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Can You Patent Nature?
Can you patent nature? Specifically, DNA? That’s at the bottom of the latest round of the big government vs. big Pharma battle.
Government lawyers argue “No”. They say you cannot, for instance, patent a tree. (Yet, the US patent office awards plant patents.)
Myriad Genetics, Inc., has had a patent on a cloned BRCA gene — a potential precursor to breast cancer –
for over 10 years. (Test for the gene, and you can get a jump start on treatment.) Myriad answers that while you might not be able to patent a tree, you can patent, say, a unique baseball bat that humans fashioned from that tree.
The isolation and use of DNA is accelerating the development of “personalized medicine” that’s
bringing us safer, more effective drugs. Throwing out R&D companies’ ability to do so would have a huge negative impact on the worlds of science, medicine, business and law.
I have patented numerous DNA molecules. I have studied the science — and based on the specific science used here, the government lawyers are wrong! Here’s why:
They claim that pretty much anyone could used a microscope and look into a cell to see DNA. In fact, you
could not see DNA through a microscope because it is wrapped around in proteins and other natural products that protect it from early decay. ONLY in the laboratory — after complex multi-step processing — can you isolate the DNA that’s claimed in patents.
Question: Has Myriad indeed found the best way to get the BRCA test to women? As a descendant of women who died of ovarian and breast cancers, I take a special interest in this debate.
(The main plaintiff is a part-time nanny, who like many cannot easily lay her hands on enough funds to
pay for the test.)
Patent Approval is not Always
Perfect
As folks in the medical and
biotech fields sometimes discover, FDA approval and patents can be
intertwined.
FENTORA — a powerful, short-acting anesthetic
developed by Cephalon , Inc. — is covered by two patents. When Watson
Pharmaceuticals Inc. began to market generic forms of FENTORA, Cephalon sued to stop them.
However, in a recent patent
lawsuit the court ruled that Watson’s generic was in fact a different salt form
and therefore did not infringe the two patents.
Cephalon disagrees with
that verdict. Their position is that if
their salt forms and Watson’s were indeed so different, the FDA should not have
approved Watson’s product as a generic form of FENTORA, but as a distinctly separate drug.
Cephalon is now suing the
FDA for wrongfully approving a new drug under the generic rules.
Sometimes statements made
in one court proceeding (the patent lawsuit) can be used
against the party in another forum (an FDA lawsuit).
(Cephalon was recently
purchased by Teva Pharmaceuticals, Inc.)
There are pitfalls and
potholes on the way to a bulletproof patent.
You need a strong, experienced patent attorney to protect your work
– t’s not an option. Barbara Luther has
almost a decade of experience obtaining FDA approvals, plus 20 years of
experience in intellectual property.
(Post Comments in Forum)
When is the Same Not the Same?
Johnson & Johnson was
greatly displeased in a recent patent dispute with Abbott Laboratories in
connection with a J&J drug, Humira, developed to combat several afflictions
including rheumatoid arthritis and Crohn’s disease.
J&J claimed that Abbott
violated J&J’s patent when Abbott developed its own big-selling antibody. A
lower court agreed, and awarded J&J $1.8 billion.
Abbott, however,
appealed. In throwing out the lower
court’s verdict, the U.S. Court of Appeals ruled that the two companies
appeared to have used different developmental strategies, thereby producing
essentially different antibodies.
Note that Abbott was on the
winning side. This hits very close to
home — Barbara
Luther has herself worked with Abbott on antibody tests.
(Post Comments in Forum)
Are
You a Smarter Creative Person?
Not long ago, the US
Supreme Court divided 4-4 in Costco
Wholesale Corporation vs. Omega, a Swiss watchmaker, on the issue of
copyright protections for imported goods.
The question: does the “First Sale Doctrine*”
apply to imported goods manufactured abroad?.
Omega makes watches in
Switzerland then sells them to authorized distributors around the world. Watches bought by some of these distributors
were eventually sold to Costco, which sold them to US consumers without
authorization from Omega.
In a 4-4 split, the US
Ninth Circuit Court of Appeals ruled that the First Sale Doctrine does not
apply to imported goods. (The split means that the court’s decision is
affirmed, but that the ruling does not set precedent.)
This means we can still use
the Customs Branch to stop importation of copies of sculptures, books, CD’s,
DVD’s, etc. for which we have obtained copyright certificates in the US.
The smart creative person knows that copyright is automatic, basically
upon creation of your work. The smarter
creative person knows that if you obtain a legal Copyright Certificate up front
– before
any infringement takes place — you have obtained cheap, one-payment insurance
that will stop any infringing action without delay.
If you wait until you actually discover that someone has been copying your work and only then hurry to get your Copyright Certificate — which could take weeks or months — before you can file suit, the knock-off artist may have stolen your market!
A patent attorney like Barb
Luther is the best friend you can have in the creative process!
*The “First Sale Doctrine” — Legal Definition
The First Sale
Doctrine, codified at 17 U.S.C. § 109, provides that an individual who
knowingly purchases a copy of a copyrighted work from the copyright holder
receives the right to sell, display or otherwise dispose of that particular
copy, notwithstanding the interests of the copyright owner. The right to
distribute ends, however, once the owner has sold that particular copy. See
17 U.S.C. § 109(a) & (c). Since the first sale doctrine never protects
a defendant who makes unauthorized reproductions of a copyrighted work, the
first sale doctrine cannot be a successful defense in cases that allege
infringing reproduction.
Further, the
privileges created by the first sale principle do not “extend to any
person who has acquired possession of the copy or phonorecord from the
copyright owner, by rental, lease, loan, or otherwise, without acquiring
ownership of it.” See 17 U.S.C. § 109(d). Most computer
software is distributed through the use of licensing agreements. Under this
distribution system, the copyright holder remains the “owner” of all
distributed copies. For this reason, alleged infringers should not be able to
establish that any copies of these works have been the subject of a first sale.
(Post Comments in Forum)