Tag: United States

New Developments in Patent Eligibility of Diagnostic Methods
New Zealand joins the Global Patent Prosecution Highway
Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court
The Charging Bull and the Fearless Girl: Moral Rights Protections in Australia and the U.S.
Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument
Kardashian #copyright saga
U.S. Supreme Court Rules that Cheerleader Uniform Elements May Be Eligible for Copyright Protection
High Court of Australia Finds Claims for Isolated Genetic Material not Patentable Subject Matter
Consider Fair Use Before Submitting Takedown Request
Southern District of New York Court Parses ‘Fair Use’ in Fox News’ Copyright Infringement Dispute with Media Monitoring Service

New Developments in Patent Eligibility of Diagnostic Methods

The U.S. Courts have repeatedly invalidated patents under 35 U.S.C. § 101 as lacking patentable subject matter in areas such as business methods and computer-based inventions. However, decisions addressing inventions in the life sciences are substantially less frequent.  In Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017), the Federal Circuit provided some additional guidance for patent eligibility of life sciences inventions.

Three of the patents at issue were directed to methods of detecting myeloperoxidase (MPO) (diagnostic patents), and the fourth patent was directed to methods of treating patients with heart disease based on the MPO detection methods of the other patents. The district court granted the defendant’s motion to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim because the diagnostic patents lacked patentable subject matter, and the Federal Circuit affirmed that decision.

According to the Federal Circuit, the diagnostic patents were directed to a law of nature: the correlation between MPO level and heart disease. Interestingly, the opinion notes that the correlation was known in the art prior to filing the patents, however, there was no way to directly detect the MPO or correlate the levels to a risk of heart disease. The Court found that the claims did not teach a new test or laboratory technique, nor did they alter the MPO levels. Rather, the levels existed in nature without human action. Thus, the Court concluded that the claims did “not result in an inventive concept that transforms the natural phenomena of MPO being associated with cardiovascular risk into a patentable invention.”

The Court left open the question of whether the method of treatment patent contained patent-eligible subject matter because the Court held that the pleadings for that patent were deficient (this patent was only alleged to be infringed through inducement or contributorily infringed).

Unlike other decisions on patentable subject matter in the life sciences area, the holding did not turn on whether the claims broadly preempted application of a law of nature. The Patent Owner argued that the claims should be patent eligible because they were narrow and did not preempt all uses of the alleged law of nature, but the Court stated that the preemption argument was fully addressed and made moot by its determination that the claims only disclosed patent-ineligible subject matter.

In view of this decision, care should be taken when drafting claims directed to diagnostic methods to be sure to clearly claim more than the diagnostic correlation.

By: Margaux Nair and Aaron Morrow

New Zealand joins the Global Patent Prosecution Highway

On 6 July 2017, New Zealand joined the Global Patent Prosecution Highway (GPPH) pilot program, providing applicants for New Zealand patents with a means of expediting prosecution of their application.

The GPPH is an arrangement between the intellectual property offices of several jurisdictions including Australia, the United States, Japan, Canada and Korea.  Under the GPPH, an applicant who receives a ruling that at least one claim has been allowed by a participating patent office may request that another participating patent office expedite examination of their application.

To be eligible for examination under the GPPH, the following requirements must be met:

  • the patent application to be examined under the GPPH must have the same earliest priority or filing date as the associated application which has already been examined by the participating patent office
  • the associated application must include one claim which has been deemed allowable by the participating patent office, and
  • the claims to be examined under the GPPH must sufficiently correspond with the allowed claims.

With regard to the third requirement above, applicants have the option of amending their claims so that they sufficiently correspond with those that have been allowed by another participating patent office. However, before making such amendments, applicants should consider the possibility of obtaining broader claims in certain jurisdictions. Patent laws vary between jurisdictions and a claim that was allowed in, say, the U.S., might be narrower that what could be obtained in New Zealand.

Prior to New Zealand’s entry into the GPPH, the options available to applicants seeking expedited examination were limited and burdensome. The GPPH now provides patent applicants with a simple way of accelerating prosecution of their patent application in several jurisdictions, potentially reducing the costs and time required to obtain a granted patent.  However, allowance of a claim in one jurisdiction does not necessarily mean that a corresponding claim will be allowed in another jurisdiction.

By: Michael Christie

Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court

The U.S. Supreme Court unanimously decided Sandoz Inc., v. Amgen Inc., on Monday June 12, 2017, construing the Biologics Price Competition and Innovation Act (BPCIA).  The Court held:  (1) that the patent dance is not enforceable by injunction under Federal law, and  (2) that a biosimilar applicant’s 180-day “notice of commercial marketing” can be provided before FDA approval.  (See Sandoz Inc. v. Amgen Inc., Nos. 15-1039 and 15-1195, slip op. and our IP Alert Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument.)

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The Charging Bull and the Fearless Girl: Moral Rights Protections in Australia and the U.S.

The Charging Bull has been an iconic New York City landmark since it was placed outside the New York Stock Exchange in December 1989 in an act of guerrilla art.  Despite initially being removed, the statue’s popularity caused it to be relocated to Bowling Green days later, where it has since remained, on loan to the New York City Council.  Earlier this year, on the eve of International Women’s Day, Charging Bull was joined at Bowling Green by a second guerrilla-art installation, sculptor Kristen Visbal’s four foot statue titled Fearless Girl, who stares defiantly at the Charging Bull.

The artist behind the Charging Bull, Artutro Di Modica, claims that the placement of Fearless Girl is an insult to the Charging Bull and that her placement is ‘attacking the bull’.  The competing interests of the artists raise interesting questions in intellectual property law, specifically regarding Di Modica’s ‘moral rights’.  Does the Fearless Girl have reason to fear impending intellectual property litigation? Or will the Charging Bull have to accept the new kid on the block?

Click here to read more.

By: Sophie Taylor

Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument

All nine U.S. Supreme Court justices heard argument on Wednesday April 26th, in Sandoz Inc., v. Amgen Inc.  The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (BPCIA) made by the U.S. Court of Appeals for the Federal Circuit. Wednesday’s arguments focused on four main issues:

  1. whether the FDA could preliminarily grant licensure prior to the expiration of the 12 year statutory period;
  2. whether the notice of commercial marketing requires official licensure to be made;
  3. whether the “patent dance” was required by the BPCIA; and
  4. whether state law could be used to enforce compliance with the “patent dance” elements of the BPCIA.

Industry watchers hope that the Supreme Court will streamline the process for getting biosimilars to market by providing increased certainty.

To read the full alert, click here.

By: Theodore J. Angelis, Peter Giunta, Kenneth C. Liao, Margaux L. Nair and Jenna Bruce

Kardashian #copyright saga

Is this the right angle?
Is this the best filter?
Do I have the legal right to post this content?

While the first two questions may be at the forefront of the mind of social media users, the third is arguably as important as the pressure to push content to followers mounts in a saturated market. It is all too easy to download, screen-shot or take a photo of an image and share it across many platforms, however, taking a laissez-faire attitude to copyright ownership can land social media users in hot water.

Not only is uploading and sharing content protected by copyright a breach of the terms of use of most social media platforms (and could lead to a  user’s accounts being suspended or terminated in some cases) but it may also lead to copyright litigation, as Khloe Kardashian recently discovered.

Last week, Xposure Photos UK LTD, an “international celebrity photo agency”, filed proceedings against Ms Kardashian in the Central District Court of California alleging that she had infringed its copyright in an image that was posted to her Instagram® account.[1]  The image in question had originally been licensed to The Daily Mail and contained a copyright notice “© XPOSUREPHOTOS.COM”. The version of the image that appeared on Ms Kardashian’s account did not contain this notice nor any acknowledgement of Xposure Photos. The unauthorised removal of the copyright notice attracts 17 US Code § 1202 -1203 which provide the basis for a civil action for such conduct. In addition to seeking an injunction to prevent Ms Kardashian from using the image, Xposure Photos is also seeking US$25,000 in statutory damages as well as any profits resulting from the infringement.

While this is arguably small change for Ms Kardashian (who allegedly earns up to US$250,000 for a sponsored post on her social media sites), once legal costs and any time invested in litigation or negotiating a settlement is considered, it seems a hefty price to pay for failing to obtain an appropriate licence from the copyright owner. It is a timely reminder to social media users to ensure that they have the appropriate rights to the content they intend to use.

  1. Xposure Photos UK Ltd v Khloe Kardashian et al, 2:17-CV-3088 (C.D. Cal).

By: Jaimie Wolbers

U.S. Supreme Court Rules that Cheerleader Uniform Elements May Be Eligible for Copyright Protection

Yesterday, in a decision that will be welcomed by the fashion industry, the United States Supreme Court ruled that certain design elements of cheerleader uniforms may be eligible for copyright protection.  Star Athletica, L.L.C. v. Varsity Brands, Inc.  The Court held that, “a feature incorporated into the design of a useful article is eligible for copyright protection only if the feature (1) can be perceived as a two- or three-dimensional work of art separate from the useful article and (2) would qualify as a protectable pictorial, graphic, or sculptural work—either on its own or fixed in some other tangible medium of expression—if it were imagined separately from the useful article into which it is incorporated.”  Justice Clarence Thomas authored the 6-2 majority opinion, addressing disagreement among lower courts as to the proper test for determining if certain design elements could ever qualify for copyright protection.

This case involved lines, chevrons, and colorful shapes on cheerleader uniforms. In finding that these elements could be covered by copyright, the appeals court below had identified nine different approaches that various courts and the Copyright Office had employed over the years to address “separability.” The appeals court fashioned its own test and found that the design features of Varsity Brands’ cheerleader uniform played no role in the overall function of the article as a cheerleading uniform, and the elements were separable from the utilitarian aspects of the uniform and thus eligible for copyright protection.

The Supreme Court affirmed.  Applying § 101 of the Copyright Act, the Court found that the decorations on the uniforms at issue could be identified as having pictorial, graphic, or sculptural qualities, and the arrangement of the decorations could be placed in another medium (e.g. placed on a painter’s canvas) without replicating the uniforms themselves.  Thus, the two-dimensional work of art fixed in the uniform fabric met both the separate-identification and independent-existence requirements of the statute. Importantly, the Court held only that the uniform elements are eligible for protection in concept; now the trial court must determine whether Varsity Brands’ specific lines, chevrons, and shapes are original enough to merit copyright protection.

Justice Ruth Bader Ginsburg concurred in the result, pointing out that the Court did not have to discuss the separability test at all because the designs at issue were not themselves useful articles, but rather standalone, two-dimensional pictorial and graphic works reproduced on a useful article.  Justice Stephen Breyer, joined by Justice Anthony Kennedy, dissented, arguing that even under the majority’s test, the designs cannot be perceived as separate from the cheerleading uniform.

Thus, although the majority offers some clarity about the proper approach to separability, the dissent demonstrates that analysis may yield divergent results.  The decision is likely to be embraced by fashion industry leaders and other garment design stakeholders for its recognition that certain garment design elements may be protectable under the Copyright Act.  K&L Gates will continue to monitor litigation in this area and provide updates.

A link to the opinion can be found here: https://www.supremecourt.gov/opinions/16pdf/15-866_0971.pdf

By: David Byer, John Cotter, Shamus Hyland and Eric Lee

High Court of Australia Finds Claims for Isolated Genetic Material not Patentable Subject Matter

On 7 October 2015, the High Court of Australia (High Court) issued its decision[1] in the long running dispute concerning Myriad Genetics, Inc.’s (Myriad) patent relating to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide. Mutations in the BRCA1 gene can serve as indicators of a woman’s risk of developing breast cancer.

In a unanimous decision, the High Court found that claims directed to the isolated nucleic acid are invalid on the basis that they are not a ‘manner of manufacture’ and therefore not patentable subject matter. The High Court took the view that the claimed invention would extend the scope of the concept of “manner of manufacture” and that this was not something which was appropriate for courts to do. In light of the High Court’s decision, it will be interesting to see whether there is a legislative response to this issue.

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Consider Fair Use Before Submitting Takedown Request

The U.S. Digital Millennium Copyright Act (DMCA) has been a potent tool for combatting copyright infringement on the Internet. Section 512 shields Internet service providers from liability if they expeditiously remove content after copyright owners submit takedown requests notifying the ISP of infringing content. Last week, in Lenz v. Universal Music Corp., the Ninth Circuit held that copyright owners must consider fair use before sending takedown notices, or they could face liability for damages.

This decision cautions copyright owners to take a closer look at infringing content and document their fair use analysis before submitting takedown requests. An intensive investigation is not required and the fair use analysis may not be correct, but the copyright owner must have a good faith belief that fair use does not apply.

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Southern District of New York Court Parses ‘Fair Use’ in Fox News’ Copyright Infringement Dispute with Media Monitoring Service

On 25 August 2015, the U.S. District Court for the Southern District of New York (SDNY) ruled that certain functions of the TVEyes media-monitoring service infringe Fox News’ copyrights in its programming content.

TVEyes is a for-profit, media-monitoring service with over 22,000 subscribers that indexes nearly all news-related television and radio content in a searchable database. TVEyes allows users to track the usage of words or phrases of interest and to view the transcripts and video clips of the portions of the television broadcast that use the search term. Subscribers may set ‘watch lists’ for terms to receive real time alerts when certain terms are used and search past broadcasts. TVEyes also provides subscribers with analytic data such as a segment’s Nielsen viewership rating, the frequency with which a term has been mentioned over a specified time period and the geographic markets and channels where a term is used. Additionally, TVEyes users may archive, indefinitely, video clips that appear in response to search queries on TVEyes’ server. Users can also email the video clip links to others, allowing the recipients of the link to view the video clip on TVEyes’ server, as well as download copies of identified digital video clips for offline use and permanent storage.

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