Interactive Case Study Operating Instructions. Identifying the Pathway to Successful Patient Care Practical Implementation of IncretinBased Therapies in Type 2. Carsten Worsoe, Principle Scientist, Novo Nordisk. Bjorg Kaae Hunter, Device Engineering Manager, GSK. Francesco Malavasi, Global Quality Device Risk Manager, Novartis. Yahoo Lifestyle is your source for style, beauty, and wellness, including health, inspiring stories, and the latest fashion trends. Novo Knocks it Out of the Park with New Echo Smart Insulin Pen Its not an app. Its not a pump. Its a superpen from Novo Nordisk called the NovoPen Echo, one. Insulin is used as a medication to treat high blood sugar. This includes in diabetes mellitus type 1, diabetes mellitus type 2, gestational diabetes, and. Brand Manual Novo Nordisk News' title='Brand Manual Novo Nordisk News' />Orange Book Blog Orange Book Issues. Novo Nordisk v. Caraco Pharm. Labs.  et al., No. Fed. Cir. 2. 01. 0In the Medicare Modernization Act of 2. Congress gave ANDA applicants who have been sued for patent infringement the statutory right to file a counterclaim seeking the delisting of the patent from the Orange Book If an owner of the patent or the holder of the NDA for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the ANDA applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder. USC 3. 55j5Cii. Get the latest health news, diet fitness information, medical research, health care trends and health issues that affect you and your family on ABCNews. By Aaron F. Barkoff. Novo Nordisk recently became the fourth company to ask FDA for guidance concerning whether patents on prefilled drug delivery devices should be. Newsletter with articles on current research finds, industry news, job listings and event schedules. Includes sign up form and information about the company. Pursuant to this provision, after Novo Nordisk sued Caraco for infringement of U. S. Patent No. 6,6. Caracos paragraph IV certification, Caraco filed a counterclaim requesting an order directing Novo to change the Orange Book patent use code for the 3. Prandin repaglinide is FDA approved for three uses  1 repaglinide by itself i. The 3. 58 patent, which is the only patent listed in the Orange Book for Prandin, claims, A method for treating non insulin dependent diabetes mellitus NIDDM comprising administering to a patient in need of such treatment repaglinide in combination with metformin. Accordingly, the original patent use code for Prandin was Use of repaglinide in combination with metformin to lower blood glucose. Caracos ANDA contained a paragraph IV certification to the 3. Caraco was not seeking approval for the repaglinide metformin combination therapy. Because there was no overlap between Caracos proposed carve out label and the repaglinide metformin use code, FDA accepted the proposed label. Thereafter, Novo changed the use code for the 3. A method for improving glycemic control in adults with type 2 diabetes mellitus. The new use code covered all three approved uses for Prandin, even though the 3. Caracos carve out label now overlapped with the use code, and therefore FDA retracted its approval of Caracos proposed label and section viii statement. As a result, Caracos current label now includes the repaglinide metformin combination therapy, which is stipulated to infringe claim 4 of the 3. This prompted Caracos counterclaim seeking an order directing Novo to replace the new use code with the former listing. On September 2. 4, 2. U. S. District Court for the Eastern District of Michigan ruled that Caraco was entitled to the requested injunction. The court stated, Novo, by the change in the use code narrative is attempting to extend the life of an expired patentnamely, U. Lost Torrent Vostfr Saison 3 Reign. S. patent RE3. 7,0. According to the court, the clear legislative intent behind the 2. Hatch Waxman that added the counterclaim provision, section 3. Cii, was to curb Orange Book abuses arising from misinformation regarding listed patents. The next day, the court issued an order granting the injunction sought by Caraco. On Wednesday, in a 2 1 decisionover a 2. Judge Dykthe Federal Circuit reversed and vacated the injunction. The majority reasoned that the statutory language is clear on its face  an approved method of using the drug means any approved method as Novo urged rather than all approved methods as Caraco argued. Further, according to the majority, its decision to vacate the injunction is consistent with the legislative intent  the counterclaim provision in the 2. Act sought to correct the specific issue raised in Mylan v. Thompson Fed. Cir. In addition, the majority concluded that the patent information referred to in the counterclaim provision meant the patent number and the expiration datenot also the use code narrative. In dissent, Judge Dyk expressed strong disagreement with the majority. He wrote In 2. Congress enacted the counterclaim provision of the Hatch Waxman Act in order to prevent manipulative practices by patent holders with respect to the Orange Book listings. These practices were designed to delay the onset of competition from generic drug manufacturers. In my view, the majority, in reversing the district court, now construes the statute contrary to its manifest purpose and allows the same manipulative practices to continue in the context of method patents. Judge Clevenger, in a short concurring opinion, stated that, in his view, Novo did nothing that was illegal or forbidden. He acknowledged that FDA may have inadvertently upset the careful balance of interests represented by the efficient dispute resolution mechanism Congress created in the Hatch Waxman Act. But, he concluded, Congress is the appropriate entity to readjust, if necessary, the delicate balance it has struck between original drug manufacturers and their generic counterparts. Perhaps Congress will readjust the Act time will tell. Caraco and Novo Nordisk have not yet commented on the Federal Circuits decision.