Thus far, biosimilar uptake has been low in the United States, with market shares for most biosimilars under 10%. Given the cost-saving potential, trying to increase biosimilar uptake has been high on Congress's agenda and there are many bills pending before it dealing with issues from a variety of angles. But will they actually help to bring biosimilars to market more quickly?
Thus far, 2019 has been an eventful year for US patent law. Over the past seven months, the Supreme Court and the Court of Appeals for the Federal Circuit (the US appellate court tasked with reviewing all district court patent decisions) have issued several significant rulings that may affect the rights of patent owners. This article reviews the most important of these rulings, including decisions on the application of the on-sale bar and state sovereign immunity.
A Federal Circuit panel recently held that state sovereign immunity does not apply to inter partes review proceedings conducted before the Patent Trial and Appeal Board of the Patent and Trademark Office. The dispute had arisen after the University of Minnesota (UMN) sued LSI and Ericsson customers in a district court for the infringement of several UMN patents claiming 4G LTE telecoms technology.
The Supreme Court recently ruled six-to-three that a federal agency cannot petition for the review of an issued patent under the America Invents Act. This decision prevents the government from challenging the validity of issued patents through inter partes, post-grant and covered business method reviews.
While the biosimilar market in the United States has gotten off to a relatively slow start compared with Europe – where biosimilars have been available since 2006 – it has recently gained momentum and will continue to grow in the coming years as more blockbuster biologics lose regulatory exclusivity and patent protection.
The Supreme Court recently held that the sale of a patented invention to a third party that is contractually obligated to keep the invention confidential can trigger the on-sale bar of the Leahy-Smith America Invents Act. The decision clarifies statutory language in the act, which has been a source of considerable confusion to patent litigants. The decision also requires that IP owners carefully ensure that public disclosure of their business dealings does not interfere with their patent rights.
A Federal Circuit panel recently held that a patent term extension (PTE) granted pursuant to 35 USC Section 156 was not invalid for obviousness-type double patenting. The decision should provide pharmaceutical patentees with some assurance that their PTEs generally will not fall foul of the obviousness-type double patenting doctrine.
The Federal Circuit recently held that the assignor estoppel is not available in inter partes review proceedings. Assignor estoppel is a common law doctrine which prevents a party that assigns a patent to another party from later challenging the validity of the assigned patent. In a decision by Chief Judge Prost (joined by Judges Schall and Chen) the Federal Circuit held that the assignor estoppel is not available in inter partes reviews.
The Federal Circuit recently affirmed the Patent Trial and Appeal Board's determination that there was no interference-in-fact between the University of California's Patent Application 13/842,859 and the 12 patents and one patent application owned by the Broad Institute, the Massachusetts Institute of Technology and Harvard University concerning CRISPR-Cas9 technology.
The Federal Circuit recently affirmed a district court's denial of the US Patent and Trademark Office's request for reimbursement of attorneys' fees which it had incurred in defending a district court action brought against it under 35 USC § 145. The majority held that Section 145 expenses do not include attorneys' fees because any statute seeking to depart from the default 'American Rule' must do so using specific and explicit language, which Section 145 lacks.
The US Supreme Court recently held that patent owners can recover lost profits damages under 35 USC Section 271(f)(2) based on acts occurring outside the United States. Section 271(f)(2) imposes patent infringement liability where a party supplies components from the United States that are not "suitable for substantial noninfringing use" which it intends to be combined abroad in a manner that would infringe if the combination had occurred within the United States.
The Patent Trial and Appeal Board (PTAB) has designated a recent order as 'informative'. Although not precedential, the order provides guidance concerning the PTAB's treatment of motions to amend patent claims challenged in inter partes review proceedings following Aqua Products, Inc v Matal, wherein it was held that a patent owner in an inter partes review proceeding does not bear the burden of demonstrating the patentability of substitute claims presented in a motion to amend.
After a week-long trial and four days of deliberation, a federal jury has determined that Samsung owes Apple over $533 million in damages for infringing three design patents asserted by Apple. The jury also found Samsung liable to pay more than $5 million for infringing two utility patents.
In a recent case, the Supreme Court held that when the US Patent and Trademark Office (USPTO) institutes an inter partes review, it must decide the patentability of all of the claims challenged by the petitioner, based on the plain text of 35 USC Section 318(a). The court found no basis in the statutory text or framework for the USPTO's partial institution practice.
Two recent Federal Circuit orders have provided answers to certain venue-related questions that have arisen in patent cases. The first order stipulates that alien corporate defendants remain subject to venue in any judicial district, reaffirming the Supreme Court's long-established Brunette ruling. Further, the second order confirms that when a defendant moves to dismiss for improper venue, the burden of proving that venue is proper rests with the plaintiff and is governed by Federal Circuit law.
The Supreme Court recently heard oral argument in a case which will determine whether US patentees can recover lost profits damages arising under 35 USC Section 271(f) for certain activities occurring outside the United States. Among other things, the justices who asked questions seemed to accept the argument that the application of proximate cause would be sufficient to limit the risk of excessive damages awards and mitigate any potential harm to international comity.
In a precedential copyright decision, the Federal Circuit recently held that Google Inc's use of Oracle America, Inc's Java application programming interface was not fair use as a matter of law, contrary to a jury's finding. In so doing, the Federal Circuit reversed a decision denying Oracle's requests for judgment as a matter of law and for a damages trial.
The US Court of Appeals for the Second Circuit recently held that certain aspects of TVEyes's service – which allows users to watch video clips of programmes on Fox News and other channels – are not protected by the copyright fair-use doctrine under 17 USC Section 107. The Second Circuit addressed each of the four statutory fair-use factors and reversed the district court's determination that TVEyes's watch function constituted fair use.
A number of district court decisions have held patent claims to be ineligible under Section 101 during motions brought at the start of litigation or on motions for summary judgment. However, two recent Federal Circuit decisions indicate that factual disputes over aspects of the two-step test for assessing patent eligibility established by the Supreme Court, including the tangibility of claims, may hinder such early or summary Section 101 determinations.
In a recent case, the US Court of Appeals for the Fourth Circuit held that an internet service provider (ISP) was not entitled to the safe harbour of 17 USC Section 512(a) of the Digital Millennium Copyright Act. In so holding, the Fourth Circuit rejected the ISP's argument that the safe harbour requires that an ISP take action only against subscribers who are adjudged in court to be 'repeat infringers'.