Patent Docs

Webinar on Double Patenting

March 1, 2013

Strafford will be offering a webinar/teleconference
entitled "Double Patenting:
Defeating Rejections and Avoiding Terminal Disclaimers" on April 4,
2013 from 1:00 – 2:30 pm (EDT). Thomas
L. Irving of Finnegan Henderson Farabow Garrett & Dunner and Donna M.
Meuth, Senior Patent Counsel, Intellectual Property at Eisai will provide
guidance to IP counsel for understanding B delay possibilities and double
patenting, and offer best practices to defeat double patenting rejections and
avoid terminal disclaimers. The panel
will review the following questions:

• What is the scope of double patenting?
• What is the examiner's duty for rejecting double patents?
• What steps can be taken to defeat double patenting rejections?
• What best practices can be employed to avoid terminal disclaimers?

The registration fee for the webinar is $297 ($362
for registration and CLE processing). Those
registering by March 8, 2013 will receive a $50 discount. Those interested in registering for the webinar,
can do so here.
29th Annual Joint Patent Practice Seminar

March 1, 2013

The Connecticut, New Jersey, New York, and
Philadelphia Intellectual Property Law Associations will be holding their 29th
Annual Joint Patent Practice Seminar on April 16, 2013 in New York, NY. The seminar will consist of five panels: USPTO Practice, Pharmaceuticals/Life Sciences,
Licensing/Foreign Practice/ITC, Ethics, and Litigation with each panel
addressing a series of cases and topics.
An agenda for each of the panels can be found here.

A featured morning address will be given
between 8:54 and 9:35 am by Teresa Stanek Rea, Acting Under Secretary of
Commerce for Intellectual Property and Acting Director of the U.S. Patent and
Trademark Office. In addition, Janet
Gongola, USPTO Patent Reform Coordinator and Associate Commissioner for Patent
Examination Policy, will present a USPTO Viewpoint on Third Party Submissions
during the USPTO Practice panel.

The registration fee for the conference is $450
(for those registering by April 3, 2013) or $480 (for those registering after
April 3, 2013). Those interested in
registering for the conference can do so here.
China IP Conference

March 1, 2013

American Conference Institute (ACI) will be
holding its 5th Advanced China IP Counsel Forum on April 15-16, 2013 in Shanghai,
China. ACI faculty will offer
presentations on the following topics:

• IP strategy discussion: Inside the year's
top China IP cases and what they mean for your IP corporate strategy;
• Preparing for the impact of the 4th patent
law amendment: What to expect from SIPO and China court new enforcement
authority and tools;
• Invention remuneration: How companies are
upgrading their remuneration practice and managing related risks and
administrative burden;
• The view from China Supreme Court bench on
current China IPR environment — keynote address by Li Zhu, Judge, Supreme
People's Court (Beijing);
• How to prevent becoming the victim of bad
faith utility model patents and how utility model patents may help you;
• When a Chinese company brings litigation: Best
practices in the art of IP defense;
• Maximizing the value of your IP: Subsidies,
tax, and fund benefits;
• Developing a proactive China IP strategy: Corporate
perspective on how to restructure your IP portfolio in the current litigation
environment;
• Developing your company's trade secret heat map:
Improving your trade secret protection through lessons of trade secret
litigations cases;
• How to adjust your company strategy under the
5th Anti-trust Law Guideline; and
• How SAC's new rules and procedures under
draft national standards involving patents will affect the treatment of patent
rights in the context of national standards.

Two post-conference working groups will be
offered on April 17, 2013. The first
working group, entitled "Mitigating the Risks and Challenges of Technology Third Party
Arrangements," will be held from 9:00 to 12:30, and the second, entitled "Understanding the Essential
IP & Regulatory Framework for Operating Successful and Compliant R&D
Centers in China," will be held from 13:30 to 17:00.

An agenda for the conference can be found here, and a complete
brochure for this conference, including an agenda, detailed descriptions of
conference sessions, list of speakers, and registration form can be obtained
here.

The registration fee is US $2,295 (conference
alone), US $2,895 (conference and one working group), or $3,495 (conference and
both working groups). Those registering
by March 15, 2013 will receive a $200 discount.
Those interested in registering for the conference can do so here,
by e-mailing CustomerService@AmericanConference.com, by calling 416-926-8200
(in the U.S.) or 44 20 7878 6888 (in Europe), or by faxing a registration form
to 416-927-1563.
In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)

February 28, 2013

By
Andrew Williams —

On
the first day of February, the Federal Circuit rejected Impax's efforts to get
out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride
Extended-Release Capsule Patent Litigation. The opinion wasn't released until February 14, 2013, however, because it
contained confidential information that needed to be redacted. The Federal Circuit also interpreted the
settlement agreement between Impax and Cephalon (the patent holder), confirming
the lower court's decision that the ability of Impax to begin selling
generic AMRIX® under the agreement had not been triggered. As a result, the discussion regarding the
preliminary injunction was somewhat irrelevant, because Impax was otherwise
precluded from marketing the drug. The decision
in this Eurand, Inc. v. Impax Labs., Inc.
case is somewhat limited to the facts, because the injunction and settlement
agreement discussed by the Court were specific to this case. Nevertheless, a review of the Court's
reasoning and analysis is relevant because other parties involved in
Hatch-Waxman litigation may find themselves in similar situations.

This
substantive issues related to validity for this case were discussed in detail
in a Federal Circuit opinion of the same name that was handed down last year,
as reported here. The drug that was at issue in all of these cases
was an extended-release formation of the muscle relaxant cyclobenzaprine
hydrochloride, manufactured and sold under the tradename AMRIX® by
Cephalon. Shortly after receiving the
NDA for this formation, Mylan Inc. and Mylan Pharmaceuticals, Inc. (collectively
"Mylan") filed an ANDA to market a generic version of the drug,
followed shortly by several other generic manufactures, including Impax. The Federal Circuit ultimately found that the
patents-at-issue in the case were valid and infringed by the various parties.

Nevertheless,
Cephalon and Impax settled their dispute on the last day of trial. In the settlement agreement, Cephalon granted
Impax a non-exclusive license to the patents-in-suit, the timing of which was
controlled by five different potential triggering events, the first (and
latest) of which was the date one year prior to the expiration of one of the patents
in suit. The other events were tied to "Third-Party"
generic manufacturers entering the market, whether by authorization, by
launching "at risk," or by obtaining a final non-appealable judgment
of non-infringement, invalidity, or unenforceability. The parties also entered a "Transfer
Price Agreement" ("TPA"), by which Impax agreed to market and
sell Cephalon's generic AMRIX®, and Cephalon began supplying its generic
product to Impax.

Cephalon
also entered a "Sales Agent Agreement" with another generic
manufacturer, Watson. However, under
this agreement, Watson was only given authority to solicit orders for
Cephalon. In fact, Cephalon maintained
title of the drugs at all times until the drugs were transferred to the final
customer. Watson was foreclosed under
the agreement to market or sell any other version of the drug.

After
the bench trial, on May 12, 2011, the District Court issued its decision,
finding the asserted claim invalid as obvious. Mylan launched "at-risk" the next day. In response, Cephalon instructed Watson to
begin soliciting orders. On May 24,
2011, the District Court enjoined both parties, along with all persons "acting
in active concert or participation" with them, from selling their
respective generic versions of the drug, in order to maintain the status quo
pending appeal. On November 7, 2011,
Mylan asked the lower court to confirm that the injunction covered parties in privity
with Cephalon, because Mylan had become aware that other generic manufacturers
were planning to launch at the end of the 180-day marketing exclusivity
period. As a result, the District Court
clarified its injunction by explicitly referencing that Impax was subject to
the injunction. Incidentally, because
the lower court issued its May 2011 injunction after Mylan launched, Mylan lost
almost all of its exclusivity period. This may have been a more contentious point, but for the fact that the Federal
Circuit overturned the lower court's validity decision.

Impax
moved to modify both the May and November 2011, injunctions, and to enforce
the settlement agreement by clarifying that Watson's launch was a triggering
event for its own ability to enter the market. The lower court confirmed that the May 24 injunction, as clarified by
the November 8 order, was still in effect and that it prohibited Impax from
selling any generic product. It also
concluded that Cephalon's use of Watson as a sales agent did not trigger Impax's
right to begin selling its supply of Cephalon's drugs under the settlement
agreement. Impax appealed.

No
Jurisdiction to Review Injunction

The
Federal Circuit determined that Impax was subject to the May 2011 injunction,
and that because Impax did not object to that injunction within the requisite
30 days, it did not have jurisdiction to review the propriety of the
order. The May 24, 2011 injunction
prevented Mylan, Cephalon, and all persons "acting in active concert or
participation" with these parties, from selling a generic version of
AMRIX®. Impax had argued that it was not
subject to this injunction because it was not a party to the action when the District Court issued the injunction. The Federal
Circuit pointed out, however, that Impax was a party that was "acting in
active concert or participation" with Cephalon. Impax derived its right to sell generic
AMRIX® from the Cephalon-Impax Agreement, and it could have only entered the
market because of the settlement agreement. Therefore, there was privity of contract between Impax and Cephalon,
because a settlement agreement is akin to a contract. Also, if Impax had attempted to sell the
authorized generic product pursuant to the TPA, it would have been directly "acting
in concert" with Cephalon. As the
Court pointed out, any alternative result would have allowed Cephalon to
circumvent the injunction by funneling its generic product to Impax.

Impax
also contended that the District Court's November 8, 2011 order modified the
May 24, 2011 injunction, and its appeal of this modification was timely. However, because Impax was subject to the
earlier injunction, the Federal Circuit pointed out that the District Court's
clarification made no substantive changes. Therefore, the November 8, 2011 order did not give rise to an
independent right to appeal.

In
a final attempt to modify the injunction, Impax argued that it timely appealed
the District Court's denial of its attempt to prospectively seek modification
of the injunction. The Federal Circuit agreed
that it would have had jurisdiction over a modification of an injunction, or
denial thereof, citing 28 U.S.C. § 1292(a)(1). However, such review would be limited to the propriety of the denial,
not the underlying injunction. The Court
rejected Impax's assertions that the circumstances had changed since the May
24, 2011 order was issued. First, Impax
asserted that it had been just recently added to the injunction, but the Federal
Circuit had already addressed this issue. Second, Impax alleged that the injunction needed to be modified because
Mylan's exclusivity period had expired. However,
the length of this exclusivity period was known at the time of the original
injunction, and therefore the predicted end of this period had no bearing on
Impax's rights. Finally, Impax argued
that its receipt of authorized generic product from Cephalon somehow warranted
modification of the injunction. However,
the May 24, 2011 order prohibited sale of these products, and Impax had
received them months before it sought to modify the order. Therefore, the Court did not consider this to
be a "changed circumstance." As a result, the Federal Circuit found no support for a modification of
the injunction.

Cephlon's
Appointment of Watson as Sale Agent Was Not A Trigger Event Under The Contract

The
Federal Circuit also addressed Impax's challenge to the lower court's
interpretation of the settlement agreement. On its face, the Federal Circuit's decision should not extend beyond the
contract between Cephalon and Impax. However, because Court reasoning is applicable to the interpretation of
other settlement agreements, it is worth reviewing. Interestingly, for the present, this aspect
of the decision appears to be irrelevant, because according to the District Court's docket, Impax is still subject to the preliminary injunction (and
therefore couldn't sell any drugs anyway). In other words, regardless of whether an event had triggered Impax's
ability to sell generic AMRIX® under the settlement agreement, Impax was still
barred from launching until the District Court lifts the injunction.

The
relevant section of the settlement agreement is Section 3.2, in which five
different "triggering events" dictate when Impax can enter the
generic market. The "trigger"
in dispute is the third, which provides that Impax may enter the market on:

[T]he same entry
date that any Third Party which is not entitled to First to File Exclusivity is
licensed or authorized by [Cephalon] to begin selling Generic Equivalent
Product in the Territory.

Impax
alleged that Watson was such a "Third Party," but the Court
disagreed. A "Third Party" was
defined in the agreement as a party that is not Anesta, Eurand, Cephalon,
Impax, nor any of their affiliates. As
such, Cephalon's entry into the market was not defined to be a triggering
event. And, because Watson was no more
than a sales agent for Cephalon, Watson was
Cephalon based on the agreement.

Important
in this determination was the fact that Cephalon was merely using Watson's
expertise and distribution channels. Watson had not filed its own ANDA to the product. In fact, Watson was only soliciting orders,
and was required to notify potential customers that it was only Cephalon's
sales agent. Moreover, Cephalon retained
the right to set price floors, and retained title until the drugs were
transferred to the customer. Because
Watson never obtained title to the product, it could not "sell" the
generic drugs within the meaning of § 3.2(c). The Court pointed out that if Watson was, in fact, characterized as a "Third
Party," it would have meant that Cephalon would have needed to operate the
entire production and distribution chain of its own generic product to avoid
triggering Impax's ability to launch. Otherwise, any party that would have aided Cephalon would have been
considered a "Third Party." The Court pointed out that this was a nonsensical result.

The
Federal Circuit concluded by noting that this provision in the settlement
agreement was meant to act as a "most favored nation" clause. In other words, it was protection for Impax
from losing market share from other generic manufacturer, whether they were
authorized or whether they launched at risk. This should serve as a warning to any generic company (or branded
pharmaceutical company for that matter) to make sure any equivalent situations
are properly addressed in any settlement agreements — otherwise a similar
outcome is almost guaranteed.

In
re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation
(Fed. Cir. 2013)
Panel:
Circuit Judges Newman, O'Malley, and Reyna
Opinion
by Circuit Judge O'Malley
Par/Paddock Answers FTC Before Supreme Court

February 27, 2013

By Kevin E. Noonan —

Par/Paddock,
one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement
case now before the Supreme Court) filed its reponsive brief last week. In it, the generic drug company not only
answers the FTC's charges of non-competitive behavior but also exposes the
shadings of the nuances of truth behind the Commission's position and
illustrates the "change" in philosophy on competitiveness occasioned
by the Obama Administration.

The
brief makes several important points. These include what may be most relevant to the question before the
Court, that the "problems" caused by reverse payment settlement
agreements are largely historical and were corrected by the passage of the
Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA),
which included forfeiture provisions of the 180 exclusivity period for a first
ANDA filer who enters into a reverse payment settlement agreement. The predicted consequence of passage of the
law has ensued, i.e., the number of
reverse payment settlement agreements has declined from a high of 50% to 18%
(adjusted to exclude agreements wherein an innovator drug company agreed not to
market an authorized generic version of the branded drug).

The
brief also argues that the Court has never found an antitrust violation for
exercise of a patent that was not somehow a sham. The brief asserts that antitrust law is
intended to proscribe behavior not compel it, and is not empowered to force
private companies to "pursue the course that maximizes competition and
consumer welfare" as asserted in the FTC's brief. Finally, the brief contends that as to
Par/Paddock, its behavior was compelled by a restraining order by the District Court and thus it is immune from antitrust liability under the Noerr-Pennington doctrine and,
regardless, as the second ANDA filer under "pre-MMA rules" it could
not have entered the market before the date agreed upon by the parties.

The
brief begins with an explication of the provisions of the Hatch-Waxman Act and
the perceived deficiencies in the law that provoked Congress (at the FTC's
behest and upon its recommendations) to enact the MMA in 2003. Resorting to traditional antitrust principles, the brief rejects the "quick look" rule of reason analysis promoted
by the FTC and argues that the "default analysis" is the rule of
reason which starts, in a patent case, with an assessment of whether the
purported "restraint" on trade is within the scope of the
patent. The brief notes that even for
patents produced by fraud, or in suits that are objectively baseless, all other
provisions of Sections 1 and 2 of the Sherman Act must be established, i.e.,
patent shenanigans of even this egregious nature are not enough per se to amount to an antitrust
violation. The brief contrasts this with the FTC's position that "a
reverse payment patent-settlement alone establishes a presumptive antitrust
violation," illustrating (and not for the last time) the unreasonableness
of the FTC's stance.

Moreover,
the brief criticizes the primary legal basis for the FTC's argument — Prof'l
Real Estate Investors v. Columbia Pictures (PRE), 508 U.S. 49,
60-61 (1993) — for being a case that did not
involve a patent, and asserts that the FTC has ignored the legitimate
exclusionary rights of the patentee in considering reverse payment settlement
agreements to be "horizontal" restraints on trade. This presumption is valid if and only if the "winning"
side in ANDA litigation can be predicted, something contrary to the FTC's own
Guidelines for IP licensing and that the Commission admits to being "doctrinally
anomalous and likely unworkable in practice." (And yet, of course, such a
prediction, more akin to a presumption, that any reverse payment settlement
agreement involves a "bad" patent is the philosophical root for the
Commission's anti-reverse payment crusade.) The brief further notes the
Commission's departure from the accepted practice of looking at the nature of
the restraints, rather than the amount of consideration underlying the
agreements, when assessing an agreement for antitrust purposes, as well as the
propensity for the FTC's position to encourage (actually, force) ANDA litigants
to litigate to a final judgment and the consequences of such a requirement.

The
brief notes the anomaly of using antitrust law to coerce "parties
'to pursue the course that maximizes competition and consumer welfare accords
with basic antitrust norms'" in the face of copious precedent that private
parties "are free to choose the parties with whom they will deal, as well
as the prices, terms, and conditions of that dealing," citing Pac. Bell
Tel. v. Linkline Commc'ns, 555 U.S. 438, 448 (2009) (citing United
States v. Colgate, 250 U.S. 300, 307 (1919)), and noting the
sentiment that "'[c]ourts are ill suited 'to act as central planners,
identifying the proper price, quantity, and other terms of dealing.'" Finally in its argument regarding antitrust
law, Par/Paddock's brief discusses the three cases where the Court reviewed the
"quick look" rule of reason analysis prior to rejecting it in California
Dental Ass'n v. FTC, 526 U.S. 756, 781 (1999), and finding in no
instance that the Court had approved of this standard.

Turning to the FTC's approach to patent
law the brief finds similar deficiencies. Most outrageous is the FTC's position that patent law does not confer a
right to exclude, but rather the right to try
to exclude, in a "probabilistic" manner. The brief reminds the Court that it "recently
rejected a similar challenge to the statutory presumption of patent validity"
in the Microsoft v. i4i case, 131
S. Ct. 2238 (2011), where the Court expressly rejected the FTC's position that
invalidity should be capable of being established by a preponderance of the
evidence. The brief also highlights the
FTC's argument that the scope of the patent test is inappropriate because it "allows
the patentee to purchase the same period of exclusivity that a successful infringement
suit would produce, even if all would concede that the patentee had
little likelihood of prevailing in the infringement litigation" (emphasis in original). But the brief contends that the Commission
provides no avenue for establishing "this Greek chorus of agreement"
on the likelihood vel non of a patent
being upheld successfully.

Finally, the brief speaks to the
Commission's position that reverse-payment settlement agreements somehow "frustrate
the purposes of the Hatch-Waxman Amendments," in the context of the Hatch-Waxman
Act containing no provisions intended to "change the outcomes of
pharmaceutical patent litigation." In this regard the brief argues that the FTC ignores the very changes in
Hatch-Waxman (effectuated by the MMA) that it promoted before Congress in
assisting in getting the provisions of the MMA involving reverse-payment
settlement agreements passed in 2003. And
the brief notes that there are bills now before Congress that "propose[]
the very standard the FTC seeks here," citing S. 214.

Finally, the brief notes the change in
position by the FTC with regard to the illegality (presumptive or otherwise) of
reverse payment settlement agreements in ANDA litigation, something that
Par/Paddock contends "warrants special mention." In so doing, the brief reminds the Court that
the government took exactly the opposite position with regard to the
reverse-payment settlement agreement in Schering-Plough Corp. v. FTC,
402 F.3d 1056 (CA11 2005). The brief
contends that, in view of the positions taken in the Schering-Plough case, "[t]he United States' new position is
entitled to little deference," citing colloquy from Chief Justice Roberts
in the oral argument for Kiobel v. Royal Dutch Petroleum, No.10-1491 (Oct. 1, 2012).

The brief then sets forth several
propositions that it contends are not disputed:

1. This is a pre-MMA case and,
therefore, is not governed by current Hatch-Waxman law.

2. Paddock copied AndroGel® unaware
of any patent because under the old Patent Act, Solvay's patent application was
not public.

3. Par/Paddock could not have
obtained an earlier settlement-entry date even absent any alleged
reverse-payment.

4. The FTC does not allege that
Par/Paddock were aware that Solvay planned to introduce a new AndroGel® version
in 2015.

5. Respondents settled under
Eleventh Circuit precedent.

6. The District Court's Consent
Judgment and Order of Permanent Injunction binds Solvay and Par/Paddock and
restrains Par/Paddock's generic entry until 2015.

7. After the Eleventh Circuit
affirmed dismissal, the Third Circuit decided K-Dur.

(With regard
to the last point, the brief notes that the precedential basis for the 3rd
Circuit panel's decision, Edward Katzinger Co. v.
Chicago Metallic, 329 U.S. 394 (1947), was abrogated by Lear v.
Adkins, 395 U.S. 653 (1969), which overruled in part Automatic Radio v.
Hazeltine Research, 339 U.S. 827 (1950)).

Par/Paddock's
brief makes several important policy arguments. One argument is that "[o]ur
founders [] viewed patent rights as essential for the innovation that would
power our nation's free-market economy." Another is that "[t]he most basic right of any patentee is the
right to exclude others from using her property," citing 35 U.S.C.
§ 154(a)(1). Further, the brief argues
that to effectuate these rights, patentees are given the right to enter into "all
manner of licenses," citing Bement v. Nat'l Harrow, 186 U.S.
70, 91 (1902). The exclusion the FTC
objects to is in reality a well-considered societal decision: "[o]ur
nation early-on made the policy choice to accept exclusion in the
short-run for sake of promoting innovation and competition in the long run,
and, thereby, achieve hoped-for net gains for consumer welfare,"
citing Scott Paper v. Marcalus Mfg., 326 U.S. 249, 255
(1945). And this is a bargain that
benefits the people: "[e]xclusion is short-lived, while the public-benefit
is enduring: 'A suppression can endure but for the life of the patent, and the
disclosure he has made will enable all to enjoy the fruit of his genius,'"
the brief states, citing Heaton Peninsular v. Eureka Specialty,
77 F. 288, 294-295 (CA6 1896), quoted in Bement, 186 U.S. at 90. These effects of the patent right permit
patentees to act in ways that would otherwise violate the antitrust laws,
according to Par/Paddock, citing four such activities: "(i) territorial
market-allocation; (ii) field-of-use restrictions and customer-allocation;
(iii) output limitation; and (iv) refusals-to-deal." Taken together, these
arguments illustrate how far afield the FTC has gone in attempting to sacrifice
traditional patent rights on the altar of less expensive and more available
generic drugs.

These rights include the right under "settled
law" for a patentee to "reap the full reward of their time-limited
monopolies" by "enter[ing] into agreement[s] that restrain the
practice of the patent [] for the patent holder's financial benefit." The brief argues that this behavior is
permissible under the rubrics established by the Supreme Court in Standard
Oil (Indiana) v. United States, 283 U.S. 163, 171 (1931),
specifically "that (i) parties may settle patent-litigation without
antitrust liability as long as there were "legitimately conflicting
claims," (ii) such conflict turns on the nominal scope-of-the patent,
which is not second-guessed by inquiring whether infringement would have
been proven; [] and (iii) the financial terms and consideration of a settlement
are irrelevant." All of the circuit
courts of appeal ruling on reverse-payment settlement agreements except the 3rd Circuit in K-Dur have relied on these principles. And the brief distinguishes the five cases
cited by the FTC in support of the proposition that "this
Court has never suggested that the bundle of rights a patent provides to its
holder includes the right to share the patentee's monopoly profits to induce
potential competitors to abandon their efforts to
compete or stay out of the market altogether," on the grounds that the
Court has never adopted a rule requiring courts to appraise the financial
consideration that underlie "undisputable good faith patent litigation."

Finally, in its discussion of Walker Process fraud and its effect on
antitrust determinations, the brief argues that there is an "important
distinction between nominal and adjudicated scope" of patent claims, so
that the fact that a claim has been invalidated did not implicate antitrust
concerns provided that the suit was
not objectively baseless and the patent was not obtained by fraud. And the brief ends with an explication of the
effects of the Noerr-Pennington
doctrine in protecting a citizen's right to petition the government for redress
of grievances on the scope of Actavis' potential antitrust liability. This section of the brief also cites the Professional
Real Estate Investors case for the
proposition that a party's subjective views on litigation cannot be the "sole
basis for a presumptive antitrust violation." The FTC's liability theory has two
problems, according to the brief: "it incorrectly presumes that a payment
reflects the parties' shared subjective-litigation views; and, in any event, PRE
bars antitrust liability based solely on parties' subjective-litigation views." This assessment is wrong, inter alia, insofar as ANDA litigation
is "a highly artificial act of infringement" that imposes an "asymmetry
of risk" on the parties. And it
would also require that the parties "had a conscious
commitment to a common scheme designed to achieve an unlawful objective,"
citing Monsanto v. Spray-Rite,
465 U.S. 752, 758, 764 (1984) (emphasis in original).

The brief ends with a discussion of Par/Paddock's
inability to enter the marketplace earlier because it is governed by a prior
ANDA filer. "The FTC's complaint against Par/Paddock thus dangles by an
allegation of 'ample financial incentive' for continued-litigation when
Congress enacted the MMA's remedial changes precisely because such incentives
were lacking under pre-MMA law," they say, citing Mova Pharm. v. Shalala,
140 F.3d 1060, 1073 (CADC 1998). "Our
antitrust laws do not compel firms to litigate," according to the brief,
and this may provide the most cogent and simple basis for the Court to disagree
with the government on reverse-payment settlement agreements.
USPTO News Briefs

February 26, 2013

By Donald Zuhn —

USPTO Modifies PKI
Subscriber Agreement

On February 11, the U.S.
Patent and Trademark Office distributed a Patents Alert e-mail in which the
Office noted that the Public Key Infrastructure ("PKI") Subscriber
Agreement had been modified such that PKI certificate holders are strictly
prohibited from using Private PAIR to access any nonpublic patent application
or documents owned by another, absent specific authorization. In particular, the PKI Subscriber Agreement
states that:

Any inadvertent or other disclosure of
nonpublic documents shall in no way be construed as authorized access to such
documents. Disclosure of other’s nonpublic documents constitutes involuntary
unauthorized access and I understand that I must immediately destroy all such material
without dissemination to anyone else, retrieve and destroy any such material if
disseminated, notify the USPTO of the nature and extent of the unauthorized
use, and certify that I have destroyed such material, that I have not granted
rights to others to access such material, and that I will not otherwise make
use of such material.

The Agreement also states
that the Office may immediately revoke PKI certificates at any time without
prior notice if, inter alia, "there
is unauthorized use such as attempting or gaining access to nonpublic
information or inadvertently disclosed nonpublic information," a PKI
holder "use[s] Private PAIR to view another applicant's unpublished application
without authorization," or the PKI holder "refuse[s] to destroy,
cease dissemination, and/or retrieve any dissemination of any inadvertently
disclosed or other nonpublic documents."

The Office's e-mail
indicated that continued use of the system following the posting of the notice constituted
agreement to the updated terms. The new
version of the PKI Subscriber Agreement can be found here.

The changes in the PKI
Subscriber Agreement are likely related to an issue with the Private PAIR system
between September 15-19, 2012. In
response, the USPTO issued Notices of Erroneous Access to Certain Patent
Application Information Between September 15 and
September 19, 2012 to applicants whose applications were erroneously
accessed. The Notices stated, in part:

Between September 15, 2012 and September 19,
2012, registered users of the Private Patent Application Information Retrieval
(PAIR) system were able to access certain data regarding unpublished applications
other than their own. This unauthorized
access was caused by a software error that was corrected on September 19, 2012,
the day it was detected. The United
States Patent and Trademark Office (USPTO) immediately fixed the problem,
quickly identified and addressed its root cause, and is putting measures in
place to prevent future occurrences and notifying the affected applicants. The USPTO takes the security of our IT
systems very seriously, and this letter reports the results of our ongoing
investigation.

USPTO Upgrades to PPH 2.0 with
KIPO and INPI-PT

In February 2012, the U.S.
Patent and Trademark Office implemented a new version of the enhanced Patent
Prosecution Highway (PPH) pilot program known as PPH MOTTAINAI. Under the new version of the PPH MOTTAINAI
program — known as PPH 2.0 — the European Patent Office (EPO) joined the
original seven MOTTAINAI offices — the USPTO, Canadian Intellectual Property
Office (CIPO), Japan Patent Office (JPO), IP Australia (IPAU), National Board
of Patents and Registration of Finland (NBPR), Federal Service on Intellectual
Property, Patents & Trademarks of Russia (Rospatent), Spanish Patent and
Trademark Office (SPTO), and United Kingdom Intellectual Property Office
(UKIPO) — to bring the total number of participating offices at that time to
nine.

On February 12, the USPTO
announced that the Office had implemented PPH 2.0 programs with both the Korean
Intellectual Property Office (KIPO) and the Portugal National Institute of Industrial
Property (INPI-PT), with each program commencing on January 29. The PPH 2.0 program with KIPO supersedes the
prior PPH program with that office, but does not affect the USPTO-KIPO PCT-PPH
program.

In order to participate in any
of the PPH 2.0 programs in the USPTO, applicants must satisfy the following
requirements:

1. One of the other
PPH 2.0 participating offices has determined that at least one claim is
allowable/patentable (under the PPH 2.0 program, applicants no longer need to
submit a copy of the allowed claim or any English translation thereof).

2. The application
before the PPH 2.0 participating office (i.e., containing the
allowable/patentable claim) and the U.S. application for which participation in
the PPH 2.0 program is being requested must have the same priority/filing date
(the Annex to the USPTO's notice on the PPH 2.0 program provides fifteen
schematics outlining situations in which this requirement would be satisfied).

3. All claims on
file, as originally filed, or as amended in the U.S. application must
sufficiently correspond to one or more of the claims indicated as allowable in
the application filed in the PPH 2.0 participating office (the USPTO notice
states that "[a] claim is considered to 'sufficiently correspond' where,
accounting for differences due to translations and claim format, the claim in
the U.S. application is of the same or similar scope as a claim indicated as
allowable in the application filed in the PPH 2.0 participating
office"). Under the PPH 2.0 program, applicants must submit a claims
correspondence table (in English), indicating how all the claims in the U.S.
application correspond to the allowable/patentable claims in the application
filed in the PPH 2.0 participating office.

4. Examination of the
U.S. application for which participation in the PPH 2.0 program is being
requested has not yet begun.

5. The applicant has
filed a request to participate in the PPH 2.0 program.

6. The applicant must
submit a copy of the office action issued just prior to the "Decision to
Grant a Patent" (along with an English translation, which may be a machine
translation) for the application before the PPH 2.0 participating office (under
the PPH 2.0 program, applicants no longer need to submit a statement that the
English translation is accurate).

7. The applicant must
submit an information disclosure statement listing all documents cited in the
office action of the PPH 2.0 participating office.

8. All of the
documents described above must be filed via the EFS-Web and indexed using the
document description: "Petition to make special under Patent Pros
Hwy."

Additional information
regarding the PPH 2.0 program with KIPO can be found here,
and with INPI-PT can be found here.

USPTO Implements PCT-PPH
with INPI-PT

Since implementing its
first Patent Prosecution Highway (PPH) program with the Japan Patent Office
(JPO) in 2006, the U.S. Patent and Trademark Office has established close to
forty PPH programs with more than twenty other patent offices. Earlier this month, the USPTO increased the
number of PPH programs (full or pilot) by one with the announcement
that the Office was establishing a PPH pilot program based on Patent
Cooperation Treaty (PCT) work products (PCT-PPH) with the Portugal National
Institute of Industrial Property (INPI-PT).

Under the USPTO-INPI-PT PCT-PPH,
which went into effect on January 29, an applicant receiving a positive written
opinion or a positive international preliminary report in a PCT application
where the USPTO or INPI-PT was the International Searching Authority or the
International Preliminary Examination Authority may request that the other office
fast track the examination of corresponding claims in corresponding
applications. The USPTO-INPI-PT PCT-PPH
pilot program is scheduled to expire on January 28, 2014, but may be extended
if necessary to adequately assess the feasibility of the program.
Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation

February 25, 2013

By
Kevin E. Noonan —

The
Obama Administration issued a Report earlier this month, entitled "Administration
Strategy on Mitigating the Theft of U.S. Trade Secrets," that sets forth
its efforts to prevent trade secret misappropriation. The Report involves the Departments
of Commerce, Defense, Homeland Security, Justice, State, Treasury, Director of
National Intelligence, and the Executive Office of the President, and the U.S.
Trade Representative (USTR) in the effort. The
Obama Administration, as evidenced by this document, recognizes the
contributions made to the economy by intellectual property, but also that some
of that creativity cannot be captured by traditional intellectual property
tools such as patents, copyrights, and trademarks. In this regard the Report cites increases in trade
secret theft and industrial espionage, citing The Office of the National
Counterintelligence Executive (ONCIX), "Foreign Spies Stealing US Economic
Secrets In Cyberspace", November 2011, at 1. These efforts at trade secret
misappropriation take the form of recruitment of former employees by foreign
corporation and governments as well as "cyber" attacks on "electronic
repositories" of trade secrets. All
these activities harm the U.S. economy and national security, according to the
preamble of the Report.

The
Administration enunciates a policy in protecting trade secrets to prevent
foreign corporations or governments "to gain an unfair economic edge"
from trade secret misappropriation. The Report
sets forth 5 "Strategy Action Items":

1.    Focus Diplomatic Efforts to Protect Trade
Secrets Overseas

The
Report indicates that the Obama Administration intends to "continue to
apply sustained and coordinated diplomatic pressure" on other governments to
discourage trade secret theft. This will
be done by directing a "sustained, consistent and coordinated message from
all appropriate agencies to foreign governments" and by pressuring
governments to "take steps to strengthen their enforcement against trade
secret theft." Trade secret theft by
governments will be raised "at the most senior levels" of the
Administration, including officials from the "Departments of Commerce,
Defense, Justice, Homeland Security, State, Treasury and the U.S. Trade
Representative." This pressure will
be diplomatic, through representatives from the Department of State, as well as
through attempts at coalition building by representatives from the Department
of Commerce and the USTR. The
Administration will also implement trade secret protection protocols at U.S.
Embassies in countries "known to present high-risk conditions for trade
secret theft" particularly through their IPR Working Groups.

Under
this Action Item are included "Trade Policy Tools" directed towards "increase[ing]
international enforcement against trade secret theft to minimize unfair
competition against U.S. companies." These include:

•    Deeper cooperation with trading partners
that share U.S. interests with the objective of promoting enhanced trade secret
and other intellectual property protection in ways that are consistent with
U.S. approaches and helpful in curbing trade in goods and services containing
stolen trade secrets;

•    Targeting
weaknesses in trade secret protection through enhanced use of the annual
Special 301 process, including the Special 301 Report, action plans and
related tools to gather and, where appropriate, act upon information about the
adequacy and effectiveness of trade secret protection by U.S. trading partners;

•    Seeking, through
USTR-led trade negotiations such as the Trans Pacific Partnership, new
provisions on trade secret protections requiring parties to make available
remedies similar to those provided for in U.S. law; and

•    Continuing to
raise trade secret protections as a priority issue in all appropriate
bilateral, regional, and multilateral trade discussions and appropriate trade
and IP-related forums, including the Trade-Related Aspects of Intellectual
Property Rights Council and the Asia Pacific Economic Cooperation, informed by
interagency and stakeholder input regarding partners and issues of concern.

Also
included in this Action Item are efforts to increase international law
enforcement cooperation, international training and capacity-building, and
involvement of international organizations (the counterparts of the U.S.
Departments that sponsored this Report).

2.    Promote Voluntary Best Practices by Private
Industry to Protect Trade Secrets

Some
of the responsibility for increased protections for trade secrets depend on
efforts by private companies. The
Administration contends that companies "need to consider whether their
approaches to protecting trade secrets keeps pace with technology and the
evolving techniques to acquire trade secrets enabled by technology." Under this Action Item, the Report commits the
Administration to "help facilitate efforts by organizations and companies
to develop industry led best practices to protect trade secrets," in an
effort led by the U.S. Intellectual Property Enforcement Coordinator
(IPEC). The Report, in a caveat that
could bring the whole effort to naught, qualifies the scope of such voluntary,
coordinated efforts by private companies, limits the scope of these practices
to those "consistent with [U.S] antitrust laws. Suggestions for such "best practices"
include:

•    Research and development compartmentalization;

•    Information security policies;

•    Physical security policies; and

•    Human Resources policies.

And
the Administration's efforts will be qualified by the statement that "it
should be emphasized that such guidelines are intended solely to offer
suggestions to assist businesses in safeguarding information they wish to keep
secret and are not designed to be a minimum standard of protection."

3.    Enhance Domestic Law Enforcement Operations

These efforts are led by
the FBI, which in 2011 "increased the number of trade secret theft
investigations by 29 percent from 2010" as a result of the Attorney
General's Task Force on Intellectual Property. These efforts are a "top priority" at the Bureau, according to
the Report, with the FBI "expanding its efforts to fight computer
intrusions that involve the theft of trade secrets by individual, corporate,
and nationstate cyber hackers." This Action Item also notes that the Office of the Director of National
Intelligence is involved in coordinating the efforts of "the intelligence
community" in assisting private companies in resisting trade secret
theft. The Office of the National
Counterintelligence Executive (ONCIX) will share "threat warnings"
and increase awareness in the private sector using (unspecified) "counterintelligence
tradecraft procedures tailored to the private sector." The regional scope of these efforts are
illustrated in the following map:

Several
"national outreach organizations, including the Domestic Security Alliance
Council, the National Security Business Alliance Council, and InfraGard"
will also be involved with the FBI in "local, regional and national
efforts" intended to "reach a broad swath of companies in multiple
sectors such as information technology, communications, aeronautics,
engineering, energy, financial services, and consumer retail."

Enforcement
of U.S. trade secret laws will be facilitated through training by the FBI and the
DOJ of prosecutors and investigators, targeting "domestic law enforcement
officers, prosecutors, and international partners." The Department of Defense also has a role in
this effort, and "will collect, analyze and report on threat information
to cleared industries that support Department of Defense programs and the
missions of other U.S. government departments and agencies" and will "deliver
security training and education on counterintelligence."

4.    Improve Domestic Legislation

The
Report cites several legislative initiatives, including:

•    Public
Law112-236—The Theft of Trade Secrets Clarification Act of 2012 (S.
3642), closed a loophole in the
Economic Espionage Act that had allowed the theft of valuable trade secret
source code. This legislation was introduced by Senate Judiciary Chairman
Senator Patrick Leahy in response to the Second Circuit decision in United
States v. Aleynikov, 676 F.3d 71 (2d Cir. 2012), which overturned a verdict
that found that the defendant violated 18 U.S.C. § 1832(a) by stealing
proprietary computer code, a trade secret, from his employer. This legislation
was in line with the overall IPEC objective of protecting trade secrets from
misappropriation.

•    Public Law 112-269—The
Foreign and Economic Espionage Penalty Enhancement Act of 2012 (H.R.
6029/S. 678),
bolstered criminal penalties for economic espionage and directed the Sentencing
commission to consider increasing offense levels for trade secret crimes. Its
passage is an important step in ensuring that penalties are commensurate with
the economic harm inflicted on trade secret owners. The passage of this
legislation could not have been achieved without the efforts of former House of
Representatives Judiciary Chairman Representative Lamar Smith and retired
Senator Herb Kohl.

5.    Public Awareness and Stakeholder Outreach

The
report concludes by listing efforts by the Department of Commerce, the U.S.
Patent and Trademark Office and the FBI to increase public awareness of trade
secret theft. The Report also sets out
websites having additional information, including:

•    Department of Commerce STOPfakes.gov IPR training module includes an
introduction to trade secrets (available here).

•    Special 301 Report released by the U.S. Trade Representative summarizes
troubling trends involving trade secrets and forced technology transfer (available here).

•    The Department of State (available here).

•    DOJ National Security Division (available here).

•    DOJ Criminal Division – Computer Crimes and Intellectual Property Section
(available here).

•    FBI Counterintelligence Division (available here).

•    National Intellectual Property Rights Coordination Center (available here).

•    The Office of the National Counterintelligence Executive (available here).

•    The Department of Defense – Defense Security Service (available here).

•    Create.org study that includes recommendations for companies operating in
foreign countries to mitigate the risk of trade secret theft (available here).

•    The World Intellectual Property Organization (WIPO) has more trade secret
information specifically designed for small and medium-sized enterprises
(available here).

Sprinkled
throughout the Report are specific instances of trade secret misappropriation,
limited (of course) to those instances detected or thwarted, including:

1.    Theft of Ford Motor Company Trade
Secrets

In
April 2011, Yu Xiang Dong was sentenced to 70 months in federal prison for
theft of trade secrets and economic espionage. Yu was a former Ford Motor
Company employee who resigned to work at Beijing Automotive Company. He copied
4,000 Ford documents onto an external hard drive, which he took to China. Ford
valued the loss of the trade secrets at $50 million dollars.

2.    Theft of DuPont Trade Secrets

Hong
Meng was a research chemist for DuPont. He was involved in researching Organic
Light Emitting Diodes (OLED). DuPont's OLED research efforts resulted in the
development of a breakthrough and proprietary chemical process for OLED
displays. Mr. Meng stole trade secret compounds and passed them to a Chinese
university. He was caught by the FBI and prosecuted by the U.S. Attorney's
Office for the District of Delaware and was sentenced to 14 months in federal
prison. DuPont valued the loss of the trade secrets at $400 million dollars.

3.    Theft of General Motors Trade
Secrets

On
November 30, 2012, a Federal jury in Detroit found Shanshan Du, a former
General Motors (GM) engineer, and her husband, Yu Qin, both found guilty of
stealing GM trade secrets related to hybrid vehicle technology worth $40
million. Du and Qin tried to pass the trade secrets to Chinese automaker Chery
Automobile Company.

4.    Theft of Cargill and Dow Chemical
Trade Secrets

In
October 2011, Kexue Huang, a former employee of both Cargill and Dow Chemical
passed trade secret information to a Chinese university that was developing
organic pesticides on behalf of China's government. Financial losses to both
companies from his criminal acts exceed $7 million. In December 2011, after
many months of hard work by FBI agents, CCIPS prosecutors and the U.S.
Attorneys' Offices in Indiana and Minnesota, Huang was sentenced to 87 months
in prison — the strongest sentence possible.

5.    Theft of Valspar Trade Secrets

David
Yen Lee worked for Valspar, an Indiana paint company. He stole trade secrets
from Valspar and tried to pass them to Nippon Paint in China. Mr. Lee purchased
a plane ticket to China, but was caught by the FBI before he could leave the
U.S. On December 8, 2010, Mr. Lee was sentenced to 18 months in prison. Valspar
valued the trade secrets between $7 and $20 million.

6.    Theft of Motorola Trade Secrets

In
November 2011, Customs and Border Protection officers at Chicago's O'Hare
Airport stopped Hanjuan Jin, a former Motorola software engineer, while she was
allegedly carrying 1,000 sensitive Motorola documents, $30,000 in cash, and a
oneway ticket to China. Jin was in the process of traveling to China to turn
over stolen trade secret information relating to mobile telecommunications to
Kai Sun News Technology Co., also known as SunKaisens, and to the Chinese
military.

7.    Theft of Goldman Sachs Trade Secret

Goldman
Sachs spent $500 million dollars developing computer source code to support its
high frequency trading program. Sergey Aleynikov, a Goldman Sachs computer
programmer, resigned from his job to work for a competitor, and on his final
day of employment transferred this extremely valuable proprietary computer code
to an external computer server. Mr. Aleynikov had also transferred thousands of
proprietary computer code files to his home computers. Mr. Aleynikov was investigated
by the FBI and prosecuted by the U.S. Attorney's Office of the Southern
District of New York. He was sentenced to 97 months in Federal prison. In
February 2012, his conviction was overturned by the Second Circuit based on the
court's interpretation of the Economic Espionage Act. This loophole was fixed
when President Obama signed Public Law 112236 The Theft of Trade Secrets
Clarification Act of 2012 (S. 3642) on December 28, 2012.

The
Obama Administration's record on intellectual property policy is spotty at
best, including as it does the Department of Justice's benighted position of
the patent-eligibility of isolated human DNA and the laughable "magic
microscope," as well as comments as recently as last week illustrating
that the President has at best an uninformed opinion on intellectual property
issues (see video of comments). But the Report is replete with precatory
admonitions on the value of intellectual property, including statements by the
President that:

Our single
greatest asset is the innovation and the ingenuity and creativity of the
American people. It is essential to our prosperity and it will only become more
so in this century.

We cannot look back
years from now and wonder why we did nothing in the face of real threats to our
security and our economy.

The
proof of this particular pudding will be whether the Administration follows
through on the aims and goals set forth in the Report.
Court Report

February 24, 2013

By Sherri Oslick —

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

Novartis Pharmaceuticals
Corp. v. Actavis LLC et al.
2:13-cv-01028; filed February
20, 2013 in the District Court of New Jersey

• Plaintiff: Novartis
Pharmaceuticals Corp.
• Defendants: Actavis LLC; Apotex,
Inc.; Apotex Corp.; Bedford Laboratories, Inc.; Dr. Reddy's Laboratories, Inc.;
Dr. Reddy's Laboratories Ltd.; Emcure Pharmaceuticals USA, Inc.; Emcure
Pharmaceuticals USA, Inc.; Hospira, Inc.; Pharmaceutics International Inc.;
Pharmaforce, Inc.; Sagent Pharmaceuticals, Inc.; ACS DOBFAR Info S.A.; Strides,
Inc.; Agila Specialities Private Ltd.; Sun Pharmaceuticals Industries, Inc.;
Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories, Ltd.; Sun
Pharmaceutical Industries Ltd.; Teva Parenteral Medicines, Inc.; Wockhardt USA
LLC; Wockhardt Ltd.

Infringement of U.S. Patent
Nos. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament
for the Treatment of Bone Metabolism Diseases," issued December 4, 2012),
8,052,987 ("Method of Administering Bisphosphonates," issued November
8, 2011), and 7,932,241 ("Pharmaceutical Products Comprising
Bisphosphonates," issued April 26, 2011) based on defendants' anticipated
launch of a generic version of Novartis' Zometa® (zoledronic acid, used for the
prevention of skeletal-related complications associated with cancer) and
Reclast® (zoledronic acid, used to treat osteoporosis and Paget's
disease). View the complaint here.

Precision Biosciences Inc. et
al. v. Cellectis S.A. et al.
1:13-cv-00247; filed February
19, 2013 in the District Court of Delaware

• Plaintiffs: Precision
Biosciences Inc.; Duke University
• Defendants: Cellectis S.A.;
Cellectis Bioresearch; Cellectis Bioresearch Inc.

Infringement of U.S. Patent
No. 8,377,674 ("Method for Producing Genetically-Modified Cells with
Rationally-Designed Meganucleases with Altered Sequence Specificity,"
issued February 19, 2013) based on Cellectis' manufacture, use, and sale of
certain products, including the cGPS® Custom HepG2 Full Kit DD and the CLS4617
meganuclease targeting the human CCR5 gene.
View the complaint here.

Bayer Pharma AG v. Warner
Chilcott Co., LLC et al.
2:13-cv-00265; filed February
19, 2013 in the District Court of Nevada

• Plaintiff: Bayer Pharma AG
• Defendants: Warner Chilcott
Co., LLC; Warner Chilcott (US), LLC

Infringement of U.S. Patent
No. RE43,916 ("Composition for Contraception," reissued January 8,
2013) based on Warner Chilcott's manufacture and sale of its Loestrin® 24 Fe
(norethindrone acetate and ethinyl estradiol tablets, and ferrous fumarate
tablets, used for oral contraception).
View the complaint here.

Promega Corp. et al. v.
Life Technologies Corp. et al.
3:13-cv-00119; filed February
19, 2013 in the Western District of Wisconsin

• Plainitffs: Promega
Corp.; Max-Planck Gesellschaft Zur Forderung Der Wissenschaften E.V.
• Defendants: Life
Technologies Corp.; Applied Biosystems, LLC

Infringement of U.S. Patent
No. RE37,984 ("Process for Analyzing Length Polymorphism in DNA Regions,"
reissued February 11, 2003) based on defendants' use, manufacture, importation,
sales and offers for sale of a line of small tandem repeat products called
AuthentiFiler. View the complaint here.

Unimed Pharmaceuticals LLC et
al. v. Perrigo Co. et al.
1:13-cv-00236; filed February
15, 2013 in the District Court of Delaware

• Plaintiffs: Unimed
Pharmaceuticals LLC; Besins Healthcare Inc.
• Defendants: Perrigo Co.;
Perrigo Israel Pharmaceuticals Ltd.

Infringement of U.S. Patent
No. 6,503,894 ("Pharmaceutical Composition and Method for Treating
Hypogonadism," issued January 7, 2003) following a Paragraph IV
certification as part of Perrigo's filing of an ANDA to manufacture a generic
version of AbbVie's AndroGel® (testosterone gel, used to treat conditions associated
with a deficiency or absence of endogenous testosterone). View the complaint here.

Cellerant Therapeutics, Inc.
v. Rea
1:13-cv-00201; filed February
12, 2013 in the Eastern District of Virginia

Review and correction of the
patent term adjustment calculation made by the U.S. Patent and Trademark Office
for U.S. Patent No. 8,252,587 ("Methods of Expanding Myeloid Cell
Populations and Uses Thereof," issued August 28, 2012). View the complaint here.
Conference & CLE Calendar

February 24, 2013

February
26-27, 2013 – Biotech & Pharmaceutical Patenting (IBC Legal) – Munich, Germany

February 27-28, 2013 – Life Sciences
Collaborative Agreements and Acquisitions*** (American Conference
Institute) – New
York, NY

February 28, 2013 – Patent
Prosecution Dilemmas Under the AIA: Unanswered Questions After the USPTO's
Final Rules (Intellectual Property Owners Association) – 2:00 – 3:00 pm (ET)

March 1, 2013 – Intellectual Property Panel
Symposium (George
Washington University Law School) – San Francisco, CA

March 5-6, 2013 – Medical Device
Patents*** (American Conference
Institute) – Chicago, IL

March 7, 2013 – Implementing the New
Priority Rules Under the AIA (Technology
Transfer Tactics) – 1:00 – 2:00 pm
(Eastern)

March 7, 2013 – Patent Inventorship:
Best Practices for Determination and Correction (Strafford) – 1:00 – 2:30 pm (EST)

March 10-13, 2013 – Genes & Diagnostics: A Myriad
of Issues in Biotech IP (Cold
Spring Harbor Laboratory) – Cold
Spring Harbor Laboratory

March 13, 2013 – First to File: Final
Rules and Guidance — Navigating Significant Changes to Derivation Practice,
What Constitutes Prior Art and More (Strafford) – 1:00 –
2:30 pm (EDT)

March
14, 2013 – 2013 Intellectual Property Institute (USC Gould
School of Law) – Beverly Hills, CA

March 18-19, 2013 – 7th Annual Patent Law Institute (Practising
Law Institute) – San Francisco, CA

March 19-20, 2013 – FDA Boot Camp*** (American Conference
Institute) – New York, NY

March 20, 2013 – Improving the Success of Appeals to the
Patent Trial and Appeal Board (McDonnell
Boehnen Hulbert & Berghoff LLP) – 10:00 – 11:15 am (CT)

March 20, 2013 – Patent Claim Drafting
and Construction in 2013: Crafting Claims to Withstand Scrutiny and Avoiding
Claim Limitation Attack (Strafford) – 1:00 – 2:30 pm
(EST)

March 25-27, 2013 – 2013 Spring Intellectual
Property Counsels Committee (IPCC) Conference (Biotechnology
Industry Organization) – San
Diego, CA

April 3-5, 2013 – 28th
Annual Intellectual Property Law Conference (American Bar
Association (ABA) Section of Intellectual Property Law) – Arlington,
VA

***Patent Docs is a media partner of this conference or CLE
ABA 28th Annual Intellectual Property Law Conference

February 22, 2013

The American Bar
Association (ABA) Section of Intellectual Property Law will be holding its 28th
Annual Intellectual Property Law Conference on April 3-5, 2013 in Arlington,
VA. Among the topics that will be
covered at the conference are:

• Working at the
Edge of Settlement/ADR: What You Can and Cannot Dos

• Hot Topics in
Patent Damages: Deconstructing Apple v.
Motorola, Should The Federal Circuit Revisit Its Precedents on Past
Damages?

• Pay-For-Delay
Settlement Agreements: Are Pharma Companies Playing by a Different Set of
Rules? — panel includes Patent Docs
author Kevin Noonan

• New Patent World
Post AIA: What Has Changed?

• Patentability
Trials of the AIA — The First 120 Days — panel includes Teresa Stanek Rea,
Acting Director, U.S. Patent and Trademark Office, and Hon. Michael Tierney,
Patent Trial and Appeal Board, U.S. Patent and Trademark Office

• New Infringement
Case Law — Staying Ahead of the Curve

• Patent
Procurement in the Age of Harmonization: Strategies for Building a Solid Global
Patent Portfolio

• When Should Patent Owners Be Required to Reduce the Number of Asserted Claims
and Select Claims for Trial?

• Patent Examiner
Interviewing: Strategies and Skills

• Fraud on the US Patent and Trademark Office: Has the Plague of Inequitable
Conduct Been Eradicated?

• Aggrandizing
"Petty Innovation": The Growing Use of Utility Models

The program
schedule for the conference can be found here.

The registration
fee is $295 (law students), $345 (corporate counsel and government, public
interest, and academic rate), $695 (ABA-IPL section members and members of
co-sponsoring section), $770 (ABA members), or $845 (non-ABA members). Those registering before March 15, 2013 will
receive a $50 discount (or a $100 discount off the non-ABA member rate). Detailed registration information can be
found here.

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