Review explaining why drugs are so expensive -- the US has a complex FDA and patent law process to approve generic drugs.

1. © 2008 Stephen Zweig
Drug development in the US and
FDA approval Procedures.
Protection of Pharmaceutical
Intellectual Property Rights
US rules for a Japanese audience
(reprint of a talk originally given in 2008, partially updated for 2016)
Stephen E. Zweig, Ph.D., JD.; Patent Attorney
Patentassociate.com
1

2. Speaker’s background
• Ph.D. Biophysics (UCSD), JD Taft Law School
• Former Pharmacology Asst. Prof. (Baylor)
• Director R&D, Johnson & Johnson
• Founder, Avocet Medical, Inc. (VC backed
startup)
– 10 years CEO/CTO/Chairman experience
– Business, FDA, Clinical Trial, & R&D management
• Presently patent attorney at patentassociate.com
2

3. Overview of talk:
1: Cultural and legal differences between the US
and Japan
2: Review of US Food and Drug Administration
(FDA)
3: Review of US patent office (USPTO) and
patent rules
Break
3

4. Overview of talk:
4: Hatch-Waxman act: connecting the FDA and
the USPTO (continued)
5: Drug patent extension and regulatory
exclusivity rules
6: Patent issues during drug R&D, and the Bayh-
Dole act
7: Recent changes in US patent law: impact of
KSR v Teleflex
Break
4

5. Overview of talk:
8: Orange Book examples of FDA & USPTO
interconnections (topical drugs)
Questions
5

6. 1: US and Japan differences
• US still has some Wild
West influences:
• Japan has a higher
preference for mediation
and conciliation. US is
more likely to litigate.
• US tends to view patent
claims more broadly than
Japan
6
Tombstone, Arizona, 1882

7. 1: US and Japan differences
• Differences in legal systems:
– Japan has a mixed common/civil law system –
Judge’s decisions mostly impact specific cases
– US & British common law system – Judges
decisions on specific cases have greater impact on
establishing new law and impacting other cases
– US lawyers always citing specific court cases as a
result – these court cases can act to redefine or
reinterpret US regulations & laws
7

8. Where common law is used
8

9. 2: Review of the US FDA
• History:
• In 1902, Biologics Control Act. started regulating
vaccines
• In 1906, FDA started regulating drugs
• In 2008, the two parts are still somewhat
separate: the biologics division is called CBER
and handles biotech drugs, and the drug division
is called CDER, and handles drugs and antibiotics.
They don’t always use the same rules!
9

10. FDA organization
10

11. FDA Drug approval stages
• Drug approval stages:
– Investigational new drug (IND)
– Phase I (small numbers of humans for safety)
– Phase II (small numbers of humans for efficacy)
– Phase III (large numbers of humans for
safety/efficacy)
– Phase IV (post marketing studies)
11

12. New drugs & generic drugs
• New (first time) drugs filed by New Drug
applications (NDA) – massive effort
• Generic (copy) drugs filed by Abbreviated New
Drug Applications (ANDA).
• ANDA are easier to file because they can make
use of previous NDA clinical studies and data.
12

13. Hatch-Waxman act
• History
• 1980’s crisis: FDA drug approval time became
so long that drugs were almost off-patent by
the time of FDA approval.
• At the same time, generic drug companies
could not start studies before patent
expiration due to patent infringement issues.
• Both sides suffered.
13

14. Hatch-Waxman act
• 1984 Hatch-Waxman act: Extended exclusive
lifetime (patent, FDA exclusivity) for new drugs
• … in exchange for allowing generic drug
companies to start FDA approval studies
before patent expiration.
14

15. Hatch-Waxman rules:
• Patent extension starts on day of initial filing,
ends on FDA approval,
• get 1 day credit for every day of FDA delay,
and ½ day credit for every day of applicant
delay, up to a maximum of 5 years, for the
claims directed to the approved drug only.
• FDA communicates dates to patent office,
which publishes patent term extension dates.
15

16. Effect of Hatch-Waxman
16

17. The “orange book”
• The “Orange book” is the nickname for the
FDA’s “Approved Drug Products List with
Therapeutic Equivalence Evaluations”
• First published in 1979
• In 1984, FDA started adding patents to the
“Orange book” to keep track of which drugs
are covered by patents
• We will come back to this later in more detail
17

18. 3: Review of the USPTO
• Patents are part of US constitution. First patent
granted soon after federal government formed in
1790. Initially run by Thomas Jefferson, who
stored patents in his old shoeboxes!
• Prior to 1995, US patent term was 17 years after
issue
18
• After 1995, US conformed to WIPO rules
of 20 years after filing, but a US inventor
can file a “provisional patent” to get an
extra year (21 years total).

19. US patent rules
• US has a modified “first to file” system
• US rules allow for continuations, new patents
based on old patents.
• Japanese patent applications treated favorably
using PCT system
19

20. US patent requirements
• Utility: - 35 USC 101 (compounds and targets
must have a plausible function)
• Novel: - 35 USC 102 (defeated by single
reference)
• Non-obvious: 35 USC 103 (defeated by a
combination of references) – the 2007 KSR
decision now makes it easier to challenge on
the basis of obviousness
20

21. US patent requirements
• Contain detail: - 35 USC 112 described with
enough detail (how to manufacture)
• Be invented by the applicant for the client
(must get proper assignment)
• Must be filed within 1 year of publication
anywhere or first US sale.
21

22. Public use bar:
• Patent aspects of clinical trials in the US: the
public use bar: Although filing before public
use is best, patents can be filed within one
year of first public use or sale in the US.
22

23. Patents relevant to drugs
1: Compound patents (broadest –drug, salts,
esters, hydrates)
2: Medical use patents (treating specific
diseases)
3: Formulation patents (stabilizers,
preservatives
4: Other (manufacturing, device, etc.)
23

24. Types of drug patents
• US drug patents can be on the form of the
active compound: sterioisomers, polymorphs,
salt forms, in-vivo conversion, particle size,
formulations, manufacturing process,
combination of therapies, methods of
treatment, drug delivery systems, and other
areas.
24

25. Other US patent aspects
• US Patent office overburdened and patents
take years to issue
• Patents may have continuations and
continuations in part
• Patents may be reissued – sometimes may
have broader claims
• No opposition, but patents can be
reexamined – only publications used
• Main way to challenge patents is in the courts
25

26. Trademarks
• The US patent office also handles trademarks -
- drug color, pill size and shape, name can also
be protected
26
http://tess2.uspto.gov/bin/gate.exe?f=searchss&state=b9nsj7.1.1
25 trademarks with the words “skin cream”

27. Break one
Question:
Where did Thomas Jefferson,
first commissioner of the US
patent office, and later the
3rd US president, store the
first US patents?
27

28. Answer
• Legend has it that he stored them in his
shoeboxes under his bed.
28

29. 4: Hatch-Waxman act: connecting the
FDA and the USPTO
• The “Orange book”: FDA list of approved drugs,
approval dates, indication, regulatory exclusivity,
and the patents that cover each drug.
• The patent list includes active drug, formulation,
inactive ingredients or excipients, approved
medical indications.
• The patent list does not cover manufacturing
method patents, metabolites of the active drug,
manufacturing intermediates, packaging and
container patents
29

30. Generic drug approval
• Generic drugs can get approval if they show
that their drug is bioequivalent to original
drug by filing an ANDA that can reference the
original drug NDA
30

31. Generic drugs and patents
• When a generic drug company files an ANDA
application, it must examine the status of the
drug patents from the Orange Book, and certify
that either:
1: There is no patent information listed
2: There is a listed patent but it is expired
3: That the listed expired will expire on a stated date
(usually soon)
4: That the listed patent is invalid or will not be
infringed.
31

32. Examples:
1: There is no patent information listed
2: There is a listed patent but it is expired
• If a generic drug manufacturer certifies 1 & 2,
then the FDA starts processing the generic
ANDA right away
32

33. Examples:
3: That the listed patent has expired or will
expire on a stated date (usually soon)
• If a generic drug manufacturer certifies 3, then
the FDA starts processing the ANDA, and gives
approval when the patent expires
33

34. The start of a patent fight!
4: That the listed patent is invalid or it will not be
infringed.
– ANDA filer notifies patent holder within 20 days
– Patent holder must sue for infringement within 45
days
– If the patent holder sues, FDA must withhold
approval for 30 months (one time only)
– If the patent holder does not sue, FDA may approve
ANDA at any time
– If a court rules that the patent is not infringed or
invalid, FDA may proceed after decision.
34

35. Be careful…
• A US company may also wait, and then sue
after the generic drug is approved.
35

36. 5: Drug patent extension and
regulatory exclusivity rules
A: A new drug can get up to 5 years patent
extension to make up for FDA delays
B: The first generic ANDA filer gets 180 days
exclusivity (per product)
C: New chemical entities get a 5 year ban on
use of their NDA data for generic ANDA
applications.
36

37. 5: Drug patent extension and
regulatory exclusivity rules
D: Orphan drugs (use less than 200,000 US
patients) get a 7 year hold on other NDA and
ANDA applications
E: New therapeutic use or new formulation gets
a 3 year hold on ANDA FDA approval
F: Pediatric exclusivity gets a 6 month additional
hold on FDA approval of any ANDA
applications
37

38. Research using drugs under patent
• Research using drugs still under patent: US 35
USC 271(e)(1)
• 1) It shall not be an act of infringement to make,
use, offer to sell, or sell within the United States
or import into the United States a patented
invention …solely for uses reasonably related to
the development and submission of information
under a Federal law which regulates the
manufacture, use, or sale of drugs or veterinary
biological products.
38

39. Strategy:
• Generic companies frequently file for an early
ANDA long before patent expiration in order
to get the 180 day exclusivity.
• They then challenge the patent as either being
invalid or not being infringed, and hope that
the US courts agree with them.
39

40. 6: Patent issues during drug R&D,
and the Bayh-Dole act
A: US has a modified “first to file” system.
B: In the US, the inventions are owned by the
inventors first, not the company
C: Must be careful with ownership issues: Need to
understand and clarify
1: When does invention occur?
2: Who are the inventors?
• Academic (can accidentally ruin patents by early publication)
• Within a single company
• Joint inventorship
40

41. Who owns the US patent?
Who actually owns the patent?
• Research agreement –
– if no agreement is joint inventorship
• Much US drug & biotech R&D is government
funded – for government funding, the Bayh-
Dole act controls the government ownership
issues.
41

42. The Bayh-Dole act
• Before Bayh-Dole, the US government owned
all US government-funded research.
• But nobody did anything with the inventions!
• After Bayh-Dole, university/business owns
government funded research, if the institution
complies with law 35 USC 200 – 212. These
rules are that the institution must:
42

43. The Bayh-Dole act
1: Promptly disclose invention to the funding
agency
2: Ask for title to the invention within two years
3: File a patent application before it is too late
4: Give the funding agency license to the
invention
5: Periodically (annually) file reports to the
agency
43

44. The Bayh-Dole act
6: State that the government has rights on the
patent application
7: Preferably license to small US firms
8: If there is exclusive license, licensee must
agree to manufacture in the US!
44

45. 35 USC 204 Preference for US industry:
• “no assignee of any such small business firm or nonprofit
organization shall grant to any person the exclusive right to
use or sell any subject invention in the United States unless
such person agrees that any products embodying the
subject invention or produced through the use of the
subject invention will be manufactured substantially in the
United States. However, in individual cases, the requirement
for such an agreement may be waived by the Federal
agency under whose funding agreement the invention was
made upon a showing by the small business firm, nonprofit
organization, or assignee that reasonable but unsuccessful
efforts have been made to grant licenses on similar terms
to potential licensees that would be likely to manufacture
substantially in the United States”
45

46. The Bayh-Dole act
E: Failure to comply with Bayh-Dole:
• a competitor may use the failure to comply
with Bayh-Dole as an excuse to attack the
drug’s patents
46

47. Obviousness in US patent law:
impact of KSR v Teleflex
• Patent crisis in US – computer and electronics
products covered by so many patents that it is
difficult to make new products. These companies
want fewer and weaker patents.
• However drug and biotech companies depend on
small number of strong patents, and do not want
to make patents weaker.
• US Supreme Court decided that it was too easy to
get obvious patents, and decided to make
obvious patents both harder to get and easier to
challenge.
47

48. KSR v Teleflex
48
The patent claimed a
electronic throttle control
mounted to a pedal support
•Prior art was very close,
such as a pedal with pivot
cables going to throttle
controls.
•Other prior art included an
electronic potentiometer
throttle control mounted on
the pedal support bracket

49. KSR v Teleflex
• KSR v Teleflex (2007): Old US rules were that to
be obvious, the examiner had to find proof of a
prior art, “teaching, suggestion or motivation”
(TSM) to produce the invention
• There was none here, but the patent still looked
too obvious anyway
• Supreme Court made it easier to invalidate
patents by stating that this old TSM rule was not
sufficient. Even without prior art TSM, some
patents may still be obvious.
49

50. KSR v Teleflex
• Supreme Court Justice Steven Breyer joked
that if he had to move a sensor on his garage
door because raccoons were gnawing on it,
should he be able to patent this?
50

51. KSR v Teleflex
The Supreme Court ruled: “ And as progress beginning
from higher levels of achievement is expected in the
normal course, the results of ordinary innovation are not
the subject of exclusive rights under patent laws.” 127 S.
Ct. at 1745.
“The combination of familiar elements according to
known methods is likely to be obvious when it does no
more than yield predictable results.” 127 S. Ct. at 1739.
“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.” 127 S. Ct. at 1742.
51

52. KSR v Teleflex
“One of the ways in which a patent’s subject matter can be proved
obvious is by noting that there existed at the time of invention a known
problem for which there was an obvious solution encompassed by the
patent’s claims.” 127 S. Ct. at 1742.
“Common sense teaches, however, that familiar items may have
obvious uses beyond their primary purposes, and in many cases a
person of ordinary skill will be able to fit the teachings of multiple
patents together like pieces of a puzzle.” Id.
52

53. KSR v Teleflex
“When there is a design need or market pressure
to solve a problem and there are a finite number
of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the
known options within his or her technical grasp.
Net effect: makes it easier to invalidate patent
applications & patents as being obvious:
53

54. KSR v Teleflex
• Impact of KSR still being felt. As a guideline, a
patent is likely to be non-obvious if prior art
“teaches away” from the claimed invention or
if the patent has advantageous properties
unexpected from the prior art.
54

55. KSR v Teleflex
D: Some examples of drug patents that now
may be obvious:
“[S]tructural similarity between claimed and
prior art subject matter, proved by combining
references or otherwise, where the prior art
gives reason or motivation to make the claimed
compositions.
55

56. KSR v Teleflex
D: Some examples of drug patents that now may
be obvious:
“‘Structural similarity, alone, may be sufficient to
give rise to an expectation that compounds similar
in structure will have similar properties’”
“When chemical compounds have ‘very close’
structural similarities and similar utilities
56

57. KSR v Teleflex: non-obvious patent
Takeda v. Alapharm (Actos®) 492 F.3d 1350 (Fed. Cir. 2007).
Patented drug Prior art
The court ruled: “Not obvious because prior art had toxic side effects
that taught away from its use, and no reasonable expectation that the
modification would reduce toxicity.
In order for it to be obvious, there must be some reason that would
have led a chemist to modify a known compound in a particular
manner, and a suggestion to have made this specific modification.”
57

58. KSR v Teleflex: Aventis v. Lupin (Altace®)
An ACE inhibitor Ramapril is the SSSSS configuration of a compound
with 32 possible stereoisomers, prior art was a mixture of SSSSS and
SSSSR. A similar ACE inhibitor enalapril is 700x more powerful in the
SSS form than the SSR form. Ruled obvious
The court ruled: “one skilled in the art would have expected ramapril
to be more potent based on the example of enalapril and there was no
evidence that separating ramapril was outside the skill of the art.
“If it is known or believed that some desirable property of a mixture
derives from a particular one of its components, the purified compound
is obvious over the mixture even without an explicit teaching that the
ingredient should be concentrated . Additionally, there were no
unexpected results”
58

59. KSR v Teleflex: Pfizer v. Apotex (Norvasc®)
• Patent claimed the besylate salt form of
amlodipine as superior to the prior art
maleate salt form of amlodipine (better
stability).
• Prior art disclosed that besylate salt used as 1
of the 53 salts used in FDA approved drugs,
used in about 1 out of 400 drugs. Also used in
other prior art patents.
59

60. KSR v Teleflex: Pfizer v. Apotex (Norvasc®)
The court ruled: “Sufficient motivation existed to
combine prior art to make amlodipine besylate; one
skilled in the art would have narrowed the genus of 53
salts “to a few, including benzene sulphonate.”
there was a “reasonable expectation of success” because
the prior art patent “contained a strong suggestion that
any and all pharmaceutically acceptable anions would
work” for amlodipine..
there was “a reasonable expectation of success,” which
could be verified by “routine testing.”
60

61. Break two
What do raccoons
have to do with US
patent law?
61

62. Answer
• US Supreme Court Justice Breyer, during
review of KSR v. Teleflex, compared the
invention to a problem he had with raccoons
chewing on the sensor part of his garage
door opener. If he moved the sensor up out
of the reach of the raccoons, would the (pre
KSR v. Teleflex) patent law let him get a
patent on that?
62

63. 8: Orange Book examples of FDA & USPTO
interconnections (topical drugs)
63
Examples:
A generic company
wants to produce a
new topical generic
drug. What might be a
good possibility?
Search for “Topical” in
2008 Orange book, get
427 hits

64. An example of a topical drug listing
64

65. Another topical drug listing
65

66. Generic drugs and patents
• When a generic drug company files an ANDA
application, it must examine the status of the
patents from the Orange Book, and certify that
either:
1: There is no patent information listed
2: There is a listed patent but it is expired
3: That the listed expired will expire on a stated date
(usually soon)
4: That the listed patent is invalid or will not be
infringed.
66

67. The start of a FDA patent fight!
4: That the listed patent is invalid or will not be
infringed.
– ANDA filer notifies patent holder within 20 days
– Patent holder must sue for infringement within 45
days
– If the patent holder sues, FDA must withhold
approval for 30 months (one time only)
– If the patent holder does not sue, FDA may approve
ANDA at any time
– If a court rules that the patent is not infringed or
invalid, FDA may proceed after decision.
67

68. US patent check
• Have any other generic drug companies
decided to challenge the validity of any drug
patents for topical drugs?
• Can check this by going on the web at:
http://www.fda.gov/CDER/ogd/ppiv.htm
68

69. Paragraph IV issues
Paragraph IV Patent Certifications
• The PDF contains a list of drug products for which an
Abbreviated New Drug Application (ANDA) has been
received by the Office of Generic Drugs (OGD) containing a
"Paragraph IV" patent certification. This list includes the
name of the drug product, dosage form, strength (subject
of Paragraph IV certification), reference listed drug
(RLD), and the date on which the first substantially
complete generic drug application was submitted to the
Agency (on a prospective basis beginning 3/2/2004). The
Agency will not disclose the identity of the applicant.
69

70. Topical drugs in a FDA patent fight
Drug Name Dosage Form Strength RLD Date of
Submission
Calcipotriene Topical Solution 0.005% Dovonex 5/19/2006
Clobetasol
Propionate
Topical Foam 0.05% Olux 6/27/2005
Clobetasol
Propionate
Lotion 0.05% Clobex 3/27/2006
Imiquimod Cream 5% Aldara 10/17/2006
Mometasone
Furoate
Topical Solution
(Cream)
0.1% Elocon
Mometasone
Furoate
Topical Solution
(Lotion)
0.1% Elocon 6/10/2004
Silver
Sulfadiazine
Cream 1% Silvadene
Tretinoin Cream 0.025%, 0.05%
and 0.1%
Retin-A
70

71. Mometasone furoate (Mometasone)
• a moderately potent glucocorticoid steroid
used in the treatment of inflammatory skin
disorders (such as eczema and psoriasis)
• What patents made the generic drug company
decide to file a category IV (4) patent
challenge with the FDA?
71

72. Check patent status in Orange book
72
Go here to
search by
ingredient
http://www.accessdata.fda.gov/scripts/cder/ob/

73. http://www.fda.gov/cder/ob/docs/queryai.htm
73
Enter drug name

74. Mometasone Furoate cream
74
http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=019625&TABLE1=OB_Rx
Look here for patent information

75. No FDA listed patents
75
Mometasone Furoate cream
The FDA will not delay an ANDA filing for this drug

76. Calcipotriene cream
76

77. Calcipotriene cream
77
Look here for patent information

78. Calcipotriene cream does have patents
78
Recently expired patent
Doesn’t expire for a long time!

79. What is going on here?
• Why did the generic drug company file a
category IV (4) ANDA application for the
Calcipotriene topical cream if the drug was
covered by a patent(s) 5,763,426 and RE39706
that do not expire until June 9, 2015?
79

80. Now we go to the USPTO web site
80
http://patft.uspto.gov/netahtml/PTO/srchnum.htm
Enter the patent number

81. Download patent 5,763,426
81

82. Look at 5,763,426 claims:
• 1. Calcipotriol monohydrate characterized by its storage stability at 40.degree. C. after 12 months,
its ready wettability and wet ball milling characteristics.
2. Pharmaceutical composition containing the compound of claim 1.
3. Pharmaceutical composition according to claim 2 which is a cream.
4. Pharmaceutical composition according to claim 2 which is a gel.
5. Pharmaceutical composition according to any one of claim 4, with a content of the active
component of 1-100 .mu.g/g of the composition.
6. The method of preparing calcipotriol monohydrate which comprises dissolving calcipotriol in
organic solvent and then adding water to the resulting solution to precipitate the hydrate, said
hydrate being characterized by its storage stability at 40.degree. C., its ready wettability and wet
ball milling characteristics.
7. In the preparation of a gel formulation which involves wet ball milling a calcipotriol component
and adding the wet milled calcipotriol component to a gel base, the improvement which comprises
wet milling calcipotriol hydrate as said component and using this wet milled hydrate for addition to
said gel base, said hydrate being characterized by its storage stability at 40.degree. C. after 12
months, its ready wettability and wet ball milling characteristics.
82
Claim 3 covers the cream

83. 5,763,426 covers the cream
• Since 5,763,426 covers the topical cream form
of Calcipotriene, and the patent doesn’t
expire until 2015, why did the generic drug
company file the category (IV) (4) ANDA?
83

84. The ANDA was for Topical Solution
Drug Name Dosage Form Strength RLD Date of
Submission
Calcipotriene Topical Solution 0.005% Dovonex 5/19/2006
Clobetasol
Propionate
Topical Foam 0.05% Olux 6/27/2005
Clobetasol
Propionate
Lotion 0.05% Clobex 3/27/2006
Imiquimod Cream 5% Aldara 10/17/2006
Mometasone
Furoate
Topical Solution
(Cream)
0.1% Elocon
Mometasone
Furoate
Topical Solution
(Lotion)
0.1% Elocon 6/10/2004
Silver
Sulfadiazine
Cream 1% Silvadene
Tretinoin Cream 0.025%, 0.05%
and 0.1%
Retin-A
84

85. 5,763,426 covers the cream
• 1. Calcipotriol monohydrate characterized by its
storage stability at 40.degree. C. after 12 months,
its ready wettability and wet ball milling
characteristics.
2. Pharmaceutical composition containing the
compound of claim 1.
3. Pharmaceutical composition according to claim
2 which is a cream.
85
Since the cream is different from the topical solution,
The generic drug company probably thought that they
were not infringing on patent 5,763,426

86. Is the generic drug company OK?
86
Look at RE39706
US patent rules allow an inventor to file for a “broadening
reissue” as much as two years after a patent has issued!

87. RE39706 is a “reissue” of 5,763,426
87
Go back to the USPTO
web site and investigate
RE39706.
RE39706 issued recently
on June 26, 2007, after
the generic drug company
filed with the FDA

88. Claims for RE39706
1. Calcipotriol monohydrate characterized by its storage 40 stability at 40° C. after 12 months, its ready
wettability and its suitability for wet ball milling [characteristics].
2. Pharmaceutical composition containing the [compound] calcipotriol monohydrate of claim 1.
3. Pharmaceutical composition according to claim 2 which is a cream.
4. Pharmaceutical composition according to claim 2
which is a gel.
5. Pharmaceutical composition comprising calcipotriol monohydrate according to any one of [claim 4]
claims 2-4 and a pharmaceutically acceptable vehicle, with a content
of the [active component of] calcipotriol monohydrate being 1-100 ug/g of the composition.
…
12. Pharmaceutical composition according to claim 2 which is an ointment.
13. Pharmaceutical composition according to claim 2 which is a lotion.
14. Pharmaceutical composition according to claim 2 which is a solution.
88
The newer claims
are broader and
cover a topical
solution!

89. What might have happened
• When the generic ANDA was filed on
5/19/2006, the 5,763,246 patent only covered
creams.
• On June 26, 2007 however, the reissue of
RE39706 of this patent issued, which now also
covers topical solutions.
• Is the generic company’s ANDA in trouble?
We will have to wait and see
89

90. References:
90
IP conferences:
(2007 Conference)
Courses:
Pharmaceutical and Biotech
Patent Law, by Kaye Scholer, LLP
http://www.pli.edu/product/book_detail.asp?ptid=501&stid=59&id=EN00000000040242
http://www.americanconference.com/Pharmaceuticals_Biotech_Life_Sciences/PBPatentBC.htm
Books:
The generic challenge,
By Martin. A. Voet
http://www.amazon.com/Generic-Challenge-Understanding-Pharmaceutical-Life-Cycle/dp/1581124309
http://www.aipla.org/
Societies:
American Intellectual
Property Law Association

91. Disclaimer:
This talk was originally prepared in 2008. Although many of the
issues discussed here have not changed significantly since 2008,
certain sections may be dated. Thus you should check to for
changed regulations or laws.
This talk is not intended to give legal advice.
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92. Contact information:
Stephen E. Zweig, Ph.D., JD
Patent Attorney
Patentassociate.com
15466 Los Gatos Blvd. 109-355
Los Gatos, CA 95030
Phone: (408) 348-1495
Email: szweig@patentassociate.com
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