Patent Law

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In a decision that is quickly gaining attention, the Federal Circuit held that the district court abused its discretion by excluding both of Plaintiff’s experts and subsequently granting Defendants’ judgment as a matter of law (JMOL) of no infringement. Barry v. DePuy Synthes Companies.

The ruling is notable given the Federal Circuit’s recent en banc decision in Google v. EcoFactor, which reinforced district court’s gatekeeping authority over expert testimony. In Barry, however, the Court seems to be shifting greater responsibility back to the jury to assess expert credibility and weight.

The Supreme Court’s decision to review Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. places renewed attention on a familiar but unsettled issue in pharmaceutical patent law: how the induced infringement doctrine applies when a generic drug launches with a concededly “skinny” label, but engages in broader marketing and communications outside the FDA-approved label.

Although the case arises under the Hatch-Waxman Act, it squarely implicates the scope and enforceability of method-of-use patents, particularly for later-developed indications that often represent substantial additional investment by brand-name manufacturers.

The Federal Circuit’s recent decision last week in Inland Diamond Prods. Co. v. Cherry Optical Inc., offers an important reminder for patent litigators: a PTAB’s factual finding in an inter partes review (IPR) does not automatically bind a district court. The case underscores that issue preclusion has clear boundaries when different forums apply different standards of proof.

Patent eligibility under 35 U.S.C. § 101 should be a straightforward threshold question: any “new and useful process, machine, manufacture, or composition of matter” is eligible for protection. Yet over time, this once-clear principle has become anything but.

Although the statute itself has remained unchanged for two centuries, its interpretation has evolved dramatically through judicial decisions. And it is this common law precedent that has shaped the approach to the determination of patent subject matter eligibility.

For many patent cases, the United States District Court hearing your patent dispute can have a big impact on case strategy, budget and management, and even, to some extent, case outcomes. As we discussed earlier this year, how a patent owner approaches an alleged infringer can turn into a costly and inconvenient endeavor if forced to defend their patents in an unexpected jurisdiction. A recent case out of the District of Arizona illustrates the opposite scenario – where the activities of an accused infringer results in a suboptimal venue for that defendant.

The practice of serially filing continuation applications through a patent’s lifetime has come under increased pressure in recent years from newly implemented continuing application fees to expanded case law on non-statutory obviousness-type double patenting. A somewhat new interpretations of the doctrine of prosecution laches emerging from Sonos, Inc. v. Google…

Method-of-treatment (“MoT”) claims can be powerful tools for pharmaceutical companies seeking to extend market exclusivity for their products after the original composition-of-matter patents expire. However, the District of Delaware’s recent decision in Novo Nordisk v. Mylan is another reminder that the scope of method of treatment claims must be aligned with an FDA approved drug label. 

The Federal Circuit recently reversed a $4.7M verdict in a patent lawsuit involving two patents concerning next-generation sequencing methods—U.S. Patent Nos. 10,017,810 and 10,450,597. Both patents concern DNA preparation using different types of primers: “target-specific primers” that bind to regions of interest in the genome and other primers or adaptors…

In the past few months, the U.S. Patent and Trademark Office (“PTO”) Acting Director has made substantial changes to the process for, and factors considered in, exercising discretion to deny institution of an inter partes review (“IPR”) petition. We have discussed these changes and recent decisions in prior blogs. Now, the PTO is facing legal challenges stemming from these policy changes. In one pertinent example, SAP America, Inc. filed a Petition for Writ of Mandamus to the Federal Circuit resulting from the PTO’s discretionary denial of its IPR petition, challenging the PTO Acting Director’s authority to enforce these new policies.

On the heels of the U.S. Patent and Trademark Office Acting Director’s recent decision to deny institution of iRhythm Technologies’ inter partes review petition, the PTO has now issued additional decisions clarifying the role of parties’ “expectations” in IPR proceedings. Along with the Acting Director’s guidance regarding discretionary denials of institution, decisions on two recent petitions further illuminate the PTO’s view of which factors should be given weight in deciding whether to deny an IPR petition.