Will CW Appeal?

John Simpson, point man on Consumer Watchdog's embryonic stem cells issues, told Kosher Goldfish that CW "expects to" appeal the dismissal of its case by the CAFC.  To summarize a complicated process, the appeal lies with the US Supreme Court.  CW must petition for cert., which is not a guaranteed right. If SCOTUS denies cert, not only will CW be denied a hearing, but it sets a bad precedent for all non-profits who wish to appeal in the "post-grant" proceeding newly created under the America Invents Act.  The Act is a giant new patent law which has just gone into effect.  CW has until September 2, 2014 to file the petition for cert.
Keep tuned for further details or visit the Consumer Watchdog website for a press release.

CW v WARF decided

On June 4, 2014 the CAFC decided the case of CW v WARF
See
The Court dismissed the appeal, i.e. threw it out of court for lack of "standing."
The entire opinion is reproduced below.

United States Court of Appeals

for the Federal Circuit

______________________

CONSUMER WATCHDOG,

(formerly known as The Foundation for Taxpayer

and Consumer Rights),

Appellant,

v.

WISCONSIN ALUMNI RESEARCH FOUNDATION,

Appellee.

______________________

2013-1377

______________________

Appeal from the United States Patent and Trademark

Office, Patent Trial and Appeal Board in Reexamination

No. 95/000,154.

______________________

Decided: June 4, 2014

______________________

SABRINA Y. HASSAN, Public Patent Foundation Benjamin

N. Cardozo School of Law, of New York, New York,

argued for appellant. With her on the Brief was DANIEL

B. RAVICHER.

KARA F. STOLL, Finnegan, Henderson, Farabow, Garrett

& Dunner, LLP, of Washington, DC, argued for

appellee. With her on the brief were WILLIAM B. RAICH

and SARAH E. CRAVEN.

CONSUMER WATCHDOG 2 v. WISCONSIN ALUMNI RESEARCH

MARK R. FREEMAN, Attorney, Appellate Staff, Civil

Division, United States Department of Justice, of Washington,

DC, argued for amicus curiae. With him on the

brief were STUART F. DELERY, Assistant Attorney General

and SCOTT R. MCINTOSH, Attorney. Of counsel on the

brief were NATHAN K. KELLEY, Solicitor, and SCOTT C.

WEIDENFELLER, Senior Counsel for Patent Law and

Litigation, United States Patent and Trademark Office, of

Alexandria, Virginia.

______________________

Before PROST,* Chief Judge, RADER,** and HUGHES, Circuit

Judges.

RADER, Circuit Judge.

Consumer Watchdog appeals from the Patent Trial

and Appeal Board’s decision affirming the patentability of

claims 1–4 of U.S. Patent No. 7,029,913 (’913 patent).

Because Consumer Watchdog has not established an

injury in fact sufficient to confer Article III standing,

however, this court dismisses the appeal.

I.

Consumer Watchdog is a self-described “not-for-profit

public charity dedicated to providing a voice for taxpayers

and consumers in special interest-dominated public

discourse, government and politics.” Appellant’s Br. 1. In

2006, Consumer Watchdog requested inter partes reexamination

of the ’913 patent, which is owned by Appellee

Wisconsin Alumni Research Foundation (WARF). J.A.

106. The ’913 patent is generally directed to human

embryonic stem cell cultures. E.g., ’913 patent abst.

* Sharon Prost assumed the position of Chief Judge

on May 31, 2014.

** Randall R. Rader vacated the position of Chief

Judge on May 30, 2014.

CONSUMER WATCHDOG v. WISCONSIN ALUMNI RESEARCH 3

Consumer Watchdog has not alleged any involvement

in research or commercial activities involving human

embryonic stem cells. Nor has it alleged that it is an

actual or prospective competitor of WARF or licensee of

the ’913 patent. Instead, Consumer Watchdog simply

alleges that WARF’s “broad and aggressive assertion of

the ’913 patent has put a severe burden on taxpayerfunded

research in the State of California where [Consumer

Watchdog] is located.” Appellant’s Br. 2. Indeed,

Consumer Watchdog states that it filed the reexamination

request because it was concerned that the ’913 patent

allowed WARF to completely preempt all uses of human

embryonic stem cells, particularly those for scientific and

medical research. Id. Consumer Watchdog was ultimately

unsuccessful in the reexamination, however, and filed

the present appeal.

II.

Federal courts do not have authority to entertain

every dispute. Relevant to this appeal, Article III only

allows the federal courts to adjudicate “Cases” and “Controversies.”

U.S. Const. art. III, § 2, cl. 1. Ostensibly,

these broad terms could cover a wide range of disputes.

Over the years, however, the federal courts have developed

a variety of doctrines to clarify that Article III limits

the federal courts’ jurisdiction to those disputes seeking to

“redress or prevent actual or imminently threatened

injury to persons caused by private or official violation of

law.” Summers v. Earth Island Inst., 555 U.S. 488, 492–

93 (2009). These doctrines—including standing, ripeness,

and mootness—distinguish justiciable disputes from those

that are not. Prasco, LLC v. Medicis Pharm. Corp., 537

F.3d 1329, 1336 (Fed. Cir. 2008). Collectively, these

doctrines represent a fundamental limitation on the

authority of the federal courts. Hollingsworth v. Perry,

133 S. Ct. 2652, 2661 (2013).

CONSUMER WATCHDOG 4 v. WISCONSIN ALUMNI RESEARCH

The present appeal concerns Article III standing. To

meet the constitutional minimum for standing, the party

seeking to invoke federal jurisdiction must satisfy three

requirements. Lujan v. Defenders of Wildlife, 504 U.S.

555, 560 (1992). First, the party must show that it has

suffered an “injury in fact” that is both concrete and

particularized, and actual or imminent (as opposed to

conjectural or hypothetical). Id. at 560–61. Second, it

must show that the injury is fairly traceable to the challenged

action. Id. at 560. Third, the party must show

that it is likely, rather than merely speculative, that a

favorable judicial decision will redress the injury. Id. at

561.

These constitutional requirements for standing apply

on appeal, just as they do before district courts. Hollingsworth,

133 S. Ct. at 2661. Accordingly, these requirements

apply with equal force to appeals from

administrative agencies, such as the U.S. Patent and

Trademark Office (PTO), to the federal courts. See Sierra

Club v. E.P.A., 292 F.3d 895, 899 (D.C. Cir. 2002). To be

clear, although Article III standing is not necessarily a

requirement to appear before an administrative agency,

once a party seeks review in a federal court, “the constitutional

requirement that it have standing kicks in.” Id.

That said, where Congress has accorded a procedural

right to a litigant, such as the right to appeal an administrative

decision, certain requirements of standing—

namely immediacy and redressability, as well as prudential

aspects that are not part of Article III—may be relaxed.

See Massachusetts v. E.P.A., 549 U.S. 497, 517–18

(2007). However, the “requirement of injury in fact is a

hard floor of Article III jurisdiction that cannot be removed

by statute.” Summers, 555 U.S. at 497. That

injury must be more than a general grievance, Hollingsworth,

133 S. Ct. at 2662, or abstract harm, City of

Los Angeles v. Lyons, 461 U.S. 95, 101 (1983).

CONSUMER WATCHDOG v. WISCONSIN ALUMNI RESEARCH 5

Indeed, “a disagreement, however sharp and acrimonious

it may be” will not suffice for the injury in fact

requirement. Hollingsworth, 133 S. Ct. at 2661 (internal

quotations and citation omitted). Rather, the party

invoking federal jurisdiction must have “a personal stake

in the outcome.” Lyons, 461 U.S. at 101. The personal

stake in the outcome—and injury in fact—generally will

be easier to show where the party seeking to invoke the

federal courts’ jurisdiction is the object of the complained

of action (or inaction). Lujan, 504 U.S. at 561. By contrast,

where a party is alleging an injury arising from the

government’s allegedly unlawful action or inaction pertaining

to a third party, injury in fact is much more

difficult to prove. Id. at 561–62.

III.

With these principles in mind, this court turns to

Consumer Watchdog’s appeal. Consumer Watchdog does

not identify any alleged injury aside from the Board

denying Consumer Watchdog the particular outcome it

desired in the reexamination, i.e., canceling the claims of

the ’913 patent. Appellant’s Br. in Response to United

States 3. Consumer Watchdog does not allege that it is

engaged in any activity involving human embryonic stem

cells that could form the basis for an infringement claim.

It does not allege that it intends to engage in such activity.

Nor does it allege that it is an actual or prospective

licensee, or that it has any other connection to the ’913

patent or the claimed subject matter. Instead, Consumer

Watchdog relies on the Board’s denial of Consumer

Watchdog’s requested administrative action—namely, the

Board’s refusal to cancel claims 1–4 of the ’913 patent.

That denial, however, is insufficient to confer standing.

To be sure, “Congress may enact statutes creating

legal rights, the invasion of which creates standing, even

though no injury would exist without the statute.” Linda

R.S. v. Richard D., 410 U.S. 614, 617 n.3 (1973) (citations

CONSUMER WATCHDOG 6 v. WISCONSIN ALUMNI RESEARCH

omitted). That principle, however, does not simply override

the requirement of injury in fact. Lujan, 504 U.S. at

578. Here, the Board’s disagreement with Consumer

Watchdog did not invade any legal right conferred by the

inter partes reexamination statute. The statute at issue

here allowed any third party to request reexamination,

and, where granted, allowed the third party to participate.

35 U.S.C. §§ 311(a), 314(b)(2) (2006). The statute

did not guarantee a particular outcome favorable to the

requester. See generally 35 U.S.C. §§ 311–318 (2006).

Consequently, the Board’s denial of Consumer Watchdog’s

request did not invade any legal right conferred upon

Consumer Watchdog.

For this reason, Consumer Watchdog’s analogy to the

Freedom of Information Act (FOIA) and Federal Election

Campaign Act (FECA) is unpersuasive. These acts created

substantive legal rights—access to certain government

records—the denial of which inflicts a concrete and particularized

injury in fact. See FEC v. Akins, 524 U.S. 11,

21 (1998). Unlike the plaintiffs in the FOIA and FECA

cases, Consumer Watchdog was not denied anything to

which it was entitled. Consumer Watchdog was permitted

to request reexamination and participate once the

PTO granted its request. This is all the statute requires.

See generally 35 U.S.C. §§ 311–318. Accordingly, unlike

the FOIA and FECA cases, the PTO did not abridge any

of Consumer Watchdog’s rights. See Lujan, 504 U.S. at

562 (“[W]hen the plaintiff is not himself the object of the

government action or inaction he challenges, standing is

not precluded, but it is ordinarily ‘substantially more

difficult’ to establish.”) (quoting Allen v. Wright, 468 U.S.

737, 758 (1984)).

Nor is it enough that the inter partes reexamination

statute allows a third party requester to appeal decisions

favorable to patentability. 35 U.S.C. § 315(b). A statutory

grant of a procedural right, e.g., right to appeal, does

not eliminate the requirements of Article III. See

CONSUMER WATCHDOG v. WISCONSIN ALUMNI RESEARCH 7

Lexmark Int’l, Inc. v. Static Control Components, Inc., 134

S. Ct. 1377, 1386 (2014). To be clear, a statutory grant of

a procedural right may relax the requirements of immediacy

and redressability, and eliminate any prudential

limitations, Massachusetts, 549 U.S. at 517–18, which

distinguishes the present inquiry from that governing a

declaratory judgment action. But the statutory grant of a

procedural right does not eliminate the requirement that

Consumer Watchdog have a particularized, concrete stake

in the outcome of the reexamination. Summers, 555 U.S.

at 496 (“[D]eprivation of a procedural right without some

concrete interest that is affected by the deprivation—a

procedural right in vacuo—is insufficient to create Article

III standing.”).

The estoppel provisions contained within the inter

partes reexamination statute likewise do not constitute

an injury in fact for Article III purposes. 35 U.S.C.

§ 317(a), (b). Consumer Watchdog is not engaged in any

activity that would give rise to a possible infringement

suit. Nor does Consumer Watchdog provide any indication

that it would file another request seeking to cancel

claims at the Patent Office. In any event, as Consumer

Watchdog only has a general grievance against the ’913

patent, the “conjectural or hypothetical” nature of any

injury flowing from the estoppel provisions is insufficient

to confer standing upon Consumer Watchdog. DaimlerChrysler

Corp. v. Cuno, 547 U.S. 332, 344 (2006);

Warth v. Seldin, 422 U.S. 490, 509 (1975); see also Sea-

Land Serv., Inc. v. Dep’t of Transp., 137 F.3d 640, 648

(D.C. Cir. 1998); cf. also Ass’n for Molecular Pathology v.

U.S. Patent & Trademark Office, 689 F.3d 1303, 1323

(Fed. Cir. 2012) (holding various plaintiffs lacked standing

in declaratory judgment action because alleged injuries

were too speculative), rev’d on other grounds sub nom.

Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,

133 S. Ct. 2107, 2114 (2013). The court, however, leaves

it to future panels to decide whether, under other circumCONSUMER

WATCHDOG 8 v. WISCONSIN ALUMNI RESEARCH

stances, the preclusive effect of the estoppel provisions

could constitute an injury in fact.

In sum, aside from its procedural right to appeal,

Consumer Watchdog has only alleged a general grievance

concerning the ’913 patent. It states that it is a nonprofit

consumer rights organization that is concerned about the

potential preemptive reach of the ’913 patent and the

alleged burden it places on taxpayer-funded research in

the State of California. Appellant’s Br. 1–2. While Consumer

Watchdog is sharply opposed to the Board’s decision

and the existence of the ’913 patent, that is not

enough to make this dispute justiciable. Lujan, 504 U.S.

at 577.

IV.

Because Consumer Watchdog has not identified a

particularized, concrete interest in the patentability of the

’913 patent, or any injury in fact flowing from the Board’s

decision, it lacks standing to appeal the decision affirming

the patentability of the amended claims. The court has

considered Consumer Watchdog’s remaining arguments to

the contrary, but finds them unpersuasive. Accordingly,

Consumer Watchdog’s appeal is dismissed.

DISMISSED

Update on Sequenom Case

The Sequenom case (patent on human embryonic stem cells) is proceeding, but at a slow pace.  It has attracted an amicus brief from the San Diego Intellectual Property Law Association.
If you want to look it up on Pacer it will save you some time if you know the number of the lead case is 14-1139 in the Court of Appeals For the Federal Circuit.

An Enlightening Conversation

Arthur,

 

Of course you may use my reply in any manner you think suitable and I sent a 'Cliff Notes' summary under a separate eMail header:

 

1.  The PROCESS to clone an organism is patentable.

2.  The RESULT of the process (Dolly the Sheep) is NOT patentable.

 

Pardon my simplistic summary of a complex case!

 

-Kim, 11 May 2014

 

 

-----Original Message-----
From: Arthur Gershman <art.gershman@verizon.net>
To: k50047 <k50047@aol.com>
Sent: Sun, May 11, 2014 8:26 am
Subject: Re: Kosher Goldfish News Flash

Dear Kim,

Thank you.

It occurs to me that others might have the same questions.

I would ask your permission to post this email correspondence on my blog No To Gene Patents.

I so, please  let me know.

Best regards,

Art

On May 11, 2014, at 8:09 AM, k50047@aol.com wrote:

Thank-You Arthur,

 

You set forth the issues and explained the underlying arguments very clearly - obviously, I did not realize that the cell line (biological material) of Dolly 'lives on' in the commercial (and presumably research) sectors and, now knowing that fact, I see the potential for commercial gain.

 

Finally, the issue of the rights of non profits under the AIA law, is, as you pointed out, a complexity with broader consequences beyond the instant issue of the cell 'line' of Dolly, the departed but not forgotten sheep!

 

Thanks again.

 

-Kim, 11 May 2014

 

 

 

-----Original Message-----
From: Arthur Gershman <art.gershman@verizon.net>
To: k50047 <k50047@aol.com>
Sent: Sun, May 11, 2014 7:21 am
Subject: Re: Kosher Goldfish News Flash

Hi Kin,

Regarding nuclear transfer, I urge you to read the decision, which explains the biology in very clear terms and far better than I could.

In answer to your question, you have fallen into the same trap as the relatives of Henrietta Lacks.

They mistook her cell line for her actual living presence.  A whole book was written about it and it is on my reading list.  People tell me it's a great read.

Now on to the second part of my answer. This particular case (Dolly). is a procedural issue, whether a nom-profit can sue in a post-grant proceeding.  A post-grant proceeding was an animal created under the AIA, the America Invents Act, signed into law September 16, 2011.  Kinks are being worked out by the courts.

Now on to the third part of my answer.  The underlying issue in this case is whether embryonic stem cells can be patented.  If the courts find that non-profits cannot sue under the AIA then this issue will not be resolved and the patent will prevent others from making, using, selling, or importing the embryonic stem sell line of Dolly.  This may not be the end of the issue, however, because some money making enterprise who wold be harmed in a monetary sense could still sue to have Dolly, or some other embryonic stem cell line patent declared invalid.

I hope I have clearly answered your question on this complicated matter at the intersection of cutting edge biotechnology and IP law.

Please don't hesitate to ask me any questions.

Arthur

On May 9, 2014, at 7:48 PM, k50047@aol.com wrote:

Arthur,

 

Dolly has passed over the Rainbow Bridge to that Great Meadow in the Sky.

 

Wikipedia notes:

 

Dolly (5 July 1996 – 14 February 2003) was a female domestic sheep, and the first mammal to be cloned from an adult somatic cell, using the process of nuclear transfer.^[2][3] She was cloned by Ian Wilmut, Keith Campbell and colleagues at the Roslin Institute, part of the University of Edinburgh, and the biotechnology company PPL Therapeutics near Edinburgh in Scotland, the United Kingdom. The funding for Dolly's cloning was provided by PPL Therapeutics and the Ministry of Agriculture.^[4] She was born on 5 July 1996 and died from a progressive lung disease 5 months before her seventh birthday.^[1] She has been called "the world's most famous sheep" by sources including BBC News and Scientific American.^[5][6]

The cell used as the donor for the cloning of Dolly was taken from a mammary gland, and the production of a healthy clone therefore proved that a cell taken from a specific part of the body could recreate a whole individual. On Dolly's name, Wilmut stated "Dolly is derived from a mammary gland cell and we couldn't think of a more impressive pair of glands than Dolly Parton's".^[1]

 

 

So, since Dolly the Cloned Sheep is no more, how can she be patented?

 

-  I assume the process "nuclear transfer" (the nuclear obviously referring to the nucleus of the cell) could be or has already been patented, so what is at issue in the current patent decision - some remnant of Dolly in a petri dish was to be patented?

 

Just curious.

 

-Kim, 09 May 2014

 

-----Original Message-----
From: Arthur Gershman <art.gershman@verizon.net>
To: Undisclosed recipients: ;
Sent: Fri, May 9, 2014 2:48 pm
Subject: Kosher Goldfish News Flash

News Flash

Dolly, the Cloned Sheep, was held patent ineligible by the Court of Appeals for the Federal Circuit.

Read the decision.

Kosher Goldfish

Watchdog v WARF

Below are links to the oral arguments in the Watchdog v WARF case.  To remind you:
The Wisconsin Alumni Research Foundation (WARF) has obtained a patent on Human Embryonic Stem Cells, USPN 7,029,913.  The validity of the patent is opposed by the Consumer Watchdog (formerly known as the Foundation for Taxpayer and Consumer Rights), a non-profit located in California with an office in D.C. Click on the links below to listen.  

2013-1377_3132014.mp3
2013-1377.mp3

What is at stake here is patents on embryonic stem cells, clearly a hot topic.  This case is a procedural issue whether under the new patent law (America Invents Act, the AIA) allows a non-profit to sue in a post-issue grant.  This post-issue grant, created under the AIA, is a patent which has been granted.

Dolly, the Cloned Sheep Held Not Patentable!!!

Dolly, the Cloned Sheep, Held Not Patentable

Patent Office Guidelines on Myriad and Prometheus

The Patent Office has issued a new set of Guidelines for examiners of genetic-type patent applications in light of the Myriad and Prometheus cases.  I am just now trying to absorb them.  Here's a handy chart published in the Guidelines.  I will report more on this later.