Purdue Pharmaceuticals® Litigation

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Dec 6, 2012 (4 years and 7 months ago)

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1

PATENT LAW OVERVIEW

AND

PATENT SEARCH CASE STUDY

April 7, 2008

Alicia A. Russo, Esq.

Fitzpatrick, Cella, Harper & Scinto


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PATENTS IN GENERAL


A patent is the exclusive right

granted by a government to

an inventor to make, use,

or sell an invention for a

certain number of years
.



Actual reduction to practice

not required


i.e., you

need not actually make the

invention to seek a patent



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PATENTS IN GENERAL


A patent is a contract:


Government grants inventor a limited monopoly

(20 years from date of filing).


In return, inventor discloses the complete invention to the public in order to
promote the progress of technology.



A patent is a right to exclude others from practicing the invention.



A patent is not a right to practice the invention.



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4

PATENTS IN GENERAL


What Can Be Patented?


“Anything under the sun made by man”

Diamond v. Charkarbarty,

447 U.S. 303 (1980).







U.S. Supreme Court


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PATENTS IN GENERAL


Examples Of Patentable Subject Matter


Chemical Compounds


Biotechnology methods


Isolated genes and proteins


Plants


Computer Software applications


Internet/World Wide Web applications


Business methods


Designs


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IMPORTANCE OF PATENTS


One facet of overall plan to protect competitive position in marketplace.



Offensive
-

to stake out territory in marketplace.



Defensive
-

to protect against patent and non
-
patent attacks by competitors.



Mutual benefit


to allow peaceful co
-
existence of competitors through mutually beneficial
cross
-
licensing.


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7

INVENTORSHIP OF PATENTS


Inventorship may be sole or joint.


Anyone who made a material contribution to claimed subject matter is an inventor.


Not necessarily everyone involved in a project.



Project managers?


Technicians?



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OWNERSHIP OF PATENTS


Patent applications are filed in the name(s) of, and initially owned by, the inventor(s).



Employer
-
employee agreements wherein employee agrees to assign all rights in invention to
employer.



Assignment of patent or patent application from inventor(s) to employer.



Patents may be licensed to others, on an exclusive or non
-
exclusive basis.



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PARTS OF A PATENT APPLICATION

Specification.

Claims.

Drawings.

Abstract of the Disclosure.

Declaration of Inventor(s).

Power of Attorney.

Assignment.

Filing Fee.


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Describe the metes and bounds of the invention.


Only that which is enabled may be claimed.


Only that which is claimed is protected.



Example: Push button folding chair v. folding chair

PARTS OF A PATENT APPLICATION: CLAIMS


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Search tool used to quickly determine the subject matter to which the patent relates.


Usually a paraphrase of one of the main claims.

PARTS OF A PATENT APPLICATION: ABSTRACT OF THE
DISCLOSURE


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Only required if necessary to understand the invention.


Examples: block diagrams, flow charts, circuits, mechanical structures.

PARTS OF A PATENT APPLICATION: DRAWINGS


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REQUIREMENTS FOR PATENTABILITY : NOVELTY


(35 U.S.C.
§

102)


Subject matter on which protection is sought must be different than what came before it.


If all elements of the claimed subject matter are found in a
single

reference, then the
subject matter is not novel.


If no single reference discloses all claimed elements, the novelty hurdle is overcome.


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REQUIREMENTS FOR PATENTABILITY: NOVELTY


(35 U.S.C.
§

102)

102(a) the invention was known or used by others in this country, or patented or described in a printed
publication in this or a foreign country, before the invention thereof by the applicant for patent.

102(b) the invention was patented or described in a printed publication in this or a foreign country or in
public use or on sale in this country, more than one year prior to the date of the application for
patent in the United States, or

102(e) the invention was described in
-

(1) a published application for patent, published by another filed
in the United States before the invention by the applicant for patent or (2) a patent granted on an
application for patent by another filed in the United States before the invention by the applicant for
patent. An international application filed under the treaty defined in 351(a) shall have the effects for
the purposes of this subsection of an application filed in the United States only if the international
application designated the United States and was published under such treaty in the English
language.


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REQUIREMENTS FOR PATENTABILITY: NONOBVIOUSNESS


(35 U.S.C.
§

103)


“A patent may not be obtained though the invention is not identically disclosed or
described . . . if the differences between the subject matter sought to be patented and the prior
art are such that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which the subject matter
pertains.” 35 U.S.C.
§

103.


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CONSIDERATIONS IN DETERMINING NONOBVIOUSNESS

(Graham Factors)



Scope and content of the prior art. (More than one reference may form the basis of an
obviousness determination)


Differences between the prior art and the claims at issue.


The level of ordinary skill in the pertinent art.


Unexpected results.


Teaching away from the invention.


Hindsight is impermissible.


Secondary considerations:


Commercial success.


Long felt but unsolved needs.


Failure of others.


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REQUIREMENTS FOR PATENTABILITY:

WRITTEN DESCRIPTION (35 U.S.C.
§

112 ¶ 1)


The patent specification must disclose all features recited in the claims.


It must be apparent to one of ordinary skill in the art, from reading the specification, that
the inventor was in possession of the invention.


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REQUIREMENT FOR PATENTABILITY:

ENABLEMENT (35 U.S.C.
§

112 ¶ 1)


The patent specification must teach a person skilled in the art how to make and use the
invention without any undue experimentation.



It is not enough to simply state what the invention is; you must also describe how to build
it.



Typically done through a combination of drawings (block diagrams, circuits, flow charts,
etc.) and narrative text.


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REQUIREMENT FOR PATENTABILITY:

BEST MODE (35 U.S.C.
§

112 ¶ 1)


“The specification . . . shall set forth the best mode contemplated by the inventor

of
carrying out the invention.” 35 U.S.C.
§

112.


This requirement is at the heart of the
quid

pro

quo
of the patent system: you may

not
obtain a patent on your invention, but keep the best aspects of it

secret.


Which mode is “best” is subjective, in the mind of the inventors.


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RELEVANT DATES FOR PRIOR ART


“[B]efore the invention thereof by the applicant for patent.”



“[M]ore than one year prior to the date of the application for patent in the United

States.”


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PRIOR ART

The body of knowledge that came before the subject matter sought to be patented.

Frame of reference for determining whether subject matter is novel and nonobvious.


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TYPES OF PRIOR ART


“Known or used by others.”



“Patented or described in a printed publication.”



“In public use or on sale.”



“Described in a patent.”



“Made by [another] inventor.”




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EXAMPLES OF PRIOR ART


Patents (U.S. or foreign).


Publications (
e.g.
, journals, textbooks, conference proceedings).


Tradeshow demonstrations.


Information on Web sites.


Any prior public use, sale, or offer for sale.


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WHAT IS THE DATE OF INVENTION?


Date of filing (constructive reduction to practice).


Date of actual reduction to practice (sample, prototype, or model).



Date of conception, if there is diligence between invention and filing



Conception and reduction to practice.



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TERRITORIAL LIMITATIONS OF PATENTS


A U.S. patent only affords protection against infringing activities in the U.S.


In order to stop infringing activities in foreign countries, individual patents

must
be obtained in each country.


European Patent Office (EPO): can grant a single patent that affords

protection in most European countries.


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KSR Int’l Co. v. Teleflex, Inc.
, 127 S. Ct. 1727 (2007)


“What matters is the objective reach of the claim” and “if the claim extends to what is obvious, it is invalid
under
§

103.”


“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 in the art has a good reason to pursue the
known options within his or her technical grasp. If this leads to the anticipated success, it is likely the
product [is] not of innovation but of ordinary skill and common sense.
In that instance
the fact that a
combination was obvious to try might show that it was obvious under
§

103.”


Thus, the fact that something was obvious to try might be sufficient to show obviousness only in the
instance where there is a design need or market pressure to solve the problem and there are a finite
number of identified predictable solutions.



Held that the TSM (teaching, suggestion motivation) test should be applied flexibly rather than rigidly.


Before declaring obviousness, the Federal Circuit will likely continue to look for some evidence of a
motivation to combine prior art references. See
Omegaflex, Inc. v. Parker
-
Hannifin Corp.
, No. 07
-
1044
(Fed. Cir. June 18, 2007) (holding in part in a nonprecedential decision that evidence of skill and motivation
is still relevant to the obviousness analysis)

Supreme Court


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Takeda Chem Co. v. Takeda Pharm. North Amer., Inc.
, 492 F.3d
1350 (Fed. Cir. 2007)


Compound was patentable and not obvious over the prior art because “rather
than identify predictable solutions . . . the prior art disclosed a broad selection of
compounds any one of which could have been selected as a lead compound for
further investigation.”

Federal Circuit


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Ortho
-
McNeil Pharm. Inc. v. Mylan Lab. Inc.
, 2007
-
1223 Slip
Opinion (Fed. Cir., March 31, 2008)


Compound was patentable and not obvious over the prior art because “this
clearly is not the easily traversed, small and finite number of alternatives that
KSR

suggested might support an inference of obviousness.”


The court also held that there was objective criteria showing
nonobviousness. Such as unexpected results, skepticism of experts,
copying and commercial success. These are all independent evidence of
nonobviousness.


The court noted that “a flexible TSM test remains the primary guarantor against
non
-
statutory hindsight analysis” and that “it merely assures that the
obviousness test proceeds on the basis of evidence


teachings, suggestions (a
tellingly broad term), or motivations (an equally broad term)


that arise before
the time of invention, as the statue requires.

Federal Circuit


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Case Study: Novelty (35 U.S.C.
§
102)


Invention: One
-
handed alloy bat


U.S. Patent No. 4,098,503 discloses a one
-
handed bat


no mention of alloy.


U.S. Patent No. 4,113,248 discloses a conventional bat made of a metal alloy.


Because neither reference discloses all the elements of the invention, the
subject matter is novel, but not necessarily patentable.



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Case Study: Nonobviousness (35 U.S.C.
§
103)


Invention: One
-
handed alloy bat


U.S. Patent No. 4,098,503 discloses a one
-
handed bat


no mention of alloy.


U.S. Patent No. 4,113,248 discloses a conventional bat made of a metal alloy.


Obvious?



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Case Study: Nonobviousness (35 U.S.C.
§
103)


Invention: One
-
handed alloy bat


U.S. Patent No. 4,098,503 discloses a one
-
handed bat


no mention of alloy.


U.S. Patent No. 4,113,248 discloses a conventional bat made of a metal alloy.


Examiner’s rejection: “It would have been obvious to one of ordinary skill
to incorporate the metal alloy feature disclosed by the ‘248 patent into the
one
-
handed bat disclosed by the ‘503 patent.


Attorney files response arguing that it would not have been obvious.
Probably obvious. May need to add additional limitations to overcome the
rejection.




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Case Study: Nonobviousness


Invention: One
-
handed graphite and zinc alloy bat


U.S. Patent No. 4,098,503 discloses a one
-
handed bat


no mention of alloy.


U.S. Patent No. 4,113,248 discloses a conventional bat made of nickel alloy.


Obvious?




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33

Case Study: Nonobviousness


Invention: One
-
handed graphite and zinc alloy bat


U.S. Patent No. 4,098,503 discloses a one
-
handed bat


no mention of alloy.


U.S. Patent No. 4,113,248 discloses a conventional bat made of nickel alloy.


Examiner’s rejection: “It would have been obvious to one of ordinary skill
to incorporate the metal alloy feature disclosed by the ‘248 patent into the
one
-
handed bat disclosed by the ‘503 patent.


Attorney files response arguing that it would not have been obvious
because there are multitudes of possible metal alloys and the skilled
artisan would not have chosen a graphite/zinc alloy. In addition, the
attorney provides evidence that the graphite and zinc alloy bat has
unexpected properties, e.g., light and strong but providing greater
precision hitting.




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