Enzo Biochem v. Gen-Probe: Complying with the written description requirement under US patent law

2003 ◽  
Vol 21 (1) ◽  
pp. 97-99
Author(s):  
Sasha Blaug ◽  
Michael Shuster ◽  
Henry Su
Keyword(s):  
Patent Law ◽  
Written Description

scholarly journals Is Patent Law Technology-Specific?

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
New Technologies ◽  
Computer Software ◽  
Patent Law ◽  
The Other ◽  
Legal Rules ◽  
Legal Standards ◽  
Structural Problems ◽  
Prior Art ◽  
Federal Circuit ◽  
Written Description

Patent law has a general set of legal rules to govern the validity andinfringement of patents in a wide variety of technologies. With a very fewexceptions, the statute does not distinguish between different technologiesin setting and applying legal standards. In theory, then, we have a unifiedpatent system that provides technology-neutral protection to all kinds oftechnologies.Of late, however, we have noticed an increasing divergence between therules themselves and the application of the rules to different industries.The best examples are biotechnology and computer software. In biotechnologycases, the Federal Circuit has bent over backwards to find biotechnologicalinventions nonobvious, even if the prior art demonstrates a clear plan forproducing the invention. On the other hand, the court has imposed stringentenablement and written description requirements on biotechnology patentsthat do not show up in other disciplines. In computer software cases, thesituation is reversed. The Federal Circuit has essentially excused softwareinventions from compliance with the enablement and best mode requirements,but has done so in a way that raises serious questions about howstringently it will read the nonobviousness requirements. As a practicalmatter, it appears that while patent law is technology-neutral in theory,it is technology-specific in application.The paper explains how the application of the same general legal standardscan lead to such different results in diverse industries. Much of thevariance in patent standards is attributable to the use of a legalconstruct, the "person having ordinary skill in the art" (PHOSITA), todetermine obviousness and enablement. The more skill those in the art have,the less information an applicant has to disclose in order to meet theenablement requirement - but the harder it is to meet the nonobviousnessrequirement. The level of skill in the art affects not just patentvalidity, but also patent scope.We do not challenge the idea that the standards in each industry shouldvary with the level of skill in that industry. We think the use of thePHOSITA provides needed flexibility for patent law, permitting it to adaptto new technologies without losing its essential character. We fear,however, that the Federal Circuit has not applied that standard properly ineither the biotechnology or computer software fields. The court has aperception of both fields that was set in earlier cases but which does notreflect the modern realities of either industry. The changes in an industryover time present significant structural problems for patent law, bothbecause law is necessarily backward-looking and precedent-bound and becauseapplying different standards to similar inventions raises concerns abouthorizontal equity. Nonetheless, we believe the courts must take more carethan they currently do to ensure that their assessments of patent validityare rooted in understandings of the technology that were accurate at thetime the invention was made.

scholarly journals What is the "Invention"?

2018 ◽  
Author(s):  
Christopher A Cotropia
Keyword(s):  
Supreme Court ◽  
Patent Law ◽  
Single Sentence ◽  
Natural Reaction ◽  
The Supreme Court ◽  
Federal Circuit ◽  
Written Description

Patent law is in flux, with recent disputes and changes in doctrine fueled by increased attention from the Supreme Court and en banc activity by the Federal Circuit. The natural reaction is to analyze each doctrinal area involved on its own. Upon a closer look, however, many patent cases concern a single, fundamental dispute. Conflicts in opinions on such issues as claim interpretation methodology and the written description requirement are really disagreements over which "invention" the courts should be considering. There are two concepts of invention currently in play in patent decisions. The first is an "external invention" definition, in which courts define the invention by the detailed technology discussion in the patent specification's descriptions and drawings. Other decisions invoke a "claim-centered invention" definition, which relies almost exclusively on the claim, a single sentence at the end of the patent. Judging these two definitions against common patent theories can help to determine which best fits the theories'narratives.T his Article concludes that the external invention is more favorable because it grounds exclusivity in what the inventor has actually done or plans to do and, accordingly, is more likely to comport with common patent theories.

scholarly journals Biotechnological Inventions and Patent Law: National and International Perspective

2016 ◽  
Vol 50 (3) ◽  
pp. 132-135
Author(s):  
Jyoti Rattan
Keyword(s):  
Intellectual Property Rights ◽  
Knowledge Society ◽  
Theoretical Perspective ◽  
International Perspective ◽  
Patent Law ◽  
Judicial Decisions ◽  
Biotechnological Inventions ◽  
Biotechnological Invention ◽  
Real Assets ◽  
Written Description

ABSTRACT In the knowledge society of 21st century, intellectual property rights (IPRs) are real assets and much more valuable and important than are materialistic assets like house, motor car, and so on. Patents are given for inventions which fulfill few important conditions, such as novelty, inventiveness, industrial application, and written description. Significantly, biotechnological invention involves monopoly over life or living beings or living processes, and morally and ethically these are considered to involve tinkering with life or nature. However, today, biotechnological inventions are patentable because of their benefits and utility to the industry. This article is a humble attempt to examine international and national law and judicial decisions relating to patents and biotechnological inventions from a theoretical perspective. How to cite this article Rattan J. Biotechnological Inventions and Patent Law: National and International Perspective. J Postgrad Med Edu Res 2016;50(3):132-135.

scholarly journals The Changing Meaning of Patent Claim Terms

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Patent Application ◽  
Fundamental Principle ◽  
Patent Law ◽  
Legal Rule ◽  
Patent Claim ◽  
Prior Art ◽  
Patented Invention ◽  
Sufficient Detail ◽  
One Act ◽  
Written Description

In order to construe the claims of a patent, the court must fix the meaningof the claim terms as of a particular point in time. Both the knowledge ofthe PHOSITA in a particular field and the meaning of particular terms tothat PHOSITA will frequently change over time. But at which point in timeshall we fix the meaning of the claims?It is a fundamental principle of patent law that the time at which wedetermine the meaning of claim terms varies depending on what legal rule isat issue. Where the question is one of novelty or nonobviousness - whetherthe invention is truly new - the courts compare the patented invention tothe prior art as both were understood at the time of the invention. Wherethe question is one of enablement or written description - whether theinventor understood and described the invention in sufficient detail -courts evaluate the adequacy of the disclosure based on the meaning of theclaims at the time the patent application was filed. Where the questioninvolves the meaning of a special patent claim element called ameans-plus-function claim, courts evaluate the scope of that claim elementat the time the patent issues. And where the question involves allegedinfringement of the patent, courts evaluate infringement in at least somecircumstances based on the meaning of the claim at the time ofinfringement.An equally fundamental principle of patent law is that patent claims mustbe construed as an integrated whole. In particular, patentees (or accusedinfringers, for that matter) are not permitted to argue that a patent claimmeans one thing when it comes to validity and something else entirely whenit comes to infringement. Instead, courts give claims a single meaning inany given case, engaging in only one act of claim construction for anygiven patent.These two principles contradict each other. In this paper, I seek toresolve this conflict. In Part I of this paper, I document thedistinguished pedigree of both principles. In Part II, I argue that patentclaim terms should have a fixed meaning throughout time, and that thatmeaning should be fixed at the time the patent application is first filed.Part II also discusses some complications that arise as a result of theprosecution process, and how to deal with the problem of later-developedtechnology.

scholarly journals Current topics in biotechnology patent law: The written description requirement

2005 ◽  
Vol 11 (4) ◽  
Author(s):  
Benjamin A Adler
Keyword(s):  
Patent Protection ◽  
Legal Protection ◽  
Patent Law ◽  
Molecular Medicine ◽  
Court Cases ◽  
Research Institutions ◽  
Legal Decisions ◽  
Biotechnology Companies ◽  
Biotechnological Inventions ◽  
Written Description

Universities and medical research institutions are as interested in securing patent protection for their biotechnological inventions as pharmaceutical and biotechnology companies. Obtaining adequate patent protection by universities and research institutions has been hampered by the 'embryonic' nature of its inventions. This problem is particularly noticeable in the fields of biotechnology and molecular medicine. This paper focuses on recent court cases in US biotechnology patent law and analyses the effects of the legal decisions on the effort by universities and research institutions to secure meaningful legal protection for biotechnological inventions.

scholarly journals Biotechnology's Uncertainty Principle

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Uncertainty Principle ◽  
New Technologies ◽  
Structural Features ◽  
Patent Law ◽  
Patent Policy ◽  
Prior Art ◽  
Practical Matter ◽  
Federal Circuit ◽  
Special Rules ◽  
Written Description

In theory, we have a unified patent system that provides technology-neutralprotection to all kinds of technologies. However, we have recently noticedan increasing divergence between the rules actually applied to differentindustries. Biotechnology provides one of the best examples. Inbiotechnology cases, the Federal Circuit has repeatedly held thatuncertainty in predicting the structural features of biotechnologicalinventions renders them nonobvious, even if the prior art demonstrates aclear plan for producing the invention. At the same time, the court claimsthat the uncertain nature of the technology requires imposition ofstringent patent enablement and written description requirements that arenot applied to patents in other disciplines. Thus, as a practical matter itappears that although patent law is technology-neutral in theory, it istechnology-specific in application. Much of the variance in patentstandards is attributable to the use of a legal construct, the "personhaving ordinary skill in the art" (PHOSITA), to determine obviousness andenablement. We do not challenge the idea that the standards in eachindustry should vary with the level of skill in that industry. We think theuse of the PHOSITA provides needed flexibility for patent law, permittingit to adapt to new technologies without losing its essential character. Wefear, however, that the Federal Circuit has not applied that standardproperly in biotechnology. The court has a static perception of the fieldthat was set in its initial analyses of biotechnology inventions, but whichdoes not reflect the realities of the industry. In the final part of thepaper, we offer a very preliminary policy assessment of theseindustry-specific patent cases. We suggest that the special rules theFederal Circuit has constructed for biotech cases are rather poorly matchedto the specific needs of the industry. Indeed, in some ways the FederalCircuit cases have it exactly backwards. We offer a few suggestions as towhat a consciously designed biotechnology patent policy may look like.

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