A) Study in detail about Para - IV filing. B) Case studies for Para - IV Filing.

Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
EXPERIMENT NO.: DATE:
AIM: A) Study in detail about Para - IV filing.
B) Case studies for Para - IV Filing.
REFERENCES:
1) http://investor.mylan.com/releasedetail.cfm?ReleaseID=406712
2) http://www.law360.com/articles/62128/astrazeneca-files-ninth-suit-over-crestor-patent
3) http://www.ranbaxy.com/us/ranbaxy-and-pfizer-settle-lipitor-litigation-worldwide/
4) http://www.orangebookblog.com/2012/06/genzyme.html
5) http://www.pharmapatentsblog.com/2013/02/26/federal-circuit-upholds-cephalon-fentora-
patents/
6) http://www.ipfrontline.com/depts/article.aspx?id=25185&deptid=4
7) http://www.law360.com/articles/459143/mylan-infringed-cephalon-painkiller-patents-
judge-says
8) http://scholar.google.co.in/scholar?q=impurity+study+of+cinacalcet+HCL+bulk&hl=en&
as_sdt=0&as_vis=1&oi=scholart&sa=X&ei=8D9OUtaqLumaiAekuIDgDA&ved=0CCcQ
gQMwAA
THEORY:
A. PARAGRAPH - IV FILING
 INTRODUCTION
Generic drugs are important options that allow greater access to health care for
public. They are copies of brand-name drugs and are the same as those brand name drugs
in dosage form, safety, strength, route of administration, quality, performance
characteristics and intended use. Health care professionals and consumers can be assured
that FDA approved generic drug products have met the same rigid standards as the
innovator drug. All generic drugs approved by FDA have the same high quality, strength,
purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and
testing sites must pass the same quality standards as those of brand name drugs.

FDA Requirements for Generic Drugs
 Same active ingredients, same dosage form, same labelled strength, labelling as the
brand-name product.
 Generic drug manufacturers must show that a generic drug is bioequivalent to the
brand-name drug, which means the generic version delivers the same amount of
active ingredients into a patient's bloodstream in the same amount of time as the
brand-name drug.
 Generic drug manufacturers must fully document the generic drug's chemistry,
manufacturing steps, and quality control measures.
 Firms must assure the FDA that the raw materials and finished product meet
specifications of the U.S. Pharmacopoeia, the organization that sets standards for
drug purity in the United States.
 Firms must show that a generic drug will remain potent and unchanged until the
expiration date on the label.
 Firms must comply with federal regulations for good manufacturing practices and
provide the FDA a full description of facilities they use to manufacture, process,
test, package, and label the drug. The FDA inspects manufacturing facilities to
ensure compliance.
 HATCH WAXMAN (HW) ACT:
The Drug Price Competition and Patent Term Restoration Act of 1984, usually referred to
as the Hatch-Waxman Act, was designed to promote generics while leaving intact a
financial incentive for research and development. It allows generics to win FDA marketing
approval by submitting bioequivalence studies (as opposed to clinical data, which is
costlier to compile).
It also grants a period of additional marketing exclusivity to make up for the time a
patented pipeline drug remains in development. This extension cannot exceed five years,
and it is in addition to the 20 years exclusivity granted by the issuance of a patent.
Additionally, the generic manufacturer must file a certification regarding patents listed in
the Orange Book (also known as Approved Drug Products with Therapeutic Equivalence
Evaluations).

A paragraph IV certification states that the patent is invalid or will not be infringed and
begins a process by which that question may be answered by the courts prior to expiration
of the patent. Under Hatch-Waxman, FDA approval of an ANDA is automatically stayed
for 30 months when a patent owner files a patent infringement lawsuit within 45 days of
receiving a paragraph IV notification. During the stay, the FDA is prohibited from
approving another ANDA. Additionally, the first ANDA is granted a 180-day exclusivity
period, as an incentive whereby the generic company does not have competition from
other generic companies and can both establish market share and charge a higher price.
Although the net effect of HW on pharmaceutical innovation is ambiguous, its effect on
generic drug development has been explicit, and the effect on consumers has been
beneficial. Hatch-Waxman resulted in increased ANDA applications and paragraph IV (P-
IV) challenges, especially since 1998. There has also been a high success rate for patent
invalidation, particularly formulation and polymorph patents. Since Hatch-Waxman,
virtually all top-selling drugs not covered by patent face generic competition; whereas
pre–Hatch-Waxman, only 35% had generics available. Similarly, today more than 70% of
prescriptions are for generics.
An unexpected consequence resulting from HW, especially over the past 10 years, has
been the filing of patent applications by generic companies and increased generic research
and development for branded products. Table-1 represents the major loopholes in HW act.
Table No. – 1: Major loopholes in HW Act
Major loopholes of Hatch Waxman Act
1 Sharing of 180 days exclusivity by several generic manufacturers
2 Filing “Citizen petition” to freeze the ANDA application
3 Risky generic launch strategies
4 No prohibition against “Authorized generics”
Hatch Waxman (HW) amendments:
HW was amended several times to close these loopholes and/or decrease generic drug
approval times. Additionally, over the years, the FDA issued many guidance documents
clarifying Hatch- Waxman with the goals of reducing generic approval time; improving
ANDA application quality to avoid multiple review cycles; avoiding time-consuming legal

delays; and closing “loopholes” which delayed competition. Unfortunately,
anticompetitive strategies and loopholes continue today and fuel the momentum for further
legislative Hatch-Waxman reform. HW act amendments were listed below.
Amendments of Hatch Waxman Act
1. Medicare prescription drug, Improvement and Modernization Act of 2003(MMA).
2. FDA Amendments act of 2007.
3. QI programme supplemental funding Act of 2008.
 ANDA SUBMISSION AND APPROVAL PROCESS:
An Abbreviated New Drug Application (ANDA) contains data which when submitted to
FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for
the review and ultimate approval of a generic drug product. Once approved, an applicant
may manufacture and market the generic drug product to provide a safe, effective, low
cost alternative to the public.
When patent information is submitted for a new drug application the patent information is
included in the Orang Book. Through the abbreviated new drug application (“ANDA”)
process, a party may obtain FDA approval of generic drugs without clinical trials if the
drug is a bioequivalent of a drug previously granted NDA approval. ANDA approval
requires that an applicant make a patent certification “with respect to each patent issued by
the United States Patent and Trademark Office that, in the opinion of the applicant and to
the best of its knowledge, claims the reference listed drug or claims a use of such listed
drug for which the applicant is seeking approval Certification requires the ANDA
applicant to state that:
(1) The NDA holder submitted no patent to the FDA;
(2) Any patent submitted has expired;
(3) The date the applicable patent expires; or
(4) That “the patent is invalid, unenforceable, or will not be infringed by the manufacture,
use, or sale of the drug product for which the abbreviated application is submitted.”

Patent Exclusivity
ANDA has four types of submissions, Paragraph-I (P-I): patent information relating to the
innovator drug has not been filed; Paragraph-II (P-II): the patent has expired; Paragraph-
III (P-III): ANDA will be approved after the particular patent expires and Paragraph-IV
(P-IV): Challenging a particular patent that is listed by the Innovator in the "Orange
Book."
Figure 1: Parts of ANDA submission
Paragraph IV (P-IV) Certification
The basis of P-IV certification is The Drug Price Competition and Patent Term
Restoration Act that came to be known as the “Hatch-Waxman Act.”
The Hatch-Waxman rules created processes and incentives for both branded and generic
companies involving challenges to patents.
 Branded pharmaceutical companies are required to list patents involving composition
of matter (substance), formulation, and method of use in the Food and Drug
Administration “s (FDA) Orange Book.
 When applying to enter the market with a generic form of a reference product, the
generic company files an Abbreviated New Drug Application (ANDA) and certifies
against patents listed in the Orange Book. The certification states that its generic
ANDA
Submission
Para I
No Listed Patents
Para II
Listed Patents has expired
Para III
Patent will expire on perticular date
Para IV
Patent is invalid or will not be infringed by the
drug, for which approval is being sought

product does not infringe on the listed patents or that those patents are not enforceable,
called a Paragraph IV filing.
 If the generic company files an ANDA with a Paragraph IV certification, then the
branded company is notified within 20 days. After the notice, the branded company
has 45 days to file a patent infringement action against the generic company. After the
suit has been filed, the FDA cannot approve of the application until the generic
company successfully defends the suit or until 30 months, whichever comes first.
 “30 MONTH STAY” PERIOD
In patent litigations between branded pharmaceutical companies and generic
manufacturers, where the generic company files a P-IV certified ANDA and is attempting
to sell a product that is equivalent to the branded company’s product, much of the
litigation focus and drama revolves around the so-called “30-month” FDA stay date.
Under the HW Act, once the branded pharmaceutical company files a timely complaint,
the FDA will not grant the generic company final approval of its product for “30-months,”
absent a court decision that the patent is not infringed, invalid or unenforceable.
USFDA-ANDA Paragraph-IV applicant
CTD Submission
(Hard copy)
eCTD submission
through ESG
Submission
rejection
FDA
Acceptance
Letter
Submission
Rejection
ANDA applicant raises the letter to innovator by
explaining existing patent is invalid

Figure 2: Paragraph IV submission and 30 months stay.
 180 Days Market ‘EXCLUSIVITY”
HW Act provides an incentive of 180 days market exclusivity to the “first” ANDA
applicant who challenges a listed patent by filing a paragraph IV certification and thereby
runs the risk of having to defend a patent infringement suit. After USFDA approval and
successful court litigations, begins commercial marketing of the generic drug product with
180 days market exclusivity. In some cases, a generic manufacturer who obtains 180-day
exclusivity may be the sole marketer competing with the brand product for market share
In some cases, if there is no court decision and the first applicant does not begin
commercial marketing of the generic drug, there may be prolonged or indefinite delays in
the beginning of the first applicant’s 180-day exclusivity period. Until an eligible ANDA
applicant’s 180-day exclusivity period has expired, FDA cannot approve subsequently
submitted ANDAs for the same drug. This is possible even if the later ANDAs are
otherwise ready with tentative approval and the sponsors are willing to begin marketing
immediately. Therefore, an ANDA applicant who is eligible for exclusivity can often
delay other generic competition for the brand product by delaying the market entry.
Innovator can file a patent infringement lawsuit,
even if authentic claim by the ANDA applicant
Suit on ANDA No suit on ANDA
30 months stay is
effective
No 30 months stay, FDA
will give the approval

Only a “first” ANDA applicant filing a paragraph IV certification shall be eligible for
exclusivity. If an applicant changes from a paragraph IV certification to a paragraph III
certification, for example, upon losing its patent infringement litigation, the ANDA will no
longer be eligible for exclusivity.
The 180-day exclusivity provision has been the subject of considerable litigation and
administrative review in recent years, as the courts, industry, and FDA have sought to
interpret it in a way that is consistent both with the statutory text and with the legislative
goals underlying the HW Amendments. A series of Federal court decisions beginning with
the 1998 Mova case describe acceptable interpretations of the 180-day exclusivity
provision, identifying potential problems in implementing the statute, and establish certain
principles to be used by the Agency in interpreting the statute. As described in June 1998
guidance for industry, FDA currently is addressing on a case-by-case basis those 180-day
exclusivity issues not addressed by existing regulations.
One of the most basic changes to the 180-day exclusivity program, in view of the legal
challenges to FDA’s regulations, is the determination by the courts of the meaning of the
phrase “court decision.” The courts have determined that the “court decision” that can
begin the running of the 180-day exclusivity period may be the decision of the district
court, if it finds that the patent at issue is invalid, unenforceable, or will not be infringed
by the generic drug product. FDA had previously interpreted the “court decision” that
could begin the running of 180-day exclusivity (and the approval of the ANDA) as the
final decision of a court from which no appeal can be or has been taken - generally a
decision of the Federal Circuit. FDA’s interpretation had meant that an ANDA applicant
could wait until the appeals court had finally resolved the patent infringement or validity
question before beginning the marketing of the generic drug.
FDA had taken this position so that the generic manufacturer would not have to run the
risk of being subject to potential treble damages for marketing the drug, if the appeals
court ruled in favor of the patent holder. The current interpretation means that if the 180-
day exclusivity is triggered by a decision favorable to the ANDA applicant in the district
court, the ANDA sponsor who begins to market during that exclusivity period now may
run the risk of treble damages if the district court decision is reversed on appeal to the

Federal Circuit. As a practical matter, it means that many generic applicants may choose
not to market the generic and thus the 180-day exclusivity period could run during the
pendency of an appeal.
B. CASE STUDIES PARA-IV FILING:–
1. Andrx, Sciele Sue Lupin Over Diabetes Drug ANDA
Law360, New York (January 16, 2009, 12:00 AM ET) -- Andrx Corp. and Sciele Pharma
Inc. have accused Lupin Ltd. of infringing two patents related to type 2 diabetes treatment
Fortamet after Lupin sought approval to make a generic version of the pill prior to the
expiration of the patents. Andrx, which own the patents-in-suit, and Sciele, which licenses
the patents, sued Lupin and its subsidiary, Lupin Pharmaceuticals Inc., in the U.S District
Court.
According to the complaint, Andrx is the owner of the patents-in-suit, titled “Controlled
release oral tablet having a unitary core” and “Controlled release metformin
compositions,” which covers extended-release metformin hydrochloride tablets. The
tablets, marketed by Sciele under the brand name Fortamet, can be used to improve
glycemic control in adults with type 2 diabetes as an adjunct to diet and exercise,
according to the complaint. Lupin filed an ANDA that included certification with respect
to the patents-in-suit, seeking approval to make and sell 500 mg and 1000 mg metformin
hydrochloride tablets, and soon after sent a letter to Andrx notifying the companies of its
intent, the complaint says. The plaintiffs accuse Lupin of knowingly infringing the
patents-in-suit by submitting the ANDA and certification to the FDA. Andrx and Sciele
are seeking a permanent injunction barring Lupin from making or selling a generic version
of Fortamet prior to the expiration dates of the patents-in-suit, an order that no ANDA be
approved for the generic until the patents expire, attorneys' fees, and other costs. A
representative for Lupin said the company had no comment on the suit, and an attorney for
Andrx did not immediately respond to a request for comment. Watson Pharmaceuticals
Inc. acquired Andrx in 2006 for about $1.9 billion, resulting in the merger of the
pharmaceutical companies' patent portfolios. Japan-based pharmaceutical
manufacturer Shionogi & Co. Ltd. acquired Sciele in October. Earlier this week, Watson,

which makes and markets a number of generic drugs, reached a settlement with Warner
Chilcott Ltd. to make generic versions of the birth control pills Loestrin 24 and Femcon
Fe, starting no later than 2014 and 2013, respectively. That settlement ended pending
litigation over two patents related to the pills in the U.S. District Court for the District of
New Jersey.
2. Mylan Wins Omeprazole Patent Litigation against Astrazenneca
Mylan Laboratories Inc. (NYSE: MYL) announced today that the United States District
Court for the Southern District of New York has ruled that Mylan's 10 mg and 20 mg
omeprazole delayed-release capsules, which are the generic versions of AstraZeneca LP's
Prilosec (R), do not infringe patents asserted against it by AstraZeneca. The Court also
found that omeprazole products from Apotex and Impax do infringe the same patents
asserted against Mylan. Mylan launched its omeprazole products on August 4, 2003
despite the patent infringement litigation, which at the time was unprecedented in the
generic pharmaceutical industry. Mylan Laboratories Inc. is a leading pharmaceutical
company with three principle subsidiaries, Mylan Pharmaceuticals Inc., Mylan
Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix
Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and
distributes an extensive line of generic and proprietary products.
3. Ranbaxy and Pfizer settle Lipitor litigation worldwide
Ranbaxy Laboratories Limited (Ranbaxy), announced today that it has entered into an
agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving
Atorvastatin (Lipitor), the world’s most-prescribed cholesterol-lowering medicine. This
decision will allow for an earlier introduction of a generic formulation that will benefit
patients and many healthcare systems throughout the world. Lipitor is the world’s largest
selling drug with worldwide sales in 2007 of $12.7 billion.
The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal
challenges to the Lipitor patents involving other generic manufacturers. However, as
Ranbaxy was the first generic challenger to the listed Lipitor patents, it retains the right to
the marketing exclusivity of 180 days in the United States. Under the terms of the
agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and the

fixed-dose combination of Atorvastatin-Amlodipine besylate in the United States effective
Nov. 30, 2011.
Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7
countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and
Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in
Malaysia, Brunei, Peru and Vietnam.
In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be
dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the
fixed dose combination product containing Atorvastatin and amlodipine will be dismissed
in the U.S. and Ranbaxy will no longer contest the validity of Pfizer’s patents in such
countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in
numerous markets since 2003.
The Atorvastatin patents involved in this agreement are the basic compound patent, which
expires in the United States in 2010; the enantiomer patent, which expires in the United
States in 2011; and various process and crystalline form patents, which expire in 2016 and
2017; and the combination patent for fixed-dose combination product which expires in
2018.
The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine
besylate, a fixed-dose combination product indicated for patients suffering from both high
blood pressure and high levels of cholesterol. The patent for the fixed-dose combination
expires in 2018. The settlement also resolves additional patent litigation between the
companies involving the branded drugs Accupril (in the U.S.) and Viagra (in Ecuador) and
all patent litigation with Ranbaxy relating to generic formulation of Quinapril
hydrochloride in the United States and Sildenafil in Ecuador.
Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other
European countries — Finland, Spain, Portugal, Denmark and Romania.
4. District Court Finds Inducement of Infringement in Doxercalciferol Case
The U.S. District Court for the District of Delaware found in favor of Genzyme and
against ANDA applicants Roxane, Sandoz, and Anchen in the paragraph IV litigation
concerning HECTOROL (doxercalciferol), Genzyme's drug for the treatment of secondary

hyperparathyroidism (SHPT) in patients with end-stage renal disease (ESRD). The court
ruled that defendants' ANDA products would induce infringement of claims 7 of U.S.
Patent No. 5,602,116; that claim 7 is entitled to a 1988 priority date; and that claim 7 is not
invalid as "inoperative" or obvious. This post focuses on the inducement issue.
Claim 7 of the '116 patent is directed to:
A method for lowering or maintaining lowered serum parathyroid hormone [PTH] in
patients suffering from hyperparathyroidism secondary to end stage renal disease,
comprising: administering to said patients an effective amount of [doxercalciferol] to
lower and maintain lowered serum parathyroid hormone levels.
After a Markman hearing, the court construed the term "effective amount of
doxercalciferol to lower and maintain lowered serum parathyroid hormone levels" to mean
"an amount of doxercalciferol sufficient to lower and maintain lowered blood
concentrations of PTH with a lower incidence of hypercalcemia than would result from
using calcitriol or alfacalcidol to achieve the same level of PTH suppression."
After concluding that claim 7 would be directly infringed by the defendants' ANDA
products (a predicate to finding inducement of infringement), the court addressed whether
the defendants have the required intent to induce infringement. The key issue here was
whether the defendants intend to induce infringement of claim 7 notwithstanding that their
proposed labeling says nothing about the incidence of hypercalcemia resulting from
doxercalciferol relative to the incidence resulting from calcitriol or alfacalcidol.
The court thus concluded:
With respect to the specific intent element of inducement, the court concludes that the
plaintiffs have sufficiently shown that the defendants "knew or should have known their
actions would induce actual infringements." In this case, all defendants filed ANDAs with
the FDA seeking approval to market a doxercalciferol product that would be sold
accompanied by information instructing physicians and medical professionals to
administer doxercalciferol according to the method explained in claim 7 for treating SHPT
in patients with ESRD. This FDA-approved indication is the same use set forth in claim 7
of the patent-in-suit . . . .
The court concludes that, based on the clinical trials and literature available, the

defendants knew or should have known that doxercalciferol has been shown to lower and
maintain lowered PTH levels with a lower incidence of hypercalcemia than would result
from using calcitriol or alfacalcidol at the same level of PTH suppression. Thus, the court
concludes that the defendants, in submitting their ANDAs, knew or should have known
that their proposed products would induce actual infringement of claim 7. The court finds
this level of intent sufficient for inducement purposes
5. Federal Circuit Upholds Fentora Patents, But Affirms Non- Infringement
In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district
court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product
were invalid, but affirmed the district court’s finding that Watson’s ANDA product would
not infringe the patents. The Federal Circuit decision reviews the “undue experimentation”
standard for lack of enablement, and underscores the importance of aligning evidence of
infringement with the governing claim construction.
The Patents At Issue
The two Orange Book-listed patents at issue were U.S. Patent 6,200,604 and U.S. Patent
6,974,590. The patents are directed to methods of administering a drug across the oral
mucosa. The methods use formulations comprising effervescent agents that promote
penetration across the buccal, sublingual, and gingival mucosae.
The ANDA Litigation
FENTORA® is a fentanyl buccal tablet approved for the treatment of breakthrough cancer
pain. As set forth in the Federal Circuit decision, FENTORA® contains fentanyl citrate,
mannitol, sodium starch glycolate, magnesium stearate, citric acid, sodium bicarbonate,
and sodium carbonate, with the sodium bicarbonate and citric acid forming an effervescent
couple that reacts to evolve carbon dioxide.
Watson filed an Abbreviated New Drug Application (“ANDA”) seeking approval to
market a generic version of FENTORA®, and including a Paragraph IV certification
against the patents. As set forth in the Federal Circuit decision, Watson’s ANDA products
contain the active ingredient fentanyl citrate and the inactive ingredients mannitol, sodium

starch glycolate, potassium bicarbonate, and magnesium stearate.
In response to Watson’s Paragraph IV certification, Cephalon, Inc. and CIMA Labs, Inc.
(collectively, “Cephalon”) brought suit in the U.S. District Court for the District of
Delaware. The district court found that the patents were invalid for lack of enablement and
would not be infringed by Watson’s product. On appeal, the Federal Circuit reversed on
enablement and affirmed on non-infringement.
Enablement
As noted above, the district court construed “effervescent agent” as requiring the presence
of a single compound that “evolves gas by means of an effervescent reaction.” The
enablement issue therefore turned on whether the patents enabled methods where the
soluble acid source of the effervescent reaction is administered in a separate dosage form
from the effervescent agent.
Non-Infringement
The infringement issue turned on whether the potassium bicarbonate and mannitol in the
Watson products would undergo an effervescent reaction in saliva. Because Cephalon only
had provided evidence on the acid properties of mannitol in water, the Federal Circuit
upheld the district court’s finding of non-infringement.
Thus, Cephalon was able to restore the validity of these patents. And, even though
Cephalon lost on the infringement claims, according to Watson’s press release, a third
patent will keep Watson’s ANDA products off the market until October of 2019.
6. Preliminary Injunction Ordered in POZEN Treximet Patent Litigation
POZEN Inc. announced April 15 that the U.S. District Court for the Eastern District of
Texas has granted a preliminary injunction ordering Par Pharmaceutical Inc. not to make,
use, sell, offer to sell, or import into the United States a generic version of
sumatriptan/naproxen sodium that competes with Treximet(R) (sumatriptan and naproxen
sodium) sold by GlaxoSmithKline in the United States under an exclusive license from the
Company.

The order was entered in connection with the patent infringement lawsuit pending among
the Company and Par, Alphapharm Pty Ltd., Teva Pharmaceuticals USA, Inc., and Dr.
Reddy's Laboratories, Inc. relating to the submission to the U.S. Food and Drug
Administration (FDA) of Abbreviated New Drug Applications by the four generic
companies and the generic companies' plans to market sumatriptan and naproxen sodium
products pursuant to such ANDAs, which the Company contends infringe three of its
patents covering Treximet. Teva was dismissed without prejudice from the consolidated
litigation in April 2010. The case against the other three defendants was tried before Judge
Leonard Davis in the Eastern District of Texas on October 12-15, 2010. A decision is
pending in the case.
The injunction will remain in effect until a final decision is issued in the pending patent
litigation. The Company continues to believe that its patents covering Treximet are valid
and enforceable, and that these beliefs will be upheld by the Court.
7. Mylan Infringed Cephalon Painkiller Patents, Judge Says
Law360, New York (July 22, 2013, 6:50 PM ET) -- A Delaware federal judge on Monday
ruled that Mylan Pharmaceuticals Inc. infringed three patents for Cephalon Inc.'s cancer
painkiller drug Fentora, saying the former company's proposed generic version of the drug
includes components coverby the patents.
U.S. District Judge Sue Robinson said in a Monday order that Mylan infringed U.S. Patent
Numbers 6,200,604; 6,974,590; and 8,119,158, through its attempts to market a generic
version of Fentora. Judge Robinson also found that the 158 patent and another related
patent, U.S. Patent Number 8,092,832, are valid.
The patents, which Cima Inc. owns and licenses exclusively to.

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