded that the inventors had violated
the best mode requirement in their '698 application by:

(1) concealing
their preferred and only host strain, WC80-196S, via a misrepresentation of the
steps actually performed to create a mutant Idc
host strain; (2) concealing sucrose as their preferred carbon source, which
materially affects achieving the claimed invention; and (3) submitting data
associated with fictitious host strains in support of best mode.

With regard to the '160 patent, the ALJ
concluded that the inventors had (1) purposely concealed their preferred host
strain, AE-70; and (2) submitted fictitious data in support of their best
mode.

The ALJ then considered the inequitable conduct
issue and found that (1) the necessary materiality was established via the
inventors' best mode disclosure violations; and (2) the intent to deceive was
established through proof of the inventors' submission of fictitious data coupled
with their concealment of the best mode; and, with respect to the '698 patent,
(3) concealing the preferred carbon source. Ajinomoto petitioned the ITC for a review of the ALJ
decision, but the ITC took no position on the ALJ's finding. Ajinomoto then appealed to the Court of
Appeals for the Federal Circuit for review.

Writing for the majority, Judge Lourie cites to Teleflex, Inc. v. Ficosa N. Am. Corp.,
299 F.3d 1313, 1330 (Fed. Cir. 2002) for the proposition that the best mode
requirement "comprises part of the quid
pro quo of the patent grant, prohibiting inventors from receiving the
benefit of the right to exclude while at the same time concealing from the
public preferred embodiments of their inventions." Judge Lourie also stated that "in
order to satisfy the best mode requirement, an inventor must disclose the
preferred embodiment of the invention as well as preferences that materially
affect the properties of the invention." Bayer AG v. Schein
Pharm., Inc., 301 F.3d 1306, 1319 (Fed. Cir. 2002). Judge Lourie then reiterated the
two-prong inquiry for compliance with the best mode requirement. In the first "subjective"
prong, the court must determine "whether, at the time the patent
application was filed, the inventor possessed a best mode of practicing the
claimed invention." United States Gypsum Co. v. Nat'l Gypsum Co.,
74 F.3d 1209, 1212 (Fed. Cir. 1996). Judge Lourie noted the subjectiveness of the prong as it "focuses
on the inventor's own personal preferences as of the application's filing date." In the second "objective"
prong, if an inventor has a subjective preference for one mode over all others,
the court must determine whether the inventor "concealed" the
preferred mode from the public. Chemcast Corp. v. Arco Indus. Corp., 913
F.2d 923, 928 (Fed. Cir. 1990).

The Federal Circuit then addressed Ajinomoto's issues on
appeal: whether the ITC made
multiple legal errors in defining the scope of the claimed inventions and the
scope of the best mode requirement. As its first argument, Ajinomoto claimed that
the ITC erred in defining "best" in terms of "overall production
of lysine" rather than in terms of the claimed invention. Ajinomoto supported its position with
the argument that the ITC erroneously applied the best mode requirement to
areas beyond the patents' innovative aspects (the claimed genetic
mutations). Both the ITC and the defendants countered that the best mode requirement relates to the "claimed
invention, not just to its 'inventive aspects,' as claimed by Ajinomoto. The CAFC agreed with the
ITC/defendants' reasoning, concluding that nothing in Federal Circuit precedent
limits the best mode requirement to "vague 'innovative aspects' or 'inventive
features' of the invention." The Court also concluded that the ITC correctly included the obligation
of the inventors to include their preferred host strains as the best mode. The Court reasoned that the ITC's
definition of the method to include the host strains properly defined the scope
of the claimed invention to include "cultivating a bacterium."

Ajinomoto also argued that the ITC's interpretation
was erroneous because Ajinomoto's best mode obligations extended only to the
claimed Idc and dapA mutations, without which Ajinomoto could not exclude others
from cultivating lysine-producing strains. Central to Ajinomoto's position was its argument that
because the two mutations could be used in any E. coli strain, the
inventors had no obligation to disclose their preferred strain. In support of its position, Ajinomoto
cited to numerous cases where inventors were found not to have concealed the
best mode even where they had not disclosed their preferred embodiments. The Federal Circuit disagreed and
distinguished the cited cases from the current case on the grounds that, in all
of the cited cases, the asserted claims as construed did not cover the
embodiment alleged to have been concealed. The Federal Circuit reasoned that, as Ajinomoto's host
strain was "claimed rather than unclaimed subject matter," the
inventors' were under an obligation to disclose their preferred strain. The Court also stated that
Ajinomoto's claimed right to exclude competitors from practicing a method of
producing lysine using bacteria with the disclosed mutations also obligated
them to disclose the best bacterium for carrying out the invention, thereby
satisfying the "two-way street" of the best mode obligation.

Ajinomoto also argued that, even if the best mode
requirement did extend to disclosure of the preferred bacteria strains, the ITC
erred in its application of the requirement with respect to the '698
patent. Specifically, Ajinomoto
argued that the ITC erred in finding that the inventors were required to
disclose the host strain into which they inserted the Idc mutation. Ajinomoto also stressed that the inventors' deposit of a strain
containing the lysC variant and
disclosure of said deposit within the specification satisfied their
responsibilities under the best mode requirement. The ITC countered that the inventors "concealed the
only bacterial strain altered to contain the patented Idc mutation, and thus the only embodiment of the invention, by
failing to identify it in any way, either by name or by its method of creation." The Federal Circuit disagreed with
Ajinomoto, stating that the ITC opinion found that the inventors improperly
concealed the identity of the preferred host strain, not the method of creating
the host strain. The Court also
stated that the best mode requirement "cannot be satisfied by the deposit
of a non-preferred strain. The Court noted that the strain deposited by the inventors lacked the sucrose
utilization genes of the preferred embodiment and, therefore, was not the
strain that contained the Idc
mutation. The Federal Circuit conceded that
the deposited strain contained the lysC
variant; however the Court also concluded that this, in and of itself, was
insufficient to satisfy the best mode requirement. The Court reasoned that as the specification contained no
disclosure of the fact that the deposit contained the lysC variant, thereby precluding one having skill in the art from
knowing of the alteration, the deposit "failed to enable one of skill in
the art to practice the inventors' preferred embodiment and thus concealed the
best mode."

Ajinomoto's final argument addressed its position
that the ITC erred in invalidating claim 15 of the '160 patent. Ajinomoto stated that even if the
inventors concealed the best host strain as of the filing date of the 1993
Japanese application, the only result is that the Ajinomoto cannot rely on that
date for priority purposes under 35 U.S.C. § 120. Ajinomoto asserted that it could still claim
priority to the November 24, 1994 PCT filing date, thereby necessitating a
finding by the Court that the defendants had infringed the '160 patent, thereby
violating § 337. The ITC and
the defendants countered that Ajinomoto, by not raising the matter in its
pre-trial brief as required under the ALJ's stated ground rules, had waived its
right to rely on its PCT application's filing date. The ITC also argued that Ajinomoto's claim of priority from
the 1993 benefited Ajinomoto by concealing its best mode's priority date from
the public and limiting the prior art upon which the defendants could rely for
their invalidity defenses. The Federal Circuit
agreed with the ITC and the defendants, stating that "a patentee cannot,
as Ajinomoto attempts here, reverse a finding of invalidity by unveiling after
trial an alternative priority date on which it would now like to rely."

Ajinomoto Co. v. International Trade Commission
(Fed. Cir. 2010)
Panel: Circuit Judges Newman, Lourie, and Linn
Opinion by Circuit Judge Lourie
USPTO and UKIPO Announce Plan to Reduce Global Application Backlog

March 15, 2010

By
Sarah Fendrick —

The U.S. Patent and Trademark Office (USPTO) announced in a March
10,
2010 press release that it has joined forces with the UK Intellectual Property Office
(UKIPO) to develop a plan to reduce patent processing backlogs in both
offices. The joint effort is a
result of the hindrance the patent backlog is believed to have on the global
economy. Specifically, in a study
conducted by the London Economics, it was estimated that patent backlogs cost the global economy as much as $11.4 billion each year.

In the USPTO release, Under Secretary of Commerce for Intellectual Property and Director of
the USPTO David
Kappos commented that:

Every quality patent application that
sits on the shelf represents jobs not created. For that reason, the USPTO
has made reduction of the patent backlog our highest priority. At the USPTO,
we have already undertaken substantial reform of our system for processing
patent applications. Work-sharing is an important feature of this
reform. Thus far, however, our work-sharing efforts at the USPTO have
largely been applicant driven and therefore dependent on whether individual
applicants know about, and appreciate, the clear benefits of
work-sharing. So I am particularly delighted that we are today embracing
with the UK an office-driven mechanism for reutilization of work.

Each Office has
committed to developing plans to ensure the work product of patent applications
filed jointly at the USPTO and the UKIPO will be utilized for patent processing
in each office. The USPTO and
UKIPO will identify areas in which resuse of information can occur among the
two offices to increase efficiency and reduce backlog.
Court Report

March 14, 2010

By Sherri
Oslick —

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

Biovail Laboratories International SRL v. Paddock Laboratories,
Inc.
0:10-cv-00687; filed March 9, 2010 in the District
Court of Minnesota

Biovail Laboratories International SRL v. Paddock Laboratories
Inc.
1:10-cv-00185; filed March 8, 2010 in the District
Court of Delaware

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), 7,553,992 (same title, issued June 30, 2009), and 7,671,094 ("Bupropion
Hydrobromide and Therapeutic Applications," issued March 2, 2010)
following a Paragraph IV certification as part of Paddock'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.

Simonian v. Allergan, Inc.
1:10-cv-01544; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Allergan's marking of its Avage®,
Tazorac® cream, and Tazorac® gel products indicating that these products are
covered by U.S. Patent No. 5,089,509 ("Disubstituted Acetylenes Bearing
Heteroaromatic and Heterobicyclic Groups Having Retinoid Like Activity,"
issued February 18, 1992), marking of its Restasis® product indicating that
this product is covered by U.S. Patent No. 4,839,342 ("Method of
Increasing Tear Production by Topical Administration of Cyclosporin,"
issued July 13, 1989), and marking of its Zymar® product indicating that this
product is covered by U.S. Patent No. 4,980,470 ("8-alkoxyquinolonecarboxylic
Acids and Salts Thereof," issued December 25, 1990), all of which are
expired. View the complaint here.

Simonian v. Abbott Laboratories
1:10-cv-01542; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Abbott's marking of its
Ery-Tab® product indicating that this product is covered by U.S. Patent No.
4,340,582 ("Erythromycin Base Tablets," issued July 20, 1982) and
marking of its PCE® product indicating that this product is covered by U.S.
Patent No. 4,874,614 ("Pharmaceutical Tableting Method," issued
October 17, 1989), all of which are expired. View the complaint here.

Simonian v. Amgen, Inc.
1:10-cv-01540; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Amgen's marking of its
Neupogen® product indicating that this product is covered by U.S. Patent Nos.
4,810,643 ("Production of Pluriptent Granulocyte Colony-stimulating
Factor," issued March 7, 1989) and 4,999,291 (same title, issued March 12,
1991), which are expired. View the
complaint here.

Simonian v. Baxter Healthcare Corp.
1:10-cv-01547; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Baxter's marking of its
Advate® product indicating that this product is covered by U.S. Patent Nos. 4,757,006
("Human Factor VIII: C Gene and Recombinant Methods for Production,"
issued July 12, 1988) and 4,891,319
("Protection of Proteins and the Like," issued January 2, 1990),
marking of its Artiss®, Bebulin VH®, Feiba®, Floseal®, and Tisseel® products
indicating that these products are covered by U.S. Patent No. 4,640,834 ("Method
of Inactivating Reproducible Filterable Pathogens in Blood Products as Well as
a Method of Producing Blood Products," issued February 3, 1987) and
marking of its Bebulin VH® product indicating that this product is covered by
U.S. Patent No. 4,388,232 ("Method of Producing Plasma Fractions Free of
Side-effects Using Fast-reacting Antithrombin," issued June 14, 1983), all
of which are expired. View the
complaint here.

Simonian v. Astellas Pharma US, Inc.
1:10-cv-01539; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Astellas' marking of its
Amevive® product indicating that this product is covered by U.S. Patent No. 4,956,281
("Antifungal Carbinols," issued September 11, 1990), which is
expired. View the complaint here.

Teva Women's Health, Inc. v. Mylan Pharmaceuticals, Inc. et al.
2:10-cv-01234; filed March 9, 2010 in the District
Court of New Jersey

• Plaintiff: Teva Women's Health, Inc.
• Defendants: Mylan Pharmaceuticals, Inc.; Mylan
Inc.; Famy Care Ltd.

Infringement of U.S. Patent No. 7,615,545 ("Oral
Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology,"
issued November 10, 2009) following a Paragraph IV certification as part of
Mylan's filing of an ANDA to manufacture a generic version of Teva's
LoSeasonique® (ethinyl estradiol and levonorgestrel, used as oral
contraception). View the complaint here.

Teva Women's Health, Inc. v. Mylan Pharmaceuticals, Inc. et al.
2:10-cv-01235; filed March 9, 2010 in the District
Court of New Jersey

• Plaintiff: Teva Women's Health, Inc.
• Defendants: Mylan Pharmaceuticals, Inc.; Mylan
Inc.; Famy Care Ltd.

Infringement of U.S. Patent No. 7,320,969 ("Oral
Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology,"
issued January 22, 2008) following a Paragraph IV certification as part of
Mylan's filing of an ANDA to manufacture a generic version of Teva Women's
Health's Seasonique® (levonorgestrel/ethinyl estradiol, used as oral
contraception). View the complaint here.

Merck, Sharp & Dohme Corp. et al. v. Teva Pharmaceuticals
USA, Inc. et al.
1:10-cv-01851; filed March 9, 2010 in the Southern
District of New York

• Plaintiffs: Merck, Sharp & Dohme Corp.;
Bristol-Meyers Squibb Co.
• Defendants: Teva Pharmaceuticals USA, Inc.; Teva
Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent Nos. 6,639,071 ("Crystal
Forms of
(-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one,"
issued October 28, 2003) and 6,939,964 (same title, issued September 6, 2005)
following Paragraph IV certifications as part of Teva's filing of ANDAs to
manufacture generic versions of Gilead's Atripla® (efavirenz, emtricitabine,
and tenofovir disoproxil, used for the treatment of HIV-1 infection)
products. View the complaint here.

Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Kappos
1:10-cv-00370; filed March 5, 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.
7,585,845 ("Hepatitis C Inhibitor Compound," issued September 8,
2009). View the complaint here.

Gilead Sciences, Inc., et al. v. Teva Pharmaceuticals
Industries Ltd. et al.
1:10-cv-01798; filed March 5, 2010 in the Southern
District of New York

• Plaintiffs: Gilead Sciences, Inc.; Emory
University
• Defendants: Teva Pharmaceuticals Industries
Ltd.; Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 5,814,639 ("Method
for the Synthesis, Compositions, and Use of 2'-Deoxy-5-Fluoro-3'-Thiacytidine
and Related Compounds," issued September 29, 1998) and 5,914,331 ("Antiviral
Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane,"
issued June 22, 1999) following Paragraph IV certifications as part of Teva's
filing of ANDAs to manufacture generic versions of Gilead's Truveda®
(emtricitabine and tenofovir disoproxil fumarate, used for the treatment of
HIV-1 infection) and Gilead's Atripla® (efavirenz, emtricitabine, and
tenofovir disoproxil, used for the treatment of HIV-1 infection) products. View the complaint here.

Gilead Sciences, Inc., v. Teva Pharmaceuticals USA, Inc. et al.
1:10-cv-01796; filed March 5, 2010 in the Southern
District of New York

• Plaintiffs: Gilead Sciences, Inc.
• Defendants: Teva Pharmaceuticals USA, Inc.; Teva
Pharmaceuticals Industries Ltd.

Infringement of U.S. Patent Nos. 5,922,695 ("Antiviral
Phosphonomethoxy Nucleotide Analogs Having Increased Oral Bioavailability,
issued July 13, 1999), 5,935,946 ("Nucleotide Analog Composition and
Synthesis Method," issued August 10, 1999), 5,977,089 ("Antiviral
Phosphonomethoxy Nucleotide Analogs Having Increased Oral Bioavailability,
issued November 2, 1999), and 6,043,230 (same title, issued March 28, 2000),
following Paragraph IV certifications as part of Teva's filing of ANDAs to
manufacture generic versions of Gilead's Viread® (tenofovir disoproxil
fumarate, used for the treatment of HIV-1 infection), Gilead's Truveda®
(emtricitabine and tenofovir disoproxil fumarate, used for the treatment of
HIV-1 infection), and Gilead's Atripla® (efavirenz, emtricitabine, and
tenofovir disoproxil, used for the treatment of HIV-1 infection) products. View the complaint here.

Endo Pharmaceuticals Inc. et al. v. Watson Pharmaceuticals, Inc.
et al.
2:10-cv-01242; filed March 4, 2010 in the District
Court of New Jersey

• Plaintiffs: Endo Pharmaceuticals Inc.; Penwest
Pharmaceuticals Co.
• Defendants: Watson Pharmaceuticals, Inc.; Watson
Laboratories, Inc.; Watson Pharma, Inc.

Infringement of U.S. Patent Nos. 5,662,933 ("Controlled
Release Formulation (Albuterol)," issued September 2, 1997) and 5,958,456
(same title, issued September 28, 1999) following a Paragraph IV certification
as part of Watson's filing of an ANDA to manufacture a generic version of Endo's
Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in
patients requiring continuous, around-the-clock opioid treatment for an
extended period of time). View the
complaint here.

Merck Serono S.A. v. Kappos
1:10-cv-00348; filed March 3, 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.
7,585,840 ("Use of Osteoprotegerin for the Treatment and/or Prevention of
Fibrotic Disease," issued September 8, 2009). View the complaint here.
Conference & CLE Calendar

March 14, 2010

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
14, 2010 – "Obviousness
Standard for Patents
Post-KSR: Strategies to Withstand USPTO
Obviousness Rejections and
Attacks on Patent Validity" (Strafford) – 1:00
– 2:30 PM (EST)

April
23-24, 2010 – 12th
Comprehensive PCT Seminar (Franklin Pierce Law Center &
World Intellectual Property
Organization) – Concord,
NH

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

April
27-28, 2010 – Corporate
IP Counsel Summit (World
Research
Group) – 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

May
24-25,
2010 – Hatch-Waxman
Boot Camp*** (American
Conference
Institute) – San
Diego, CA

***Patent Docs is a media partner of this conference or CLE

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