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Abstract:
India developed a world-class generic drug manufacturing industry by excluding pharmaceutical products from patent protection in 1972. In 2005, India reintroduced pharmaceutical patenting in order to comply with its obligations as a WTO member. For an emerging superpower still mired in poverty and public health crises, the change did not come quickly or without controversy. This Article provides the first major comparative analysis of India's new patents regime. Based on the author's data gathering and interviews in India, the Article evaluates the regime's first eighteen months. It critiques the new law and the capacity of India's administrative and judicial infrastructure to implement it. Multiple influences shape India's mosaic view of patents: a huge population, widespread poverty, lack of health insurance, wariness towards foreign influences, a developed but fragmented pharmaceutical sector, a fledgling entrepreneurial culture of innovation among indigenous pharmaceutical and biotechnology firms, a fragile coalition government, and a vocal citizenry remarkably aware of esoteric patent law developments. Concluding that the new patents regime is neither the fully-Westernized panacea hoped for by its pro-TRIPS advocates nor the unmitigated disaster for the Indian public predicted by its fiercest critics, the Article offers recommendations for the future of India's evolving patent system.

patent, intellectual property, India, pharmaceutical, generic, innovation, health, developing country, WTO, TRIPS

Abstract:
This article evaluates TRIPS-level patent protection as an incentive mechanism for biotechnology innovation in India. Recent enhancements to India's patent laws, a new acceptance of biotechnology patents by the Indian judiciary, and an expanding global demand for generic bio-pharmaceuticals all predict a surge in biotechnology process development and patenting in India.

Many Indian biotechnology companies have developed proprietary processes for manufacturing "bio-generics" or "bio-similars," i.e., copies or derivative forms of first-generation biologics such as recombinant human insulin and erythropoietin now coming off patent in the U.S. and elsewhere. Despite their success in process development, the Indian firms are not yet filing a significant number of patent applications in India. Data gathered for this article, limited to companies generating significant biotechnology revenues in India in 2005 and 2006, reveal that they filed only a handful of Indian patent applications during that period.

Are the Indian firms' efforts to meet the growing worldwide demand for generic biologics draining resources that might otherwise be put towards now-potentially patentable innovation? Rather than developing novel recombinant proteins or methods of manufacturing them, for example, the bulk of India's skilled biotechnologists might remain focused on merely copying off-patent biologics. The enhanced incentives provided by India's newly strengthened patents regime might take a back seat to supplying the demand for generic biologics.

This article rejects such a scenario. The TRIPS-mandated term extension of Indian chemical (including biotechnological) process patents from seven to twenty years from filing, coupled with a shifted burden of proof for alleged infringements of process patents, will work in concert with the Indian biotechnology industry's desire to lead the world in supplying generic biologics. As multiple Indian companies compete to sell the same biotechnology product, each firm's need to distinguish itself by process development increases. Stronger process patent protection will facilitate competitive advantage among Indian biotechnology companies.

Patent, Intellectual Property, India, Biotechnology, Generic, Bio-Generic, Pharmaceutical, Process, Innovation, Health, Developing Country, TRIPS

Abstract:
This article examines the impact of the U.S. Supreme Court's April 2007 decision in KSR Int'l Co. v. Teleflex Inc., with particular focus on the nonobviousness requirement as applied to the pharmaceutical and life sciences arts. Some commentators assumed that KSR, which involved a mechanical combination of an adjustable automobile gas pedal with an electronic sensor, would have little impact on pharmaceutical and biotechnology patenting. Federal Circuit decisions following KSR show otherwise. Post-KSR, it is unquestionably easier to establish a prima facie case of obviousness in the chemical arts. As a result, debate has already reframed around other issues, including (1) the level of ordinary skill in the art pertinent to a claimed invention; (2) whether prior art teachings would have been combined with a reasonable expectation of success; and (3) whether a prima facie case of obviousness, if established, can be rebutted. The Federal Circuit's opinions in Pfizer v. Apotex and Takeda v. Alphapharm illustrate two sharply contrasting applications of KSR's obvious to try definition. Taken with PharmaStem v. ViaCell, these decisions signal that the reasonable expectation of success prong for combining or modifying prior art teachings will be pivotal in nonobviousness analyses. The newly-precedential Daiichi v. Apotex suggests that KSR may have helped validity challengers bootstrap a conclusion of obviousness by asserting a heightened level of ordinary skill for a re-defined hypothetical person. These initial Federal Circuit applications of KSR in pharmaceutical and biotechnology cases show that its impact extends well beyond merely expanding the reasons for combining multiple prior art teachings. KSR is decidedly not limited in application to mechanical combinations. KSR's repercussions in the chemical arts will be equally, if not more, significant and pervasive.

patent, patentability, nonobviousness, KSR, Federal Circuit

Abstract:
Long a doctrinal and policy morass, the concept of anticipation by inherency can be justly termed the metaphysics of patent law. The Federal Circuit has tended to apply inherency as a per se tool to short-circuit perceived patent ever-greening, especially in the pharmaceutical industry. By wielding inherency too broadly, the court avoids the difficulties of a multi-factored nonobviousness analysis. We argue that the anticipation by inherency doctrine should be cabined. Narrowing reliance on inherency principles would promote important policy goals as well as conform U.S. patent law to the treatment of inherency in foreign regimes. Patent claims (or limitations thereof) should be held anticipated under principles of inherency only when the inherency is truly inevitable. Inevitability is inextricably bound up with the quality of the prior art's teaching. To establish that one practicing the prior art would inevitably have produced a claimed invention, the prior art must satisfy a heightened level of enablement. Despite the silence of the prior art as to the later-claimed invention (or limitation thereof), focus on enablement is the key to inherency. Whatever teaching was explicitly provided in documentary prior art, be it instructions, examples, or other guidance, such teaching must be so clear that when replicated, no more than de minimis experimentation is required to obtain the claimed invention; i.e., to put the public in possession of that invention. Enablement doctrine should be fine-tuned when used in a patent-defeating manner, just as the Federal Circuit has required a heightened degree of enablement for certain patent-obtaining disclosures.

patents, novelty, inherency, anticipation, obviousness, pharmaceutical, ever-greening, Federal Circuit

Abstract:
The United States offers legal protection for designs - the overall aesthetic appearances of objects - through the patent system. To obtain a U.S. design patent has long required something more than novelty. Just as the patentability of a utilitarian device mandates a “nonobvious” advance over earlier technology, the patentability of a new and ornamental design requires that it differ from prior designs to an extent that would not have been “obvious to a designer of ordinary skill who designs articles of the type involved.” Ostensibly promoting progress in design, Congress in 1842 shoehorned design protection into the existing utility patent system. From that time forward, the design patent system has languished from prolonged inattention rather than benefited from any purposeful development. Even the initial imposition of a qualitative requirement for “invention” in designs (from which the modern requirement of nonobviousness derives) was likely the product of a typographical error. Failing to appreciate the fundamental distinctions between designs and utility inventions, the legislature and judiciary have repeatedly sought to assimilate these very different types of intellectual property. Nowhere in the design patent system is this assimilation more blatant and harmful than in the imposition of the nonobviousness requirement. The USPTO and courts continue to struggle with gauging the nonobviousness of designs despite repeated acknowledgement that the requirement is inapt, subjective, unworkable, and even “impossible.” Although design protection would be more appropriately provided through a sui generis system outside the patent regime, a wholesale restructuring of U.S. design protection appears unlikely. Nonobviousness therefore continues to be imposed for design patentability. Our insight is that courts and the USPTO have previously unrecognized flexibility in how they apply the nonobviousness requirement to designs. Drawing from the industrial design literature as well as our interviews with experienced designers of differing career paths, we conclude that the current nonobviousness framework is fundamentally misaligned with the creative processes and objectives of designers. We accordingly propose a number of powerful yet practical tools for reconceptualizing the nonobviousness requirement in a manner that truly promotes innovation in design. The Federal Circuit’s recent decisions in Egyptian Goddess v. Swisa and Titan Tire v. Case New Holland signal a welcome judicial receptiveness to rethinking design nonobviousness. The time is ripe to bridge the gap between design patent standards and the reality of design. This article offers a roadmap for overcoming the supposedly “impossible issue” of applying the nonobviousness requirement to designs.

patent, patent law, design patent, utility patent, designs, industrial design, nonobviousness, invention requirement, combination of references, ordinary observer, substantial similarity, 35 U.S.C. § 103, Patent Office, USPTO, Gorham, Whitman Saddle, KSR, Titan Tire, Egyptian Goddess

Abstract:
In marked contrast with all leading foreign patent law regimes, no statutory provision in the U.S. Patent Act provides a general exemption from infringement liability for unlicensed use of patented inventions in contexts such as scholarly research and scientific experimentation. Early U.S. judicial decisions spoke approvingly of a common law-based doctrine that would exempt unlicensed uses of patented technology for purposes of scientific experimentation or purely personal use. More recently, the U.S. Court of Appeals for the Federal Circuit, which since 1982 has exercised exclusive nationwide jurisdiction over patent-based appeals, has also recognized the experimental use exemption. The court interprets the exemption so narrowly, however, that for all practical purposes it has become a nullity. In Madey v. Duke University (2002) and Integra Lifesciences I, Ltd. v. Merck KgaA (2003), the Federal Circuit severely constrained the already limited reach of the experimental use doctrine. The court in Madey mapped an exceedingly limited role for the experimental use defense through a distorted application of the "legitimate business" criterion of Pitcairn v. United States (Ct. Cl. 1976) to basic research conducted by university researchers. By narrowly construing the issues on appeal, the panel majority in Integra ducked the important questions raised by the Integra dissent's strong defense of the experimental use doctrine. Despite the Federal Circuit's seeming discomfort with the experimental use exemption, a narrowly defined but practically meaningful experimental use exemption is long overdue for the U.S. patent system. Without such an exemption, scientific research functions that require the use of patented inventions are more likely to be shifted offshore to legally hospitable forums. The patent system's goal of technology dissemination must, of course, be balanced against the incentivizing function of patents. An experimental use exemption, like any incursion on the exclusivity of the patent owner's right to exclude others from her invention, must therefore be carefully defined and judiciously applied so as not to significantly compromise incentives for innovation. This Article calls for the congressional enactment of a limited but balanced experimental use exemption in patent law, just as Congress did in enacting the Copyright Act's fair use provision in 1976. The Article proposes and applies a set of factors for inclusion in a legislative codification of the experimental use exemption.

experimental use, research exception, research exemption, patent, infringement, defenses, intellectual property, university, nonprofit

Abstract:
Antitrust issues in intellectual property cases arise mainly in commercial disputes involving patents, although antitrust issues also come up in the copyright context. This paper’s primary focus is the patent/antitrust interface.

Are the antitrust and patent laws in tension? Antitrust promotes marketplace competition; patent law creates temporary monopolies that impede competition because the patented invention can not be copied and sold without permission of the patent owner. The intersection of these two critically important fields of law clearly involves some dissonance. The common ground is that the antitrust and patent laws seek to achieve same goal - consumer welfare - through different mechanisms. Antitrust enhances consumer welfare by promoting competition in the marketplace. Patent law enhances consumer welfare by enhancing competition in ideas through patent law’s disclosure requirements and by creating incentives for the introduction of new inventions.

This paper reviews the most commonly disputed legal issues at the patent/antitrust interface. For example, patent licensing activity between patent owners and third parties, as well as other contractual arrangements between multiple patent owners, may give rise to collusive concerns under Section One of the Sherman Act. Section One principles also impact mergers and acquisitions between patent-owning firms. Patent enforcement and refusals to license are unilateral forms of conduct that may give rise to antitrust concerns under Section Two of the Sherman Act. The paper concludes by discussing appellate jurisdiction and choice of law issues unique to the patent/antitrust interface.

intellectual property law, patent law, antitrust law, Sherman Act, Sherman One, Sherman Two, competition, consumer welfare, commercial disputes, licensing, disclosure, incentives, appellate jurisdiction, choice of law

Abstract:
The existence of a patent on a particular technology conveys the statutory right to exclude, but in no way guarantees economic power in the marketplace. When a patented technology is adopted as an industry standard, however, that equation can change radically. Because of competitive necessity to practice the patented standard, particularly in industries characterized by network effects, the power potentially conveyed by the patent is greatly amplified. Industry standards are subject to "capture" when firms that participate in formulating a standard have also obtained (or are seeking) patent or other proprietary rights in some aspect of the technical subject matter of the standard, without disclosing the existence of those rights to the standard-setting organization. Conflicts arise when a license under these patents is essential to practicing a standard and the patent owner refuses to license certain competitors, or grants licenses only at terms perceived by users as commercially unreasonable. Absent a mechanism to compel licensing, a hold-up problem ensues.

This Article contends that patents are not fundamentally incompatible with industry standards, but that the existence of patents on standards must be transparent and the licensing of such patents subject to appropriate controls so as to ensure widespread industry access. In order-to make fully informed choices about technology under consideration for adoption as an industry standard, standards-setting organizations must be made aware of any relevant patent rights or pending patent applications owned by standards-setting participants. In cases of "abusive" standards capture, defined as the intentional or willful nondisclosure of patent rights by a standards setting participant who thereafter refuses to license all users at reasonable and nondiscriminatory terms, courts should refuse to enforce such patents altogether under a theory of patent misuse.

patents, patent rights, misuse, economic power, technology, industry standards, abusive standards capture, disclosure, abuse, standard setting, license

Abstract:
Remember the story of the evil troll who lived under the bridge and the three billy goats Gruff who narrowly escaped his wrath? According to the likes of Microsoft and Intel, the troll has relocated to the high technology marketplace. These major corporations are complaining loudly about “patent trolls.” The prototypical patent troll is a holding company that has purchased patents, often in bankruptcy proceedings, for the purpose of asserting them against manufacturers of products that the troll alleges infringe the patents. Patent trolls do not themselves manufacture the products their patents cover, and the patents may be of questionable validity. Nevertheless, the threat of an injunction if patent infringement were to be found helps the trolls coerce their target into settling the disputes by taking licenses under the patents. Because litigating patent infringement and validity can take years and cost millions of dollars, the target companies often agree to pay licensing fees rather than to fight it out with the patent trolls in court.

patent trolls, patent licensing, patent infringement, injunction, U.S. patent system, U.S. Patent Office, H.R. 2795, Patent Act of 2005, litigation, licensing fees, validity, relief

Abstract:
A United States patent must provide a "written description" of the invention claimed therein. In its earliest implementation, a patent's written description fulfilled a notice function of putting the public in possession of the boundaries of the patentee's property right. Under modern practice, that notice function is performed by the claims of the patent. In 1967, the Court of Customs and Patent Appeals (CCPA) breathed new life into the written description requirement of section 112 of the Patent Act by applying it for a different purpose, that of ensuring "support" for claims first presented or substantively amended after a patent application has been filed. The court viewed written description compliance as a means of ensuring that the patent applicant had actually invented the later-claimed subject matter as of the earlier filing date of the application. The CCPA and its successor, the Court of Appeals for the Federal Circuit, repeatedly recognized that the manner in which the written description was provided was not critical, so long as those of ordinary skill would understand the newly-claimed subject matter to be fairly within the patentee's original contribution.

Written description jurisprudence significantly diverged from these principles with the Federal Circuit's 1997 decision in Regents of the University of California v. Eli Lilly. In Lilly, the court applied the written description requirement to claims originally filed in a pioneering University of California patent application directed to the recombinant production of insulin, and held that the written description requirement is not satisfied for claims to DNA absent an express disclosure of nucleotide sequence. The Lilly decision may profoundly limit the scope of protection available for new gene inventions; viewed in tandem with contemporaneous Federal Circuit decisions interpreting the enablement requirement of section 112 , it represents the latest advance in an ominous trend towards imposition of uniquely heightened patentability requirements for biotechnological inventions. Lilly aptly illustrates the increased widening of the gulf between the norms of the business and scientific communities and the U.S. patent system, as users of the latter come to understand that the patent system no longer reflects the realities of scientific contribution.

United States patent law, U.S. patent system, written description requirement, written description of the invention, new matter, possession, priority, biotechnological inventions, DNA, Regents of the University of California v. Eli Lilly, Court of Customs and Patent Appeals, CCPA, Federal Circuit

Abstract:
This article explores the legal and moral implications surrounding human embryonic stem cells (HESCs). Derived from human embryos that have been artificially fertilized but not yet implanted in a woman's uterus, HESCs are capable of giving rise to cells found in all tissues of the body. Public awareness of stem cell technology's enormous potential ignited in November 1998, when University of Wisconsin biologist Dr. James Thomson and his team announced that they had successfully isolated and cultured HESCs. The Wisconsin Alumni Research Foundation (WARF), the licensing arm of Dr. Thomson's employer, owns a broad portfolio of U.S. patents directed to the fruits of Thomson's work in primate/human embryonic stem cells. WARF contends that its patents "apply to all human embryonic stem cells in the United States." Despite WARF's policy of granting free licenses for academic research use of the patented cells, the patents' existence and their licensing and commercialization have proved controversial. As detailed in this article, the United States Patent and Trademark Office is currently reexamining three of WARF's fundamental patents on HESCs, signaling that substantial new questions exist concerning the patents' validity.

Patent law, human embryonic stem cells, HESCs, stem cell research, United States Patent and Trademark Office, USPTO, Wisconsin Alumni Research Foundation, WARF, Dr. James Thomson, morality

Abstract:
Lauded as "the sine qua non of 21st-century biology," bioinformatics (formerly referred to as computational biology) is a burgeoning discipline at the intersection of information technology and the life sciences. The February 2001 announcement of the complete sequencing of the human genome represents the signature event in the relatively short history of bioinformatics. The central goal of bioinformatics is to organize, analyze, and generally make sense of the massive quantities of genetic data and information that resulted from this tremendous scientific achievement.

This article examines the proper role of intellectual property rights (IPRs) in bioinformatics. IPRs are property rights in intangible "knowledge goods," such as inventions and discoveries, which convey to their owners the right to prevent unauthorized uses of the identified property. Just as the owner of a parcel of land has an exclusive possessory interest to prevent others from trespassing, so too does the owner of an intellectual property right have the power to prevent unauthorized uses of her invention or discovery.

Many have criticized the notion of establishing and enforcing any IPRs in the fruits of the human genome project, characterizing it as an endeavor intended to benefit all mankind. Regardless of one's philosophical and economic views on that larger question, which this article does not attempt to answer, many IPRs in genomic material such as genes and gene fragments have already been obtained or at least applied for by private sector firms. This latter-day "gold rush" is ongoing despite the parallel movement to put as much genetic information into the public domain as possible.

Given that IPRs already exist in genomic material and are likely to be enforced (at least if it is economically rational to do so), the inquiry should shift to consideration of the manner in which society can ensure unrestricted access and use of the genetic data and information, for purposes of research and development that leads to new innovation in health care-critically important therapeutics, diagnostics, methods of streamlined drug screening, and the like. Any proposed framework must balance the public health rationale for unrestricted access against the possibility of damaging powerful incentives for investment in the research and development leading to these innovations. This article does not purport to suggest a single answer to this complex balancing of interests, but rather proposes several different responses for further consideration.

Part II of this article provides an overview of the various forms of intellectual property protection that are potentially relevant to bioinformatics research and development. Part III specifically focuses on the issues of statutory subject matter and the utility requirement of patentability as relevant to bioinformatics-related inventions. Part IV surveys some of the possible responses to public access concerns raised by the ownership of patents in the life sciences. Part V considers how patent rights will intersect with the rise of industry standards in the life sciences, which will likely proliferate through advances in bioinformatics, as has been the case in the electronics and computing industries.

bioinformatics, computational biology, human genome project, patents, intellectual property rights, IPRs, industry standards

Abstract:
Scientists who require multiple "research tools" (i.e., laboratory resources such as transgenic animals and biological receptors) to develop new drugs and medical diagnostic products are frequently finding that these tools are patented or subject to other proprietary constraints. Stacking royalty obligations and heightened transaction costs resulting from the proliferation of patents on research tools threaten to slow or stop the development of new drugs and devices critical to public health. Because U.S. courts have very narrowly interpreted the common law "experimental use" defense of patent law as limited to "dilettante" uses of inventions for mere "amusement" or ''philosophical'' inquiry, scientists face the daunting choice of either negotiating numerous licenses or risking the possibility that their research and development will be enjoined. In response to this dilemma of mounting transaction costs and increasingly restricted access to patented research tools, this Article argues for a broadened rule of "development use" that would permit scientists to use certain patented research tools without prior authorization, but require that the research tool patent owner be paid an ex post royalty based on the ultimate commercial success of the new drugs or other products developed through use of the tool. This "reach-through" royalty approach maintains incentives for the development and patenting of new research tools, but alleviates the access restrictions and up-front costs currently associated with their acquisition and use.

patents, patent infringement, biomedical research tools, developmental use, royalty, restrictions, proprietary constraints, experimental use exemption, Hatch-Waxman Act, exclusivity, transformative, commercial

Abstract:
Do the antitrust laws have a role to play in policing the actions of patent owners that participate in industry standard setting? If so, how will the Federal Circuit’s appellate participation impact the treatment of patent owners, whom the court presently accords powerful antitrust immunities under the Noerr-Pennington doctrine? Should these immunities be “rolled back” so as to permit the successful assertion of antitrust violations based on a patentee’s anticompetitive manipulation, “gaming,” or “capture” of the industry standard setting process?

This paper first reviews some of the basic mechanics of antitrust counterclaims as they are raised in patent cases and the immunities that presumptively protect patent owners from antitrust liability for enforcing their statutory right to exclude. The paper then addresses the rise of industry standards and the current disputes involving the assertion of patent rights by companies that participate as members of standard setting organizations.

This paper concludes that although the antitrust laws “can serve as a useful check on abuses of the standard-setting process,” after-the-fact enforcement under the antitrust laws can not substitute for clearer, more expansive rules that will mandate full disclosure of all potentially pertinent intellectual property rights. The disclosure must occur early enough in the process to permit fully informed selection of industry standards. As explored in Section VI, the assertion of Noerr-Pennington immunities may limit the role of antitrust enforcement against the holders of patents on industry standards in certain instances.

antitrust laws, antitrust counterclaims, patent law, patent infringement, patent misuse, equitable estoppel, industry standards, industry standard setting, standard setting organizations, disclosure obligations, Nobelpharma AB v. Implant Innovations, U.S. Court of Appeals for the Federal Circuit, I

Abstract:
Patents on genetically modified (GM) crop technology arm their owners with powerful control over farmers' ability to grow, harvest, distribute, and profit from GM crops. No clearer example exists than the April 2004 decision of the U.S. Court of Appeals for the Federal Circuit in Monsanto Co. v. McFarling (McFarling II), in which the court upheld Monsanto's patent licensing practice of forbidding farmers to save seed from GM crops for replanting. McFarling II thus confirms the illegality of a custom engaged in by farmers for centuries. The Federal Circuit's conclusion that Monsanto's restriction on planting saved seed does not violate the antitrust laws nor amount to patent misuse deserves further scrutiny, as demonstrated by the Supreme Court's invitation to the Acting Solicitor General to file an amicus brief in McFarling II. This paper details the facts of McFarling II and critiques the Federal Circuit's analysis of the unique patent and antitrust law issues raised thereby.

patents, patent controls, patent licensing, genetic modification, crop technology, U.S. Court of Appeals for the Federal Circuit in Monsanto Co. v. McFarling (McFarling II), patent misuse, antitrust law

Abstract:
The Federal Circuit's recent sua sponte grant of rehearing en banc in Knorr-Bremse v. Dana Corporation has catalyzed a vocal debate concerning the nature and consequences of willful patent infringement. Subject to virtually unanimous condemnation is the Federal Circuit's "adverse inference" rule, which forces a party accused of willful infringement to choose between two unpalatable options: (i) disclosing privileged advice of counsel to mount a willfulness defense, or (ii) not disclosing such information and being subjected to an adverse inference that an exculpatory opinion was not or could not be obtained. This commentary concurs that the adverse inference rule should be abandoned, for its provenance is far from clear and the harm it works to attorney-client privilege is substantial. More broadly, this commentary questions whether the notion of willful infringement remains defensible in a patent system marked by significant uncertainties as to the boundaries of literal claim scope and the doctrine of equivalents. At a minimum, the question of willfulness should no longer be given to juries. The analyses of willfulness and damages enhancement are inextricably bound together and both should be decided by the courts. Practical benefits and policy considerations support this proposal and Seventh Amendment concerns do not preclude it.

willful patent infringement, adverse inference rule, disclosure, doctrine of equivalents, enhancement of damages

Abstract:
In comparison to prominent courts in other fields of law, the U.S. Court of Appeals for the Federal Circuit issues decisions that impact the conduct of patent litigation at a 'lightning pace'. In its capacity as the court of last resort for virtually all U.S. patent cases, the Federal Circuit issues on average about 10 precedential patent decisions each month. Not all of those decisions are equally noteworthy, of course. This article analyzes eight precedential patent decisions of particular significance to intellectual property litigators. All were issued by the Federal Circuit during the one-year period from November 2003 through October 2004.

patent law, patent claim interpretation, doctrine of equivalents, patent litigation, patent infringement, willfulness, U.S. Court of Appeals for the Federal Circuit, Phillips v. AWH Corp., Knorr-Bremse v. Dana Corp., Walker Process fraud, market definition, printed publication, nascent technology

Abstract:
In this work, author Janice Mueller discusses the USPTO’s 1999 proposed examination guidelines for compliance with the written description requirement of 35 U.S.C. § 112 and the utility requirement of 35 U.S.C. § 101. While PTO guidelines do not have the force of law, they do impact the examination process. For practical purposes, the guidelines bind examiners and applicants. Mueller believes that the proposed written description guidelines’ requirement that examiners identify the “essential distinguishing characteristics” of a claimed invention, as part of applying the “possession” test, is problematic. Not only is the “essential elements” test an extra-statutory inquiry, but it may also trigger unforeseen prosecution history estoppels. The implementation of the utility guidelines will be particularly important for the patentability and interpretation of claims to expressed sequence tags (ESTs, short segments of genetic material) that include an open-ended “comprising” transition.

written description requirement, utility requirement, ESTs, DNA, 35 U.S.C. § 112, 35 U.S.C. § 101, U.S. Patent and Trademark Office, USPTO, examination guidelines, patent Law, patent reform, possession test, essential elements test, Regents of the University of California v. Eli Lilly , Gentry Galle

Abstract:
At what stage in the developmental process of an invention can it be said that the invention is capable of being put "on sale" within the meaning of Section 102(b) of the U.S. Patent Act? The Federal Circuit's on sale decisions have failed to produce any clear consensus on the extent-of-development issue; the court's view on the degree of completion required has varied from case to case in almost cyclical fashion. Although its early decisions appeared to adopt a requirement that an invention be built and tested before the on sale bar could be triggered, the Federal Circuit in 1987 rejected that notion in its UMC Electronics decision. During 1996-97, the court decided a series of on sale cases in which the requisite degree of development varied from "completed" to "substantially completed" to "no physical embodiment necessary."

The Federal Circuit's erratic treatment of the extent-of-development issue has not gone unnoticed. On March 9, 1998, the U.S. Supreme Court granted the petition for writ of certiorari in the most recent of the Federal Circuit’s on sale decisions, Pfaff v. Wells. In anticipation of the Supreme Court’s decision, this article argues that the need for certainty in identifying the commencement of the one year statutory clock, coupled with the legislative and decisional history of Section 102(b), suggest that an invention should be “complete” before its offer or sale can trigger the on sale bar. Because the patent laws do not define when an invention has been completed, the most practical solution is to require an actual reduction to practice, defined by the existence of a physical embodiment of the invention known to work for its intended purpose. Admittedly, imposing an actual reduction to practice requirement may artificially postpone the triggering of the Section 102(b) bar in certain instances and result in some commercial exploitation beyond the statutory period. But on balance, such costs on the patent system will be outweighed by the benefits of relative certainty, enhanced communications between inventors and prospective customers, and greater progress of the useful arts through the filing of patent applications on fully-developed inventions.

on sale, offer for sale, statutory bar, loss of right, experimental use, research tools, U.S. patent system, patent claims, patentability requirements, development of inventions, 35 U.S.C. Section 102(b), Federal Circuit, Pfaff v. Wells, undue commercialization

Abstract:
The afternoon was not unlike many other memorable times spent in the company of Judge Giles Rich, the patriarch of modern U.S. patent law. One of several former law clerks who had come to visit the judge in his hospital room in Washington, I had arrived that morning from Boston while others had traveled from as far as California. The judge seemed quite cheered by the law clerk mini-reunion gathered in a semicircle around him and in a mood for talking and reminiscing. We chatted about recent developments at the Federal Circuit, the news in that morning's Washington Post, and updates on our respective lives -- upcoming travel, new work responsibilities, spouses, friends, children, even pets. Always the center of attention, Judge Rich held forth for several hours, interspersing the talk with stories of drafting the 1952 Patent Act and tales of the Judge Worley days on the Court of Customs and Patent Appeals. The memory of that last magical afternoon with Judge Rich is a gift that I and the others present will always cherish. I share here some other special remembrances of Judge Rich, many expressed in his own words.

Judge Giles S. Rich, U.S. Court of Appeals for the Federal Circuit, Judge Rich, Federal Circuit Court, judiciary, patent law, modern patent law, in memoriam, legacy

Abstract:
In June 2005, the U.S. Supreme Court in a unanimous decision in Merck v. Integra, No. 03-1237, broadly interpreted the scope of a rather ambiguously-worded provision of the U.S. patent statute, 35 U.S.C. 271(e)(1).

That provision provides a "safe harbor" from patent infringement liability for firms that, in the course of conducting tests and experiments needed to gather information for submission to the Food & Drug Administration (FDA), make or use inventions that are patented by others.

The Supreme Court held that the safe harbor protects not just generic manufacturers who are seeking FDA approval to market generic equivalents of branded drugs, but also protects innovator firms (research institutions as well as corporations) who conduct the clinical trials and pre-clinical tests required to seek FDA approval of new, "pioneer" drugs.

patent infringement liability, safe harbor, Merck v. Integra, Supreme Court decision, interpretation, U.S. patent statute, 35 U.S.C. 271(e)(1), FDA approval, drugs, patent system, reform, research, experimentation, commercialization

Abstract:
When jurors decide whether a putative patent infringer is liable under the doctrine of equivalents, Federal Circuit law requires that the patent owner's trial presentation provide "particularized evidence" and "linking argument" with respect to each prong of the classic tripartite test for liability (i.e., substantial identity of "function," "way," and "result" between each element of the claimed invention and accused device). The court has recognized that absent such evidentiary roadmapping, jurors are "put to sea without guiding charts." In its August 2001 decision in Monsanto Co. v. Mycogen Plant Science, Inc., the Federal Circuit refused to extend this same evidentiary framework to an accused infringer's affirmative defense that the patent in suit was invalid for prior invention under 35 U.S.C. section 102(g)(2). This article contends that the Federal Circuit in Monsanto improvidently deprived jurors of analytical guideposts that are essential to the kind of fully informed fact-finding that should underlie any verdict on the validity or invalidity of an issued patent. The article proposes that the evidentiary requirements for contextualization, particularization, and application of pertinent facts to applicable law, as previously required for liability determinations under the doctrine of equivalents, should likewise be mandated for all cases in which patent validity is challenged before a jury. The jury's deliberational task is no less complex in the validity phase of a patent trial than in the liability phase, and is further informed by the presumption of validity that attaches to issued patents. The risks of juror error that warrant imposition of particularized evidentiary requirements for liability determination are even more potent in the validity setting, for a jury's decision to sustain or invalidate an asserted patent affects not only the parties to the lawsuit but also the public at large. In keeping with its mandate to enhance predictability and uniformity in patent disputes, the Federal Circuit has the power and the responsibility to improve patent jury trial practice by requiring that validity challenges be tried under the same evidentiary ground-rules as those that the court has already established for equivalents liability.

patent invalidity, patent infringement tripartite test for liability, Federal Circuit, doctrine of equivalents, patent jury trial practice, evidentiary requirements, equivalents liability, liability, validity

Abstract:
The startling result of Holmes Group v. Vornado is that for the first time since the Federal Circuit's creation twenty years ago, the regional circuit courts of appeal will be asked to resolve patent law-based claims (i.e., causes of action), not merely the occasional patent law-based issue that might be tangentially encountered in non-patent actions. The decision in Holmes Group resurrects the specter of regional circuit-specific, non-uniform patent jurisprudence and the potential for forum shopping that entails, the very problems that the Federal Circuit was created to remedy. By narrowly construing statutory text and nonanalogous judicial decisions while purposefully ignoring the legislative intent expressed in the Federal Courts Improvement Act of 1982, the Supreme Court in Holmes Group has frustrated Congress's goal of creating a more uniform and stable patent law jurisprudence.

patent jurisprudence, forum shopping, patent law jurisprudence, Federal Courts Improvement Act of 1982, jurisdiction, U.S. Court of Appeals for the Federal Circuit, judicial procedure, choice of law, arising under

Abstract:
In August and September 2006, patients with cancer, lawyers for patient advocacy groups, and representatives of nongovernmental organizations (NGOs) converged on the offices of Novartis in Mumbai, India, to protest the company's efforts to obtain an Indian patent on Gleevec, the company's brand-name version of imatinib mesylate. Gleevec (spelled Glivec outside the United States) is used to treat chronic myeloid leukemia, and Novartis has patented the drug in 35 countries. The protesters also decried the drug's high price: Novartis sells it in India (where only 5% of people have private health insurance) for $26,000 per year; generic-drug manufacturers offer the drug at less than one tenth that price.

This work was originally published in the New England Journal of Medicine (Feb. 8, 2007), at 541-43, Copyright © 2007 Massachusetts Medical Society.

patent law, Novartis, Gleevec, Glivec, patient advocacy, imatinib mesylate, patent protection, generic drug manufacturing, Indian Patent Office, pharmaceuticals, inventive step, Agreement on Trade-Related Aspects of Intellectual Property, TRIPS.