Transcript INTELLECTUAL PROPERTY: WHY BOTHER?

Intellectual Property Protection
for Drugs, Biologics and Medical Devices
in the U.S. and European Union
Comparative EU and U.S. Science, Law and Policy
in the Regulation of Pharmaceuticals and Medical
Technology
Chuck Schmal
Patent & Trademark Attorney
[email protected]
Patenting Medical Inventions
 Definition of statutory subject matter in the U.S.
is a broad, simple one which dates from the time
of Thomas Jefferson
 The European definition is the result of recent
political debate between the representatives of
over a dozen countries and shows clear
evidence of compromise drafting
Patenting Medical Inventions in the U.S.
 U.S. patent law generally takes a fairly liberal
approach to the patenting of medical inventions.
 Invention only has to meet standard tests for
patentability (utility, novelty, and
nonobviousness)
Patenting Medical Inventions in the EU
 European Patent Office (EPO) takes a much stricter
approach
 European patent law explicitly excludes from
patentability “methods of treatment of the human or
animal body by surgery or therapy and diagnostic
methods practised on the human or animal body”
 Policy: it is in the interest of public health that
doctors and veterinarians should not be hindered by
patents in the care they give to their patients
Patenting a Surgical Method in the U.S.
 Example 1: A method of surgery for
correcting vision using known surgical
tools
 Patentable in the U.S.
 Sample claim:
1. A method for correcting vision, the method
comprising the steps of:
[recite the surgical steps].
Patenting a Surgical Method in the EU
Example 1: A method of surgery for
correcting vision using known surgical
tools
Not patentable in EU
Case law of the EPO has established that any
surgical method, regardless of its purpose (e.g.
therapeutic or cosmetic) is excluded from
patentability
Patenting a Surgical Method in the EU
Note: non-surgical cosmetic methods are
patentable
Non-surgical teeth straightening
Hair coloring
However, cosmetic methods having health
implications are excluded
Methods of weight loss for obese people
Plaque removal from teeth
Patenting a Drug Treatment in the U.S.
Example 2: A method of treating
asthma using a known drug previously
used for treating headaches
Patentable in the U.S.
Sample claim:
1. A method for treating asthma, the method
comprising [administering the drug].
Patenting a Drug Treatment in the EU
Example 2: A method of treating asthma
using a known drug previously used for
treating headaches
Not patentable in the EU
Considered to be a therapeutic method
Patenting a Drug Treatment in the EU
 HOWEVER, European attorneys have
developed a special claim format approved by
the EPO: “Swiss-style” or “second medical use”
claim.
 Example claim: “Use of [the known drug] to
manufacture a medicament for the treatment of
asthma.”
 Only applies to drugs: cannot be used for
second medical use of a known medical device.
Patenting a Drug Treatment in the EU
 Problems with “Swiss-style” claims:
 Not literally provided in the European Patent Convention (EPC)
but adopted through a decision by the appeals board for the
European Patent Office (EPO)
 As a result, nonuniform interpretation between countries and
within EPO itself.
 For example, dosing regime claims (where novelty lies in the
method of how the known drug is used) may be invalid in the
United Kingdom but valid in other EPC countries.
 EPC 2000 (effective December 13, 2007) now expressly
allows protection of second (or further) medical
indications.
 Example Claim: “Substance X (known) for the treatment of
disease Y.”
Patenting a Diagnostic Method in the U.S.
Example 3: A method of testing blood
samples to diagnose diabetes
Patentable in the U.S.
Sample claim:
1. A method of testing blood samples, the method
comprising [steps in the test].
Patenting a Diagnostic Method in the EU
Example 3a: An in vivo method of testing
blood samples to diagnose diabetes
Not patentable in the EU
Excluded diagnostic methods are those carried
out on a living human/animal body
Patenting a Diagnostic Method in the EU
Example 3b: A method of testing in vitro
blood samples to diagnose diabetes
Patentable in the EU
Not excluded if samples permanently removed
from the body (e.g. by syringe)
BUT, excluded if samples returned to the body
(e.g. testing during dialysis)
Patenting a New Drug in the U.S.
 Example 4: A new chemical compound useful
in treating cancer

Patentable in the U.S.

1.
Sample claim:
A pharmacological compound, comprising [chemically
define the compound].

Can also claim the method of treating a disease using
the drug
Patenting a New Drug in the EU

Example 4: A new chemical compound useful in treating cancer
 Patentable in the EU – law states that products, in particular
substances and compositions, for use in excluded medical methods
are not excluded
 Sample claim:
1. A pharmacological compound, comprising [chemically define the
compound].
 Cannot claim the method of treating a disease using the drug
Patenting a New Drug in the EU
 The EPC does not restrict the patentability of
pharmaceutical products. Rather, it restricts
methods of treatment of the human/animal body
by therapy, surgery or diagnosis.
 Therefore, not possible to claim the method of
treating a disease using the new drug, but can
claim a drug for use in treating a disease
Patenting a New Drug in the EU
 Practice has developed in EU of filing “first
medical use” claims
Sample: [The new drug] for use as a
medicament.
Also used for cases where a known chemical
not previously used as a pharmaceutical is
found to have a therapeutic effect.
Even if drug not patentable in its own right,
can be patented for the first medical use
made of the compound
Patenting a New Drug in the EU
 First medical use claims are typically accompanied by “Swiss-style” claims directed to
the specific disease(s) of interest
 Sample: Use of [the new drug] to manufacture a medicament for the
treatment of cancer.
 Approved by the Swiss Patent Office and later affirmed by the EPO
Board of Appeals
 As noted before, second medical use claims now expressly allowed
under EPC 2000, and therefore, more than one medical use can be
claimed.
 Example Claim(s):
 “Substance X for the treatment of disease Y.”
 “Substance X for the treatment of disease Z.”
Patenting a New Medical Device in the U.S.
 Example 5: A new heart valve

Patentable in the U.S.

1.
Sample claim:
A heart valve, comprising [describe new heart valve
features].

Can also claim the method of implanting the heart valve
Patenting a New Medical Device in the EU

Example 5: A new heart valve

Patentable in the EU

1.
Sample claim:
A heart valve, comprising [describe new heart valve
features].

However, cannot also claim the method of implanting the
heart valve (falls under the medical methods exclusion)
Patenting a New Medical Device in the EU
 EPO Board of Appeals has ruled that a method
of refining the use of a pacemaker to reduce
energy consumption is not a therapy even
though the pacemaker has a therapeutic effect,
and the method can therefore be patented.
 The patented method “does not have the effect
of preventing or treating a pathological
condition.”
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
Invented in the U.S. and client wished to
protect the invention in both the U.S. and
in Europe
Perceived commercial markets in both
regions
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
 U.S. Patent No. 5,690,656
 Claims “Method for forming an anastomoses
between first and second adjacent viscera,
comprising the steps of:
(a) inserting a first magnet…
(b) inserting a second magnet…
(c) allowing tissue compressed between the first
and second magnets…to undergo ischemic
necrosis.”
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
 U.S. Patent No. 5,690,656
 Also claims: “A device for forming an anastomosis
between adjacent viscera, comprising:
a first magnet…
a first jacket having opposing first and second rims…
a second magnet….
a second jacket having opposing third and fourth rims…
wherein…the first and second magnets are selfcentering when they are magnetically coupled through
walls of the adjacent viscera.”
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
 European Patent No. EP 0 754 434 B1
 Claims only the device (a pair of magnets) in a
fashion similar to the U.S. device claims
 Does not (and cannot) claim the method of
using the magnets inside the patient to form the
anastomosis.
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
 What is effect?
 Limits who is an infringer
 In the U.S.
 Manufacturer of the magnet set
 Doctor (more likely hospital) performing the procedure
 In the EU
 Only the manufacturer of the magnet set
 Doctor’s use not covered by a claim, therefore cannot be
sued
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
 What is the effect?
 Limits number of acts of infringement
 In the U.S., both the sale and the subsequent use are
actionable
 if magnets are reusable, each successive procedure
using the same set of magnets would be a separate
act of infringement
 In the EU, only the sale of the magnets to the doctor
would be an act of infringement
Comparative Protection Real World Example:
Method & Apparatus for Creating Abdominal
Visceral Anastomoses
 What is the effect?
 Limits the monetary base for calculating
damages
 In the U.S., both the $500 sale of magnets and the
$5,000 surgical procedure are available on which to
base a claim of damages
 In the EU, only the $500 sale of the magnets is
available
Patenting Biotechnology Inventions in EU
 So far, the decisions of the EPO Board of Appeals have
been consistent with the USPTO
 1980: U.S. Supreme Court upheld the patenting of an oil
slick eating bacteria (Diamond v. Chakrabarty)
 1987: USPTO approved Harvard patent for the
“oncomouse”
 the animals must be "given a new form, quality, properties or
combination not present in the original article existing in nature in
accordance with existing law." The oncomouse clearly met this
criteria.
 1992: EPO accepted the Harvard Oncomouse patent
and affirmed it on appeal
 Over 20 genetically-modified animal patents have been issued
by the EPO
Patenting Biotechnology Inventions in EU
• EU Biotechnology Patent Directive
– Clarifies what is patentable and is favorable to
patenting transgenics
– Plant and animal varieties (a whole genome
that is distinct from other varieties) are
patentable
– Procedures for breeding plants and animals
are not patentable
Patenting DNA and Protein Sequences in US/EU
•
Patentable as long as utility (US)/industrial applicability (EU) is disclosed in the
application
•
EU Biotechnology Patent Directive: inventions capable of industrial application - even
when they concern a product made of or containing biological material or a procedure
for producing, processing, or using biological material - are clearly patentable. Even if
a biological material preexists in the natural state, if it is separated from its
natural environment or produced with a technical procedure it may still form
the subject matter for an invention. For example, a naturally occurring human
protein, if separated from the human body or produced by a technical procedure, may
constitute a patentable invention, even if the structure of that element is identical to
that of a natural element. The one provision is that the industrial application must be
clearly specified in the application for a patent. In the case of full-length sequence or
the partial sequence of a gene, the function of the gene must be disclosed.
•
Not sufficient to simply show that a protein or nucleic acid sequence can be made
and used
•
Function of the nucleic acid and/or protein is required, and claiming a use based upon
a predicted (but not proven) function fails to meet the requirement
Specific Exceptions to Patentability in the EU
 Art. 53(a) of the EPC states that European
patents shall not be granted for inventions of
which publication or exploitation would be
contrary to order public or morality
 Inventions likely to breach public peace or social
order, or to seriously prejudice the environment are
contrary to order public
Specific Exceptions to Patentability in the EU
 Rule 23d of the EPC states the following patents shall
not be granted:
 Processes for cloning human beings
 Processes for modifying the germ line genetic identity of human
beings
 Uses of embryos for industrial or commercial purposes
 Although the EPO ethics group has stated that patents to modified
stem cell lines can be granted
 Processes for modifying the genetic identity of animals which are
likely to cause them suffering without any substantial medical
benefit to man or animal, and also animals resulting from such
processes
Summary
 Medical inventions are more difficult to patent in the EU
 EU exclusion for medical therapy, surgery or diagnosis
 Medical devices and pharma compounds are patentable
in the EU
 Drug treatments may be protected in EU by using first and
second “medical use” claims
 Transgenic animals are patentable in the U.S. and EU
 Requirements for patenting of DNA sequences similar in
the U.S. and EU
 Must pass morality test in the EU