Last month, following a jury verdict in federal district court in Delaware awarding Plaintiff Idenix Pharmaceuticals LLC $2.54 billion in damages—“the largest damages verdict ever returned in a patent [infringement] trial”—Chief Judge Leonard Stark denied Idenix’s motion for enhanced damages. Idenix Pharm. LLC v. Gilead Scis., Inc., No. 14-CV-00846, at *2, 15 (D. Del. Sept. 22, 2017).  Chief Judge Stark determined that even though the jury concluded that Defendant Gilead Sciences, Inc. willfully infringed Idenix’s patent directed to novel treatments of the Hepatitis C Virus (“HCV”), the totality of the circumstances did not warrant the award of enhanced damages. He based the denial of the motion on the public health benefit of the accused products and on the amount of the jury award.

Continue Reading Chief Judge Stark Rejects Motion for Enhanced Damages Award Due to the Public Interest in the Accused Hepatitis C Virus Treatments

On September 6, 2017, an expanded panel of the Patent Trial and Appeal Board issued an “informative” decision in General Plastic Industrial Co., Ltd, v. Canon Kabushiki Kaisha setting forth the Board’s framework for analyzing follow-on inter partes review (IPR) petitions.  In response to five concurrent requests for rehearing, a panel of seven administrative patent judges reviewed the factors articulated in NVIDIA Corp. v. Samsung Elec. Co., IPR2016-00134, Paper 9 (PTAB May 4, 2016) and, in doing so, denied all five requests.  While acknowledging that multiple petitions challenging the same patent may be permitted based on specific facts of each case, the Board explained that follow-on petitions run the risk of undue inequities and prejudices to patent owners, and petitioner’s submission of multiple, staggered petitions constituted “an inefficient use of the inter partes review process and the Board’s resources.”

Continue Reading General Plastic Industrial Co. v. Canon Kabushiki Kaisha: PTAB Explains Factors for Follow-On Petitions

The public version of ALJ Shaw’s Initial Determination (ID) in U.S. International Trade Commission (ITC) investigation Certain Magnetic Data Storage Tapes and Cartridges Containing the Same, Inv. No. 337-TA-1012 (1012 Investigation), provides important guidance on enforcement of standard-essential patents (SEPs) in the ITC.  Respondent and accused infringer Sony argued that several of the patents asserted by patentee Fujifilm wereessential to the LTO-7 standard (relating to “linear tape open” magnetic media) and therefore that Fujifilm had waived its right to injunctive relief and was obligated to license its patents on FRAND terms.  ALJ Shaw ultimately found that Sony had not met its burden of demonstrating essentiality, but he nevertheless provided helpful instructions on the quantum of proof necessary to make out such a claim, as well as other factors relevant to ITC enforcement of SEPs, all of which affirmed that the ITC is a viable forum for enforcement of SEPs.  In sum he ruled that:

  • The party arguing that a patent is essential bears the burden of proof on that point;
  • Unless a patent is, in fact, essential to a given standard, there can be no breach of the standard-setting organization (SSO) agreement(s) giving rise to the FRAND obligation at issue;
  • Breach of an SSO agreement and of forum selection clauses are not valid defenses in ITC investigations; and
  • Respondents bear the burden of proving that a complainant/patentee relinquished its rights to equitable relief by joining the SSO in question.

Continue Reading ALJ Shaw: ITC is a Viable Forum for Enforcement of SEPs

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize laws relating to protection of intellectual property in the EU and Canada, thereby bringing about a number of changes in Canadian patent law, particularly with respect to laws relating to the issuance of patents covering pharmaceutical products.  One of the biggest changes is the implementation of a Certificate of Supplementary Protection (CSP) Regime in Canada for pharmaceutical products that have been granted regulatory approval.

Continue Reading Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

The United States Court of Appeals for the Federal Circuit’s recent decision in Aqua Products Inc., v. Matal materially changes the burden of proof associated with the patentability of amended claims during an inter partes review (“IPR”), shifting the burden from the Patent Owner seeking the amendment to the IPR Petitioner opposing it.

Prior to the Aqua decision, if a Patent Owner sought to amend claims during an IPR, the Patent Trial and Appeals Board (the “Board”) placed the burden on the Patent Owner to prove that the proposed amended claims were patentable.  When Patent Owner Aqua attempted to amend its claims during an IPR challenge to its U.S. Patent No. 8,273,183, the Board found that Aqua had not met its burden and denied Aqua’s motion to amend.

Continue Reading AQUA PRODUCTS: The Federal Circuit Shifts The Burden of Proof On Amending Claims During An IPR From The Patent Owner To The Petitioner

This post is a follow-up to our prior post To Seek Design Protection or Not, That is the Question! where we discuss situations where it is worth considering seeking a design patent.  Here we highlight takeaways from a USPTO Inventor Info Webinar (the “Webinar”) held on September 21, 2017, that focused on design patent drawing requirements, as well as on other issues on design patents. The Webinar’s slides can be found here.

As a brief recap, 35 U.S.C. § 171 states that “Whoever invents any new, original and ornamental design for an article of manufacture may obtain a patent therefor, subject to the conditions and requirements of this title.”  Thus, the statute requires that a design be for an article (i.e., rather than a disembodied design, a design per se) and that the article have one or both of some surface ornamentation and configuration that differs this article from others.

Continue Reading Recap on Design Patent Drawings

The Federal Circuit yesterday issued an opinion in In re: Smith Int’l, Inc., No. 2016-2303 (Fed. Cir. Sept. 26, 2017) reversing an affirmance by the Patent Trial and Appeal Board of the rejection of several claims of U.S. Patent No. 6,732,817 being challenged in ex parte reexamination.  In so doing, the Court held the Board’s construction of “body” in the ’817 Patent claims to be unreasonable as inconsistent with the specification.

The ’817 Patent concerns a downhole drilling tool for oil and gas operations.  In affirming the examiner, the Board found it “perfectly reasonable” to interpret the “body” of the tool as encompassing other components because neither the claims nor the specification explicitly limit the scope of the term.  Even though the specification describes the body as separate from other elements, the Board reasoned that it doesn’t expressly define “body” or otherwise preclude the examiner’s interpretation.  But according to Smith, the ’817 Patent consistently refers to and depicts the body as a component distinct from other components of the drilling tool – like the “mandrel” or “piston” located inside the drilling tool – and should be interpreted simply as an “outer housing.”

Continue Reading “In Light of the Specification”: Federal Circuit Weighs in on the Broadest Reasonable Interpretation

The United States Supreme Court decided earlier this year that a 1957 opinion is still valid and still limits venue choices for patent infringement actions under 28 U.S.C. § 1400.  See TC Heartland LLC v. Kraft Foods Group Brands LLC, 581 U.S. ___ (2017) (citing Fourco Glass Co. v. Transmirra Products Corp., 353 U.S. 222, 226 (1957)).  In its extensively-covered TC Heartland decision issued in May, the Court held that “[a]s applied to domestic corporations, ‘reside[nce]’ in § 1400(b) refers only to the State of incorporation,” where the accused infringer has a “regular and established place of business” in the venue. While framed as merely confirmation of precedent from the 1950s, many practitioners and commentators viewed this decision as a dramatic change in the patent litigation landscape.

Since TC Heartland came down, lower courts have applied the new paradigm in differing ways.  As trends have developed in recent months, we thought it useful to provide a sampling of the various approaches to venue issues post-TC Heartland.  These issues include, for example, whether defendants who did not contest venue prior to the TC Heartland decision waived the defense of improper venue because the case was—or was not—an “intervening change” in the law, and how to assess whether a defendant has regular and established place of business in a particular venue.

Continue Reading Making the Sausage: Lower Courts Grapple With the Supreme Court’s TC Heartland Venue Decision

This post is the second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful launch. Consideration of intellectual property (IP) protection early in the development of a health app is important.  Otherwise you could lose the opportunity to do so in the future or be forced to change the name or other details of your app after you have already invested time and money in the app.

Trademark

Does your health app have a name? A logo? A tagline or slogan? Will it be marketed anywhere? If the answer to any of these questions is “yes,” you should think about applying for trademark protection.  Words, names, slogans, sounds, symbols, and more can be protected by trademark if used to indicate a source of the goods/services (i.e., the health app) and to identify and distinguish the health app from those offered or sold by others.

To read the rest of the post on our Health Law & Policy Matters blog, please click here.

Late last week, the Federal Circuit granted a writ of mandamus in In re Cray, 2017-129 (Fed. Cir. Sept. 21, 2017), overturning Judge Gilstrap’s four-factor test for determining whether a defendant possesses “a regular and established place of business” in a district such that the defendant could be sued for patent infringement in that district.  In re Cray provides useful guidance because it is the first time since the Supreme Court’s TC Heartland decision that the Federal Circuit has weighed in on what constitutes a “regular and established place of business.”  The patent venue statute, 28 U.S.C. § 1400(b), provides that venue is proper in a patent infringement lawsuit only where the defendant (1) resides or (2) has “committed acts of infringement and has a regular and established place of business.”  TC Heartland clarified that a defendant “resides” only in the state in which it is incorporated.  It did not address the second prong, however, which is an alternative way of establishing venue.  More frequently patent owners are looking to the second prong to determine the locus of an appropriate venue now that the first prong of the statute has been interpreted narrowly.

Continue Reading Federal Circuit Clarifies Venue Requirement Post-TC Heartland by Granting Mandamus Relief in In re Cray