Chair's Message

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CHEMISTRY AND THE LAW AMERICAN CHEMICAL SOCIETY Volume 21, No. 1 http://membership.acs.org/c/chal/ Spring 2005 EVENTS AT SAN DIEGO Executive Board Meeting All welcome 6:00 - 8:00 p.m. Sunday, March 13, 2005 Convention Center, Room 24C Joint Reception COMSCI-CHAL-ANYL 5:00 - 7:00 p.m. Monday, March 14, 2005 Convention Center, Room 24C Sponsored by Thomson Scientific Presentation of Papers Sunday to Thursday March 13 - 16, 2005 Convention Center, Room 24C Notice of Open Meeting Monday, March 14, 2005 (after the morning session) NEWSLETTER INDEX PAGE 20 Chairs Message Happy New Year to all CHAL members and thank you for giving
me the opportunity to be your Chair.
While I am looking forward to a pro-
ductive year as the Chair of our
Division, I continue to reflect on the
successes that our Division has had in
the past. I am reminded of the two-
faced Roman god of doorways, Janus,
from whence we get the name for the
month of January. Even as he looked
to the future, he did not forget about
the past from which he came. In keeping with this idea, I would first like to take this opportunity to
thank our immediate Past-Chair, Bill
Johnson, and the entire Executive
Committee for their leadership in
2004. Their names are too numerous
to mention but they can be found
throughout this newsletter. Their hard
work and dedication resulted in a
successful 2004 and has laid the foun-
dation for another successful year in
2005. In looking forward to 2005 and beyond, I am truly excited about the
opportunities that lie ahead for CHAL.
But yet, we cannot stop here. I am
reminded of the theme behind the
Enterprise 2015 project recently pre-
sented by Bill Carroll, the incoming
president of ACS. From his own
words, Enterprise 2015 is a project
undertaken to maximize future oppor-
tunities in the global chemical enter-
prise by understanding, planning for
and making the most of inevitable
changes. In thinking about the goals
of Enterprise 2015, I am struck by
how important planning and prepar-
ing for the future is to the success of
our Division. In order to maximize
our future opportunities and success, I believe we need to embrace the
efforts of the president and adopt his
goals as our own. Thus, I would like
to challenge you to begin preparing
and planning for the future of CHAL. You may be asking yourself - How? What? Where? and When can I
help prepare and plan for the future
of CHAL? As a first step, please con-
sider becoming more involved in the
Division. Your involvement can start simply by getting to know the Executive
Committee and other members of
CHAL. Come and see us at the
National Meeting in San Diego. Our
upcoming series of technical sessions
has the diversity, breadth and depth
that we continually strive for. Of par-
ticular note, our San Diego program
includes sessions directed to
Intellectual Property, Forensics,
Environmental Law, Biotechnology
and Labor/Employment Law, just to
name a few (more information on the
program can be found in the pages
following this message). In looking at
our technical program, I think you This newsletter is published in the United States of America and copyright 2005 Division of Chemistry and The Law, Inc. Primary version is as print on paper, mailed twice-yearly from Palo Alto, California, prior to ACS national meetings, and distributed at those
meetings; also to be on http://membership.acs.org/C/CHAL/ Opinions expressed are those of the authors and not necessarily of CHAL or
ACS. While great effort is made for accuracy, factual errors are possible; CHAL and ACS bear no liability for such errors, and CHAL invites
correction for future publication. References, including Internet sites, cited as bibliography or for general interest, are intended for readers
convenience only, and are not endorsed as to opinions or for detailed accuracy or timeliness, which are the responsibilities of the authors
and publishers of those references. Internet site citations were thought to be timely within a few weeks before this newsletter went to press;
however, some may have become stale. Mention of publications, products, or services is intended for readers convenience only and not as
commercial endorsement. Discussion of legal issues is for information and educational purposes and is not legal advice; legal advice should
be sought from licensed lawyers formally consulted for that purpose. Readers comments are welcome and future articles from them are invit-
ed especially to broaden the range of topics and viewpoints address to: M. Grossman, editor. Design, layout and printing by
MontiGraphics, Palo Alto, California. 94043. Phil Monti, montigrp@atdial.net, 650-691-0900, fax 650-691-0902. continued on next page The Division of Chemistry and the Law gratefully acknowledges the generous support of Snell & Wilmer L.L.P. of One Arizona Center, 400 East Van Buren, Phoenix, Arizona for funding the periodic Board teleconferences. Page 2 CHEMISTRY AND THE LAW Spring 2005 will find that CHAL is not just for
patent lawyers, or even lawyers in
general but, rather, for all chemists
from all professions. If you have never attended a CHAL Board meeting, our Executive
Board meeting in San Diego is sched-
uled for Sunday evening, following
the technical program. This is an
open meeting where your attendance
is always welcome. Please stop by
and provide us with your thoughts
and impressions of CHAL. Let us know
what you like and what you do not
like. Your feedback is always welcome. At the very least, please stop by our reception on Monday evening. In
San Diego, following our Monday
technical sessions, we are co-sponsor-
ing a reception with the Committee
on Science and the Division of
Analytical Chemistry. There, you can
come, eat, have a drink, and meet the
members of CHAL along with other
members from throughout the Society,
before heading to the ever popular
Sci-Mix presentations by Dr. Howard
Peters. If you cannot join us in San Diego, then please consider attending
or even participating in one of our
future meetings. For starters, it is not
too late to participate in our technical
program in Washington, D.C. this fall.
So, consider yourself invited. Please remember that our Divisional activities also continue
between national meetings. We hold
monthly Executive Committee confer-
ence calls on the second Tuesday of
every month to discuss future pro-
gramming and other issues of impor-
tance to the Division and the Society.
These calls are open to all who wish
to participate and your participation is
welcomed. Please let me know if you
would like to participate and I will be
sure to send you more information. Whatever forum you choose, I urge you to help us plan and prepare
for our Divisions future by simply contributing your thoughts and ideas.
Please tell us how we can make the
Division more relevant to you and
your particular profession. The choice
is up to you. This is your Division
and it needs you. The future of CHAL
is bright but its long-term success
depends on the involvement of its
members. I look forward to seeing you in San Diego. Brian C. Meadows continued from front page Membership Application blank is on page 18 of this Newsletter. Ask a colleague to join you in the Best Division in the ACS. Personal invitations support our growth. Treasurers Report January 1 December 31, 2004 Starting Balance $ 1,834.59 Income ACS Division Dues, July-December, 2003 7,490.00 ACS Division Dues, January-June, 2004 4,358.00 Thomson Scientific Sponsorship for Anaheim 2,500.00 SCHB Payment for Anaheim Joint Reception 3,088.03 ACS 2004 Division Allocation 4,429.71 ACS Reimbursement for Councilor Expenses 3,014.50 Thomson Scientific Sponsorship for Philadelphia 5,000.00
SCHB Payment for Philadelphia Joint Reception 2,500.00 New Member Dues 45.00 Fall Newsletter Advertising 500.00 Total (income plus starting balance) $34,759.83 Expenses Incorporation - C. T. Corp. System 219.00
Spring Newsletter 5,467.05 Annual Bulk Mail Fee for 2004 and 2005 300.00 Deposit for Bulk Mail Account 500.00 Postal Expenses for Spring Newsletter 233.12 Councilor Reimbursement for Anaheim 3,352.66 Microsoft Works for Newsletter Editor 85.00 Anaheim Joint Reception 9,264.10 Anaheim Executive Board Meeting 477.80 Bank Charges, January-December, 2004 29.20 Leadership Conference Reimbursement 417.50 Fall Newsletter 3,594.25 Chemical Heritage Foundation 406.25 Philadelphia Joint Reception - Jeffery Miller Catering 3,060.44 Philadelphia Speaker Registration plus Audio/Visual 696.30 Councilor Reimbursement for Philadelphia 3,185.20
Awards 279.27 Total $31,567.14 Ending Balance $ 3,192.69 Spring 2005 CHEMISTRY AND THE LAW Page 3 This is the happiest report I've written. That is because one of our
own has made it. Howard Peters,
one of CHAL's founders, and my col-
league as CHAL Councillor, has been
elected to the ACS Board of Directors
as Director-at-Large for the term
2005-2007. With this good news focusing your attention, it might be a good
time to describe ACS' election proce-
dures for national offices. The Committee on Nominations and Elections (N&E, a committee
itself elected by the Council) selects
4 candidates for each position -
President-Elect and those Board of
Directors positions coming up in any
one year. At the Spring ACS Meeting,
the Council chooses 2 of the 4 as
candidates. Subsequent to that Spring
meeting, candidates can also be
nominated by petition and if they
receive sufficient signatures, also
appear on the ballot and in C&EN.
Petition candidates can be nominated
by signatures of 300 or more ACS
members, with no more than 50
from any one local section. This year more positions had petition candidates than I can recall.
For President-Elect, Anne Nalley of
Cameron University was a petition
candidate, and as you know, was
elected by the ACS membership as
ACS President-Elect for 2005. District Directors are elected by ACS members of that district. For
District Director in District IV, John
Massingill of Texas State University
was a petition candidate along with
N&E nominations, Eric Bigham of
Glaxo Smith Kline, Paul Jones of the
University of North Texas and Robert
Lichter of Merrimack Consulting. This
was a close contest, leading to a run-
off between Eric Bigham and Paul
Jones; Eric Bigham is the winner. And of most direct interest to CHAL. Directors-at-Large are elected Councilors Report by the Council. For the 2005-2007
term, the N&E candidates were
David Eaton of Light Insights and
Ted Tabor of Technology Transfer
Consulting (Tabor withdrew before
balloting). The petition candidates
were Howard Peters, David Rahni of
Pace University and Judith Giordan
of Visions In Education. As I wrote
happily at the start of this report,
Howard won the election. Directors are also Councillors, and a Councillor can't wear two hats,
so Howard has had to step down as
CHAL Councillor. Alternate
Councillor James Carver will fill the
remainder of Howard's 2004-2006
term. Meanwhile, I am gratified to
have been chosen to represent you
again for the 2005-2007 term. Ken
Colton is Alternate Councillor for my
position, or if Jim is unavailable for a
meeting. The Council meeting itself gener- ated much controversy. First, N&E
had decided to reduce the length of
candidate statements for President-
Elect and Board of Directors from
the traditional 1000 words to 750
words. Former President Attila
Pavlath moved that the limit remain
at 1000 words. The measure was
debated hotly, and was defeated by
a close vote. The Council also discussed a proposal from the Committee on
Committees (ConC) to establish an
Ethics Committee to coordinate
ethics-related activities, serve as a
clearinghouse, raise awareness,
review recognition opportunities for
acknowledging ethical behavior, and
develop and oversee other ethics-
related activities. The committee
would not be an adjudicatory body.
There was much interest in this
issue, but a concern that it needed to
be thought through further before
enactment. The Council voted to
refer the recommendation back to
ConC for further study. The Council also accepted three petitions for amendments to the
Constitution and/or Bylaws. The peti-
tions have been thoroughly evaluat-
ed by the Committee on Constitution
& Bylaws. The petitions/amendments
are: 1) to permit (not require) elec-
tronic balloting; 2) to change division
annual report deadlines to be consis-
tent with local section report dead-
lines; and 3) to allow experienced
qualified chemistry teachers who
may not otherwise meet ACS mem-
bership requirements to become
members based on their status and
experience and to allow those who
do not meet status and experience
requirements to become associate
members. These petitions/amend-
ments passed Council and the
Constitutional changes have been
submitted to ACS members for vote
(and passed). Finally, at the last few Council meetings, there have been special
discussion items brought up for com-
ment and study, but not for enact-
ment of any specific proposals. This
meeting's special discussion issue
was the multidisciplinarity/dispersion
of chemistry as a discipline and its
impact on ACS members and the
profession. There has been concern
that the practice of chemistry in disci-
plines not labelled as chemistry
impacts many aspects of the chemi-
cal enterprise. The Board and
President have established a joint
Board-Council task force to assess
the challenges and opportunities that
multidisciplinarity presents to the
ACS and chemical scientists in gener-
al, and wanted input from
Councillors. We will hear more from
this task force in the future. Alan M. Ehrlich Page 4 CHEMISTRY AND THE LAW Spring 2005 Program for San Diego Meeting Division of Chemistry and The Law March 13 - 17, 2005 B. C. Meadows, Chair of the Division and Program Chair SUNDAY MORNING Convention Center, Room 24C CHALs Ongoing Intellectual Property
Series: Key Topics in U.S. Patent Law
B. C. Meadows, Organizer, Presiding 9:25 Introductory Remarks. 1. 9:30 Did you lose your right to
a patent if you published
the invention?
X. Pillai 2. 10:00 Fight for your invention: Final
rejection and the appeals
process for inventors.
T. J. Kennedy III, M. Catania 3. 10:30 Defending against frivolous
inequitable conduct allegations:
strategies for patent
prosecution and litigation.
J. J. Hasford 4. 11:00 Inventorship: Getting it right
the first time.
S. Thompson 5. 11:30 Patent attorneys are from
Venus, inventors are from
Mars. S. Thompson SUNDAY AFTERNOON Convention Center, Room 24C The Attorney-Client Privilege, Work
Product Immunity, and Confidentiality
in Patent Prosecution and Litigation
B. C. Meadows, Organizer
J. J. Hasford, Organizer, Presiding 1:25 Introductory Remarks. 6. 1:30 An introduction to the
attorney-client privilege for
scientists, inventors, and their
lawyers. J. J. Hasford 7. 2:00 The basics of work product
immunity in patent litigation.
E. H. Barash 8. 2:30 Confidentiality issues for
patent attorneys, their clients,
and third parties.
B. C. Meadows 9. 3:00 Attorney-client privilege,
work product immunity, and
confidentiality considerations
from a corporate perspective.
E. R. Puknys MONDAY MORNING Convention Center, Room 24C Hiring Your Competitor's Employees
Without Stirring The Trade Secrets
Hornet's Nest
G. Lemmer and R. Hayashi,
Organizers, Presiding 10. 9:00 Introduction to trade secrets
law for the non-lawyer.
G. Lemmer, R. Hayashi 11. 10:00 Mock trial: an employer's
request for a preliminary
injunction.
G. Lemmer, R. Hayashi 12. 11:00 Panel discussion.
G. Lemmer, R. Hayashi Finding Criminals with Forensic
Chemistry (Part 1)
Cosponsored with COMSCI and ANYL Take Two: New Careers for Ph.D. Chemists
Cosponsored with YCC MONDAY AFTERNOON Convention Center, Room 24C
Patenting Polymorphs: From the
Laboratory to the Courtroom
E. H. Barash, Organizer, Presiding 1:25 Introductory Remarks. 13. 1:30 Crystal polymorphism in
pharmaceuticals:
Fundamentals of discovery
and characterization.
A. J. Matzger 14. 2:00 Claiming a chemical invention.
M. Feldstein 15. 2:30 Polymorphs in patent
litigation. J. Swan 16. 3:00 Polymorph workshop.
E. H. Barash Finding Criminals with Forensic
Chemistry (Part 2)
Cosponsored with COMSCI and ANYL MONDAY EVENING Convention Center, Room 24C
Sci-Mix
H. M. Peters, Organizer, Presiding
8:00 - 10:00 17. Inventure Place. H. M. Peters, S. B. Peters 18. National Inventors Hall of
Fame. ( www.invent.org ) H. M. Peters, S. B. Peters 19. The Original Hawaiian
Chocolate Factory.
H. M. Peters, S. B. Peters TUESDAY MORNING Convention Center, Room 24C
Value Creation and IP Protection for the
Small Molecule Start-Up
M. Murphy, Organizer, Presiding 8:25 Introductory Remarks 20. 8:30 Freedom to operate within a
Patentscape: issues for the
biological targets of small
molecules. G. Spratt 21. 9:00 Designing for the defense:
creating patents that withstand
litigation and best practices in
laboratory notebook
maintenance.
H. J. Leonhardt 22. 9:30 Dangerous discussions:
The pitfalls of scientific
collaborations for patents.
C. L. Curfman 10:00 Intermission 23. 10:15 Preparing a small company
to enter into a licensing and
development arrangement.
R. B. Murphy 24. 10:45 When to prepare and file an
original small molecule patent
application. M. Murphy 25. 11:15 Strategies for maximizing
patent protection during the
progression from generic
structures to optimized
compounds. D. Hart TUESDAY AFTERNOON Convention Center, Room 24C
Advanced Topics in Patent Law
Cosponsored with BIOCOM
D. L. Rieger, Organizer, Presiding 1:25 Introductory Remarks 26. 1:30 Safe Harbor and experimental
use exceptions: can your
research be free from
infringing patents?
G. P. Einhorn Spring 2005 CHEMISTRY AND THE LAW Page 5 27. 2:00 Inventorship and Records of
Invention. L. A. Axford 28. 2:30 Introduction to pharmaceutical
IP lifecycle management.
B. J. Greenspan 3:00 Intermission 29. 3:15 Post grant opposition in the
U.Sit is coming: proposals
and pending legislation.
S. L. Biggs, C. S. Berkman 30. 3:45 Intellectual property issues in
global outsourcing.
D. L. Rieger 31. 4:15 Assessing the patent
environment for generic
pharmaceuticals. L. A. Haile WEDNESDAY MORNING Convention Center, Room 24C Current Environmental Issues Facing
California and the San Diego Area
S. Thompson, Organizer, Presiding 9:25 Introductory Remarks 32. 9:30 Californias Proposition 65:
A (so far) unique approach
to regulating chemical risks.
T. Norris 33. 10:00 Cross-border waste water
issues. C. M. Stites 34. 10:30 Environmental health and
safety issues for biotech
companies: Disposing of
hazardous and radioactive
wastes. K. J. Nardi 35. 11:00 Air quality issues in Southern
California and San Diego.
R. R. Rothman, M. McDonough 11:30 Panel Discussion WEDNESDAY AFTERNOON Convention Center, Room 24C
Where Biotechnology Meets the Law:
Current Issues Facing the Industry
S. Thompson, Organizer, Presiding 1:25 Introductory Remarks 36. 1:30 The pharmaceutical life cycle:
Part I. A. Konski 37. 2:00 The pharmaceutical life cycle:
Part II. A. Konski 38. 2:30 Orphan drug laws. D.W. Maher 39. 3:00 Biotechnology law update.
B. J. Duft, P. D. Weinstein 40. 3:30 IP rights and generics.
J.W. Collett 4:00 Panel Discussion THURSDAY MORNING Convention Center, Room 24C The Attorney Is In
B. C. Meadows, Organizer, Presiding 41. 10:00 Meet the members of CHAL.
B. C. Meadows, S. Thompson I have now been editing this newsletter for 4 years (including the
present issue). I think I have succeed-
ed in its most vital function to pub-
lish the CHAL Program and Abstracts
on time in advance of the Meeting.
More or less successful, I hope, in
other ways too presenting the usual
reports of the business of the Division,
along with some hopefully interesting
features and serious commentary. But in another way, not so suc- cessful there is still not a broad
enough range of topics and viewpoints.
My only response is to continue to
encourage other and new contributors,
with new items, or to argue with
opinions expressed in the newsletter.
There have unfortunately also been
occasional production glitches for
which I apologize and hope to not
repeat too often; such is the nature of
publishing. A result of two few contributors is that there is too much room in the newsletter for my own opinions which
leads me to give some explanation.
The views I have expressed continue
to reflect the biases that come along
with my own interests in law and sci-
ence. These include areas of chemistry
that find application in criminal law
defence and in workplace health and
safety. Included within these are
aspects of large laboratory organization
and quality assurance; and the science,
engineering and labor organization of
Canadian workplaces. I write about
what I think I know about, and opine
about current issues that surround me
here in Toronto. Readers may also
notice that my opinions on such are
usually critical of Canadian law and
government practices but that is
such an important function of govern-
ment to be criticized. Again, I encourage readers to make their own contributions to this
newsletter from their own perspectives
in science and law. Readers may have noticed from the CHAL Treasurers Report in the
Spring 2004 (Anaheim) issue that this
newsletter has been a major expense
for the Division. Too major. That is
why the Fall 2004 (Philadelphia)
issue was limited to 16 pages, and
CHAL has considered alternatives to
print-on-paper and U.S. Postal Service
mailing to all its members. The alter-
native chosen is to carry the primary
presentation in the CHAL web site http://membership.acs.org/c/chal/ , with an e-mail notice to the member-
ship. By this alternative it could be
downloaded by members. It could
also be distributed at the National
Meetings. Congratulations to Dr. Howard Peters, a CHAL Founder and long-
time Councillor, on his election to the
ACS Board. Michael Grossman From the Editor Page 6 CHEMISTRY AND THE LAW Spring 2005 Spring 2005 CHEMISTRY AND THE LAW Page 7 Minutes of CHAL Executive Meeting Philadelphia Sunday, 22 August 2004 Attendees: Brian Meadows, Chair Elect; Michael Grossman; Barbara
Lences; Alan Ehrlich; Didi Wijbenga,
Hugh Dubb, Sandy Bercham, Ken
Colton, Neil Langerman, Beatrice
Ngatcha, Jack Riley, Bill Carroll, ACS
President-Elect and Sandra Thompson. Dr. Bill Carroll spoke at the beginning of the meeting regarding
possible activities by the CHAL group.
ACS members may have questions
about personal situations or employ-
ment situations that border on the
need for legal advice; potential for ask
a lawyer for basic legal issues. An
ACS member who has been down-
sized and interested in knowing
employment agreements and sever-
ance agreements. How do I know if
my situation needs an attorney?
Another issue may be age discrimina-
tion. We can direct them to resources
on a geographic basis. We can also
provide articles on specific issues. The
lawyer is in session at the meetings.
Dr. Carroll would help us roll this out
and promote it. What 2-3 topics are
important? Intellectual Property,
Employment Agreements,
Downsizing/Lay-offs. We need to contact the groups that are currently in place, such as the
professional affairs committee, to see
what activities and services that are
already available and see if theres a
need for the law division. Barbara
Lences volunteered to contact this
group. Ken suggested a session co-
sponsored by one of these groups as
a hypothetical situation. Bill Johnson: Minutes approved as written with no changes. Councilors Report: Reviewed the three petitions mentioned in Anaheim:
1) Permit electronic balloting (not
require it) - Alan thinks its fine, but
theres one problem with issues that
were not well drafted - some issues
were sent back to nominations and elections; 2) Change the annual
reporting date to February 15 for
Divisions from March 15th - currently
its that way for local sections, but
they are trying to make it consistent;
3) Provide that high school teachers
who are teaching chemical sciences
can be full members of the society -
even without a BS. They have to have
been employed for three years. All
three petitions passed. Discussion Item: multidisciplinary items - is there a better description of
the different kinds of chemists? Vacancy for Director at Large - 4 candidates. Howard is up by petition. Treasurers Report: $3000.00 Overall balance. Letter from Mid-Atlantic
Region Meeting requesting funding.
January-July 2004 dues have been
deposited ($4000.00). Upcoming
expenses include: newsletter, coun-
cilor reimbursement, and Philadelphia
meeting costs. Propose a budget of
about $3000-$4000 for the newsletter.
($3550.00). Newsletter Report: e-mail provided from Michael Grossman expressing
thoughts on newsletter. Most serious
issue is the timing of getting the man-
uscript to the graphics place. Editing
and publishing functions should be
merging. Our next newsletter will be
Spring 2005. Two issues: software and
hardware needs and/or we need
assistance. Pilot plans by the end of
the year. They will take the current
newsletter and mock it up for the
Exec Board. We are considering sell-
ing ads for the newsletter. Are we
going to put prices in the newsletter?
Sandy Bercham will contact compa-
nies about ads and give us the prices
that CINF charges. We still want to put out the paper copies for those members who want
it in that format. The expanded ver-
sion will go on the web. Expenses for Fall 2004 newsletter handed out by J. Riley. If we shift to
desktop publishing - it affects the
Embedded cost of $1.06. Editorial Control of the content of the newsletter needs to be a board
issue and should be discussed during
a future conference call. Membership/Webmaster Report: 6 newsletters have been added to the
website. Membership is increasing at
about 100-120 new members/year. Programming Issues Upcoming
San Diego programming: Forensics programming Non-IP Programming. Jim Carver -
can we get him involved? Regional Programming for San Diego: Sandie Thompson The titanic: Howard Peters - when the lawyers got a hold of everything Labor and Employment Issues: David Jaffer Mock Trials: Jim Carver Washington: 25th Anniversary of Tech. Transfer Legislation. CPRM joint
symposium. Ken and Alan are
appointed to work with CHAL on that
symposium. Bill Carroll: Predictions on society future in the next 10 years. A position
paper developed out of the San
Diego meeting. New Business: Bills presentation to Judge LaDoris H. Cordell to become
honorary member of CHAL.
Approved. Barbara Hodsen Ullyot:
Presentation to her because of all she
does for CHAL. She will be at the
meeting/reception. Approved. Howard gave a brief presentation about his discussion on chocolate. An
article on this discussion can be found
in the Fall 2004 CHAL newsletter.
Howard will be giving this discussion
at several Regional Meetings. A teleconference is scheduled for the 2nd week in September. Meeting Adjourned. Sandra Thompson Page 8 CHEMISTRY AND THE LAW Spring 2005 1. Did you lose your right to a patent if you published the invention? Xavier Pillai, Leydig, Voit & Mayer, Ltd, Two Prudential Plaza, Suite 4900,
Chicago, IL 60601, Fax: 312-616-5700, xpillai@leydig.com If you published your invention in a conference or a scientific journal, dis-
played it to potential buyers, or made an offer to sell your invention, you
may not have lost your rights to a patent forever. In this talk, I will review
the law, as reflected in recent court opinions, and provide practical sug-
gestions for inventors and entrepreneurs if they have a desire to protect
their inventions. I'll also provide practical tips for obtaining and maintain-
ing strong patents if you choose to write your own patents. 2. Fight for your invention : Final rejection and the appeals process for inventors Thomas J. Kennedy III, Research and Development, TopFlite Golf,
a division of the Callaway Golf Company, 425 Meadow Street, Chicopee,
MA 01021, Fax: 413-322-5358, tom.kennedy@callawaygolf.com, and
Michael Catania, Legal Department, Callaway Golf When a final rejection office action is received from the USPTO, it may be
somewhat deflating to an inventor. There has been, presumably, a trail of
correspondence, research, extra experiments and review of cited prior art
previous to this final rejection. Many times, the inventor will give up and
let the rejection stand due to either lack of interest, good prior art argu-
ments from the examiner, or simply due to lack of time or money. Should
the inventor, however, still be committed to the invention and believes that
the USPTO has not fully understood the previous arguments to the exam-
iner, there is the route of sending the patent application to the Court of
Appeals for the Federal Circuit (CAFC). At this point, there are very defi-
nite steps that an inventor should take, particularly in the area of golf
equipment, to insure that the full story of the invention is explained. The
author will discuss these steps and the areas where the inventor needs to
have input to the process. 3. Defending against frivolous inequitable conduct allegations: strategies for patent prosecution and
litigation Justin J. Hasford, Finnegan, Henderson, Farabow, Garrrett and Dunner,
1300 I Street, NW, Washington, DC 20005, Justin.Hasford@finnegan.com Inequitable conduct, an affirmative defense to a claim of patent infringe-
ment, derives from the equitable doctrine of unclean hands. The defense
prohibits a person who obtains a patent by intentionally misleading the U.S.
Patent and Trademark Office from enforcing the patent. Inequitable conduct
consists of an affirmative misrepresentation of a material fact, failure to dis-
close material information, or submission of false material information, cou-
pled with deceptive intent. Frequently, inequitable conduct allegations
encompass either 1) intentional withholding of material scientific references
or information, or 2) presentation of intentionally false affidavits to over-
come Examiner rejections. Because alleged infringers plead the defense of
inequitable conduct in virtually all patent infringement cases, applicants and
attorneys involved in patent prosecution must exercise utmost care in com-
plying with their duty of candor to the Patent and Trademark Office. In addi-
tion, patent litigation attorneys can engage in a number of effective
counterattacks against unjustified inequitable conduct allegations. 4. Inventorship: Getting it right the first time Sandra Thompson, Bingham McCutchen LLP, 600 Anton Boulevard,
Costa Mesa, CA 92626-1950, Fax: 714-830-0722,
sandra.thompson@bingham.com Determining inventorship in an industrial setting can be difficult, especial-
ly with joint disclosure agreements and collaboration agreements between
companies. We will discuss the basics of inventorship and build on those
basics to explore more difficult inventorship questions. 5. Patent attorneys are from Venus, inventors are from Mars Sandra Thompson, Bingham McCutchen LLP, 600 Anton Boulevard,
Costa Mesa, CA 92626-1950, Fax: 714-830-0722,
sandra.thompson@bingham.com We will dissect and discuss the working relationship between patent attor-
neys/agents and inventors, including introductions, how to improve the
relationship and long-term interaction that will help both parties and the
company/client. 6. An introduction to the attorney-client privilege for scientists, inventors, and their lawyers Justin J. Hasford, Finnegan, Henderson, Farabow, Garrrett and Dunner,
1300 I Street, NW, Washington, DC 20005, Justin.Hasford@finnegan.com Abstract text not available. 7. The basics of work product immunity in patent litigation Eyal H. Barash, Finnegan, Henderson, Farabow, Garrett and Dunner,
1300 I Street, NW, Washington, DC 20005, Fax: 202-408-4400 Abstract text not available. 8. Confidentiality issues for patent attorneys, their clients, and third parties Brian C. Meadows, Needle & Rosenberg, PC, 999 Peachtree Street,
Suite 1000, Atlanta, GA 30309, Fax: 678-420-9301,
bmeadows@needlerosenberg.com Abstract text not available. 9. Attorney-client privilege, work product immunity, and confidentiality considerations from a corporate
perspective Erik R. Puknys, Finnegan, Henderson, Farabow, Garrett & Dunner LLP,
700 Hansen Way, Stanford Research Park, Palo Alto, CA 94304,
erik.puknys@finnegan.com Abstract text not available. 10. Introduction to trade secrets law for the non-lawyer Greg Lemmer and Roberta Hayashi, Pillsbury Winthrop LLP,
2475 Hanover Street, Palo Alto, CA 94304 This session provides an overview of trade secret laws for non-lawyers,
including such items as the distinction between trade secrets and propri-
etary information and the types of protective measures employers often
use to protect such information. Following the overview, attorneys will
present a mock hearing on an employer's request for a preliminary injunc-
tion to protect its trade secrets from being used by a former employee who
has left the employer to join a direct competitor. 11. Mock trial: an employer's request for a preliminary injunction Greg Lemmer and Roberta Hayashi, Pillsbury Winthrop LLP,
2475 Hanover Street, Palo Alto, CA 94304 The mock hearing will illustrate several of the factual and legal issues that
arise when a former employer seeks to restrain or prohibit a former
employee from joining a competitor. 12. Panel discussion Greg Lemmer and Roberta Hayashi, Pillsbury Winthrop LLP,
2475 Hanover Street, Palo Alto, CA 94304 Abstracts for Chemistry and The Law Papers 229th ACS National Meeting San Diego March 13-17, 2005 continued on next page 18. National Inventors Hall of Fame (www.invent.org) Howard M. Peters, Peters Verny Jones Schmitt & Aston, LLP,
425 Sherman Avenue, Suite 230, Palo Alto, CA 94306, Fax: 650-324-1678,
peters4pa@aol.com, and Sally B. Peters, PARC Inc, 3333 Coyote Hill Road,
Palo Alto, CA 94304, Fax: 650-812-4028, speters@parc.com The National Inventors Hall of Fame (NIHF) celebrates the creative and
entrepreneurial spirit of great inventors. The creative genius of invention
is showcased through exhibits and presentations which allow visitors to
experience the excitement of discovery, creativity and imagination. The
NIHF furthers the inventive spirit to address specific problems of declin-
ing technological leadership and creativity in America. The NIHF was
established in 1973 by the National Council of Patent Law Associations,
now the National Council of Intellectual Property Law Associations, and
the Patent and Trademark Office of the U. S. Department of Commerce.
The National Inventors Hall of Fame Foundation was created to adminis-
ter it. National Inventors Hall of Fame, 221 S. Broadway St, Akron, OH
44308-1505. 19. The Original Hawaiian Chocolate Factory Howard M. Peters, Peters Verny Jones Schmitt & Aston, LLP,
425 Sherman Avenue, Suite 230, Palo Alto, CA 94306, Fax: 650-324-1678,
peters4pa@aol.com, and Sally B. Peters, PARC Inc, 3333 Coyote Hill Road,
Palo Alto, CA 94304, Fax: 650-812-4028, speters@parc.com Cocoa beans are grown and processed at only one location in the United
States. That is at The Original Hawaiian Chocolate Factory in Kona on
the Big Island of Hawaii - sometimes now referred to as the smallest
gourmet chocolate company in the world. But that title is guaranteed to
change as it expands. The web site for more information is http://www.originalhawaiianchocolatefactory.com/index.html . Bob and Pam Cooper moved from North Carolina several years ago to
a producing theobroma cocoa tree grove in Kona. They produce
gourmet chocolate that is estate grown only in Hawaii using a single
variety of bean -- never blending. Their chocolate product is fine -- it can
be injected directly to a vein. The sugar industry is leaving Hawaii for
the Philippines. The pineapple industry will be the next to immigrate.
The Coopers' vision is to create a viable chocolate industry in Hawaii in
the near future. 20. Freedom to operate within a Patentscape: issues for the biological targets of small molecules Gwen Spratt, Needle & Rosenberg, P.C, 999 Peachtree Street, NE, Suite 1000,
Atlanta, GA 30309, gspratt@needlerosenberg.com Companies with small molecules should be concerned about the impact
of patents covering the biological targets on their freedom to screen for
molecules of interest using those targets. Knowing the Patentscape is the
key to determining freedom to operate. The Patentscape also includes
the company's own patents. These patents can be used to prevent com-
petitors from practicing a technology, to create the ability to charge a
monopoly price, to create negotiating power, to create licensing rev-
enue, and to provide a corporate asset. 21. Designing for the defense: creating patents that withstand litigation and best practices in laboratory
notebook maintenance Harry J. Leonhardt, Senomyx, Inc, 11099 North Torrey Pines Road,
La Jolla, CA 92037, Harry.Leonhardt@senomyx.com Abstract text not available. 22. Dangerous discussions: The pitfalls of scientific collaborations for patents Chris L. Curfman, Needle & Rosenberg, P.C, 999 Peachtree Street NE,
Suite 1000, Atlanta, GA 30309, ccurfman@needlerosenberg.com Many patentable inventions are the result of scientific collaborations. And
during these collaborations, scientists often discuss various aspects of an
invention, share data, and make improvements. These discussions and
interactions can, however, jeopardize the ability to obtain patent protec-
tion on the invention. According to often overlooked statutes, communi-
cations between scientists or inventors can, in certain situations, destroy Spring 2005 CHEMISTRY AND THE LAW Page 9 The session will conclude with a panel discussion by the participant
attorneys analyzing the steps that the former employer and competitor
in the mock hearing could have taken to better protect its trade secrets
or to avoid this type of litigation when hiring away a competitor's
employees. 13. Crystal polymorphism in pharmaceuticals: Fundamentals of discovery and characterization Adam J Matzger, Department of Chemistry and Macromolecular Science
and Engineering, University of Michigan, 930 N. University, Ann Arbor,
MI 48109-1055, Fax: 734-615-8553, matzger@umich.edu The role of solid-state form in determining the properties of pharmaceuti-
cals is a critical issue in drug distribution. The ability of a solid to exist as
more than one polymorph, supramolecular isomers that differ only in
packing and not constitution, creates a situation where each crystal form
may differ substantially in properties ranging from manufacturability to
bioavailability. The scientific foundation of this phenomenon will be dis-
cussed in general and several case studies will be introduced.
Characterization techniques commonly employed to prove that new com-
positions of matter have been discovered will be discussed. 14. Claiming a chemical invention Mark Feldstein, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P,
901 New York Avenue, NW, Washington, DC 20001,
mark.feldstein@finnegan.com Focusing on polymorphs as a technically and commercially relevant
example, issues related to describing and claiming a chemical invention
will be addressed. Due to the particularities of the patent system, a
chemist's intuition concerning the style and format of a patent application
and its claims may lead to unanticipated problems down the road.
Ultimately, the commercial value of the claimed invention could be sig-
nificantly affected. In order to explain the unique perspective applied to
patents, questions of importance to the chemist inventor, such as "When
do I have enough information to support an application," "How should
my invention defined in the claims," and "How broad should the claims
be," will be addressed. 15. Polymorphs in patent litigation Jennifer Swan, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P,
901 New York Avenue, Washington, DC 20001,
jennfier.swan@finnegan.com An overview of the patent litigation process will be presented with partic-
ular emphasis on those areas most pertinent to cases involving poly-
morphs. As part of this overview, a discussion of recent case law related
to polymorphs will be presented, and the relationships between claim
drafting, interpretation, and enforcement will also be explored. 16. Polymorph workshop Eyal H. Barash, Finnegan, Henderson, Farabow, Garrett and Dunner,
1300 I Street, NW, Washington, DC 20005, Fax: 202-408-4400 As part of the symposium, we will ask participants to consider how best
to turn scientific data into patent claims. We will present the audience with
laboratory results and data and work together to craft patent claims. This
interactive approach should bring together both the scientific and patent
aspects of polymorph patents. 17. Inventure Place Howard M. Peters, Peters Verny Jones Schmitt & Aston, LLP,
425 Sherman Avenue, Suite 230, Palo Alto, CA 94306, Fax: 650-324-1678,
peters4pa@aol.com, and Sally B. Peters, PARC Inc, 3333 Coyote Hill Road,
Palo Alto, CA 94304, Fax: 650-812-4028, speters@parc.com Inventure Place celebrates the creative and entrepreneurial spirit of inven-
tion innovation and inventors. The creative genius of invention is show-
cased through exhibits and presentations which allow visitors to
experience the excitement of discovery, creativity and imagination.
Inventure Place furthers the inventive spirit to address specific aspects of
encouraging technological leadership and creativity in America. Inventure
Place was created in 1991 and moved into new facilities at 221 S.
Broadway St, Akron, OH 44308-1505 in 1995. The programs of invention
and innovation are presented. Page 10 CHEMISTRY AND THE LAW Spring 2005 the novelty of an invention or, in combination with other references, ren-
der an invention obvious. While the harsh consequences of these collab-
orative discussions can be avoided under narrow exceptions, recent
legislation has been proposed to broaden these exceptions. The impact
that these legislative amendments will have on the state of scientific col-
laborations and the effect joint R&D agreements will have on avoiding
such pitfalls will be discussed. 23. Preparing a small company to enter into a licensing and development arrangement Richard B. Murphy, Director, Research Licensing, Schering-Plough
Corporation, 3525 John Hopkins Court, San Diego, CA 92121,
richard.murphy@sp-corp.com One of their primary business objectives of most small pharmaceutical
companies is to enter into a relationship with a major pharmaceutical com-
pany to further develop their technology into a commercial product.
Frequently these discussions and negotiations are unnecessarily time con-
suming for a variety of reasons, many of which relate to a misunder-
standing of the decision making process within a major pharmaceutical
company and a failure of the small company to have adequately prepared
their technology for licensing. This presentation will focus on specific
actions that can be taken by a small company to ensure that it is ready to
enter into negotiations with a major pharmaceutical company, what to
expect of a due diligence investigation by a potential pharma partner and
how to plan for it and some insight into the decision making process with-
in a major pharmaceutical company. Additionally, there will be discussion
of some specific deal terms which often lead to stalemates and some
potential ways to resolve them. 24. When to prepare and file an original small molecule patent application Mark Murphy, Needle & Rosenberg, PC, 999 Peachtree Street,
Atlanta, GA 30309 The first patent application for a new genus of small molecules falls into a
complex and shifting middle ground between the issues that predominate
in biotechnology patent applications and traditional chemical patent appli-
cations. The legal standards used in examination, the types and breadth of
claims that may issue and then be enforceable also differ widely in various
countries. When deciding when to draft and file the first patent application
to a new class of small molecules, the maturity of the R&D work, the
Applicants business position and goals, competitor pressures, the relevant
prior art, especially the Applicants' prior applications, the ability to enable
and describe both the synthesis and biological administration of the
claimed compounds, and the data in hand or likely to be soon obtained on
biological activity, and the Applicants' long term ability to pay internation-
al prosecution costs all need to be considered and balanced. 25. Strategies for maximizing patent protection during the progression from generic structures to optimized
compounds Dan Hart, Knobbe, Martens, Olson & Bear, LLP, 550 West C Street,
San Diego, CA 92101, dhart@kmob.com Often, patent protection is initially sought before lead compounds have
been fully optimized and subsequent patent applications hone in on the
optimized compounds. This presentation will address patent prosecution
strategies relevant in this scenario and pitfalls to be avoided. 26. Safe Harbor and experimental use exceptions: can your research be free from infringing patents? Gregory P. Einhorn, Morrison & Foerster LLP, 3811 Valley Centre Drive,
Suite 500, San Diego, CA 92130, geinhorn@mofo.com What happens when you discover an important part of your proposed
research project is within the scope of another party's patent? Are your
options limited to negotiating a license for that patent or stopping that aspect
of your work? Not necessarily. There are exceptions - and you should be
aware of them so your research is not unnecessarily limited or blocked. For
example, research undertaken solely for uses reasonably related to the
development and submission of information required for FDA drug
approval may be protected from infringement claims. Also, the experimen-
tal use exemption for purely scientific research, for example, to study and understand a patented invention, has recently been severely limited. The
changing scope of these protections will be discussed. 27. Inventorship and Records of Invention Laurie A. Axford, Burns Doane Swecker and Mathis LLP, 402 W. Broadway,
Suite 400, San Diego, CO 92101, laxford@burnsdoane.com Under our patent laws, only inventors are entitled to apply for patent pro-
tection. Thus, it is important to establish inventorship before filing a patent
application. Inventorship is determined by evaluating the contributions of
the parties on view of specific legal standards. During this session, we will
discuss those standards and provide several real world examples. Also,
when inventorship is at issue, resolution of disputes usually involves an
analysis of invention records. We will also discuss best practices for keep-
ing invention records, the importance of records, and provide examples in
a modern laboratory setting. 28. Introduction to pharmaceutical IP lifecycle management Bernard J. Greenspan, Director, IP Strategy Management,
Pfizer La Jolla Laboratories, San Diego, CA 92127,
bernie.greenspan@pfizer.com Developing a strong IP portfolio is crucial to launching a successful prod-
uct. Careful attention must be paid to IP throughout development. This
presentation will examine strategic elements of IP lifecycle planning as
they relate to the lifecycle of a pharmaceutical product. 29. Post grant opposition in the United Statesit is coming: proposals and pending legislation Suzanne L. Biggs, Pillsbury Winthrop, LLP, 11682 El Camino Real,
Suite 200, San Diego, CA 92130, slbiggs@pillsburywinthrop.com, and
Charles S. Berkman, Associate General Counsel and Chief Patent Counsel,
Ligand Pharmaceuticals, Inc, 10275 Science Center Drive,
San Diego, CA 92121, cberkman@ligand.com A discussion of the pending and proposed legislation for post-grant oppo-
sition in the United States and its potential effects on patent strategies. Will
post-grant opposition have more impact on certain types of patents and
patentees? A comparison of the U.S. proposals to opposition proceedings
in other jurisdictions will also be explored. 30. Intellectual property issues in global outsourcing Dale L Rieger, Fish & Richardson, P.C, 12390 El Camino Real, San Diego,
CA 92130, Fax: 858-678-5099, rieger@fr.com Global outsourcing is becoming increasingly important in pharmaceutical
and other areas of research. This talk will explore the intellectual proper-
ty implications of global outsourcing, examine the pitfalls, and provide
thoughts on managing such outsourcing arrangements. 31. Assessing the patent environment for generic pharmaceuticals Lisa A. Haile, Piper Rudnick Gray & Cary, 4365 Executive Drive,
Suite 1100, San Diego, CA 92121, lisa.haile@piperrudnick.com This session will review the current patent environment with respect to
design grounds, patent validity, patent enforcement and infringement, and
product-by-process patents for generic pharmaceuticals. We will also dis-
cuss patent strategies for follow-on or generic pharmaceuticals including
strategies for new IP. Important case law that affects the generic pharma-
ceutical field will be discussed including Festo Corporation v. Shoketsu
Kinzoku Kogyo Kabushiki Co. Ltd.; SmithKline Beecham Corp. v. Apotex
Corp.; Ranbaxy Pharmaceuticals Inc. v. Apotex, Inc.; and product-by-
process cases Atlantic Thermoplastics Co. v. Faytex Corp. and Scripps
Clinic & Research Foundation v. Genentech, Inc. 32. California's Proposition 65: A (so far) unique approach to regulating chemical risks Trent Norris, Bingham McCutchen LLP, Three Embarcadero Center,
San Francisco, CA 94111, trent.norris@bingham.com Following a ballot initiative almost 20 years ago, California has taken a
unique approach to regulating hundreds of chemicals that are "known served on a number of ACS division programs.
He has had more than 10 papers published in
journals and monographs, performed his first
industrial/patentable research at 21, is a co-
inventor on 7 U.S. patents, given numerous tech-
nical and legal lectures and has filed and written
hundreds of U.S. and foreign patent applications. Dr. Peters has been involved in ACS pro- grams dealing with patents, economics, chemical Howard M. Peters, Ph.D., J.D., a Palo Alto, California, chemist and patent attorney, has been
elected to the board of directors as a director-at-
large for the American Chemical Society, the
world's largest scientific society. He will serve
through 2007. A founding partner of Peters, Verny, Jones & Schmitt, LLP, he has been an ACS member since
1963. For more than 40 years Dr. Peters has been
active on a wide variety of ACS committees and has Spring 2005 CHEMISTRY AND THE LAW Page 11 by the State" to be carcinogens or reproductive toxicants. For example,
the law covers exposures to reproductive toxicants at 1/1000th of the
level at which no observable effect is found in animal studies. It is
enforced primarily by "private attorneys general" (also known as
"bounty hunters"), as opposed to publicly elected officials. It covers
exposures in the workplace, emissions from smokestacks, and expo-
sures caused by consumer products -- everything from tuna fish to rain-
coats, nail polish to china, carbonless paper to telephone cords.
Companies with no California presence can be affected if they supply
materials that end up in products sold in California. This session will
provide an introduction to Proposition 65 as well as key resources for
ensuring compliance. 33. Cross-border waste water issues Catherine M. Stites, Bingham McCutchen LLP, 300 South Grand Avenue,
Los Angeles, CA 90071, catherine.stites@bingham.com This presentation will explore the history of cross-border, Mexican-U.S.
pollution issues in Southern California, including both lessons learned and
progress made. 34. Environmental health & safety issues for biotech companies: Disposing of hazardous and radioactive
wastes Karen J. Nardi, Bingham McCutchen LLP, Three Embarcadero Center,
San Fancisco, CA 94111, karen.nardi@bingham.com This presentation will explore the federal and California requirements for
disposal of radioactive and hazardous wastes in a biotech company.
Topics will include what the law requires in terms of storage, transport and
disposal of these wastes and how these laws are enforced by federal, state
and local agencies. Additionally, it will also review issues that commonly
come up in entering into vendor contracts for removal of hazardous and
low level radioactive wastes. 35. Air quality issues in Southern California and San Diego Rick R. Rothman and Michael McDonough, Bingham McCutchen LLP,
355 South Grand Avenue, Los Angeles, CA 90071,
rick.rothman@bingham.com, michael.mcdonough@bingham.com An overview of the how natural events and cross border emissions can
impact local air pollution regulation in Southern California and the San
Diego area, including the impact of the 2004 wild fires and Mexican devel-
opment and how local air agencies are struggling with the implications. 36. The pharmaceutical life cycle: Part I Antoinette Konski, Bingham McCutchen LLP, 1900 University Avenue,
East Palo Alto, CA 94303, Fax: 650.849.4800,
anoinette.konski@bingham.com A strong patent position is critical to maximizing research and development
investments in all areas of pharmaceutical science. However, a patent is but
one means to obtain a market advantage through exclusivity. We will
review the various mechanisms by which market exclusivity can be obtained for a new chemical entity (NCE) as well as the timing and legal
landscape for bringing a generic version of the NCE onto the market. 37. The pharmaceutical life cycle: Part II Antoinette Konski, Bingham McCutchen LLP, 1900 University Avenue,
East Palo Alto, CA 94303, Fax: 650.849.4800,
anoinette.konski@bingham.com A strong patent position is critical to maximizing research and development
investments in all areas of pharmaceutical science. However, a patent is but
one means to obtain a market advantage through exclusivity. We will
review the various mechanisms by which market exclusivity can be
obtained for a new chemical entity (NCE) as well as the timing and legal
landscape for bringing a generic version of the NCE onto the market. 38. Orphan drug laws David W. Maher, Buchanan Ingersoll, PC, First National Bank Center,
401 West A Street, Suite 1900, San Diego, CA 92101, maherdw@bipc.com US and European orphan drug laws, status and related issues will be
discussed. 39. Biotechnology law update Bradford J. Duft, Buchanan Ingersoll LLP, San Diego, CA 92101-7908,
Fax: 619-578-5940, duftbj@bipc.com, and Peter D. Weinstein,
Buchanan Ingersoll, PC, San Diego, CA 92101, weinsteinpd@bipc.com Recent legal developments and changes in the field of biotechnology
will be discussed. 40. IP rights and generics James W. Collett, Buchanan Ingersoll, P.C, First National Bank Center,
401 West A Street, Suite 1900, San Diego, CA 92101, collettjw@bipc.com Public policy has recently given much attention to enhancing the avail-
ability of low cost generic drugs to consumers. This talk will provide a
review of patent term and The Drug Price Competition and Patent Term
Extension Act (Hatch-Waxman). Recent thoughts and selected topics relat-
ing to the Hatch-Waxman act will be presented. 41. Meet the members of CHAL Brian C. Meadows, Needle & Rosenberg, PC, 999 Peachtree Street,
Suite 1000, Atlanta, GA 30309, Fax: 678-420-9301,
bmeadows@needlerosenberg.com, and Sandra Thompson,
Bingham McCutchen LLP This will be an informal drop-in session where questions can be asked of
lawyers and/or patent agents including, but not limited to those listed
above. These lawyers and patent agents will be members of CHAL,
available here without fee. Questions may be about any topic you desire:
about legal career options, and about the law itself: patent, trademark,
copyright, trade secret, etc. Questions may be of practical or theoretical
interest. The discussions should be interesting, notwithstanding that cor-
rect answers are not guaranteed. This session will be of an informational
and educational nature only; the considerations of questions asked will
not be in the context of any lawyer-client relationship; answers (if known)
will not be given as legal advice CHAL Founder and Councillor Elected to Board of ACS* continued on next page Page 12 CHEMISTRY AND THE LAW Spring 2005 information, minority affairs, awards, chemistry and the
law and chemical education. He believes the Society should focus on using addi- tional resources and programs "to benefit ACS members in
their career development and career transitions." Dr. Peters
also would like the ACS to expand programs to improve
science literacy and science education in the U.S. from
pre-kindergarten through graduate school. He also cites
the importance of legal issues to chemistry and chemistry
professionals. Dr. Peters received a B.S. degree in chemistry in 1962 from Geneva College, Beaver Falls, Pennsylvania. In 1967,
he earned his Ph.D. in chemistry from the Stanford
University and his J.D. in 1978 from Santa Clara University.
He and his wife Sally (also a CHAL member and ACS
Councillor from the Santa Clara Valley Local Section) live
in Menlo Park. Over the years since the founding of CHAL, Dr. Peters has always been an active participant; and he has fre-
quently contributed to this newsletter --- recent readers
would be aware of his PATENT TRUTHS column.
Attendees at the SciMix at ACS meetings may recognize
his and Sallys posters on patent topics, with both of them
near-by as purveyors of the ten pound chocolate bar --
and free chocolate raffle. See the election report in C&EN http://pubs.acs.org/cen/news/8246/8246election.html His web site, created for the ACS election http://www.howardpeters.net/ may be of interest. He may be contacted at PETERS4PA@aol.com . * adapted from Dr. Peters news release Monsanto v Schmeiser Monsanto v Schmeiser was reported in the CHAL newsletter, Fall 2001. 1 It has now been heard by the Supreme Court of Canada, and
judgment rendered. 2, 3, 4 Notes:
1. Vol. 17, No. 2, pages 16 - 24.
2. Monsanto Canada Inc. v. Schmeiser, Supreme Court of Canada, Neutral citation: 2004 SCC 34. File No.: 29437,
20 January 2004; 21 May 2004. On appeal from the
Federal Court of Appeal.
http://www.lexum.umontreal.ca/csc-scc/en/
http://www.lexum.umontreal.ca/csc-scc/en/
rec/html/2004scc034.wpd.html 3. www.percyschmeiser.com
4. http://www.monsanto.com/monsanto/layout/ default.asp http://www.monsanto.com/monsanto/layout/media/04/05-
21-04.asp Spring 2005 CHEMISTRY AND THE LAW Page 13 On Becoming a Patent Agent A Chemical Career Alternative What You Need to Know and Some Practical Advice John A. DiNatale* There seems to be a need for an overview of the patent agent occupation from a scientists point of view
that isnt merely a regurgitation of facts about patent law
and licensure procedures. Ive tried to walk the line
between opinion and fact in writing this article in order to
provide the chemist-reader with some insight which might
assist in career choices. If this article serves its purpose by
being unique via its style, the results may be a double-
edged sword: I urge the reader to investigate further
before making any important decision or investment of
time/money based on one brief article.
What is a patent agent ? In order to obtain a patent, an inventor (and, if appro- priate, the inventors employer) initiates a legal proceeding
with the US Patent and Trademark Office by filing an
application. An inventor can handle that filing and subse-
quent legal engagement, or more wisely, may seek the help
of a patent practitioner who is licensed by the USPTO to
represent inventors (similar to the way attorneys represent
clients in civil or criminal matters before the courts). In
order to gain licensure as a patent practitioner, the greatest
hurdles are (a) significant technical coursework in sci-
ence/engineering, and (b) a passing grade on an exam in
patent law administered by the USPTO (a/k/a the patent
bar exam). If the prospective practitioner fulfills all the
requirements for registration to the patent bar, and addi-
tionally is, or subsequently becomes, a state-licensed attor-
ney, he is deemed a patent attorney; if the prospective
practitioner is not an attorney, he is a patent agent. The
USPTO requirements for registration to the patent bar is
the same for both patent attorneys and patent agents. Since
patent law is federal law, the requirements do not vary
from state to state. Logically, the requirements for registra-
tion that are administered by the USPTO allow one to han-
dle patent issues with the USPTO. That means that if
patent matters go beyond the USPTO, for example in a
patent infringement lawsuit in a federal court setting, this is
beyond the scope of the duties of the patent agent, and
only an attorney would be able to handle the representation. All the legal procedures and requirements necessary to become registered as a patent agent are located on the
USPTO website ( www.uspto.gov ) in the form of a (pdf) booklet with the long-winded title General Requirements
Bulletin for Admission to the Examination for Registration
to Practice in Patent Cases before the United States Patent
and Trademark Office. As the title suggests, the require-
ments must be met are in order to sit for the exam. As of
1/1/05 the pdf file can be accessed from www.uspto.gov/ web/offices/dcom/olia/oed/examregist.htm , but as the USPTO often moves things around, be aware that its exact
location on the website may change. My advice to the
novice is to follow the document to the letter of the law.
You might as well get used to it.
What does a patent agent do? The easiest way to understand what a patent agent does is to understand the activities that must be performed
in order to obtain a patent. Consider for example, a small
R&D company that synthesizes a new protective polymer
coating. The company approaches an independent patent
law firm to handle the matter with the USPTO. The law firm
will usually make sure that the following activities are per-
formed: 1) the researchers responsible for the invention are
interviewed for information about the invention, 2) the
patent literature is searched for similar inventions (i.e.,
patent searching), 3) the patent text is written and submit-
ted to the USPTO in the form of a patent application (i.e.,
patent drafting), and 4) concerns and rejections posed by
the USPTO are responded to (i.e., patent prosecution). There are different ways that law firms can get these activities accomplished. It may be helpful to think of it
from an economic point of view and by way of some
examples. If it is a small law firm, all these activities may be per- formed by a sole patent attorney; similarly, a patent agent
may even have a business which perform all activities. In
the case of the polymer invention, the R&D company may
be well-advised to approach a practitioner with a knowledge
of polymer chemistry. Although licensed practitioners must
have had the aforementioned coursework in science/ engi-
neering, there is nothing, except professional discretion,
that prevents a practitioner with coursework in a different
field (e.g., electrical engineering) from handling the poly-
mer case. Some fields are easily bridged by the practition-
er, some are not. Additionally, it should be noted that it
may be cost effective (and hopefully quality effective) for
either the agent or attorney practitioner to subcontract the
patent searching stage to a professional patent searching
firm; this type specialization of activity may occur more
often at a larger firm. If a large patent law firm is retained, it may have found it to be cost effective to hire full-time scientists with exper-
tise in certain technologies (often designated patent engi-
neers or technical specialists or similar title) to work on
the patent drafting and prosecution stages rather than
occupy the time of their higher-paid, experienced patent
attorneys. Additionally, those scientists have been hired
because they have specializations in technical fields in continued on next page Page 14 CHEMISTRY AND THE LAW Spring 2005 which the firm has (or anticipates having) a client base.
The polymer case may be delegated to a Ph.D. polymer
chemist with the ability to understand and write about the
advantages of the invention. That scientist may be encour-
aged or even expected to successfully pass the patent bar
examination in a reasonable period of time to become a
patent agent, thereby extending his own knowledge and
ultimate usefulness to the firm. To further departmentalize
activity, the firm may have even hired scientists with expe-
rience in patent searching to perform the patent searching
stage. For law firms, hiring scientists without a J.D. may
lower salary costs while simultaneously raising specializa-
tion and extending their scientific knowledge base. As an example of specialization of all activity, consider a large pharmaceutical company with its correspondingly
large number of patent matters and filings, that has found
it economically advantageous to hire their own in-house
patent attorneys in order to avoid frequent and expensive
charges from independent patent law firms. In addition to
patent agents, that company may also have scientists that
act as patent liaisons who interview the researchers and
provide invention summaries to their patent practitioners
to use for patent drafting, thus saving the time of their
more experienced, higher-salaried practitioners. It is fairly
common for these companies to encourage their patent
liaisons to pass the patent bar exam to become agents. As
patent attorneys become more familiar with experienced
liaisons/agents they might allow them to draft more of the
patent and it is not unfamiliar for the attorney to merely
sign-off on the entire patent draft. In addition, the compa-
ny may employ information scientists for patent search-
ing who might have an information science, traditional
science, and/or library science degree, and may interact
with patent practitioners or the research scientists them-
selves in order to perform their searches most effectively.
Where are the patent agents employed? It should probably be clear after reading this far that patent agent jobs exist where it becomes economically
advantageous. Extracting from the previous section, the
likely places are patent law firms and companies with
R&D activity. Though a small R&D company may have no
practitioners on staff (thereby electing outside patent coun-
sel) at some point that companys patent portfolio may
grow to where it is advantageous to employ a salaried
practitioner rather than pay for many billable hours
charged by an independent law firm. Another place for a technical professional to work in patents is at the USPTO itself. The scientist who examines
patent applications as they are submitted by practitioners
are appropriately called patent examiners and the
USPTO has many on staff. You do not need to have
passed the patent bar exam to work as an examiner, only
to apply for the job opening; the major prerequisite is the particular scientific background they seek for any given
hire. It is common for former examiners to be hired by law
firms as they have a unique perspective on the patent
application process; hence the USPTO is considered a for-
midable training ground.
How do I learn patent law? In addition to working as a patent examiner at the USPTO, another way for a scientist to learn patent law is to
be hired as a technical specialist by a large patent law firm
willing to train a patent novice. This is the most traditional
entry point into the field and training consists of on-the-job
patent drafting and prosecution while being supervised by
an experienced patent practitioner. The scientist then takes
the patent bar examination based on the laws and regulations
learned through on-the-job experience and private study. There are a few patent bar exam preparation courses available by private vendors that will teach patent law in
order to pass the exam but will do little to provide the
drafting and prosecution experience that on-the-job training
brings. Nevertheless, some can be very good for teaching
patent law principles quite effectively. Much in the way
that organic chemists have a place in their heart for their
own undergraduate introductory organic textbook, many
practitioners have the same feeling toward their patent bar
prep course, so it is actually difficult for anyone who has
taken only one course to be objective. An internet search
of the phrase patent bar review brings numerous hits.
Without any previous patent law exposure, but with a
friends advice on course choice, I purchased the home
study option provided by the Patent Resources Group, Inc.
and found I could understand all the material without
assistance, given enough time to study. Some of the legal-
ese may be new but the home study course allows study-
ing at ones own pace, and video pausing prevents losing
the logical thread that may occur in live lecture; the one
drawback of the home study option is the unavailability of
a lecturer to question. An insightful prospective employer
might realize that in addition to having the particular tech-
nical specialization desired, you have taken the time to
study patent law and pass the patent bar exam, so they
may be more apt to hire you at the level of technical spe-
cialist or patent liaison (even though having passed the
exam you are a patent agent) as a big fish in a small pond.
But if the employer is not that insightful, then you may be
categorized as a patent agent with no on-the-job experi-
ence, and therefore a small fish in a big pond. Another alternative is to begin patent training as (the aforementioned) patent liaison at a large company that
has found it economically advantageous to create that posi-
tion. It is additionally advantageous for that company to
hire a scientist who understands the specific technology
that the inventors are engaged in, and so from that point of
view, the liaison may come directly from the scientific Spring 2005 CHEMISTRY AND THE LAW Page 15 ranks of the company. This may pose opportunity for
someone who is looking to transition from the lab to
patents as the in-house hire may be more amenable to
human resources than an outhouse hire. Less common, but, as is always possible if there is economic justification, small R&D companies without
patent practitioners may find it advantageous for a scien-
tist-employee to extend his duties to be the contact for
outside patent counsel, slowly building patent experience
with a ceiling on responsibility that ultimately is company-
specific. But companies that are small to mid-size that
decide to make a larger leap by formally hiring their first
practitioner might not be in an economic position to train
a novice and would likely hire a registered practitioner
with at least 2 years experience, if not more, in order to
handle all patent matters from A-to-Z, without supervision. How closely will I by involved in chemical research if I enter chemical patent law? The cultures may be as different as the fields of chem- istry and law are. Although an in-house corporate patent
liaison, which is probably the patent position closest to that
of the researcher, may be involved in interviewing researcher-
inventors, that may be as far as the position gets to the lab.
The position will be most likely under the umbrella of the
law department not the research department, and the cul-
ture will be that of attorneys, not scientists. The terminal
degree in chemical patent law is not a Ph.D. in chemistry,
it is a J.D. degree. A Ph.D. chemist who becomes a patent
agent may very well find himself working under a B.A.
chemist who is a patent attorney. The difference between
the values and lifestyles of chemists and attorneys can be
vast, and the importance of this point easily underestimat-
ed. Scientists may have to break the instilled habit of care-
fully checking the science and analyzing data, and turn
their focus to production and the need of their employer to
record a profit. An employer will more likely be wondering
while an application wasnt submitted to the USPTO yester-
day than appreciative that you were up all night finding a
misplaced point on an inconsequential graph.
What must the scope of my chemical knowledge be? Chemists with all levels (B.A., M.S., Ph.D.) of chem- istry degrees can become patent practitioners. Those with
Ph.D.s may be a bit more desirable to employers, if for no
other reason to use the Ph.D. degree as indirect advertise-
ment to (external or internal) inventor-researchers who
appreciate the ability of their practitioner to understand
their invention. The experience that a doctorate brings
may also assist in confronting patent projects outside your
immediate chemical expertise, but is probably not a rea-
son to attend chemistry graduate school. But what the
employer, whether it be a corporation or law firm, is look-
ing for in the way of technical background is the ability to
write about and understand the chemical technology and the advantages of the inventions you will be presented
with. Your technical background is your strength and what
makes you desirable. The reason that law firms hire each
technical person is due to the firms interest in that per-
sons specific technical background, albeit that may be, for
some employers, as general as chemistry. With a degree
in biochemistry, for example, pharmaceutical technology
may be straightforward; but at a medium-sized law firm, a
biochemistry background may make you a relative expert
in plastics if your colleagues have only backgrounds in
electrical and mechanical engineering. It should be noted
that often there is a demand for technical people in areas
of science that are hot as those areas begin to result in
patents (i.e. if there is considerable influx of plastics patent
proposals, it might be time to give the biochemist a break
and hire someone with an appropriate background).
How much does a patent agent get paid? It is insightful to understand the billable hour system that most law firms use. Practitioners at independent law
firms typically keep track of the time they spend on each
of their projects, the firm billing each client at the practi-
tioners hourly rate (which is higher than the rate at which
the practitioner is paid by the firm). A firms receivables
then pay practitioner salaries, administrative salaries, over-
head, and the leftover is kept as profit by the firm. A firm
typically requires a certain number of billable hours of
their patent attorneys and patent agents, usually in the
range of 35-40 hours per week. If the firm requires 1800
hrs/yr (that is, 36 hrs/wk x 50 weeks) and bills the client
at a rate of $120/hr, that is a revenue of $216,000/yr. One-
third of that money may be returned to the agent as a
salary of ~$70,000/yr. The actual amounts may vary con-
siderably, via the billing rate, depending on the area of the
country and the experience of the practitioner. A billable
hour requirement may even be expected of any patent
engineers or patent searchers on staff, even though they
may bill the client at a lower rate for these services (or
they might not!). So the system is innately based on pro-
duction; the greater the production by the practitioner, the
more money is made by the firm. If the billable hour
requirements are exceeded by the practitioner, that practi-
tioner may also be paid one-third of the revenue generat-
ed from the extra hours. It should be noted that the salary
of an experienced patent agent will tend to hit a ceiling
(though a lucrative ceiling) sooner than that of an experi-
enced attorney. Of course, an option for all chemists is to
solve that problem by attending law school, though this
option should be considered carefully, and perhaps above
all else, from an economic point of view. In addition to
the time crunch night school may bring (or, for day
school, lost earning time), a significant student loan debt
may be incurred that a quick calculation reveals is quite continued on next page Page 16 CHEMISTRY AND THE LAW Spring 2005 Puzzled by the Law? Here is a law-related puzzle to ponder readers comments are sought to be summarized in the next issue: According to the Canadian Weights and Measures Act, 1 the pound Unit of Measurement, by definition = .45 359 237 kilogram. How is this
possible, when pound is a unit of force or weight, and kilogram is a unit of mass;
and weight and mass are related on our planet Earth by: mass = weight / the accel-
eration of gravity; and it is known that the acceleration of gravity varies with location
on the Earths surface and with altitude? 2 In the previous Puzzled by the Law readers were invited to derive the equation:
car speed = 15.946 x (drag constant x skid distance) 1/2 (km/hr) that was said to be usable to calculate a cars speed from its visible tire skid marks
and an experimentally found drag constant. When the wheels lock and the skid starts leaving a mark on the horizontal road
surface the frictional drag of the tires on the road will cause the car to decelerate
in a straight line. The constant frictional drag force = - f = m x a = (w/g) x a where: f = frictional drag force m = car mass
a = acceleration (the cars deceleration = -a)
w = car weight
g = acceleration of gravity = 9.81 metres/sec 2 Therefore: the cars deceleration = - a = - f x g/w [eq.1] 3 Now, in general,
an accelerating body, here the car, may be described by: v t = v t=0 + (a x t) [eq.2] where: v t=0 = initial velocity v t = velocity at time t t = time When the wheels lock and the car starts into the skid, its velocity, which is sought to
be calculated here = v t=0 . The velocity when the car skids to a stop = velocity at time t = v t = 0. Thus, 0 = v t=0 + (-a x t) [eq.3] steep and will take some time to be paid off. This should
be weighed economically against a patent agent situation
that requires relatively no time or money invested. There
are some law firms that pay tuition to attend night classes
after work, though I suggest this be made clear at the
onset of employment. If the agent works at company instead of a law firm, there is a good chance that the agent/ liaison will not
have to reach a certain billable hour requirement, though
that doesnt necessarily mean that hours spent on each
project will not be tracked by the powers that be.
Although agent salaries may vary considerably, companies
are more likely to have salaries that reflect the educational level obtained and industrial experience acquired, similar to
that of a chemist. It is difficult to provide exact figures as
there is most likely a very large variation based on region
of the country. It was my goal to provide you with some information about the patent agent occupation which you can use
along with other criteria to support a measured and proper
career reflection. I hope that Ive done that and I wish you
all the best.

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