Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer (DTC) genetic testing companies. Companies distributing DTC tests should evaluate their current data privacy policies and practices against the obligations the new Utah law imposes on data use and protection, including user consent, data security, and access and deletion rights, to ensure they are in a position to comply with the new law.
Continue Reading New State Genetic Privacy Law Directed at Consumer Genetic Tests

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious. See 35 U.S.C. §§ 102 and 103. Thus, innovative step-improvements to, and new applications of, existing technology may be patentable. Moreover, these step-improvements may prove lucrative, particularly when the underlying technology has entered the public domain, e.g., due to the expiration of the original patents. This concept is illustrated time and time again in the pharmaceutical industry where companies therein typically pursue competitive advantages by attempting to extend the patentable life of key technologies. One recent story illustrating this point was amplified in recent news when the FDA cleared a new pill produced by Aprecia Pharmaceuticals—the first pill of its kind produced using patented 3D printing technology.
Continue Reading Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

On January 20, 2015, the FDA issued draft guidelines[1] designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as medical devices under Section 201(h) of the Food Drug & Cosmetics Act (the “Act”) and are therefore subject to the Act’s regulatory requirements for devices.
Continue Reading FDA Issues Guidance for Low-Risk General Wellness Products

Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the Orange Book, called the “Reference Listed Drug” or “RLD”. Issues have arisen as to whether a RLD sponsor can provide samples for bioequivalence studies when the RLD is subject to a Risk Evaluation and Mitigation Strategy (“REMS”). A REMS is a program design to assure that a drug with a known significant risk or risks can and will be used safely, by a variety of different measures, including, for example, restricted distribution and labeling. The existence of a REMS has been used by RLD sponsors to refuse to sell samples of their RLD drug product to ANDA applicants who are seeking them for use in bioequivalence studies. This has led to litigation over whether it is legal for the RLD sponsor to do so, as will be discussed hereinafter.
Continue Reading New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?

Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may harm competition or competitors.  The Supreme Court has recognized an exception to this immunity for “sham litigation,” which it has defined as litigation that is “objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits,” and is motivated by a desire “to interfere directly with the business relationships of a competitor.”  (Prof’l Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49, 60-61 (1993)).
Continue Reading Sham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?

Apple’s apps store lists close to a 100,000 health apps.  Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare market in the United States is undergoing a significant transformation.  Whether and how to regulate this evolving market is subject to substantial discussion and debate.
Continue Reading Mobile Medical App Regulations on the Move – Proposed Bills To Further Alter the Regulatory Landscape of Mobile Medical Applications

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) might be short-lived.  FDA, in a Federal Register notice dated November 13, 2013, has proposed to allow holders of Abbreviated New Drug Applications (“ANDA’s”) for generic drugs to file supplements for labeling changes that might cause its labeling – on at least a temporary basis – to differ from the labeling of its Reference Listed Drug.  The proposed rule was published at 78 Fed. Reg. 67,985 and allowed for comments to be filed by January 13, 2014.  By notice of Federal Register of December 27, 2013, 78 Fed. Reg. 78,796, FDA extended the comment date to March 13, 2014.  What generic manufacturers need to know about this proposed rule is not only would it eliminate product liability protection, but it would increase their regulatory burdens.
Continue Reading A Short-Lived Victory for Generic Manufacturers? – Part 2

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.
Continue Reading HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

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]
Continue Reading 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 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.
Continue Reading A Short-Lived Victory for Generic Drug Manufacturers?

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.
Continue Reading Thoughts on Regulatory Constraints of Business Models