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Shook Hardy & Bacon LLP | USA | 30 Sep 2016

Learning the Steps of the BPCIA's Patent Dance : notice of commercial marketing is mandatory

The Federal Circuit’s second opinion interpreting the Biologics Act in Amgen v. Apotex is dense, but the outcome is simple. There are two takeaways…
Article

Shook Hardy & Bacon LLP | USA | 13 Nov 2014

Dissatisfied patent reexamination plaintiff contends standing conferred by statute

A consumer-interest organization that was dissatisfied by a Board of Patent Appeals and Interferences (BPAI) ruling in the appeal of a patent…
Article

Shook Hardy & Bacon LLP | USA | 13 Nov 2014

Ninth Circuit rules out state’s claims in class settlement with fetal-gender testing co

The Ninth Circuit Court of Appeals has enjoined California's effort to obtain restitution on behalf of individual citizens bound by the bargainedfor…
Article

Shook Hardy & Bacon LLP | USA | 13 Nov 2014

Bio-Rad agrees to pay $55 million to resolve SEC bribery charges

A California-based clinical diagnostic and life science research company has reportedly agreed to pay $55 million to resolve U.S. Securities and…
Article

Shook Hardy & Bacon LLP | USA | 13 Nov 2014

FTC settles deceptive sales-tactics claims against MPHJ Technology

The U.S. Federal Trade Commission (FTC) has agreed to settle claims that MPHJ Technology Investments, LLC—a patent-assertion entity (PAE)—and company…
Article

Shook Hardy & Bacon LLP | USA | 13 Nov 2014

RAND Corp. predicts $44.2 billion in savings with biosimilars

The Rand Corp. has issued a perspective titled "The Cost Savings Potential of Biosimilar Drugs in the United States." It predicts that "biosimilars…
Article

Shook Hardy & Bacon LLP | USA | 13 Nov 2014

CNS drug approvals take longer, are rejected more often

A new Tufts Center for the Study of Drug Development report reveals that drugs to treat central nervous system (CNS) disorders take longer to develop…
Article

Shook Hardy & Bacon LLP | USA | 13 Nov 2014

College research program partners with diagnostics firm

The Baylor College of Medicine and diagnostics company Miraca Holdings have reportedly formed a joint venture—Baylor Miraca Genetics…
Article

Shook Hardy & Bacon LLP | India, USA | 13 Nov 2014

Ranbaxy loses FDA approval for two generics

According to a statement that Ranbaxy Laboratories Ltd. provided to the Bombay Stock Exchange Website, the U.S. Food and Drug Administration (FDA)…
Article

Shook Hardy & Bacon LLP | USA | 13 Nov 2014

News bytes

The U.S. Food and Drug Administration (FDA) makes available Guidance for Industry and staff titled "Molecular Diagnostic Instruments with Combined…
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