Federal Circuit Finds Apotex ANDAs Do Not Infringe Lysteda Patents

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 (ANDAs). In this article, I focus on the decision relating to the Apotex ANDAs, and the Federal Circuit’s discussion of the patentee’s burden when an ANDA does not answer the infringement question. (You can read my article on the non-obviousness analysis here.)

Continue reading this entry

Federal Circuit Upholds Validity Of Lysteda Patents

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 (ANDAs). In this article, I focus on the decision relating to the validity of the patents. Although Judge Lourie only spends three pages on his obviousness analysis, any Federal Circuit decision that upholds the validity of formulation claims seems to be worth noting! I also find it interesting that the Federal Circuit cited the FDA’s “fast track” review of Lysteda® as evidence of non-obviousness. Continue reading this entry

Humira Patent Invalid For Obviousness Type Double Patenting

In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, the Federal Circuit affirmed the district court’s finding that a second patent covering  AbbVie’s Humira product is invalid under the doctrine of obviousness-type double patenting. The decision reaffirms the court’s stance in Gilead that the doctrine remains valid under the 20-year patent term system, and serves an important public policy goal of ensuring that once a patent protecting an invention has expired, the public is free to practice that invention and its obvious variants. The court may have gone too far, however, in relying on the disclosure of the reference patent to support its obviousness determination. Continue reading this entry

Airing The USPTO’s Naturally Occurring Dirty Laundry — The Subject Matter Eligibility Stain

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 involving laws of nature/natural principles, natural phenomena, and/or natural products.” While many of the rejections based on this Guidance are expected, some rejections leave even the most jaded practitioners scratching their heads. Do these rejections reflect the official USPTO position, or are individual examiners misapplying the Guidance?

Unfortunately, it will take many months and many more dollars to find out, and many would-be patent holders may be discouraged from pursuing important technologies due to this unprecedented uncertainty surrounding what types of inventions can be patented in the United States. Continue reading this entry

Federal Circuit Upholds Inequitable Conduct Defense Against Apotex Patent

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 “at a minimum, come[s] close to the type of affirmative misconduct” that can “justify finding inequitable conduct without showing but-for materiality.” This case also serves as a reminder that the USPTO still has not acted on its proposal to align Rule 56 with TherasenseContinue reading this entry