Any US patent application filed on or after March 16, 2013 will be subject to the new first-to-file system mandated by the America Invents Act, while any application filed prior to March 16 will still be subject to the old first-to-invent system.
March 2013
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This advisory discusses how, on February 19, 2013, the United States Supreme Court unanimously clarified the scope of antitrust immunity available to political subdivisions of states under the “state action” doctrine, giving the Federal Trade Commission (FTC) a victory in its longstanding campaign to limit such immunity.
March 12, 2013
Advisories
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By creating a definition for “qualified mortgage,” the Bureau has created a minimum standard for all future, private-label, residential mortgage loans. This new regulation will create a safe harbor for all residential lenders, one that could possibly become a jumping-off point for future RMBS “put-back” litigation.
March 12, 2012
Advisories
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On January 1, 2013, Fish and Wildlife CEQA document filing fees increased. If a project will have no effect on fish and wildlife, the CEQA filing fee will continue to be waived. In addition, projects that are statutorily or categorically exempt from CEQA are also not subject to the fee and do not require a “no effect” determination.
March 2013
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“The Final Word on Drug Sample Reporting: Coming Soon?” Pharmaceutical Compliance Monitor, March 11, 2013.
March 11, 2013
Publications
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HIPAA’s long-awaited “Omnibus Rule” (also referred to in this advisory as the “Rule”), published on January 25, 2013, modifies numerous aspects of the HIPAA regulations concerning privacy, security, enforcement and breach notification. The Rule is effective on March 26, 2013, and requires compliance for most provisions by September 23,
2013. HHS has advised covered entities and business associates to update their policies and procedures and retrain workforce members, as appropriate, as a result of the changes implemented by the Omnibus Rule. While many of the changes are primarily applicable to health care providers, some action will also be required on the part of employer plan sponsors and their group health plans, as well as their business associates and subcontractors.
This advisory focuses on the Omnibus Rule provisions that most directly impact employer plan sponsors and group health plans.
March 11, 2013
Advisories
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This advisory discusses today’s USCIS issuance of a newly revised Employment Eligibility Verification form (Form I-9), which employers are required to use to verify the identity and employment eligibility of each individual they hire to work in the United States.
March 8, 2013
Advisories
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The following is a summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit for the week ending March 8, 2013.
March 8, 2013
Publications
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In the first Foreign Corrupt Practices Act (FCPA) enforcement action of the year, the Securities and Exchange Commission (SEC) announced on February 28, 2013, that it had entered into a settlement agreement with Keyuan Petrochemicals Inc. (“Keyuan”) and its former Chief Financial Officer, Aichun Li. The company agreed to pay $1 million, and Li agreed to pay $25,000, for alleged violations of federal securities laws that included FCPA-related accounting violations. This advisory summarizes the FCPA related aspects of the SEC’s allegations and discusses what guidance companies and executives can draw from the case.
March 8, 2013
Advisories
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Effective February 28, 2013, the Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) rescinded two Bush-era enforcement documents relating to the agency’s procedures for investigating possible compensation discrimination. The two documents have now been replaced by newly issued OFCCP Directive 307 (the “Directive”), which replaces all prior OFCCP guidance on compensation investigations and analyses and sets forth the procedures that OFCCP will now use in conducting compliance reviews regarding compensation issues.
March 7, 2013
Advisories
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"Proving Obviousness in Patent Cases," Corporate Counsel, March 6, 2013.
March 6, 2013.
Publications
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Section 1558 of the Affordable Care Act (ACA) protects employees against retaliation by an employer for reporting alleged violations of Title I of the Act, which is the portion of the ACA that includes the prohibition of lifetime dollar limits on coverage, the requirement for most plans to cover recommended preventive services with no cost-sharing and, starting in 2014, guaranteed issue protections ensuring coverage without regard for pre-existing conditions and the prohibition of the use of factors such as health status, medical history, gender and industry of employment to set premium rates. This advisory discusses a Department of Labor interim final rule setting forth procedures and time frames for handling whistleblower complaints.
March 6, 2013
Advisories
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This advisory discusses an FDA Warning Letter that was issued to a dietary supplement manufacturer because, among other violations, the company “liked”—a function unique to Facebook that is utilized by a user simply clicking a button underneath the post—a post on its Facebook wall that was posted by a consumer.
March 5, 2013
Advisories
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On February 25, 2013, the U.S. Food and Drug Administration (FDA) issued a proposed rule amending its regulations to update the standards for FDA acceptance of data from clinical studies. FDA is proposing to amend these regulations so that acceptance of data from clinical studies is consistent across all types of device submissions.
March 4, 2013
Publications
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The Federal Energy Regulatory Commission (FERC) has issued its first two orders on Order No. 1000 compliance filings. Order No. 1000 established major new transmission planning and cost allocation requirements for electric utilities regulated by FERC, with a goal of removing barriers to the development of needed transmission facilities.
March 4, 2013
Advisories
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“Lessons from Retractable Technologies v. Becton Dickinson, Avoiding Limiting the Claims to the Specific Embodiments Disclosed in the Specification,” Maryland Bar Bulletin, March 2013.
March 2013
Publications
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The Administration has indicated that it will pursue fundamental tax reform; leaders on the Hill have also indicated interest in doing so. Therefore, it might happen this time. Given the dispute over the constitutionality of the health insurance tax, potential constitutional issues in tax reform perhaps should be viewed as having slightly more importance than is usually considered for tax legislation. This advisory discusses parts of the Constitution of the United States that might be relevant to fundamental tax reform.
March 1, 2013
Advisories
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There were no precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit for the week ending March 1, 2013.
March 1, 2013
Publications
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The DOJ and the SEC have demonstrated an increased commitment to pursuing Foreign Corrupt Practices Act enforcement actions against foreign companies and foreign nationals for extraterritorial conduct; however, there has been little guidance on the limitations on the government’s extraterritorial enforcement power under the Due Process Clause, which requires that a defendant have sufficient “minimum contacts” and that the exercise of personal jurisdiction in the United States be “reasonable.” Two recent opinions—<i>S.E.C. v. Straub</i> and <i>S.E.C. v. Sharef</i>—provide new guidance on these issues in the context of SEC enforcement actions against foreign nationals. This advisory summarizes the personal jurisdiction analysis in each opinion and then notes several key considerations in light of the opinions.
March 1, 2013
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