Watch the exclusive video of Dr. Sheetal Chopra about preparing of Indian Patent Agent Examination. She is also author of the first book on Indian Patent agent examination.
Sunday, 2 September 2018
Thursday, 28 June 2018
VPATAPP Alert_New Local Patent Rules May Speed Up Patent Litigation In Massachusetts
Massachusetts
is home to one of America’s chief innovation hubs. Yet, historically, the
District of Massachusetts has seen relatively few patent cases when compared to
other high-tech venues around the country. While there are several reasons that
may explain this dearth of patent cases, factors many have pointed to include
that a large number of patent cases filed in the district ended up taking 3 or
more years to reach trial. Additionally, patent case schedules issued in the
district were often criticized as slowly paced and lacking in certainty. And so
plaintiffs looking for a quick and certain resolution tended to file their
cases elsewhere.
Change
appears to be here, however, as effective June 1, 2018, the District of
Massachusetts amended its Local Rule 16.6 to provide for mandatory patent rules
and scheduling. The prior local rules suggested a schedule for patent
proceedings that parties could use in their scheduling orders but left it up to
the parties to agree to certain deadlines in the proposed order. The amended
rules, however, require that the assigned judge set a trial date that is within
2 years of the initial scheduling conference (a court hearing that usually
takes place within months of the complaint filing), and set certain other patent-specific
deadlines on dates calculated from the initial scheduling conference date.
Tuesday, 26 June 2018
VPATAPP Alert_Missed opportunity for review of principles of equivalents?
On
19 June the Court of Appeal gave judgment in Jushi v OCV [2018] EWCA
Civ 1416, an appeal from the Intellectual Property Enterprise Court (IPEC). The
case concerned a patent for glass fibre strands for use in fibre-reinforced
composite materials. The main issue on the appeal was the validity, or
otherwise, of a claim which included numerical limits. There were several
ranges in the claim, the most relevant one being a requirement that the ratio
of calcium oxide to magnesium oxide be "≤ 2, preferably ≥ 1.3".
In
the wake of last year's Supreme Court judgment in Actavis v Eli Lilly [2017]
UKSC 48, one issue that has remained unresolved is whether the scope of
protection of a claim for infringement, including by equivalents, remains the
same as the claim's scope validity. In Mylan [2017] EWHC 2629
(Pat) Arnold J held obiter that the
previous symmetry of infringement and validity no longer held. However, the
issue has not been addressed in detail since.
What
is apparent, however, is that the Court of Appeal did not discuss any arguments
about equivalents. It may be that Jushi felt unable to run any such argument on
the facts, or that it felt precluded from doing so in the context of a validity
argument. Whatever the reasons, a case which, at least from the outside, would
appear to have offered an opportunity for debate about the application of the
principles of equivalence contains no reference to the Actavis decision
at all. Whether this is merely a reflection of the parties' choice of arguments
or whether it reflects, at least in part, a desire by the Court of Appeal to
minimise the change in approach to the majority of patent cases notwithstanding Actavis is
not an easy question to answer.
Sunday, 24 June 2018
VPATAPP Alert_Mexico: Can Two Patents For The Same Invention Be Obtained Under Mexican Patent Law?
It is important to clarify that the Mexican
IPL does not have a specific provision that prohibits double patenting.
However, the Mexican Institute of Industrial Property (hereinafter referred to
as 'IMPI') applies the criteria applied by most patent systems, which is that
two patents cannot be granted for the same invention. The basis for the
criteria applied by the IMPI is that an applicant has no legitimate interest in
the proceedings that lead to the granting of a second patent for the same
subject matter if he already possesses one granted patent for said matter.
Unlike US patent law, which expressly defines double patenting and specifically
mentions that there are two different types of double patenting rejections
('same invention' type double patenting and 'non-statutory' type double
patenting), the IPL does not expressly define double patenting. This can lead
to a series of different interpretations with each Examiner giving their
specific prohibitions, creating an inherent uncertainty around the double
patenting issue.
Thursday, 21 June 2018
VPATAPP Alert_PTAB Strategies and Insights - June 2018: How to Survive Post-Grant Proceedings
Though it can be difficult to avoid post-grant
challenges, patents can be drafted to increase the chances of survival. In
today’s environment, patents subject to post-grant proceedings face a very high
likelihood of being invalidated, even taking into consideration the decreasing
institution rates and claim cancellation rates at final written decision. So it
is imperative to both draft stronger patent applications and to more
effectively prosecute applications to deter petitioners from even filing a proceeding.
Tip #1: Draft a thorough specification with many
embodiments.
Tip #2: Vary claim scope and make dependent claims
meaningful for layers of validity.
Tip #3: Perform a search and submit prior art during
examination.
Monday, 11 June 2018
VPATAPP Alert_I Need My Patent Now! Tips on Accelerated Patent Examination in USA
There are three ways to jump to the front of
the line at the USPTO: (1) Track 1 requests submitted at the filing of the
application, (2) accelerated examination requests submitted anytime during
examination and (3) requests to enter the patent prosecution highway before
examination begins. Each option has its own costs and limitations.
Wednesday, 6 June 2018
VPATAPP Alert_Trends in pharma patent litigation in Russia
Patent infringement
During recent years the number of patent infringement cases in
the pharmaceutical field has increased significantly. A battle between patent
owners and generic companies has revealed different interpretations in the
Russian judicial system.
The law allows lawsuits to prevent activities that infringe an
exclusive right or create a threat of infringement. Such suits may be filed
against those who undertake specific activities or make necessary preparations
for such activities or against other persons that can prevent infringing
activities.
A range of defendants are to be found in pharmaceutical patent
litigation in Russia, including:
- the
marketing authorisation holder;
- contractual
manufacturers indicated in the marketing authorisation;
- local
distributors participating in state tenders for the supply of medicines;
and
- the
Ministry of Health, as the authority entitled to revoke the marketing
authorisation.
Where the marketing authorisation holder is not the manufacturer
of the medicines, infringement liability cannot be imposed on the marketing
authorisation holder. The courts have disagreed with this argument, indicating
that the introduction of a medicine into civil circulation is impossible
without the will of the marketing authorisation holder (First Commercial Appeal
Court, March 23 2017, A43-12199/2015).
According to Section 26.1(4) of the Federal Law on the
Circulation of Medicines (April 12 2010, 61-FZ), the marketing authorisation
holder is:
- the
medicine developer;
- the
medicine manufacturer; or
- another
legal entity that owns the marketing authorisation and is responsible for
the medicine’s quality, effectiveness and safety.
Since medicines are legally commercialised on condition that a
marketing authorisation is granted, it is logical to assume that obtaining a
marketing authorisation for the generic product where a patent is used (before
its expiration) creates at least the necessary pre-condition for launching the
generic medicine before the expiration of the patent term.
Further, the same applies where the patented medicine and
generic medicine refer to life-saving and essential drugs. The maximum sale
price registration is required to commercialise such drugs via state tenders.
Development of live-saving and essential drugs by innovators is
costly and involves numerous factors. Patent prosecution and subsequent patent
protection are the crucial elements of further investment activity.
By obtaining the marketing authorisation and maximum sale price
registration within the patent term for the original (referential) medicine,
the generic medicine may not appear on the market until the court, enforcement
authority or regulator takes measures. Taking such measures involves patentee
participation (eg, filing a lawsuit) and, until the enforcement decision, the
interest of patients and innovators’ distributors should be paramount.
There is no
express Bolar-like provision under the Civil Code (the main legal act on
patent protection matters), where it is clearly and expressly written that it
is completely legal to obtain the marketing authorisation or maximum sale price
registration of the medicine within the patent protection term. However,
reflection regarding a Bolar-like provision as interpreted by the courts is
found in Article 1359 of the Civil Code. Among other exemptions, the article
provides that performance of scientific research on the product or process in
which the invention is used or experimented with does not constitute an
infringement of patent rights.
The precedential case applying this norm was Case 2578/09 of the
Supreme Commercial Court (June 16 2009), where the court indicated that
manufacturing and submitting the samples of the generic medicine (for obtaining
an marketing authorisation) cannot be considered as an infringement of the
patent rights. However, the court highlighted that the manufacturing and
storage of a medicine before a patent expiration for sale or other
commercialisation following patent expiration would be patent infringement.
Despite being applied in later cases (eg, Ninth Commercial
Appellate Court, October 14 2009, 09A∏-14020/2009-GK (Case A40-56217/08-110-454)
the position of the Supreme Commercial Court did not answer the question
regarding whether obtaining the marketing authorisation (including but not
limited to cases where there was a gap of several years between the generic
marketing authorisation grant and the patent expiration, let alone the maximum
sale price) is a threat of patent infringement.
Further, the Supreme Commercial Court decision was rendered at a
time when there were no such provisions in the Medicines Law regarding termination
of a marketing authorisation should the medicine be unavailable in the market
within three years of the marketing authorisation grant.
Indeed, if there is a gap between the generic medicine marketing
authorisation grant and expiration of the patent – and under the Medicines Law
the marketing authorisation is revoked if the medicine is not commercialised
within three years of the marketing authorisation grant – is the position of
the defendant, arguing that the medicine was registered for scientific purposes,
well-grounded and reasonable?
The fact that the marketing authorisation is granted during the
patent protection term may lead to the premature launch of a generic medicine
on the market during the patent protection term. Such a situation occurred in
Cases A40-30124/2015 and A40-30012/2015, where the defendants’ medicines were
offered for sale via state tenders before expiration of the patent term. The
patent owner was successful in the said patent infringement actions, but it
demonstrated that a marketing authorisation is obtained to commercialise the
generic medicine and the courts should use other legal tools to prevent such
infringements.
The breakthrough example changing this can be found in the
recent decision of the Ninth Commercial Court of Appeals (December 26 2017,
10A∏-18326/2017, Case A41-85807/16). In this case, the defendant argued that
threat of infringement was not proven since the defendant was not advertising,
manufacturing or offering for sale his generic product by participating in state
tenders. The court dismissed these arguments, citing the two following
provisions:
- The
defendant’s generic medicines were registered on October 5 2016. The
plaintiff’s patent is effective until July 4 2023. Under Section 8(32) of
the Medicines Law, the absence of the product within three years (from
2016 to 2019) entails the termination of the marketing authorisation.
- Under
Articles 28 and 29 of the Medicines Law, the impossibility to submit
information regarding the monitoring of the medicine’s safety within five
years (from 2016 to 2021) gives rise to the termination of the marketing
authorisation.
If applied in further cases and shared by other courts, the
position will lead to a more enhanced level of protection for innovators.
Available remedies
The patentee in a pharmaceutical patent dispute could consider
the following remedies:
- a
claim to recognise the right;
- a
claim to prevent activities infringing the patent right or creating a
threat of its infringement;
- a
reimbursement of damages;
- a
payment of compensation instead of damages;
- the
seizure and destruction of counterfeit medicines; and
- the
publication of the court decision.
Court expenses in Russia, unlike in some jurisdictions, may be
recovered by the court from the losing party.
Interim measures (eg, arrest of products and prohibition to
undertake specific activity pending adjudication of the dispute) are
procedurally possible in Russia. However, the imposition of interim measures
requires an increased burden of proof and, thus far in patent infringement
cases, the court tends to dismiss interim measures motions on the grounds that
enforcement of interim measures may breach the balance of interests or
predetermine the results of the dispute.
Nevertheless, with the emerging trend necessitating more careful
attention to the ‘threat of rights’ concept, it is impossible to exclude the
fact that consistent filing of interim measures may lead to a much-expected
increase of interim measures applied in judicial practice.
Regulatory regime and patent enforcement
Articles 47 and 57 of the Medicines Law expressly ban the import
and sale of counterfeit medicines into Russia (as medicines in circulation in
breach of civil (including IP) legislation). Manufacture of such medicines is
also banned under the general provisions of the Civil Code. According to
Resolution 674 (September 3 2010), such medicines are subject to seizure and
destruction at the expense of the importer or seller under the procedure
approved by the government.
Under Section 7(32) of the Medicines Law, a court decision holding that
exclusive rights were infringed is grounds to revoke the marketing
authorisation of the generic medicine. Judicial practice interprets the
provision to the extent that such a decision must be rendered within a civil
lawsuit, not within a case challenging the decision of the administrative
authority (the Intellectual Rights Court, September 20 2016, C01-542/2016, Case
N A40-158999/2015).
Another important aspect is that patent protection in Russia is
additionally backed up with data
exclusivity protection. In particular, information regarding the results
of pre-clinical drugs trials and clinical trials of medicines submitted by the
applicant for state registration of the medicine, without permission and within
six years of the registration of the original medicine in Russia, is not
allowed for commercial purposes. Filing for marketing authorisation is allowed
after four years have lapsed since registration of the original medicine (for biosimilar
medicines that term is three years since the original medicine registration).
In 2017 the provisions were effectively applied in Russian
judicial practice when the Ninth Commercial Appeal Court held that the Ministry
of Health decision to dismiss the examination of the generic medicine was
legitimate. The court indicated that a marketing authorisation application
could be filed no earlier than the expiration of the original medicine’s
marketing authorisation (June 16 2017, Case A40-657/17).
Patent linkage
Medicines and pharmaceutical substances are recorded in the
state register. The registers do not provide information regarding whether the
specific medicine or substance is under patent protection. There is also no
obligation for the marketing authorisation applicant to cite any patent
protection in the application and registration dossier or to provide a
guarantee that third parties’ intellectual rights are not infringed.
The introduction of information on patent protection in the
state register, as well as the applicant’s obligation to guarantee that the
filed medicine does not infringe patent rights, may serve as a measure to
increase awareness and decrease prospective infringements.
Another option to safeguard a more comfortable and predictable
environment will be to introduce a marketing authorisation system with a
delayed effect of operation (ie, a specific indication in the regulatory
register that the marketing authorisation for a generic medicine becomes
effective after the expiration of the patent for the original (referential)
medicine).
Maximum sale price registration
On February 14 2018 the Ministry of Health issued an information
letter (418/25-5) regarding clarifying questions relating to the supply of
medicines for state needs. The ministry lists examples of cases where the state
customer may reject the maximum sale price submitted by a participant (eg, the
presence of the maximum sale price registration is grounds for participation in
state tenders for the supply of life-saving and essential drugs).
Among such cases are situations where the specific medicines at
issue are not commercialised on the Russian pharmaceutical market and cannot be
supplied to a state customer in case the state supply contact is entered into
(ie, breach of exclusive rights). Such a position, expressly shared by the
regulator, is a breakthrough in comparison with a 2014 case in which the court
indicated that the protection of patent rights should be sought in a judicial
or administrative order and not by rejecting the participation of a generic
medicine in a tender (Federal Commercial Court of Moscow Region, February 17
2014, F05-17393/2013, Case A40-32698/13-17-317).
State procurement system
Federal and local health authorities and institutions regularly
purchase medicines via state tenders. On October 26 2017, as part of its powers
within the procurement system, the Ministry of Health approved the template
contract for supplying medicines (Order 870n).
The template contract includes Provision 13 entitled ‘Exclusive
Rights’, under which:
- the
supplier guarantees that until the expiry of the best-before date, there
is no breach of exclusive rights of third parties to intellectual activity
results relating to the supply and use of the goods; and
- all
damages sustained by the customer in case of breach of exclusive rights of
third parties to intellectual activity results during the supply and use
of the goods (including those resulting from termination of marketing
authorisation) and the impossibility to use the medicines (including court
expenses and reimbursement of material damage) are reimbursed in full by
the supplier.
The presence of such a provision in the template contract for
the supply of medicines is a cold shower for potential infringers. The
provision demonstrates the authorities’ proactive approach to decrease the risk
of potential patent rights infringement.
Tuesday, 5 June 2018
VPATAPP Alert_An Exceptional Example Of How NOT To Run A Patent Defense
A recently unsealed fees decision out of New Jersey is illustrative of the consequences a games-playing defendant can face as the loser of a patent case. The March 28, 2017, decision by Judge Jerome B. Simandle in Sabinsa Corporation v. Olive Lifesciences Pvt. Ltd., Civ. Act. No. 14-4739 (D.N.J.) awarded nearly a million dollars in attorneys’ fees in a competitor patent case with an interesting fact pattern.
Sunday, 3 June 2018
VPATAPP Alert_Using Patent Data Analytics in Patent Valuation
This article focuses on
how patent prosecution data analytics can be applied to the valuation of
patents. Because there are a variety of methodologies for such valuations, and
each method uses multiple metrics for establishing patent value, the scope of this
discussion will be limited to a base case scenario involving a newly-issued
patent associated with little or no relevant litigation data. Further, it
is assumed that the patent can be evaluated relative to a statistically
significant data set of patents in the same or similar technology spaces.
Finally, the patent is assumed to be valid. With this context in mind,
throughout this article multiple patent prosecution statistics will be
evaluated for use in valuing the patent, including allowance rate, number of
office actions, and Patent Trademark and Appeal Board (PTAB) review
disposition.
Monday, 28 May 2018
VPATAPP Alert_WIPO Translate: Republic of Korea is First to Adopt WIPO’s “Artificial Intelligence” - Powered Patent Translation Tool
The
Republic of Korea is adopting WIPO’s ground-breaking “artificial
intelligence”-based translation tool for patent documents, making it the first
member state to use WIPO Translate in an important advancement for the use of
machine learning in the technology-heavy patent sector.
VPATAPP Alert_New patent term extension framework in Canada
The amendments to the Patent Act and the
enactment of the Certificate of Supplementary Protection (CSP) Regulations
flowing from the Canada-EU Comprehensive Economic and Trade Agreement
introduced a new framework in Canada for the issuance of CSPs (for further
details please see "Publication of final regulations on patent linkage and
term restoration relating to CETA"). CSPs provide an additional
patent-like protection term and are intended to partly compensate innovators
for the time required to research and obtain regulatory approval in Canada.
CSPs are similar to the EU and European Economic Area supplementary protection
certificates, with a number of key differences, including a capped term of two
years compared with five years in the European Union.
Wednesday, 23 May 2018
VPATAPP Alert_Patent litigation in China
Disputes over standards essential patents are
increasingly being exposed in the courts, as can be seen from the CJEU
decisions (such as Huawei v ZTE) and in the UK in relation to the Unwired
Planet litigation1, giving a detailed insight into a wide range of issues
beyond simple infringement and validity. In his discussion of Sony's defeat in
the recently established Beijing IP Court, Toby Mak shows that such cases in
China are no different, with punitive damages and an injunction being granted,
as well as (by Chinese standards) substantive costs.
Monday, 21 May 2018
VPATAPP Alert_Patent Backlogs Fuel Efforts To Extend Pharma Patent Terms In Thailand And Brazil, AIDS Activists Say
For a variety of
reasons, Thailand and Brazil have huge backlogs of pharmaceutical patent
applications. The delay in patent examinations is creating pressure on the
countries to extend patent protection terms to the detriment of access to
affordable medicines, AIDS organisations say.
Thailand “Innovative Step Examination” Creates Patent Logjam
Patent Term Extension “Must Not Happen in Thailand”
Brazilian Patent Exam System “Overwhelmed”
Article 40 Creates “Extra Monopoly Years”
Bringing “Public Interest Considerations to the Core of the
Patent System”
VPATAPP Alert_Patent attorneys will now enjoy legal privilege before the Danish courts
The proposition to amend the Administration of Justice Act
(which was first reported on here) passed in the Danish parliament
(Folketinget).
The most
important issue relates to introduction of a legal privilege for patent
attorneys. Danish industry and patent attorneys, including the author of this,
have worked for the introduction of such a legal privilege for a number of
years.
I am personally
very satisfied with the wording of the amendment, which provides a legal
privilege of European patent attorneys very similar to that of lawyers.
The amended act
enters into force on 1 July 2018, and the legal privilege is retroactive. So,
from this date, a European patent attorney may, as the general rule, not be
called as a witness before the Danish courts – and his or her written advice
may not be used as evidence.
The amended act
was passed with 100 votes for and zero against. This reflects the unconditional
support gained by the proposal from all political parties represented in the
parliament.
Saturday, 19 May 2018
VPATAPP Alert_Important amendments under Mexican law regarding patents, utility models and industrial designs
Mexico has recently put
into effect a number of provisions regarding diverse IP issues that merit close
attention.
1.
Amendments
related to availability of information
2.
An
amendment directed to optimize the prosecution time of patent applications
3.
New
concepts for industrial design examination
4.
New
regime for the validity of designs
Friday, 18 May 2018
VPATAPP Alert_Impact of Brexit on SPCs
Firstly, with respect to how the duration of SPCs will be
calculated in the EU-27, the notice confirms that:
- Any marketing authorisation
granted by the UK on or after the withdrawal date will not be
considered a first authorisation for purposes of the SPC Regulations; and
- Any marketing authorisation
granted by the UK before the withdrawal date will be
considered a first authorisation for the purposes of the SPC Regulations.
VPATAPP Alert_Law of the Flag and Patent Infringement on the High Seas
Due process ordinarily requires that a court have personal jurisdiction over the parties to a lawsuit. In its 2016 opinion, the District Court dismissed M-I Drilling’s lawsuit against the Brazilian company Dynamic Air Ltda. (DAL) for lack of personal jurisdiction. M-I Drilling Fluids UK Ltd. v. Dynamic Air Ltda, 2016 U.S. Dist. LEXIS 27357, 2016 WL 829900 (D. Minn. 2016). On appeal here, the Federal Circuit has reversed. M-I Drilling Fluids UK Ltd. v. Dynamic Air Ltda., 2018 U.S. App. LEXIS 12497 (Fed. Cir. May 14, 2018).
Tuesday, 8 May 2018
VPATAPP Alert_Introducing IPRs as the De Facto Administrative Claim Construction (ACC) Procedure
The combination of (1) the USPTO’s new proposed court-like
claim-construction for IPRs and (2) the Supreme Court’s SAS decision
collectively provides some opportunity for a de facto administrative claim
construction procedure. It is likely
that a substantial portion of IPR participants will now be focused as much on
claim construction as on the underlying validity arguments themselves. Although this is already going on to some
extent, once the courts and PTO apply the same standard of law, PTAB claim
construction determinations could then be taken as decided issues of law (or at
least highly persuasive authority) handed back for the stayed (or upcoming)
district court litigation.
Monday, 7 May 2018
VPATAPP Alert_Rapid changes in the Chinese legal system, an increasingly attractive venue for IP litigation
For
many years, foreign companies were reluctant to seek and enforce intellectual
property protection in China. A combination of challenging litigation
with low damages, the lack of ability to effectively enforce judgments,
allegations of protectionism by the courts; a lack of ability to patent certain
subject matter, a lack of transparency on legal matters and other factors made
China a less desirable jurisdiction. The Chinese intellectual property
legal system has matured rapidly, however. From improvements in the scope
of allowable patent subject matter to enhancements of litigation options, and a
strong desire by China to be seen as having a level playing field for all
parties, China deserves a second look.
Wednesday, 2 May 2018
VPATAPP Alert_When is it too late to petition for IPR?
By statute, an
IPR cannot be instituted if the petitioner, real party in interest, or its
“privy” was sued for infringing the patent more than one year before the
petition for the IPR. 35 U.S.C. § 315(b). As we previously reported, in Wi-Fi
One, LLC v. Broadcom Corp., 878 F.3d 1364 (Fed. Cir. 2018), the
Federal Circuit en banc held that it had jurisdiction to review the PTAB’s
time-bar decisions. Last Friday, we got the first inkling of what such review
will look like, as the Wi-Fi panel
affirmed the PTAB’s decision on remand. If Wi-Fi One is any
indicator, the Federal Circuit’s review will be highly deferential.
Friday, 27 April 2018
VPATAPP Alert_Annual 2018 Special 301 Report published by USTR
Executive summary:
A top trade priority for the Administration is
to use all possible sources of leverage to encourage other countries to open
their markets to U.S. exports of goods and services and provide adequate and
effective protection and enforcement of U.S. intellectual property (IP) rights.
Toward this end, a key objective of the Administration’s trade policy is
ensuring that U.S. owners of IP have a full and fair opportunity to use and
profit from their IP around the globe.
The Special 301 Report (Report) is the result
of an annual review of the state of IP protection and enforcement in U.S.
trading partners around the world, which the Office of the United States Trade
Representative (USTR) conducts pursuant to Section 182 of the Trade Act of
1974, as amended by the Omnibus Trade and Competitiveness Act of 1988, the
Uruguay Round Agreements Act, and the Trade Facilitation and Trade Enforcement
Act of 2015 (19 U.S.C. § 2242).
The Report reflects the resolve of this
Administration to call out foreign countries and expose the laws, policies, and
practices that fail to provide adequate and effective IP protection and
enforcement for U.S. inventors, creators, brands, manufacturers, and service
providers. The identification of the countries and IP-related market access
barriers in this Report and of steps necessary to address those barriers are a
critical component of the Administration’s aggressive efforts to defend
Americans from harmful IP-related trade barriers.
The Report identifies foreign trading partners
where IP protection and enforcement has deteriorated or remained at inadequate
levels and where U.S. persons who rely on IP protection have difficulty with
fair and equitable market access. For example:
• USTR continues to place China on the Priority Watch List (and, as
before, Section 306 monitoring remains in effect). China’s placement on the
Priority Watch list reflects the urgent need to remediate a range of IP-related
concerns, including as to trade secret theft, online piracy and counterfeiting,
the high-volume manufacture and export of counterfeit goods, technology
transfer requirements imposed as a condition to access the Chinese market, the
mandatory application of adverse terms to foreign IP licensors, and IP ownership
and research and development localization requirements. Structural impediments
to administrative, civil, and criminal IP enforcement are also problematic, as
are impediments to pharmaceutical innovation.
• USTR identifies India
on the Priority Watch List for lack of sufficient measurable improvements to
its IP framework on longstanding and new challenges that have negatively
affected U.S. right holders over the past year. Longstanding IP challenges
facing U.S. businesses in India include those which make it difficult for
innovators to receive and maintain patents in India, particularly for
pharmaceuticals, enforcement action and policies that are insufficient to curb
the problem, copyright policies that do not properly incentivize the creation
and commercialization of content, and an outdated and insufficient trade
secrets legal framework. New and growing concerns, including with respect to
reductions in transparency by India’s pharmaceutical regulator through the
removal of a requirement that applicants submit information about a product’s
patent status, as well as positions that India supports and voices in
multilateral fora on IP issues, continue to 6 generate skepticism about whether
India is serious about pursuing pro-innovation and - creativity growth
policies.
• USTR identifies Indonesia
on the Priority Watch List due to the lack of adequate and effective IP
protection and enforcement. For example, revisions to Indonesia’s patent law
have raised serious concerns, including with respect to patentability criteria
and local manufacturing and use requirements.
• USTR identifies Colombia
on the Priority Watch List with an Out-of-Cycle Review focused on certain
provisions of the United States-Colombia Trade Promotion Agreement (CTPA) and
monitoring the implementation of Colombia’s National Development Plan. In 2017,
USTR conducted an Out-of-Cycle Review of Colombia focused on certain provisions
of the CTPA and monitoring the implementation of Colombia’s National
Development Plan. Colombia’s lack of meaningful progress warrants its elevation
to the Priority Watch List. In 2018, Colombia will be subject to an
Out-of-Cycle Review on the same issues to determine whether a change in status
to Watch List is warranted.
• The Report also highlights trading partners
such as Chile
that have not delivered on IP commitments made to the United States.
The Report also identifies significant
cross-cutting IP issues with regard to adequate and effective IP protection and
enforcement worldwide. For example:
• USTR has been engaging with trading partners,
including Algeria, Argentina, Canada, China, Korea, India, Indonesia, Japan,
Malaysia, Saudi Arabia, and the United Arab Emirates (UAE), to address concerns
related to IP protection and enforcement and market access barriers with
respect to pharmaceuticals
and medical devices so that trading partners contribute their fair
share to research and development of new treatments and cures.
• In virtually all countries identified in this
Report, IP enforcement
is lacking. Many of the listed trading partners, including Canada, Egypt,
Indonesia, Mexico, Turkey, Turkmenistan, UAE, and Uzbekistan, do not provide
adequate or effective border enforcement against counterfeit and pirated goods;
in addition, many listed countries’ customs officials lack authority to take ex
officio action to seize and destroy such goods at the border or to take such
action for goods in-transit.
• Several countries, including China, Mexico,
Russia, Ukraine and Vietnam, have not addressed the continuing and emerging
challenges of copyright
piracy. Countries such as Argentina, Greece, Tajikistan,
Turkmenistan, Uzbekistan, and Venezuela do not have in place effective policies
and procedures to ensure their own government agencies do not use unlicensed
software.
• Online piracy remains a challenging copyright enforcement
issue in many trading partner markets, including Canada, China, India, the
Netherlands, Romania, Russia, Switzerland, Taiwan, Ukraine, and elsewhere.
• U.S. innovators face challenges including restrictive patentability
criteria that undermine opportunities for export growth in countries
such as Argentina, India, and Indonesia. Innovators also face—for example in
Argentina, China, India, Indonesia, Saudi Arabia, Thailand, and Russia—a lack
of adequate and effective protection for regulatory test or other data
submitted by pharmaceutical and agricultural chemical producers.
• Inadequate protection for trade secrets in a number of countries,
notably in China and India, also puts U.S. trade secrets at unnecessary risk.
• The Report highlights negative market access
effects of the approach of the European Union (EU) to the protection of geographical indications
(GIs) in the EU and third-country markets on U.S. producers and traders,
particularly those with prior trademark rights or who rely on the use of common
names.
Thursday, 26 April 2018
VPATAPP Alert_UK ratifies the Unified Patent Court Agreement
The UK has ratified the Unified Patent Court
Agreement that enables a single judgment on patent disputes across its
contracting states.
The
Minister for Intellectual Property, Sam Gyimah MP, has (26 April 2018)
confirmed that the UK has ratified the Unified Patent Court Agreement (UPCA).
Wednesday, 25 April 2018
VPATAPP alert_US Supreme Court: Patent Office Retains IPR Authority, Loses Discretion to Streamline Proceedings
Today (April 24, 2018), the U.S. Supreme Court released two important
decisions regarding the authority of the U.S. Patent and Trademark Office
(“PTO”) to conduct Inter Partes Review (“IPR”)
proceedings. IPRs, an administrative process to challenge the validity of
existing patent claims, originated with the America Invents Act of 2011 and
have become a popular and successful avenue to challenge patent validity, as
they can be lower in cost and faster than litigation.
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