Novartis Pharmaceuticals sued West-Ward Pharmaceuticals for patent infringement on U.S. Patent 8,410,131 after Novartis filed its Abbreviated New Drug Application (ANDA), because West-Ward is seeking to make and sell a generic version of Novartis chemotherapy drug everolimus (a treatment method for solid tumors).
Novartis Pharm., Corp. V. West-Ward Pharm., Intl., Ltd. (Fed. Cir. 2019). Both the district court and the Federal Circuit found in favor of the patentee and adopted the “obviousness” test in this case.
The district court agreed that a person having ordinary skill in the art (PHOSITA) would have been motivated to pursue everolimus as a potential treatment for advanced solid tumors; however, this statement contradicted another district court statement “there was no motivation to combine the prior art.”
The Federal Circuit rejected the district court’s contradicted holding and agreed with the lack of “reasonable expectation of success” factor in the “obviousness” test.
Using the “obviousness” test, patent claims shall be invalid “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made” to a person of ordinary skill in the art to which said subject matter pertains. 35 U.S.C. § 103(a).
Specifically, there are two factors to be considered: “Motivation to Combine” and “Reasonable Expectation of Success.” The Federal Circuit held that “Motivation to Combine” is not required for the obviousness test, and the district court erred in requiring the patentee to prove that a PHOSITA would have selected everolimus over any other prior art treatments.
In addition, the district court and the Federal Circuit both held that the claimed treatment method in this case would not have been obvious because the prior art did not appear to have sufficiently high “reasonable expectation of success,”; because these courts found that there was no clinical data on everolimus as an anti-cancer treatment and no completed trial for similar compounds.
Moreover, the district court found that there has been some promising attempts of finding a compound that may work as an anti-cancer treatment. Therefore, the Federal Circuit affirmed the district court’s decision for non-obviousness in this case.
On December 20, 2018, the 2018 Farm
Bill was signed into law and hemp-derived cannabidiol (CBD) was removed from
the Controlled Substance Act (CSA). To comply with the enactment of the 2018
Farm Bill, on May 2, 2019, the United States Patent and Trademark Office
(USPTO) published Examination Guide 1-19 to elaborate the procedure for
examining marks for cannabis and cannabis-derived goods in regard to trademark
Specifically in the Examination
Guide, the USPTO clarifies that trademark applicants must specify that their
goods are derived from “hemp, or cannabis with no more than 0.3% concertation
of a delta-9 terahydrocannabinol (THC) on a dry-weight basis,” because the 2018
Farm Bill removed hemp from the CSA’s definition of marijuana and cannabis
plants and its derivatives such as CBD that contain less than 0.3% THC on a
dry-weight basis are no longer considered as controlled substances under CSA.
The USPTO also states that
trademark applications that involve CBD or cannabis filed before the 2018 Farm
Bill (December 20, 2018) will be refused due to the unlawful use or lack of
bona fide intent to use in lawful commerce under the CSA. However, trademark
applications that involved CBS or cannabis filed on or after December 20, 2018
may be accepted as long as the USPTO examined the goods that are derived from
hemp or Cannabis/CBD that contain less than 0.3% THC on a dry-weight basis.
However, registration of marks for
foods, beverages, dietary supplements, or pet treatments containing CBD or
cannabis will still be refused for trademark registration, even if the goods
are derived from hemp or Cannabis/CBD less than 0.3% THC on a dry-weight basis,
because the Federal Food Drug and Cosmetic Act (FDCA) stated that goods that
are currently undergoing clinical trials cannot be lawfully introduced into
An Inter Partes Review (IPR) is a
procedure for challenging the validity of a United States patent and is
conducted by the Patent Trial and Appeal Board (PTAB).
Under Section 311(b) of the Patent Act,
someone may only challenge a patent using an IPR only under the grounds that
could be raised under 35 U.S.C. Section 102 (which generally relates to when an
invention is already public) or Section 103 (which provides that a patentable
invention must not have been obvious to a “person having ordinary skill in the
Additionally, the challenge can be
made only based on the existence of a prior art. A patent owner can amend their
patent claims for reexamination if their patent is found to be ineligible under
an IPR and the reexamination would once again be an IPR conducted by the PTAB.
In the case, Amazon.com Inc. v. Uniloc Luxembourg SA, Amazon challenged and filed for an IPR for claims 1-25 for one of
Uniloc’s patents. Uniloc then filed a Contingent Motion to Amend, which meant
that if claims 1, 22 and 25 were found to be unpatentable, Uniloc would be able
to replace those claims with claims 26, 27 and 28.
In response to the Contingent Motion to Amend, Amazon filed an Opposition to the Motion to Amend on the grounds that the amended claims (claims 26, 27 and 28) were not an eligible subject matter under Section 101.
However, under Section 311(b) of the Patent Act it states that, you can petition for an IPR, “only on a ground that could be raised under Section 102 or 103”. Knowing this Uniloc, instead of arguing how its patent was indeed an eligible subject matter under Section 101, argued that Amazon was not permitted to challenge a Section 101 issue in an IPR.
argument, the PTAB made a determination on both the original and amended claims.
Not only did it rule the original claims 1, 22 and 25 patent ineligible but it
additionally ruled the amended claims 26, 27 and 28 patent ineligible under the
grounds of Section 101.
justified its decision to rule on the substituted claims even though it was not
a Section 102 or 103 issue. It pointed out how while the law in Section 311(b)
prevents it from considering the patentability of a claim under other grounds,
it did not extend that same restriction to the PTAB for considering the
patentability of an amended claim under other grounds.
The PTAB emphasized that there is a difference between a claim and an amended claim to justify why the PTAB was able to consider different grounds when determining the patent eligibility of an amended claim. The main difference between a claim and an amended claim is that the amended claim can only be added in after “a final written decision and action of the Director” had already taken place.
the consequence of this case is that the PTAB can deny a substituted or amended
claim based on grounds other than those found in Sections 102 and 103.
Copyright owners cannot sue for infringement until the Copyright Office has granted registration
by Michael Ginsberg
The U.S. Supreme Court on
March 4, 2019 announced a unanimous decision in Fourth Estate Public Benefit
Corporation v. Wall-Street.com, 586 US _ (2019) that a copyright owner must
wait for registration from the Copyright Office before being able to claim
infringement in court. Fourth Estate is a news organization that produces
online journalism and licenses its articles to other websites while maintaining
the copyrights for these articles. Fourth Estate and Wall-Street.com came to a
licensing agreement that allowed Wall-Street.com to obtain the licenses to
several articles produced by Fourth Estate. Under this agreement, Wall-Street
was required to remove all content produced by Fourth Estate from their website
if Wall Street were to cancel the arrangement. However, when Wall-Street
cancelled the licensing arrangement with Fourth Estate, they did not remove the
content from their website, triggering Fourth Estate to sue for copyright
infringement. Yet, although Fourth Estate had filed for registration with the
Copyright Office, the Office had not yet approved their request.
Wall-Street argued that the case should be dismissed on
the grounds that Fourth Estate could not sue until after the Copyright Office
acted on Fourth Estate’s copyright registration application. The U.S. District
Court for the Southern District of Florida granted Wall-Street’s motion to
dismiss the case on the grounds that according to Section 411 of the Copyright
Act, “registration” required the Register of Copyrights to register the claim
which had not yet occurred for Fourth Estate. Therefore, because there was no registered
copyright for Fourth Estate’s content, there were no grounds for an
infringement lawsuit. The Eleventh Circuit affirmed the District Court’s
decision leading Fourth Estate to file a petition for the U.S. Supreme Court to
hear the case.
Moving forward, the U.S. Supreme Court agreed to hear the
case and oral arguments were held on January 8, 2019, with the case being
decided on March 4, 2019 unanimously for Wall-Street.com. The Court cited
Section 411 of the Copyright Act which states that a copyright infringement
lawsuit could not be filed until “preregistration or registration of the
copyright claim has been made”. Fourth Estate attempted to argue that the
registration of the copyright claim referred to the copyright applicant and not
the Copyright Office. Nevertheless, the Supreme Court rejected this application
approach ruling that it was an inconsistent reading of Section 411. Justice
Ginsburg delivered the opinion of the Court stating that the registration
approach is the “only satisfactory reading” of the relevant statue. She
explained that the Copyright Office refusing an application would become
“superfluous” or unneeded had the Supreme Court ruled with an application
What does this case mean for the future of copyrights?
Justice Ginsburg acknowledged that the registration processing times has
increased from weeks to months, but it still didn’t allow her to change
congressionally composed text in Section 411 of the Copyright Act. During these
months in which an applicant is waiting, other people could “infringe” on their
copyright and the applicant could not file an infringement suit against them. While
this ruling protects people from unfair lawsuits of infringement when there is no
officially registered copyright to be infringed upon, the copyright applicant
can still sue for infringement that occurred preregistration but after the
application had been filed if the Copyright Office approves the application.
Moreover, Justice Ginsburg also acknowledged that “in limited circumstances,
copyright owners may file an infringement suit before undertaking registration”
if “a copyright owner is preparing to distribute a work of a type vulnerable to
predistribution infringement” which usually refers to movies and musical
compositions. She did however state that even in these “exceptional
scenarios…the copyright owner must eventually pursue registration in order to
maintain a suit for infringement. This means that while in certain exceptional
circumstances a copyright owner may sue for infringement preregistration, that
eventually it would need the actual registration from the Copyright Office to
keep the lawsuit going.
this ruling puts pressure on the Copyright Office to exercise great due
diligence when working on applications as the applicant is dependent on the
Office’s decision before they can seek to protect their copyright. Furthermore,
it is up to Congress to alleviate shortages in staffing and budget to increase
the speed of the registration process.
The landmark Treaty allows VIPs (Visually Impaired People) access to copies of books
Donald J. Trump signed the documents for the U.S. to ratify the Marrakesh
Treaty on January 28 , 2019 and the United States Patent and
Trademark Office (USPTO) has welcomed the recent ratification. The Treaty
requires those involved to create exceptions to typical copyright rules in
order to make published works in formats that VIPs (Visually Impaired People)
would be able to read. Additionally it permits exchanging these works across
borders by organizations that serve these VIPs.
definition of “works” within the Treaty is limited to materials in the form of
text, notation and/or related illustration (including audiobooks). Works that
fall within the scope of the Treaty must be publicly available in any media.
element of the Treaty is the role played by authorized organizations which are
the organizations in charge of providing the services to VIPs. The Marrakesh
Treaty does not require an organization to fulfill any formalities or undertake
specific procedures to obtain recognition as an “authorized organization”. Both
government and non-government organizations can be recognized as an authorized
organization. The authorized organizations provide education and information
access to the VIPs and it is within the authorized organizations responsibility
to make sure that the people receiving the benefits are indeed VIPs and only
VIPs. Furthermore they must maintain great care in handling the copies of work.
Marrakesh Treaty has a clear structure and provides specific rules for both
domestic and cross-border exceptions.
requires that Contracting Parties or those involved to have domestic copyright
laws for VIPs including the right of reproduction, the right of distribution,
and the right of making available to the public. Additionally Authorized
Organizations may on a non-profit basis, make accessible format copies which
can be distributed by non-commercial lending or by electronic communication.
However there are some prerequisite conditions that need to be met before an
Authorized Organization may do so. The conditions include having lawful means
to access the work, only introducing changes needed to make the work more
accessible, and supplying the copies only for use by VIPs.
forward, secondly, the Marrakesh Treaty requires Contracting Parties to allow
the import and export of accessible format copies made under certain conditions.
It requires that the works are exclusively used by VIPs and that prior to such
distribution the Authorized Organization must not know that the accessible
format copy would be used by others.
Marrakesh Treaty leaves Contracting Parties the freedom to have its own
provisions that take into account its own legal systems and practices. This
includes determinations on fair practice dealings or uses, provided that the
Contracting Parties comply with the three-step test. The three-step test is a
basic principle that is used to determine if an exception is permissible under
international copyright norms.
three-step test includes that any exception:
Shall cover only certain cases;
Shall not conflict with the normal exploitation
of the work; and
Shall not reasonably prejudice the
legitimate interests of the right holder
there is no requirement to be a member of any other international copyright
treaty to join the Marrakesh Treaty and membership is open to all member states
of WIPO and the European Union.
the Marrakesh Treaty requires WIPO (World Intellectual Property Organization)
to establish an information access point which would allow voluntary sharing of
information in order to make identifying Authorized Organizations easier. WIPO
is also encouraged to share information about the functioning of the Treaty.
Marrakesh Treaty establishes an Assembly of the Contracting Parties whose main
task is to address matters concerning the maintenance and development of the
Treaty. The Marrakesh Treaty also entrusts to the Secretariat of WIPO the
administrative tasks concerning the Treaty.
U.S. ratification of the Marrakesh Treaty Landmark treaty facilitates accessible copies of books to persons who are blind, visually impaired, and print disabled
WASHINGTON – The United States Patent and Trademark Office (USPTO) welcomed the recent ratification of the Marrakesh Treaty, which allows limited copyright exceptions for the reproduction of published works in formats accessible to the blind and visually impaired.
President Donald J. Trump signed the documents for the U.S. to ratify the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled on January 28, 2019.
As a fifth and last post on this blog series regarding blockchain, Stein IP introduces “Regulating Blockchain: A New Challenge for Society”
As known and explained on our previous posts, Blockchain is a growing technology that promises to streamline processes, clarify transactions and avoid third parties interventions and costs. Moreover, it’s better known as the platform where Bitcoin and other cryptocurrencies are processed, which triggered governments and regulatory agencies to realize that a lot of the money involved in financial transactions worldwide was carried out using these kinds of digital currencies.
Along with this, in some cases this money was used to fund certain illegal activities. Due to this, countries all around the globe have started issuing regulations to control Blockchain technology.
Below there are some examples of regulations in different countries on Blockchain technology:
On May 25, the General Data Protection Regulation (GDPR) issued a regulation that allows users to delete personal information on a Blockchain network. This is obviously against Blockchain principles where transparency is one of its main advantages. In addition, some countries like France warn citizens about making investments using cryptocurrencies. On the other hand, Switzerland seems to be a pioneer about projects being developed on Blockchain technology. As an example, Zug (a city located in the previously mentioned country) provides tax benefits and flexible legislation to startups that build its business on Blockchain bases.
Eastern Asian is the most advanced region using Blockchain and cryptocurrencies. When this technology appeared, nations in this region established a “business first, regulations later” mindset and companies were given the freedom to operate without restriction. But as cryptocurrencies exploded last year, East Asian nations began to subject blockchain to more significant regulatory measures.
With regards to China, Chinese ministries restricted the use of Bitcoin on December 2013 and in January 2017, the People’s Bank of China banned initial coin offerings (ICOs) in the country. Japan and South Korea took similar measures but not as severe as in China. In India the use of Bitcoin is contentious.
Other countriesOn March 20, 2018, G20 countries gathered in Buenos Aires to discuss the possible regulation of cryptocurrency. Argentina, Australia, Turkey, South Africa, and the United Kingdom proclaimed that they decided not to regulate cryptocurrencies. On the other hand, Russia is drafting a bill that will allow the registration of cryptocurrency exchanges only on official government websites.
United States of America
In the US, the “regulations first, business later” approach was adopted by government agencies. The overwhelming skepticism has prompted regulators to restrict the potential mainstream applications of blockchain programs utilizing cryptocurrency. U.S. regulatory agencies have had some of the most controversial regulatory discussions about the future of this technology, especially with regard to security-related topics. The U.S. Securities and Exchange Commission has mandated that cryptocurrencies will be considered “assets” under governmental purview, deterring many major international crypto-companies from wanting to operate in America.
However, states across the US have shown interests in leveraging blockchain technology to stimulate local economies and improve various aspects of public service. For example, the state of Delaware announced in 2016 the Delaware Blockchain Initiative, a comprehensive program intended to spur adoption and development of Blockchain and smart contract technologies in both private and public sectors in the state. In 2017, the state of Illinois announced the Illinois Blockchain Initiative, which calls for a consortium of state and county agencies to “collaborate to explore innovations presented by Blockchain and distributed ledger technology”. Similar to Delaware, the state of Illinois aims to utilize blockchain and distributed ledger technologies to “transform the delivery of public and private services, redefine the relationship between government and the citizen in terms of data sharing, transparency and trust, and make a leading contribution to the State’s digital transformation.”
The Brookings Institute provides a state classification according to their levels of engagement with the blockchain technology into the following categories:
Unaware: State that have taken no actions – states for which we were not able to find any relevant information through publicly available sources (e.g., Arkansas, South Dakota), although there are substantial activities within private industries and academia in some of these states
Reactionary: States that have taken a negative stand against cryptocurrencies or flagged them as potentially risky (e.g., Indiana, Iowa, Texas).
Appreciative: States that have made initial attempts to pass bills concerning cryptocurrencies without any successes (e.g., North Dakota).
Organized: States that have succeeded in passing some legislation in this regard (e.g., Washington, New Hampshire).
Active Engagement: Seven states have gone beyond cryptocurrencies and examined the governmental use of blockchain, either as isolated applications in specific government functions, or as integration across different government functions. Vermont, for example, recognizes data stored on a blockchain as admissible in the court system.
Recognizing Innovation Potential: States that envision a broader role for blockchain in their economies. In addition to Delaware and Illinois, Arizona has introduced or passed regulations ranging from making signatures, transactions, and contracts on a blockchain legally valid to allowing residents to pay their income tax in cryptocurrencies.
It is expected to see less developed states evolving on regulations related to this technology.
The following map reflects how governments around the world regulate cryptocurrencies and blockchain technology.
Although some regulations exist, Blockchain technology seems to keep growing at a fast pace rate. It is very important that this regulations veil for people’s rights and security but allowing this new breed of business to leverage its benefits at the same time. This is certainly a challenge that starts today and remains for the upcoming generations. An interdisciplinary team of lawyers, engineers, economists, software experts and more will be necessary to achieve this objective, so it is crucial to educate people in such area.
By Pablo N. Garcia Rodriguez
“Bitlegal | Tracking Blockchain Technology And Regulation Around The World”. Bitlegal.Io, 2018, http://bitlegal.io/.