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HTMLRound Two: Prosecutors Reopen Bank Settlements
Thaddeus Rogers McBride, Cheryl Palmeri; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 6, 2015, previously published on November 6, 2014
With our political system suffering from a growing chasm down party lines, our public servants seem to be increasingly vulnerable to public pressure. Politicians scramble to fight for whatever cause du jour will garner them the most support. And lately, no political act is guaranteed to please Main...

 

HTMLDistrict Court Strikes Down Regulation of Purely Intrastate Species on Private Land
Alexander L. Merritt; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 6, 2015, previously published on November 11, 2014
In a significant Endangered Species Act case, the Utah District Court has ruled that Congress may not regulate take of the threatened Utah prairie dog, a purely intrastate species, on non-federal land. The court found that the challenged regulation went beyond the scope of the Commerce Clause...

 

HTMLECR Episode XI: Rewriting the Guide to the Galaxy - Satellites Passed to Commerce Control
Reid Whitten; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 6, 2015, previously published on Novembe 6, 2014
Glancing through the fictional but fascinating Hitchhiker’s Guide to the Galaxy (Rsch. Ford Prefect; Pub. Megadodo Publications), one might recognize that the assertions therein are a bit confusing. Similarly, one might become confused when reviewing another, less whimsical, guide to the...

 

HTMLCalifornia To Expand Its Data Breach Notification Rules
Brian R. Blackman; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 6, 2015, previously published on November 4, 2014
California has broadened its data breach notification statutes in response to the increasing number of large data breaches of customer information. AB 1710, which Governor Jerry Brown signed into law, amends California’s Data Breach Notification Law to (1) ban the sale, advertising for sale...

 

HTMLIf They Could Be All You Wanted: The FCC Gets Serious About Small Cells
J. Aaron George, Douglas A. "Drew" Svor, Dave Thomas; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 5, 2015, previously published on October 28, 2014
Say what you will about inside-the-Beltway leadership vacuums, political gridlock and the indecipherable output from the grey, grinding gears of our government agencies, but once in a while Washington actually gets it right. Or mostly right.

 

HTMLNew FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?
Peter S. Reichertz, Carrie A. Ross; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 5, 2015, previously published on January 5, 2015
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...

 

HTMLUpdate: Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions Before Bringing Suit
Michelle C. Kim, Peter S. Reichertz; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 5, 2015, previously published on December 16, 2014
In our previous blog post of November 11, 2014, we noted that Celltrion had filed a declaratory judgment action against Kennedy Trust for Rheumatology Research for invalidity of certain patents covering methods of treating rheumatoid arthritis. Celltrion Healthcare Co. v. Kennedy Trust for...

 

HTMLCMS’ Proposed Regulations Include Significant Antitrust Implications For Entities Interested In Forming ACOs
Helen Cho Eckert, David R. Garcia; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on January 5, 2015
The Centers for Medicare & Medicaid Services (CMS) released proposed regulations to clarify and build on current regulatory requirements for Accountable Care Organizations (ACOs) that participate in the Medicare Shared Savings Program (MSSP). Among the changes is one addressing when an ACO must...

 

HTMLThe Terrorism Risk Insurance Act (TRIA) Set to Expire Year End
Eric L. Altman; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on December 17, 2014
The Terrorism Risk Insurance Act (TRIA) now appears set to expire as of December 31, 2014, barring further action from Congress. The Terrorism Risk Insurance Program Reauthorization Act of 2014 would have extended the existing terrorism insurance coverage under TRIA. Although the House of...

 

HTMLWhat Can You Expect in 2015 Regarding HIPAA Enforcement?
Lynsey Mitchel; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on December 22, 2014
As of earlier this month, 1,170 breaches involving 31 million records have been reported to the Department of Health and Human Services (HHS) since mandated reporting of breaches began in September 2009. An increase in the number of breaches isn’t the only statistic on the rise. Although...

 


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