Intellectual Property Health

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Patent Profile: DermTech Receives Patent for Method of Detecting Melanoma in Human Subjects

The U.S. Patent and Trademark Office recently issued a notice of allowance for U.S. Application No. 14/199,900, which is entitled "Diagnosis of Solar Lentigo by Nucleic Acid Analysis." The '900 application, which is assigned...more

North Carolina Business Court Holds Pleading Stage Too Early to Dismiss Broad Non-compete

On May 7, 2015, Judge Gregory McGuire of the North Carolina Business Court denied defendants’ motion to dismiss a claim that a physician’s assistant breached non-competition and non-solicitation provisions in her employment...more

Biosimilar Makers Turn to IPRs before Litigation under the BPCIA

A number of biosimilar makers have turned to inter partes review (IPR) proceedings in order to litigate the validity of patents that cover their proposed products prior to submission of their biosimilar applications to FDA. ...more

State May Not Disclose Trade Secrets Submitted as Part of RFP Response

If you have ever agonized about whether to include certain confidential business information in a bid for a state contract in New Hampshire because of concerns that your competitors might get their hands on it, you should...more

More Biosimilar Q&A’s Released by FDA

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

Republican HELP Committee Members Request FDA to Step Up Finalizing Biosimilars Guidances and Transparency

On April 30, 2015, Senators on the Health Education Labor and Pensions Committee (HELP) urged FDA to provide additional guidance on “important issues relating to the review and approval of license applications for biosimilar...more

Amgen Wins Injunction against Neupogen® Biosimilar Pending Appeal

The Federal Circuit has granted Amgen’s emergency motion for an injunction against Sandoz, preventing that company from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO®...more

Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation...more

Federal Circuit Grants Injunction Keeping Sandoz’s Biosimilar Version of Neupogen Off Market Until Appeal Decided

The Federal Circuit yesterday granted Amgen’s motion for a preliminary injunction to keep Sandoz’s biosimilar form of Neupogen off the market until the Court renders its decision on the merits of the appeal. The parties had...more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

BakerHostetler Data Security Incident Response Report Shows Human Error is More Often to Blame

Human error was the number one cause of data security incidents according to a new report released today by the Privacy and Data Protection Team at BakerHostetler. In the incidents that the firm worked on last year, employee...more

FDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed

The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese...more

Can My U.S. Company Offer Online Second Opinions in China?

This post is the sixth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market. As U.S. companies continue...more

Pfizer’s strategic response to the threat of generic competition upheld by the Federal Court

On 25 February 2015, the Federal Court handed down its much-anticipated judgment in the matter of ACCC v Pfizer Australia Pty Ltd. In dismissing the Australian Competition and Consumer Commission’s (ACCC) allegations, Justice...more

Biosig Instruments, Inc. v. Nautilus, Inc. (Fed. Cir. 2015)

The Federal Circuit considered the question of indefiniteness on remand from the Supreme Court's reversal in Nautilus v. Biosig and, perhaps not surprisingly, found again that the Biosig's claims were not indefinite....more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

Court Report - April 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Medicis Pharmaceutical Corp. v. Taro Pharmaceuticals U.S.A., Inc. et el. 3:15-cv-02841; filed April 22, 2015 in the...more

Amicus Briefs on Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

Polsinelli Podcasts: Cloud Computing, From Cybersecurity to Confidentiality Issues [Video]

Hosting and securing data is a concern for both businesses and consumers. As companies and health systems are quickly adopting the idea of hosting data “in the cloud,” regulatory agencies are crafting laws to protect private...more

In Non-precedential Case, Third Circuit Affirms Fracking Trade Secrets Trump Physician’s Right to Know, Absent Actual Harm

Fracking in Pennsylvania continues to create work for the courts. On March 16, 2015, in a non-precedential opinion in Rodriguez v. Secretary of Pennsylvania Environmental Protection of PA et al., the Third Circuit issued a...more

Trademarks in Cuba, Successful Whistleblowers, Big Data, Health Care Encryption, Jury Instruction Tips [Expect Focus – Vol. 1,...

IN THE SPOTLIGHT · Is your Company Ready to Comply with Encryption of Individually Identifiable Health Information? LIFE INSURANCE · STOLI Schemers Must Make Good on Damages Caused · At the State Level, Is a Fixed-Index...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA [Video]

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

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