En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion in The Medicines Company v. Hospira Inc., Case No. 14-1469 (Fed. Cir. July 11, 2016) considerably mitigates patent law’s disparate treatment of inventors who rely upon contract manufacturing organizations (CMOs) and an those who manufacture in-house.

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New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR).

The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for example, to product classification; quality system standards; pre-market authorization; and reporting of adverse events.

The final version of the MDR – a hefty 352 pages – was published on June 27 and is now reviewed by the EU’s legal editor for drafting or law-technical errors. It then needs to be translated into all EU member languages, followed by formal publication. After publication, expected in late 2016 or early 2017, there will be a three-year transition period as the medical device industry will need time to comply with the new requirements.

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PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative:

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Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

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

Day One Notes – JP Morgan Healthcare Conference, San Francisco

Someone asked me last week what it was like to attend the JP Morgan Healthcare Conference in San Francisco, which started its annual run today. Outside the conference hotel right now is the obligatory lunchtime sidewalk protest with chants of “Personal Health, Not Corporate Wealth,” while inside healthcare industry investors and operators together are chanting “pop health” instead.  The conference again is well attended, with a broad representation of for-profit and non-profit companies from the health services, health information technology and life sciences sectors.  In a sense, it’s the old-style Times Square of the healthcare industry – stand in one spot at the conference long enough and you’ll see almost every major organization walk by. Continue Reading

HHS Recognizes Changing Environment of Research: Still Time to Comment

Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016  to the comment period for the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking (NPRM).  The proposed rulemaking is the most sweeping since 1991 when HHS codified The Common Rule, 45 C. F. R. part 46,  and  recognizes the changed research environment with many multisite studies and the  expansion of research with more data accessible through technology.  The NPRM seeks to further the principles of autonomy and  beneficence by protecting privacy and improving the consent process  in the new world of research while creating avenues to lessen the administrative burden  and to promote research.   Continue Reading

What’s in a Name? That Which We Call a Biological Product…

The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). One of the most eagerly awaited guidance documents has been that on nonproprietary names to be used for biosimilar products. On August 28, 2015, the FDA finally issued its draft “Guidance for Industry: Nonproprietary Naming of Biological Products” (“the draft Guidance”). The draft Guidance will apply to all newly licensed and previously licensed biological drug products approved under Sections 351(a) and (k) of the Public Health Service Act (“PHSA”), except those for which a nonproprietary name is provided in 21 C.F.R. Part 600 and certain other biologic products “for which there are well-established, robust identification and tracking systems to ensure safe dispensing practices and optimal pharmacovigilance.” See 80 Fed. Reg. 52296 (August 28, 2015). Continue Reading

FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?

On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”).  The FDA is taking a risk-based approach, focusing its oversight on apps that (1) meet the definition of medical devices under section 201(h) of the Federal Food Drug and Cosmetic Act, and (2) could pose a risk to a patient’s safety if the app did not function as intended.  The FDA will not exercise authority over apps that are not medical devices under section 201(h), nor will it enforce its rules and regulations against the numerous apps that meet the definition of medical devices but present only minimal risk to consumers or patients.

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