dismissed EB-2 NIW Case: Pharmaceutical Science

'dentifjing data deleted to 
Wvent clearly Unwmted 
invasion of personal privacy 
U.S. Department of Homeland Security 
U.S. Citizenship and Immigration Services 
OfJice ofAdministrative Appeals MS 2090 
Washington, DC 20529-2090 
U. S. Citizenship 
and Immigration 
SRC 07 800 23706 
IN RE: Petitioner: 
Beneficiary: 
PETITION: 
 Immigrant Petition for Alien Worker as a Member of the Professions Holding an Advanced 
Degree or an Alien of Exceptional Ability Pursuant to Section 203(b)(2) of the Immigration 
and Nationality Act, 8 U.S.C. 5 1 1 53(b)(2) 
ON BEHALF OF PETITIONER: 
INSTRUCTIONS: 
This is the decision of the Administrative Appeals Office in your case. All documents have been returned to 
the office that originally decided your case. Any further inquiry must be made to that office. 
If you believe the law was inappropriately applied or you have additional information that you wish to have 
considered, you may file a motion to reconsider or a motion to reopen. Please refer to 8 C.F.R. 5 103.5 for 
the specific requirements. All motions must be submitted to the office that originally decided your case by 
filing a Form I-290B, Notice of Appeal or Motion, with a fee of $585. Any motion must be filed within 30 
days of the decision that the motion seeks to reconsider or reopen, as required by 8 C.F.R. 5 103.5(a)(l)(i). 
kkf~izinistrative Appeals Office 
Page 2 
DISCUSSION: The Director, Nebraska Service Center, denied the employment-based immigrant visa 
petition. The matter is now before the Administrative Appeals Office (AAO) on appeal. The AAO will 
dismiss the appeal. 
The petitioner seeks classification pursuant to section 203(b)(2) of the Immigration and Nationality Act 
(the Act), 8 U.S.C. 9 1 153(b)(2), as a member of the professions holding an advanced degree. The 
petitioner seeks employment as a development scientist at Amylin Pharmaceuticals, Inc., San Diego, 
California. The petitioner asserts that an exemption from the requirement of a job offer, and thus of a 
labor certification, is in the national interest of the United States. The director found that the petitioner 
qualifies for classification as a member of the professions holding an advanced degree, but that the 
petitioner has not established that an exemption from the requirement of a job offer would be in the 
national interest of the United States. 
On appeal, the petitioner submits a brief from counsel and copies of exhibits already in the record. 
Section 203(b) of the Act states, in pertinent part: 
(2) Aliens Who Are Members of the Professions Holding Advanced Degrees or Aliens of 
Exceptional Ability. -- 
(A) In General. -- Visas shall be made available . . . to qualified immigrants who are 
members of the professions holding advanced degrees or their equivalent or who 
because of their exceptional ability in the sciences, arts, or business, will substantially 
benefit prospectively the national economy, cultural or educational interests, or welfare 
of the United States, and whose services in the sciences, arts, professions, or business 
are sought by an employer in the United States. 
(B) Waiver of Job Offer - 
(i) . . . the Attorney General may, when the Attorney General deems it to be in 
the national interest, waive the requirements of subparagraph (A) that an alien's 
services in the sciences, arts, professions, or business be sought by an employer 
in the United States. 
The director did not dispute that the petitioner qualifies as a member of the professions holding an 
advanced degree. The sole issue in contention is whether the petitioner has established that a waiver of 
the job offer requirement, and thus a labor certification, is in the national interest. 
Neither the statute nor the pertinent regulations define the term "national interest." Additionally, 
Congress did not provide a specific definition of "in the national interest." The Committee on the 
Judiciary merely noted in its report to the Senate that the committee had "focused on national interest by 
increasing the number and proportion of visas for immigrants who would benefit the United States 
economically and otherwise. . . ." S. Rep. No. 55, 101 st Cong., 1 st Sess., 1 1 (1 989). 
Page 3 
Supplementary information to regulations implementing the Immigration Act of 1990 (IMMACT), 
published at 56 Fed. Reg. 60897,60900 (November 29, 1991), states: 
The Service [now U.S. Citizenship and Immigration Services] believes it appropriate 
to leave the application of this test as flexible as possible, although clearly an alien 
seeking to meet the [national interest] standard must make a showing significantly 
above that necessary to prove the "prospective national benefit" [required of aliens 
seeking to qualify as "exceptional."] The burden will rest with the alien to establish 
that exemption from, or waiver of, the job offer will be in the national interest. Each 
case is to be judged on its own merits. 
Matter of New York State Dept. of Transportation, 22 I&N Dec. 215 (Commr. 1998), has set forth 
several factors which must be considered when evaluating a request for a national interest waiver. First, 
it must be shown that the alien seeks employment in an area of substantial intrinsic merit. Next, it must 
be shown that the proposed benefit will be national in scope. Finally, the petitioner seeking the waiver 
must establish that the alien will serve the national interest to a substantially greater degree than would 
an available U.S. worker having the same minimum qualifications. 
It must be noted that, while the national interest waiver hinges on prospective national benefit, it clearly 
must be established that the alien's past record justifies projections of future benefit to the national 
interest. The petitioner's subjective assurance that the alien will, in the hture, serve the national interest 
cannot suffice to establish prospective national benefit. The inclusion of the term "prospective" is used 
here to require future contributions by the alien, rather than to facilitate the entry of an alien with no 
demonstrable prior achievements, and whose benefit to the national interest would thus be entirely 
speculative. 
We also note that the regulation at 8 C.F.R. 5 204.5(k)(2) defines "exceptional ability" as "a degree 
of expertise significantly above that ordinarily encountered" in a given area of endeavor. By statute, 
aliens of exceptional ability are generally subject to the job offerllabor certification requirement; 
they are not exempt by virtue of their exceptional ability. Therefore, whether a given alien seeks 
classification as an alien of exceptional ability, or as a member of the professions holding an 
advanced degree, that alien cannot qualify for a waiver just by demonstrating a degree of expertise 
significantly above that ordinarily encountered in his or her field of expertise. 
The ~etitioner filed the netition on Julv 27. 2007. 
 The ~etition included several witness letters. 
Technology (NJIT), stated: 
[Ulnder my guidance, [the petitioner] applied his engineering expertise and skills to the 
development of new methods of studying dissolution testing and dissolution testing 
equipment, identified several problems with the current design of dissolution testing 
equipment, and provided recommendations on how to improve the performance of 
dissolution testing equipment. 
. . . Dissolution testing is a critical analytical method in the stage of formulation design 
during drug development. . . . Dissolution testing also serves as a required regulatory 
quality control tool. . . . Failures in drug dissolution testing could have three possible 
reasons: poor formulation or manufacturing of drug, unreliable performance of the USP 
[United States Pharmacopeia] Dissolution Test Apparatus 11, or both. . . . Not until a few 
years ago did a small group of researchers begin to conduct fundamental studies to seek 
the source of the unreliability of the USP Dissolution Test Apparatus I1 and possible 
solutions to the problem. [The petitioner] has been one of these pioneer researchers 
playing a key role in these research efforts. Working on a research project funded by 
Merck & Co[.], Inc., [the petitioner] has been conducting a comprehensive study on the 
USP Dissolution Test Apparatus I1 in order to identify the cause of USP Dissolution 
Test Apparatus 11's inconsistent and unreliable test results. 
[The petitioner] contributed significantly to this research field through his development 
of an innovative approach to study the hydrodynamics of dissolution testing apparatuses 
that was different from those adopted by most researchers. . . . Such information is 
critical to advancing our fundamental understanding of the dissolution rate process, 
enhancing the reliability of dissolution testing, and eliminating artifacts associated with 
test equipment. 
- Associate Director of Pharmaceutical Development at Merck & Co., Inc., 
collaborated with the petitioner and 
 called the petitioner's "findings . . . 
highly valuable for current users of the USP Dissolution Test Apparatus 11." Regarding the petitioner's 
current work, tated: "My understanding is that he participates in the development of an 
innovated diabetes drug." 
through his mesentations and ~ublications even though I have not worked with him ~ersonallv." (The 
, , 
record shows that 
 has collaborated wiyh 
 the two share several author 
credits.) credited the petitioner with "several significant contributions to our 
understanding of the hydrodynamics of the [UISP Dissolution Test Apparatus 11." stated 
that the petitioner "is among the pioneers in this area." did not comment on the 
petitioner's more recent work at Amylin. 
, Senior Research Scientist at Canada's Bureau of Pharmaceutical Sciences, stated 
that the petitioner's "efforts . . . are highlighting problems [alffecting current dissolution practices. His 
experimental studies will provide improved understanding bf the issues which then $11 lead to the 
solutions for the problems." letter is dated several months after the petitioner left NJIT. 
id not state how the petitioner's post-NJIT work related to dissolution problems. 
enhanced our understanding dramatically of hydrodynamics effects on dissolution test results." 
Regarding the petitioner's current work at Amylin, states only that it relates to diabetes drugs. 
a Research Scientist at the U.S. Food and Drug Administration (FDA), stated that 
the petitioner's "research points out the direction for improving the USP Dissolution Test Apparatus 11." 
stated that the petitioner now works "on development of the first once-a-week diabetes drug, 
Exenatide LAR," but did not elaborate as to the nature of that work. stated that the petitioner's 
"research is indispensable to the success of improving dissolution testing," but did not explain how the 
petitioner's work at Amylin relates to the improvement of dissolution testing. 
Senior Research Investigator at Bristol-Myers Squibb and one of the petitioner's 
collaborators, stated that the petitioner's "original findings are highly valuable for the current users of 
the USP Dissolution Apparatus 11," and that the petitioner "is now participating in the development of 
Exenatide LAR, the first once-a-week drug for diabetes in the world. . . . It is currently in phase 3 
clinical studies." This letter, like the other letters, leaves open the nature of the petitioner's exact role 
in developing the drug. Given that the petitioner joined Arnylin only a few months before this letter was 
written, and Exenatide LAR is already in phase 3 clinical studies, it does not appear that the petitioner 
was at Amylin at the time the company first formulated the drug. 
The petitioner's own resume contains this description of his work at Amylin: 
Initiate and support sustained-release formulation development and manufacturing 
process development studies for proteinslpeptides in Amylin's pipeline; plan and 
schedule development work according to department's and company's timetables and 
establish short and long term goals to meet project timelines; assist in maintaining 
laboratory instrumentation and inventories of chemicals and reagents; maintain accurate 
and complete laboratory notebooks; and participate in decision-making process 
regarding development priorities of the group. 
The petitioner submitted copies of articles based on his doctoral studies. He did not claim independent 
citation of these articles, or state that his work at Amylin would produce further publications. 
On September 10, 2008, the director instructed the petitioner to submit evidence of his "influence on 
[his] field." The director specifically requested evidence that other researchers have cited the 
petitioner's published work. 
In response, the petitioner documented one citation of his work. Counsel stated "the lack of citations 
should not detract from the impressiveness of [the petitioner's] research and impact [on] the field." 
few researchers are enrraeed in hvdrodvnamic studv of the USP Dissolution Test A~~aratus 11. so the 
u u 
low citation rate of the petitioner's work 
"is quite understandable," 
the appearance of "many more citations of [the petitioner's] research in the near future." 
 Prof. 
asserted that it takes time for citations to follow the publication of an influential article. We 
do not dispute this assertion, but the petitioner must still establish the impact and influence of his work. 
The 
 is not exempt from this re uirement simply because hi filed his petition before such 
citations had time to appear. Also, 
 claims do not require us to presume that the 
petitioner's work will be heavily cited in the future. 
Counsel is correct that citations are not the only conceivable gauge of the petitioner's impact, although 
they do have the advantage of existing objectively and independently of the petition. If there is no 
documented reaction to a researcher's influence until that researcher requests letters discussing his 
work, it is reasonable to question the true extent of that influence. In the petitioner's case, witnesses 
have very heavily emphasized his studies of the USP Dissolution Test Apparatus 11. Therefore, in the 
absence of heavy citation of his work, a good gauge of the petitioner's influence would be to see how 
much the petitioner's work has affected the use or design modifications of the USP Dissolution Test 
Apparatus 11. If the petitioner cannot show any such changes in the apparatus' use or design, then it is 
not clear how the petitioner could be said to have had influence relating to the apparatus. (Being among 
the first to study a particular problem is not, by itself, influence or impact within a given field.) With 
this in mind, we examine the second group of witness letters. 
Six independent witnesses all discussed the petitioner's work with the USP Dissolution Test Apparatus 
11. None of the witnesses indicated that the petitioner continues such work, and the record contains 
nothing from Amylin to indicate that the petitioner continues to work on this problem. Given that the 
record strongly suggests that the petitioner no longer concentrates his work on the USP Dissolution Test 
Apparatus 11, we will not entertain the argument that the petitioner's continued presence in the United 
States is required for further progress on such studies. We will consider evidence of the impact of the 
petitioner's past work, but his work in this area has already been published and will continue to be 
available to researchers regardless of whether the petitioner remains in the United States in the future. 
- of Life Science at Simulations Plus, Inc., Lancaster, California, stated that 
the petitioner "is clearly a pioneer in the field of hydrodynamic study on the USP Dissolution Test 
Apparatus 11. . . . His numerous past discoveries of major significance leave little doubt that [he] will 
continue to make even more important breakthroughs in the area of pharmaceutical research and 
development." 
of the FDA's Office of Generic Drugs stated that the petitioner's "research 
findings have resulted in a significant impact on the drug dissolution test field. . . . His pioneering work, 
cutting-edge findings, and significant achievements in his field have been highly acclaimed and widely 
accepted by the international scientific community." did not elaborate on what those findings 
are, or how they have been "widely accepted," except to state that the petitioner showed that the 
"apparatus is extremely sensitive to the operating conditions." stated that the petitioner's work 
with simulations "opens the door for making the dissolution test unnecessary in the future," but did not 
indicate that the FDA is considering eliminating the dissolution test requirement. 
"original findings are highly valuable for current users of the USP Dissolution [Test] Apparatus I1 and 
very helphl to eliminate dissolution testing variability." stated: "We have enhanced our 
productivity and shortened our product development cycle by applying [the petitioner's] research 
findings into our projects." Regarding the petitioner's more recent work at ~rn~lin stated: 
[The petitioner] successfully reduced the residual silicone oil amount in the formulation 
of Exenatide LAR to an accepted level. He optimized [the] Exenatide LAR injection 
device to ease the administration of the drug product. He [has] developed [a] high yield 
sieving process of the Exenatide LAR powder to reduce the needle clogging rate during 
injection. He is developing a high throughput filling process for the final Exenatide 
LAR product, which consists of drug powder and diluent. . . . [The petitioner] is 
challenging science to bring this new drug to the patients as quickly as possible. 
Senior Principal Scientist at Pfimr, Inc., in the United Kingdom, asserted that the 
etitioner "has gained international acclaim" for his work with the USP Dissolution Test Apparatus 11. 
h asserted that the petitioner's "research work and findings have been invaluable to my own 
work." 
 is the author of the sole submitted paper that cited the petitioner's work. 
of the University of Iowa stated that the petitioner "is among the very 
iew pioneering scientists to have had a substantial impact in research to characterize the hydrodynamics 
and to identify its effects on drug dissolution testing." He is one of several witnesses to assert that the 
petitioner's findings were reported to the FDA in 2005, but the record does not show what action, if 
any, the FDA hastaken in the years since the report. (The petitioner did not write the report, but the 
report's authors, used their past work with the petitioner as source 
material.) 
Director of Analytical Development at Conor Medsystems, LLC, stated: 
I would rate [the petitioner] as a top research scientist for his outstanding contributions 
in his field. Although I have never personally worked with him, I reviewed [the 
petitioner's] research paper manuscript titled "Hydrodynamic Investigation of USP 
Dissolution Test Apparatus 11" in 2006 and suggested its acceptance for [publication in 
the] Journal ofPharmaceutica1 Sciences. . . . 
[The petitioner] found that although the working volume of the USP Dissolution Test 
Apparatus I1 tank is small and the impeller rotation speed is low, the hydrodynamics in 
the bottom region of this tank is extremely complicated. This is the most critical region, 
because the drug tablet under test stays in this region during the dissolution test. . . . [A] 
small variation in the location of the tablet on the tank bottom . . . [is] very likely to 
result in significantly different velocity gradients and shear strain rates experienced by 
the tablet. This phenomenon first discovered by [the petitioner] introduces huge 
variability into the dissolution test results generated by the USP Dissolution Test 
Apparatus 11. . . . The ultimate solution of this problem is to redesign this analytical 
equipment, where [the petitioner's] research findings will provide critical guidance and 
direction in these efforts. 
The petitioner submitted nothing fiom the USP or any other governmental or industry body to indicate 
that the petitioner's work has, in fact, led to efforts to redesign the USP Dissolution Test Apparatus 11. 
An updated version of the petitioner's r6sum6 indicated that he uses "Computational Fluid Dynamics 
(CFD) to develop and optimize drug delivery devices for different drug candidates in Amylin's 
pipeline." 
The director denied the petition on January 21,2009, citing the petitioner's "modest publication record" 
and minimal citation of the petitioner's work. The director acknowledged the petitioner's witness 
letters, but stated that if the petitioner's contributions were especially significant, then there would be 
some evidence of their importance other than witness letters solicited to support the petition. 
On appeal, counsel asserts that the previously submitted witness letters "not only attest to the 
recognized importance and impact of [the petitioner's] research results [in] the field of drug discovery 
research, but also to their implementation in laboratories and companies around the world." The record 
does identify individuals who have put the petitioner's findings to use, but the record does not show that 
their statements represent anything approaching a consensus or widespread implementation in the field. 
Counsel asserts that the petitioner's "findings . . . have since been passed on to the FDA as 
recommendations for possible improvements to the apparatus," but the petitioner has submitted nothing 
from the FDA to show that that the FDA has taken any concrete action on those recommendations, or 
that the petitioner's work has resulted in any implemented improvements to the USP Dissolution Test 
Apparatus 11. The petitioner has submitted letters from two FDA researchers, but he has not shown that 
either of those officials has the authority to implement the petitioner's findings. The letters do not 
amount to institutional notice of the petitioner's work. 
Counsel attempts to explain the petitioner's low citation rate by stating: "The pharmaceutical industry is 
a highly competitive industry and as a result, researchers in pharmaceutical companies tend to file 
patents on their findings and results rather than journal papers in order to protect their companies' 
proprietary findings." This assertion seems to be off-point, however, because the petitioner's principal 
contribution does not involve the private intellectual property of any one pharmaceutical company. 
Rather, it concerns (in counsel's words) "a critical instrument that is widelv used in the pharmaceutical 
indust&." ~ounsei's explanation is also at odds with 
 prediction df "many more 
citations of [the petitioner's] research in the near future." With respect to counsel's claim that 
pharmaceutical companies rely on patents rather than journal publications, the record contains no 
evidence of any patents or patent applications resulting fiom the petitioner's work. 
The record shows that the USP Dissolution Test Apparatus I1 was already known to produce 
questionable results at times, well before the petitioner began his research. The record does not indicate 
that the petitioner's work has yielded any improvements to the apparatus. At best, some witnesses 
assert that the petitioner's work points the way to eventual future improvements, even though the FDA 
and USP remain institutionally silent on the matter. 
Furthermore, there is no indication that the petitioner continues to work on improvements to the 
apparatus. That work appears to be 
 focus, with which the 
 was temporarily 
involved owing to his doctoral studies in 
 laboratory. If the petitioner no longer 
works directly on the problems with the USP Dissolution Test ~~~arahls 11, then there is no reason to 
believe that holding the petitioner to the labor certification requirement will delay or hamper continued 
progress in such research. 
The petitioner had already left NJIT for Amylin before he filed the petition, but the record contains 
little evidence about that work, except to indicate that the petitioner participates in efforts to refine 
an already-developed drug. His claimed reputation appears to rest not on a sustained series of 
contributions, but on his now-completed Ph.D. program. The petitioner has not met his burden to 
establish that his ongoing work will continue to have the same impact as what he was previously 
doing in the laboratory of an already-established university professor. 
As is clear from a plain reading of the statute, it was not the intent of Congress that every person 
qualified to engage in a profession in the United States should be exempt from the requirement of a job 
offer based on national interest. Likewise, it does not appear to have been the intent of Congress to 
grant national interest waivers on the basis of the overall importance of a given profession, rather than 
on the merits of the individual alien. On the basis of the evidence submitted, the petitioner has not 
established that a waiver of the requirement of an approved labor certification will be in the national 
interest of the United States. 
The burden of proof in these proceedings rests solely with the petitioner. Section 291 of the Act, 
8 U.S.C. 5 1361. The petitioner has not sustained that burden. 
This decision is without prejudice to the filing of a new petition by a United States employer 
accompanied by a labor certification issued by the Department of Labor, appropriate supporting 
evidence and fee. 
ORDER: The appeal is dismissed.