Sunday, March 23, 2014
Assignment 7, Blog Post 2: USPTO Guidelines on Determining Obviousness
Since this week's
assignment was to talk about obviousness, I wanted to go over some of USPTO's
guidelines for determining obviousness.
As Professor Lavian mentioned in class, some law schools, such as
Stanford, have an entire course on obviousness! In 2010, USPTO released a set
of updated guidelines on determining obviousness. In link [1] below, you can
find a table from the Federal Register that talks about "Combining Prior
Art Elements", "Substituting One Known Element for Another",
"The Obvious to Try Rationale",
and "Consideration of Evidence".
Here, I will briefly
summarize some of the facts that I learned:
-- Even when there
exists a general method to make the claimed product and this method can be used
by an ordinary artisan, the claim is still nonobvious if the suggested use of
the method had not been known before.
-- The claimed
invention is likely to be obvious if the inventor combines elements from prior
art that would reasonably have been expected to maintain their respective
properties or functions after they have been combined. While this may seem
self-evident, I think it is good to state explicitly. Here, the question that arises is how one
would define reasonable.
-- "When
determining whether a reference to a different field of endeavor may be used to
support a case of obviousness (i.e. is analogous), it is necessary to consider
the problem to be solved." The professor talked about this in class as
well: For example, a processor can refer to a processor in a laptop or
electronic device or it could refer to a food processor. (this was the example
given in class). So when is it appropriate to link these two completely
separate fields and when is it not appropriate to do so? Here, USPTO is saying
that we need to consider the problem being solved when making the connection.
Another related guideline is: "Analogous art is not limited to references
in the field of endeavor of the invention, but also includes references that
would have been recognized by those of ordinary skill in the art as useful for
applicant's purpose".
When it comes to
learning more about obviousness, I think these tables are a good place to
start-- so definitely take a look at them!
Assignment 7, Blog Post 1: Narrow Range versus Broader Range
For this week's blog
posts, the theme is obviousness. I wanted to discuss an article from
Patentlyo.com titled, "Whither Obviousness: Narrow Range Anticipated by
Broader Range in Disclosure" by Dennis Crouch. Consider an invention "that is anticipated, but
likely not obvious. According to the apellate panel, the prior artfully
discloses and enables the invention but also teaches that the proposed
invention is impractical and does not work well." [1] This is part of a
classic hypothetical case presented in law schools.
The patent that we
are considering is given in link [2] below. This patent protects a process for
clarifying water using a flocculated suspension of aluminum and quarternized
polymers. The patent owner and inventor, Richard Haase, has filed more than 50 patents
on water purification/ energy and is the CEO of ClearValue. Pearl River, who
was once a customer of ClearValue, later began making its own patented process. Haase sued them for patent
infringement and for trade secret violation. The conclusion is that "a
broad range disclosure found in the prior art ("less than 150 ppm")
anticipates the narrower range found in the claims ("less than 50
ppm"). Under 35 U.S.C. § 102, "a claim will be anticipated and
therefore invalid if a single prior art reference describes 'each and every
claim limitation and enable[s] one of skill in the art to practice an
embodiment of the claimed invention without undue experimentation'"[1]
The Federal Circuit
addressed a similar situation in the 2006 Atofina decision, in which there was
a narrow claimed temperature range and the prior art dictated a broader
temperature range. At that time, the final decision was that the broad range
disclosed in the prior art did not anticipate the narrow range claimed later.
Instead, it was agreed that there was something significant about the claimed
temperature range. However, in this case, the court ruled that "the narrow
range is not critically different from the broad range….[and] that the claimed
narrow range was fully disclosed by the broad range and therefore is
unpatentable."[1]
Okay, so how does
all this relate to obviousness? The article states:
"The mechanism that the court used to
distinguish this case from Atofina is very much akin to obviousness
principles-- looking essentially for synergy or unexpected results that make
the narrow range qualitatively different from the broad range" [1]
Take a look at the
article and actual patent if you are interested in learning more about the
case! (see links below)
Friday, March 7, 2014
Assignment 6, Blog Post 2: Bioprinting Patents
So, my last blog
post was on 3D printing technology in general, and I somewhat focused on the
stereolithography part since some of those patents were expiring very soon-- in
the next five days! I wanted to stick
to a similar topic for my second blog post this week, and wanted to talk about
3-D printing in tissue engineering applications. Usually, there are many
arguments with patents that are in the health and biology area (such as patents
on genetic sequences), because it is important to differentiate the human
innovation versus something made by nature.
The article I read
is titled, "A Look at The Patentability of 3-D Printed Human Organs".
Bioprinting is the intersection of 3D printing and inkjet printing to print
layers of living cells. Multiple layers of cells are stacked within a gel-based
material to form functional living tissue. As a bioengineer, I think this is
really interesting and exciting area. As of today, scientists have already
created functional 3D human blood vessels and mini-livers using this
technology. There is also the potential to generate entire human-sized living
organs (although there are some scientific challenges to overcome that I won't
get into here-- but feel free to ask me in person!).
In class, we all
have learned that patent protection is extremely important, for it allows
inventors to fully capitalize on their investment, by discouraging or delaying
competition. In this blog, I wanted to focus on some issues related to
patenting artificially created living human tissue. The patent office and Congress rule that
patens on human organisms are not eligible for patent protection. However,
according to the article, inventors have successfully been able to "obtain
protection for genetically engineered animals by narrowing the claim scope to
'nonhuman' subjects" [1]. One
example of this is U.S. Patent No. 8,088,968, which claims:
"a
'non-human mammal' with a particular genome composition where the nonhuman
mammal is a mouse. A 'tissue' of such nonhuman mammal is also separately
claimed."
Also, it is
important to note, that while the above is deemed patentable, the USPTO has
rejected patent claims on a human embryo under 35 U.S.C. Section 101 and also
because it violates Section 33(a) of the Leahy-Smith America Invents Act.
Back to bioprinting
human organs. The previous argument was for patenting animals other than
humans. What are some arguments in favor of patents for bioprinted organs?
"Rather
than viewed as products of nature, bioprinted organs and tissue may be
considered to be manmade living materials artificially arranged in accordance
with a particular printing geometry that facilitates any naturally occurring
cell behavior"[1].
One similar example
is U.S. Patent No. 8,394,141, which includes claims directed to an implant
created from "fibers of defatted, shredded, allogeneic human tissue"
such as "tendon, fascia, ligament, or dermis" and further including a
"growth factor" (which helps in the differentiation of cells to the
desired cell type). Allogenic tissue is basically tissue not from the same
individual (which would be autologous), but from the same species. Thus, if
patents on tissue-
engineered implants
are allowed, so should patents on bioprinted organs.
So, what do you guys
think? Do you think patents on bioprinted organs should be allowed or not?
Please respond in the comments below!
Thursday, March 6, 2014
Assignment 6, Blog Post 1: Patents in 3D Printing
This topic was
actually brought up (quite randomly actually!) by a friend of mine recently. He
works at the machine shop at UC Berkeley, and he mentioned how in 2009, the
patent on the 3D printer expired and how everyone started delving into that
market, since it was so lucrative. Soon after, smaller desktop 3D printers came
out. Thus, I decided to look into it.
According to an
article written by John Hornick and Dan Roland on a few months ago, 3D printing
is a 30 year technology that has recently starting entering the mainstream, but
has not yet become commonplace. Hornick and Roland questioned what is holding this
industry back? Some people argue that patents have held back innovation in 3D
printing technology, because the companies are worried about getting sued, so
they do not spend the resources to develop the technology. This in turn,
reduces competition, keeping prices high and creating barriers to discourage
others from entering the market. Other people argue that this is not actually
the case, and what is holding 3D printers from becoming more commonplace is
that the printers are too slow and cumbersome. "Regardless of where one stands in this debate, the threat
of a lawsuit is certainly real and the 3D Printing Patent Wars, like Smart
Phones Wars, are probably not too far down the pike." [1]
Link 1 below is a
very good website to go to for a summary on the key 3D printing patents. Some
of them have expired last year or beginning of 2014, but there are still many
more that are expiring this month, as well as the next coming months (as well
as some in 2015). I just wanted to spend some time talking about the patents
that will expire soon and how this will affect the 3D printing industry in
general.
There are several
patents that are expiring in just the next few days (on March 11th):
Patent 5,609,812 is
titled, "Method of Making a Three-Dimensional Object by
Stereolithography". This is for making a 3D object from a medium that will
soilidify after exposure to synergistic stimulation, such as ultra violet or
infared radiation. While stereolithography is a very common invention, this
method improves on it by allowing to identify an endpoint of the first vector
and the beginning of the second vector (the vectors define the pattern of
exposure). The invention also comprises a method for scanning at a fixed
velocity along the first vector and mechanically blocking the UV or IR.
Patent 5,609,813 is
also titled "Method of Making a Three-Dimensional Object by
Stereolithography." This goes back to what we discussed in class this week
on how mulitple patents can have the
same name. However, since patents talk about innovation, their claims must be
different. This patent protects a method of applying a layer or flowable
material, generating and sequencing the pattern of exposure paths for the
layer, and exposing these paths to the UV/IR radiation according to the
sequence. To me, this sounded really broad at first, but I'm sure there are
more details that can easily be discerned by someone who is knowledgeable in
the area.
Patent 5,610,824 is
titled, "Rapid and Accurate Production of Stereolithographic
Parts". This patent protects an apparatus and a method for the same type of
process talked about in the first two patents. We also discussed in class what
can be patented (basically anything made by man). While the previous two
patents protected methods (or processes), this patent protects both a product
(a container with the medium) and a method (generating a beam of radiation).
Here, what is different is that the beam of radiation has different first and
second intensities and thus the two lines are scanned at different intensities.
This is useful for large and complex objects, because the laser can be directed
over portions of the material without curing a significant amount.
A patent that I am
interested in is expiring June 2nd of this year. This patent (No.
5,503,785) protects a process for
producing 3D objects having overhanging fragments freely suspended in space. I
believe that once this patent expires, many others will come into the market,
since it is a huge space.
The article
concluded by saying that it is unknown "when the major battles of the 3D
Printing Patent Wars will begin. New laws, evolving technology, and an
unpredictable economy might affect 3D printing more than any of these patents.
Thus, if would be imprudent to say that the expiration of one or more of them
is the key to growth because the market can dictate otherwise."[1]
Saturday, March 1, 2014
Assignment 5, Blog Post 2: Patent War in Pharmaceutical Industry
Since I find the
patent wars in the pharmaceutical industry particularly interesting, I decided
to focus on that topic this week. I find patents on drugs interesting due to
the huge amount of funding and time needed to even get a drug into market.
According to forbes.com, the average cost of bringing a new drug to market is
$1.3 billion. To put this price in perspective, 1.3 billion dollars would allow
a person to buy 371 Super Bowl ads, 16 million official NFL footballs, two
pro-football stadiums, almost all NFL football player's salaries, and every
seat in the NFL stadium for six weeks in a row.
The drug developed by major pharmaceutical companies costs between $4
billion to $ 11 billion.[2]
This is an example
of patent war with another popular company in the Bay Area-- Bayer, which has a
manufacturing center located in Emeryville (although its headquarters is in
Germany). Bayer was battling Pharma Dynamics, a Cape Town- based generic drug maker.
I learned that Bayer is called the "evergreening" of pharmaceutical
patents, meaning that they make small changes to existing products in order to
extend their patent protection and keep makers of cheaper generics out of the
market.
On March 2011,
Pharma Dynamics obtained registration from Medicines Control Council (MCC) for
Ruby, a contraceptive drug. Ruby was a generic version of Yasmin, a drug that
was still under patent protection by Bayer. Pharma Dynamics believed that the
Yasmin patent, which was granted in 2004, was invalid and applied to revoke the
patent, after obtaining approval from the Medicines Control Council (MCC) to
sell Ruby. The company claimed that "the Yasmin patent lacked 'novelty'
and 'inventiveness' because Bayer had already patented the product in
1990." This would mean that the patent expired in 2010, since the standard
practice, followed internationally, calls for 20-year protection. This 20-year
period is set to allow the inventor to compensate for their investment and make
a profit before other competitors can copy them. The business development
director of Pharma Dynamics', Tommy Scott, said that the company waited for the
Yasmin patent to expire, and wasn't aware of the second patent issued in 1999.
Bayer claimed that this patent was original, because it contained an active
ingredient that allowed the drug to dissolve faster.
It seems that there
have been growing patent disputes in many developing countries, as companies
try to bring down the cost of medicine by promoting generic versions, normally
termed "incremental innovation" by research-based companies. Competitors
argue that by doing this (filing several patents on discoveries made years
ago), the original inventors limit competition.
Assignment 5, Blog Post 1: Patent War in Pharmaceutical Industry
Genzyme Corporation
is a company based in Cambridge Massachusetts, and Genentech (which many of you
probably have heard about) is headquartered right here in the bay area in South
San Francisco. These two companies filed lawsuits against each other over a
clot-breaking agent for heart attack patients.
Genzyme had a 1994
patent for a chemical produced through genetic engineering of DNA. The company
claimed that Genentech's TNKase "clot-busting" product infringed this
patent. This dispute was mainly focused
on "whether payments were due under a license Genzyme had granted to
Genentech" according to William Marsden Jr., the Genzyme lawyer.
Genentech then sued
back in 2001, asserting that the technology they use is different, hoping that
the court would rule that the patent didn't cover the product or that the
patent was invalid.
Here is another similar case with a different drug (t-PA) that I found even more interesting: Toboyo is a four
billion dollar textile and pharmaceutical maker, which is involved in making
the t-PA drug, under license from Genzyme. In late 1991, Osaka District court
bailiffs decided to confiscate the drug at the Toyobo plant in Japan, because
Toyobo's sale infringed Genentech's Japanese patent. What I find extremely
interesting about this case, especially from a patent's perspective, is that
"Royalties from the drug's sales in Japan were not expected to make major
contributions to revenues at either Genentech or Genzyme, but the case was
called significant because of its implications for patents in Japan…[for] the
case was the first seizure of a product by Japanese authorities to protect a
biotechnology patent". G Kirk Raab,
the Chief executive of Genentech, said that "It's a strong affirmation on
the part of Japan's judicial system. It says to the biotech industry that
strong patents will be supported by Japanese courts". Unfortunately, this
decision was bad news for Toboyo, because t-PA was one of Toboyo's first major
pharmaceutical and the company had invested in establishing production
processes and marketing scheme for t-PA.
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