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Intellectual Property Law Updates
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Around the clock, the National Law Review's editors screen and classify breaking news and analysis authored by recognized legal professionals and our own journalists.
There is no log in to access the database and new articles are added hourly.
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FDA releases additional draft guidance regarding implementation of Biologics Price Competition and Innovation Act (BPCIA)
On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of the Biologics Price Competition and Innovation Act (BPCIA). The final version of the Q & A document noticeably did not contain several questions present in the earlier draft of 2012. ..
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Apotex Petitions Supreme Court to Review Therasense Standards
In Apotex, Inc. v. UCB, Inc., Appeal No. 2013-1674 (Fed. Cir. August 15, 2014) the court affirmed the district court's ruling that one actor, Dr. Sherman, the chairman of Apotex had committed inequitable conduct by engaging in what the court found was a perfect storm of misrepresentations during the prosecution of U.S. Pat. No. 6,767,566 that claimed a method to make the magnesium (Mg) salt of Moexipril. ..
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Patent Safe Harbor Applies To Supplemental New Drug Applications
On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. ? 271(e)(1) can shield post-FDA approval activities from liability for patent infringement when the activities generated information that was submitted to the FDA to support a supplemental New Drug Application and Citizen's Petition. ..
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Ninth Circuit Rules Against Takedown of Anti-Islam Video on Copyright Grounds
In an en banc decision, Garcia v. Google, No. 12-57302 (9th Cir. 2015), the Ninth Circuit overturned a highly controversial panel decision that enjoined Google from displaying the anti-islamic video that was purported to have started the Benghazi riots. The full Circuit ruled that the district court had not erred in refusing to grant an injunction and that the plaintiff's claims, which sounded only in copyright, did not warrant an injunction despite the death threats that she had received as a result of the video. ..
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