Monday, October 15, 2018

The idea of compulsory licensing of patents in the health context?


This author has discussed the relevance of certain World War I federal statutes on later patent policy. See for example:

Where have you gone, Richard K. Lyon?, Int. Prop. Today, p. 20 (Dec. 2001) (discussing patent issues with CIPRO during the anthrax scare)

The Impact of World War I on Present Day Patent Issues, Int. Prop. Today p. 35 (Feb. 2005).


Now, in 2018, from healthleadersmedia :


Section 1498 was used to negotiate lower drug prices in the 1960s and '70s, but has since faded. In 2001, during the nation's anthrax scare, the Department of Health and Human Services threatened to invoke it to procure more of the antibiotic used to treat the deadly bacterial disease, according to contemporaneous reports. Last year, Louisiana's health secretary unsuccessfully tried to use it to ease the toll pricey hepatitis C medications exerted on the state's Medicaid program.NIH Director Francis Collins remains skeptical, repeatedly saying that a drug's price doesn't constitute a health or safety concern within the agency's jurisdiction.HHS Secretary Alex Azar, speaking at a June Senate hearing, described march-in, also known as "compulsory licensing," as a "socialist" approach.




link: https://www.healthleadersmedia.com/strategy/battle-control-drug-costs-old-patent-laws-get-new-life

See also

http://ipbiz.blogspot.com/2008/12/gilead-sues-teva-over-truvada.html

See also


Patents on drugs are not the only issue in the release of generic formulations


with text:


As to a choice "between the generic version of the older
but effective drug and the convenient but more expensive patented version," see some of
the discussion surrounding the drug -- tenofovir alafenamide fumarate ("TAF")-- compared with the drug --tenofovir disoproxil fumarate ("TDF"), a component of Truvada. Truvada made the recent FDA list of Reference Listed Drug (RLD) Access Inquiries (with no REMS issue). The FDA approved generic Truvada in 2017, with Teva and Gilead making a deal. Some of the lawsuits involving Gilead and TAF are over issues other than patents,
including asserted ethics issues of delaying market entry of a drug with superior safety profiles.



See also

https://ipbiz.blogspot.com/2018/05/aids-healthcare-foundation-loses-appeal.html

Friday, October 12, 2018

Kavanaugh, Henius, and McLean


One thing that was not disputed in the Senate hearings on Judge Kavanaugh was that, as a young man, Kavanaugh enjoyed beer.
As one bit of trivia, Max Henius (Ph.D., chemistry, University of Marburg, 1881) founded the Chicago-based American Brewing Academy, which became a school for brewmasters, and later was instrumental in creating Rebild National Park in Denmark, supposedly the site of the largest "Fourth of July" celebrations outside of the United States (Rebildfesten). Beer is patriotic [?]

Separately, one issue related to Kavanaugh which did not "take off" seemed to be the role of Monica McLean, a high school classmate of Ford's and a graduate of the University of Baltimore School of Law.

Links:

https://www.google.com/amp/s/theconservativetreehouse.com/2018/10/03/retired-fbi-agent-doj-lawyer-ms-monica-mclean-attended-kavanaugh-hearing-with-blasey-ford/amp/

https://threadreaderapp.com/thread/1047681243633111040.html


Teva loses appeal of invalidity of patent claims of 40mg Copaxone multiple sclerosis drug


The CAFC affirmed the decision of D. Delaware of invalidity of claims:



Plaintiffs-Appellants Teva Pharmaceuticals USA,
Inc., Teva Pharmaceutical Industries, Ltd., Teva Neuroscience,
Inc., and Yeda Research and Development Co.,
Ltd., appeal the decision of the United States District
Court for the District of Delaware invalidating all asserted
claims of patents directed to COPAXONE® 40mg/mL, a
product marketed for treatment of patients with relapsing
forms of multiple sclerosis. Because the district court
correctly held the asserted claims invalid as obvious
under 35 U.S.C. § 103, we affirm.




Footnote 1 of the case


In a companion case decided today, Yeda Research
& Development Co., v. Mylan Pharmaceuticals Inc., Nos.
17-1594, 17-1595, 17-1596 (Fed. Cir. Oct. 12, 2018), Yeda
Research and Development Co. appealed from the Patent
Trial and Appeal Board’s final written decisions finding
all claims of U.S. Patent Nos. 8,232,250, 8,399,413, and
8,969,302 unpatentable as obvious in three related inter
partes review proceedings.
[Therein: "We affirm the
Board’s decisions."]



The use of the Khan (2009) reference was of interest:


The district court admitted the Khan 2009 reference
for the limited purpose of showing the state of the art at
the time of the invention. In re Copaxone Consolidated
Cases, No. 14-1171-GMS, 2017 WL 401943, at *14 (D. Del.
Jan. 30, 2017). Khan 2009 was published three weeks
after August 20, 2009, the priority date of the Copaxone
patents, but the study began two years earlier. J.A.
23904–05. The study abstract noted that “[t]here is
considerable interest in studying a more patient friendly
dosing regimen of GA that may be as efficacious and
better tolerated than daily GA.” J.A. 23904. Following
the results of Khan 2008, which showed that alternate
day administration of GA appears to be as effective as
daily administration, Khan 2009 compared 20mg GA
administered twice a week to 20mg GA administered
daily in a pilot, prospective, randomized, and raterblinded
two-year study. J.A. 23904.

(...)

In light of these factual findings, the district court
concluded that a 40mg GA 3x/week dosage would be
obvious to try, noting that there were only two tested
dosage amounts in the prior art—20mg and 40mg—and
that researchers were pursuing less frequent dosing
regimens while recognizing there are a limited number of
days in a week on which to test frequency. See id. at *19.
The court recognized that obvious-to-try logic is not
always appropriate, but found that “[h]ere, there was
market pressure to solve a known problem—the fact that
many MS patients could not tolerate daily injections—and
there were a finite number of predictable solutions that a
person of ordinary skill in the art would have good reason
to pursue.” Id. The district court cited to Khan 2009,
Teva’s GALA study, and trial testimony as evidence of the
motivations of POSITAs at the time of the invention, and
noted evidence and testimony supporting the proposition
that a dosing schedule based on three predetermined days
each week is preferable for patients over an every other
day schedule. Id. at *20. The district court highlighted
testimony from Dr. Green that a regimen of injections on
three pre-determined days of each week is more convenient
for patients and has better patient adherence than an
every other day regimen, in which the days on which
patients inject differ depending on the week. Id.



Teva's position:


Teva contends that the district court erred in finding
the claimed 40mg GA 3x/week dosing regimen obvious.
Specifically, Teva argues that the district court impermissibly
relied on hindsight and an improper “obvious to try”
analysis, and analyzed the obviousness of individual
claim elements, rather than the invention as a whole.
Teva further maintains that the district court’s decision is
at odds with this court’s decision in In re Cyclobenzaprine
Hydrochloride Extended-Release Capsule Patent Litigation,
676 F.3d 1063 (Fed. Cir. 2012).



Of obvious to try


We have previously identified two categories of impermissible
“obvious to try” analyses that run afoul of
KSR and § 103: when what was “obvious to try” was (a) to
vary all parameters or try every available option until one
succeeds, where the prior art gave no indication of critical
parameters and no direction as to which of many possibil-
ities is likely to be successful; or (b) to explore a new
technology or general approach in a seemingly promising
field of experimentation, where the prior art gave only
general guidance as to the particular form or method of
achieving the claimed invention. See In re Kubin, 561
F.3d 1351, 1359 (Fed. Cir. 2009) (quoting In re O’Farrell,
853 F.2d 894, 903 (Fed. Cir. 1988)).
This case falls into neither of the two impermissible
categories. Here, the prior art focused on two critical
variables, dose size and injection frequency, and provided
clear direction as to choices likely to be successful in
reducing adverse side effects and increasing patient
adherence. As of the priority date, only two GA dose sizes
had been shown to be effective, safe, and well-tolerated:
20mg and 40mg. Concerning frequency, the 1996 FDA
SBOA, Flechter, and Khan 2008 all encouraged POSITAs
to pursue a less frequent than daily dosing regimen; these
references indicated that less frequent injections of GA
were just as effective as daily injections, and less frequent
injections improved patient adherence and reduced adverse
reactions.

(...)

Given this motivation, a POSITA had only a limited
number of permutations of dose and frequency to explore
that were not already disclosed in the prior art. Because
a thrice-weekly 40mg injection would result in a total
weekly dose very close to that in the already-approved
daily 20mg injection—120mg/week versus 140mg/week—
the district court found a POSITA would have had a
reasonable expectation of success in pursuing the thriceweekly
dose frequency in terms of effectiveness, patient
adherence, and FDA approval.

(...)

Although the universe of potential GA doses is
theoretically unlimited
, the universe of dosages in the
prior art that had clinical support for being effective and
safe consisted of only two doses: 20mg and 40mg. Even if
there were multiple injection frequencies not yet tested in
the prior art—1x, 2x, 3x a week etc.—these still represent
a limited number of discrete permutations.

This is not a situation where the prior art gave no direction
in how to reach a successful result; the prior art
clearly indicated that less frequent doses should be explored
(i.e., moving away from the daily, “7x/week” dose
towards less frequent doses) and that higher doses, while
maintaining the same weekly dose (i.e., moving from
20mg daily to 40mg every other day), could increase
efficacy while not affecting adverse reactions.

(...)

Nor do we find merit in Teva’s argument that the district
court separately analyzed the 40mg dose limitation
and the 3x/week limitation, without considering them
together “except to conclude that the mash-up would be
obvious to try.” Appellants’ Opening Br. 55. We note that
the district court spent considerable time discussing why
the combination of a 40mg dose administered 3x/week
would be obvious to try. See In re Copaxone, 2017 WL
401943, at *19. And while “[t]he determination of obviousness
is made with respect to the subject matter as a
whole, not separate pieces of the claim,” SanofiSynthelabo
v. Apotex, Inc., 550 F.3d 1075, 1086 (Fed. Cir.
2008), this court has previously employed the same frequency-and-dosage-amount
approach to obviousness used
by the district court here. In Hoffmann-La Roche, 748
F.3d at 1329, the court considered whether it would have
been obvious at the time of invention to select a once a
month oral dosing regimen of 150mg of ibandronate to
treat osteoporosis. The court first discussed how the prior
art taught that infrequent dosing, such as monthly dosing,
was preferred. Id. at 1329–31. The court then separately
discussed why a POSITA would have selected a
150mg dose, before considering the limitations together
and concluding that “[a]t the very least, the 150mg dose
was obvious to try.” Id. at 1331–33. Teva makes no
convincing argument why a similar approach is inappropriate
here.


Footnote 14 gets into "needle fatigue"


See, e.g., J.A. 4676–77 (Kolodny deposition, describing
needle fatigue associated with Copaxone
20mg/day); J.A. 4869 (Dr. Green, describing Khan 2008:
“It reveals clear and obvious patient preference for an
every-other-day dosing regimen when compared to a daily
dosing regimen given the option.”); J.A. 4857 (Dr. Green:
“As we discussed, most of the adverse events associated
with the use of glatiramer acetate, and in fact the most
troubling set of adverse events had to do with injection
site reactions or immediate post-injection reactions. Both
of those are tied to injections. So if you reduce the frequency
of injections, well, it’s clearly obvious that you
would reduce the frequency of those injection site reactions
or immediate post-injection reactions.”).



As to unknown mechanisms


Finally, this court’s decision in In re Cyclobenzaprine,
676 F.3d at 1063, does not warrant a different outcome.
Teva argues that prior to the invention, higher doses of
GA were not necessarily known to be more effective, GA’s
pharmacokinetic and pharmacodynamic (“pk/pd”) profile
was and remains unknown, GA’s mechanism of action is
still unknown, and the cause of patient’s reactions to
injections of GA is unknown. Teva contends that the
unpredictable nature of GA categorically precludes the
obvious-to-try analysis employed by the district court.
Appellants’ Opening Br. 50.
In Cyclobenzaprine, we held that bioequivalence alone
could not establish obviousness because “skilled artisans
could not predict whether any particular PK profile,
including a bioequivalent one, would produce a therapeutically
effective formulation.” 676 F.3d at 1070. The court
applied traditional motivation and reasonableexpectation-of-success
analysis, reasoning that “[w]hile it
may have been obvious to experiment with the use of the
same PK profile [from an immediate-release formulation]
when contemplating an extended-release formulation,
there [wa]s nothing to indicate that a skilled artisan
would have had a reasonable expectation that such an
experiment would succeed in being therapeutically effective.”
Id. In Cyclobenzaprine, there were no prior art
clinical studies to suggest what would be a therapeutically
effective formulation.

We do not read Cyclobenzaprine as establishing a rigid
rule categorically precluding obviousness findings
without pk/pd data.

(...)
In this case, the evidence shows that pk/pd data
was largely irrelevant to the invention.
Numerous clinical
studies in the prior art describe GA and its effects on
the human body. Although the precise mechanism of GA
is not known, it is known to be immunomodulating—i.e.,
it changes the immune system—and is not necessarily
measurable in the bloodstream and its levels are not
indicative of efficacy. See In re Copaxone, 2017 WL
401943, at *21–22; J.A. 3998–99, 4886–87. Testimony
was given at trial that pharmacokinetic studies for drugs
like GA are less appropriate than for small molecule
drugs, such as those at issue in Cyclobenzaprine. J.A.
4886–87. GA was also known to be “forgiving,” in that
occasional missed doses would not reduce efficacy, and
that fact gave POSITAs further confidence in eliminating
one dose every two weeks. J.A. 4848–49; 4884–85; 4732.
Higher doses were clinically shown to be at least as
effective as lower doses; Cohen shows, at the very least,
that 40mg is as effective and well-tolerated as 20mg, but
with a more rapid onset of action. Finally, Teva itself, in
its 1996 application to FDA, indicated that pharmacokinetic
studies “would be of limited value.” J.A. 20689.



Is invocation of "common sense" camouflage for conclusory assertions?


Teva finds fault with the district court’s reference to
“common sense” in its reliance on Dr. Green’s testimony.
During trial, Appellees’ expert Dr. Green testified that a
POSITA would expect reducing the frequency of injections
to be associated with enhanced overall tolerability of the
regimen. J.A. 4911. In its post-trial briefing, Teva argued
that Dr. Green’s testimony was conclusory and
unsupported by the prior art. The district court rejected



The bottom line for the CAFC:


In light of the foregoing, we conclude that the district
court did not err in invalidating all asserted claims of the
Copaxone patents as obvious.




Thursday, October 11, 2018

Plagiarism at speech at the World Medical Association (WMA)?


See the post ISRAELI DOCTOR APOLOGIZES TO CANADIAN MEDICAL ASSOCIATION, AFTER BEING ACCUSED OF PLAGIARISM
about charges leveled against Dr. Leonid Eidelman, the newly installed president of the WMA.

Lawsuit asserting bad effects from the use of gadolinium contrast agents in MRI


Another case related to (alleged) bad effects from the use of gadolinium contrast agents in MRI, as for example to seek active
lesions in multiple sclerosis.

Case No.3:18-cv-491, in the United States District Court for the Western District of North Carolina.

For background, see the previous post on IPBiz

Linear gadolinium imaging agents and clear and convincing evidence

Wednesday, October 10, 2018

Roche loses in Rifampin case


The issues in the Roche case were :101


The only issues on appeal are whether the aforementioned
primer claims and the method claims of the ’723
patent are patent-ineligible within the meaning of § 101.
Section 101 provides that “[w]hoever invents or discovers
any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the
conditions and requirements of this title.” 35 U.S.C.
§ 101. There are certain exceptions to this provision: laws
of nature, natural phenomena, and abstract ideas are not
patent-eligible subject matter. Alice Corp. v. CLS Bank
Int’l, 134 S. Ct. 2347, 2354 (2014) (collecting cases).



Roche lost.


Appellant Roche Molecular Systems, Inc. (“Roche”)
owns U.S. Patent No. 5,643,723 (“the ’723 patent”), titled
“Detection of a Genetic Locus Encoding Resistance to
Rifampin in Microbacterial Cultures and in Clinical
Specimens.” The United States District Court for the
Northern District of California found that the asserted
claims of the ’723 patent are directed to patent-ineligible
subject matter and are therefore invalid under 35 U.S.C.
§ 101. Roche appeals from a grant of summary judgment
of invalidity. We affirm.

Mixed 101 result in Data Engine Technologies v. Google


From the opinion:



Data Engine Technologies LLC (“DET”) appeals the
district court’s entry of judgment on the pleadings holding
that the asserted claims of DET’s U.S. Patent
Nos. 5,590,259; 5,784,545; 6,282,551; and 5,303,146 are
ineligible under 35 U.S.C. § 101. The district court held
that the asserted claims are directed to abstract ideas and
fail to provide an inventive concept. We conclude that,
with the exception of claim 1 of the ’551 patent, the asserted
claims of the ’259, ’545, and ’551 patents (“Tab
Patents”) are directed to patent-eligible subject matter.
These claims are not abstract, but rather are directed to a
specific improved method for navigating through complex
three-dimensional electronic spreadsheets. We agree,
however, that the asserted claims of the ’146 patent,
reciting methods for tracking changes to data in spreadsheets,
are directed to the abstract idea of collecting,
recognizing, and storing changed information. After a
searching review, we find nothing in these claims that
provides an inventive concept sufficient to render the
claims patent eligible. Accordingly, we affirm-in-part,
reverse-in-part, and remand.



QuatroPro is mentioned:


Although these spreadsheet interfaces have become
ubiquitous, Quattro Pro, the first commercial embodiment
of the claimed invention, was highly acclaimed as having
revolutionized three-dimensional electronic spreadsheets.
During prosecution, DET submitted contemporaneous
articles showing the state of the art at the time of the
invention and evidencing the significance of the claimed
methods to spreadsheet technology. For example, PC
World, a leading computer magazine, published a frontpage
article, “Quattro Pro for Windows: The Ultimate 3-D
Spreadsheet.” J.A. 981. The article reflected the industry’s
view that “keeping large, complex worksheet projects
organized, manageable, and reliable ha[d] long been a
major concern for serious spreadsheet users” and that
existing spreadsheets had “data and results hidden all
over the place.” J.A. 982. The article touts the claimed
notebook-tabbed spreadsheet interface as a solution to
that problem, explaining that it “makes developing nifty
applications far easier for the average spreadsheet user,
and [that] intelligent command organization makes
navigation efficient.” Id. PC World published another
cover story naming Quattro Pro “The Best of 1992,” again
lauding it as “the first spreadsheet to make threedimensional
modeling an accessible, useful analytic tool.”
J.A. 1007. The article stated that “[o]ne of the keys to the
product’s success is a notebook metaphor, in which each
worksheet page can be assigned a descriptive name and
users can navigate through the set by clicking on page
tabs.” Id.



Of the '146 patent:


Google filed a motion for judgment on the pleadings
under Federal Rule of Civil Procedure 12(c), arguing that
the asserted claims of the Tab Patents and the ’146 patent
are directed to patent-ineligible subject matter under
§ 101. The district court granted the motion with respect
to the Tab Patents, concluding that representative
claim 12 of the ’259 patent is “directed to the abstract idea
of using notebook-type tabs to label and organize spreadsheets.”
District Court Op., 211 F. Supp. 3d at 678. The
district court also agreed with Google that claim 12 “is
directed to an abstract idea that humans have commonly
performed entirely in their minds, with the aid of columnar
pads and writing instruments.” Id. at 679. The
district court held that the remaining limitations of
claim 12 fail to recite an inventive concept. Id.



Of the '259 patent:


When considered as a whole, and in light of the specification,
representative claim 12 of the ’259 patent is not
directed to an abstract idea. Rather, the claim is directed
to a specific method for navigating through threedimensional
electronic spreadsheets. The method provides
a specific solution to then-existing technological
problems in computers and prior art electronic spreadsheets.
The specification teaches that prior art computer
spreadsheets were not user friendly. They required users
to “master many complex and arbitrary operations.”
’259 patent col. 2 ll. 28–29. Users had to search through
complex menu systems to find appropriate commands to
execute simple computer tasks, which required users to
memorize frequently needed commands. Id. at col. 2
ll. 29–45. This was burdensome and hindered a user’s
ability to find or access the many commands and features
available in prior art computer spreadsheets, undercutting
the effectiveness of the computer as a means to
review and edit a spreadsheet. Id. at col. 2 ll. 45–56. This
was particularly true for three-dimensional spreadsheets,
which allowed users to build spreadsheet workspaces
consisting of multiple two-dimensional spreadsheets,
further increasing the complexity of using and navigating
between multiple spreadsheets. Id. at col. 2 l. 66–col. 3
l. 24



Note footnote 2:



The district court declined to consider the articles
included in the prosecution history, relying only on the
pleadings and the patents attached to DET’s complaint.
District Court Op., 211 F. Supp. 3d at 681 n.4. On a
motion for judgment on the pleadings, however, the court
may consider “matters of public record.” Cf. Bruni v. City
of Pittsburgh, 824 F.3d 353, 360 (3d Cir. 2016) (quoting
Pension Benefit Guar. Corp. v. White Consol. Indus., Inc.,
998 F.2d 1192, 1196 (3d Cir. 1993)). Prosecution histories
constitute public records. See Hockerson-Halberstadt, Inc.
v. Avia Group Int’l, Inc., 222 F.3d 951, 957 (Fed. Cir.
2000) (“The prosecution history constitutes a public
record . . . .”); see 37 C.F.R. § 1.11(a) (“The specification,
drawings, and all papers to the file of: [a] published
application; a patent; or a statutory invention registration
are open to inspection by the public . . . .”). We consider
this evidence relevant in our de novo review because it is
part of the Tab Patents’ prosecution histories and was
relied on in DET’s opposition to Google’s Rule 12(c) motion.




Note



Google avers that humans have long used tabs to organize
information. It cites tabbed notebooks, binder
dividers, file folders, and sticky Post-it notes as wellknown
examples of organizing information using tabs.
We agree that tabs existed outside the context of electronic
spreadsheets prior to the claimed invention. It is not
enough, however, to merely trace the invention to some
real-world analogy. The eligibility question is not whether
anyone has ever used tabs to organize information.
That question is reserved for §§ 102 and 103. The question
of abstraction is whether the claim is “directed to” the
abstract idea itself. Id. We must consider the claim as a
whole to determine whether the claim is directed to an
abstract idea or something more. Google fails to appreciate
the functional improvement achieved by the specifically
recited notebook tabs in the claimed methods. The
notebook appearance of the tabs was specifically chosen
by the inventors because it is easily identified by users.
The tabs are not merely labeled buttons or other generic
icons. DET has disclaimed as much. See Oral
Arg. at 11:03–47. Rather, the notebook tabs are specific
structures within the three-dimensional spreadsheet
environment that allow a user to avoid the burdensome
task of navigating through spreadsheets in separate
windows using arbitrary commands

American Chemical Society goes after ResearchGate for copyright infringement


The American Chemical Society (and Elsevier) filed suit in the federal District Court of Maryland on 2 October 2018 asserting copyright infringement by the German entity ResearchGate.

The complaint is available on the internet.

There are a variety of issues.

As a condition of publishing, the American Chemical Society ["ACS"] requires authors to execute an assignment of copyright. Sometimes, authors will modify the agreement to allow use for "advertising" the authors or the institutions of the authors. Sometimes, authors, who do not modify, are not fully aware of the restrictions imposed by the standard ACS form. ResearchGate apparently gets some of its copies from websites into which authors have posted copies of their articles.

As to publication requirements on papers arising from federally-funded research, note the policy impacting papers arising through funding by
the National Science Foundation [NSF]:



NSF's policy on public access to copyrighted material (Public Access Policy) reflects the Foundation's commitment to making certain that, to the extent possible, the American public, industry and the scientific community have access to the results of Federally funded scientific research. Pursuant to this policy, grantees must ensure that articles in peer-reviewed scholarly journals and papers in juried conference proceedings:

are deposited in a public access compliant repository (as identified in the Public Access Policy);
are available for download, reading, and analysis within 12 months of publication
;
possess a minimum set of machine-readable metadata elements as described in the Public Access Policy; and
are reported in annual and final reports with a persistent identifier.
Either the final printed version or the final peer-reviewed manuscript is acceptable for deposit. NSF’s Public Access Policy applies to awards, funded in whole or in part, as a result of proposals submitted, or due, on or after January 25, 2016. NSF’s Public Access Policy may be viewed at: http://www.nsf.gov/news/special_reports/public_access/index.jsp.


If the ACS policy sounds vaguely familiar, look back to a post on IPBiz in the year 2006:



Journal publication, pubmedcentral and the ACS
, including the text:


In context, Nally is complaining about posting of scientists' final, peer-reviewed articles on an internet website (pubmedcentral) within 12 months AFTER publication in the journal.

I could not help thinking about Dan Hunter's article, Walled Gardens, 62 Wash & Lee L. Rev. 607, which complained about the requirement of some law reviews that articles which had been pre-published on an internet website to be removed from the website BEFORE publication in the journal.

The common theme is the perceived undesirability, by the journals, of information being made available on the internet. The noncommon theme is the timing. The SCIENCE journals have the expectation of presenting the information FIRST, and worry about the impact of later publication. The LAW journals do not care that the information has been presented somewhere else first, but don't want someone to access the information (presented elsewhere first) AFTER they decide to publish it LATER.



See also the 2004 post
American Chemical Society suing Google over google scholar?



Saturday, October 06, 2018

NAI loses appeal of IPR decision at the CAFC; 120 and chain of priority issues



Woodbolt Distributors, LLC (“Woodbolt”) requested
that the United States Patent and Trademark Office
(“PTO”) reexamine U.S. Patent No. 8,067,381 (“the ʼ381
patent”) owned by Natural Alternatives International,
Inc. (“NAI”). The PTO ordered inter partes reexamination,
and the examiner rejected the challenged claims as
anticipated by or obvious over cited prior art, including a
parent of the reexamined patent. NAI appeals the Patent
Trial and Appeal Board’s (“Board”) final determination
affirming the examiner’s rejections and its subsequent
denial of NAI’s request for rehearing. Woodbolt is not a
party to this appeal. The Director of the PTO has intervened
to defend the Board’s decision. We have jurisdiction
pursuant to 28 U.S.C. § 1295(a)(4)(A). We affirm.



Of the history


District court litigation involving the ʼ381 patent
commenced between NAI and Woodbolt in December
2011.2 In May 2012, during that proceeding, Woodbolt
sought inter partes reexamination of the asserted patent
claims.3 The request alleged that “the asserted claim to
priority of the ʼ381 Patent is defective” because the “applicants
deliberately and expressly terminated their claim
to the priority of the first four applications[,]” which thus
“broke[] the chain of priority between the Fourth and
Fifth Applications.” J.A. 45–46. During reexamination,
NAI did not dispute that it had waived priority to the
fourth through the first applications in its fifth application.
J.A. 971. But it insisted that the sixth application
maintained priority back to the first application because
NAI did not amend the “Cross Reference of Related Applications”
in the sixth application. According to NAI, it was
irrelevant what happened to the fifth application once the
sixth application became entitled to the first application’s
filing date. J.A. 975. Unpersuaded, the examiner finally
rejected the reexamined claims in view of prior art including
the ʼ596 patent (i.e., the patent that issued from the
first application), and then closed prosecution.4 J.A. 1210,
1226.

NAI appealed the examiner’s decision to the Board.
The Board determined that when NAI filed the eighth
application, “[t]he fifth application [was] not entitled to
the benefit of the fourth application since the specific
reference to the fourth application was deleted in the
fifth.” J.A. 13. Because the eighth application claimed
priority to the first application via the fifth application,
the Board determined that the eighth application (and
thus the ʼ381 patent) was also not entitled to the benefit
of the fourth through the first applications. See J.A. 16.
The Board issued a final written determination affirming
the examiner’s rejections and denied NAI’s request for
rehearing.

(...)

The Board determined that
when filed, the eighth application did not meet the “specific
reference” requirement of § 120 as to the filing date
of the first application. J.A. 11–12. That was so, according
to the Board, because the eighth application claimed
the benefit of the first application’s filing date by way of
the fifth application, and NAI had amended the fifth
application to claim priority to only the 2003 provisional
application. See id. In other words, because the fifth
application lacked priority to the first application, the
eighth application’s priority claim to the first application
(via the fifth application) did not satisfy all of § 120’s
requirements. The Board, therefore, did not err in determining
that the ʼ381 patent was not entitled to claim the
benefit of the filing date of the first application under
§ 120, as the priority claim in the ʼ381 patent was defective
from the start.




The MPEP arises:



As an initial matter, we note that the MPEP “does not
have the force of law[,]” Molins PLC v. Textron, Inc., 48
F.3d 1172, 1180 n.10 (Fed. Cir. 1995), and does not bind
us, Litton Sys., 728 F.2d at 1439. Nonetheless, we have
reviewed MPEP § 201.11 and find that nothing in its text
limits the scope of waiver to only the instant application.
Indeed, § 201.11 does not contemplate all possible consequences
of waiving a benefit claim in a particular application.
Moreover, at least in the context of terminal
disclaimers, the MPEP has explicitly indicated when a
disclaimer applies only to the instant application and not
to downstream applications. See, e.g., Hagenbuch v.
Sonrai Sys., 2015 U.S. Dist. LEXIS 39083, *10–13 (N.D.
Ill. Mar. 27, 2015) (explaining that “[t]he MPEP in effect
in 1993 described the effect of a disclaimer that, by its
terms, applied only to the ‘instant application’”); see also
MPEP § 1490(VI)(B) (9th ed., Rev. 8) (2017) (“A terminal
disclaimer filed to obviate a nonstatutory double patenting
rejection is effective only with respect to the application
or patent identified in the disclaimer unless by its
terms it extends to continuing applications . . . .”).



A Civil War era patent case is cited:



NAI, however, neither explains why § 120 compels
this interpretation of priority claims nor provides any case
law to support its conclusion. Nor does NAI provide any
argument to undermine the long-standing interpretation
of priority as a single chain, growing with each additional
continuation. The Supreme Court has previously explained
that under § 120, parent and continuing applications
“are to be considered as parts of the same
transaction, and both as constituting one continuous
application, within the meaning of the law.” Godfrey v.
Eames, 68 U.S. 317, 326 (1863); see also Sticker Indus.,
405 F.2d at 93 (stating that “each application in a long
chain grows out of the one immediately preceding it”). We
therefore decline to adopt NAI’s interpretation of chain of
priority.

Frito-Lay prevails in crispbread slices trademark dispute


In Real Foods v. Frito-Lay, appellant Real Foods lost, cross-appellant Frito-Lay won, although not
for the reasons argued by Frito-Lay.

The general issue:


Appellant Real Foods Pty Ltd. (“Real Foods”) [represented by Norris, McLaughlin & Marcus]
sought registration of two marks: “CORN THINS,” for “crispbread
slices predominantly of corn, namely popped corn
cakes”; and “RICE THINS,” for “crispbread slices primarily
made of rice, namely rice cakes.” J.A. 279 (emphasis
omitted). Cross-Appellant Frito-Lay North America, Inc.
(“Frito-Lay”) opposed the registrations, arguing that the
proposed marks should be refused as either generic or
descriptive without having acquired distinctiveness.



Frito-Lay won its cross-appeal, but not for the reasons it argued:



Specifically, Frito-Lay contends the TTAB erred by
finding “‘thins’ is not a generic term” “based solely on the
fact that it is used within some third-party brand names”
because “‘thins’ is commonly used as a generic term for
snack food products, including crackers and crispbread
slices.” Id. at 22. We agree that the TTAB erred, but not
for the reasons asserted by Frito-Lay.


“[A] term can be generic for a genus of goods or services
if the relevant public understands the term to refer
to a key aspect of that genus.” Royal Crown, 892 F.3d at
1367 (ellipsis, internal quotation marks, and citation
omitted). Genericness involves a “two-step inquiry” that
asks: (1) “what is the genus of goods or services at issue,”
and (2) “is the term sought to be registered or retained on
the register understood by the relevant public primarily
to refer to that genus of goods or services?” Princeton
Vanguard, 786 F.3d at 965 (internal quotation marks and
citation omitted); see id. at 968 (explaining that the TTAB
should consider “the record evidence of the public’s understanding
of the mark as a whole”). “The authority is
legion that the question of registrability of an applicant’s
mark must be decided on the basis of the identification of
goods set forth in the application[,] regardless of what the
record may reveal as to the particular nature of an applicant’s
goods . . . .” In re Cordua, 823 F.3d at 602 (internal
quotation marks and citation omitted).

The TTAB improperly narrowed the genus of the
goods at issue.




Olivia de Havilland takes her "truth in docudrama" case to the U.S. Supreme Court


Back in 2007, IPBiz discussed California's anti-SLAPP law in the context of the Cha/Flamm plagiarism matter.
See Judge to hear anti-SLAPP arguments in Cha/Flamm matter on Nov. 20 .

Anti-Slapp issues arose in the context of actress Olivia de Havilland's fight against her false depiction in a docudrama.

In March 2018, the New York Times discussed an anti-SLAPP issue in the de Havilland/FX matter:


FX tried to have the lawsuit tossed last summer, on the grounds of California’s anti-Slapp (Strategic Lawsuit Against Public Participation) statute, designed to quickly set aside lawsuits that may be designed to chill free speech. But a trial judge surprised legal observers by ruling that Ms. de Havilland had sufficient grounds to proceed with her lawsuit.



Although de Havilland won on the anti-SLAPP issue, she lost at the California appellate level.

As to the core of the unsuccessful argument by de Havilland, the California appellate court noted:


“Books, films, plays and television shows often portray real people,” the court decision reads. “Some are famous and some are just ordinary folks. Whether a person portrayed in one of these expressive works is a world-renowned film star — ‘a living legend’ — or a person no one knows, she or he does not own history.”



See FX Prevails in ‘Feud’ Defamation Suit Filed by Olivia de Havilland

One would assume de Havilland would point out that a false statement is not history.

Now, in October 2018, de Havilland is taking her fight to the US Supreme Court


“We must persevere and speak truth to power,” the 102-year-old two-time Oscar winner said Friday as her attorneys petitioned SCOTUS in the ongoing legal battle. “The fight is itself important to the principle of honesty, so much in need today in the face of deliberate public confusion for selfish agendas,” she added in a statement from her Paris home

Having suffered a number of legal setbacks and defeats since filing her lawsuit in June 2017, — including the California Supreme Court’s decision in July not to review her case — de Havilland is seeking to have the nation’s highest court re-examine what jurisdictions in the Golden State have decided.




See Olivia De Havilland Takes ‘Feud’ Feud With FX & Ryan Murphy To Supreme Court