Greenblum & Bernstein, P.L.C.


Recent News in Intellectual Property


April 2016

In This Issue:

·    Acorda Therapeutics v. Mylan Pharma: ANDA Filers Beware

·    FTC Files Complaint Against Endo, Other Drugmakers for Blocking Consumer Access to Generics

·    Ferring Pharms, Inc. v. Burwell

·    Amgen Seeks to Compel Sandoz to Participate in “Patent Dance”

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Acorda Therapeutics v. Mylan Pharma: ANDA Filers Beware

On March 18, 2016, the Federal Circuit affirmed a district court’s decision that the filing of an abbreviated new drug application (ANDA) for a generic drug with FDA opens the door to personal jurisdiction in any state where the generic drug will be marketed if approved.

The Federal Circuit’s ruling involved two actions on appeal from the District of Delaware against generic drug manufacturer Mylan Pharmaceuticals, Inc., one by brand-name drug manufacturers Acorda Therapeutics Inc. and Alkermes Pharma Ireland Ltd., and the other by AstraZeneca AB.

Acorda, Alkermes, and AstraZeneca had sued for patent infringement under 35 U.S.C. § 271(e)(2).  Mylan had moved to dismiss the cases on the ground that the State of Delaware – and therefore the federal district court in Delaware – could not exercise personal jurisdiction over Mylan in these cases under the Due Process Clause of the Fourteenth Amendment.

The Due Process Clause standards permit a state to exercise specific personal jurisdiction over a defendant when the defendant has certain “minimum contacts” with the state such that the maintenance of the suit does not offend “traditional notions of fair play and substantial justice.”

Although Mylan is incorporated in West Virginia and has its principal place of business there, Mylan sent notices to AstraZeneca’s subsidiary in Delaware.  Mylan also appointed an agent to accept service in Delaware.  Of particular importance to the case, Mylan intends to direct sales of its drugs into Delaware upon approval. 

In view of the above, the Federal Circuit affirmed the lower court’s rulings that Mylan had sufficient contacts related to the subject matter of these cases such that Delaware could exercise specific personal jurisdiction over Mylan.

The implications of the decision are consequential.  It now appears that the filing of an ANDA may essentially opens the door to suit filers in any state in the Union where a generic drug company intends to market an FDA-approved drug. 

FTC Files Complaint Against Endo, Other Drugmakers for Blocking Consumer Access to Generics

Endo Pharmaceuticals Inc. and several other drug manufacturers were sued by antitrust regulators on March 30, 2016, in a complaint filed by the Federal Trade Commission (FTC) in the U.S. District Court for the Eastern District of Pennsylvania.

The complaint alleges that Endo; Endo International PLC; Teikoku Pharma USA, Inc.; Teikoku Seiyaku Co., Ltd.; Watson Laboratories, Inc.; Allergan PLC; and Impax Laboratories, Inc. were parties to anticompetitive reverse-payment agreements orchestrated by Endo, and that these agreements violated antitrust law by blocking access to generics of two brand-name drugs: Opana ER and Lidoderm.

In a statement issued on March 31, 2016, the FTC asserted that the “enforcement action is the first FTC case challenging an agreement not to market an authorized generic – often called a ‘no-AG commitment’ – as a form of reverse payment.”  In the statement, FTC Chairwoman Edith Ramirez also states that such pay-for-delay settlements harm consumers twice – “first by delaying the entry of the generic drugs and then by preventing additional generic competition in the market following generic entry.”

Ferring Pharms., Inc. v. Burwell

In a memorandum opinion issued March 15, 2016, the U.S. District Court for the District of Columbia granted FDA summary judgement on its interpretation of “drug” to mean “drug product” (rather than “drug substance”) under the five-year exclusivity provisions for new chemical entities of the Federal Food, Drug, and Cosmetic Act (FDCA).

Ferring Phaarmaceuticals, Inc. manufactures PREPOPIK, a combination drug product that contains three substances: sodium picosulfate, magnesium oxide, and anhydrous citric acid.  The drug is intended for use in cleansing the colon in preparation for colonoscopy.  Ferring sought five-year marketing exclusivity because one of the substances, sodium picosulfate, had never been approved by FDA in a new drug application.  FDA determined that PREPOPIK was not entitled to five-year marketing exclusivity because two of the active ingredients had previously been approved for market.

In response, Ferring filed a Petition for Reconsideration and a separate Citizen Petition with FDA, which resulted in FDA’s change in position on the matter as to prospective applicants, but not Ferring. 

By statute, a five-year period of marketing exclusivity may be obtained “for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application,” 21 U.S.C. §355(j)(5)(F)(ii) (emphasis added). 

Among other things, Ferring challenged FDA’s (old) interpretation of the five-year exclusivity provisions as contrary to the plain language of the FDCA or an unreasonable interpretation of statutory ambiguity.

However, the court found nothing in the statute compelling a particular definition for “drug” as set forth in the five-year exclusivity provisions.  Further to this, the court found that FDA’s (old) interpretation of the term “drug” as referring to a “drug product” was reasonable.

However, Ferring also argued that FDA’s refusal to apply its new interpretation of “drug” as referring to a “drug substance” retroactive to it was arbitrary and capricious.  On this point, the court directed the parties to file renewed motions for summary judgement that more fully address the retroactivity issue.  Thus, Ferring’s ultimate fate with regard to PREPONIK remains to be determined.

Amgen Seeks to Compel Sandoz to Participate in Biosimilars “Patent Dance”

In a complaint filed on March 4, 2016, (New Jersey Civil Action No. 16-cv-01276), Amgen seeks a declaration that Sandoz has failed to participate in the patent information exchange provisions, also known as the “patent dance” under the Biologics Price Competition and Innovation Act (“BPCIA”).  Amgen also seeks an order to compel Sandoz to participate.  The Amgen complaint raises two issues of interest to biosimilar stakeholders.  First, the complaint seeks to address the question of whether a biosimilar applicant must participate in the “patent dance” after providing the reference product sponsor with its application and manufacturing information (as well as its contentions regarding invalidity, unenforceability, and non-infringement).  Second, Amgen raises the issue of whether a biosimilar applicant’s decision not to participate requires the reference product sponsor to file a suit for patent infringement earlier than it otherwise would have under the BPCIA, i.e., prior to the negotiation and exchange of patent lists that are part of the “patent dance.”