Well I was confused.
The Intellectual Property protections of the Trans-Pacific Partnership
had been published and these radical new agreements were going to: 1) disrupt
commerce and end innovation throughout the world; and 2) strip nations of their
sovereignty and deprive millions of people of access to their basic
necessities. Apparently, it depends on
whether you listen to Fox News or MSNBC.
And so, in one of the worst personal decisions I had made
since I traded a Land Rover for a dog and a cat, I decided to actually read
Chapter 18 of the TPP to see what was going on.
The short version:
not much.
The longer version is provided below.
Administrative Process
The parties agree to: 1) respond to requests for IP protection with
written decisions that include legal justifications and reasoning for these decisions;
2) provide the applicant with the opportunity to respond to a decision; 3)
provide a written response to the applicant’s response that includes legal
justifications and reasoning for the decisions provided in the written
response; 4) provide an opportunity to appeal decisions described in point 3);
and, 5) provide a written decision regarding the appeal that includes legal
justifications and reasoning for the decisions provided in the appeal decision.
Trade Secrets
The parties will put in place legal remedies to protect
against the loss of trade secrets through fraudulent action, unauthorized
access, or misappropriation.
Trademarks and
Geographic Indications
The parties will recognize Geographic Indications and
treat them like trademarks.
Internet Service
Providers
Each party will establish laws that require internet
service providers to cooperate with right holders to remove protected materials
from the internet. Each party will also
establish laws that provide internet service providers with safe harbor
protections if they unknowingly or inadvertently distribute protected
materials.
Patents
The standards for determining the patent eligibility of
an invention will follow reasonably closely to USPTO practices with the
exceptions that: 1) diagnostic,
surgical, and therapeutic methods do not have to be patentable; 2) plants do
not have to be patentable; and, 3) biological processes do not have to be
patentable.
The parties agree to make publically available
information about patents and patent applications the maps fairly closely the
practices of the USPTO. This is a fairly
consistent practice across most countries.
Protection of
Proprietary Data by Regulatory Agencies
When seeking marketing approval for an Agricultural
Chemical, Pharmaceutical or Biologic product, each party will not permit the
use of undisclosed or proprietary data that was used for the marketing approval
of a previously submitted Agricultural Chemical, Pharmaceutical or Biologic product
that is the same or a similar product unless the same right holder owns both
products. Each party also agrees not to
use such undisclosed or proprietary data received from other countries or other
entities whether or not the other country or other entity is a part of the TPP
agreement.
For Agricultural Chemicals, this protection will expire
ten years after the marketing approval of the Agricultural Chemical product.
For Pharmaceuticals, this protection will expire five
years after the marketing approval of the Pharmaceutical product. Clinical trial data for pharmaceuticals is
protected for three years.
For Biologics, this protection will expire eight years
after the marketing approval of the Biologic.
There is a provision within the biologics to reduce this protection to
five years if the reducing party compensates the right holder in a manner that
creates a comparable market outcome. I
think the intent is clearly that a party can force a right holder of Biologic
products to accept a buy out for the last three years. This is a pretty fuzzy section of the chapter
and, unfortunately, the devil will be in the implementation details.
The definition of a pharmaceutical product is a product
that does not contain a chemical entity that has been previously approved. I am assuming that the definition of an
agricultural chemical product is similar.
The definition of a biologic product is a protein made using
biotechnology methods that is intended for use in humans. If these definitions are not met by a product
seeking marketing approval, the above protections will not apply.
The above protections will be provided by a party to
Agricultural Chemical products, Pharmaceutical products or Biologic products
whether or not the products have patent protections from the party.
The Australia and
Chile “Exemption” Claim
There has been some noise made that Australia and Chile
are claiming that the five year biologic rule means they do not have to change
their laws. This sounds worse than it
actually is because Australia and Chile have already changed their laws. Australia and Chile already have trade
agreements with the US that are considered to be generally consistent with
Chapter 18. In addition, the US has
already reached agreements with both Chile and Australia that work out which
sections of Chapter 18 will replace the existing agreements.
Patent Term
Extension
The parties agreed to patent term adjustment if the
approval process for a patent application takes longer than five years. The parties also agreed to extend the patent
term for Pharmaceutical products that faced unreasonable or unnecessary delays
in the market approval process. This
extension does not appear to apply to Agricultural Chemical products or
Biologic products which is a little surprising to me. The language of this section is a little
vague.
Copyrights
The actual copyright section was fairly straight
forward. It is the enforcement section
where things got interesting in this area.
In general, the normal copyright protections apply. In addition, the parties agree to legally
protect the use of Technology Protection Measures and Rights Management
Information techniques and technologies.
There will be civil and criminal legal remedies for people and entities
who knowingly bypass these techniques and technologies. The parties also agreed to make it illegal to
make or sell equipment to get around Technology Protection Measures, Rights
Management Information, or satellite decryption technologies involving
programmed content.
Libraries, museums, archives, educational institutions,
and non-commercial broadcasting entities can be exempted from criminal
penalties.
Enforcement
Each party agrees to put in place the laws and
enforcement mechanisms to enforce the agreements in this chapter. This includes judicial procedures that
provide the judicial system with the authority to order injunctive relief,
restitution, and damage payments. In
addition, the judicial system will be given the authority to order payment of
bonds or to suspend the release of counterfeit, misleadingly labeled, or
pirated goods based on prima facie evidence of an intellectual property rights
violation. The chapter goes into a lot
of detail about what this means and what appropriate relief measures should be. The chapter also goes into a lot of detail
regarding what constitutes criminal activity and the appropriate criminal
remedies.
Final Observations
In interpreting all of this, I am going to avoid
addressing the argument that the US could have cut a better deal because I
can’t speak to that point.
What I would point out is that in many respects, this
section of the TPP is pretty consistent with, if somewhat less generous than,
existing United States laws and procedures in most of the major intellectual property
protection areas. In trademarks we got
protection of geographic indicators.
While the copyright section is updated to accommodate new technologies
and the internet, the basic copy right protections are essentially the same as
they have been since the 1950s. From
what I can see, no changes in US law will be required to accommodate the patent
protections and industrial design protections called for in the TPP. I was surprised to see that trade secrets
were even addressed because, by definition, trade secrets are secret and will
not generally be registered with a government.
Even the differences between US law and the TPP were
predictable. For example, within the
patent community opinions are divided regarding the appropriateness of
patenting medical methods and biological processes and practices vary by
country. The result that the agreement
does not require patents for these sorts of innovations should not have been
unexpected.
In reading the popular press, one seemingly controversial
point that I hear coming from the mainstream media is the idea that the
administrative process described in the TPP will infringe on the national
sovereignty of the parties. This seems
misguided to me. The administrative
processes described in Chapter 18 seem reasonable and are consistent with the
standard procedures of many, if not most, countries. Unless you hold the opinion that disagreeing
with the administrative decisions of a government is an infringement of
national sovereignty, I don’t really see an issue here.
I would point out is that the proprietary data
protections and the patent term extensions that were agreed to are unusual. These types of protections are rare
especially beyond the first world countries.
In my mind, these are not valueless concessions for the protection of
Agricultural Chemical products, Pharmaceutical products or Biologic products. Even if these protections are flawed, if I
were betting I would think these industries would rather have these weaker
protections than to not have the protections at all.
At David’s request, I have published an article by
article summary of the intellectual property agreements that were made in
Chapter 18 of the Trans-Pacific Partnership.
This summary has been put up on the Agathon Associates website.
And yes – I still have the dog and the cat J
Jim Carson is a principal of RB Consulting, Inc
and a registered patent agent. He has
over 30 years of experience across multiple industries including the biotechnology,
textile, computer, telecommunications, and energy sectors. RB
Consulting, Inc specializes in providing management,
prototyping, and IP services to small and start-up businesses. He can be reached via email at jim@rbconsulting.us or by phone at (803)
792-2183.
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