Advanced Topics in Patent Law

They have also attacked patent listings in the Food and Drug Administration “Orange Book” and have alleged monopolization through fraud on the Patent and Trademark Office and sham litigation. Yet other cases have condemned distribution agreements as unlawful exclusive dealing. These government actions have led to substantial private class action litigation against the pharmaceutical industry. The FTC has also challenged numerous mergers and acquisitions in the industry over the last decade. One common feature in all of these cases is the need to define a relevant market. In nonmerger cases, the FTC and private plaintiffsgenerally allege narrow markets, limited to a single drug and its generic equivalent in some cases and to generic drugs excluding the bioequivalent “brand-name” drug in other cases. In its merger challenges, on the other hand, the FTC has alleged markets ranging from those based upon a particular chemical compound, to broader markets based upon various drugs’ manner of interaction or dosage form, to still broader markets of all drugs used to treat a disease or condition. In numerous pharmaceutical merger challenges, the government has included in the market not only currently marketed drugs but also other drugs under development, alleging “innovation markets.”

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Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

Protection of intellectual property are investments based on acquired knowledge, thought and effort by one or multiple individuals on behalf of themselves, the business they work for when the property is created, and a financial investment. Each of these – acquired knowledge, thought, physical effort, financial investment – have a value that can be attached as it relates the usefulness or importance of the resulting product. That value will have a level of importance to the individual(s) creating the product and if applicable, the investor providing the funds in support of the creation.

Proponents of patent reform largely focus on the cost of patent infringement litigation to the U.S. economy and companies. While some argue that the type of patents issued should be limited in order to uphold the intent of Article I, Section 8, others claim that standards for issuing patents should be strengthened in order to reduce the number of costly patent infringement lawsuits. The cost of litigation and standards for issuing a patent is the focus of the proceeding text and justification for patent reform in the United States.

It is intended both to provide thumbnail descriptions of the various intellectual property regimes to economists working in this area and to indicate where additional economic research might be useful. The other papers in this symposium provide important examples of ongoing research on the economics of intellectual property. Suzanne Scotchmer analyzes the complex effects of patent protection when innovation is cumulative. Rather than analyzing situations in which several firms vie to develop the same innovation-the approach of the "patent race" literature-her analysis examines circumstances in which only one firm can develop an initial innovation but others can also build upon it. She focuses on how the incentive to develop both the initial and subsequent inventions may be affected by the scope of patent protection. Janusz Ordover considers ways of adjusting the patent system that may help to both provide returns to the inventor, and encourage the diffusion of the innovation in the economy. His paper is part of a line of work that explores the place of the intellectual property system among the large number of institutions that affect the amount and nature of research and development that takes place. In the final paper, David

Evidently, both the EU and the U.S. enacted special provisions legislative, which extended the pharmaceuticals patents' life. As is the case with America, the Waxman-Hatch Act increased the copyright protection based on name-brand drugs with up to five years, but still it also puts

I selected the oral argument in the United States Supreme Court case Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854 (argued, October 2014). This argument was presented on October 15, 2014. First I will provide a summary of the prosecution history behind this case. Teva Pharmaceuticals USA created a multiple sclerosis drug called Copaxone and subsequently obtained a patent for the drug. Sandoz Inc. desired to create a generic version of Copaxone and submitted their request to the Food and Drug Administration. In 2012, Teva sued Sandoz in the U.S. District Court for the Southern District of New York on the grounds of patent infringement. The District Court then considered the patent through claims construction by examining the patent’s plain language and its prosecution history. Then, the court examined expert testimony and the public record to the patent in order to see if the terms were definite. The

The United States Patent and Trademark Office granted the exclusive right to the Knoll brothers to profit from their invention – Photoshop, which Adobe acquired through a licensing deal. While rewarding a person for his invention is good to promote innovation, rule utilitarians would disagree in grating the patent to them because it implicates a social cost that far outweighs the benefits of that one software and the people involved in making it. The inelastic nature of the patent gives tremendous amounts of leverage to Photoshop as it is the undisputed market leader of photo editing programs because it has features that its competitors aren’t allowed to offer due to the patent.

The proto-institution created by the Health of Education and Welfare’s (HEW) Institutional Patent Agreements (IPA) was the start of increasing university patenting. A proto-institution is a weak version of an institution in that its goals are often narrowly focused, but has the potential to become an institution. HEW established an IPA waiving all inventions sponsored by Hew so that universities would not have to go through the hassle of applying for individual waivers and could simply apply for a single IPA instead. However not many IPAs were filed and approved because HEW did not think universities needed to patent inventions since these universities were supposed to serve the public. However, Norman Latker, the first patent counsel who worked for the National Institute of Health, changed IPAs. He tended to favor the government-license policy, believing that the government was incapable of managing patent

Competition amongst researchers intensified and instead of collaborating with each other, they kept their research restricted, in hopes of striking it rich someday. As an example, there are currently 4,875 U.S. patents for Lyme disease in comparison to 808 for Parkinson’s disease, or 2,148 for Alzheimer 's disease. (Due to the similarity in symptoms, and the unknown cause of both Parkinson’s, and Alzheimer’s disease, some believe it is really just Lyme disease.) Nevertheless, with all the interest in a “hard to catch and easy to cure” disease like Lyme, the number of patents cannot be ignored; patents equal money.

The patenting race takes advantage of the same computer technology that made the sequencing possible. Companies seeking patents have been using automated DNA-sequencing machines to identify genes easily and cheaply. At the time when they file for the patents,

Therefore, protection of patents is one of the key conditions necessary for further development of the pharmaceutical industry. At the same time, non-efficient legislation that does not provide the necessary level of patent protection is one of the factors that hamper expansion of “Big Pharmaceutical” companies to the developing countries8.

China’s patent system can be traced back to the late Qing Dynasty when China began signing international treaties. For example, on August 18, 1903, China and the United States agreed on a treaty on navigation and commerce. The treaty provided for a “reciprocal patent-granting arrangement whereby citizens of one contracting party could apply for and secure patent rights for their inventions in the other contracting party.”1 After the Qing Dynasty was over thrown in 1911, the

Cipla should look to protect their patents on particular medications and explains why rules governing intellectual property rights in industrialized nations should not apply to poorer countries.