In This Issue
· Delaware
District Court Ruling Allows Generics To Bypass Crestor® Patents
· Shionogi and CIMA Sue Mylan over Generic
Orapred ODT®
· European
Commission Announces That It Will Review 2010 Patent Deals For Potential
Problems
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Delaware
District Court Ruling Allows Generics To Bypass
Crestor® Patents
In AstraZeneca Pharmaceuticals v. Apotex, the United States District
Court for the District of Delaware recently issued an order allowing several
generic drug makers to continue pursuing approval for their generic versions
of AstraZeneca’s blockbuster cholesterol drug Crestor®, holding that the
companies’ applications would not violate patents on the drug. Specifically, the Delaware District Court
held that the ANDAs, including those held by Apotex and Teva Pharmaceutical
Industries, seeking approval for unclaimed methods of use of Crestor®
(rosuvastatin calcium), do not infringe AstraZeneca’s
U.S. Patent Nos. 6,858,618 and 7,030,152 (the ‘618 patent and ‘152 patent),
which are listed in the Orange Book for Crestor®.
By way of background,
Crestor® is approved for the treatment of various cholesterol-related
conditions, including hyperlipidemia, hypertriglyceridemia, homozygous
familial hypercholesterolemia (HoFH) and heterozygous familial
hypercholesterolemia (HeFH), and for the prevention of cardiovascular disease
in patients with elevated levels of C-reactive protein. The ‘618 and ‘152 patents are directed to
the last two indications, but do not cover the first three indications. The ANDAs do not seek approval to market
the generic version of Crestor® for the covered indications.
AstraZeneca had argued that,
if the FDA approved the Crestor® ANDAs, it would require the generic drug
makers to change their labels to match those of the brand drug, thus
infringing the ‘618 and ‘152 patents. The Delaware District Court disagreed stating that “Because the
Hatch-Waxman Act allows ANDAs to carve out FDA-approved indications, and
because there is no reason to believe that the FDA will not continue to
approve qualified ANDAs, plaintiffs’ claims are based on contingent future
events that are unlikely to occur.” If
this ruling is affirmed, it would allow the generic drug manufacturers to
bypass the ‘618 and ‘152 patents on Crestor®, which expire in 2018 and 2022,
thereby knocking, at least, two years off the drug’s exclusivity. AstraZeneca has indicated that it intends
to appeal the Delaware District Court’s ruling.
Shionogi and CIMA Sue Mylan over
Generic Orapred ODT®
Shionogi Pharma, Inc. and
CIMA Labs, Inc. recently filed a patent infringement suit against Mylan
Pharmaceuticals in the United States District Court for the District of
Delaware, in response to Mylan’s ANDA, with Paragraph IV certification,
seeking to market generic 15 mg and 30 mg versions of Shionogi’s anti-inflammatory
drug Orapred ODT® (prednisolone). Shionogi claims that Mylan’s proposed generic versions of Orapred ODT®
infringe U.S. Patent No. 6,740,341 (the ‘341 patent), which is directed to a
taste masking rapid release coating system to provide effective taste masking
for in mouth dosage forms that contain highly objectionable tasting drugs;
the ‘341 patent expires in November 2019.
Shionogi has also requested
that the Delaware District Court issue an injunction preventing Mylan from
marketing its generic versions of Orapred ODT®, which had a market share of
roughly $28 million for the year period ending September 30, 2010.
European Commission Announces That It Will Review
2010 Patent Deals For Potential Problems
The European Commission (EC)
has announced that it has requested copies of all 2010 patent-settlement
agreements from some pharmaceutical companies to ensure generic medicines are
not being delayed from the market. The
EC further announced that it plans to publish a report detailing its findings
in the first half of 2011.
As part of this review, the
EC will review all agreements, annexes thereto, related agreements and
amendments, and if the EC believes that a patent settlement raises concerns
including delay, the agency will conduct a more detailed and targeted
investigation of that agreement. This
review is expected to be similar to the EC’s 2009 review, which the EC noted
showed a decrease in the number of potentially problematic patent
settlements. The number of such
agreements fell from 22 percent in previous years to 10 percent, and the
payments involved in the settlements decreased from more than $266 million to
less than $1.3 million. However, the
EC’s findings did show that some generic drugs were being delayed through such
settlement agreements.
The EC has specifically
stated that “The outcome of our first [2009] monitoring exercise showed that
potentially problematic agreements had decreased significantly since the
Commission’s sector inquiry,” and that “The 2011 monitoring exercise is
important to assess whether this positive trend is confirmed and to identify
potentially problematic patent settlements.” |
