Wednesday, June 28, 2017

Patent Docs on Cleveland Clinic. Matter of cherry-picking.


Kevin Noonan's post on Cleveland Clinic Foundation v. True Health Diagnostics LLC begins:



Most people have had the experience of becoming lost and, having arrived at their destination, realizing that it was only one false turn that caused their confusion. For those with a physics background one can recall the feature of vector calculus that a small displacement at a first position can result in a large displacement at a later position further along the vector's path. Both these thoughts come unbidden when reading the Federal Circuit's decision on June 16th in Cleveland Clinic Foundation v. True Health Diagnostics LLC (where the one false turn was the Court's decision in Ariosa Diagnostics v. Sequenom and that initial "small nudge" can be found in the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories decision).


Within his text, the topic of cherry-picking arose:


Addressing the procedural issues, the panel held that considering (and granting) a motion to dismiss based on Fed. R. Civ. Proc. 12(b)(6) without claim construction was not error, nor was there error in considering certain claims to be representative. Curiously, the Court based its affirmance of the latter principle on substantive grounds, that it disagreed with Cleveland Clinic that other claims provided the requisite "inventive concept" that the representative claims did not. This basis does not address the underlying question, of whether generally a district court can cherry pick claims asserted by a plaintiff to find that the Mayo/Alice test is not satisfied, and while this conclusion may be the correct one, in this case affirming this procedural shortcut precludes future plaintiffs of the ability to overcome a Section 101 challenge based on there being at least one asserted claim that satisfies the test. Of course, the precedent regarding Cleveland Clinics' second challenge, that a district court can grant a motion to dismiss without claim construction, is as prevalent as it is mystifying, and the panel here relies upon some of it to affirm the procedural posture of the case (e.g., Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1373–74 (Fed. Cir. 2016).



link to patent docs post:
http://www.patentdocs.org/2017/06/cleveland-clinic-foundation-v-true-health-diagnostics-llc-fed-cir-2017.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+PatentDocs+%28Patent+Docs%29

Cherry-picking mentioned in other cases:

From 833 F.3d 656 (CA6 2016)

For instance, various appellate briefs supporting the Secretary's position now characterize Metzger's report, which was included with the plaintiffs' complaint, as "junk science" and attack its alleged "cherry picking" of data. But the Secretary never submitted any contrary proof to the district court. She did not even request limited discovery until July 13, 2016, the day before the hearing on plaintiffs' motion for a preliminary injunction and over seven weeks after the motion was filed. By that point, the district court reasonably concluded that her request was not timely.



From 2016 U.S. App. LEXIS 5578



Zheng asserts that the BIA "ignored relevant sections of the country reports" and "abused its discretion by cherry-picking the record evidence." "We presume that [the agency] has taken into account all of the evidence before [it], unless the record compellingly suggests otherwise." Xiao Ji Chen v. U.S. Dep't of Justice, 471 F.3d 315, 336 n.17 (2d Cir. 2006).


From 786 F.3d 733 :


As Garcia characterizes it, "the main issue in this case involves the vicious frenzy against Ms. Garcia that the Film caused among certain radical elements of the Muslim community." We are sympathetic to her plight. Nonetheless, the claim against Google is grounded in copyright law, not privacy, emotional distress, or tort law, and Garcia seeks to impose speech restrictions under copyright laws meant to foster rather than repress free expression. Garcia's theory can be likened to "copyright cherry picking," which would enable any contributor from a costume designer down to an extra or best boy to claim copyright in random bits and pieces of a unitary motion picture without [**9] satisfying the requirements of the Copyright Act. Putting aside the rhetoric of Hollywood hijinks and the dissent's [***1609] dramatics, this case must be decided on the law.

Tuesday, June 27, 2017

Stanford wins appeal at CAFC in interference case


The outcome:


The Board of Trustees of the Leland Stanford Junior
University (“Stanford”) appeals from orders of the Patent
Trial and Appeal Board (“Board”) in three interference
proceedings between Stanford and the Chinese University
of Hong Kong (“CUHK”). In all of these proceedings, the
Board found that Stanford’s claims were unpatentable for
lack of written description. See Quake v. Lo, No. 105,920
(P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105,923
(P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105,924
(P.T.A.B. Apr. 7, 2014).1 Because we conclude that the
Board relied on improper evidence to support its key
findings and did not cite to other substantial evidence to
support its findings, we vacate the Board’s interference
decisions and remand for further proceedings.




Of written description:



Whether a patent claim satisfies the written description
requirement of 35 U.S.C. § 112, paragraph 1, depends
on whether the description “clearly allow[s] persons of
ordinary skill in the art to recognize that [the inventor]
invented what is claimed.” Vas-Cath Inc. v. Mahurkar,
935 F.2d 1555, 1562–63 (Fed. Cir. 1991) (internal quotation
marks omitted) (quoting In re Gosteli, 872 F.2d 1008,
1012 (Fed. Cir. 1989)).
[W]hatever the specific articulation, the test requires
an objective inquiry into the four corners of
the specification from the perspective of a person
of ordinary skill in the art. Based on that inquiry,
the specification must describe an invention understandable
to that skilled artisan and show that
the inventor actually invented the invention
claimed.
Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en banc).

(...)


For these reasons, we vacate the interference decisions
and remand for the Board to reconsider whether
Quake’s relevant patents and applications satisfy the
written description requirement. In re Nuvasive, Inc., 842
F.3d 1376, 1382 (Fed. Cir. 2016) (finding that the Board
must “make the necessary findings and have an adequate
‘evidentiary basis for its findings’” (quoting In re Lee, 277
F.3d 1338, 1344 (Fed. Cir. 2002)); Ariosa Diagnostics v.
Verinata Health, Inc., 805 F.3d 1359, 1365 (Fed. Cir.
2015) (“[W]e must not ourselves make factual and discretionary
determinations that are for the agency to make.”)
(citing In re Lee, 277 F.3d at 1342, Interstate Commerce
Comm’n v. Bhd. of Locomotive Eng’rs, 482 U.S. 270, 283
(1987), and Chenery, 332 U.S. at 196–97).

Monday, June 26, 2017

CAFC in Nantkwest: “[a]ll expenses of the proceedings” under § 145 includes the pro-rata share of the attorneys’ fees the USPTO incurred to defend applicant’s appeal.



The outcome Nantkwest v. Matal :


Nantkwest, Inc. appeals from a decision of the United
States District Court for the Eastern District of Virginia
granting-in-part and denying-in-part the United States
Patent and Trademark Office (“USPTO”) Director’s motion
for fees. In its order, the district court granted the
Director’s requested witness’ fees but denied the requested
attorneys’ fees. The Director appeals the court’s denial
of attorneys’ fees. We reverse.



Some history


Section 145 provides that an applicant dissatisfied
with the PTAB’s decision may appeal directly to the
United States District Court for the Eastern District of
Virginia in lieu of immediate appeal to this court. 35
U.S.C. § 145. The statute further provides that the applicant
must pay “[a]ll of the expenses of the proceeding,”
id., “regardless of the outcome,” Hyatt v. Kappos, 625 F.3d
1320, 1337 (Fed. Cir. 2010) (en banc), aff’d and remanded,
132 S. Ct. 1690 (2012). After prevailing at the district
court on the merits, the Director filed a motion to recover
$111,696.39 of the USPTO’s fees under the § 145 expense
provision. See J.A. 84 (seeking $78,592.50 in attorneys’
fees (including paralegal fees) and $33,103.89 in expert
fees).1

(...)

The district court concluded that the “[a]ll expenses” provision of the
statute was neither sufficiently specific nor explicit
enough for the authorization of attorneys’ fees under this
Rule. Id. On appeal, the Director argues that the district
court erred by excluding the USPTO’s attorneys’ fees
under § 145. We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(C).



The main issue in the case:


The principal issue on appeal is whether § 145’s “[a]ll
expenses of the proceedings” provision authorizes an
award of the USPTO’s attorneys’ fees under this section.



Justice Scalia might have enjoyed this case:


The definitions and explanations that standard legal
dictionaries and treatises provide for the term “expense”
support this conclusion. Wright & Miller on Federal
Practice and Procedure, for example, defines this term as
“includ[ing] all the expenditures actually made by a
litigant in connection with the action,” including “attorney’s
fees.” 10 Charles Alan Wright et al., Federal Practice
and Procedure § 2666 (3d ed. 1998). Similarly, Black’s
Law Dictionary defines “expenses” as “expenditure[s] of
money, time, labor, or resources to accomplish a result.”
Black’s Law Dictionary 698 (10th ed. 2014) (“Black’s”)
(emphasis added).

The dissent summarily dismisses these definitions,
declaring that “they are not contemporaneous with Congress’s
introduction of the word ‘expenses’ into the Patent
Act in 1839.”
Dissenting Op. 14. Relying on Nineteenth
Century dictionaries instead, the dissent concludes that
“the words ‘expense,’ ‘cost,’ and ‘damage’ were considered
synonymous around the time of the 1839 Amendments.”5
Id. at 6. Not so. The Patent Act of 1836 specifically distinguished
among these three terms. Compare Act of July 4,
1836, ch. 357, 5 Stat. 117, § 9 (“[M]oneys received into the
Treasury under this act shall constitute a fund for the
payment of salaries of the officers and clerks herein
provided for, and all other expenses of the Patent Office.”
(emphasis added)), with id. § 14 (“[W]henever, in any
action for damages for making, using, or selling the thing
whereof the exclusive right is secured by any patent . . . ,
a verdict shall be rendered . . . , it shall be in the power of
the court to render judgment for any sum above the
amount found by such verdict as the actual damages
sustained . . . , not exceeding three times the amount
thereof, according to the circumstances of the case, with
costs.” (emphases added)). The historical statute that the
dissent relies on simply does not support its conclusion. If
anything, this statute lends support to the majority’s
position by expressly characterizing the salaries of
USPTO officers and clerks and as “expenses.” Id. § 9. The
Supreme Court has observed the distinction between
“expenses” and “costs” recently, providing an interpretation
that comports with the modern definitions that the
dissent disregards.



Note footnote 5:


The dissent’s position here not only lacks support
in the briefing, but also directly undermines the party’s
position it purports to advance. Specifically, in arguing
that § 145 does not include attorneys’ fees, Nantkwest
cited the same dictionary and definitions that the dissent
now concludes bear no relevance to the interpretation of
this statute.



The bottom line


Accordingly, we hold that “[a]ll expenses of the proceedings”
under § 145 includes the pro-rata share of the
attorneys’ fees the USPTO incurred to defend applicant’s
appeal. To conclude otherwise would conflict with Hyatt,
where we recognized the “heavy economic burden” that
§ 145 shifts onto applicants for electing this favorable
appellate path. Hyatt, 625 F.3d at 1337.



The dissent noted:


This presumption against fee
shifting in American litigation dates back more than 200
years to Arcambel v. Wiseman, 3 U.S. (3 Dall.) 306 (1796).
“[T]he law of the United States, but for a few wellrecognized
exceptions not present [here], has always been
that absent explicit congressional authorization, attorneys’
fees are not a recoverable cost of litigation.” Runyon
v. McCrary, 427 U.S. 160, 185 (1976) (footnote omitted).



AND


It is a fundamental principle of statutory interpretation
that, “[w]here Congress includes particular language
in one section of a statute but omits it in another section
of the same Act, it is generally presumed that Congress
acts intentionally and purposely in the disparate inclusion
or exclusion.” Russello v. United States, 464 U.S. 16,
23 (1983) (quoting United States v. Wong Kim Bo,
472 F.2d 720, 722 (5th Cir. 1972)).



AND


Finally, if § 145 were a fee-shifting statute, it would represent a
particularly unusual divergence from the American Rule because it obligates
even successful plain-tiffs to pay the PTO’s attorneys’ fees.
“[W]hen Congress has chosen to depart from the American rule by statute,
virtually every one of the more than 150 existing federal fee-shifting
provisions predicates fee awards on some success by the claimant.”
Ruckelshaus v. Sierra Club, 463 U.S. 680, 684 (1983); see also Baker Botts, 135 S. Ct. at 2164
(recognizing deviations from American Rule “tend to authorize
the award of ‘a reasonable attorney’s fee,’ ‘fees,’ or ‘litigation costs,’
and usually refer to a ‘prevailing party’ in the context of an adversarial ‘action.’”).
Nothing in § 145 confines the award of expenses to a prevailing party.
Instead, it requires the applicant to pay “[a]ll the expenses of the proceedings,”
which according to the majority means the applicant pays for the PTO’s attor-neys’
fees in every § 145 proceeding. In these atypical circumstances,
I think Congress’s intent to award the PTO attorneys’
fees in every case should have been more clear.
I cannot agree that Congress used the word “ex-penses”
to effect such an unusual departure from the American Rule—
a departure that would saddle even prevailing applicants with the PTO’s attorneys’ fees.
3

Which law school for the study of "intellectual property"?

A letter to Law Admissions Q&A at US News stated:


I completed a Master of Science in biotechnology this year, and I want to shift
into intellectual property law, hence I will be taking my LSAT this September and
applying to law schools for the fall 2018 term.

I've listed out a few of the questions I had regarding this: 1. Is it necessary for me to have
prior knowledge about law in order to apply, or is it okay that I am from a STEM background? 2.
What is, on average, the minimum GPA required by top law schools? 3. Should I apply to law schools
that have an overall higher ranking or those that are specifically known to be good for patent law? –Prospective Patent J.D.




Part of the answer included:


Pay attention to other resources, too. Some schools have an entire department devoted to the
study of issues with patents, copyrights, trademarks and trade secrets, such as
Texas A&M University's Center for Law and Intellectual Property. Clinical work and externship opportunities are also worth considering.


link: https://www.usnews.com/education/blogs/law-admissions-lowdown/articles/2017-06-26/maximize-summer-courses-for-law-school-recommendations

The website for Texas A&M includes:


At the Center for Law and Intellectual Property (CLIP) at Texas A&M University School of Law,
we combine classroom time with hands-on experience to prepare our students to navigate
the complex legal issues surrounding patents, copyrights, trademarks and trade secrets.

Most recently, peer surveys conducted by U.S. News and World Report have
ranked Texas A&M ​7th among the top IP law programs in the United States.



link: https://law.tamu.edu/current-students/academics/centers-clinics-programs/clip

Glynn S. Lunney, Jr.is at Texas A&M.

See for example: http://ipbiz.blogspot.nl/2006/09/more-on-patent-grant-rate-in-law.html

The Atlantic on plagiarism: garden variety stuff?


Covering the Jay Solomon matter, the Atlantic wrote:


Journalism scandals are all too common: Reporters are as fallible as the practitioners of
any other profession, and because the press loves to cover itself, such stories receive great attention.
But typically they’re of the garden variety—plagiarism, dishonesty, fabrication.

The story of Jay Solomon is in an entirely different league. Solomon, until Wednesday [21 June 2017]
The Wall Street Journal’s chief foreign-affairs correspondent, apparently considered
becoming involved in business deals with a source who has worked for the CIA—and in particular,
Solomon was asked to take a proposal for hundreds of millions of dollars to the government
of the United Arab Emirates, according to the Associated Press. He was offered a 10 percent
stake in Denx, a company owned by the Iranian-born mogul Farhad Azima, the AP reports,
though there’s no evidence Solomon ever took it.




link: https://www.theatlantic.com/international/archive/2017/06/arms-and-the-man/531168/

Interplay of enablement with written description



As to written description, IPWatchdog contains the following:



The third description requirement is the written description requirement, which is also found in 35 U.S.C. §112(a).
The written description requirement is separate and distinct from the enablement requirement, although related in
important ways. The written description requirement serves a teaching function, as a “quid pro quo” in which the
public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.

Still confused as to what this means? If you are confused you are understanding well. To be sure, the definition of the written description requirement is quite elusive. For generations the written description requirement had been confined to making sure that what was originally filed in the patent application adequately defined the full parameters of the invention being claimed. Today, the written description requirement means much more, but the Federal Circuit has yet to be able to articulate the requirements in a truly easy to explain way.


Perhaps the key to understanding the difference between enablement and the written description requirement is
that you can bootstrap knowledge of one of skill in the art into your application for enablement purposes, but
no such bootstrapping is allowable under the written description requirement. If you leave something out
it is not a part of your written description even if someone of skill in the art would understand that you left
something out. In this sense the written description requirement is a “four corners” requirement. What you include
in your patent application defines the possible extent of the exclusive rights you will obtain, nothing more.
Once it is known what is in the four corners of your patent application and, therefore, the invention that you
actually possess, the law then turns to the enablement question and asks whether one of skill in the art would know
how to make and use the invention. In this regard the written description requirement and the enablement requirement
are similar and directly related, yet separate requirements.



link: http://www.ipwatchdog.com/2017/06/24/patentability-adequate-description-requirement-35-u-s-c-112/id=85039/

One recalls the recent CAFC case Storer v. Clark, which included text:


The Board agreed with Clark’s position, and held that
the S1 provisional’s description of the 2´-keto precursor, in
combination with the Matsuda reference, was insufficient
to enable and thereby to establish possession of the
2´F(down) methyl(up) compound of claim 1 before Clark’s
priority date.
The Board stated, correctly, that for new
chemical compounds the specification must provide sufficient
guidance that undue experimentation is not required
to obtain the new compounds.



link: http://ipbiz.blogspot.com/2017/06/cafc-affirms-ptab-in-storer-v-clark.html

Separately, from blawgsearch on June 26, 2017:


***
As to recent cases involving "lack of written description,"

apart from Storer, 2017 U.S. App. LEXIS 10945 (June 21, 2017): The Board agreed with Clark's position, and held that the S1 provisional's description of the 2´-keto precursor, in combination with the Matsuda reference, was insufficient to enable and thereby to establish possession of the 2´F(down) methyl(up) compound of claim 1 before Clark's priority date. The Board stated, correctly, that for new chemical compounds the specification must provide sufficient guidance that undue experimentation is not required to obtain the new compounds. ,

RIVERA v. ITC . 857 F.3d 1315; 2017 U.S. App. LEXIS 8931 . "For the foregoing reasons, we affirm the Commission's conclusion that claims 5-7, 18, and 20 are invalid for lack of written description"

Cisco v. Cirrex, 856 F.3d 997; 2017 U.S. App. LEXIS 8264; 122 U.S.P.Q.2D (BNA) 1595: "Substantial evidence supports the Board's finding of lack of written description support for the diverting element claims. Because we affirm the Board's finding of lack of written description support, we need not and do not reach the Board's alternate grounds for unpatentability of the diverting element claims."

Sunday, June 25, 2017

Invalidating patents at PTAB



An article by Rochelle Dreyfuss in SLATE included


Versata Software learned the difference between the PTAB and the courts the hard way. In court, it successfully enforced a patent
on software for determining prices. Later on, the PTAB revoked the claims that the court had just found valid.



which is a "logical" possibility, because the standard for invalidity is more
easily met at PTAB.

However, recall the Acorda / Ampyra situation, wherein patents that passed muster at PTAB
were invalidated by the District of Delaware court.

link to Dreyfuss: http://www.slate.com/articles/technology/future_tense/2017/06/should_the_patent_and_trademark_office_be_allowed_to_change_its_mind.html

CBS Sunday Morning on 25 June 2017, noting the 10th anniversary of the iPhone

Jane Pauley introduced the stories for June 25, 2017, beginning with David Pogue on the 10th anniversary (of public availability) of the iPhone, and then to Susan Spencer on John McEnroe, Erin Moriarty on Dick Gregory and Seth Doane on Murano glass and Lee Cowan, and Cyndi Lauper.

The news was a landslide in Xinmo, China, oil spill/fire in Pakistan, the GOP healthcare plan and the opening of the Wilshire Grand Center in Los Angeles. A blurb on a Neopolitan Mastif winning the ugliest dog contest.

The cover story by David Pogue noted the 10th anniversary of the iPhone to the public coming up on June 29, 2017. There was a reunion of four technical writers (including Steven Levy and Pogue (then at the NY Times)) who were given iPhones to try before the public unveiling. There was discussion of the touchscreen feature being worked on in 2005. And no one supposedly knew "how big this could be." There was a question of whether or not Apple is sunsetting. And a statement/opinion on Jobs: I don't think he foresaw the hugeness [?]

See also the 29 June 2009 piece on WIRED: June 29, 2007: iPhone, You Phone, We All Wanna iPhone

Almanac: June 25, 1997. Date of death of Jacques Costeau.

The piece by Seth Doane on Murano glass included "There are no secrets anymore," suggesting glass was now all art. [Could this be said of the iPhone, which primarily borrowed known technology?] In 1291, glass blowing moved from Venice to Murano, to limit the consequences of fires from the glass kilns. From a current glass person with different ideas: I am not threatening anybody. I'm trying to bring glass to another step.
In the earlier days, glass technology was a state secret, and one could not leave Murano with the knowledge.

The piece on Dick Gregory pointed to the symbolic significance of Dick Gregory being allowed to sit on the couch next to Jack Paar.
"Turn me loose." 1989 piece on Gregory on "60 Minutes."

Moment of nature. Horseshoe crabs on New Jersey side of Delaware Bay.

Thursday, June 22, 2017

Desired qualities for next director of the USPTO?



From a post at norningconsult about qualities in the next patent office director:


The next PTO director should have served as a senior executive at a company that engages in research and development, and for which building and managing a patent portfolio is a central part of its business model. Patents and commercialization must have occupied the lion’s share of this person’s time and energy.




link: https://morningconsult.com/opinions/novel-idea-pick-pro-patent-patent-office-chief/

One contemplates the two Obama selections in comparison to the previous two Republican (Bush) selections.

National Review on Bob Dylan "copying"

From the National Review:



To use the word “plagiarism” to describe what Dylan does, then, seems incorrect, tarnished as the word is with allegations of theft and deceit. The intention, in Dylan’s case, could not be further from the truth. The works of others are not something he turns to in times of sloth-induced desperation to pass off as his own. Rather, they are wellsprings of invention and interpretation, works to pair with others to create something new and, in many cases a whole greater in quality than the sum of its parts.



Link: http://www.nationalreview.com/article/448806/bob-dylans-nobel-speech-plagiarism


**Separately from blawgsearch on 22 June 2017:


Analysis of Lemtrada data by researchers at Queen Mary University suggests issues in T/B cell repopulation dynamics


In a post titled Unpublished Data May Point to Link Between Lemtrada and Other Autoimmune Diseases in MS Patients , Multiple Sclerosis News Today began with text:



Previously unpublished results of clinical trials of Lemtrada (alemtuzumab) appears to contain key information as to why many multiple sclerosis patients who use it [Lemtrada] develop other autoimmune diseases.

Researchers looked at the immune cell mix after Lemtrada depleted many of those cells. They discovered that certain B-cells repopulate the body earlier than key regulatory T-cells, leading to an imbalanced immune system that is prone to turn on itself.

Although the findings pertained specifically to Lemtrada, they suggest that naturally occurring immune cell imbalance could lead to autoimmune diseases, researchers said.




This news blurb was based on a scientific paper titled Interpreting Lymphocyte Reconstitution Data From the Pivotal Phase 3 Trials of Alemtuzumab
appearing in JAMA Neurol., published online June 12, 2017. doi:10.1001/jamaneurol.2017.0676. The first named author is David Baker, Centre for Neuroscience and Trauma, Blizard Institute, Queen Mary University of London, England.

The work is summarized at Jamanetwork in the following way:


Results Alemtuzumab depleted CD4+ T cells by more than 95%, including regulatory cells (−80%) and CD8+ T cells (>80% depletion), which remained well below reference levels throughout the trials. However, although CD19+ B cells were initially also depleted (>85%), marked (180% increase) hyperrepopulation of immature B cells occurred with conversion to mature B cells over time. These lymphocyte kinetics were associated with rapid development of alemtuzumab-binding and -neutralizing antibodies and subsequent occurrence of secondary B-cell autoimmunity. Hyperrepopulation of B cells masked a marked, long-term depletion of CD19+ memory B cells that may underpin efficacy in MS.

Conclusions and Relevance Although blockade of memory T and B cells may limit MS, rapid CD19+ B-cell subset repopulation in the absence of effective T-cell regulation has implications for the safety and efficacy of alemtuzumab. Controlling B-cell proliferation until T-cell regulation recovers may limit secondary autoimmunity, which does not occur with other B-cell–depleting agents.



The multiple sclerosis news today website indicated that the data analyzed by the Queen Mary University people was obtained through a Freedom of Information request to the European Medicines Agency, thereby making this story relevant to intellectual property:


Researchers from Queen Mary University of London used a Freedom of Information request to the European Medicines Agency to obtain full results of the Phase 3 clinical trials of Lemtrada.

Scientists know that many people who take Lemtrada develop autoimmune diseases. Those who conducted the trials had presented some of the unpublished information at conferences, but had yet to submit studies involving those results to scientific journals.

“We were very surprised to find such important information on B-cell dynamics were only partially described and remained unpublished, even though they were observed and analysed several years ago following the pivotal Phase 3 trials,” Klaus Schmierer, the senior author of the study, said in a press release.



The second sentence of the press release [available at https://www.eurekalert.org/pub_releases/2017-06/qmuo-put061217.php ] noted "there is an almost 50% chance of secondary autoimmune diseases..."

Separately, an article in medpagetoday by Judy George begins:


In an analysis of previously unpublished phase III data, U.K. researchers reported a massive, rapid repopulation of a subset of B cells without effective T-cell regulation in patients with multiple sclerosis (MS) treated with alemtuzumab (Lemtrada), which might have created an environment for secondary autoimmune disease.

Examining lymphocyte reconstitution data from the pivotal Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis I and II (CARE-MS I and II) studies, Klaus Schmierer, PhD, FRCP, of Queen Mary University of London, and colleagues found that alemtuzumab depleted CD4 T cells by more than 95%, including regulatory cells and CD8 T cells, which remained well below reference levels throughout the trials. Although the drug also initially depleted CD19 B cells by more than 85%, immature B cells increased by 180% and converted to mature B cells over time. These changes were associated with the rapid development of alemtuzumab-binding and alemtuzumab-neutralizing antibodies and subsequent secondary B-cell autoimmunity. This B-cell hyperpopulation masked a long-term depletion of CD19 memory B cells that may underpin the efficacy of alemtuzumab in MS, the researchers reported in JAMA Neurology.



link: https://www.medpagetoday.com/neurology/multiplesclerosis/66037

**Separately, from an editorial by Steinman about the matter

Wednesday, June 21, 2017

CAFC affirms PTAB in Storer v. Clark


The CAFC affirmed the Board in the Storer case:


We conclude that substantial evidence supports the
Board’s finding that “a high amount of experimentation is
necessary to synthesize” the target compound. The record
before the Board showed sufficient variability and unpredictability
to support the Board’s conclusion that Storer’s
provisional application did not enable the interference
subject matter. The Board’s decision is affirmed.



The opinion, written by Judge Newman, involved a patent interference
in the pharma area:


This patent interference contest involves methods of
treating hepatitis C by administering compounds having
a specific chemical and stereochemical structure



Of note:


To establish priority, Storer relied on the disclosure in
the provisional specification from which priority was
claimed for conception and constructive reduction to
practice. In its joint decision on Clark’s motion to deny
Storer the benefit of the provisional application and on
Clark’s motion to invalidate Storer’s claims on the
grounds of lack of enablement and written description,1
the Patent Trial and Appeal Board (PTAB or “Board”)
held that Storer’s provisional application was not enabling
for the count of the interference, and on that ground
the PTAB entered judgment granting priority to Clark.2
Storer appeals that judgment and the underlying decision
on Clark’s motions.

We take note that Storer initially filed in the District
of Delaware, seeking review of the Board’s decision under
35 U.S.C. § 146. The district court dismissed the case,
Idenix Pharmaceuticals. LLC v. Gilead Pharmasset LLC,
2016 WL 6804915, at *1 (D. Del. Nov. 16, 2016), based on
this court’s ruling in Biogen MA, Inc. v. Japanese Foundation
for Cancer Research, 785 F.3d 648 (Fed. Cir. 2015),
that the America Invents Act eliminated the option of
district court review under Section 146 for interferences
declared after September 15, 2012. Although Storer says
that Biogen was incorrectly decided, that decision is
binding on this panel.





Of undue experimentation:


The Board agreed with Clark’s position, and held that
the S1 provisional’s description of the 2´-keto precursor, in
combination with the Matsuda reference, was insufficient
to enable and thereby to establish possession of the
2´F(down) methyl(up) compound of claim 1 before Clark’s
priority date. The Board stated, correctly, that for new
chemical compounds the specification must provide sufficient
guidance that undue experimentation is not required
to obtain the new compounds.

(...)

The boundary between a teaching sufficient to enable
a person of ordinary skill in the field, and the need for
undue experimentation, varies with the complexity of the
science. Knowledge of the prior art is presumed, as well
as skill in the field of the invention. The specification
need not recite textbook science, but it must be more than
an invitation for further research. Genentech, Inc. v. Novo
Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997).
In Genentech the patentee argued that the prior art
taught a method that could be used to produce a claimed
human growth hormone product, compensating for lack of
detail in the specification. The patentee argued that it
did not need to include information in the prior art. This
court agreed, but stressed the need to assure enablement
of the novel aspects of the invention:
It is true . . . that a specification need not disclose
what is well known in the art. See, e.g., Hybritech
Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
1385 (Fed. Cir. 1986). However, . . . . [i]t is the
specification, not the knowledge of one skilled in
the art, that must supply the novel aspects of an
invention in order to constitute adequate enablement.
Genentech, 108 F.3d at 1366.
The Storer provisional specification does not describe
synthesis of the 2´F(down) target compounds.

(...)

On review, we conclude that substantial evidence
supports the Board’s findings that the synthetic schemes
in Storer’s provisional application do not teach or suggest
conversion of any precursor into the 2´F(down) structure,
and that the Matsuda synthesis of a corresponding 2´-
methyl (down), 2´-hydroxyl (up) structure does not enable
a person of ordinary skill to produce the target compounds
without undue experimentation.
Wands factor 7, the predictability or unpredictability
of the art, appears to be particularly relevant. Although
Storer states that this is predictable chemistry, and
therefore that detailed specific examples are not necessary,
the Board’s findings are in accord with the record.

Tuesday, June 20, 2017

CAFC discusses websites in personal jurisdiction case Nexlearn v. Allen



The CAFC affirmed D. Kansas on lack of personal jurisdication.

Of the law:


“Personal jurisdiction is a question of law that we review
de novo.” Autogenomics, Inc. v. Oxford Gene Tech.
Ltd., 566 F.3d 1012, 1016 (Fed. Cir. 2009). We apply
Federal Circuit law when reviewing claims “intimately
involved with the substance of the patent laws” and the
law of the regional circuit when reviewing state law
claims. Elecs. for Imaging, Inc. v. Coyle, 340 F.3d 1344,
1348 (Fed. Cir. 2003). Where, as here, the district court
decided personal jurisdiction “based on affidavits and
other written materials in the absence of an evidentiary
hearing, a plaintiff need only to make a prima facie showing
that defendants are subject to personal jurisdiction.”
Avocent Huntsville Corp. v. Aten Int’l Co., 552 F.3d 1324,
1329 (Fed. Cir. 2008). We “accept the uncontroverted
allegations in the plaintiff’s complaint as true and resolve
any factual conflicts in the affidavits in the plaintiff’s
favor.” Id. To make a prima facie showing, we ask
“whether a forum state’s long-arm statute permits service
of process and whether assertion of personal jurisdiction
violates due process.” Autogenomics, 566 F.3d at 1017.
The Kansas Supreme Court has interpreted Kansas’ longarm
statute to extend jurisdiction to the fullest extent
allowed by due process. Merriman v. Crompton Corp.,
146 P.3d 162, 179 (Kan. 2006).
Pursuant to 28 U.S.C. § 1367(a), “it is well established—in
certain classes of cases—that, once a court has
original jurisdiction over some claims in the action, it may
exercise supplemental jurisdiction over additional claims
that are part of the same case or controversy.” Exxon
Mobil Corp. v. Allapattah Servs., Inc., 545 U.S. 546, 552
(2005). To exercise supplemental jurisdiction, the district
court “must first have original jurisdiction over at least
one claim in the action.” Id. at 554.




At district court:


Drawing all reasonable inferences in favor of
NexLearn, the district court held that NexLearn failed to
allege that Allen had sufficient contacts with Kansas to
permit the exercise of specific jurisdiction. It determined
the NDA and EULA Kansas choice-of-law and forumselection
provisions were not relevant for specific jurisdiction
over NexLearn’s patent infringement claim. It held
that because five of Allen’s six emails to NexLearn employees
were sent before the ’522 patent issued on August
5, 2014, NexLearn’s patent infringement claim could
not have arisen out of or related to these emails. It held
Allen’s sole post-issuance email, as well as its offer of a
free trial of ZebraZapps to a NexLearn employee, could
not form a basis for exercising jurisdiction because these
contacts were manufactured by NexLearn’s unilateral
acts. The NexLearn employees, it reasoned, received
Allen’s emails only because they subscribed to Allen’s
mass emailing list and received a free trial of ZebraZapps
only because of a purchase attempt. Regarding Allen’s
ZebraZapps website, the district court held the website
alone, absent evidence of an actual sale, was insufficient
to confer specific jurisdiction. It held neither Allen’s
single sale of an unaccused product to a Kansas resident
nor its general advertisement in a trade publication was
relevant to NexLearn’s patent infringement claim. Because
it held it lacked personal jurisdiction over
NexLearn’s patent infringement claim, and because
NexLearn did not assert breach of contract as an independent
basis for the district court’s subject matter jurisdiction,
the district court granted Allen’s motion to
dismiss.



Plaintiff-appellant Nexlearn argued:


NexLearn alleges that personal jurisdiction exists for
its patent infringement claim, the only claim over which it
asserts the district court possesses original jurisdiction. A
district court can exercise personal jurisdiction over an
out-of-state defendant pursuant to either general or
specific jurisdiction. Under general jurisdiction, a district
court can “hear any and all claims against [out-of-state
defendants] when their affiliations with the State are so
‘continuous and systematic’ as to render them essentially
at home in the forum State.” Daimler AG v. Bauman, 134
S. Ct. 746, 749 (2014) (citation omitted). Specific jurisdiction
instead “focuses on the relationship among the defendant,
the forum, and the litigation.” Walden v. Fiore,
134 S. Ct. 1115, 1121 (2014) (alteration omitted). To
comport with due process, the out-of-state defendant must
have “minimum contacts” with the forum State “such that
the maintenance of the suit does not offend traditional
notions of fair play and substantial justice.” Int’l Shoe Co.
v. Washington, 326 U.S. 310, 316 (1945). At oral argument,
NexLearn stated it alleged both general and specific
jurisdiction. Oral arg. at 15:03–16:10. NexLearn did
not argue general jurisdiction in its briefing to us or below
to the district court. See NexLearn Br. 10; J.A. 7
(“NexLearn does not allege general jurisdiction but rather
that Allen had minimum contacts with Kansas based on
specific jurisdiction.”). We thus decline to address general
jurisdiction.




The CAFC stated:


We agree with the district court’s determination that
Allen’s contacts predating the issuance of the ’522 patent
are not relevant contacts for establishing specific jurisdiction
over NexLearn’s patent infringement claim.






As to a website:


Allen’s website together with its contacts with
NexLearn create only an “attenuated affiliation” with
Kansas as opposed to a “substantial connection” with the
forum State as required for specific jurisdiction. See
Burger King, 471 U.S. at 475. We thus affirm the district
court’s dismissal of NexLearn’s patent infringement claim
for lack of personal jurisdiction.




Of the supplemental (contract) claims:


While neither party
disputes that a claim for patent infringement falls within
the district court’s subject matter jurisdiction pursuant to
28 U.S.C. §§ 1331, 1338(a), the district court’s dismissal of
that claim for lack of personal jurisdiction left no remaining
claim over which the district court could exercise
original subject matter jurisdiction. See J.A. 17. A district
court cannot exercise supplemental jurisdiction over
a claim where original subject matter jurisdiction does not
exist. 28 U.S.C. § 1367(a). Because we affirm the district
court’s dismissal of NexLearn’s patent infringement claim
for lack of personal jurisdiction, we affirm the district
court’s dismissal of NexLearn’s supplemental claim for
breach of contract.