Greenblum & Bernstein, P.L.C.



Recent News in Intellectual Property


                                                                                                          January 2011   

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.”

The GREENBLUM & BERNSTEIN NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property.  The NEWSLETTER provides monthly updates on recent issues of general interest in this field.  The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC.  Information regarding the contents of the Newsletter can be obtained by contacting P. Branko Pejic at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191.  Copyright 2011 GREENBLUM & BERNSTEIN, P.L.C. [01112331.DOC