Safe Harbors

News & Analysis as of

Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under...

The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more

House passes bill to curb QM requirements

On November 18, 2015, the U.S. House of Representatives passed a bill that would provide a safe harbor exception for depository institutions from certain provisions of the Truth in Lending Act and Regulation Z, and for...more

Labor Department Provides Guidance on ERISA Coverage of State-Run Retirement Programs for Private Sector Employers

In recent years, a number of states have explored the idea of establishing state-run retirement plans for private sector employees who do not have access to employer-sponsored retirement plans. The preemption concerns under...more

Location of Accused Activity Informs Post-Approval Enforceability of “Quality-Control” Process Patents

On November 10, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in two companion cases: Momenta Pharms. Inc. v. Teva Pharms. USA Inc. (14-CV-1274, 14-CV-1277) and Momenta Pharms. Inc. v....more

Momenta Pharma., Inc. v. Teva Pharma. USA Inc.

In Momenta Pharma., Inc. v. Teva Pharma. USA Inc., Nos. 2014-1274, -1277, -1276, and -1278 (Fed. Cir. Nov. 10, 2015) (“Momenta II”), the Federal Circuit found that, pursuant to 35 U.S.C. § 271(g), “made” is limited to steps...more

Federal Circuit Interprets Two Important Infringement Provisions

In a single decision issued for companion cases Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. and Momenta Pharmaceuticals, Inc. v Amphastar Pharmaceuticals, Inc., the Federal Circuit interpreted two important...more

U.S.-EU Safe Harbor Scheme Declared Invalid

The Court of Justice of the European Union (the “CJEU”), Europe’s highest court, declared last month that the U.S.-EU Safe Harbor Scheme is invalid. The CJEU also declared that national supervisory authorities are free to...more

California Amends Breach Notification Law: Unique New Refinements and Requirements

The California legislature has again amended the state’s breach notification statutes to impose new and unique requirements and refinements, adding further complexity to the patchwork of breach notification requirements....more

New FMLA Forms Address GINA Safe Harbor

The Department of Labor (“DOL”) recently revised and updated the template forms that the agency issues for use in Family and Medical Leave Act (“FMLA”) notice and certification. Some of these new forms have received...more

Below-threshold transactions: Enforcement and exposure

Whether a jurisdiction will investigate a consummated deal that did not require pre-close notification varies widely by country. The US and China provide examples to highlight the range of approaches to merger control where...more

Lawful Cross-Border Transfers of Employees' Personal Data: EU Commission's Communication on the Invalidation of Safe Harbor 1.0...

In the wake of last month's landmark decision by the European Court of Justice (ECJ) invalidating the U.S.-European Union (EU) Safe Harbor framework, hundreds of U.S. multinationals, no longer able to rely on the Safe Harbor...more

What you need to know about Hong Kong Competition Law (Part 4) - The Merger Rule and the Telco Rule

The implementation of the new Competition Ordinance (Chapter 619 of the Laws of Hong Kong) (the Competition Ordinance) on 14 December 2015 will mark the first time that Hong Kong has had a general and cross-sector competition...more

Safe Harbor 401(k) Plan and Non-Safe Harbor Contributions

The safe harbor notice deadline for calendar year 401(k) plans is coming December 1. This notice requirement is one of the requirements for a plan to be a safe harbor, in addition to the fully vested contribution that gives...more

FCC’s Consumer Advisory Committee Recommends Open Internet Consumer Disclosures

On November 3, 2015, the Federal Communications Commission’s (FCC’s or Commission’s) Consumer Advisory Committee (CAC) issued consumer disclosure recommendations that–subject to bureau-level review and approval–will enable...more

Supreme Court Amendments Mandate Rejection Of Nonconforming Briefs And Dismissal Of Inactive Cases

On October 16, 2015, the Rhode Island Supreme Court issued an order making important amendments to Article I of the Supreme Court Rules of Appellate Procedure....more

German Data Protection Authorities Issue Position Paper In Light of Schrems EU Court Decision

Recently, German data protection authorities issued a position paper to address potential consequences of the Court of Justice of the European Union’s (CJEU) Schrems ruling on the handling of personal data. The first section...more

SEC Proposes Rule Changes to Pave the Way for Intrastate and Regional Offerings

At the same time the Securities and Exchange Commission (the “SEC”) adopted rules implementing Regulation Crowdfunding pursuant to Title III of the Jumpstart Our Business Startups Act (the “JOBS Act”), the agency proposed...more

November and December 2015 Filing and Notice Deadlines for Qualified Retirement and Health and Welfare Plans

Employers and plan sponsors must comply with numerous filing and notice deadlines for their retirement and health and welfare plans. Failure to comply with these deadlines can result in costly penalties. To avoid such...more

Kansas: Safe harbor for insurer faced with settlement demand to only one insured

What should an insurance company do when liability of the insured is clear, the damages clearly exceed the limits, and the claimant sends a settlement demand that would exhaust policy limits while releasing only one out of...more

Will There Be an APAC Safe Harbor?

On October 5, while the European Union’s highest court was busy striking down its Safe Harbor permitting the cross-border transfer of personally identifiable information, 12 countries reached a consensus on data transfers...more

Establishing the Boundaries of the OCILLA Safe Harbor

As user-generated content explodes over the Internet, intellectual property disputes over posting or uploading such content without the owner’s consent continue to escalate. As we touched on in a recent post, social media...more

Employee Benefits & Executive Compensation: Do You Need to Send an Annual Notice to Plan Participants?

Plan sponsors of defined contribution qualified plans may need to issue one or more annual notices to participants before the end of each plan year. Failure to issue a required annual notice can have significant consequences....more

Orrick's Financial Industry Week in Review

Federal Reserve, OCC, FCA, FHFA and FDIC Adopt Joint Final Rule on Swap Margin Requirements - On October 22, the Office of the Comptroller of the Currency (the "OCC"), the Federal Reserve Board (the "Board"), the Farm...more

What’s So Special About An 80% Doing Business Threshold?

In yesterday’s post, I dipped into the SEC’s proposed amendments to Rule 147, a safe harbor for intrastate offerings exempt from registration pursuant to Section 3(a)(11) of the Securities Act of 1933.  Among other things,...more

One More Reason the New Budget Act Is Good for the Government, and Here’s a Hint: It Relates to the TCPA!

Anyone paying attention to goings-on in Washington last week might have heard a loud, bipartisan sigh of relief when both the House and the Senate passed a budget deal that temporarily averted another government shutdown or...more

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