Patent Docs

Conference & CLE Calendar

February 21, 2010

February 24-25, 2010 – 2nd
Expert Forum on ITC Litigation &
Enforcement (American Conference
Institute) – New York, NY

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

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

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

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

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

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

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

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

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

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

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

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

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

***Patent Docs is a media partner of this conference or CLE
USPTO Announces Agenda for Next BCP Customer Partnership Meeting

February 19, 2010

The
U.S. Patent and Trademark Office has announced the agenda for the next
biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting to be
held on March 2, 2010. The
proposed agenda is as follows:

Morning
Session

•
Greetings and Overview (10:00 – 10:15 am EDT): George Elliott and Remy Yucel, Directors, Technology Center
1600

•
Best Practice in Reissue — Part II (10:15 – 11:00 am): Jean Vollano, QAS, TC1600

•
Green Technology (11:00 am – 11:30 pm): Blaine Copenheaver, SPE, TC1700

•
Break (11:30 – 11:45 pm)

•
Patent Term Adjustment (11:45 – 12:45 pm): Kery Fries, Office of Patent Legal Administration

•
Lunch (12:45 – 2:00 pm)

Afternoon
Session

•
Patents and Synthetic Biology (2:00 – 2:45 pm): Kathleen Bragdon, QAS, TC1600

•
Break (2:45 – 3:00 pm)

•
Accelerated Examination (3:00 – 3:45 pm):
Bennett Celsa, QAS, TC1600

•
Closing Remarks/Discussion (3:45 – 4:00 pm): George Elliott and Remy Yucel, Directors, TC1600

The
meeting can be attended in person at the USPTO's Madison Auditorium, 600 Dulany
Street, Alexandria, VA, or viewed online here
(select the "enter as guest" option). The Patent Office asks that non-USPTO employees login using
their e-mail addresses.
26th Annual Joint Patent Practice Seminar

February 19, 2010

The Connecticut,
New Jersey, New York, and Philadelphia Intellectual Property Law Associations
will be holding their 26th Annual Joint Patent Practice Seminar on April 29,
2010 in New York, NY. The seminar
will consist of five panels:
Litigation, Pharmaceuticals/Life Sciences, Ethics, Licensing/Foreign
Practice/ITC, and the USPTO, with each panel addressing a series of cases and
topics. In particular, the panels
will focus on the following cases and topics:

Panel I —
Litigation (8:45 to 10:05 am)

• Gemtron Corp. v. Saint-Gobain Corp.
(Fed. Cir. 2009)
• Forest Group Inc. v. Bon Tool Co. (Fed.
Cir. 2009)
• Tyco Healthcare Group LP v. Ethicon
Endo-Surgery, Inc. (Fed. Cir. 2009)
• Cardiac Pacemakers, Inc. v. St. Jude
Medical, Inc. (Fed. Cir. 2009)
• Lucent Technologies, Inc. v. Gateway, Inc.
(Fed. Cir. 2009) and Cornell University
v. Hewlett-Packard Co. (N.D.N.Y.)
• In re Lister (Fed. Cir. 2009)
• Titan Tire Corp. v. Case New Holland, Inc.
(Fed. Cir. 2009)

Panel II —
Pharmaceuticals/Life Sciences (10:05 to 11:15 am)

• Bayer Schering Pharma AG v. Barr
Laboratories, Inc. (Fed. Cir. 2009)
• Ischemia Research and Education Foundation
v. Pfizer (Santa Clara County Superior Court 2009)
• Ariad Pharmaceuticals, Inc. v. Eli Lilly and
Company (Fed. Cir. 2009)
• Amgen Inc. v. F. Hoffmann-LaRoche Ltd.
(Fed. Cir. 2009)
• Abbott Labs. v. Sandoz, Inc. (Fed. Cir.
2009) (en banc)
• University of Pittsburgh v. Hedrick
(Fed. Cir. 2009)

Panel III — Ethics
(11:30 am to 12:40 pm)

• In re Bose Corp. (Fed. Cir. 2009)
• Is Civility Dead?
— Professor Paula Franzese of the Seton Hall University School of Law
• Ethical issues
relating to Mergers/Acquisitions
• Exergen Corp. v. Wal-Mart Stores, Inc.
(Fed. Cir. 2009)
• Board of Trustees of the Leland Stanford
Junior University v. Roche Molecular Systems, Inc. (Fed. Cir. 2009)
• NY – State Rules
Revised: Attorney as a Witness

Panel IV —
Licensing/Foreign Practice/ITC (1:55 to 3:35 pm)

• Epistar v. International Trade Commission
and Philips Lumileds Lighting (Fed. Cir. 2009)
• AsymmetRx, Inc. v. Biocare Med. LLC
(Fed. Cir. 2009)
• Euclid Chemical Co. v. Vector Corrosion
Technologies, Inc. (Fed. Cir. 2009)
• Current status of
Princo Corp. v. International Trade
Commission (Fed. Cir. 2009)
• Synthes v. G.M. Dos Reis Jr. Ind. Com. De
Equip. Medico (Fed. Cir. 2009)
• Inventor
Remuneration – UK, France, Germany and Japan – Is the Inventor King?
• License Drafting
– Trademarks and Patents
• Corebrace v. Star Seismatic (Fed Cir
2009)
• The International
Trade Commission and Design Patents

Panel V — USPTO
(3:50 to 5:00 pm)

• USPTO –
Enrollment and Discipline presentation
• Current status of
In re Bilski (Fed. Cir. 2008)
• Hindsight Bias
• Larson Mfg Co. of South Dakota, Inc. v.
Aluminart Products Ltd. (Fed. Cir. 2009)
• Best Practices on
Inventorship – What is a contributor and how to evaluate
• Wyeth v. Kappos (Fed. Cir. 2010)

The lunch keynote
speaker will by Circuit Judge Pauline Newman of the U.S. Court of Appeals for
the Federal Circuit.

A preliminary
program preview for the seminar can be found here.

The conference will
be held at the Hilton New York, 1335 Avenue of the Americas. The registration fee for the conference
is $420 (for those registering by April 16, 2010) or $450 (for those
registering after April 16, 2010).
Those interested in registering for the conference can do so here or by submitting a reservation form that can be
obtained here.
BPAI Conference

February 19, 2010

The Board of Patent
Appeals and Interferences (BPAI) will be holding its First Annual Board
Conference on April 7, 2010 in Alexandria, VA. The conference will include presentations on the following
topics:

• State of the
Board — Chief Judge Michael Fleming

• A View Behind the
Curtain — Vice Chief Judge James Moore, Vice Chief Judge Allen MacDonald,
Judge Ken Hairston, and Judge Murriel Crawford

• Practice
Tips: Top Ten Mistakes (panel
discussion) — Judge Linda Horner (moderator), Gary Harkcom of Greenblum &
Bernstein, P.L.C., Chief Judge Michael Fleming, Judge Jack Jeffery, and Judge
Sally Lane

• Winning Your
Non-Obviousness Case at the Board — Michael Messinger of Sterne, Kessler,
Goldstein & Fox P.L.L.C. and Charles Van Horn of Finnegan, Henderson,
Farabow, Garrett & Dunner LLP

• Luncheon Speaker
— Under Secretary of Commerce for Intellectual Property and Director of the
United States Patent & Trademark Office, David Kappos

• Inter Partes Reexam (panel discussion)
— Stephen Kunin of Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.
(moderator), Brad Pedersen of Patterson, Thuente, Skaar & Christensen,
P.A., Todd Baker of Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.,
and Gregory Morse of the USPTO Central Reexam Unit

• Panel with
Federal Circuit Judges: Role of
the Board (panel discussion) — Teresa Rea of Crowell & Moring LLP
(moderator), Chief Circuit Judge Paul Michel of the Court of Appeals for the
Federal Circuit, Circuit Judge Randal Rader of the Court of Appeals for the
Federal Circuit, and Chief Judge Michael Fleming of the BPAI

The conference
agenda can be found here.

The conference will
be held in the Madison Auditorium at the U.S. Patent and Trademark Office, 600
Dulany Street, Alexandria, VA. The
registration fee for the conference is $100. Those interested in registering for the conference can do so
here; the registration
deadline is March 30, 2010.
PhRMA Representative Questions Follow-on Biologics Paper

February 18, 2010

By
Donald Zuhn —

In
a letter to the editor published
in this week's edition of The New England
Journal of Medicine, Dr. David Wheadon, Senior Vice President of the Pharmaceutical
Research and Manufacturers of America (PhRMA) Scientific & Regulatory
Affairs team, attempts to set the record straight regarding a follow-on
biologics (FOB) paper published in that medical journal last fall. The focus of Dr. Wheadon's criticism is
a NEJM paper written by a New York
patent attorney (Alfred Engelberg) and two Harvard professors (Dr. Aaron
Kesselheim and Dr. Jerry Avorn), in which the three authors contend that the FOB
legislation being proposed in the House and Senate — which would provide 12
years of data exclusivity — would "upset[] the delicate balance between
the interests of consumers and those of innovators" (see "NEJM Authors
Say Five Years of Data Exclusivity Would Be Sufficient"). Citing the Federal Trade Commission
(FTC) report on FOBs that was released last June (see "No One Seems Happy with Follow-on Biologics According to
the FTC"),
the three authors suggest that the FOB legislation currently pending in the
House and Senate (and which was proposed at the time the paper was originally published) be amended to "give the FDA the mandate to evaluate and
approve biosimilar drugs in a reasonable period, starting, as with
small-molecule products, 5 years after the approval of the original drug,"
and conclude that "[s]uch a compromise would best balance the need for
financial incentives with the need for competition, promoting access and
motivating important subsequent innovation."

Stating
that "the record should be set straight," Dr. Wheadon offers five
counterarguments to the Engelberg et al.
paper. First, he contends that
once an FOB regulatory pathway has been established, FOB manufacturers will
have "strong incentives to enter the market" — namely, substantially
reduced developmental costs (Dr. Wheadon suggests that FOB manufacturers will
be looking at costs of between $10 million and $40 million, as compared to $1.2
billion for innovators) resulting from the FOB manufacturer's ability to use an
innovator's data to support its application for FDA approval. Next, Dr. Wheadon contends that
protection of this data, via an appropriate data exclusivity period, will be
critical given the less certain patent protection for biologic drugs (which he says is a result of the requirement that an FOB need only be similar, and not
identical, to the corresponding biologic drug). Third, Dr. Wheadon points out that data protection will not
eliminate competition because biologics will still have to compete with other
drugs. In particular, Dr. Wheadon notes that an FOB manufacturer can
bypass an innovator's data protection by generating its own data to provide support for FDA
approval. Fourth, in response to
some of the criticism regarding evergreening loopholes in the current
legislation, Dr. Wheadon observes that "changes to an innovator biologic
that do not affect the product's safety, purity, or potency would not qualify
for a new data-protection period."
Last, Dr. Wheadon asserts that recent (but as yet unpublished) data
indicates that "developers of less than one third of biologics had
recouped their research and development costs from 2003 through 2008," and
therefore "focusing on revenues associated with a select few biologics is
misleading."

Also
commenting about the Engelberg et al.
paper in a letter to the editor are Dr. Allan Pollock and Dr. Martin Zagari of
Amgen. Briefly, the Amgen researchers
seek to correct an error in the paper regarding the annualized cost of epoetin
alfa therapy for anemia of chronic renal disease. Whereas the Engelberg et
al. paper suggests that the cost of this therapy is $84,467 per patient,
Dr. Pollock and Dr. Zagari state the actual cost is $8,767 per patient. The Amgen researchers also note that the
Centers for Medicare and Medicaid Services (CMS) pays for 80% of this cost.

Two
of the authors of the original NEJM
paper, Alfred Engelberg, a New York patent attorney who represented the Generic
Pharmaceutical Industry Association and played a role in the passage of the
Hatch-Waxman Act in 1984, and Dr. Aaron Kesselheim, a patent attorney and
Instructor in Medicine at the Harvard Medical School, are given the last
word. In response to Dr. Pollock's
and Dr. Zagari's letter, Mr. Engelberg and Dr. Kesselheim explain that the $84,467
figure was the result of an arithmetic error in transcription, and that the
figure should have been $8,447 (somewhat lower than the number suggested by Dr.
Pollock and Dr. Zagari).

As
for Dr. Wheadon's letter, Mr. Engelberg and Dr. Kesselheim begin by noting that
Dr. Wheadon "does not challenge our central contention that the pending
biosimilar legislation will produce less competition and perpetuate higher
prices for biologic drugs," but "[r]ather, he attempts to justify
that outcome with a number of common arguments." First, the two authors suggest that Dr. Wheadon's $1.2
billion developmental cost estimate "has been widely disputed, and the
amount may be lower for biologics."
They note that for the drug alglucerase (Ceredase), the innovator
reported spending less than $58 million for development. The authors also dispute Dr. Wheadon's
FOB manufacturer cost estimate of $10 million to $40 million, stating that
"according to the FDA, clinical-trial requirements for biosimilars may not
be substantially different from those for new products."

As
for the currently pending FOB legislation, Mr. Engelberg and Dr. Kesselheim
argue that it "will grant a 12-year monopoly without any innovation
requirement and offers additional 12-year periods of exclusivity for minimal changes
to the original product." The
two authors conclude their letter by contending that if currently pending FOB
legislation is passed by Congress, "U.S. patients and insurers will
continue to pay unnecessarily high prices for [biologics] for decades to
come."
Biotech/Pharma Docket

February 17, 2010

By Suresh Pillai —

Court Denies Bid for Bench Trial in RNAi
Patent Suit

The U.S. District Court for the District of
Massachusetts has denied the bid of defendants Whitehead Institute for
Biomedical Research,
the University of Massachusetts,
and the Massachusetts Institute of Technology to have the merits of their patent dispute with plaintiffs Max Planck
Institute and Max Planck
licensee Alnylam Pharmaceuticals, Inc. decided in a bench trial. The
dispute concerns patent applications filed
with both the United States Patent and Trademark Office and the European Patent
Office. According to the
plaintiffs' amended complaint, the named inventors assigned their interests to
the Whitehead Institute, the Max Planck Institute, the Massachusetts Institute
of Technology, and the University of Massachusetts. The interests assigned in part to the Max Planck institute
constitute the invention referred to in the complaint as the "Tuschl I"
invention. During the same time
period, the plaintiffs allege that a separate group of Max Planck scientists
developed a series of inventions also related to RNAi (the "Tuschl II"
invention). In their complaint,
the plaintiffs allege that the defendants infringed their property rights
in the Tuschl II invention by improperly importing aspects of this invention
into the Tuschl I patent applications (see "Court Report," July 5, 2009).

In its most recent ruling, the District Court
concluded that because the plaintiffs could potentially be awarded damages for
some of their claims, the plaintiffs were entitled to a trial by jury.

Read the amended complaint here.

Federal Jurisdiction Found in
Neuralstem Case

The U.S. Court of Appeals for the Ninth Circuit has
reversed a lower court ruling that the intellectual property dispute between
plaintiff Neuralstem Inc.
and defendant ReNeuron Ltd.
over the plaintiff's proprietary stem cell technology, and has determined that the
case should be tried in California and not in England. Neuralstem first filed suit in 2008,
alleging that ReNeuron had improperly used Neuralstem's technology and that
ReNeuron had defrauded the USPTO by attempting to patent inventions that were
partly the work of Neuralstem. The
companies had both been parties to a joint venture agreement covering aspects
of the technologies in dispute. In
addition to the return of all Neuralstem proprietary information and trade
secrets, Neuralstem is seeking an injunction that would prevent ReNeuron from
using Neuralstem's proprietary information as well as both punitive and
compensatory damages.

Though the lower court found that England would be
a better forum for the suit, due to ReNeuron being incorporated in England, the
applicability of British contract law, and the locations of ReNeuron employees
and key documents, the Court of Appeals held that the District Court had
improperly failed to give adequate weight to the plaintiff's forum choice, the
fact that many of the documents related to the dispute are in California, and
the interest of the State of California and the United States in the outcome of
the litigation.

Read the order here.

Perrigo Victorious in Mucinex® Patent Dispute

The U.S. District Court for the Western District of
Michigan granted summary judgment in favor of Perrigo Co., holding that
based on its claim construction, no reasonable jury could find that the
defendant's generic version of plaintiff Adams Respiratory Therapeutics Inc.'s patented anti-mucus
drug infringed the plaintiff's patent. Adams, a subsidiary of Reckitt Benckiser Group PLC,
originally brought suit in 2007 on the heels of Perrigo's filing of an ANDA
with the FDA seeking regulatory approval to market a generic version of Mucinex®. In its complaint, the plaintiff alleged
that Perrigo's proposed drug would infringe U.S. Patent No. 6,372,252. FDA approval of Perrigo's drug had been
stayed pending the outcome of the current litigation. Following a Markman hearing and the filing of summary
judgment motions, the District Court sided with Perrigo, clearing the way for FDA
approval and Perrigo's entry into the market.
Gates Foundation Seeks to Make This “The Decade of Vaccines”

February 16, 2010

By
Donald Zuhn —

Last
month, Bill and Melinda Gates kicked off the new decade by announcing
that their Foundation will be pledging $10 billion over the next ten years to
help research, develop, and deliver vaccines to the world's poorest countries. The announcement came at the World
Economic Forum's annual meeting in January.

Noting
that "[v]accines already save and improve millions of lives in developing
countries," Mr. Gates (at right) declared that "[w]e must make this the decade
of vaccines." He also noted
that "[i]nnovation will make it possible to save more children than ever
before." In addition, Mr. and
Mrs. Gates urged governments and corporations to increase vaccine investment. To date, the Bill & Melinda Gates
Foundation has provided $4.5 billion for vaccine research, development, and
delivery.

Using
a model developed by a consortium led by the Institute of International
Programs at the Johns Hopkins Bloomberg School of Public Health, the Foundation
was able to project the potential impact of vaccines on childhood deaths over
the next ten years. The model
predicts that approximately 7.6 million children under 5 years of age can be
saved this decade by developing new vaccines to prevent severe diarrhea and
pneumonia (both of which are close to becoming available) and extending vaccine
coverage in developing countries to 90%.
The model also predicts that an additional 1.1 million children can be
saved by introducing a malaria vaccine in the developing world by 2014 (one
malaria vaccine candidate is currently in late-stage trials). In order to reach the Foundation's goal
of 90% coverage, however, Mr. Gates stated that billions in additional funding
will be required.

The
Gateses noted that their $10 billion pledge was inspired by recent progress
concerning vaccine research, development, and delivery in the developing
world. For example, the couple
pointed to World Health Organization (WHO) data showing that between 2000 and
2009, the percentage of children receiving the basic diphtheria, tetanus, and
pertussis (DTP3) vaccine in the poorest countries of the world jumped from 66%
to 79%, and that between 2000 and 2008, measles deaths in Africa dropped by 92%. In addition, a recent New England Journal of Medicine article shows
that the introduction of a rotavirus vaccine in South Africa and Malawi reduced
cases of severe diarrhea by more than 60%.

Appearing
with Mr. and Mrs. Gates was Julian Lob-Levyt, the CEO of the GAVI Alliance,
a global health partnership representing stakeholders in immunization from both
private and public sectors that was launched at the World Economic Forum ten
years ago. Mr. Gates noted that by
coordinating the resources and expertise of vaccine companies, donors, UNICEF,
WHO, the World Bank, and developing countries, the GAVI Alliance was "transforming
the business of vaccines," and had permitted the vaccination of 257
million additional children, preventing some 5 million deaths. Looking at the organization's past
accomplishments, Mr. Lob-Levyt observed that "[t]he potential to make
bigger strides in the coming decade is even more exciting."
FTC Disapproves of “Pay-for-Delay” Drug Deals

February 15, 2010

By Kevin E. Noonan —

Last month, the Federal Trade Commission released a
report about so-called "pay for delay" arrangements, agreements
between branded pharmaceutical companies and generic drug companies that delay
entry of generic versions of branded drugs. The FTC's position is clear from the title of the
Report: "Pay-for-Delay: How
Drug Company Pay-Offs Cost Consumers Billions."

The Report, by FTC staffers from the Bureau of
Competition, Bureau of Economics, and Office of Policy Planning, describes these
agreements as "win-win" for the companies, by permitting brand-name
drug prices to stay high while giving generic companies a share of the high
profits generated by an extension of the time during which the brand-name drug
has no competition. In the marketplace, the Report notes
that generic prices can be as much as 90% lower than brand-name drug prices,
designating delay in generic entry as a loss for consumers. The Report notes that the FTC had "deterred" the use of such
agreements between April 1999 and 2004, buttressed by a decision by a regional
Court of Appeals that these agreements were per
se illegal. In re Cardizem CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003). However, a decision by the Federal
Circuit, In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323 (Fed. Cir. 2008), and
other Courts of Appeal, Schering-Plough Corp. v. Fed. Trade
Comm'n, 402 F.3d 1056 (11th Cir. 2005); see also In re
Tamoxifen Citrate Antitrust Litigation, 466 F.3d 187 (2d Cir. 2006),
have "misapplied the antitrust laws" by upholding this type of
agreement. As a consequence, "pay-for-delay"
agreements between branded and generic drug companies have "re-emerged."

As a result, generic drug entry is delayed for on
average 17 months and pay-for-delay agreements "protect at least $20 billion in sales of brand-name
pharmaceuticals from generic competition." The Report estimates that the "cost
to American consumers [is] $3.5 billion per year." The nature of these agreements is
public information under the terms of the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, 42 U.S.C. § 1395w-101 (2009) note (section 110), 21 U.S.C. § 355
(2009) note (sections 1111-1118), 21 U.S.C. § 355(j)(5) (2009) (section 1102)),
which require all such agreements to be filed with the FTC.

A previous
FTC study showed that generic drug companies prevailed in ANDA litigation
against brand-name drug companies 73% of the time between 1992 and 2002. Generic Drug Entry Prior to
Patent Expiration: An FTC Study, Exec. Summary at viii (July 2002). This statistic provides the incentives for brand-name
companies to pursue these types of agreements.

Turning to
statistics, the Report notes that there have been 66 agreements that "involved
some sort of compensation" for delayed entry between FY 2004-2009, and
that in the same time period, ANDA litigation was settled in 152 instances
without pay-for-delay agreements. Of the 66 agreements involving delayed generic entry, 51 of them (77%)
were between the brand-name pharmaceutical company and the first ANDA filer. These data were significant, because (as
the Report notes) "[s]ettlements with first-filer generics can prevent all generic entry" (emphasis in original), since the generic
company to first file an ANDA has a 180–day exclusivity period to which it is
entitled under the Hatch-Waxman Act. Thus, delaying market entry for the first ANDA filer prevents any
subsequent ANDA filer from entering the market until the first filer has
utilized the 180-day exclusivity period.

These
agreements do not all involve direct cash payments to the generics companies,
however. Other arrangements
described in the Report include an agreement from the brand-name pharmaceutical
company not to introduce an "authorized generic," i.e., a generic
version of the drug made by the brand-name company, which are not excluded by
the 180-day exclusivity period awarded to the first to file an ANDA. These types of agreements
were included in about 25% of the "pay-for-delay" agreements
discussed in the Report.

The Report
also presents details regarding how the various estimates were determined
(including average length of no competition against brand-name drugs, the
annual costs to consumers (with an embedded estimate on the average savings to
consumers from generic drug entry), the likelihood of settlements containing
such pay-for-delay provisions, and the sales volume for drugs where settlements
containing such provisions (the latter two categories admittedly being highly
speculative). Indeed, the Report contains alternative
estimates with higher ($7.5 billion) and lower ($0.6 billion) amounts of
consumer costs, depending on initial assumptions.

The Report
recommends that, in the absence of consistent treatment by the Courts of Appeal
or a decision by the Supreme Court, Congress needs to effect a legislative
remedy. In the interim, the FTC is
pursuing additional remedies in two lawsuits, Fed. Trade Comm'n v.
Cephalon, No.
08-cv-2141-RBS (E.D. Pa.), and Fed. Trade
Comm'n v. Watson, No. 09-cv-00598 (N.D. GA). Possible
legislative measures recommended by the Commission (but not contained in the
Report) include forfeiture of the 180-day exclusivity period for any first ANDA
filer that enters into a "pay-for-delay" agreement with a branded
drug company or outright bans as proposed in bills introduced in both Houses of Congress
(H.R. 1706 and S. 369 or S. 1135). None of these bills have been voted on in
either chamber, however, and their fate is (at present) bound up with the
stalled healthcare reform bill.
USPTO Solicits Public Comment on Information Collection

February 15, 2010

By
Sarah Fendrick —

As
part of its effort to reduce paperwork, the U.S. Patent and Trademark Office is seeking public comment on
its current continuing information collection systems.

The
first information collection system includes information collected to pay fees
for issued patents, to request corrections of errors in issued patents, and to
submit applications for reissue patents. The USPTO
estimates that under this collection system 217,184 responses are submitted
each year at a cost of $284,296,310. The estimated cost includes the time required to prepare the
information, the postage costs, and the fees assessed by the USPTO.

The
second information collection system includes the collection of information in
relation to the deposit of biological materials. When an invention involves a biological material and words
are not sufficient to describe how to make and use the invention, the
biological material must be deposited in a suitable depository. The associated
cost for submission of biological samples is estimated to be
$9,831,120 per year. Postage and
shipping ($1,081,115 per year) and capital start-up costs ($8,750,000) account for
the total cost per year.

The
USPTO is soliciting public comment on each of the information collection system
discussed above. Specifically, the
federal notices are seeking comments on:

(a) Whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether the
information shall have practical utility;
(b) The accuracy of the agency's estimate of the burden (including hours and cost)
of the proposed collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be
collected; and
(d) Ways to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other forms of
information technology.

All written comments
must be submitted on or before April 12, 2010. Comments can be submitted via e-mail to Susan.Fawcett@uspto.gov or via regular mail directed to Susan K. Fawcett, Records Officer, Office of the
Chief Information Officer, United States Patent and Trademark Office, P.O. Box
1450, Alexandria, VA 22313–1450.
Court Report

February 14, 2010

By Sherri
Oslick —

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

Genetic Technologies Ltd. v. Beckman Coulter, Inc. et al.
3:10-cv-00069; filed February 12, 2010 in the
Western District of Wisconsin

• Plaintiff:
Genetic Technologies Ltd.
• Defendants:
Beckman Coulter, Inc.; Gen-Probe, Inc.; Interleukin Genetics Inc.;
Molecular Pathology Laboratory Network, Inc.; Monsanto, Inc.; Orchid Cellmark,
Inc.; PIC USA, Inc.; Pioneer Hi-bred International, Inc.; Sunrise Medical
Laboratories, Inc.

Infringement of U.S. Patent No. 5,612,179 ("Intron
Sequence Analysis Method for Detection of Adjacent Locus Alleles as Haplotypes,"
issued March 18, 1997) based on defendants' manufacture and sale or offering of
genotyping and genomic services, kits for gene mutation analysis, genetic
testing services, and/or genetically engineered animal or plant lines. View the complaint here.

Purdue Pharma L.P. v. King Pharmaceuticals Inc. et al.
3:10-cv-00687; filed February 9, 2010 in the
District Court of New Jersey

• Plaintiff: Purdue Pharma L.P.
• Defendants: King Pharmaceuticals Inc; Alpharma Inc.

Infringement of U.S. Patent No. 7,658,939 ("Tamper-Resistant
Oral Opioid Agonist Formulations," issued February 9, 2010) based on
defendants' manufacture and sale of its EMBEDA product (morphine sulfate and
naltrexone hydrochloride extended release capsules, used in the management of
moderate to severe pain). View the
complaint here.

Mission Pharmacal Co. v. Trigen Laboratories, Inc.
5:10-cv-00112; filed February 9, 2010 in the
Western District of Texas

Infringement of U.S. Patent No. 6,521,247 ("Dual
Iron Containing Nutritional Supplement," issued February 18, 2003) based
on Trigen's manufacture and sale of TARON A PRENATAL (prenatal supplements,
used for combating iron deficiency anemia during pregnancy). View the complaint here.

Alzheimer's Institute of America v. Elan Corp. PLC et al.
3:10-cv-00482; filed February 2, 2010 in the
Northern District of California

• Plaintiff: Alzheimer's Institute of America
• Defendants: Elan Corp. PLC; Eli Lilly & Company; AnaSpec Inc.;
Immuno-Biological Laboratories, Inc.; Life Technologies Corp. d/b/a Invitrogen
Corp.; The Jackson Laboratory; Phoenix Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,455,169 ("Nucleic
Acids for Diagnosing and Modeling Alzheimer's Disease," issued October 3,
1995), 5,795,963 ("Amyloid Precursor Protein in Alzheimer's Disease,"
issued August 18, 1998), 6,818,448 ("Isolated Cell Comprising HAPP 670/671
DNAS Sequences," issued November 16, 2004), and 7,538,258 ("Transgenic
Mouse Expressing an APP 670/671 Mutation," issued May 26, 2009) based on
defendants' use of Alzheimer's Institute's Alzheimer's Disease-related
technology, including conducting research involving the use of, manufacturing
and selling detection systems for, and/or manufacturing and selling products
containing the Swedish mutation. View the complaint here.

Lupin Ltd et al. v. Merck, Sharp & Dohme Corp.
3:10-cv-00683; filed February 1, 2010 in the
District Court of New Jersey

• Plaintiffs: Lupin Ltd; Lupin Pharmaceuticals, Inc.
• Defendant: Merck, Sharp & Dohme Corp.

Declaratory judgment of non-infringement of U.S.
Patent Nos. 6,147,103 ("Omeprazole Process and Compositions Thereof,"
issued November 14, 2000), 6,166,213 (same title, issued December 26, 2000),
6,191,148 (same title, issued February 20, 2001), in conjunction with Lupin's
filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium®
(esomeprazole magnesium, used for the treatment of gastroesophageal reflux
disease). View the complaint here.

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