With the June 9 deadline for national implementation fast approaching, we surveyed colleagues in our other European offices to check the state of play in their jurisdiction. The picture which emerged was mixed. Much progress has been made towards natio…Continue Reading ...
Dystopian novels and science fiction often return to the subject of the loss of personal privacy which is often encouraged by the use of technology enabling constant, omnipresent surveillance. Perhaps the most famous example of this in the science fiction canon of the 20th century is George Orwell’s Nineteen Eighty-Four. First published in 1949, Orwell’s novel conceives of a world where government surveillance is so complete that the vast majority of citizens don’t mind being watched by two-way…
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Patent claims can recite a numerical range and a patent can be awarded based on the novelty and nonobviousness of the claimed range. Normally, compositions are claimed in this manner but other types of inventions can be defined in terms of a numerical …Continue Reading ...
Facebook has seen better times for sure. The reviews on Facebook’s reaction to the recent Cambridge Analytica disaster have been far from glowing. Can Facebook address consumer concerns with privacy, particularly when a good part of its business model is based on the commodification of user data? If its profit center is primarily selling data, what can Facebook do to better protect privacy. Should it obtain “more” consent? How much “consent” is enough? One potential fix (and practically I don’t know how this would be implemented) would be to change Facebook to a B Corp—a public benefit corporation. Facebook could become a corporation that is not primarily driven by maximizing shareholder value, but instead also by the public interest. Here is a description of the Delaware B Corp:A public benefit corporation (PBC) will be formed in the same manner as any other corporation formed under the Delaware General Corporation Law. However, in order to be a PBC, the corporation’s certificate of incorporation must identify one or more specific public benefits and must have a name that clearly identifies its status as a PBC. Public benefits for which corporations may be formed include, but are not limited to, those of an artistic, charitable, cultural, economic, educational, environmental, literary, medical, religious, scientific or technical nature.At least once every two years, a public benefit corporation must send its stockholders a statement with respect to its promotion of the public benefit(s) identified in its charter, as well as its promotion of the best interests of those materially affected by the corporation’s conduct.This is not a “perfect” fix, but maybe it is a move in the right direction.
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American Conference Institute (ACI) will be holding is 9th Annual Summit on Biosimilars on June 25-27, 2018 in New York, NY. Patent Docs author Kevin Noonan is a co-chair of this conference. ACI faculty will help attendees: • Explore the current initiatives to foster innovation and lower healthcare costs from the current administration; • Review current case law that will impact the biologics marketplace, such as Amgen v. Hospira and Amgen v. Sanofi; • Compare various strategies for biosimilar manufactures and reference product sponsors in view of the Supreme Court’s Sandoz v. Amgen case; • Consider strategic decisions related to…Continue Reading ...
Strafford will be offering a webinar entitled “Patent Inventorship: Best Practices for Determination and Correction — Distinguishing Between Inventor and Contributor; Navigating Joint Inventorship, Disclosure of Ownership, Real Party in Interest” on M…Continue Reading ...
The John Marshall Law School Center for Intellectual Property, Information & Privacy Law will be holding its 9th Annual Program on Ethics in the Practice of Intellectual Property Law from 12:30 to 5:15 pm on April 27, 2018 in Chicago, IL. The conference will consist of the following sessions: • What IP Lawyers Should Know About ARDC Proceedings and Client Complaints • Ethical Issues in Providing Pro Bono IP Representation • Trademark Scams and Unauthorized Practice of Trademark Law • Mental Health and Addiction Issues Among Lawyers: A Focus on Clinical Depression and Substance Use Disorders Additional information about the…Continue Reading ...
Strafford will be offering a webinar entitled “Patent Ownership Rights: Structuring Assignment and Employment Contracts — Key Provisions, Implications for Litigation, Recent Court Treatment” on May 3, 2018 from 1:00 to 2:30 pm (EDT). Eman Ahmed-Fakhry…Continue Reading ...
The Intellectual Property Owners Association (IPO) European Practice Committee will be hosting a one-day conference entitled “The Very Essence of Romance is Uncertainty” on May 3, 2017 in Amsterdam, Netherlands. The conference will include sessions on the following topics: • “Shapes Of Things to Come” — Current Legislative and Juridical Trends in the US • “My Weakness is None of Your Business” — The Present and Future of Discovery and Trade Secrets • “Traummaschine” — What Future Does the UPC Hold for Us? • “Wir Sind De Roboter” — IP and Legal Tech A program for the conference, including an…Continue Reading ...
The Knowledge Group will offer a webcast entitled “Recent Developments in Double Patenting: ODP Challenges and Considerations” on May 2, 2018 from 12:00 to 1:30 pm (ET). Russell S. Timm of Womble Bond Dickinson (US) LLP, Carl A. Morales of Dechert LLP, and Bonnie Weiss McLeod of Cooley LLP will address the following topics: • ODP — Trends and Developments • Risks for Patent Owners • Challenges and Considerations • Recent Double Patenting Court Rulings • Best Practices to Protect Against ODP Issues The registration fee for the webcast is $99. Those interested in registering for the webinar can do…Continue Reading ...
$$ The mirror 70 is bounded by and merges smoothly into a pair of convex cylindrical ears 74 that connect the walls 28, 30 an…Continue Reading ...
D. Delaware was affirmed:
West-Ward Pharmaceuticals International Limited
and West-Ward Pharmaceuticals Corp. (collectively,
“West-Ward”) appeal from the decision of the United
States District Court for the District of Delaware holding,
after a bench trial, claims 1–9, 11–13, and 16 (“the asserted
claims”) of U.S. Patent 8,586,610 (“the ’610 patent”)
infringed and not invalid. See Vanda Pharm. Inc. v.
Roxane Labs., Inc., 203 F. Supp. 3d 412 (D. Del. 2016)
(“Opinion”). For the following reasons, we affirm.
We first address whether, beyond the jurisdictional
question, a claim for infringement of the ’610 patent
under 35 U.S.C. § 271(e)(2)(A) can lie where the ’610
patent issued after the original ANDA was submitted and
Vanda sued West-Ward for infringement of the asserted
claims prior to West-Ward submitting a Paragraph IV
certification. The district court held that West-Ward’s
submission of the Paragraph IV certification for the ’610
patent was an act of infringement. See Opinion, 203 F.
Supp. 3d at 433. We review the district court’s statutory
interpretation without deference. Warner–Lambert, 316
F.3d at 1355.
Vanda argues that it proved an act of infringement
under 35 U.S.C. § 271(e)(2). According to Vanda, “[w]here
a patent issues after an ANDA is filed but before FDA
approval, and where—as here—the applicant submits a
Paragraph IV certification directed at the new patent,
that amendment of the ANDA is an act of infringement
under Section 271(e)(2).” Appellee Br. 60
West-Ward responds that there can be no infringement
under § 271(e)(2) because the ANDA was filed
before the ’610 patent issued. West-Ward contends that
the statutorily defined act of infringement excludes
amendments to an ANDA and “only reaches ANDAs
submitted ‘for a drug claimed in a patent or the use of
which is claimed in a patent’—not a drug that might or
might not later be claimed in a patent or one that has
been claimed in a provisional patent application or a
patent-pending.” Reply Br. 33 (emphases in original)
(quoting 35 U.S.C. § 271(e)(2)(A)) (other internal quotation
The CAFC observed:
Although we agree with West-Ward that only an issued
patent can give rise to a valid infringement claim
under § 271(e)(2)(A), we disagree that that conclusion
precludes Vanda’s infringement claim in this case. The
’610 patent is a patent “for a drug . . . the use of which is
claimed in a patent,” 35 U.S.C. § 271(e)(2)(A), as contemplated
in the Act even though it issued after West-Ward
filed its ANDA. West-Ward subsequently amended its
ANDA to include a Paragraph IV certification for the ’610
patent after it issued. The infringement analysis under
§ 271(e)(2)(A) “require[s] consideration of the amended
ANDA.” Ferring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d
1382, 1390 (Fed. Cir. 2014). “There is no support for the
proposition that the question of infringement must be
addressed solely based on the initial ANDA filing, given
that the statute contemplates that the ANDA will be
amended as a matter of course.”
Here, it is undisputed that West-Ward amended the
ANDA by submitting a Paragraph IV certification regarding
the ’610 patent after that patent issued. J.A. 19696;
J.A. 6414–15; Appellant Br. 10; Appellee Br. 59. Such an
act is a qualifying act of infringement under
§ 271(e)(2)(A).6 A filer of an ANDA is therefore subject to
a § 271(e)(2)(A) infringement claim on a patent that
issues after the filing of the ANDA, but before FDA approval.
The resolution of infringement claims under
§ 271(e)(2)(A) for patents that issue after an ANDA is
submitted, but before it is approved, “facilitates the early
resolution of patent disputes between generic and pioneering
drug companies” in accordance with the purpose
of § 271(e)(2)(A). Caraco I, 527 F.3d at 1283.
The FDA regulatory framework and the legislative
history further demonstrate that West-Ward is incorrect
in asserting that “application” in § 271(e)(2)(A) excludes
amendments to the ANDA.
Thus, the district court properly conducted its
infringement analysis for the ’610 patent pursuant to 35
U.S.C. § 271(e)(2)(A).
As to 101:
We next address whether the asserted claims are directed
to patent-eligible subject matter. West-Ward
argues that the asserted claims are ineligible under § 101
because they are directed to a natural relationship between
iloperidone, CYP2D6 metabolism, and QT prolongation,
and add nothing inventive to those natural laws
and phenomena. West-Ward contends that the asserted
claims are indistinguishable from those held invalid in
Association for Molecular Pathology v. Myriad Genetics,
Inc., 569 U.S. 576 (2013) and Mayo Collaborative Services
v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).
Vanda responds that the asserted claims are patenteligible
under § 101 at both steps of Mayo/Alice. Vanda
contends that the district court erred in holding that the
asserted claims are directed to a law of nature.
CJ Prost dissenting:
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I would find the asserted patent claims to be directed
to a law of nature. The majority finds the claims herein
are not directed to a natural law at step one of the § 101
analysis, but its efforts to distinguish Mayo cannot withstand
scrutiny. The majority relies on the claims’ recitation
of specific applications of the discovery underpinning
the patent to find no natural law is claimed. But it conflates
the inquiry at step one with the search for an
Michael Risch has posted an interesting empirical paper on ssrn titled Sue First, Negotiate Later. Here is a link, and here is the abstract:
One of the more curious features of patent law is that patents can be challenged by anyone worried about being sued. This challenge right allows potential defendants to file a declaratory relief lawsuit in their local federal district court, seeking a judgment that a patent is invalid or noninfringed. To avoid this home-court advantage, patent owners may file a patent infringement lawsuit first and, by doing so, retain the case in the patent owner’s venue of choice. But there is an unfortunate side effect to such preemptive lawsuits: they escalate the dispute when the parties may want to instead settle for a license. Thus, policies that allow challenges are favored, but they are tempered by escalation caused by preemptive lawsuits. To the extent a particular challenge rule leads to more preemptive lawsuits, it might be disfavored.
This article tests one such important challenge rule. In MedImmune v. Genentech, the U.S. Supreme Court made it easier for a potential defendant to sue first. Whereas the prior rule required threat of immediate injury, the Supreme Court made clear that any case or controversy would allow a challenger to file a declaratory relief action. This ruling had a real practical effect, allowing recipients of letters that boiled down to, “Let’s discuss my patent,” to file a lawsuit when they could not before.
This was supposed to help the accused potential defendants, but not everyone was convinced. Many observers at the time predicted that the new rule would lead to more preemptive infringement lawsuits filed by patent holders. They would sue first and negotiate later rather than open themselves up to a challenge by sending a demand letter. Further, most who predicted this behavior—including parties to lawsuits themselves—thought that non-practicing entities would lead the charge. Indeed, as time passed, most reports were that this is what happened: that patent trolls uniquely were suing first and negotiating later. But to date, no study has empirically considered the effect of the MedImmune ruling to determine who filed preemptive lawsuits. This Article tests MedImmune’s unintended consequences. The answer matters: lawsuits are costly, and increased incentive to file challenges and preemptive infringement suits can lead to entrenchment instead of settlement.
Using a novel longitudinal dataset, this article considers whether MedImmune led to more preemptive infringement lawsuits by NPEs. It does so in three ways. First, it performs a differences-in-differences analysis to test whether case duration for the most active NPEs grew shorter after MedImmune. One would expect that preemptive suits would settle more quickly because they are proxies for quick settlement cases rather than signals of drawn out litigation. Second, it considers whether, other factors equal, the rate of short lived case filings increased after MedImmune. That is, even if cases grew longer on average, the share of shorter cases should grow if there are more placeholders. Third, it considers whether plaintiffs themselves disclosed sending a demand letter prior to suing.
Continue Reading ...It turns out that the conventional wisdom is wrong. Not only did cases not grow shorter – cases with similar characteristics grew longer after MedImmune. Furthermore, NPEs were not the only ones who sued first and negotiated later. Instead, every type of plaintiff sent fewer demand letters, NPEs and product companies alike. If anything, the MedImmune experience shows that everyone likes to sue in their preferred venue.
The chart above comes from the newest update on Continuing Patent Applications by Cotropia and Quillen. [LINK]. The article notes “Application Allowance Rates corrected for Refiled Continuing Applications have continued to increase, reaching 96% in FY 2017.”Continue Reading ...