Posts Tagged: "ANDA"

American drugmakers Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer, Inc. (NYSE:PFE) fired off a series of nine lawsuits to prevent generic versions of Eliquis, a treatment that helps reduce the risk of stroke in patients with atrial fibrillation. The lawsuits stem from abbreviated new drug applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) to market generic versions of apixaban, the anticoagulant agent used in Eliquis. The suits have all been filed in the U.S. District Court for the District of Delaware (D. Del.).

On April 6, 2017, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in The Medicines Company v. Mylan, Inc. (2015-1113, 2015-1151, and 2015-1181) that imports certain subject matter from the specification into the claims… This case provides some key takeaways for patent practitioners, some more obvious than others. First, as has been known for some time, referring to the “invention” in a patent’s specification can hurt, as can indicating that a particular process “includes all” of the embodiments the specification describes. This is why patents for inventions in the U.S. now curiously, if understandably, usually avoid using the word “invention”. Also, setting forth definitions in a specification can have unintended consequences not just for the term being defined but also for terms that are not explicitly defined even if unequivocally characterized in some other way. Prosecution history also matters too, particularly where an applicant distinguishes its invention during prosecution by explicitly characterizing “the invention” in terms divorced from the language of the claims themselves.

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and “exclusivity” separately. “Exclusivity” refers to exclusive marketing rights granted by the FDA upon approval and was designed to promote a balance between new drug innovation and generic drug competition. Some differences are that patents can be issued or expire at any time – before, during or after FDA approval– while exclusivity attaches upon approval of a drug product. Further, some drugs have both patent and exclusivity protection while others have just one or neither… Make no mistake, it would be tremendously unwise to proceed sans patents. No patent means the generic can enter the market as soon as the FDA exclusivity period expires, and having a patent can extend the exclusivity period to the end of the patent term, often years later.

Mylan had to show by clear and convincing evidence that the idea for the ’445 patent claim was conceived by someone at the FDA and communicated to Mr. Pavliv, the named inventor. The Court agreed with the district court that Mylan did not carry the burden of showing that someone other than Mr. Pavliv had conceived a “definite and permanent idea” of an EDTA-free Acetadote formulation. Mylan argued that Mr. Pavliv’s prior communications with the FDA, including the FDA’s request for justification of the inclusion of EDTA, required Cumberland to undertake research that would have inevitably led to the invention. However, this was not the same as a suggestion to remove EDTA. Derivation is not proved by showing conception and communication of an idea different from the claimed invention, even if that idea would make the claimed idea obvious.

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a generic pharmaceutical company will be subject to personal jurisdiction if they file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). In Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2016), the Federal Circuit held that an ANDA filer opens themselves up to nationwide personal jurisdiction merely by virtue of filing an ANDA application. This is a broad holding that, in effect, subjects a generic company to personal jurisdiction in any forum that has a district court.

Horizon Pharma filed an action for patent infringement against Actavis and Lupin Pharmaceuticals in response to the filing of Abbreviated New Drug Applications (ANDAs) by both defendants for a generic version of Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID) marketed in the U.S. by Horizon. Both cases were filed in the U.S. District Court for the District of New Jersey.

The Federal Circuit held that it is not the case that a patent must spell out a claim element’s function, way, and result, for the doctrine of equivalents to apply. It looked to what the claim element’s function in the claimed composition is to one of skill in the art, which it held may be determined by looking at extrinsic evidence. The Court found no error in the district court’s finding of infringement under the doctrine of equivalents. In applying the two part test (constructing a hypothetical claim that covers the accused device and comparing that claim to the prior art), the district court correctly determined that the hypothetical claim properly included the disputed excipients, i.e. Glenmark’s excipient.

The Federal Circuit held that Mylan Pharmaceuticals, Inc. (“Mylan”), a generic drug manufacturer, was subject to specific personal jurisdiction in Delaware because Mylan had filed an abbreviated new drug application (“ANDA”) and “contemplate[d] plans to engage in marketing of the proposed generic drugs” in the state.[1] The ruling affirmed two different decisions by judges in the United States District Court for the District of Delaware that Mylan was subject to specific jurisdiction in Delaware.[2] However, as noted below, it looks like Mylan intends to seek panel or en banc rehearing and possibly pursue a petition for certiorari if the Federal Circuit does not grant the rehearing or re-hears the case and continues to find personal jurisdiction.

The sole modification in the figure amended was to change one of the 13 amino acids in the structure of daptomycin from an L-stereoisomer to a D-stereoisomer of asparagine. At the time of the invention, it was universally believed that daptomycin included the L-stereoisomer. Not until years later did Eli Lilly discover the error. In any case, the certificate of correction did not affect the validity of the patent, because daptomycin had been described in numerous ways in the application, including by referencing another application that described how to make daptomycin, which would have inherently included the D-stereoisomer.

The United States District Court for the Southern District of Indiana ruled in favor of Eli Lilly (NASDAQ: LLY), issuing a final judgment in the Hatch-Waxman infringement litigation relating to U.S. Patent No. 7,772,209. This matter arose as the result of the defendants’ filing of Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration (FDA). The ‘209 patent, covering a method of use, protects the co-administration of pemetrexed disodium with two nutrients – folic acid and vitamin B12, which protects against the side effects of the drug Alimta®. The district court found direct infringement by administering physicians under § 271(a), and thus inducement of infringement by Defendants under § 271(b).

In this issue of the Federal Circuit Review: (1) Damages for Lost Profits May Not Be Based On Extraterritorial Services Performed by an Infringer’s Customers Under § 271(f); (2) Federal Circuit Invalidates Claims Under the On-Sale Bar for Commercial Exploitation of the Invention Before the Critical Date; and (3) The PTO’s 180-Day Filing Deadline of the Optional Interim Procedure for PTA Reconsideration Request Is Not Arbitrary and Capricious.

HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). Not only is the United States government a patent troll, but the government is also trying to deprive patients who need live saving HIV drugs an affordable generic version. Egad!

In 2014 there were 1,070 fewer patent lawsuits filed than during 2013. Furthermore, the number of patent cases filed in 2014 was lower than the number of cases filed in 2012 by some 433 cases. Therefore, the stories of continued run away litigation seem to be greatly exaggerated. Given the dramatic decrease in patent litigation it seems entirely premature for Congress to be considering additional patent reform at this early stage.