The legal issues surrounding the life sciences industry may not be in the forefront of many people’s minds, but the food industry, pharmaceutical companies, medical device manufacturers, and many other businesses are impacted by the regulations and litigation that emanate from the life sciences sector. The Life Sciences Legal Blog concentrates on the business concerns that result from legal disputes in the industry, including intellectual property; funding; litigation; risk management; regulatory and compliance; mergers, acquisitions and other corporate transactions. Updated by a team of Fox Rothschild attorneys, the blog alerts companies to the latest trends in their industry.
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In a move that will effect the entire patent community, Congress has decided not to give the United States Patent and Trademark Office (" USPTO") access to all of the funds it will collect this fiscal year. Specifically, Congress authorized Public Law 112-10, which calls for withholding...
By way of follow-up to our earlier post regarding changes to the 510k process, we wanted to make sure that those who are following us are aware of an upcoming town hall style discussion being held by the Director of CDRH. This public meeting will be held on May 5, 2011 from 8 AM to 12 PM at...
In early February of this year, FDA approved a drug to help prevent premature birth in women who have had at least one preterm delivery. Manufactured by KV Pharmaceutical, which developed the drug with substantial assistance from the federal government, approval of the drug was...
The Senate is poised to have a final vote this Wednesday on the patent reform bill. As we discussed last week, this bill is designed to considerably revamp U.S. patent practice for the first time in almost 60...
The Senate is taking up the Patent Reform Act, a bill sponsored by Judiciary Committee Chairman Senator Patrick Leahy, Senator Orrin Hatch, and Senator Chuck Grassley. This legislation is designed to overhaul the U.S. patent system and bring the patent system in line with 21st century...
On May 3, 2011, FDA and Xavier University in Cincinnati, Ohio will once again team up to hold MedCon. The goal is to bring together as many members of the global medical device community together to openly dicuss pressing issues facing the industry. Leading FDA officials and field...
Unsurprisingly, Lorillard, Inc. and Reynolds American, Inc.'s R.J. Reynolds Tobacco Company unit filed suit against FDA regarding an upcoming advisory panel board that will likely recommend a ban on menthol cigarettes. Lorillard's top seller is the Newport brand and Reynolds sells, among...
FDA will hold a meeting on March 15, 2011 in Silver Spring, Maryland about its Medical Device Innovation Initiative. The purpose of the Medical Device Innovation Initiative is to assure that American patients have timely access to new technologies and next-gen products, while insuring the...
The United States Food and Drug Administration (“FDA”) has recently approved a mobile radiology application for the iPhone, iPad, and iPod touch, all manufactured by Apple, Inc. This application is the first of its kind and is designed to allow physicians to view medical images and...
The United States Patent and Trademark Office (“USPTO”) is opening its first ever satellite office in Detroit, Michigan, in 2011. The new office is expected to create more than 100 new jobs in its first year and to provide a boost to the region’s economy. The satellite...