Insights

Last week, the U.S. Court of Appeals for the Federal Circuit, in In Re: Forney Industries, Inc., held that a multicolored mark, when used on product packaging, can be inherently distinctive, and thus eligible for federal trademark registration. The proposed mark consisted of the use of black next to a yellow to red color spectrum as shown below on tools and accessories for welding:

The COVID-19 pandemic presents unique and unprecedented challenges to the ongoing need to protect confidential information and trade secrets. The massive business disruptions that enterprises of all kinds now face include (1) entire workforces forced to work remotely, accessing and using confidential information and trade secrets from home; (2) exigent circumstances created by the cessation or substantial slowing of commercial activity that may result in the disclosure of confidential information or trade secrets to third parties outside normal procedures; and (3) the off-boarding of remote employees who are accessing confidential information and trade secrets remotely.

On July 5, 2016, the Federal Circuit upheld claims for a method of preserving hepatocytes by freezing them, thawing and re-freezing them as more than a patent-ineligible law of nature under 35 U.S.C. § 101. Rapid Litigation Management Ltd., et al. v. CellzDirect, Inc., et al., No. 2015-1570 (Fed. Cir. Jul. 5, 2016) is the Federal Circuit’s first attempt to clarify the restrictive interpretation of the requirements of Section 101 for a life sciences patent established in the seminal case Mayo v. Prometheus, 132 S.Ct. 1289 (2012) and its progeny. It is also the first time that the Federal Circuit has rejected a Section 101 attack on a patent involving a natural phenomenon since the Supreme Court’s decision in Alice Corp. Pty. Ltd. v. CLS Bank International et al., 134 S.Ct. 2347 (2014). In CellzDirect, the Court held that the “[t]he end result of the [patent] claims is not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles…[r]ather, the claims are directed to a new and useful method of preserving hepatocyte cells.”

Last Tuesday, the Federal Circuit unanimously held that all biosimilar companies – even companies that participate in the so called “patent dance” – must notify brand-name rivals of their intent to sell a biosimilar drug 180 days before marketing the drug. The case, Amgen Inc., v. Apotex Inc. could have major implications for the timing of when biosimilar companies launch their drugs.

Today, the Federal Trade Commission sued Endo, Impax, Watson, and others for "anticompetitive reverse-payment agreements orchestrated by Endo to prevent lower-cost generic competition to its two most important branded prescription drug products," Opana ER, an opioid drug, and Lidoderm, a lidocaine patch. These two drugs represented approximately 64 percent of Endo's total annual revenues. According to the FTC, this is the first time the agency has brought a case "challenging an agreement not to market an authorized generic – often called a 'no-AG commitment' – as a form of reverse payment."

On Tuesday December 1, new amendments to the Federal Rules of Civil Procedure went into effect. These amendments are designed to streamline discovery and notably: (i) introduce a new proportionality standard defining the scope of discovery (replacing the former relevance standard); (ii) require greater specificity when objecting to a discovery request; (iii) speed up litigation with shorter timelines; and (iv) establish sanctions for spoliation of electronically stored information.

The Federal Circuit, sitting en banc in Akamai Technologies, Inc. v. Limelight Networks, Inc., ruled yesterday to clarify the law of divided infringement under 35 U.S.C. § 271(a). This decision clarifies and expands the grounds for finding direct infringement of a method patent claim where all of the method's steps are not performed by a single entity. In Akamai Technologies, the defendant's customers – not the defendant – performed the specific method steps of tagging and serving content as required by the method claims. The Federal Circuit held that defendant Limelight was nonetheless liable as a direct infringer because it had "directed or controlled" its customers' performance of those steps such "that all the steps of the claimed methods were performed by or attributable to Limelight." This ruling reversed a May 2015 Federal Circuit panel decision and reinstated a 2006 jury verdict in the amount of $45.5 million.

In a decision applying two recent Supreme Court decisions, the Federal Circuit on Thursday held that the claims to Teva's patents covering the multiple sclerosis drug Copaxone® were invalid for the second time. Teva Pharm.USA, Inc. v. Sandoz, Inc., 2012-1567, slip op. at 18 (Fed. Cir. June 18, 2015). Judge Moore, writing for the court again, found that the claim term "molecular weight" was indefinite because a person of ordinary skill in the art would not understand with reasonable certainty to which type of molecular weight the claim language referred. Prior to remand, the Federal Circuit had reached the same conclusion, which was vacated by the Supreme Court in Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015). There, the Supreme Court held that the appellate court must give deference to subsidiary factual findings made by district courts in construing patent claims and review those findings only for clear error. On remand, the Federal Circuit applied that guidance and reviewed several of the district court's subsidiary factual findings. Despite finding the District Court made no clear error, the Federal Circuit found that the ultimate legal conclusion of indefiniteness remained unchanged.

On Thursday, March 19, 2015, a district court ruling paved the way for the first biosimilar product approved by the U.S. Food and Drug Administration (FDA) to enter the market. Judge Seeborg in the Northern District of California granted a victory to Sandoz in its fight with Amgen, Inc. over Zarxio, Novartis AG's generic version of Amgen Inc.'s cancer drug Neupogen® (the "reference product") by denying Amgen's request for a preliminary injunction. In the order, the court sided with Sandoz on its interpretation of the portion of the Biologics Price Competition and Innovation Act (BPCIA) governing the disclosure requirements imposed on biosimilar manufacturers prior to sale of a biosimilar product. The court also rejected Amgen's interpretation of the statute that would have required Sandoz to wait 180 days from approval of the biosimilar product before going to market. Amgen (the "reference product sponsor") has said that it will appeal the ruling.

Zarxio, Novartis AG's version of Amgen Inc.'s cancer drug Neupogen®, recently won approval from the U.S. Food and Drug Administration (FDA), marking the first time that the FDA has approved a biosimilar for sale in the United States. 

On June 20, 2014, the U.S. Patent and Trademark Office's Trial and Appeal Board, for the first time, rendered final written decisions in inter partes review proceedings of pharmaceutical related patents, specifically claims covering compositions for and methods of making and using folate-containing dietary supplements said to address elevated levels of homocysteine in the blood that can lead to cardiovascular, ocular, neurological and skeletal diseases. Since the inter partes review procedure went into effect in September 2012, more than 1350 patent challenges have been initiated, more than 700 trials instituted, and more than 65 final written decisions issued, but these are the first final written decisions in cases involving pharmaceutical related patents. Of particular significance, the Board found all of the challenged patent claims it reviewed to be unpatentable.