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PHARMA BIOTECH/BIOSIMILAR

PRACTICE GROUP NEWSLETTER

Recent News in Intellectual Property

                                                                                            September 2014

In This Issue

·    A new Orphan Drug Battle:

The District Court ordered FDA to recognize orphan drug exclusivity without requiring any proof of clinical superiority or imposing any additional conditions on its owner

·    News

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A new Orphan Drug Battle: The District Court ordered FDA to recognize orphan drug exclusivity without requiring any proof of clinical superiority or imposing any additional conditions on its owner

In Depomed Inc. v. United States Department of Health And Human Services, the U.S. District Court of Columbia granted Depomed’s Motion for Summary Judgment and ordered FDA to recognize orphan drug exclusivity for GRALISE Tablets “without requiring any proof of clinical superiority or imposing any additional conditions on Depomed”.

Plaintiff Depomed has developed an orphan drug, called “GRALISE”, to treat a rare condition known as post-herpetic neuralgia (“PHN”). On January 28, 2011, FDA approved this drug product under NDA No. 022544 for the designated indication. Despite having designated GRALISE as an orphan drug for the approved indication, FDA did not grant orphan drug exclusivity because the FDA’s Orphan Drug Regulations were not met.

According the FDA’s orphan drug regulations, a “sponsor of a drug that is […] the same drug as an already approved orphan drug may seek and obtain orphan-drug designation […] if it can present a plausible hypothesis that its drug may be clinically superior to the first drug”.

If the new drug is shown to be “clinically superior” to the previous orphan drug which has the exclusivity – i.e. the new drug is shown to have greater efficacy, greater safety, or providing a major contribution to patient care compared to the previously approved drug – then the drug is not considered to be the same and the FDA may approve it notwithstanding the exclusivity period.

The new drug has to be a drug that contains the same active moiety as the previously approved drug and is intended for the same use with the exception that the subsequent drug can be shown to be clinically superior to the previous drug.

Because Depomed did not prove clinical superiority, FDA denied orphan drug exclusivity.  Depomed filed this action.

The court held that the plain language of the exclusivity provision of the Orphan Drug Act requires the FDA to recognize exclusivity for any drug that the FDA has designated and granted marketing approval and it is undisputed that GRALISE satisfied both of those criteria (i.e. designation and approval).

FDA can appeal the decision.

NEWS

• FDA creates New Purple Book for Biosimilars and Biologicals products: On September 2014, the U.S. Food and Drug Administration published its first edition of the “Purple Book”, which lists all FDA-licensed biological products and interchangeable biosimilars. The “Purple Book” is the biological equivalent of the pharmaceutical “Orange Book” and includes information such as the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.

• First US. Biosimilar insulin to receive approval in the EU:  In June 2014, the European Commission granted marketing authorization for Eli Lilly and Boehringer Ingelheim’s insulin glargine product, prescribed to treat diabetes. This drug is the first insulin treatment approved through the European Medicines Agency’s biosimilar pathway. The Lilly-Boehringer Ingelheim Diabetes alliance’s insulin glargine product is a basal insulin with the same amino acid sequence as the currently marketed insulin glargine product and is intended to provide long-lasting blood sugar control between meals and at night.

• US biopharmaceutical companies are currently developing 44 new HIV/AIDS products in US. R&D: a new report realized by Pharmaceutical Research and Manufacturers of America (PhRMA) found that there are currently 44 drugs and vaccines in the development pipeline concerning HIV/AIDS research, including 25 antivirals, 16 vaccines and three cell/gene therapies, all of which are either in clinical trials or awaiting review by the Food and Drug Administration (FDA).