Written Description Requirement Research Articles

A Singular Disclosure Requirement Is Necessary For Patent Law

The Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112 has selectively and severely curtailed innovation in the fields of pharmaceuticals and biotechnology. Specifically, the Federal Circuit’s shifting position on 35 U.S.C. § 112 and their evolving jurisprudence to combine expanding the application and scope of the written description requirement with a separate, heightened standard for enabling claims directed to innovation in a genus of therapeutic antibodies, or a genus of compounds having functional limitations, has caused havoc in the biopharmaceutical industry. Federal Circuit jurisprudence on how to interpret the disclosure requirements of the 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by mandating two separate disclosure requirements in place of one, namely that patent applications not only “enable” but also separately “describe” inventions. This recently developed and reactively evolving judge made approach raises the bar exceedingly high for obtaining any meaningful patent protection for new biomedical discoveries, goes against many decades of patent practice, and is proving to be a powerful impediment to the investment necessary for developing new and lifesaving medicines. This article examines patent law’s current disclosure requirements to highlight a failing judicial trajectory and proposes a return to a single 35 U.S.C. § 112(a) standard. By doing so, the great shock that has singled out and disrupted the biopharmaceutical industry will be removed and the law can once again encourage, in a technology-neutral manner, the private sector to innovate in all fields of endeavor, including encouraging the biopharmaceutical industry to develop new lifesaving medicines and treatments.

The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)

The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)

Biotechnology Patent Law Top Ten of 2022: Inducement, Clear Error, and Interferences Galore

Five-year anniversaries are symbolized by a product of natural biotechnology: wood. This article marks the wood anniversary of the “Top Ten Biotechnology Patent Cases” series that began in 2018. Imagining the world in 2018 is challenging, in part because it was, indeed, a different world. There had not been a major pandemic in one hundred years. Inflation was low. The economy hummed along. No individual war appeared to threaten more than regional stability. O tempora, o mores! The year 2022 was quite different. SARS-CoV-2 continued to stalk the land, having had a monumentally mortiferous effect for several years. High inflation was rampant. The economy was still recovering from one of the deepest declines in history, with imbalances across many sectors. Moreover, eastern Europe had let slip the dogs of war, threatening peace worldwide. Biotechnology also has seen changes of significant magnitude. Venture capital investment in biotechnology was small compared to what it is now. Efficient genome editing was restricted to first-generation CRISPR-Cas9 systems, while now it may be accomplished using more powerful and accurate methods, like base editing and prime editing (the latter offering hope for treatment in almost 90% of genetic diseases). Courts had declared that diagnostic methods did not constitute patentable subject matter, which remains the case today, although clever draftswomen continue their efforts to obtain claims protecting such methods to some extent. Over the course of 2022, courts decided a generous selection of cases covering a wide variety of biotechnology patent law issues. These cases ran the gamut, from patent doctrines concerning satisfaction of the written description requirement for antibody claims to mechanisms for augmenting patent terms using either Patent Term Extension, or Patent Term Adjustment, or both. This article has chosen ten of the most important, though, as is the case every year, our choice of only ten was difficult, and, by necessity, left worthy cases on the cutting room floor.

The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)

The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)

Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II

Biotechnology Law ReportVol. 41, No. 2 The Holman ReportIs the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part IIBy Christopher M. HolmanBy Christopher M. HolmanChristopher M. Holman is a Professor of Law at the University of Missouri–Kansas City School of Law; a Senior Scholar at the Center for Intellectual Property x Innovation Policy (CIP-2) at the Antonin Scalia Law School, George Mason University; and the Executive Editor of Biotechnology Law Report.Search for more papers by this authorPublished Online:12 Apr 2022https://doi.org/10.1089/blr.2022.29264.cmhAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited byThe Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words) CHRISTOPHER M. HOLMAN11 October 2022 | Biotechnology Law Report, Vol. 41, No. 5 Volume 41Issue 2Apr 2022 InformationCopyright 2022, Mary Ann Liebert, Inc., publishersTo cite this article:By Christopher M. Holman.Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II.Biotechnology Law Report.Apr 2022.58-77.http://doi.org/10.1089/blr.2022.29264.cmhPublished in Volume: 41 Issue 2: April 12, 2022Online Ahead of Print:April 4, 2022PDF download

What patent practitioners can learn from Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc.

In its Nalpropion Pharms., Inc.v.Actavis Labs. FL, Inc. decision, the US Federal Circuit provided a narrow window for satisfying the requirement for written description of a patent claim through an ‘equivalent disclosure’.1 During the course of examination of a patent application, Nalpropion v.Actavis may allow a patent prosecutor to argue for the allowability of a claim when there would otherwise be insufficient written description in the application as filed. Similarly, counsel for a plaintiff asserting a patent in litigation may be able to draw on Nalpropion to support the validity of a claim. However, the limitations on when an ‘equivalent disclosure’ may be used to satisfy the written description requirement and the ambiguities in the Nalpropion decision highlight the importance of ensuring that sufficient explicit written description supporting the claims is included when preparing a patent application, including fully defining each claim element within the claim...

Immunex Corp. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2020 964 F.3d 1049

Immunex Corp. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2020 964 F.3d 1049

Written Description Requirement For The Medical Use Inventions Characerized By A New Administration And Dosage

Written Description Requirement For The Medical Use Inventions Characerized By A New Administration And Dosage

Correcting Misunderstandings of Literal Infringement Scope Regarding After-Arising Technologies Protected by the Doctrine of Equivalents

Based on conflicting Federal Circuit case law, many academics have written, and many practitioners likely believe, that claim meanings or their applications may expand over time for purposes of literal infringement. But this common wisdom is wrong. Under existing Federal Circuit rules, the first precedent controls in the event of a conflict over doctrine, unless and until reversed en banc. The first precedent on the issue, the 2000 Schering Corp. v. Amgen, Inc. case, held that claim scope does not reach after-arising technologies for literal infringement, and suggested that if it did then such claims would lack written description support. Under existing validity precedents, temporally expanding claim scope would violate both Section 112(a)'s enablement and written description requirements, as explicitly held in the 1977 In re Hogan decision and as implied by the more recent 2010 Ariad Pharmaceuticals v. Eli Lilly & Co. en banc decision. Further, were claims able to expand over time for literal infringement, they would violate the axiomatic equivalency of claim scope for validity and infringement. Once it is recognized that claim scope for literal infringement does not protect against after arising technologies, further resort will be made to seek such protection under the doctrine of equivalents. This will lead to increased uncertainty regarding the scope of patent protection. This article demonstrates that academics and practitioners may be confused regarding the U.S. law of literal infringement's temporal scope. It describes the conflicting cases that have led to that confusion. And it explains why Section 112(f)'s rule of construction for functional claiming language may be understood to limit all claim scope to temporally fixed, known-to-be equivalent technologies. The article concludes by noting potential conflict with the pioneering invention doctrine and concerns should the law be changed to permit claiming the future.

의료방법특허의 보정에 관한 해석론 - 신규사항 추가 및 기재불비를 중심으로 -

우리 특허실무는 인도적 차원에서 사람을 대상으로 하는 의료방법에 특허를 부여하지 않는다. 이에 인간을 포함한 광의의 동물을 대상으로 하여 특허출원하면 거절결정을 받게 되는데, 특허실무상 보정을 통해 청구범위를 “사람이외의 동물”로 소극적으로 한정하면, 특허를 받을 수 있도록 하고 있다. 이와 같이 특허를 받기까지의 과정은 특허 실무상 당연히 받아들여지고 있다. 이에 본고는 광의의 동물에서 사람을 제외시키는 형태의 소극적 한정보정이 최초 명세서의 범위 내에서 이루어진 적법한 보정인지 여부에 대해 검토하고, 나아가 그러한 보정을 통하여 도입된 사람을 제외한 소극적 한정구성이 명확한 것인지 여부 및 발명의 설명에 의하여 뒷받침되는지 여부에 대해 검토하였다.BR 신규사항 추가금지의 관점에서 소극적 한정보정이라고 하여 일률적으로 허용될 수는 없지만, 수술방법 등의 대상을 감축하는 보정은 새로운 기술적 사항이 도입되는 것이라고 보기 곤란할 것이다. 나아가 그러한 보정을 통하여 도입된 수술방법 등의 대상의 소극적 한정구성은 부정적 표현이 기재되었다고 하더라도 불명확하다고 볼 수는 없을 것이다. 또한 그러한 소극적 한정의 대상이나 이유 등이 최초 명세서 등에 개시되어 있지 않다고 하더라도, 보건정책적인 요청에 의해 일관되게 적용되는 것이므로 발명의 설명에 의한 뒷받침 요건을 엄격하게 적용할 필요는 없을 것이다.BR 그러나 이에 관한 각국의 다양한 사례와 규정들이 반증하듯, 소극적 한정이라는 취지에서 해석되는 이상 여전히 이러한 보정 등은 분쟁의 소지를 안게 된다. 이에 새로운 해석론으로서 수술방법 등의 대상을 광의의 동물에서 사람을 제외하는 소극적 한정 보정이라는 인식에 갈음하여, 보다 간명하고 단순한 형태로 인정되는 보정인 분명하지 아니하게 기재된 사항을 명확하게 하는 보정으로 해석하는 것을 제안한다. 동물과 사람의 관계는 준별될 필요가 있고, 나아가 청구범위는 규범적 기능을 담당하기 때문에 법률적 개념의 측면이 우선시 되어야 한다는 점에서 더욱 그러하다. 이로써 소극적 한정보정과 관련하여 제기되는 분쟁의 여지를 해소하는데 도움이 될 수 있고, 나아가 이러한 해석이 “동물”이라는 개념의 중의적 특성에 더 부합한다고 생각한다.

First-to-File and its Effect on Biotechnology's Strict Written Description Requirement

This paper explores the competing interests between the America Invents Act (AIA) and the patent law’s strict written description requirement. In Part II, this paper will discuss the current first-to-invent system of U.S. patent law and how a first-to-file system under the AIA creates a race to the patent office that spurs competitive behavior. In addition, this section will cover the disclosure requirement of 35 U.S.C. §112, including the decades of case law that formed the strict written description burden on biotechnology. Part III will analyze the competing interest that is created by combining the new patent law with the strict written description requirement. Moreover, this part will illustrate that the conflicting interest will cause disadvantaged biotech inventors to carefully balance their odds of winning the patent race against the need to satisfy strict disclosure. As it will be shown, the scales will tip in favor of filing. Part IV will illustrate the harmful effects of this result, and will explore several possible solutions to mitigate the problem.

The Ontological Function of the Patent Document

None

Santarus, Inc. v. Par Pharmaceutical, Inc.: Is there a new written description requirement for negative limitations?

In Santarus, Inc. et al. v. Par Pharmaceutical, Inc., 694 F.3d 1344 (Fed. Cir. 2012), the Federal Circuit addressed the written description requirement for patent claims containing a negative limitation (i.e., “wherein the composition contains no sucralfate”). This case report presents the context surrounding that issue including the concern by one Federal Circuit judge that a new written description requirement was created for negative claim limitations that would “taint large numbers of issued patents.”

The Ontological Function of the Patent Document

With the passage and impending implementation of the “first-to-file” provisions of the America Invents Act of 2011, the U.S. patent system must rely more than ever before on patent documents for its own ontological commitments concerning the existence of claimed kinds of useful objects and processes. This Article provides a comprehensive description of the previously unrecognized function of the patent document in incurring and securing warrants to these ontological commitments, and the respective roles of legal doctrines and practices in the patent system’s ontological project. Among other contributions, the resulting metaphysical account serves to reconcile competing interpretations of the written description requirement that have emerged from the Federal Circuit’s recent jurisprudence, and to explain why the patent system is willing and able to examine, grant and enforce claims reciting theoretical entities. While this Article is entirely descriptive, it concludes by identifying promising normative and prescriptive implications of this work, including the formulation of an appropriate test for the patent-eligibility of software-implemented inventions in the post-Bilski era.

The Ontological Function of the Patent Document

With the passage and implementation of the “first-to-file” provisions of the America Invents Act of 2011, the U.S. patent system must rely more than ever before on patent documents for its own ontological commitments concerning the existence of claimed kinds of useful objects and processes. This Article provides a comprehensive description of the previously unrecognized function of the patent document in incurring and securing warrants to these ontological commitments, and the respective roles of legal doctrines and practices in the patent system’s ontological project. Among other contributions, the resulting metaphysical account serves to reconcile competing interpretations of the written description requirement that have emerged from the Federal Circuit’s recent jurisprudence, and to explain why the patent system is willing and able to examine, grant and enforce claims reciting theoretical entities. While this Article is entirely descriptive, it concludes by identifying promising normative and prescriptive implications of this work, including the formulation of an appropriate test for the patent-eligibility of software-implemented inventions in the post-Bilski era. ∗ Associate Professor, University of North Carolina School of Law. The author wishes to thank Adam Candeub, David Chalmers, Kevin Collins, John Conley, Michael Corrado, Tim Holbrook, David Lange, Marc Lange, Mark Lemley, Adam Mossoff, Daniel Nazer, Kristen Osenga, Arti Rai, and Kathy Strandburg for helpful comments and suggestions at different stages of this project. U N I V E R S I T Y O F P I T T S B U R G H L A W R E V I E W P A G E | 2 6 4 | V O L . 7 4 | 2 0 1 2 ISSN 0041-9915 (print) 1942-8405 (online) ● DOI 10.5195/lawreview.2012.194 http://lawreview.law.pitt.edu Table of

An Analysis of Federal Circuit Discrimination: The Evolution of the Written Description Requirement Vis-a-Vis DNA and Biotechnological Inventions Concerns for Synthetic Biology

The Federal Circuit uses particular patent doctrines as policy levers to control the nature of the nation's patent output. To this end, the Court will actively discriminate in it's application of the Patent Act, depending on the nature of the technology before it. One example of such a lever is the written description doctrine. Most recently, the court has looked to this doctrine in an effort to limit the scope of biotechnology patents in general and DNA patents in particular. This paper provides a cursory review of this law regarding the enigmatic written description requirement, examining particularly its history and purposes. It then examines some of the recent cases that allude to the Federal Circuit's particular efforts in the biotechnology industry. Finally, it presents a potentially problematic technology for future implementation of discriminatory practices by the court.

What is the 'Invention'?

Patent law is in flux, with recent disputes and change 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. However, upon a closer look, many of the cases concern a single, fundamental dispute. Conflicts in opinions on such issues as claim interpretation methodology and the written description requirement are really disagreements as to what exactly is the “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, where 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 that relies almost exclusively on the claim, a single sentence at the end of the patent. These two definitions can be judged against common patent theories to determine which best fits the theories’ narratives. The external invention definition, by grounding exclusivity around what the inventor has actually done or plans to do, is more likely to cause the patent to operate as these theories assume. And once a definition of invention is selected, doctrinal conflicts and ambiguities are more easily resolvable.

Introducing new evidence in patent appeals from USPTO

Introducing new evidence in patent appeals from USPTO

US Federal Circuit determines a written description requirement separate from the enablement requirement in US patent law

Industrial BiotechnologyVol. 6, No. 6 FEATURE COMMENTARYUS Federal Circuit determines a written description requirement separate from the enablement requirement in US patent lawStuart MacphailStuart MacphailSearch for more papers by this authorPublished Online:27 Dec 2010https://doi.org/10.1089/ind.2010.6.330AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byPatent law developments in 2010: Retrospective and future directions John B. Pegram1 March 2011 | Industrial Biotechnology, Vol. 7, No. 1 Volume 6Issue 6Dec 2010 InformationCopyright 2010, Mary Ann Liebert, Inc.To cite this article:Stuart Macphail.US Federal Circuit determines a written description requirement separate from the enablement requirement in US patent law.Industrial Biotechnology.Dec 2010.330-334.http://doi.org/10.1089/ind.2010.6.330Published in Volume: 6 Issue 6: December 27, 2010PDF download

CAFC Finds a Separate Written Description Requirement; Criticism of Bars to Patentability in Indian Law; Patent on Lysine-Synthesizing Bacteria Dies for Lack of Best Mode Description

CAFC Finds a Separate Written Description Requirement; Criticism of Bars to Patentability in Indian Law; Patent on Lysine-Synthesizing Bacteria Dies for Lack of Best Mode Description