Patent Docs

Conference & CLE Calendar

October 6, 2013

October
9, 2013 – Biosimilars: Navigating FDA's Evolving
Approval Pathway, Protecting Patents and Trade Secrets (Strafford) – 1:00 to 2:30 pm (EDT)

October 10, 2013 – Recent Judicial Decisions
Impacting Technology Licensing (McDonnell
Boehnen Hulbert & Berghoff LLP) – 10:00
to 11:15 am (CT)

October 15-17, 2013 – Business of
Biosimilars*** (Institute for
International Research) – Boston, MA

October 22, 2013 – Patent 'Trolls' Under Fire: Strategies,
Tactics and Legislation Impacting University Patents & Licensing (Technology
Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

October
23, 2013 – European biotech patent law update (D
Young & Co) – 4:00 am, 7:00 am, 12:00 pm (EDT)

October 24, 2013 – Divided Patent Infringement and Inducement:
Protecting IP Rights — Latest Strategies for Drafting and Prosecuting Claims
and Allocating Liability (Strafford) – 1:00 to 2:30 pm
(EDT)

October 29, 2013 – IP Due Diligence in M&A Transactions —
Conducting IP Investigations and Leveraging Results During Deal Negotiations (Strafford) – 1:00 to 2:30 pm (EDT)

October 29-30, 2013 – European Patent Practice Seminar (John Marshall Law
School Center for Intellectual Property Law & Kuhnen & Wacker) – Chicago, IL

October
31, 2013 – Strategic Use of Patent Reissue After the AIA
— Correcting Errors in Patents, Determining Whether and When to Pursue a
Reissue Application, and Mastering the Recapture Rule (Strafford) – 1:00 to 2:30 pm (EDT)

November 4-5, 2013 – FDA Boot Camp Devices Edition*** (American Conference
Institute) – Chicago, IL

November 4-5, 2013 – Trade Secrets: Protecting Your Intellectual Capital and Confidential
Business Information*** (American Conference
Institute) – Chicago, IL

November 6-8, 2013 – 2013 Fall Intellectual Property
Counsels Committee (IPCC) Conference (Biotechnology
Industry Organization) – Washington, DC

November 7, 2013 – On Sale and Public Use Bars to Patentability
After AIA — Minimizing the Risk of Patent Ineligibility or Invalidation (Strafford) – 1:00 to 2:30 pm (EDT)

November 17-20, 2013 – Creating and Leveraging Intellectual Property in Developing Countries: A Power Tool for Social and
Economic Growth*** (Companies and IP Commission and National
IP Management Office of South Africa) – Durban, South Africa

November
19, 2013 – PTAB or the District Court: Which
Is the Better Option When Challenging Patent Validity? (McDonnell
Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

December 9-10, 2013 – Patent Infringement Litigation Summit (Legal iQ (IQPC)) – San Francisco, CA

December 10-11, 2013 – Advanced
Forum on Patent Litigation*** (American Conference
Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
Webinar on Patent Challenges before the PTAB

October 4, 2013

McDonnell
Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled
"PTAB or the District Court: Which
Is the Better Option When Challenging Patent Validity?" on November
19, 2013 from 10:00 am to 11:15 am (CT).
MBHB attorneys Alison J. Baldwin and Dr. Sarah E. Fendrick will provide
strategies to help guide participants in choosing the best invalidity
proceeding option for their clients. The
webinar will also address the following questions:

•
What are the similarities and differences between the various PTAB invalidity
proceedings?
•
What are the risks and benefits of the different PTAB proceedings?
•
Are PTAB proceedings a better option than the district courts?

While
there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of
California, Illinois, New Jersey, New York, North Carolina, and Virginia.
Webinar on Bars to Patentability After AIA

October 4, 2013

Strafford
will be offering a webinar/teleconference entitled "On Sale and Public Use Bars to Patentability
After AIA — Minimizing the Risk of Patent Ineligibility or Invalidation"
on November 7, 2013 from 1:00 to 2:30 pm (EDT).
Thomas L. Irving of Finnegan
Henderson Farabow Garrett & Dunner and Daniel G. Brown of Latham &
Watkins will examine the on sale and public use bars to patent
eligibility and the impact of the AIA on these statutory bars, as well as discuss
recent court treatment and offer best practices to minimize the risk of patent
ineligibility or invalidation. The
webinar will review the following questions:

• How do AIA changes impact the on sale bar and the
public use bar?
• How are courts treating the on sale bar and the
public use bar?
• What best practices can counsel employ to adapt
patent prosecution and enforcement strategies?

The
registration fee for the webinar is $297 ($362 for registration and CLE
processing). Those registering by October
11, 2013 will receive a $50 discount.
Those interested in registering for the webinar, can do so here.
European Patent Practice Seminar

October 4, 2013

The John Marshall Law
School Center for Intellectual Property Law will be hosting a European Patent Practice Seminar on
October 29-30, 2013 in Chicago, IL. The
seminar, which will be presented by the
German IP law firm of Kuhnen & Wacker, is part of the Center's
first-ever Patent Week. The seminar will
consist of the following sessions:

• Introduction to
the European Patent Convention
• EP Case Law of
Interest
• EP Claim
Drafting Specialties
• Opposition
• Unitary Patent
• Moderated Panel
Discussion: EPC (UPP) vs. AIA
• Patent
Infringement Litigation
• Unified Patent
Court
• Patent Filing
Strategies
• International
Patent Litigation
• Ethics Session

An agenda for the
seminar can be found here. Those interested in registering for the
conference online can do so here; the registration fee is $100
for one day and $195 for both days, $95 (government, judicial, and academic
rate), or free (JMLS students and faculty).
Webinar on Divided Patent Infringement and Inducement

October 4, 2013

Strafford
will be offering a webinar/teleconference entitled "Divided Patent Infringement and Inducement:
Protecting IP Rights — Latest Strategies for Drafting and Prosecuting Claims
and Allocating Liability" on October 24, 2013 from 1:00 to 2:30 pm
(EDT). Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner and
Sharon L. Davis of Rothwell Figg Ernst & Manbeck will provide
guidance on handling divided infringement claims when enforcing patent rights,
as well as review recent court decisions and outline steps to protect IP rights
and allocate liability in the event of infringement. The webinar will review the following
questions:

• How are the federal courts treating the issue of
divided infringement?
• What guidance is offered in recent decisions
concerning the agency relationship and infringement?
• What steps can companies and counsel take to
assess their risk when partnering with other companies to minimize potential
exposure?

The
registration fee for the webinar is $297 ($362 for registration and CLE
processing). Those interested in
registering for the webinar, can do so here.
California Biosimilar Bill Aligns with BIO Principles on Biologic Substitution

October 3, 2013

By Donald Zuhn —

Yesterday, we noted that the
Generic Pharmaceutical Association (GPhA) recently expressed its opposition to
a California bill (SB-598)
that would authorize a pharmacist to select a biosimilar when filling a
prescription order for a prescribed biological product, provided that the
prescriber did not personally indicate "Do not substitute" (see "GPhA Opposes California
Biosimilar Bill; Points to Report on Savings from Biosimilars"). The legislation would also
require that the substitution of a biosimilar be communicated to the patient,
and that the pharmacy notify the prescriber of the substitution or enter the
substitution into a patient record within five business days of the selection. The bill, which was passed by a 30-2 vote in the
California Senate on September 4, is now before Governor Jerry Brown.

When SB-598 was passed by
the Senate, Biotechnology Industry Organization (BIO) President and CEO Jim
Greenwood issued a statement
"commend[ing] California's Assembly and Senate for overwhelmingly passing
legislation that creates a pathway for the substitution of interchangeable
biologic medicines." He also noted
that because "the policies outlined in Senate Bill 598 align with BIO's
principles on biologic substitution," BIO supported the legislation and
encouraged Governor Brown to sign the bill.

In a letter
issued in January, BIO outlined its principles on the substitution of biologic
products. In its letter, BIO notes that
while the FDA will determine whether a follow-on biologic will achieve
biosimilar or interchangeable status under the Biologics Price Competition and
Innovation Act of 2009 (BPCIA), state law will govern whether one biologic
product may be substituted by a pharmacist when a different biologic product is
prescribed. In the letter, BIO also expresses
its belief that "a sound policy in each state outlining parameters for
safe substitution of interchangeable biologics is the best option to ensure
patients have access to high-quality, safe, and effective biologic medicines." The letter outlines two principle
safeguards and three additional safeguards to guide substitution policies for
interchangeable biologics under state law.
The two principle safeguards are as follows:

•
Substitution should occur only when the FDA has designated a biologic product
as interchangeable.
•
The prescribing physician should be able to prevent substitution.

And the three additional
safeguards are:

•
The prescribing physician should be notified of the substitution.
•
The patient, or the patient's authorized representative, should, at a minimum,
be notified of the substitution.
•
The pharmacist and the physician should keep records of the substitution.

SB-598 satisfies all five
safeguards outlined in BIO's letter, with pharmacies being given the option
under the legislation to either notify the prescriber of the substitution or
enter the substitution into a patient record within five business days of the
selection.

More recently, BIO provided
testimony
during a hearing before the Health Committee of the Pennsylvania House of
Representatives in support of HB 746,
a Pennsylvania biosimilar bill that would allow a pharmacist to substitute a
biosimilar product for a prescribed biological product only if:

(1) The biosimilar product
has been determined by the United States Food and Drug Administration to be
interchangeable with the prescribed product for the indicated use.
(2) The prescriber does not
designate verbally or in writing on the prescription that substitution is
prohibited.
(3) The person presenting
the prescription provides written consent for such substitution.
(4) The pharmacist notifies
the prescriber in writing and as soon as practicable but no later than 72 hours
after dispensing.
(5) The pharmacy and the
prescriber retain a written record of the biosimilar substitution for a period
of no less than five years.

With respect to the
Pennsylvania bill, BIO indicated that the legislation "gives pharmacists
the ability to substitute lower cost interchangeable biologic medicines while
also ensuring that patients and physicians have been notified of an appropriate
switch in their medication."
GPhA Opposes California Biosimilar Bill; Points to Report on Savings from Biosimilars

October 2, 2013

By Donald Zuhn —

Last week, the Generic
Pharmaceutical Association (GPhA) released a statement regarding a California
bill (SB-598)
that the GPhA asserted would "introduce[] burdensome provisions that could
raise costs and limit patient access to more affordable biosimilar medicines." The bill, introduced in February and now
before Governor Jerry Brown, would authorize a pharmacist to select a
biosimilar when filling a prescription order for a prescribed biological
product, provided that the prescriber did not personally indicate "Do not
substitute." The legislation would
also require that the substitution of a biosimilar be communicated to the
patient, and that the pharmacy notify the prescriber of the substitution or
enter the substitution into a patient record within five business days of the
selection.

The GPhA noted that a group
of more than thirty organizations, including CalPERS, AARP, California Pharmacists
Association, California Association of Health Plans, nine state labor unions, Kaiser
Permanente and some retail pharmacies, "oppose the burdensome notification
provisions in SB 598 and call upon Governor Brown to veto the legislation." The GPhA also noted that similar legislation
has been rejected in ten of the eighteen states where it has been considered and has only been passed with "significant amendments" in three states and with "Amgen
and Genentech-backed provisions intact in only one state (North Dakota)."

In opposing the California
bill, the GPhA points to a report from Express Scripts, which determined that the
potential 10-year saving to patients and payers in California from the
introduction of biosimilars on eleven biologics that are protected by U.S.
patents that have expired or will expire in the near future unless new patents
are granted would be approximately $27.6 billion. The report, entitled "Ten-Year Potential Savings from Biosimilars in California," and authored by Dr. Sharon
Glave Frazee, Dr. Susan Garavaglia, Jonah Houts, and Dr. Steve
Miller, looked at eleven brand biologic drugs that were
considered to be good candidates for the introduction of biosimilars over the
next ten years. The eleven biologics are listed in Table 1 of
the report:

Noting that "[t]he
projected unrealized saving is significant," the report states that the
potential savings "warrant[] regulatory and legislative consideration at
both federal and state levels to improve the pathway for biosimilar evaluation
and reject industry requests to enact legislative barriers to interchangeable
biosimilar substitution."

The GPhA indicated that the
report "reinforces the importance of improving the pathway for biosimilar
evaluation and rejecting requests to enact legislative barriers to
interchangeable biosimilar substitution," and "bolsters the argument
that adding hurdles to the biosimilar pathway only can do harm to patients,
payers and the general public."
USPTO Will Remain Open . . . for Now

October 1, 2013

By Donald Zuhn —

With day one of the latest
federal government shutdown nearly at an end, and with Washington bracing for a
prolonged government shutdown, the U.S. Patent and Trademark Office issued a notice
to applicants and practitioners regarding the status of Office operations for the next few weeks. The Office indicated it would remain open and
would be "using prior year reserve fee collections to operate as usual for
approximately four weeks." The
Office also indicated that it would continue to assess its fee collections as compared
to its operating requirements in order to determine how long it will be able to
operate in this capacity during the shutdown, adding that it would provide an
update as more definitive information becomes available.

If the shutdown continues
past the time the Office exhausts its reserve funds, the Office noted that it
"would shut down at that time, although a very small staff would continue
to work to accept new applications and maintain IT infrastructure, among other
functions." The notice directs
applicants and practitioners to the agency's plan
for "an orderly shutdown," which indicates that after its reserve
funds are exhausted:

[E]xcepted employees [at the USPTO] will
ensure the functionality of processes and systems minimally necessary for the
preservation of patent rights, to allow compliance with statutory provisions
that cannot be waived, and avoid disclosures of information that would be
detrimental to the national security. Additionally,
the excepted employees will ensure the functionality of processes and systems
minimally necessary to preserve trademark rights. Preventing the public from accessing the
USPTO's electronic filing and payments systems may result in the complete or
partial loss of intellectual property. Therefore,
in order to prevent the loss of valuable intellectual property, these systems
should remain open during any closure of the USPTO.

The plan provides a list of
106 of the Office's 11,789 employees who are excepted.

In addition to the above,
the Office noted
that the 18th Annual Independent Inventors conference, originally scheduled for
October 11-12, has been cancelled. The
Office hopes to reschedule the conference after the government resumes full
operation. The Office also noted that requests
for paper files have been temporarily suspended because those files are housed in
a federal facility which is owned and operated by the General Services
Administration (GSA), and which is closed during the shutdown.

According to Wikipedia,
the government shutdown that began earlier today is only the latest in a
series of such shutdowns, which includes eight full government shutdowns lasting
between one and three days apiece during the Reagan administration, a four day
shutdown during the first Bush administration, and two full shutdowns lasting
five and 21 days during the Clinton administration — the 21-day shutdown being the longest of any
government shutdown.
Rambus Inc. v. Rea (Fed. Cir. 2013)

September 30, 2013

A Little
Reminder to the PTO about Due Process and the Importance of Objective Evidence
of Non-Obviousness

By Alison Baldwin —

In its decision on September 24th, the Federal Circuit reminded
the Patent Office that the principles of due process are still alive and
kicking and cannot be ignored by the Patent Office's judiciary.

The case came to the Federal Circuit on appeal from a decision
by the USPTO's Board of Patent Appeals and Interferences (BPAI) holding invalid
various claims of U.S. Patent No. 6,260,097, which had been finally rejected as
invalid by the examiner during an inter partes
reexamination. The '097 patent relates
to dynamic random-access memory (DRAM). Specifically,
the claims are directed to what the assignee, Rambus, refers to as the "dual-edge/double-data-rate"
functionality because the system transfers data at twice the rate by employing
both the rising and falling edges of a clock signal that synchronizes the
operations within the system. While the
technology at issue in this case is outside the normal parlance of the
Patent Docs faithful, the issues raised by the Federal Circuit in its decision
are applicable to any technology.

Rambus appealed the Board's decisions on the issues of claim
construction and obviousness. The
Federal Circuit agreed with the Board's claim construction and, for purposes of
this post, we will not address the Court's claim construction analysis as it
was fairly routine. The real take-away
for the reader of the Rambus v. Rea decision were the three errors the
Federal Circuit found with the Board's obviousness decision.

The first error by the Board was a shifting the burden onto the
Patentee to prove that the claims were not obvious. In its opinion, the BPAI had concluded that "Rambus
ha[d] not demonstrated that skilled artisans . . . would not have been able to
arrive at the broadly claimed invention." Rambus v. Rea, p. 11, citing Board decision. As the Federal Circuit reminded the Patent
Office, the burden is the Office's, not the Applicants, to present evidence of
invalidity. This is particularly true in
a reexamination proceeding where "a preponderance of the evidence must
show nonpatentability before the PTO may reject the claims." Id. at 11. As we enter the new age of reexamination
under the inter partes review
process, this opinion serves as an important reminder to the new ALJs
empaneled as part of the Patent Trial and Appeal Board.

The second error by the Board was created when the Board
supplied its own reasons, that differed from those set forth previously by the
examiner, to combine the prior art references to arrive at its obviousness
determination. The Board may not rely on
new facts and rationales not previously raised to the applicant by the examiner
because the applicant has to have a "fair opportunity to react to the
thrust of the rejection." Id. at 12. If the applicant has not had an "fair
opportunity" to respond to the rejection, then the Board must designate
its decision a new ground of rejection and provide appellant with an
opportunity to respond. The Federal
Circuit did not issue an opinion on the merits of the Board's obviousness
determination — it just took issue with the procedure used. However, it was a good reminder to the BPAI
that these steps in the process cannot be skipped.

The final error by the Board was in its mistreatment of
objective evidence non-obviousness. The
Board took a very restrictive view of the nexus required between the evidence
and the merits of the claimed invention. First, Rambus presented uncontested evidence of long-felt need and industry
praise due to the claimed dual-edge data transfer functionality through an
industry article and a press release by a Rambus competitor. However, the Board held that this evidence
was not commensurate with the scope of the claims because the evidence
discussed only one embodiment of the claims. The Court reminded the BPAI that the objective evidence need only be "reasonably
commensurate with the scope of the claims." A patentee is not required to produce
objective evidence of nonobviousness for every potential embodiment of the
claim.

Rambus also presented uncontested evidence of commercial
success through its licensing activities relating to its dual-edge data
transfer functionality. The Board held
that the evidence lacked nexus because "competitors have many reasons for
taking licenses which are not necessarily related to obviousness." Id. at 15. The Federal Circuit took issue with the Board's position because there
was no evidence in the record to support that assertion that the commercial
value of the licenses stemmed from factors other than the claimed invention.

Finally, the Board held that all of the objective evidence of
non-obviousness presented by Rambus lacked a nexus because the "dual-edge
functionality" was disclosed in the prior art and, therefore, was not
novel. The Federal Circuit reminded the
BPAI that the obviousness inquiry must center around "the claimed
invention as a whole." Id. The Court held that the evidence presented by
Rambus was not limited to just the feature disclosed in the prior art. However, the Court declined to make a final
factual determination regarding the objective evidence and remanded back to the
PTO.

Viewing the Rambus v. Rea
decision in light of other recent Federal Circuit decisions this year, such as Plantronics, Inc. v. Aliph, Inc. (July
31, 2013), Apple Inc. v. ITC (August
7, 2013), and Leo Pharmaceutical Products
v. Rea (August 12, 2013), the Federal Circuit could not be sending a
clearer message to all judiciary involved in invalidity determinations. Objective evidence of non-obviousness is not
an optional component of the obviousness inquiry — it is absolutely required
and must be given its full consideration and weight.

Rambus Inc. v. Rea (Fed. Cir. 2013)
Panel: Circuit Judges Moore, Linn, and O'Malley
Opinion by Circuit Judge Moore
Court Report

September 29, 2013

By Sherri Oslick —

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

Pfizer Inc. et al. v. Apotex
Inc. et al.
1:13-cv-01613; filed September
25, 2013 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.;
Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing
Holdings LLC
• Defendants: Apotex Inc.; Apotex
Corp.

Infringement of U.S. Patent
No. 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of
Preparing Same," issued February 12, 2013), licensed to Pfizer, following
a Paragraph IV certification as part of Apotex's filing of an ANDA to
manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible,
used for the treatment of complicated skin and skin structure infections,
complicated intra-abdominal infections, and community-acquired bacterial
pneumonia). View the complaint here.

Merck Sharp & Dohme Corp. et
al. v. Ben Venue Laboratories Inc.
1:13-cv-01611; filed September
25, 2013 in the District Court of Delaware

• Plaintiffs: Merck Sharp
& Dohme Corp.; Millennium Pharmaceuticals Inc.
• Defendant: Ben Venue
Laboratories Inc.

Infringement of U.S. Patent
Nos. 5,807,825 ("Platelet Aggregation Inhibitors," issued September
15, 1998), 5,747,447 ("Stable Polypeptide Composition," issued May 5,
1998) and 5,968,902 ("Platelet Aggregation Inhibitors," issued
October 19, 1999), licensed to Merck, following a Paragraph IV certification as
part of Ben Venue's filing of an ANDA to manufacture a generic version of Merck's
Integrilin® (eptifibatide injection, used to treat acute coronary
syndrome). View the complaint here.

Helsinn Healthcare SA et al.
v. Ben Venue Laboratories Inc.
1:13-cv-01612; filed September
25, 2013 in the District Court of Delaware

• Plaintiffs: Helsinn
Healthcare SA; Roche Palo Alto LLC
• Defendant: Ben Venue
Laboratories Inc.

Infringement of U.S. Patent
Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron,"
issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), and
7,960,424 (same title, issued June 14, 2011) following a Paragraph IV
certification as part of Ben Venue's filing of an ANDA to manufacture a generic
version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution,
used to prevent chemotherapy induced nausea and vomiting). View the complaint here.

Cornerstone Therapeutics, Inc.
et al. v. Sandoz Inc.
1:13-cv-05723; filed September
25, 2013 in the District Court of New Jersey

• Plaintiffs: Cornerstone
Therapeutics, Inc.; Cornerstone Biopharma, Inc.; EKR Therapeutics, LLC
• Defendant: Sandoz Inc.

Infringement of U.S. Patent
Nos. 7,612,102 ("Pre-mixed, Ready-to-Use Pharmaceutical Compositions,"
issued November 3, 2009), 7,659,291 ("Methods of Treatment with Pre-Mixed,
Ready-to-Use Pharmaceutical Compositions," issued February 9, 2010),
8,455,524 (same title, issued June 4, 2013), and 7,659,290 ("Methods of
Preparing Pre-Mixed, Ready-to-Use Pharmaceutical Compositions," issued
February 9, 2010) following a Paragraph IV certification as part of Sandoz's
filing of an ANDA to manufacture a generic version of EKR's Cardene® I.V.
Premixed Injection (nicardipine hydrochloride premixed injection for
intravenous administration, used for the short-term treatment of hypertension
when oral therapy is not feasible or not desirable). View the complaint here.

Forest Laboratories Inc. et
al. v. Apotex Corp. et al.
1:13-cv-01602; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs: Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants: Apotex Corp.;
Apotex Inc.

Forest Laboratories Inc. et
al. v. Hetero USA Inc. et al.
1:13-cv-01603; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs: Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants: Hetero USA Inc.;
Hetero Labs Ltd. Unit V; Hetero Labs Ltd.

Forest Laboratories Inc. et
al. v. Lupin Limited et al.
1:13-cv-01604; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs: Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants: Lupin Ltd.;
Lupin Pharmaceuticals Inc.

Forest Laboratories Inc. et
al. v. Mylan Inc. et al.
1:13-cv-01605; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs: Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants: Mylan Inc.;
Mylan Pharmaceuticals Inc.

Forest Laboratories Inc. et
al. v. Par Pharmaceutical Inc.
1:13-cv-01606; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs: Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendant: Par
Pharmaceutical Inc.

Forest Laboratories Inc. et
al. v Ranbaxy Inc. et al.
1:13-cv-01607; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs: Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants: Ranbaxy Inc.;
Ranbaxy Laboratories Ltd.

The complaints in these cases
are substantially identical. Infringement
of U.S. Patent Nos. 6,602,911 ("Methods of Treating Fibromyalgia,"
issued August 5, 2003), 7,888,342 ("Methods of Treating Fibromyalgia
Syndrome, Chronic Fatigue Syndrome and Pain," issued February 15, 2011),
and 7,994,220 ("Milnacipran for the Long-Term Treatment of Fibromyalgia
Syndrome," issued August 9, 2011), all licensed to Forest, following a
Paragraph IV certification as part of defendants' filing of an ANDA to
manufacture a generic version of Forest's Savella® (milnacipran hydrochloride,
used in the management of fibromyalgia).
View the Apotex complaint here.

Counsyl, Inc v. Myriad
Genetics, Inc.
3:13-cv-04391; filed September
20, 2013 in the Northern District of California

Declaratory judgment of
noninfringement and invalidity of U.S. Patent Nos. 5,709,999 ("Linked
Breast and Ovarian Cancer Susceptibility Gene," issued January 20, 1998),
5,747,282 ("17-Q-Linked Breast and Ovarian Cancer Susceptibility Gene,"
issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 6,951,721 ("Method
for Determining the Haplotype of a Human BRCA1 Gene," issued October 4,
2005), 7,250,497 ("Large Deletions in Human BRCA1 Gene and Use Thereof,"
issued July 31, 2007), 5,837,492 ("Chromosome 13-Linked Breast Cancer
Susceptibility Gene," issued November 17, 1998), 6,033,857 (same title,
issued March 7, 2000), and 6,051,379 ("Cancer Susceptibility Mutations of
BRCA2," issued April 18, 2000) based on Counsyl's development and
anticipated launch of genetic tests and related services related to sequencing
and analysis of BRCAI and BRCA2 genes.
View the complaint here.

Senju Pharmaceutical Co. et
al. v. Sandoz Inc.
1:13-cv-06608; filed September
18, 2013 in the Southern District of New York

• Plaintiffs: Senju
Pharmaceutical Co.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma
Holdings Corp.
• Defendant: Sandoz Inc.

Infringement of U.S. Patent
Nos. 6,335,335 ("Prolonged-Action Eye Drop," issued January 1, 2002)
and 6,645,963 (same title, issued November 11, 2003) following a Paragraph IV
certification as part of Sandoz's filing of an ANDA to manufacture a generic
version of Senju's Istalol® (timolol maleate ophthalmic solution, 0.5%, used
treat elevated intraocular pressure in patients with ocular hypertension or
open-angle glaucoma). View the complaint here.

AbbVie Inc. et al. v. Hikma
Pharmaceutical Co Ltd. et al.
1:13-cv-01557; filed September
13, 2013 in the District Court of Delaware

• Plaintiffs: AbbVie Inc.;
Wisconsin Alumni Research Foundation
• Defendants: Hikma
Pharmaceutical Co Ltd.; West-Ward Pharmaceuticals Corp.; Exela Pharma Sciences
LLC

Infringement of U.S. Patent
No. 5,597,815 ("Prevention of Hyperphosphatemia in Kidney Disorder
Patients," issued January 28, 1997) following a Paragraph IV certification
as part of defendants' filing of an NDA (under § 505(b)(2) of the Food, Drug
and Cosmetic Act) to manufacture a generic version of AbbVie's Zemplar®
(paricalcitol, used to treat secondary hyperparathyroidism in patients with
kidney failure). View the complaint here.

Eli Lilly and Co. v. Sun
Pharmaceutical Industries Ltd. et al.
1:13-cv-01469; filed September
13, 2013 in the Southern District of Indiana

• Plaintiff: Eli Lilly and
Co.
• Defendants: Sun
Pharmaceutical Industries Ltd.; Sun Pharma Global FZE

Infringement of U.S. Patent
No. 7,772,209 ("Novel Antifolate Combination Therapies," issued
August 10, 2010) following a Paragraph IV certification as part of Sun's filing
of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for
injection, used to treat malignant pleural mesothelioma and locally advanced or
metastatic non-small cell lung cancer).
View the complaint here.

Jazz Pharmaceuticals, Inc. v. Amneal
Pharmaceuticals, LLC
2:13-cv-05450; filed September
12, 2013 in the District Court of New Jersey

Infringement of U.S. Patent
Nos. 8,457,988 ("Sensitive Drug
Distribution System and and Method," issued June 4, 0213) and 8,461,203 ("Microbiologically
Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of
Narcolepsy," issued June 11, 2013) following
a Paragraph IV certification as part of Amneal's filing of an ANDA to
manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat
narcolepsy). View the complaint here.

Merck, Sharp & Dohme Corp.
et al. v. Aurobindo Pharma Ltd. et al.
1:13-cv-05442; filed September
11, 2013 in the District Court of New Jersey

• Plaintiffs: Merck, Sharp
& Dohme Corp.; Bristol-Myers Squibb Co.; Bristol-Myers Squibb Pharma
Co.
• Defendants: Aurobindo Pharma
Ltd.; Aurobindo Pharma USA, Inc.

Infringement of U.S. Patent
Nos. 6,639,071 ("Crystal Forms of
(-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one,"
issued October 28, 2003), 6,939,964 (same title, issued September 6, 2005), and
6,673,372 ("Crystalline Efavirenz," issued January 6, 2004) following
a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture
a generic version of BMS' Sustiva® (efavirenz, used to treat HIV
infection). View the complaint here.

recent posts

about