In Re Roslin Institute, the U.S. Court of Appeals delivered a potential setback to the biotechnology industry when it confirmed that inventions which are identical to those found in nature cannot be patented. Specifically, it denied patent protection to products of the somatic cloning process invented by Campbell and Wilmut, which included Dolly the Sheep. Since Dolly possesses identical DNA to her somatic donor, she falls under the “natural phenomena” exception to patent eligibility. The applicant’s counter-arguments, including those that identified other differences between Dolly and her donor, were not considered by the court as they were not claimed in the original patent.
The Issue
The dispute in this case is not the somatic cloning process, which involves implanting the nucleus of a somatic cell into an enucleated oocyte. This process has been successfully patented (Patent No 7,514,258) in the past. The issue is with the No. 09/225,233 Patent Application (“233 application”), which involves the products of the cloning method, which include sheep, cattle, pigs, and goats.
Under 35 USC § 101, a patent can be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” However, there are three exceptions –a patent cannot be obtained for abstract ideas, laws of nature, and natural phenomena. The court ruled that the 233 application falls under this last exception.
Concerns for Novelty – Creation or Discovery?
In this case, Dolly possesses identical genetic information as the sheep from which the somatic cell is taken. Since that sheep is a natural animal, then Dolly is a naturally occurring organism that cannot be patented.
There are two main arguments for upholding the natural phenomena exception. First, an identical innovation to nature is not novel [1]. The potential inventor did not create an innovation, but merely discovered what already exists.
I think this statement implies that this type of “discovery” involves less creative effort and skills than the creation of other types of innovations. However, as stated by Mr. Quinn (patent attorney and founder of IPWatchdog, Inc.), it is significantly more difficult to create a perfect product resembling nature than an imperfect product which does not resemble nature.
Denying Patents to Support Innovation – Securing Basic Research Tools
The second justification is that basic research tools (e.g. proton accelerators, compound microscopes) [2] must be kept in the public domain so that inventors can draw upon them in creating innovations. In Brenner, the Court stated that the patent system should not result in a “monopoly of knowledge” over tools that may “block off whole areas of scientific development”. More recently, in Funk Bros., the Court denied patent application of a set of bacteria strains because they are “manifestations of laws of nature, free to all men and reserved exclusively to none”.
Although it is true that any patent would deprive the public of potential research tools, the distinction that the Courts drew between successful patents and natural phenomena is one of scope. The former prevents the public from accessing narrow and particularized information whereas the latter deprive the public of a broad range of knowledge [3].
Also, it is irrelevant whether the research tool involved in the patent application is known at the time of application. In Gottschalk, the Court denied patent protection to an algorithm, and stated that even if the algorithm was unknown at the time (thus making it novel?), it will be treated as an existing prior art because it is fundamental for future research.
One Exception Fits All?
I agree that there are merits to the natural phenomena exception, but I disagree that it should be applied to every field of invention, especially cloning and personal medicine. In this case, since the process of cloning Dolly is already patented, it is doubtful that valuable research tools can be derived from the products of somatic cloning.
More significantly, the purpose of cloning is to create organs, genes, organisms, and other products that are identical to nature so they can be used for organ transplantation, research, and other important medical purposes. Blocking patent protection for those products will turn investors away from biotechnology and consequently discourage innovations in this crucial field.
Conclusion
The U.S. Court of Appeals appears to have applied the natural phenomena exception to patent applications consistently and absolutely. To some it may seem counter-intuitive that an invention perfectly replicating nature may not be patentable, when an imperfect invention different than nature might be, especially when there is a significant degree of creativity and effort in replicating nature exactly. While there are good reasons for the natural phenomena exception, it might be time to reconsider it where the benefits can be argued to outweigh the costs.
Sabrina Ding is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.
[1] Peter Lee, “Inverting the Logic of Scientific Discovery: Applying Common Law Patentable Subject Matter Doctrine to Constrain Patents on Biotechnology Research Tools” (2005) 19 Harv JL & Tech 101.
[2] Supra note 1 at 81.
[3] Supra note 1 at 105.
One Response
It is important to note that although duplication may be painstakingly laborious or undoubtedly useful, the patent system is simply not set up to reward the “sweat of the brow” and novelty objections in fact scenarios akin to Re Roslin are fairly strong. However, in this case the court clearly stated that genetic duplication is not itself a bar to patentability and confirmed that a clone with properly claimed differences from its donor can be patentable. As we saw in Re Roslin, although the patentee explained differences between their clones and the donor animals, these differences were unclaimed. This case may ultimately be best characterized as a lesson in effective claims drafting, and this sentiment should lessen the fear that this particular decision will have a chilling effect on future innovation in biotechnology and personalized medicine.
The Re Roslin facts would undoubtedly produce a different judgement in Canada, as Harvard College v. Canada set out fairly clearly that multicellular “higher life forms” are not patentable (although like Re Roslin held process claims valid). However, the practical significance of Harvard College may be questionable due to the Monsanto Canada. v. Schmeiser decision which considered the use of an unpatentable higher life form to constitute patent infringement because it contained patented genetic alterations. Although there is often concern regarding the patentability determination in industries such as biotechnology, it seems apparent that through the services of a good patent agent, adequate patent protection can ultimately be obtained for inventions that utilize living organisms.