The Takeda lawsuit, on the other hand, is not an outlier case of what is taking place in the medical and pharmaceutical industries. It is rather indicative of a much larger trend that has been happening for quite some time now. The industry giants like Merck, Coop, Mead Paper, and others have been denying and hiding information about ingredients and health risks associated with their product and/or procedures used to manufacture it. Why?
Well, generally speaking, as stated in prior articles on this site, the FDA is a bureaucratic arm of the State and it answers only to State authorities. That is why they usually take so long to approve drugs and chemicals for marketing. What they are doing is simply biding their time to finalize a patent for a new generic colchicine product or any other product that may come along. And, the courts have been accommodating to their delays and ruling in favor of the patent holders. That is why the Takeda lawsuit is so significant, and why such things as compulsory settlements, double indemnity insurance, and hidden costs (in my opinion) must be avoided where possible.
Specifically, the preliminary injunction and its application to the d.. 15, ex. application are based on the same basic concepts: namely, that there is a valid claim to the exclusive rights granted to the manufacturer under the relevant patents; and, that the current claims are either illegal or unreasonable under the circumstances existing at the time the product was manufactured.
Further, it is claimed that there was an illegal conspiracy by the manufacturer to prevent competition with its generic colchicine product. Finally, it is contended that there was a breach of fiduciary duty as a result of the failure to provide the appropriate warnings in the packaging and on the label of the product.
The first issue revolves around whether the claims are patentable.
This is the subject of the next part of this article. There are two main approaches to analyzing the question of patentability. One approach is to analyze the scope of the claim according to the product code or other specifications; the second is to analyze the scope of the claim based on the claimed invention itself. Although both approaches have merits, it would be prudent to consider the nature of the product codes and the way in which they are construed by the parties before coming to any conclusion as to the scope of the Takeda lawsuit.
Assuming the product code analysis to be valid, it is further argued that there is a reasonable likelihood that the claimed invention will cause a “greater degree of difficulty in the manufacture of the product.”
According to this view, it is likely to succeed on the basis that it is likely to cause “irreparable harm” if allowed to proceed. Accordingly, it is likely to win on its claim for an irreparable harm claim against Samsung. Irreparable harm is described as “unpunished or severe injury, which can never be restored; the victim must suffer this loss continuously for the rest of his or her life, unless care is provided.” Accordingly, it is likely to prevail on this claim.
Finally, on a section 1.2 review of the claim for damages against Samsung, it is urged that the district court abused its discretion in granting summary judgment on the patent claims against Samsung.
Specifically, it is urged that the District Court failed to take into consideration the long-standing rule of res judicata, which requires that the plaintiff show that it has suffered a genuine and legitimate injury before the United States Supreme Court. Accordingly, the claim should be allowed to proceed as a real party-of-action with Article II courts, rather than the USPTO.