Wilson Sonsini Goodrich & Rosati

FDA Issues New Draft Guidance: New Dietary Ingredient Notifications and Related Issues

Dietary supplements are big business. A recent estimate pegs the U.S. market for dietary supplements at over $35 billion annually. The U.S. Food and Drug Administration (FDA) estimates the number of dietary supplements to be…more
| Antitrust & Trade Regulation, Communications & Media Law

WSGR Obtains Another First-of-Its-Kind Victory on California's Automatic Renewal Law

California's Automatic Renewal Law (ARL), Business and Professions Code Section 17600 et seq., has been a new and potent weapon for the plaintiffs' bar in recent years. The ARL requires a business to clearly and conspicuously…more
| Civil Procedure, Civil Remedies, Constitutional Law

The Entrepreneurs Report - 1H 2016

Dual-Class Stock: A Founder Favorite Faces Growing Investor Disapproval - Earlier this year, the investment firm T. Rowe Price adopted new voting policies that penalize companies with dual-class stock structures. They join…more
| Business Organizations, Science, Computers, & Technology, Securities Law

Second Continuation of General License for Exports, Reexports, and Transfers to ZTE

For the second time, the U.S. Department of Commerce's Bureau of Industry and Security (BIS) is extending the general license for exports, reexports (shipments from one foreign country to another foreign country), and in-country…more
| International Law & Trade

FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing medical…more
| Administrative Law, Health, Science, Computers, & Technology

Seventh Circuit Decrees That Package Size Alone Is Not Enough for a Robinson-Patman Claim

On August 12, 2016, the U.S. Court of Appeals for the Seventh Circuit issued an opinion in Woodman's Farm Market, Inc. v. The Clorox Co., No. 15-3001 (7th Cir. August 12, 2016), in which it held that a plaintiff cannot state a…more
| Antitrust & Trade Regulation

New Massachusetts Pay Equity Act Calls for Employers to Examine Compensation and Hiring Practices

In a step that should immediately spur employers to review their compensation and hiring practices, Massachusetts recently enacted legislation that changes considerably the state's rules prohibiting gender-based pay disparities…more
| Labor & Employment Law

DOL Significantly Increases Certain ERISA Civil Penalties Effective August 2, 2016

The U.S. Department of Labor (DOL) has significantly increased a number of civil monetary penalty amounts (CMPs) that may be assessed by the DOL's Employee Benefits Security Administration for violations of Title I of the…more
| Labor & Employment Law

Federal Court Decision Provides Useful Guidance to Companies Offering Products and Services Pursuant to Online Terms of Use

On July 29, 2016, Judge Jed Rakoff of the U.S. District Court for the Southern District of New York issued an opinion and order in Meyer v. Kalanick, denying Uber Technologies' motion to compel arbitration of a consumer's…more
| Alternative Dispute Resolution (ADR), Antitrust & Trade Regulation, Civil Remedies, Commercial Law & Contracts

Final Regulations Issued Under Internal Revenue Code Section 83 Eliminate Taxpayer Requirement to File Section 83(b) Election with Income Tax Return

Recently issued final regulations under Internal Revenue Code Section 83 (the Final Regulations) remove the requirement that taxpayers must submit a copy of an election made under Code Section 83(b) with the taxpayer's income…more
| Real Estate - Commercial, Real Estate - Residential

The PTAB Review - August 2016

Covered Business Method Patent Review: What Constitutes a Financial Product or Service? Along with inter partes review (IPR) and post-grant review (PGR), the America Invents Act (AIA) created a transitional program for…more
| Intellectual Property, Science, Computers, & Technology

Article 29 Working Party Issues Statement Following Adoption of EU-U.S. Privacy Shield

On July 26, 2016, the body of European Data Protection Authorities (DPAs)—the "Article 29 Working Party" (WP29)—issued a statement commending the improvements made to the EU-U.S. Privacy Shield (Privacy Shield). Although the…more
| International Law & Trade, Privacy, Science, Computers, & Technology

Federal Circuit Holds Claims to Cell Freezing Methods to Be Patent-Eligible

On July 5, 2016, the Federal Circuit held that claims reciting methods for cryopreserving hepatocytes in U.S. Patent No. 7,604,929 ("the '929 patent") are eligible for patenting. The decision vacated a lower court's holding that…more
| Health, Intellectual Property, Science, Computers, & Technology

IRS Releases Temporary and Proposed Regulations Under IRC Section 50(d)(5)

On July 21, 2016, the IRS released temporary regulations section 1.50-1T under IRC Section 50(d)(5) of the Internal Revenue Code (the "Temporary Regulations") (TD 9776) that provide guidance regarding: (1) the income inclusion…more
| Business Organizations, Energy & Utilities, Real Estate - Commercial, Taxation

IRS Proposes Tax-Free Spin-Off Regulations Interpreting the "Device" and "Active Business" Tests and Addresses Recapitalizations into Control

On July 14, 2016, the U.S. Department of the Treasury issued proposed regulations under Section 355 of the Internal Revenue Code that would establish new guidelines under the so-called "device" and "active business" tests. The…more
| Business Organizations, Securities Law, Taxation
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