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FTC Data Security Authority Confirmed, For Now: Wyndham’s Motion to Dismiss Denied

The FTC’s Claim - A New Jersey federal judge has confirmed the Federal Trade Commission’s (“FTC”) authority to regulate data security and bring claims against companies suffering data breaches due to inadequate...more

Part II: Fair Notice or No Notice? The Wyndham Worldwide Case and the Expanding Power of the FTC to Police Data Security

In our first blog in this series, we provided a summary of the District Court of New Jersey’s recent decision in FTC v. Wyndham Worldwide Corp., in which Judge Salas confirmed the FTC’s authority to bring enforcement actions...more

Federal Circuit Reaffirms De Novo Standard of Review for Claim Construction

In a long-awaited decision, the Federal Circuit ruled en banc to uphold the the de novo standard for appellate review of claim construction issues, which was previously established in another en banc decision, Cybor Corp. v....more

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

Another Motion to Amend Denied in IPR Final Written Decision

While Patent Owners have finally succeeded in having claims survive an inter partes review proceeding, no Patent Owner has yet to find the magic formula that successfully navigates a motion to amend. In a Final Written...more

Federal Appeals Court Rejects False Claims Act Suit Based on Drug Packaging cGMP Violations

Last Friday, the U.S. Court of Appeals for the Fourth Circuit affirmed the dismissal of a False Claims Act (“FCA”) case brought against Omnicare. United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, 2014 WL 661351...more

Makena Drug Compounding Lawsuit Against FDA Gets New Life

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

Fresenius v. Baxter: The Importance of Timing in Patent Litigation

The Federal Circuit’s recent decision in Fresenius USA, Inc. v. Baxter Int’l, Inc., illustrates the potential value of challenging a patent's validity through administrative proceedings in the U.S. Patent & Trademark Office...more

With Complaint Against LabMD, FTC Continues to Flex Enforcement Muscle on Data Security

The Federal Trade Commission recently filed another complaint against a company for alleged data security lapses. As readers of this blog know, the FTC has initiated numerous lawsuits against companies in various industries...more

The FDA’s 510(k) Approval Process in Medical-Device Litigation

Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In...more

FTC’s Authority to Police Data Security Practices Challenged

Hotelier Wyndham Worldwide Corp’s motion to dismiss an FTC lawsuit alleging lax data security practices is likely to have significant implications for the agency’s ability to police cybersecurity practices at American...more

Compounding Animal Drugs from Bulk Ingredients

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more

Trade Secret Legislation May Increase Infringement Claims and Lead to a Private Right of Action

Congress recently took new steps to protect trade secrets, which are generally defined as all forms or types of financial, business, scientific, technical, economic, or engineering information that the owner has taken...more

Australian Patent Term Extension: A “Long-Term” Battle

If it was ever in doubt as to whether an application for an extension of a pharmaceutical patent term could be late filed after the due date, this recent decision would seem to have removed it, clarifying that late filing is...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

USPTO Issues First Decision Instituting CBM

On January 9, 2013, the Patent Trial and Appeal Board (PTAB) issued its first decision in a Covered Business Method Patent Review (CBM) proceeding, instituting the trial on all claims requested. The decision issued in...more

Supreme Court Denies Certiorari in Stem Cell Funding Case

In an order issued earlier today, the Supreme Court denied certiorari in Sherley v. Sebelius, ending the efforts by two adult stem cell researchers to prevent the National Institutes of Health (NIH) from funding research...more

Court Report - January 7, 2013

In This Issue: Life Technologies Corp. et al. v. Kappos et al.; Abbvie Biotechnology, Ltd. v. Kappos; Human Genome Sciences, Inc. v. Kappos; and Shionogi & Co., Ltd. v. Sandoz Inc. ...more

News from Abroad: Availability of Documents at the EPO -- EPO Board of Appeal Decision T1839/11

Originally published in Forresters on January 6, 2012. Background: The patent - NovozymesFollowing grant of a patent to Novozymes in November 2009, the patent was asserted in Denmark, Germany, the Netherlands...more

Top Three Stories of 2012

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

Top Stories of 2012: #4 to #7

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

Top Stories of 2012: #12 to #15

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

Upcoming Patent Law Changes Will Put Pressure on Patents

Originally published in Pharmaceutical Outsourcing’s website on December 2012. Patent law is changing rapidly. The changes are putting even greater pressure on patents as a tool for protecting a pharmaceutical or...more

Top Stories of 2012: #8 to #11

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

Court Report - December 30, 2012

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company v. Kappos et al. - 1:12-cv-01491; filed December 26, 2012 in the Eastern District of...more

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