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HTMLChanges of the Amended Regulations on Supervision and Administration of Medical Devices
Xinlan Liu; Sheppard Mullin Richter Hampton LLP;
Legal Alert/Article
April 24, 2014, previously published on April 16, 2014
The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the changes that have been made.

 

HTMLReview - U.S. Patent and Trademark Office Subject Matter Eligibility Guidelines
Anthony Navid Moshirnia; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
April 23, 2014, previously published on April 18, 2014
On March 4, 2014 the USPTO issued new patent subject matter eligibility guidelines in an attempt to provide examiners and patent practitioners with some guidance on which claims improperly encompass laws of nature, natural principles, natural phenomena, or products of nature in the wake of the U.S....

 

HTMLUpdate on Myriad Appeal and Announcing a Public Forum on the USPTO 101 Guidelines
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
April 21, 2014, previously published on April 17, 2014
Myriad has appealed the district court decision that denied its motion for a preliminary injunction against Ambry Genetics Corp. According to a report in Bloomberg BNA Life Sciences Law & Industry Report™, on April 14 , 2014, the Federal Circuit denied Myriad’s motion to expedite...

 

HTMLHeart Device Makers' Short Cut On Patient Safety
Wendy R. Fleishman; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
April 16, 2014, previously published on April 8, 2014
Twice in the last seven years, tens of thousands of Americans implanted with cardiac defibrillators have had to make the agonizing decision of whether to undergo surgery to replace their recalled device.

 

HTMLGPhA Calls for US-EU Convergence in Biosimilar and Generic Medicine Regulation
James C. Shehan; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 15, 2014, previously published on April 10, 2014
The Generic Pharmaceuticals Association (“GPhA”) opened a new front in its ongoing battle to shape the approval process for biosimilars, while also calling for more cooperation between the US and the EU in their oversight of traditional generic drugs. In a joint letter to the European...

 

HTMLLandmark Decision Confirms FTC Authority to Regulate Privacy and Data Security
Richard J. Johnson, Mark Mansour, Mauricio F. Paez, Katherine S. Ritchey, Gregory P. Silberman; Jones Day;
Legal Alert/Article
April 15, 2014, previously published on April 2014
In FTC v. Wyndham Worldwide Corp., No 13-1887, 2014 U.S. Dist. LEXIS 47622 (D.N.J. Apr. 7, 2014)—a case closely watched by privacy and data security professionals across the United States—a federal district court held that the Federal Trade Commission ("FTC") has authority...

 

HTMLDo the USPTO 101 Guidelines Violate International Trade Agreements?
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
April 11, 2014, previously published on April 9, 2014
One advantage of being a blogger in the relatively small world of patents is that I have gotten to know practitioners in other countries who also have a keen interest in patent law. One such person is Australian Registered Patent Attorney Mark Summerfield, who blogs at Patentology. I enjoyed his...

 

HTMLThe USPTO Does Not Need the Onerous Proposed Attributable Owner Rules
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
April 10, 2014, previously published on April 7, 2014
The Federal Register Notice promulgating the proposed Attributable Owner rules offers some lofty justifications for the rules. Because the rules have been promulgated pursuant to a White House initiative, they are likely to take effect in some form, but applicants and stakeholders should not miss...

 

HTMLA Second Lawsuit Tests the BPCIA Biosimilars “Patent Dance” Waters
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 4, 2014, previously published on April 1, 2014
Earlier this week, Celltrion Healthcare Co., Ltd. and Celltrion, Inc. (collectively “Celltrion”) filed a Complaint for Declaratory Judgment in the U.S. District Court for the District of Massachusetts seeking a judgment with respect to certain patents allegedly covering Janssen Biotech,...

 

HTMLThe State of Vaccines Under the USPTO 101 Guidelines
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
April 4, 2014, previously published on March 31, 2014
In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical fields.

 


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