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Documents on pharmaceuticals
 

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HTMLFederal Circuit Find Fractures in Roche Boniva Patents
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
April 16, 2014, previously published on April 14, 2014
In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable based on the Federal Circuit s recounting of the prior art, but the...

 

HTMLThe Complexities of the USPTO Proposed Attributable Ownership Rules
Simon J. Elliott; Foley & Lardner LLP;
Legal Alert/Article
April 16, 2014, previously published on April 11, 2014
The USPTO proposed attributable ownership rules would require the public disclosure of the “attributable owner” of patent applications and patents. As discussed in this article, the proposed definition of “attributable owner” reaches far beyond title holder (assignee), and...

 

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...

 

HTMLMethod for Assessing Quantum of Damages Determined by Court
Adrian J. Howard, Beverley Moore, Chantal Saunders, Ryan Steeves; Borden Ladner Gervais LLP;
Legal Alert/Article
April 15, 2014, previously published on April 9, 2014
In this case, the Court made key findings as to the method of determining quantum of s. 8 damages, and sent the parties away to determine the actual quantum. As background, a predecessor to Teva, Ratiopharm, had filed an ANDS and agreed to await expiry of the patent on the Patent Register at that...

 

HTMLFDA Seeks Information for Implementation of Drug Supply Chain Security Act
Duane Morris LLP;
Legal Alert/Article
April 15, 2014, previously published on April 11, 2014
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To accomplish this, the U.S. Food and Drug Administration (FDA) is...

 

HTMLFDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees
Duane Morris LLP;
Legal Alert/Article
April 14, 2014, previously published on April 7, 2014
On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft Guidance"), which sets forth FDA's current thinking on the...

 

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...

 

HTMLAnother REMS Antitrust Lawsuit: Mylan Sues Celgene Over THALOMID and REVLIMID to Obtain Drug Product Sample
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 11, 2014, previously published on April 4, 2014
In a 17-count, 84-page Complaint filed earlier this week in the U.S. District Court for the District of New Jersey, Mylan Pharmaceuticals Inc. (“Mylan”) alleges that Celgene Corporation (“Celgene”) has violated federal and state antitrust laws by preventing generic...

 

HTMLActos Decision Statement: $9 Billion Decision on Eli Lilly and Takeda Pharmaceuticals
Motley Rice;
Legal Alert/Article
April 11, 2014, previously published on April 8, 2014
On Monday, April 7, a federal court jury in Louisiana decided that Takeda Pharmaceuticals and Eli Lilly hid the risks of bladder cancer from the diabetes drug, Actos. Takeda was ordered to pay $6 billion and Eli Lilly was ordered to pay $3 billion.

 

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...

 


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