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Biotech and Bilski

BIO, the Biotechnology Industry Organization, filed an amicus brief  last Thursday asking the Supreme Court to overturn the Federal Circuit decision in Bilski v. Doll, a decision which created the "machine-or-transformation" test in which a method or process is only patentable if it is tied to a machine or if it transforms an article or substance into something different.

BIO joins many other industries who have voiced concerns about the uncertainty of the MOT test as applied to their technologies.  For the biotech industry, BIO points out how biological, diagnostic, and other medicinal method patents could be challenged by the MOT test resulting in negative impacts on the biotech industry.

 A key concern is that investors will shy away from the industry due to a lack of confidence in biotech patents as a vehicle for recouping research and development costs. Developing products in the biotech industry is an expensive and lengthy process often involving scientific research, clinical trials, and regulatory approval.  Without strong, enforceable patent rights, it is doubtful the industry could survive and innovation would be stifled.

Clarification on the issues presented in Bilski is certainly warranted in regard to biotech IP.  The MOT test does not seem to translate well into the biotech area.  For example, the natural phenomena utilized to produce biotech patents are not analagous to the abstract ideas utilized to produce business method patents.  A distinction cannot easily be made between patentable and nonpatentable subject matter in biotech by requiring a machine or transformation.  Photosynthesis is a process that could pass the MOT as it transforms carbon dioxide, but should not be patentable as it is a natural occuring process.  But by the same test, a diagnostic method would be deemed unpatentable if it does not incorporate a machine or if the patient is not "transformed." For biotech, a better test would better focus on whether something is a man-made biological process or a naturally occuring biological process.

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The Case for Software Patents

The Supreme Court recently granted cert in Bilski v. Doll, which most believe will change the test for patentable subject matter. Supreme Court precedent has carved out three exceptions to patentability under 35 U.S.C. § 101, these are laws of nature, physical phenomena, and abstract ideas. The quintessential law of nature is Einstein’s famous formula: e=mc^2, which is unpatentable subject matter. A patent cannot be granted that merely states this equation, as it would preempt all uses of the formula. What can -and has- been patented is the application and use of equations, for instance the Arrhenius equation in Diamond v. Diehr.

Computers and their applications have changed the world we live in. Many problems are solved by the use of the computer, from communication to commerce, and from filing your taxes to putting a man on the moon. Computers have taken over many tasks such as running your car to running voting booths. Since their creation there has been a melding of hardware and software to accomplish these goals. Many problems that computers can solve can be handled on both the hardware and software levels. Much of the power in today’s general purpose computers is that we do not need specialized hardware to perform specialized tasks. Methods that can be used to solve difficult problems thus can be solved similarly at both the hardware and software levels and so protection for one without protection for the other is meaningless. Especially since the use of these methods on a general purpose computer could require no additional hardware to perform the needed functionality.

I do not want to discuss the anti-competitive effects of patents generally, or to software patents in particular. I have not studied these in depth but will note that since software patents have been granted the United States has continued to be a hotbed for innovation in software industries having many of the largest software firms around the world. But, I also understand that software is special, there exists a vibrant open source community unlike any other field which is willing to innovate without the need for financial incentive and exclusive rights.

A problem that some have with software is that it is merely an algorithm for performing some task. And, that any task performed on a computer can be performed by a person with a pen and paper, given enough time. I both agree and disagree with that argument, as fundamentally it is correct but I believe that it is an oversimplification of what software does. Simple algorithms like converting a number from decimal to binary and back (as seen in Gottschalk v. Benson) can easily be done using either means. But, what about all those applications that are for computer specific purposes that doing them by hand does not solve the actual problem?

For instance, public key encryption such as RSA was developed as a way to securely encrypt data without first requiring the parties to have created a key to decrypt their communications. Performing the operations by hand or in our mind does not actually solve the problem where it exists, for performing operations on the internet and with computer systems. By limiting the technology to a computer (in a patent’s claims), it does not preempt uses of the algorithm in the mind or on paper, just the method’s use on the machine. This is akin to patenting a new use for a drug. Even though the drug itself may be in the public domain, this new use may be patented. Additionally, there are algorithms that make no sense without a computer system. Programs such as sending email or instant messages have no purpose without interfacing with additional hardware. For this technology to make sense, you must use additional hardware and practicing these algorithms without the use of a computer is pointless.

Software merely makes use of public domain formulas and applies them, just like traditional mechanical inventions. Take a chair for instance. It works by applying the standard laws of physics. Using a computer, or a pen and paper, the chair could be “proven” to work as well, just as a piece of software can be and just as large scale buildings and bridges are. All inventions, mechanical or software based draw upon fundamental principals that themselves are not patentable, but by applying them to solve a problem we move beyond the abstract and into the spectrum of patentability.

Novelty and obviousness also cloud the picture. When we look at the wide spectrum of patentability we see things that immediately make us cringe. Most of the things that make us cringe are because the inventions that we see on this spectrum have been done before. While difficult, it is imperative to separate patentable subject matter from fulfilling all the requirements of patentability, including §§ 102 and 103. Many of the problems that people have with the patenting of software is that the inventions are in the prior art. In this regard, the piece of technology should not be patented, but the class of technology may very fall within the prior art. I see this frequently when discussing patents like the infamous Amazon “1-Click” patent. Most who find that this patent should be invalid think that the technology is obvious.

The patent system is our way of protecting innovation. As we do not know where the next class of innovation is, or how expensive it will be to develop, we should not look to limiting the scope of patentability. Expansive scope has been a cornerstone of our system of patents and enabled the United States to have many technological advances. While not perfect, the patent system is a good trade off of exclusive rights for innovation.


A Gruesome Parade of Horribles Update

Here is an article on point from

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Patent Drafting: should highly technical language require a translation?

Part of my law school experience is to assist in mining patents and categorizing them into topics.   I have the most difficult time 1) searching for relevant patents, 2) wading through the search results to confirm relevancy, and 3) categorizing said patents based on keywords.    I can appreciate why patent landscape analysis is farmed out to specialized firms.

The biggest issue when searching for relevant patents, or even simply reading a patent to determine its scope,  is how patents are drafted. Patent drafters are increasingly coming up with creative (or shady) ways to claim subject matter to ensure broad protection, overcome prior art or avoid 101 rejection.   This is how a "vaccine" becomes an "immunological composition for treating and preventing a disease selected from the group consisting of yada, yada, and yada."   This is also how it becomes difficult to recognize a relevant patent in a landscape when one is searching for vaccine patents and ends up missing all of the immunological compositions.

Surely a patent applicant can become his/her own "lexicographer" (or lexinographer if you want to play that game) but it seems a patent can be drafted around this or that to the point of absurdity.  Of course, one could look to the specification to define the terms in the claims, but from a patent searching perspective, that is not a cost effective strategy.

This seems to become more of an issue in highly technical fields where word substitutions are not intuitive to the nontechnical person.  Certainly, in a mechanical patent, the word "fastener' in  a claim could understandably be substituted for nail or screw.  But is it so obvious to the lay person that "an epitope binding ligand" is synonymous with "antibody?" I don't even want to get into the frustration of decoding that particular example because it actually translates to "a something that attracts antibodies to bind binding binder."

Perhaps technical terms are inherently specific and the only way to broaden them or strategize with them is to make them obscure.  And the solution to this obscurity is for the reader of the patent to become more versed in the art of such obscurity in order to understand what a patent is claiming?  I don't know. Maybe there should just be a thesaurus of synonyms for commonly used words in a specific technical field that could be consulted.  I know that the Word thesaurus has made me a more creative wordsmith.

Here are some fun terms that could define a vaccine: "a prophylactic," "a therapeutic," "an immunological preparation," "a compound for eliciting immune response," "a compound for eliciting neutralizing antibodies," "a polyvalent composition," "a conjugate."

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A Gruesome Parade of Horribles? Patenting DNA

Here is an interesting article covering the issues involved in patenting biological material.

It's been almost 30 years since Diamond v. Chakrabarty, where the U.S. Supreme Court held that genetically engineered bacteria were patentable subject matter, and there is still controversy surrounding the patenting of genes, gene fragments, proteins and genetically modified material.

The main issues involve an ideology that science and scientific research should be 'free' and 'open' to facilitate progress in research and innovation, which conflicts with the practical reality that scientific research has become a business and a key component in the US economy that needs the protection the patent system offers to ensure success.

One of the arguments in support of patenting in this area is that patent rights are a way to ensure that an entity can either court or recoup  investment in research and development of necessary biotechnology.  Science is complex, expensive, and often unrewarding. Viewing biotechnology and the science behind it in a pure, ivory tower sense, where patenting should have no place, is naive at best and painfully ignorant at worst.  Science, like art, has always thrived on patronage and legal protection.  It is human nature to profit on all forms of creativity one way or another.

However, that legal rights and money are attached to innovation should not take away from the noble aspects of the work and progresses made in the scientific field. At its heart, scientific research is about understanding our world and making our lives better because of that understanding.

Aside from the main issues, there is the question of patentable subject matter that seems to be yet unresolved in the genetics arena.   It is important that the patent system respect the science behind the inventions sought to be patented if there is to be any confidence in the system or in the technology. Certainly, a gene or protein manufactured in a laboratory setting does not occur in nature and could thus meet the standard.  However, there seem to be problems  with how the PTO is dealing with genetic patents.  Specifically, it is troubling  that many patents are sought on DNA fragments whose function remains unknown.

There is still much that isn't understood about DNA and genes and it is essential that all those involved in gene patenting be educated to protect the integrity of DNA science and the biotechnology industry before either rushing to grant these patents or to condemn them.

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