Category Archives: Intellectual Property

New Edition! Medical Devices Law and Regulation Answer Book (2019 Edition)

PLI recently published the 2018 edition of Medical Devices Law and Regulation Answer Book, in which more than thirty contributors from various law and consulting firms share their expertise regarding the wide range of topics encountered in this heavily regulated field.

This book provides in-depth coverage of individual FDA programs that govern everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations and more. Presented in a question-and-answer format, this guide also discusses related topics that have a marked impact on the medical devices industry, such as intellectual property, product liability, and reimbursement.

Medical Devices Law and Regulation Answer Book is designed to distill the essential elements of this complex regulatory environment and provide a practical guide to the complexities of FDA regulation of medical devices. It is a practical, in-depth reference for all lawyers, consultants, and companies operating in the medical devices sector, as well as all companies contemplating entertering it .

This updated answer book is available on PLI PLUS, our research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

Treatise Update! Cybersecurity: A Practical Guide to the Law of Cyber Risk

PLI recently updated Cybersecurity: A Practical Guide to the Law of Cyber Risk.

Among the many developments in this fast-moving field that are reflected in this treatise release are:

  • General Data Protection Regulation: The EU’s new General Data Protection Regulation (GDPR), effective May 2018, applies to most companies that collect personal data from individuals in the EU. The GDPR sets forth requirements for maintaining substantive security safeguards and notifying the supervisory authority and impacted individuals of breaches, and provides for significant financial penalties for noncompliance.
  • OCIE Risk Alert pertaining to broker-dealers: In an August 2017 Risk Alert, the SEC Office of Compliance Inspections and Examinations summarized observations from its second cybersecurity survey of broker-dealers and investment advisers, and noted a number of areas
    where compliance and oversight merited attention, signaling the issues on which it intends to focus in its yearly examinations.
  • Regulation of cybersecurity in the financial services industry: The discussion in chapter 5, Cybersecurity in Regulated Sections, is expanded to cover additional governmental agencies and industry associations that regulate financial services.
  • Requirements for defense contractors: In September 2017, the Director of the Defense Pricing/Defense Procurement and Acquisition. Policy issued guidance that recognizes that NIST Special Publication 800-171 avoids mandating specific solutions and provides latitude to
    contractors for how they choose to implement security controls and assess their own compliance with cybersecurity requirements. The guidance is notable because it allows small businesses with limited IT or cybersecurity expertise to meet the requirements of the special publication.
  • Cybersecurity of Federal Networks and Critical Infrastructure: President Trump’s Executive Order 13800 directs a broad examination of cybersecurity vulnerabilities at federal agencies; it also reaffirms the Obama administration’s approach to cybersecurity protections for critical infrastructure, seeking to promote the growth and sustainment of the nation’s cybersecurity workforce in the public and private sectors.

The updated treatise is available on PLI PLUS, our online research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

Treatise Update! How to Write a Patent Application

PLI recently updated the acclaimed How to Write a Patent Application.

Stocked with drafting checklists and sample drafting language, documents, and drawings, the third edition of How to Write a Patent Application walks you step by step through the entire process of preparing patent applications.

In this release, the author expands and updates your treatise with
practical information on the following topics and more:

  • Micro entity status: One commentator has suggested that micro entity status should never be claimed, because the costs will outweigh the benefits.
  • Expanded Collaborative Search Pilot Program: This release describes the basic requirements to quality for the program, which results in an expedited first office action, but no further expedited examination.
  • Patent agents: The Texas Supreme Court has recognized a patent agent–client privilege, although not all communications are protected (In re Silver).
  • Patentable subject matter—preemption: In Return Mail, Inc. v. U.S. Postal Service, the Federal Circuit noted that the issue of whether a claim completely preempts others from entering the field plays a part in analysis of whether the invention is patentable subject matter. The absence of preemption supports a determination that a claim is patent eligible, but the absence of preemption does not necessarily save a claim.
  • Indefiniteness—claims that are in two statutory classes: Claims that cover two statutory classes, such as a claim that covers both an apparatus and a method of using that apparatus, can be indefinite. However, using functional language to define the properties of an apparatus does not render the claims indefinite. According to the Federal Circuit, a claim that requires specific actions performed by the user rather than capabilities of the system is indefinite under 35 U.S.C. § 112 (MasterMine Software, Inc. v. Microsoft Corp.).
  • Writing the specification—background section: The author contraststwo separate philosophies as to what should be included in the background section: One is to include substantially nothing; the other is to make a sales pitch.
  • Design patent applications—cross-references: If appropriate, a design patent application can include a cross-reference section to related applications. The cross-reference section should also include any priority claim such as to previously filed design applications or even utility applications. However, a claim to a nonprovisional utility application cannot include a claim to priority of a provisional application from which the intermediate application claims priority.
  • Software patent applications—writing a specification defining subject matter eligibility: To avoid a subject matter rejection under Alice Corp Pty. Ltd. v. CLS Bank International, it is desirable that the claims contain limitations that satisfy subject matter eligibility requirements, with support for the claims in the specification. Accordingly, the author offers six drafting suggestions for the specification.
  • Biotechnology patent applications—presentation of nucleotide and amino acid sequences: Patent Office rules standardize the disclosure of nucleotide and amino acid sequences in biotechnology patent applications. The rules facilitate the examination and printing of detailed sequence information and do not alter the substantive requirements of the patent statute. Among other things, these rules require that all patent applications containing an unbranched sequence of four or more amino acids, or an unbranched sequence of ten or more nucleotides, contain a sequence listing. The sequence listing must be submitted in paper or compact disc form, as well as submitted in a computer-readable form (CRF) using standardized symbols and format. The rules are part of an international effort to facilitate the electronic transfer of sequence information for universal use.
  • Foreign patent applications—broadening claims: Practitioners should be aware that, in Europe, once an application has been filed, it is very difficult to broaden a claim. Thus a claim directed to elements A, B, and C may not be broadened to include just A and B, even if the specification specifically reports such an option. Accordingly, it is desirable in a first filing in many foreign countries, including in the European Patent Office, to include very broad claims.

The updated treatise is available on PLI PLUS, our research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

Treatise Update! Sack on Defamation

Written by a U.S. Court of Appeals judge and cited by courts throughout the United States–including by the U.S. Supreme Court–Sack on Defamation delivers definitive legal, strategic, and tactical insight into libel, slander, and other defamation-related causes of action for both plaintiffs’ and defense attorneys.

Highlights of the new release include:

• Context of allegedly defamatory statement: In McKee v. Cosby, the
plaintiff accused the defendant of defaming her in a letter by using her
published statements out of context. But the First Circuit, applying
Massachusetts law, concluded to the contrary, noting that the quotations
were “immediately followed by a hyperlink to the source article, allowing
readers to put [the plaintiff’s quoted] statements into proper context.”
• Defamation of groups and group members: In Elias v. Rolling Stone
LLC, the Second Circuit, applying New York law, held that it was error
to dismiss a defamation cause of action brought by a group of fifty-three
members of a college fraternity, based on a false published statement
by the defendant that some nine of the fraternity’s then members had
committed or participated in a rape at their fraternity house.
• Hepps doctrine—matters of public concern: The Texas Supreme Court,
in Brady v. Klentzman, has “recognized that even if the general subject
matter of a publication may be a matter of legitimate public concern,
some of the details may not be. But if a ‘logical nexus’ exists between
these details ‘and the general subject matter’ of the article, then they are
reasonably included as a matter of public concern.”
• Opinion—emojis and emoticons: Digital media may well give rise to
a new context in which to decide whether a statement is fact or opinion.
One can guess that emojis and emoticons will, by their nature, ordinarily
be treated as nonactionable opinion or commentary. See § 4:3.1[A], at
note 121.1.
• Public officials: Persons held to be public officials include the director of
budget and finance for a public school system; a former town clerk who,
as such, “had the primary responsibility for organizing and issuing the
payroll for the town”; and the deputy manager of a U.S. shuttle projects
office partially responsible for overseeing the development and operation
of the propulsion systems for the ill-fated Challenger shuttle.
• “Actual malice”—fictionalization: In Lovingood v. Discovery
Communications, Inc., a federal district court in Alabama found no
“actual malice” where a BBC docudrama broadcast under license by the
defendant contained an invented scene defamatory of the public-figure
plaintiff; “there is no evidence from which jurors could reasonably infer
that the . . . defendants had reason to doubt the accuracy of the scenes
in the . . . film or that the defendants’ failure to do more to investigate
the accuracy of the two scenes at issue evidences ‘an intent to avoid the
truth.’”
• Absolute privilege—statements to federal authorities: Statements to
federal officials may also be entitled to absolute privilege. For example,
in Mangold v. Analytic Services, Inc., a divided panel of the Fourth Circuit
held that statements made by a government contractor in the course of
the investigation of an Air Force colonel’s dealings with the contractor
were absolutely privileged. The court saw the privilege as analogous
to immunity for testimony in court, before a grand jury, and to public
prosecutors.
• Qualified privilege—charges of child sexual abuse: In Connecticut, by
statute, charges of child sexual abuse made to the Department of Children
and Families are entitled to qualified immunity.
• Damages: Although the courts continue to monitor and sometimes limit
damage awards, there are still large libel verdicts that survive appellate
review, as a number of multi-million-dollar cases demonstrate.
• Jurisdiction—New York long-arm statute: New York’s long-arm
statute includes exceptions that limit its application in defamation cases;
this favorable treatment of defendants in defamation cases has been held
by the Second Circuit, in a thorough opinion by Judge Walker, to be
constitutional, abridging neither the plaintiff’s First Amendment right to
petition nor his or her Fourteenth Amendment rights to equal protection
(Friedman v. Bloomberg L.P.).
• Texas Defamation Mitigation Act: In addition to its anti-SLAPP statute,
Texas has enacted the Defamation Mitigation Act, which requires a
prospective plaintiff to make a request of the prospective defendant for a
correction, clarification, or retraction of offending allegedly defamatory
material before bringing a defamation action, unless the defendant has
made such a correction, clarification, or retraction without such a request.
• Anti-SLAPP laws—Massachusetts, Maine: Recent cases interpret and
apply the anti-SLAPP statutes of Massachusetts (Blanchard v. Steward
Carney Hospital, Inc.) and Maine (Gaudette v. Mainely Media, LLC),
which are both aimed at protecting the constitutional right to petition,
rather than freedom of speech or of the press generally.

The updated treatise is available on PLI PLUS, our online research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.