No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Action Before Biosimilars Application Is Filed

The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) by obtaining a declaratory judgment of patent invalidity before even submitting a biosimilars application.  See Sandoz Inc. v. Amgen Inc., Civil No. 13-2894 MMC, _____ USLW _____ (N.D. Cal. 2013).

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HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information about medical device use and patient health. Whereas once the data that could be obtained from a therapeutic or diagnostic device would be limited to time and error codes, medical devices now have the potential to store personal patient health information. Interoperability between medical devices and electronic health record systems only increases the potential for medical devices to store personal information.

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Will an FDA Rule Make People Sick? – FDA Establishes a Rule on the Labeling of “Gluten Free” Foods that Sets a Limit Above What Some Groups Claim Causes Adverse Reactions

On August 5, 2013, the U.S. Food and Drug Administration published a final rule on the labeling of foods as “gluten free.”[1] Gluten is a protein composite found in wheat, rye, barley, and their crossbred hybrids. Gluten gives elasticity to dough, helping it rise and keep its shape and often gives the final product a chewy texture. In order for a food to be labeled “Gluten Free” under the rule, the food may not contain 20 parts per million (ppm) or more gluten.[2] The rule applies to the claims “free of gluten” and “without gluten” as well.[3]

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FDA’s Draft Guidance For Industry On Pre-Launch Activities Importation Requests: Dead On Arrival?

On July 25, 2013, the Food and Drug Administration (“FDA” or “the Agency”) published a Draft Guidance for Industry entitled “Pre-Launch Activities Importation Requests”, or “PLAIR”. The draft guidance describes FDA policy on requests for importation of unapproved finished dosage form drug products by an applicant preparing for market launch pursuant to a New Drug Application (“NDA”), an Abbreviated New Drug Application (“ANDA”) or a Biologics License Application (“BLA”). The draft guidance describes the procedure for making requests for importation prior to approval, as well as the factors FDA will look to in deciding whether to grant such requests.

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A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where federal law prohibits an action required by state law. The Supreme Court had previously held in Pliva v. Mensing, 564 U.S. ____ (2011) that failure to warn claims against generic drug manufacturers are pre-empted by the Federal Food Drug and Cosmetic Act since generic drug makers must copy innovator drug labeling precisely in order to obtain approval of their products by the U.S. Food and Drug Administration (“FDA”). The Court in Mutual rejected the argument of lower courts that the generic manufacturer could comply with both federal and state law by choosing not to make and distribute the product at all.

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FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?

On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation. In FTC v. Actavis, 570 U.S. 756 (2013), the Federal Trade Commission (“FTC”) prevailed when the Supreme Court held in a 5-to-3 decision [1] that reverse payment settlements in Hatch-Waxman cases are subject to antitrust scrutiny, resolving a circuit split and impassioned debate among antitrust lawyers. This is only the second antitrust case in 20 years where the enforcers have prevailed. The Court, however, rejected the FTC’s position that reverse-payment settlements were presumptively illegal, ruling that they are subject to scrutiny under the rule of reason.

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Cybersecurity: FDA Risks for Medical Devices

On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. The draft guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” proposes cybersecurity features that should be incorporated into wireless, Internet- and network-connected medical devices (“cybersecurity-vulnerable devices”), as well as information that will be requested in premarket submissions for cybersecurity-vulnerable devices. In addition to the draft guidance, FDA also issued an FDA Safety Communication to medical device manufacturers, hospitals, medical device user facilities, health care IT and procurements staff, and biomedical engineers on cybersecurity for medical devices and hospital networks.

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Thoughts on Regulatory Constraints of Business Models

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no summation could adequately capture all of the complexity inherent in this question, it would seem appropriate to briefly comment on some of the general recent trends I have seen, and how they may be shaped by various regulatory authorities.

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Supreme Court Hears Arguments on “Pay for Delay” Agreements

On March 25, 2012, the Supreme Court heard oral argument on the legality of “reverse payment” or “pay for delay” agreements between brand-name and generic drug manufacturers.

Reverse payment agreements settle patent infringement actions brought by a brand-name drug manufacturer against a potential generic competitor under the Hatch-Waxman Act. In contrast to typical settlements of patent infringement actions, it is the patent holder (the brand-name drug manufacturer) that agrees to pay a large sum of money to the accused infringer (the generic) in exchange for an agreement that the generic will not challenge the patent or enter the market for a period of time.

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Ninth Circuit Off-Label Marketing Decision Suggests More Prosecutions Will Be Coming

The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and medical device industries exhaled a sigh of relief in response to the influential Second Circuit’s decision in United States v. Caronia, holding that truthful off-label marketing is a form of protected First Amendment speech that cannot form the basis for a criminal prosecution under 21 U.S.C. §333 of the Food, Drug and Cosmetic Act (“FDCA”). The Caronia decision followed the Supreme Court’s decision in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (June 23, 2011), which held that a Vermont statute prohibiting pharmaceutical companies from engaging in truthful marketing activities offended the First Amendment. The question after Sorell and Caronia became, can the government still prosecute off-label marketing? On March 4, 2013 the Ninth Circuit said yes, albeit in an unpublished opinion.

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