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.

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 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.

Patent Conflicts

2017 ◽  
Author(s):  
Tejas N. Narechania
Keyword(s):  
Regulatory Authority ◽  
Direct Action ◽  
Patent Policy ◽  
Context Sensitive ◽  
Court Of Appeals ◽  
Relative Preference ◽  
The Supreme Court ◽  
Federal Circuit ◽  
Indirect Action ◽  
Striking Effect

Patent policy is typically thought to be the product of the Patent and Trademark Office, the Court of Appeals for the Federal Circuit, and, in some instances, the Supreme Court. This simple topography, however, understates the extent to which outsiders can shape the patent regime. Indeed, a variety of administrative actors influence patent policy through the exercise of their regulatory authority and administrative power. This Article offers a novel description of the ways in which nonpatent agencies intervene into patent policy. In particular, it examines agency responses to conflicts between patent and other regulatory aims, uncovering a relative preference for complacency (“inaction”) and resort to outside help (“indirect action”) over regulation (“direct action”). This dynamic has the striking effect of shifting authority from nonpatent agencies to patent policymakers, thereby supplanting some regulatory designs with the patent regime’s more general incentives. This Article thus offers agencies new options for facing patent conflict, including an oft-overlooked theory of regulatory authority for patent-related regulation. Such intervention and regulation by nonpatent agencies can give rise to a more efficient and context-sensitive regime that is better aligned with other regulatory goals.

Idenix v. Gilead: The enablement and written description limits of a genus claim

2021 ◽  
Vol 17 (2) ◽  
pp. 77-83
Author(s):  
Keith A Zullow ◽  
Cindy Chang ◽  
Sean Anderson
Keyword(s):  
Case Report ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Supreme Court ◽  
The Supreme Court ◽  
Federal Circuit ◽  
Written Description ◽  
Insufficient Number

In Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019), the Federal Circuit affirmed a judgment of invalidity of a patent claiming methods for treating Hepatitis C virus for, inter alia, lack of enablement. The Supreme Court denied Idenix’s petition for a writ of certiorari, meaning that the Federal Circuit decision stands, and genus claims covering thousands of compounds that were supported by an insufficient number of examples have failed the enablement test not once, but twice. See Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013). This case report presents the context surrounding the Federal Circuit’s Idenix decision and the Supreme Court’s decision not to hear the case.

scholarly journals STRUCTURAL AND CHEMICAL CHARACTERISTIC OF PECTIN FROM PICEA ABIES GREENERY

2020 ◽  
pp. 59-71
Author(s):  
Evgeniy Gennad'yevich Shakhmatov ◽  
Elena Nikolayevna Makarova
Keyword(s):  
Cell Walls ◽  
New Technologies ◽  
Chemical Characteristic ◽  
Structural Features ◽  
Exchange Chromatography ◽  
Raw Material ◽  
Rhamnogalacturonan I ◽  
Wood Processing ◽  
Potential Source ◽  
Pectin Substances

The present work aimed to determine structural features of polysaccharides derived from the P. abies foliage by extraction with a (NH4)2C2O4 solution. The isolated polysaccharide was studied in detail by the methods of ion exchange chromatography, partial acidic hydrolys and NMR spectroscopy. It was shown that this polysaccharide contained polymers of various structures. The major constituents of PAO were low-methoxyl and low-acetylated 1,4-a-D-galacturonan and by minor parts of partly 2-O- and/or 3-O- acetylated rhamnogalacturonan-I (RG-I). The side carbohydrate chains of the branched region of RG-I were represented predominantly by highly branched 1,5-a-L-arabinan and minor portions of 1,4-β-D-galactan. In addition to the dominant pectins, polysaccharide PAO contained binding glycans of the glucomannans class, which indicated a close interaction of these polysaccharides in the cell walls. Thus, the structural features of pectin woody P. abies, extracted with a solution of (NH4)2C2O4, were first determined. It can be concluded that P. abies woody greens, a large tonnage waste from the wood processing industry, can be considered as a potential source of pectin substances. The results of studying the structure of components of woody green P. abies can be the basis for the development and improvement of new technologies for the integrated use of this raw material.

scholarly journals Life After Bilski

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Supreme Court ◽  
Real World ◽  
Subject Matter ◽  
Case Law ◽  
Patent Law ◽  
District Courts ◽  
The Supreme Court ◽  
Federal Circuit ◽  
Abstract Ideas ◽  
New Applications

In Bilski v. Kappos, the Supreme Court declined calls to categoricallyexclude business methods - or any technology - from the patent law. It alsorejected as the sole test of subject matter eligibility the FederalCircuit’s deeply-flawed "machine or transformation" test, under which noprocess is patentable unless it is tied to a particular machine ortransforms an article to another state or thing. Subsequent developmentsthreaten to undo that holding, however. Relying on the Court’s descriptionof the Federal Circuit test as a "useful and important clue', the U.S.Patent and Trademark Office, patent litigants, and district courts have allcontinued to rely on the machine-or-transformation test in the wake ofBilski: no longer as the sole rule, but as a presumptive starting pointthat threatens to effectively become mandatory. In this Article, we suggesta new way to understand the exclusion of abstract ideas from patentablesubject matter. No class of invention is inherently too abstract forpatenting. Rather, the rule against patenting abstract ideas is an effortto prevent inventors from claiming their ideas too broadly. By requiringthat patent claims be limited to a specific set of practical applicationsof an idea, the abstract ideas doctrine both makes the scope of theresulting patent clearer and leaves room for subsequent inventors toimprove upon - and patent new applications of - the same basic principle.Recasting the abstract ideas doctrine as an overclaiming test eliminatesthe constraints of the artificial machine-or-transformation test, as wellas the pointless effort to fit inventions into permissible or impermissiblecategories. It also helps understand some otherwise-inexplicabledistinctions in the case law. Testing for overclaiming allows courts tofocus on what really matters: whether the scope of the patentee's claimsare commensurate with the invention’s practical, real-world contribution.This inquiry, we suggest, is the touchstone of the abstract ideas analysis,and the way out of the post-Bilski confusion.

scholarly journals Patent Scope and Innovation in the Software Industry

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Network Effects ◽  
Software Industry ◽  
Patent Law ◽  
Fair Use ◽  
Sequential Innovation ◽  
Reverse Engineer ◽  
Prior Art ◽  
Software Patents ◽  
Software Patent ◽  
Experimental Use

Software patents have received a great deal of attention in the academicliterature. Unfortunately, most of that attention has been devoted to theproblem of whether software is or should be patentable subject matter. Withroughly 40,000 software patents already issued, and the Federal Circuitendorsing patentability without qualification, those questions are for thehistory books. The more pressing questions now concern the scope to beaccorded software patents. In this paper, we examine the implications ofsome traditional patent law doctrines for innovation in the softwareindustry. We argue that patent law needs some refinement if it is topromote rather than impede the growth of this new market, which ischaracterized by rapid sequential innovation, reuse and re-combination ofcomponents, and strong network effects that privilege interoperablecomponents and products. In particular, we argue for two sorts of new rulesin software patent cases.First, we advocate a limited right to reverse engineer patented computerprograms in order to gain access to and study those programs and toduplicate their unprotected elements. Such a right is firmly established incopyright law, and seems unexceptional as a policy matter even in patentlaw. But because patent law contains no fair use or reverse engineeringexemption, patentees could use the grant of rights on a single component ofa complex program to prevent any "making" or "using" of the program as awhole, including those temporary uses needed in reverse engineering. Whilepatent law does contain doctrines of "experimental use" and "exhaustion,"it is not at all clear that those doctrines will protect legitimate reverseengineering efforts. We suggest that if these doctrines cannot be readbroadly enough to establish such a right, Congress should create a limitedright to reverse engineer software containing patented components forresearch purposes.Second, we argue that in light of the special nature of innovation withinthe software industry, courts should apply the doctrine of equivalentsnarrowly in infringement cases. The doctrine of equivalents allows afinding of infringement even when the accused product does not literallysatisfy each element of the patent, if there is substantial equivalence asto each element. The test of equivalence is the known interchangeability ofclaimed and accused elements at the time of (alleged) infringement. Anumber of factors unique to software and the software industry - a cultureof reuse and incremental improvement, a lack of reliance on systems offormal documentation used in other technical fields, the short effectivelife of software innovations, and the inherent plasticity of code -severely complicate post hoc assessments of the "known interchangeability"of software elements. A standard for equivalence of code elements thatignores these factors risks stifling legitimate, successful efforts todesign around existing software patents. To avoid this danger, courtsshould construe software claims narrowly, and should refuse a finding ofequivalence if the accused element is "interchangeable" with prior art thatshould have narrowed the original patent, or if the accused improvement istoo many generations removed from the original invention.

scholarly journals PROTEIN TEACHING: AN APPROACH FOR TEACHER TRAINING APPLIED TO STUDENTS OF THE BIOLOGICAL SCIENCES COURSE AT UFRN

2015 ◽  
Vol 13 ◽  
pp. 34
Author(s):  
J. K.S. NASCIMENTO et al
Keyword(s):  
Biological Sciences ◽  
Teaching Practice ◽  
Basic Education ◽  
New Technologies ◽  
Lesson Plan ◽  
Three Dimensional ◽  
Structural Features ◽  
Dimensional Structure ◽  
Educational Models ◽  
Teaching Learning

Teaching biochemistry in higher education is increasingly becoming a challenge. It is notoriously difficult for students to assimilate the topic; in addition there are many complaints about the complexity of subjects and a lack of integration with the day-to-day. A recurrent problem in undergraduate courses is the absence of teaching practice in specific disciplines. This work aimed to stimulate students in the biological sciences course who were enrolled in the discipline of MOLECULAR DIVERSITY (MD), to create hypothetical classes focused on basic education highlighting the proteins topic. The methodology was applied in a class that contained 35 students. Seven groups were formed, and each group chose a protein to be used as a source of study for elementary school classes. A lesson plan was created focusing on the methodology that the group would use to manage a class. The class was to be presented orally. Students were induced to be creative and incorporate a teacher figure, and to propose teaching methodologies for research using the CTS approach (Science, Technology and Society). Each group presented a three-dimensional structure of the protein they had chosen, explained their structural features and functions and how they would develop the theme for a class of basic education, and what kind of methodology they would use for this purpose. At the end of the presentations, a questionnaire was given to students in order to evaluate the effectiveness of the methodology in the teaching-learning process. The activity improved the teacher’s training and developed skills and abilities, such as creativity, didactical planning, teaching ability, development of educational models and the use of new technologies. The methodology used in this work was extremely important to the training of future teachers, who were able to better understand the content covered in the discipline and relate it to day-to-day life.

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