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Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Make Sure You Own the Patent You Think You Do.

The biotechnology industry has a long history of successfully licensing and litigating university technology. That trend looks to be continuing, even as other industries have taken aim at limiting patent enforcement. Ten U.S....more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

Target Takes Aim at Consumers after Banks Win Opening Round

On Thursday, the attorney for Target Corporation (“Target”) made oral arguments in support of its motion to dismiss consumer claims stemming from the data breach it suffered late last year when hackers stole financial and...more

Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to...

The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory...more

Federal Circuit’s Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

On Friday, December 5, the U.S. Court of Appeals for the Federal Circuit rendered its decision in Sandoz v. Amgen, No. 2014-1693, a case with major implications for the emerging U.S. biosimilars industry. The decision...more

Court Finds Article III Standing for Food Labeling Class Action Plaintiffs

In a consumer-protection class action filed against Gerber in the District of New Jersey, In re Gerber Probiotic Sales Practices Litigation, plaintiffs alleged that the marketing and labeling of Gerber’s infant formula and...more

Recent Developments in Patent Law for Medical Device Companies

In This Presentation: - Recent Patent Cases From The Supreme Court - Medical Device Patent Statistics and Cases - USPTO Post-Grant Proceedings: Lessons Learned After Two Years - Excerpt from Recent Cases...more

FTC v. Cephalon, Inc.

Nature of the Case and Issue(s) Presented: The issue in this case is not whether the validity of the ’516 patent should be litigated in the antitrust trial, but rather, how the court’s previous finding of invalidity and...more

Food Litigation Newsletter - October 2014 #2

In This Issue: - RECENT SIGNIFICANT DEVELOPMENTS AND RULINGS ..Court rules that ‘Kosher’ suit poses religious question; dismisses with prejudice ..Settlement terms approved in stevia sweetener...more

Know the Patent Specification Before Filing a Motion to Amend

Veeam Software Corp. v. Symantec Corp. - Addressing issues of claim construction and the requirements for a motion to amend, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (Board) ruled that the...more

California Court Raises Anew Questions of Standing in Data Breach Cases

There is no question that data breaches are among the most common and costly threats to consumers and companies alike. What remains the subject of vehement debate is whether plaintiffs in cyber-attack cases must allege stolen...more

Do-Gooders Need Not Apply

According to its mission statement, Consumer Watchdog is a non-profit entity “dedicated to providing an effective voice for taxpayers and consumers in an era when special interests dominate public discourse, government and...more

States Have the Right to Protect Businesses Against NPEs

State of Vermont v. MPHJ Technology Investments, LLC; In re MPHJ Technology Investments, LLC - Addressing the issue of state efforts to reign in non-practicing entities, the U.S. Court of Appeals for the Federal...more

Ninth Circuit Upholds Alameda Safe Drug Disposal Ordinance, Triggering Implementation of King County Secure Medicine Return Rule

On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the...more

Section 230 Does Not Apply to Allegations that Website for Models Failed to Warn Plaintiff About Potential for Rape

The 9th Circuit earlier this month decided that Section 230 of the Communications Decency Act, 47 U.S.C. § 230, does not bar claims that a networking website for models failed to warn a member that a third party might use the...more

Myriad Set for Another Round

On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test...more

IP Newsflash - September 2014 #4

Federal Circuit Has Jurisdiction to Decide Non-Patent Causes of Action That Involves a Substantial, Non-Hypothetical Disputed Patent Law Issue - On September 16, 2014, a Federal Circuit panel consisting of Circuit...more

Illinois Federal Court Grants Neiman Marcus’ Motion to Dismiss Data Breach Action on Article III Standing

Once again, a court finds that data breach plaintiffs do not have the requisite Article III constitutional standing to pursue civil action against a retailer – itself the victim of a cyber attack. Last week, the United...more

Toward the enforceability of the “right to be forgotten” in Europe

The European Court of Justice, in a decision rendered on May 13, 2014, held that search engines are considered data controllers under the Directive of October 24, 1995 on data protection, and as such they must provide data...more

Are the Supreme Court’s exceptions to patentability mandated by the Constitution, or are they just “statutory stare decisis”?

There has been significant commentary, both before and after the Supreme Court’s decision in Alice, that the various judicially created exceptions to patentability under 35 USC § 101 are not only sound, but are also...more

Ferring B.V. v. Watson Laboratories, Inc. (I) (Fed. Cir. 2014)

In the first of a pair of decisions issued last Friday, Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that a generic company could moot ANDA litigation by amending its...more

Per Second Circuit: Full Text Searchable Database Is Fair Use

Authors Guild, Inc., et al. v. HathiTrust, et al. - The U.S. Court of Appeals for the Second Circuit, affirming a district court summary judgment ruling in favor of a consortium of authors, ruled that the unauthorized...more

Sham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?

Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may...more

Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC (D.N.J.)

Plaintiffs hold an NDA covering tablets containing two strengths of zolpidem tartrate, which is used in the treatment of middle-of-the-night insomnia. In July 2013, TWi Pharms., Inc. (“TWi”) submitted an ANDA containing a...more

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