Patent Law Practice Center

Actavis Announces Daytrana® Patent Challenge Settlement

On March 19, 2014, Actavis plc (NYSE: ACT) announced that it entered into an agreement with Noven Pharmaceuticals, Inc. to settle all outstanding patent litigation related to Actavis’ generic version of Daytrana® (Methylphenidate Transdermal System).  Daytrana® is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder. For the 12 months ending December 31, 2013, Daytrana® had total U.S. sales of approximately $98 million, according to IMS Health data.

The ultimate launch of Actavis’ product is, however, contingent upon Actavis receiving final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for generic Daytrana®.

This patent dispute in fact arose out of the filing of the ANDA by Actavis. An ANDA applicant must make one of four certifications regarding each patent that applies to the drug for which approval is being sought: (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is invalid or will not be infringed by the drug covered in the ANDA.

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FDA Designates Orphan Drug Status for Rare Diseases

The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. At the time of the enactment of the Orphan Drug Act, the United States Congress made several factual findings.  For example, the Congress observed that there are many diseases and conditions, such as Huntington’s disease, ALS (Lou Gehrig’s disease), Tourette syndrome, and muscular dystrophy, for example, which affect such small numbers of individuals that the diseases and conditions are considered rare in the United States.  As a result, adequate drugs have not been developed and realistically cannot be expected to be developed because companies would likely incur a financial loss in the pursuit of such drugs, given the high cost of developing drugs.

Back in the early 1980s when the Orphan Drug Act passed, Congress made the determination that a seven (7) year period of exclusivity was appropriate if a company produced a drug to treat a rare disease that affects less than 200,000 people in the United States.  Orphan designation is also possible if a disease affects more than 200,000 people if it can also be shown that there is no reasonable expectation that the cost of developing the drug could be recouped absent this period of exclusivity. This “patent-like” exclusivity is available even if the drug is not novel and non-obvious.

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Forest Labs sues over Generic Version of SAVELLA®

Forest Laboratories, Inc. (NYSE:FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced the filing of patent infringement lawsuits in the U.S. District Court for the District of Delaware against Apotex Corp.; Hetero USA Inc.; Lupin Ltd.; Mylan Pharmaceuticals, Inc.; Par Pharmaceuticals, Inc.; Ranbaxy Laboratories Ltd.; and related companies and subsidiaries. The complaint alleges the aforementioned companies are infringing U.S. Patent No. 6,602,911 (“the ‘911 patent”), U.S. Patent No. 7,888,342 (“the ‘342 patent”), and U.S. Patent No. 7,994,220 (“the ‘220 patent”), which relate to Forest’s SAVELLA^® product. Forest licenses the ‘911 patent, the ‘342 patent, and the ‘220 patent from Royalty Pharma.

Forest and Royalty Pharma received notification from these companies that they had filed Abbreviated New Drug Applications with Paragraph IV certifications seeking approval to market generic versions of SAVELLA before the expiration of the ‘911 patent, the ‘342 patent, and the ‘220 patent. The lawsuits were commenced before the expiration of 45 days from the date of receipt of each notification letter.

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Cost Benefits Of Concurrent Patent Reexamination

The following post comes from Scott A. Mckeown, Partner at Oblon Spivak, Practice Center Contributor and writer for Patents Post Grant.

Court Lists Practical Efficiencies of Patent Reexamination

In attempting to stave off a motion to a district court litigation pending patent reexamination, the opposing party (almost always the Patentee) will often characterize a parallel patent reexamination as an “all or nothing proposition.” That is to say, in the face of the argument that the patent reexamination is likely to simplify issues for trial (almost always a defendant argument), the opponent will insist that USPTO statistics demonstrate that it is very unlikely that all claims will be canceled.

In Genzyme Corp., v Cobrek Pharmaceuticals Inc., (NDIL, Order 2/17/11), the relatively rare case of a Patentee requested stay was at issue. In deciding to stay the district court proceeding based on the familiar factor based analysis, the court found that simplification of issues was likely. In doing so, the court created a list of discovery efficiencies, potential cost savings, and case management benefits to be gained from awaiting the outcome of the USPTO action. (more…)