Scope of discussion for this IP forum is the following:
US/EP/JP/WO patent law fundamentals and comparison with the Chinese patent law;
Patent prosecution, strategies for maximizing IP rights and protection (case studies);
Counter strategies of generic product manufacturers;
Legislative philosophy of Chinese patent law, special aspects as related to
pharmaceutical/chemical industries, future trends;
Litigation concerning IP infringement and violations (case studies);
Laws and regulations regarding technology transfer/licensing/export of information.
The IP Forum will invite experts in IP law from both overseas and China to
introduce and explain the legal bases for IP laws relevant to the pharmaceutical
and chemical industries, grand strategies for maximizing legal protection of IP properties,
tactical maneuvers in executing legal protection, and differences in IP laws and practices in China,
the US, Europe and Japan. Relevant high-profile IP cases will be analyzed.
Patent and trade mark application fundamentals in China/US/EU/JP.
Chinese/US/EU/JP IP law overview, how they are applied to the pharmaceutical and
Case studies of high-profile pharmaceutical and chemical IP litigation.
WIPO areas and impact.
US patent law reform.
Impact of IP law protection on pharmaceutical R&D.
Life cycle management of patented drugs and patent extension.
Defensive strategy against “me too” drugs.
Legal issues and strategies in registering generic drugs.
Impact of trademark laws in language difference in China and US.
Trademark and brand name similarity cases in China and US.
Defending brand name drugs after patent expiration.
Issues and IP strategies related to licensing, technology transfer, alliances,
Hatch-Waxman Act Change.
Maximizing the Life-cycle of Pharmaceutical Patents
The market value of pharmaceutical patents often begins several years after
the patent issues, towards the end of the normal 20-year patent term. As such,
strategies for maximizing the life cycle of the patent are extremely important
for pharmaceuticals. There are several strategies that can be used to maximize
the life cycle of a patent, particularly in the U.S. Two ways of maximizing the
life cycle of patents that can be used at the beginning of the patenting process
are the use of U.S. provisional applications and PCT international applications..
During the examination process of a US patent application, the Applicant should
consider and take actions to maximize any possible Patent Term Adjustment that
may be given to the patent. At the end of the patenting process it may be possible
to obtain additional protections that are tied to the drug approval process
administrated by the U.S. Food and Drug Administration (FDA). The resulting
Patent Term Extension, which is particularly important for pharmaceutical patents,
is given to patent claims that cover a product that has been subjected to a
regulatory approval process, and in some cases can extend the patent term by
several years. In addition, use of the FDA Orange Book can help maximize the
life cycle of a pharmaceutical patent. Finally, the drug developer should
consider alternative, non-patent, forms of exclusivity that can be obtained
from the FDA. Each of these strategies will be discussed as well as the
advantages and pitfalls associated with them.
IP Management for Worldwide Healthcare Providers
Robert L. Baechtold
Modern reality is that all commerce is global commerce. Yet there remains
considerable disparity around the world in the procedures for obtaining and
effectively enforcing the protection of intellectual property. If countries
are to stimulate the advancement of technology, companies must be assured that
their research and development investments will be recouped, and that their
intellectual property rights will be respected in the global marketplace.
In the field of pharmaceuticals, this requires a particularly careful balance
between competing policy interests, including providing affordable medicines
to all who need them, safeguarding the public against potential health and
safety risks, and providing the necessary business incentives for pharmaceutical
companies to undertake the expensive and risky process for developing new drugs.
In this presentation, we provide an overview of how these competing interests
are balanced by pharmaceutical and intellectual property laws and the United
States and around the world. In particular, we summarize the United States’s
1984 Hatch-Waxman Act, which over the past 25 years has encouraged technological
innovation by providing branded pharmaceutical companies with periods of market
exclusivity and means to enforce their intellectual property rights against
competitors, while also allowing the public widespread access to low-cost
medicines by removing costly regulatory hurdles for generic drug makers.
We also summarize salient features of the proposed 2009 United States legislation
for the regulation of the next generation of drugs – “biologics” and “biosimilars”
– which are predicted to dominate the pharmaceutical industry in the coming years,
but which present a new set of legal and regulatory challenges.
We then compare and contrast the legal and regulatory mechanisms that govern
the pharmaceutical industry in the United States with their counterparts around
the world, focusing on the different types of patent protection that are available
for different types of pharmaceuticals; the different types of regulatory protections
and incentives, such as market exclusivity periods to encourage the development
of new chemical entities and new therapeutic indications; the abbreviated regulatory
processes and other concessions available to generic drug makers in different
countries; and how (if at all) the patent laws of various countries interface
with their pharmaceutical regulatory structures. We take a close look at Canada
and Europe, whose pharmaceutical laws differ markedly from those in the United
States. (For example, Canada, unlike the United States, significantly limits the
scope of legal proceedings that branded pharmaceutical manufacturers may bring to
enforce their patent rights against generic drug makers.)
Finally, in view of these global comparisons, we suggest some general principles
that countries should follow to ensure the effective, uniform treatment of
intellectual property rights of pharmaceutical makers, while also satisfying the
public demand for safe, high-quality generic alternatives. Though different
countries admittedly have differing priorities, the expansive global reach of
the pharmaceutical industry ideally requires a unified legal and regulatory
The International Patent System: Issues and Opportunities
Margo A. Bagley
This presentation will provide an introduction to key aspects of the international
patent system focusing on the function and scope of international agreements
concerning patents, such as the Paris Convention, Patent Cooperation Treaty,
and the Agreement on Trade Related Aspects of Intellectual Property (TRIPS)
and governing bodies such as the World Intellectual Property Organization (WIPO)
and the World Trade Organization (WTO). It will also highlight the importance
of regional patent agreements such as the European Patent Convention and regional
trade agreements, and touch on some of the current global patent issues such as
harmonization efforts, compulsory licensing and access to essential medicines,
and genetic resources/traditional knowledge protection.
IP Management in Global Pharmaceutical Companies
Robert DeBerardine Vice President and Head of Global Patents Sanofi-aventis
China is ready to move to the next stage of its economic evolution, as an
innovation and knowledge based economy. This evolution was signaled by the
introduction of the 3rd Amendment to the Chinese Patent Laws. The predictability
of obtaining and enforcing patents is the foundation upon which highly risky,
expensive and high value innovative products rests. One of the most patent
sensitive industries is the pharmaceutical industry. This talk focuses on the
elements of a strong patent system that a typical global pharmaceutical company
relies upon and the IP strategies for innovative medicines.
New Patent Law Development in the U.S.
Frank S. DiGiglio
The United States Court of Appeals for the Federal Circuit:
Its Critical Role in the Revitalization of U.S. Patent Juridprudence,
Past, Present, and Future
Donald R. Dunner
The innovative crisis that led to the Federal Circuit’s formation in 1982.
The Federal Circuit’s formation was an outgrowth of great concerns in the patent
bar about the huge conflicts and disparities between the views in patent cases of
the various Federal Courts of Appeal, resulting in lack of uniformity and
predictability in the patent law. Great concern also existed regarding
undignified races to courts having views favorable to the party filing suit.
These concerns came to a head in the late 1970’s - early 1980’s as a result
of a perceived innovation crisis in the United States. The Federal Circuit
was created in 1982 to solve these problems by combining two existing courts.
Widespread concerns about the undesirability of specialized courts were eased
by assigning diverse areas of subject matter jurisdiction to the new court,
supplementing the court’s essentially exclusive jurisdiction over patent cases.
The court’s early years: The Markey Court and its response to the critical
need for providing uniformity and greater predictability in the patent law.
The early years of the court were devoted to clearing up existing conflicts in
the patent law decisions of the federal appellate courts and to developing a
body of law that would instruct the bar and the district courts in the proper
application of the patent laws. The court accomplished this through the issuance
of long and detailed opinions, which served as tutorials on sound patent law,
as well as important en banc decisions on critically important patent law
topics in order to provide uniformity in the law.
Important legal landmarks in the court’s jurisprudence.
Toward the foregoing end, the court issued important decisions dealing with:
new technologies, including biotechnology, computer-based inventions, and
the issuance of preliminary injunctions
the law of obviousness of potentially patentable subject matter
the doctrine of equivalents
prosecution history estoppel
Looking back. A report card -- How the court has performed from the view
of its original detractors and proponents.
Concerns that the court would become a dumping ground for spent politicians and
otherwise weak judges have disappeared, as have the concerns that the judges
of the new court would speak an arcane language that no one else understands.
Nor have concerns persisted that the court would become too pro-patent, since
the court has taken a relatively balanced, middle-of-the-road approach to the
needs of patent owners and accused infringers. The court has succeeded in
eliminating many conflicts in the patent laws and providing an increased level
of uniformity in its application of the patent laws, though there are still
pockets of concern and -- like other courts -- its decisions are often
panel-dependent. The court has also reduced considerably, but not eliminated,
forum shopping. And, finally, the court receives high grades for the quality
of its decision-making, though there are dissenting views on the subject.
Looking forward: Issues the court can be expected to confront in the future.
Important issues remain to be resolved by the Federal Circuit. To mention just a few,
the court’s law on inequitable conduct is in critical need of clarification and
improvement. Its recent Bilski decision on patentable subject matter has raised
more questions than it has resolved. There are significant differences in the
court on the written description requirement, and there is much debate in the
patent bar on the law of patent damages.
How to maximize success before the Federal Circuit.
Suggestions as to how to maximize success before the Federal Circuit
(which will be elaborated upon) include:
choice of appellate counsel
when appellate counsel should be retained
preparation of the brief
predicting success on appeal.
Overview of ANDA Pharmaceutical Patent Litigation in the United States.
Pharmaceutical patent litigation arises under the Hatch-Waxman Act when a
generic pharmaceutical company submits an Abbreviated New Drug Application
(ANDA) seeking approval from the U.S. Food and Drug Administration (FDA) to
market a generic copy of an innovator drug before the expiration of a patent
covering that drug. Upon filing an ANDA with the FDA including a so-called
Paragraph IV certification, which is an act of patent infringement, the generic
company must send to the patent owner and New Drug Application owner a detailed
statement of the factual and legal bases for the generic company's challenge
that the claims of the patent are invalid and/or not infringed, and/or that
the patent is unenforceable because of alleged inequitable conduct before the
U.S. Patent and Trademark Office. The patent owner then has 45 days to file
suit against the generic company for infringement, at which time a statutory
stay of FDA approval of the generic company's ANDA will commence so that the
patent infringement suit may be adjudicated. This presentation will discuss
the basic substantive and procedural law underlying pharmaceutical patent
infringement litigations that arise from ANDA submissions.
Commercialising Technology and the role of Universities
The story of Isis Innovation Ltd, the technology transfer company of
the University of Oxford, and the interface between academia and industry.
Universities and Industry exist for different reasons; they have different
aims and objectives. Universities exist to disseminate new knowledge, through
teaching and research, generally in an open and free way, and also sometimes
through commercial routes. Commercialising technology is not one of the
main purposes of a university.
Businesses exist to make money, and some choose to do this through
commercialising new technology. It is therefore sensible for universities
to work with businesses so that businesses can commercialise University
research. The Isis Innovation Ltd and Oxford University experience is one
example of a successful approach, supporting researchers' interests, focusing
on transferring technology and acting as skilled intermediaries. In this
way, Isis has successfully transferred technologies out to business for the
benefit of society and generated financial returns for the University.
Isis Innovation is the University of Oxford's technology company and manages
the University's intellectual property portfolio, working with University
researchers on identifying, protecting and marketing technologies through
licensing, spin-out company formation and material sales. Isis files on
average one new patent application each week, has concluded over 400 technology
licensing agreements, and established 62 new spin-out companies from Oxford.
Isis also manages Oxford University Consulting, which arranges consulting
services providing clients access to the world-class expertise of the
University's academics to enhance innovative capability. Last year OUC
arranged over 100 consulting deals. Isis has established a separate business
division, Isis Enterprise, offering consulting expertise and advice in
technology transfer and open innovation to university, government and
industrial clients around the world. Isis was founded in 1987 and is today
one of the world's leading technology transfer and innovation management
China's Opportunities Now and in the Future for Taking Advantage of the
USFDA Orange Book and the Hatch Watchman regime with respect to its Innovative
Protection of the fruits of pharmaceutical innovation, whether small
molecules or biotech products, will be key for Chinese innovative
pharmaceutical companies as they begin to compete in the U.S. market.
This talk will focus on protection of small molecules. Regulatory approval
of pharmaceutical products is conducted in the U.S. by the Food and Drug
Administration (“FDA”), and U.S. patents covering approved small molecules,
formulations thereof, and pharmaceutical uses thereof, are listed in the
FDA’s “Orange Book.” A listing in the Orange Book places the U.S. New Drug
Application ("NDA") holder (often the patentee) within the framework of
certain U.S. laws referred to as “Hatch-Waxman.” A generic manufacturer,
to compete before the relevant patents expire, often will certify against
the listed patents, usually leading to litigation in the U.S. with the NDA
holder. For block buster drugs, the NDA holder might reap billions of
dollars of additional profit if he can defeat the generic manufacturer's
challenge. Conversely, a defective Orange Book-listed small molecule
patent could have adverse, if not atastrophic, results for the innovator.
Such high stakes compel innovative pharmaceutical companies to obtain
the best advice possible regarding both Orange Book matters and the U.S.
patents to be obtained and listed therein. Mr. Irving, an expert in
obtaining and listing Orange Book patents, will share his extensive
experience in those matters.
The Ying and Yang of Drugs: An Uneasy Balance
Innovative medicine helps to improve and extend patient’s life (Yang).
But the innovation is high-risk and expensive (Ying). China is moving from
a manufacturing country to an innovation one and its improving IP environment
favors pharmaceutical R&D. As a result, sanofi-aventis is making a major
commitment in its R&D in China.
Patent Law Reform, Follow-on Biologic Drug Legislation, and Biotechnology
Innovation: Finding the Right Balance for the Future
The U.S. biotechnology industry is currently facing a confluence of
legislative events that will impact its business model for decades to come.
On the one hand, the U.S. Congress is currently considering the most expansive
reform to the U.S. Patent Act since 1952. Many of the proposed amendments
would impact the way biotechnology patent rights are prosecuted, licensed,
defended and enforced, and have generated a long and significant controversy
that has pitted the biotechnology industry and other stakeholders against
large companies in the computer, software, telecommunication and financial
services sector. Among the most controversial questions in U.S. patent
law reform are: should there be an administrative proceeding under which
patents could be challenged throughout their entire term, repeatedly if
necessary, without the protections and evidentiary standards that would
apply in a court of law? Should there be a new standard for calculating
appropriate compensation for patent infringement which is based on the
‘inventive features’ of the patent instead of the commercial value of
using the claimed invention? Should there be reform of the “doctrine
of inequitable conduct,” which is unique to U.S. patent law and
permits the elimination of valid patents because the patent
applicant engaged in misconduct in the Patent Office? This
controversy highlights that industries which operate under a long
innovation cycle, such as biotechnology, have special patent needs
that must be protected if the industry is to grow and advance.
At the same time, the U.S. Congress is poised to create, for the first time,
a regulatory pathway for follow-on biologic drugs under which the demonstrated
safety, purity and potency of an innovator biologic drug could be used to
approve a competing “follow-on” product. To encourage future biotechnology
innovation, it will be important that this pathway includes protections for
the innovator’s intellectual property as well as incentives to invest in the
future development of innovative biologic drugs. Many stakeholders acknowledge
that the cost of developing a new biologic drug is so high – exceeding USD
1.2 billion by recent estimates – that innovators need a reasonable period
of exclusivity in the marketplace to recover their investment before
follow-on competitors are permitted to benefit from the innovator’s
investment. Currently, there is much debate over whether such a period of
exclusivity should be accomplished by relying on the patent system, or
whether a statutory period of “data exclusivity” would be more appropriate
to regulate the timing of market entry for follow-on biologics. Proposed
follow-on biologics legislation also contains controversial provisions that would create a separate system for the assertion, litigation and enforcement of biologics patents.
This ongoing debate over patent reform and follow-on biologics legislation is
important not only for the U.S.-based biotechnology industry, but also for foreign
biologics companies who operate in the U.S. market or plan to do so in the
Compulsory licenses in Patent Law – new developments in Europe?
Wolfgang von Meibom
The “ordinary” compulsory license in patent law (see e.g. sec. 24 German
Patent Act, Article 31 TRIPs) used to have very little practical relevance
in the past. A compulsory license is (theoretically) available, if there is
a public interest in granting such license. There must be very exceptional
circumstances to fulfil this requirement, according to the case law.
However, there is a recent development concerning compulsory licenses coming
from Antitrust Law (Art. 81, 82 EC): According to case law of the German
Federal Supreme Court, the (un-) availability of compulsory licenses under
Patent Law does not exclude that compulsory licenses may be granted under
Antitrust Law. In a landmark decision, the German Federal Supreme Court now
clarified the preconditions of a licensing defence based on Antitrust Law.
This decision may give rise to new discussions on the availability of
compulsory licenses based on Antitrust Law, especially in the pharmaceutical
According to the "Orange Book" decision of the German Federal Supreme Court,
the compulsory license defence based on cartel law is, in principle, admissible
in patent infringement proceedings. Therefore, the patentee's claim for cease
and desist may be opposed by the defendant on the grounds of abuse of a dominant
market position (Article 82 EC).
This so-called "cartel law defence" is based upon the assumption, that
the patentee must not discriminate an undertaking asking for a license by
way of charging higher license fees than it usually requests of other
licensees or denying licensing at all, if the relevant patent is essential
to the marketing of products on a license-dependent market. Such behaviour,
so the Court, must in any case be objectively justified. Otherwise, the
patent infringement claim itself as well as the foregoing denial of
(non-discriminatory) licensing constitute an abuse of a dominant market
However, such an abuse does not automatically result in a right of the
defendant to make use of the patent in suit for free. Rather, the Court has
ruled that, in order for the cartel law defence to be well founded and the
ongoing making use of the patent in suit to be lawful, the defendant is
required to report on the usage of the patent to the patentee on a regular
basis and pay the license fees resulting from this usage accordingly. Payment
can be made to the patentee or into an escrow account. These payments must
amount to at least objectively adequate license fees.
The Biosimilars Debate: A Perspective on the Regulatory and Patent
Challenges facing the Innovative Biotech Industry
Biotechnology holds the promise of developing treatments for the most
deadly and debilitating diseases of our time – cancer, Alzheimer’s, heart
disease and autoimmune disorders. In order to deliver on this promise,
the biotech industry invests billions of dollars each year in researching
and developing potential innovative therapies. It is a high cost, high risk
effort, and in order to continue to attract sufficient investment dollars,
the biotech industry needs effective regulatory and patent protection for
its products. In an effort to lower health care costs, the United States
Congress is debating the statutory approach for creating an abbreviated
regulatory pathway for “biosimilars.” In this presentation, we will use
the current U.S. debate to examine the regulatory and patent policy issues
presented by biosimilars and discuss the real world factors that should
guide the debate. We will also review the challenges that the innovative
biotech industry faces in today’s business, regulatory and patent environment
as it confronts potential competition from biosimilars.
Some of the legislative proposals for biosimilars have suggested an approach
that parallels the Hatch-Waxman legislation on generic drugs adopted 25 years
ago in the U.S. Other proposals suggest an approach similar to that adopted
in Europe. The discussion begins with an analysis of the differences between
generic drugs and biosimilars. Unlike generic drugs, biosimilars are not
identical copies of the innovative biotech products they seek to compete
with – they are only similar products. Structural identity cannot be
established for biosimilars. Because differences in manufacture can result
in structural differences in the products that can impact the safety and
efficacy of biologics, even under an abbreviated regulatory pathway,
biosimilars should be required to present sufficient clinical data to
confirm their safety and efficacy. Moreover, due to the structural
differences between biosimilars and the innovative products, patents
may play a different role with respect to biosimilars as compared to
generic drugs. In reviewing the balance of interests struck in adopting
Hatch-Waxman, much has changed in the intervening 25 years. The clinical
testing and regulatory review time and expense required to bring an
innovative biological product to market has increased dramatically,
and with the adoption of a 20 year patent term in the U.S., the
effective patent term for biologics today is much shorter. Without
adopting significant data exclusivity for innovative therapies, the
innovators will not have sufficient exclusivity to protect their
products and the investments made in clinical development. The
result will be a decline in innovation, and the biotech industry
will be unable to deliver the promising therapeutics to treat
disease and lower health care costs. In contrast, smart policy
decisions on regulatory and patent issues will increase the
investment in biotech innovation and fund our search for the
IP Incentives for Innovator Pharma in China - Solving Unmet Medical Needs
in an Innovation Driven Economy
Lawrence T. Welch
An integrated approach is needed to provide appropriate incentives for
innovator pharmaceutical companies to expend the resources needed to develop
new medicines. This involves a combination of intellectual property
protections including patents and data exclusivity. Implementation of these
rights necessarily requires the involvement of the State Intellectual
Property Office (SIPO), the State Food and Drug Administration (SFDA) and the
courts. China has come a long way in providing intellectual property incentives
for innovator companies, and the implantation of the Third Amendment of the
Patent Law provides an opportunity to improve the IP regime to encourage
innovators, both foreign and domestic, to solve unmet medical needs in China.
As the new law is implemented, it is hoped that regulations can be formulated
to address concerns such as:
Transparency: How to provide appropriate procedures regarding how and
when generic products are approved in relation to the legitimate intellectual
property rights of the innovator
Compulsory licenses: Conditions under which compulsory licenses would
ever be appropriate under existing treaties
Patentability and validity issues: Including whether the courts should
consider patent validity and what needs to be disclosed in patent applications
in relation to biotechnological products
Patent exhaustion: Whether it is appropriate for patent rights for
products sold in global commerce to be “exhausted” impacting the legitimate
commercial expectations of the innovator as well as options for local
Research in China: Conditions for compensating Chinese inventors and for
filing patent applications on joint inventions between Chinese and non-Chinese
New efforts designed to better implement data exclusivity, through a clear
definition of a new chemical entity, will also help in this regard.