Life Sciences

Fed. Circ. Ruling May Affect Eligibility Of Life Sciences Patents

In view of the Federal Circuit's recent decision in American Axle v. Neapco and the turbulent state of Section 101 case law generally, to increase their odds of patent eligibility, applicants in the pharmaceutical, biotech and medical industries should claim their inventions at various levels of detail, say David Ludwig and Ted Mathias of Axinn.

Health Care Fraud Lessons For Lawyers Advising Doctors

The U.S. Department of Justice's seven recent health care fraud takedowns reflect an overall shift in how this type of fraud works, from doctor-driven to doctor-enabled schemes, says Stephen Lee at Benesch.

How To Hire Lateral Partners More Effectively

Although lateral partner hiring is the preferred method of inorganic growth among law firms, the traditional approach to vetting does not employ sufficient due diligence by the hiring firm, says Michael Ellenhorn at executive search firm Decipher Competitive Intelligence.

The Coming Storm Of Biometric Privacy Laws: How To Comply

To respond to the rapidly evolving legal landscape, companies that incorporate biometric data into their business practices can take several steps to minimize the risk of privacy litigation exposure, say Jeffrey Rosenthal and David Oberly of Blank Rome.

The Coming Storm Of Biometric Privacy Laws: What To Expect

While there are only three state biometric privacy laws on the books, there is a growing trend of states' introducing biometric privacy bills, many of which feature far-reaching private right of action provisions that would substantially increase the level of regulatory and litigation risk, say Jeffrey Rosenthal and David Oberly of Blank Rome.

Engaging With International Carcinogen Evaluations

Defense-oriented attorneys and corporations should be aware of the International Agency for Research on Cancer's list of chemicals, pharmaceuticals and other exposures slated for review over the next five years, and begin preparing for eventual hazard evaluations by IARC working groups, say Eric Lasker and John Kalas of Hollingsworth.

Texas Could Take Page From Mass.'s Judicial Selection Book

As Texas and other states review their judicial election processes, they would be well served by taking guidance from Massachusetts' Governor’s Council system, which protects the judiciary from the hazards of campaigning, says Richard Baker of New England Intellectual Property.

A Possible USPTO Solution To PTAB Constitutionality Ruling

While courts continue to debate whether the Federal Circuit's remedy in Arthrex v. Smith & Nephew is sufficient to save the constitutionality of the Patent Trial and Appeal Board, perhaps it is time for the U.S. Patent and Trademark Office to remove its self-imposed limits on precedential opinion panel rehearings, say James Carmichael and Stephen Schreiner of Carmichael IP.

Genetic Testing Gold Rush Gives Rise To Fraud Allegations

As Medicare payments for genetic testing rise, recent federal indictments over related fraud schemes suggest that a crackdown is already underway, says Alexander Owens of Pietragallo Gordon.

Revised USPTO Trial Practice Guide Leans Pro-Patent Owners

The U.S. Patent and Trademark Office recently released its updated Trial Practice Guide, which includes several policy changes that tip the scales toward patent owners and make the PTAB less attractive than district courts for litigating patent validity, says Brian Berliner of O’Melveny.

Series

Judging A Book: McKeown Reviews 'Conversations With RBG'

Reading Jeffrey Rosen’s "Conversations With RBG: Ruth Bader Ginsburg on Life, Love, Liberty, and Law" is like eavesdropping on the author and his subject while they discuss how the restrained judicial minimalist became the fiery leader of the opposition, says Ninth Circuit Judge M. Margaret McKeown.

Legislative Trends May Kill Texas Employer Cannabis Tests

Following recent legislative developments — such as a Texas law that expands patient access to medical marijuana and proposed amendments to the federal Controlled Substances Act — many Texas employers are questioning whether to continue cannabis testing because it has become somewhat problematic, says Stephen Roppolo at Fisher Phillips.

Noteworthy Changes From FDA's Latest Software Guidance

The U.S. Food and Drug Administration's new software-related guidance is largely consistent with previous drafts, but makes a variety of technical changes and clarifications to the FDA’s interpretation of the 21st Century Cures Act exemptions for certain software functions, say attorneys at Akin Gump.

Citizen Petitions Are Crucial In Managing A Drug's Life Cycle

When properly applied, citizen petitions allow drug companies to extend the valuable near-end period of drug market exclusivity, and in some instances they can broadly impact the availability of drug products, say attorneys at Wilson Sonsini.

State Net

States' Vaping Bans Face Legal Hurdles

With a still-developing outbreak of lung injuries linked to vaping, and e-cigarette bans in some states already blocked by courts, regulatory maneuvering over this issue is likely to be a major policy concern in the months to come, says Dave Royse of State Net Capitol Journal.