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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…
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…
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…
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…
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…
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…
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…
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…
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)…
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…
