Viewing post categorized under: Patent



November 1 / All Articles, Patent

Shopping for Expedient, Inexpensive & Predictable Patent Litigation

Intellectual property has experienced an explosion in recent decades as the value of American corporations has become increasingly reliant on intangible assets. [1] This explosion is reflected in the massive increase in patents issued by the United States Patent and Trademark Office (“USPTO”) [2] and the corresponding spike in patent litigation. [3] Moreover, patent litigation has become a high stakes game [4] that is time consuming and unpredictable. [5] Faced with a system of patent litigation that most people agree is too expensive, too time-consuming, and too unpredictable, [6] plaintiffs frequently attempt to capitalize on their virtually unencumbered choice of venue to shop for the best district courts to file their suits. [7] This environment has destabilized the patent system, and reforms are needed to restore fairness, efficiency, and certainty in patent litigation.

 

This article will begin by providing a background of patent jurisdiction, forum shopping, and claim construction. Next, the article will explain the most prominent proposals for improving patent litigation. The article will then critically analyze these theories and conclude that greater efficiency and predictability could be achieved through improvements at the USPTO, adopting expedited procedures, designating certain judges to hear patent cases, and giving district court claim constructions greater deference on appeal….

Kevin A. Meehan

 

March 26 / All Articles, Patent

Inequitable Results in Transnational Patent Infringement Liability: Closing The Method Loophole

A set of recent patent infringement cases are primed to have major impacts and, some argue, inequitable effects on the current patent scheme in the United States. A problem has arisen concerning what kind of patent protection, or lack thereof, method and process patents should receive when certain steps of those methods or processes are implemented outside the U.S. Read literally, as the courts have, current law requires a method to have taken place in the U.S. for protection. But what results when a method or process patent is infringed partially in the U.S. and partially abroad? Should the patent receive protection by U.S. patent laws or has it not been infringed because the entire method has not been carried through in the U.S. from start to finish?

 

To illustrate the problem in a simple analogy, imagine a mother standing over the kitchen sink preparing dinner in full concentration. Her son and his friend sit in the middle of the kitchen floor playing catch with a ball. The mother, becoming aware of the game of catch, reprimands her son, telling him, as she has before, that the rule of the house is that catch is not to be played in the kitchen. She points to a list of rules hanging from the refrigerator that specifically states, “No catch in the kitchen.” The son waves his friend off through the kitchen door, until the son is throwing the ball from the kitchen to his friend in the living room and vice versa. Is the son still playing catch in the kitchen? Technically, he is not. A traditional game of catch requires two people, and there is only one in the kitchen. Thus, the son is not technically disobeying the rules.

 

Nonetheless, most mothers would override the written rule here, explaining to the son that his activities are meant to be included in the rule because any throwing or catching of the ball creates the same hazard. But what if the mother was bound to the rule on the refrigerator, however technically it was being read, and she could not reprimand the son further? Is the resulting restraint on the mother fair even though the son’s actions constitute, at best, an honest attempt to obey the rules or, at worst, a creative attempt to flout the rules on a technicality?

 

This is the problem facing the current U.S. patent regime with respect to process or method patents that are implemented internationally. Under this regime, a patented method is not considered infringed so long as a single step of that method takes place on foreign soil. [1] Thus, like the son who cleverly relocates his friend to the living room to avoid further trouble from his mother, alleged infringers are not technically infringing if they implement one or more steps of someone else’s patented method in a different country. [2] And like the mother who must respect the written rule on the refrigerator, courts have shown much deference to the rules that claim to deal with the extraterritorial application of patent rights, enforcing the current rule which allows this avoidance of infringement. [3] This seemingly inequitable result is one that stares U.S. patent law in the face as geographical borders erode making transnational infringement easier with each passing day….

 

Alejandro Valencia

November 29 / All Articles, Patent

Was The FDA Exemption To Patent Infringement, 35 U.S.C. § 271(e)(1), Intended To Exempt A PHarmaceutical Manufacturer’s Activities In The Development Of New Drugs?

The general rule of patent infringement, 35 U.S.C. § 271(a), states: “whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.” Congress created the so-called FDA exemption with the Drug Price Competition and Patent Term Restoration Act of 1984 (“1984 Act”), later codified in 35 U.S.C. § 271(e)(1), which states: [i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products. [1]

 

Attached as Appendix A. The FDA exemption was created as a part of a legislative package intended to speed generic pharmaceuticals to the market in hopes of reducing the price of pharmaceuticals and increasing access. [2] Included in the legislation was a compromise between the interests of the brand and generic pharmaceutical industries. In order to speed generics to the market, the generic pharmaceutical companies were given the ability to file an ANDA, an abbreviated application for marketing approval, and the FDA exemption from patent infringement. [3] The ANDA allows a generic manufacturer to file for FDA approval prior to the expiration of the brand patent. The FDA exemption allows the generic manufacturer to do the studies necessary to prove bioequivalence, a requirement of the ANDA, while the brand medication’s patent is still in force. In exchange, the brand pharmaceutical industry received the ability to extend the terms of their patents to compensate for the long regulatory approval process.

 

The legislative history of the FDA exemption clearly shows that it was intended to apply only to generic pharmaceuticals. The legislation, in part, was meant to cure the unfair patent term extension that resulted when a generic manufacturer had to wait until the expiration of the brand patent before applying to the FDA for regulatory approval. [4] It was hoped that the legislation would get generic drugs to the market around two years earlier than under the prior system. [5]

 

Both the Supreme Court and the Federal Circuit have interpreted the text of the FDA exemption. In Eli Lilly and Company v. Medtronic, Inc., the Supreme Court interpreted the exemption to include medical devices. [6] In Intermedics, Inc. v. Ventritex Co., Inc., the Federal Circuit held that an intent to commercialize prior to the expiration of the patent did not violate the exemption. [7]

 

In the subsequent Merck v. Integra case, the Supreme Court and the Federal Circuit considered the meaning of the phrase “solely for uses reasonably related to the development and submission of information under a Federal law.” [8] At first instance, the Federal Circuit interpreted this language narrowly. [9] In the majority opinion, Judge Rader focused on the word “solely” in the statute and viewed it as limiting. [10] Applying the statute narrowly, the court found that the Scripps experiments, which were designed to identify a new drug candidate, did not fall within the exemption. [11] Judge Rader also held that if the FDA exemption were interpreted broadly so as to include the Scripps experiments then the exemption may unintentionally destroy the patent protection for all research tools. [12]

 

On appeal, the United States Supreme Court interpreted the exemption as including “all uses of patented compounds ‘reasonably related’ to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs.” [13] This interpretation creates a vast exemption to patent infringement that goes well beyond the scope of Congress’s intent and well beyond reason.

 

The FDA exemption was not created to assist in the generation of new drug candidates, which are included in the broad interpretation of the “reasonably related” language by the Supreme Court in Merck. Applying the Supreme Court’s interpretation to the facts of Merck means that a pharmaceutical manufacturer may use the patented products and methods of another manufacturer to identify new drug candidates and not infringe. In fact there is almost no limit to what can be considered “reasonably related” to the development of information for submission to the FDA since a great deal of the research and development in the natural sciences is directed at identifying new drugs. Patented research tools are particularly vulnerable because they are often used in basic research that may now be considered “reasonably related” to submission to the FDA. Arguably, any use of the two research method patents at issue in Merck, the ‘997 and ‘237 patents, could be considered “reasonably related” under the Supreme Court’s broad interpretation. [14] Such development of new drugs using others’ patented technology was not meant to fall under Congress’s exemption to patent infringement….

 

Paul Wiegel, Esq.

 

November 7 / All Articles, Patent

Remembering The Public’s Interest In The Patent System – A Post-Grant Opposition Designed To Benefit The Public

Patents are supposed to benefit the public. The Constitution implicitly expresses this intent [1] and the Supreme Court has so interpreted it. [2] Yet the current patent system falls miserably short of realizing this purpose in several critical respects. One glaring example of the system’s failure is the absence of a timely, inexpensive mechanism for invalidating the high number of bad patents being issued. As a result of this void, the public is suffering and the need for reform is dire.

 

The first step in any significant patent reform proposal should be consideration of the constitutional basis for granting patents. Article I, Section 8, Clause 8 states that Congress shall have the power “to promote the progress of useful arts … by securing for limited times to inventors the exclusive right to their discoveries.” [3] Implicit in this clause is an emphasis on a system having limited scope designed to benefit the public — not on an overly expansive system preoccupied with the rights of inventors, corporations or other entities. Thomas Jefferson, the chief architect of the original patent system, [4] espoused this view by resolutely stating that patents are for “the benefit of the public” and unequivocally rejecting the theory that inventors have natural rights in their inventions. [5] And the Supreme Court recognized that Congress’ power to adopt a patent system is not a blanket one, but is instead limited by the Constitutional intent of promoting society’s welfare. It stated, “Congress … may not overreach the restraints imposed by the stated constitutional purpose. Nor may it enlarge the patent monopoly [system] without regard to the … advancement or social benefit gained thereby.” [6] Thus, Congress may adopt a patent system to promote innovation useful to the public, but the system must not exceed its public-centered constitutional aim.

 

So how is the current patent system exceeding this constitutional restraint? It is allowing too many bad patents to prevail, without offering an inexpensive and timely mechanism for invalidation. Therefore, by virtue of omission, it is “overreach the restraints imposed by …  constitutional purpose,” ignoring the “social benefit” gained by granting patents, and overlooking the fundamental fact that patents are for the “benefit of the public.” [7]

 

The problems associated with the existence of bad patents and the need for an effective, inexpensive vehicle for challenging them are nothing new. Over the past twenty-five years, several laws were proposed and passed intending to remedy these ills. [8] Most recently, Congress introduced a bill aimed at curbing the adverse effects of bad patents, [9] and prominent policy organizations [10] and commentators [11] advocated for, inter alia, the adoption of a new post-grant opposition as an antidote to the poison of bad patents. While these recent developments are certainly promising, without due attention given to the “advancement or social benefit gained thereby,” such measures may fall upon deaf ears or fail to reform the patent system in a manner that furthers the constitutional mandate of promoting the public welfare. [12]

 

Part II of this paper briefly explains the meaning of bad patents and then summarizes past legislative attempts to design an administrative review procedure for correcting them. Part III discusses the provisions of an administrative post-grant opposition procedure contained in a patent reform bill recently introduced in Congress. Part IV provides a public welfare rationale for adopting a new administrative post-grant opposition highlighting the adverse public effects of granting bad patents. Part V argues for the addition of specific provisions to the current bill that better serve the constitutional purpose of advancing the public’s welfare….

 

Eric Williams *

September 30 / All Articles, Patent

Repairing The Bayh-Dole Act: A Proposal For Restoring Non-Profit Access To University Science

The Wide Scope of Federal Research Spending

The United States government invests billions of dollars every year in scientific research. Government agencies such as the Department of Energy, NASA and the Pentagon directly employ legions of scientists and engineers. The National Institutes of Health (NIH) funds a tremendous amount of biomedical research. Besides running its own labs, the NIH gives generous grants to hundreds of universities and medical schools, and to the thousands of research professors who fill them. The federal government today provides about 60% of the total research funding for America’s many prestigious research universities.1 In addition, the government pays private, for-profit contractors vast amounts of money to complete science-intensive projects on its behalf.

Though some government-funded research is theoretical “science for science’s sake,” even this “basic research” often leads directly or indirectly to practical developments. Research at American universities has facilitated products ranging from Gatorade to synthetic insulin.2 The fact that 71.6% of citations to papers in U.S. biotechnology patents are to government-funded research3 demonstrates the practical value of government research to the private sector.

 

Aaron Miller*

June 8 / All Articles, Patent

The Disruption Of The U.S. Constitutional Symmetry Of Intellectual Property To Gain Conformity With An International Property Framework: A Road To A Global Market Or A Tripping Point To The Gradual Collapse Of The U.S. Economy?

In a spectrum of governments that range from totalitarian (dictator or communism) to tribal (without any central government), there is a unique form that provides a symmetrical balance between the government and the independent inventor; this symmetrical balance produces technological advancement.1 Once this symmetrical balance is discovered, it allows independent inventors to have secure and unchangeable protection from the federal government that facilitates the courage and mentality to take risks of time, effort and wealth. The willingness of free inventors to take a chance on the free market without government intervention but with inventor controlled government exclusionary protection should be the goal of every patent law system. At one time the United States (U.S.) government held this precise symmetrical balance.2

The global harmonization of U.S. patent law has initiated a process of destroying that unique, symmetrical, Constitutional balance that fostered the greatest two hundred year period of technical advancement the world has ever known. The goal of the U.S. government has now been shifted to transform the U.S. patent law system into one of many uniform multinational global patent law systems; the implementation of this new international intellectual property framework began in 1995 through the Uruguay Round Agreements Act (URAA). A fixed and secure rule (over a hundred years of law) of having a fixed patent term was toppled for a 20-year floating patent term. This change ended the confidence of the financial world in a 17-year fixed term that allowed the investor a more secure rate of return on a high-risk investment. The American Inventors Protection Act of 1999 (AIPA) patched the four-year blunder by making the 17-year patent term recoverable through extensions.

However, the AIPA was used as a second global harmonization implementation against the U.S. patent law system. The AIPA now forces U.S. inventors and financial investors who want to test the value of their inventions in foreign markets to publish the application within 18-months of filing corresponding to the Patent Cooperation Treaty (PCT) 18-months of filing publication rule.

Between 1995 and 1999, the U.S. economy began to stagnate and crumble; between 1999 and 2003, the U.S. economy has continued to fall at an alarming and progressive downward rate.

Given the fact that the 20-year floating patent term was a horrific mistake in terms of the U.S. Constitution and the U.S. economy, will the 18-month publication rule start the U.S. on the road to a global market or continue on past the URAA tripping point to the gradual collapse of the U.S. economy?3

 

John C. Hughs*


October 31 / All Articles, Patent

Foreseeability As A Bar To The Doctrine Of Equivalents

The common-law doctrine of equivalents extends a patent’s protection to cover certain similar devices that do not literally infringe on the patent’s claims. [1] It is an equitable doctrine meant to protect patentees against devices whose elements perform substantially the same functions, in substantially the same ways, with substantially the same results as the patentee’s claimed elements (the “function-way-result” test). [2] Absent this doctrine, competitors could easily subvert the monopoly protection granted by a patent simply by substituting an unclaimed equivalent for a claimed element, thereby skirting liability for literal infringement. Such a loophole would severely threaten the patent system by “convert[ing] the protection of the patent grant into a hollow and useless thing.” [3] Courts have justified the doctrine as necessary to insulate a patentee from the limits inherent in using language to describe inventions. [4]

 

Broad application of the doctrine of equivalents can, however, create uncertainty as to how substantial an improvement a competitor must make to avoid non-literal infringement. [5] Normally, a patent’s claims set out the “metes and bounds” of the invention, just as a deed does for real property. [6] The claims serve a dual purpose: they both define and provide public notice of what the patent protects (and, by implication, what it does not). Both functions stimulate innovation in different ways. The definitional, or protective, function defines what aspects of the invention patent law will protect and, therefore, is the principal incentive for inventors to seek patents. The public-notice function encourages innovation by allowing competitors to make incremental improvements without fear of infringing on the claims of existing inventions. Typically, emphasizing the protective function promotes the investment necessary for breakthrough inventions, whereas emphasizing the public-notice function promotes improvements to existing technologies. [7] Uncertainty as to whether a patent’s claims cover an improvement can chill innovation by exposing the would-be improver to potential liability for infringement under a claim of equivalency. The doctrine of equivalents emphasizes the protective function of patents over the public-notice function because its added protection means that competitors cannot rely solely on the literal claim language to avoid creating infringing variants.

 

The courts created another rule, prosecution history estoppel, to cabin the expansion of protection that the doctrine of equivalents provides. Prosecution history estoppel prevents a patentee from claiming the equivalents that it surrendered during the prosecution of its patent. [8] Estoppel arises in such situations because a patentee disclaimed an equivalent to obtain its patent; it would be improper to permit the patentee to re-establish rights to the same equivalent through the doctrine of equivalents. Prosecution history estoppel also helps reinforce the public-notice function by permitting competitors to rely on the public patent prosecution record to help determine what the patentee has disclaimed. [9]

 

Both the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court have grappled with articulating the factual situations in which a patent’s specification and prosecution history precludes the added protection the doctrine of equivalents affords. The judges of the Federal Circuit hold a broad range of opinions on this issue, and the Supreme Court has had to issue repeated guidance to them.

 

Several opinions in these cases suggest that a patentee should not be able to invoke the doctrine of equivalents to obtain protection from equivalents that one skilled in the art would have reasonably foreseen before the patent issued. Federal Circuit Judge Rader, in particular, is a strong advocate of such a “foreseeability bar.” [10] The United States and the Institute of Electrical and Electronics Engineers (IEEE) also advanced the idea in their amici briefs to the Supreme Court in Festo Corp. v. Shoketsu Kinzoku Kogyu Kabushiki Co., the Court’s latest case involving the issue. [11] The Court’s opinion in that case also appears to limit the doctrine’s reach in cases involving amended claims to cover only those complained-of equivalents that were not foreseeable when the patentee amended its claims.

 

This paper examines a series of cases related to the applicability of foreseeability to the doctrine of equivalents. [12] It then attempts to synthesize the current state of the law in the area, and analyzes arguments for and against adopting a foreseeability rule.

 

Jeremy T. Marr*