Gibbons Law Alert
Yesterday, the United States District Court for the District of New Jersey held that patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”), but not asserted under the Hatch-Waxman framework, are subject to declaratory judgment actions by later ANDA filers seeking to trigger the first ANDA filer’s exclusivity period.
On the heels of CLS Bank Int’l v. Alice Corp. Pty presently before the Supreme Court, the Federal Circuit and district courts in 2014 have continued to issue decisions analyzing computer-implemented inventions under 35 U.S.C. § 101. These courts have generally sought to answer similar questions: whether the claim is an abstract idea; whether this abstract idea preempts all other uses or can be performed in the human mind (or on a pen and paper); and whether the claim contains other limitations to narrow it sufficiently, such as being tied to a specific machine or transforming the data into a different thing.
This week, United States District Judge Sue L. Robinson issued a new Patent Case Scheduling Order dictating how patent cases will proceed in Her Honor’s Court. The District of Delaware is second only to the Eastern District of Texas in the number of patent cases filed; both of which have nearly three times the number of patent cases as the third busiest district, the Central District of California. In order to help streamline the hundreds of patent cases assigned to Her Honor, Judge Robinson issued a new Patent Case Scheduling Order, requiring the identification of key issues earlier in the case, which should improve overall case efficiencies.
Concerns about shake-down patent assertion have prompted response at federal and state levels, from all branches of government. Proposed legislative solutions have included bills that would penalize bad faith claims, impose fines on patent assertion entities (“PAEs”) that send letters with vague allegations of infringement, or make the awarding of attorney’s fees standard in PAE patent litigations. While no legislative proposal answers all the unique challenges patent trolls represent, these lawmaking efforts have highlighted the issue and are prompting other stakeholders to meaningfully assess the holes in the current patent system.
Patent indemnification agreements, common in asset purchases, mergers and acquisitions, manufacturing, and patent licensing agreements, reduce the possibility of liability should a third party later assert its patent against the asset purchaser or licensee. However, entering into such agreements to mitigate risk can actually increase exposure. During the damages stage of patent infringement lawsuits plaintiffs often seek, with varying success, to bring in evidence of the existence of a defendant’s indemnification agreement to show that defendant knew of the patent and committed willful infringement. Thus, the very vehicle used to shift the risk of monetary liability can sometimes itself be used as a mechanism to enhance damage awards.
In Kilopass Tech., Inc. v. Sidense, Corp., No. 13-1193, 2013 U.S. App. LEXIS 25671 (Fed. Circ., Dec. 26, 2013), the Court of Appeals for the Federal Circuit recently relaxed the standard for finding “an exceptional case” to justify attorneys’ fees in patent infringement actions. For IP practitioners, this case highlights the current state of the law regarding the necessary showing of bad faith to justify an award of attorneys’ fees in a patent infringement suit.
In a decision of first impression, Judge Maxine M. Chesney of the Northern District of California dismissed Sandoz’s declaratory judgment action against Amgen for lack of jurisdiction. Sandoz had brought its suit on June 24, 2013 seeking a ruling that its biosimilar version of Amgen’s patented arthritis drug Enbrel (etanercept) would not infringe and that the patents are invalid. Amgen moved to dismiss the case for lack of subject-matter jurisdiction or, alternatively, to decline to exercise Declaratory Judgment jurisdiction.
Judge Rich gave us the adage, “the name of the game is the claim.” Given the number of cases issued by the Federal Circuit on written description, perhaps the adage should be revised as “the name of the game is the claim – supported by the specification.” In In Re Bimeda Research & Development Ltd., the Federal Circuit issued another decision requiring the entire scope of the claims to be supported by the disclosure. While this is nothing new in patent law, the claim at issue is a negative claim that expressly excluded an element. The original claim was directed to a prophylactic method to treat infections in cow mammary glands by providing a physical barrier to the teat canal.
The Supreme Court asked the U.S. Solicitor General to weigh in on whether to hear an appeal from the Federal Circuit’s decision in Akamai Technologies Inc. et al v. Limelight Network, Inc. on induced infringement. This is a very closely watched case for the software industry, but may have far reaching implications in the pharmaceutical field as well.
This Spring has been fruitful for seed giant, Monsanto. We reported earlier that Monsanto and rival DuPont entered into technology licensing agreements, ending nearly four years of patent and antitrust litigation. On Monday, May 13, Monsanto’s cornucopia arrived, with the Supreme Court ruling unanimously in its favor. This case revolved around the question of whether the doctrine of patent exhaustion allowed a farmer who bought patented seeds to, without permission, reproduce the seeds through planting and harvesting. The seeds in question were glyphosate herbicide-resistant soybean seeds, covered under two patents issued to Monsanto.