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HTMLFederal Circuit Upholds Validity of Lysteda Patents
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
August 29, 2014, previously published on August 28, 2014
In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either Apotex’s or Watson’s Abbreviated New Drug Applications...

 

HTMLPrescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction
Tara E. Swenson; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
August 28, 2014, previously published on August 25, 2014
Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations. While manufacturers are likely not out from underneath the microscope, it...

 

HTMLOIG Finds Risk of Abuse in Specialty Pharmacy’s Per-Fill Fee Proposal
Rachel Irving Pitts; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
August 28, 2014, previously published on August 22, 2014
In an Advisory Opinion posted August 15, 2014, the Office of Inspector General (“OIG”) concluded that a proposed arrangement by a specialty pharmacy (“Requestor”) might generate prohibited remuneration under the Federal anti-kickback statute and would pose a risk of fraud...

 

HTMLAiring the USPTO's Naturally Occurring Dirty Laundry — the Subject Matter Eligibility Stain
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
August 27, 2014, previously published on August 21, 2014
It has been five months since the USPTO issued its Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products to aid examiners in applying the principles of Myriad and Prometheus to any claim “reciting or...

 

HTMLSecond Circuit Clarifies the Use of Legal Presumptions of Consumer Confusion and Injury in Certain Lanham Act Cases
Bruce A. Colbath; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 27, 2014, previously published on August 21, 2014
On Tuesday, July 29, the United States Court of Appeals for the Second Circuit “clarified certain aspects of [its] false advertising jurisprudence” and held that, where literal falsity and deliberate deception have been proved in a market with only two players, it is appropriate to use...

 

HTMLInvalidity Allegations re Anticipation and Obviousness Found Justified
Adrian J. Howard, Beverley Moore, Chantal Saunders, Ryan Steeves; Borden Ladner Gervais LLP;
Legal Alert/Article
August 27, 2014, previously published on August 20, 2014
In this case, Apotex sought to enter the market with its generic version of travoprost. The Court dismissed the proceeding on the basis that Apotex’ allegations as to anticipation and obviousness were held to be justified. The Court construed the claims at issue to claim the use of a compound...

 

HTMLFederal Circuit Upholds Inequitable Conduct Defense Against Apotex Patent
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
August 22, 2014, previously published on August 18, 2014
In Apotex Inc. v. UCB, Inc., the Federal Circuit upheld the district court’s finding that Apotex’s patent is unenforceable due to inequitable conduct. While affirming on the ground of “but-for materiality,” the Federal Circuit noted that the inventor’s conduct...

 

HTMLCMS Re-Opens Open Payments System
Kate F. Stewart; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
August 22, 2014, previously published on August 18, 2014
As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the Sunshine Act report payments and transfers of value made to physicians and...

 

HTMLSham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?
Robert L. Magielnicki; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 19, 2014, previously published on August 12, 2014
Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may harm competition or competitors. The Supreme Court has...

 

HTMLWith Quantum of Damages Settled, Parties Unable to Agree on Quantum of Costs or Calculation of Pre- and Post-Judgment Interest in Section 8 Case
Adrian J. Howard, Beverley Moore, Chantal Saunders, Ryan Steeves; Borden Ladner Gervais LLP;
Legal Alert/Article
August 19, 2014, previously published on August 14, 2014
In the Federal Court’s earlier decision (summary here), the parties were instructed to attempt to reach an agreement on the quantity of damages and costs in an action for damages under section 8 of the PM(NOC) Regulations. These supplementary reasons report that the parties agreed on the...

 


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