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special to the national law journal Brian V. Slater is a partner, and Lucian C. Chen is an associate, at New York’s Fitzpatrick, Cella, Harper & Scinto, specializing in complex patent litigation. They can be reached at [email protected] and [email protected], respectively. At the heart of the patent system is the fundamental tension between rewarding inventions and encouraging competition, a tension that is heightened in the fast-moving field of biotechnology. The U.S. Court of Appeals for the Federal Circuit has grappled with balancing these competing interests, seeking to delineate the proper breadth of patent claims through application of the written description and enablement requirements of the patent statute. Although the former requirement has received the most attention, the recent case of Plant Genetic Systems N.V. v. DeKalb Genetics Corp., 315 F.3d 1335 (Fed. Cir. 2003), puts enablement into the spotlight and raises several important issues, including whether pioneering patents deserve broader protection, and the conflict between enablement and later-developed technology. As part of the quid pro quo for receiving patent protection and the period of exclusivity it provides, the patent statute requires inventors to make a number of disclosures in the body of the patent. 35 U.S.C. 112, ¶ 1. One of those, the “enablement requirement,” requires the disclosure of information sufficient for the ordinary skilled person to make and use the full scope of the claimed invention without undue experimentation, judged as of the patent filing date. In re Wright, 999 F.2d 1557, 1560-61 (Fed. Cir. 1993). This requirement ensures that when the patent expires, the public is able to practice the invention, and the inventor does not receive an unwarranted extension to the statutory period of exclusivity. The Federal Circuit has employed a number of illustrative factors in deciding enablement, including the quantity of experimentation necessary, the amount of direction or guidance presented and the predictability or unpredictability of the art. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988); Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991). When dealing with biotechnology patents, the focus has been on the unpredictable nature of biotech, the notion being that chemical and physiological reactions are more unpredictable than, say, the mechanical or electrical arts. This emphasis has resulted in a de facto heightened enablement standard that has led to the striking down of a number of biotechnology patents as overbroad and not-enabled. See, e.g., In re Vaeck, 947 F.2d 488, 495-96 (Fed. Cir. 1991). The natural consequence of a heightened enablement requirement is narrower patent claims. While this may spur competition, it arguably reduces the incentive to patent because of the ease with which others can design around narrow claims. The less people patent, the less they disclose to the public, which can have a negative impact on innovation. On the other hand, while broad claims satisfy the public interest in early disclosure of inventions, overbroad claims tend to stifle competition. Finding the correct balance between these competing interests has proved challenging. This balancing act is at its most difficult when the patent relates to a significant breakthrough having broad application, which is known as a “pioneer” patent. The courts have struggled with the effect the pioneering nature of an invention should have on the breadth of claims allowed and the enablement standard by which they should be judged. This is precisely the issue the Federal Circuit faced in the Plant Genetic case. The ‘Plant Genetic’ decision The patent held by Plant Genetic Systems (PGS) is directed to transgenic plant cells, whole plants and seeds genetically modified for resistance to nonselective herbicides, which indiscriminately kill plants and weeds by blocking an essential metabolic pathway. PGS sued DeKalb, alleging that sale of its transgenic corn product was a patent infringement. The cell claims in the PGS patent broadly encompassed all plants, including both monocots and dicots, the two general divisions of flowering plants. Monocots, such as corn, initially develop as one leaf, whereas dicots, like tomato, potato and tobacco, start life with two leaves. However, there were no working examples in the PGS patent of any monocots, only examples of dicots. The district court found that in 1987, the filing date of the patent, transformation of monocots would have been difficult, if not impossible, and would have required undue experimentation. Plant Genetic Systems N.V. v. DeKalb Genetics Corp., 175 F. Supp. 2d 246, 265 (D. Conn. 2001). The Federal Circuit affirmed the holding that the cell claims were not enabled. Of particular interest, PGS argued on appeal that the district court erred by ignoring the allegedly pioneering status of its invention, which, it claimed, should entitle its patent to a broad scope of coverage and lower standard of enablement. In essence, PGS argued that it was entitled to stop DeKalb from selling its later-developed transgenic corn product because PGS had been the first to transform any plant, whether monocot or dicot, to make it resistant to nonselective herbicides, a development from which DeKalb had allegedly benefited. PGS relied on dicta in In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970), that stated: “[A]n inventor should be allowed to dominate the future patentable inventions of others where those inventions were based in some way on his teachings.” In Fisher, the court invalidated for lack of enablement claims to certain hormone preparations of a given potency or greater, with no upper limit, when it appeared theoretically possible to achieve greater potencies than those disclosed by the applicants. Admonishing PGS for selectively relying on dicta, Judge Paul R. Michel, writing for the Federal Circuit, pointed out that Fisher went on to hold that the inventor “must not be permitted to achieve this dominance by claims that are insufficiently supported and hence not in compliance with the first paragraph of 35 U.S.C. 112.” Id. Another case heavily relied upon by PGS was In re Hogan, 559 F.2d 595 (C.C.P.A. 1977), which supported in dicta a policy of broad protection for pioneer inventions. The patent application in that case described a crystalline form of a solid polymer of propylene, but the claims were not limited to any particular form and, thus, also covered the amorphous form that was not discovered until years after the filing date. The Hogan court reversed a nonenablement determination, and remanded, stating that later-existing improvements, such as the amorphous form, could not be used “to ‘reach back’ and preclude or invalidate a patent on the underlying invention.” 559 F.2d at 606. The Plant Genetic court distinguished Hogan on the basis that monocots and their transformation were not unknown concepts as of the filing date. On the contrary, monocots existed at that time and their stable transformation was “highly desirable.” However, they were difficult to produce and the patent gave no instruction to one skilled in the art on how to make them. Similarly, the court stated that PGS’ reliance on Hormone Research Foundation Inc. v. Genentech Inc., 904 F.2d 1558 (Fed. Cir. 1990), was unfounded. Concluding that the dicta in these precedents could not be used to alter their holdings, the Federal Circuit held that the PGS patent was not entitled to a broad scope of coverage or a lower standard of enablement. Foreseeability factor The main takeaway from Plant Genetic is the addition of a new factor to be considered in determining enablement: reasonable foreseeability. If it is foreseeable at the time of filing that an improvement could be made to an invention, and there is a motivation to make that improvement, then failure to disclose that later development cuts against enablement. Conversely, when the improvement is not reasonably foreseeable, such as the later discovery of the amorphous form of propylene in Hogan, disclosure of the making and using of the improvement is apparently unnecessary for enablement. While Plant Genetic could also be read as shutting the door on the argument that a pioneering invention deserves broader protection, the Federal Circuit stopped short of saying so. The court merely stated that the patent in suit was not entitled to broad coverage, not that no patent deserves such protection. Also, the court did not clearly distinguish the Hogan court’s direction to the lower tribunal to consider on remand the alleged pioneering status of the patent. Unfortunately, then, it is still unclear when, if ever, it is appropriate to take an invention’s pioneer status into account in determining enablement. Another recent enablement case involving later-developed technology is Amgen Inc. v. Hoechst Marion Roussel Inc., 314 F.3d 1313 (Fed. Cir. 2003), which also addressed written description. [See story, Page S1.] Amgen’s patents disclose production of erythropoietin (EPO)-a hormonal substance that stimulates red blood cell for- mation-by introducing exogenous DNA into monkey and hamster ovary cells that then express recombinant human EPO. The defendants’ later-developed method involves production of EPO from endogenous EPO DNA in human host cells. The defendants argued nonenablement based on the fact that the patent described the production of EPO in only two species of vertebrate or mammalian cells, yet claimed the broad class of all vertebrate and mammalian cells. The court concluded that the claims were enabled based on testimony that a person of ordinary skill as of the filing date could have overcome, without undue experimentation, any challenge encountered in attempting to make and use the claimed invention using the nondisclosed cells. However, Judge Raymond C. Clevenger III stridently dissented from the majority view, citing Vaeck for the proposition that “disclosure of one or two species may not enable a broad genus.” Id. at 1360. The majority countered that Vaeck was inapposite because of the evidence of the small differences to the ordinary skilled person between carrying out the invention in the two disclosed cells and the numerous undisclosed cells. Thus, the Amgen court concluded that disclosure of how to practice the invention in two species out of many was enabled. This conclusion may appear to contradict that of Plant Genetic, where a one-out-of-two disclosure was held not enabling, but these two decisions are reconcilable. While in Amgen the differences between using the various cells was minimal, the difference between transforming dicots and monocots was apparently significant. Interestingly, the Amgen court did not directly address whether the use of the nondisclosed cells was foreseeable or desirable, but there appears to have been no evidence that producing EPO in human cells was advantageous, as the end product apparently was the same as that produced according to Amgen’s patent. In light of Plant Genetic, broad biotechnology patents now face a new hurdle. In addition to the heightened standard of enablement that is generally applied to biotechnology claims because of the perceived unpredictability in this field, the foreseeability approach in Plant Genetic is likely to restrict further broad claiming that would encompass later-discovered technology. Moreover, proclaiming status as a “pioneer” patent does not appear to offer a safe haven for applicants seeking broad protection. Only time will tell whether this approach strikes the right balance between encouraging patent disclosure and fostering competitive innovation.

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