Program

Program at a Glance

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.

Topics of special interest are as follows:

• 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 chemical industries.
• 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, and outsourcing.
• Hatch-Waxman Act Change.

PRESENTATION ABSTRACT

Maximizing the Life-cycle of Pharmaceutical Patents

MaryAnne Armstrong

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 approach.

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:

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:

Overview of ANDA Pharmaceutical Patent Litigation in the United States.

Justin Hasford

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

Tom Hockaday

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 companies.

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 Pharma

Tom Irving

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

Frank Jiang

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

Hans Sauer

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 future.

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 sector.

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 position.

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

Stuart Watt

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 cures.

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:

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