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At the heart of the patent system is the fundamentaltension between rewarding inventions and encouraging competition, a tensionthat is heightened in the fast-moving field of biotechnology. The U.S. Court ofAppeals for the Federal Circuit has grappled with balancing these competinginterests, seeking to delineate the proper breadth of patent claims throughapplication of the written description and enablement requirements of thepatent statute. Although the former requirement has received the mostattention, the recent case of Plant Genetic Systems N.V. v. DeKalb GeneticsCorp., 315 F.3d 1335 (Fed. Cir. 2003), puts enablement into the spotlightand raises several important issues, including whether pioneering patentsdeserve broader protection, and the conflict between enablement andlater-developed technology. As part of the quid pro quo for receiving patent protectionand the period of exclusivity it provides, the patent statute requiresinventors 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 thedisclosure of information sufficient for the ordinary skilled person to makeand 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 patentexpires, the public is able to practice the invention, and the inventor doesnot receive an unwarranted extension to the statutory period of exclusivity. The Federal Circuit has employed a number of illustrativefactors in deciding enablement, including the quantity of experimentationnecessary, the amount of direction or guidance presented and the predictabilityor 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 theunpredictable nature of biotech, the notion being that chemical and physiologicalreactions are more unpredictable than, say, the mechanical or electrical arts.This emphasis has resulted in a de facto heightened enablement standard thathas led to the striking down of a number of biotechnology patents as overbroadand not-enabled. See, e.g., In re Vaeck, 947 F.2d 488, 495-96 (Fed. Cir.1991). The natural consequence of a heightened enablementrequirement is narrower patent claims. While this may spur competition, itarguably reduces the incentive to patent because of the ease with which otherscan design around narrow claims. The less people patent, the less they discloseto the public, which can have a negative impact on innovation. On the otherhand, while broad claims satisfy the public interest in early disclosure ofinventions, overbroad claims tend to stifle competition. Finding the correctbalance between these competing interests has proved challenging. This balancing act is at its most difficult when thepatent relates to a significant breakthrough having broad application, which isknown as a “pioneer” patent. The courts have struggled with theeffect the pioneering nature of an invention should have on the breadth ofclaims allowed and the enablement standard by which they should be judged. Thisis precisely the issue the Federal Circuit faced in the Plant Geneticcase. THE ‘PLANT GENETIC’ DECISION The patent held by Plant Genetic Systems (PGS) is directedto transgenic plant cells, whole plants and seeds genetically modified forresistance to nonselective herbicides, which indiscriminately kill plants andweeds by blocking an essential metabolic pathway. PGS sued De�Kalb, allegingthat sale of its transgenic corn product was a patent infringement. The cell claims in the PGS patent broadly encompassed allplants, including both monocots and dicots, the two general divisions offlowering 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, onlyexamples of dicots. The district court found that in 1987, the filing date ofthe patent, transformation of monocots would have been difficult, if notimpossible, and would have required undue experimentation. Plant Genetic SystemsN.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 thedistrict court erred by ignoring the allegedly pioneering status of itsinvention, which, it claimed, should entitle its patent to a broad scope of �coverageand lower standard of enablement. In essence, PGS argued that it was entitledto stop DeKalb from selling its later-developed transgenic corn product becausePGS had been the first to transform any plant, whether monocot or dicot, tomake it resistant to nonselective herbicides, a development from which DeKalbhad 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 todominate the future patentable inventions of others where those inventions werebased in some way on his teachings.” In Fisher, the courtinvalidated for lack of enablement claims to certain hormone preparations of agiven potency or greater, with no upper limit, when it appeared theoreticallypossible to achieve greater potencies than those disclosed by the applicants.Admonishing PGS for selectively relying on dicta, Judge Paul R. Michel, writingfor the Federal Circuit, pointed out that Fisher went on to hold thatthe inventor “must not be permitted to achieve this dominance by claimsthat are insufficiently supported and hence not in compliance with the firstparagraph 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 broadprotection for pioneer inventions. The patent application in that casedescribed a crystalline form of a solid polymer of propylene, but the claimswere not limited to any particular form and, thus, also covered the amorphousform that was not discovered until years after the filing date. The Hogancourt reversed a nonenablement determination, and remanded, stating thatlater-existing improvements, such as the amorphous form, could not be used”to ‘reach back’ and preclude or invalidate a patent on the underlyinginvention.” 559 F.2d at 606. The Plant Genetic court distinguished Hoganon the basis that monocots and their transformation were not unknown conceptsas of the filing date. On the contrary, monocots existed at that time and theirstable transformation was “highly desirable.” However, they weredifficult to produce and the patent gave no instruction to one skilled in the arton how to make them. Similarly, the court stated that PGS’ reliance on HormoneResearch Foundation Inc. v. Genentech Inc., 904 F.2d 1558 (Fed. Cir. 1990),was unfounded. Concluding that the dicta in these precedents could not be usedto alter their holdings, the Federal Circuit held that the PGS patent was notentitled to a broad scope of coverage or a lower standard of enablement. FORESEEABILITY FACTOR The main takeaway from Plant Genetic is the additionof a new factor to be considered in determining enablement: reasonableforeseeability. If it is foreseeable at the time of filing that an improvementcould be made to an invention, and there is a motivation to make thatimprovement, then failure to disclose that later development cuts againstenablement. 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 unnecessaryfor enablement. While Plant Genetic could also be read as shuttingthe door on the argument that a pioneering invention deserves broaderprotection, the Federal Circuit stopped short of saying so. The court merelystated that the patent in suit was not entitled to broad coverage, not that nopatent deserves such protection. Also, the court did not clearly distinguishthe Hogan court’s direction to the lower tribunal to consider on remandthe alleged pioneering status of the patent. Unfortunately, then, it is stillunclear when, if ever, it is appropriate to take an invention’s pioneer statusinto account in determining enablement. Another recent enablement case involving later-developedtechnology is Amgen Inc. v. Hoechst Marion Roussel Inc., 314 F.3d 1313(Fed. Cir. 2003), which also addressed written description. Amgen’s patents disclose production of erythropoietin (EPO) — a hormonalsubstance that stimulates red blood cell formation — by introducing exogenousDNA into monkey and hamster ovary cells that then express recombinant humanEPO. The defendants’ later-developed method involves production of EPO fromendogenous EPO DNA in human host cells. The defendants argued nonenablementbased on the fact that the patent described the production of EPO in only twospecies of vertebrate or mammalian cells, yet claimed the broad class of allvertebrate and mammalian cells. The court concluded that the claims were enabled based ontestimony that a person of ordinary skill as of the filing date could haveovercome, without undue experimentation, any challenge encountered inattempting to make and use the claimed invention using the nondisclosed cells.However, Judge Raymond C. Clevenger III stridently dissented from the majorityview, citing Vaeck for the proposition that “disclosure of one ortwo species may not enable a broad genus.” Id. at 1360. The majoritycountered that Vaeck was inapposite because of the evidence of the smalldifferences to the ordinary skilled person between carrying out the inventionin the two disclosed cells and the numerous undisclosed cells. Thus, the Amgen court concluded that disclosure ofhow to practice the invention in two species out of many was enabled. Thisconclusion may appear to contradict that of Plant Genetic, where aone-out-of-two disclosure was held not enabling, but these two decisions arereconcilable. While in Amgen the differences between using the variouscells was minimal, the difference between transforming dicots and monocots wasapparently significant. Interestingly, the Amgen court did not directlyaddress whether the use of the nondisclosed cells was foreseeable or desirable,but there appears to have been no evidence that producing EPO in human cellswas advantageous, as the end product apparently was the same as that produced �accordingto Amgen’s patent. In light of Plant Genetic, broad biotechnologypatents now face a new hurdle. In addition to the heightened standard ofenablement that is generally applied to biotechnology claims because of theperceived unpredictability in this field, the foreseeability approach in PlantGenetic is likely to restrict further broad claiming that would encompasslater-discovered technology. Moreover, proclaiming status as a”pioneer” patent does not appear to offer a safe haven for applicantsseeking broad protection. Only time will tell whether this approach strikes theright balance between encouraging patent disclosure and fostering competitiveinnovation. Brian V. Slater is a partner, and Lucian C. Chen is an associate,at New York’s Fitzpatrick, Cella, Harper & Scinto (www.fchs.com), specializing in complexpatent litigation. They can be reached at [email protected] and [email protected],respectively. If you are interested in submitting an article to law.com, please click here for our submission guidelines.

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