Fenwick & West LLP

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

The Ninth Circuit Holds That Accessing a Website After Receiving a Cease & Desist Letter Is a Violation of the Computer Fraud and Abuse Act

Last week, the Ninth Circuit limited the scope of the Computer Fraud and Abuse Act (CFAA) in affirming a grant of summary judgment against the defendant in Facebook, Inc. v. Power Ventures, Inc., et. al. and affirmed the rule…more
| Civil Remedies, Communications & Media Law, Science, Computers, & Technology

The Second Circuit Limits The Government’s Ability To Access Data Stored Overseas

In a case with important privacy implication for U.S. companies providing services ranging from e-mail, social networking, chat communications and remote storage, the Second Circuit Court of Appeal this week held in Microsoft…more
| Civil Procedure, Constitutional Law, International Law & Trade, Privacy, Science, Computers, & Technology

Privacy Shield – A Shield worth having?

Earlier this week, the European Commission voted to formally approve the Privacy Shield—a set of principles agreed between the E.U. and the U.S. to enable certified U.S. companies to receive and process personal data from the…more
| Commercial Law & Contracts, Consumer Protection, International Law & Trade, Privacy, Science, Computers, & Technology

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant must…more
| Civil Procedure, Civil Remedies, Intellectual Property, Science, Computers, & Technology

The Ninth Circuit Addresses the Scope of the Computer Fraud and Abuse Act

This week, the Ninth Circuit clarified the scope of the Computer Fraud and Abuse Act (CFAA) in upholding the defendant’s criminal conviction in United States v. David Nosal…more
| Criminal Law, Labor & Employment Law, Privacy, Intellectual Property

Client Alert: Brexit – What Silicon Valley Needs to Know

The vote of the UK Electorate to leave the EU has politicians, economists, lawyers and commentators from all sectors speculating on what will happen next and over exactly what period. While it is unlikely that there will be a…more
| Commercial Law & Contracts, Labor & Employment Law, Intellectual Property, International Law & Trade, Science, Computers, & Technology

Will the USPTO’s “Patents 4 Patients” Program Even Make It Off the "Cancer Moonshot" Launch Pad?

The White House recently announced the Cancer Moonshot Task Force, an effort to “focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement…more
| Health, Intellectual Property, International Law & Trade, Science, Computers, & Technology

Litigation Alert: Supreme Court Leaves Intact PTAB Authority to Institute and Regulate Inter Partes Review Proceedings

This week in Cuozzo Speed Technologies, LLC v. Lee, the United States Supreme Court decided two important questions related to the power of the Patent Trial and Appeal Board (PTAB) over inter partes review proceedings. First,…more
| Administrative Law, Civil Procedure, Intellectual Property, Science, Computers, & Technology

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views of…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

Litigation Alert: U.S. Supreme Court Addresses Attorney’s Fee Awards in Copyright Cases

Last week in Kirtsaeng v. John Wiley & Sons Inc., the Supreme Court held that district courts have wide discretion to grant attorney’s fee awards but should give substantial weight to whether the losing party was objectively…more
| Civil Procedure, Civil Remedies, Intellectual Property

Two Years After Alice: A Survey of the Impact of a "Minor Case" (Part 2)

AliceStorm at the USPTO - While AliceStorm's effect is most visible in the courts, because of their public nature, the real impact is largely unseen: it is the widespread rejection of patent applications by the USPTO. …more
| Intellectual Property, Science, Computers, & Technology

Two Years After Alice: A Survey of the Impact of a "Minor Case" (Part 1)

Two years ago this Sunday, the Supreme Court in Alice Corp. Pty Ltd. v. CLS Bank Int'l addressed a relatively narrow issue: does a claim reciting a generic computer implementation transform an abstract idea into a…more
| Intellectual Property, Science, Computers, & Technology

Litigation Alert: Supreme Court Expands Discretion to Award Enhanced Damages for Patent Infringement and Eliminates the Federal Circuit's “Seagate Test”

This week in Halo Electronics, Inc. v. Pulse Electronics, Inc., the United States Supreme Court changed the law regarding when enhanced damages should be awarded in patent infringement cases, by eliminating the two-part test for…more
| Civil Procedure, Civil Remedies, Intellectual Property, Science, Computers, & Technology

Corporate and Securities Alert: SEC Updates Form 10-K

On June 1, the SEC issued a new Interim Final Rule?, amending Item 16 of Part IV to the Form 10-K, specifically permitting issuers to include a summary section in an Annual Report on Form 10-K. The summary section will…more
| Business Organizations, Securities Law
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