The Human Genome is OURS not theirs:
Gene Patents Should be Void on their Face
Let us say, prior to our comments about In re Kubin, that we think that gene patents should be void and voided by legislation as a matter of public policy, including all gene patents thus far granted.
The very idea that any component of the human body can be patented is absurd and shows how far away from its legitimate foundations the patent law has come in the modern era.
The Constitution of the United States never intended that human genes – or any genetic sequence of them – be patentable – for any reason. No stretch of the language or the intentions of the American Founders can possibly make a gene sequence a human invention worthy of patent protection – a monopoly provided at taxpayer cost for the benefit of the greedy few.
Pharmaceutical viz. biotech companies get richer and richer, and there is good reason for this. Patents – justifiably or unjustifiably granted – provide the pharmaceutical industry with a host of government-sponsored monopolies that lead to spectacular profits and raise the cost of health care to astronomical levels for all citizens. In a world where the average age of the population in the countries of Western Civilization has reached unprecedented levels, controversial patent policies which grant patents where they need not be granted and which lead to expensive and unnecessary burdens on the health care system should be cast aside as inimical to the common weal (see also).
Patents in the area of biotechnology have scarcely anything to do with “invention”. For example, gene sequences ALREADY exist in nature and NATURE itself is the prior art. No researcher invents a “code” when he or she “decodes” a gene sequence and once a protein is known, that decoding is for the most part simple technical routine that any versed lab assistant can carry out in a trial and error process. Nothing is actually being invented.
On the other hand, what genetic and biotech patents DO have a great deal to do with, is less science and more MONEY. There is a constant battle between researchers, pharmaceutical and biotech companies and those affiliated with them for the gigantic windfall profits which stem from monopolies granted to them via patent protection from patent offices.
In re Kubin is a great example of the gold rush mentality prevalent in this field.
In re Kubin : Enough is Enough : Establishing Sensible Limits to Biotech Patents
The Federal Circuit will soon decide the appeal in the gene sequence patent case In re Kubin (oral arguments were held on January 8, 2009).
As Kevin E. Noonan observes at Patent Docs regarding the oral arguments in In re Kubin:
“Judge Friedman … set forth some background information, asking for a brief synopsis of what the patent applicants were trying to do. [Ms. Rudolph] responded by explaining the underlying immunology of natural killer (NK) cells. In response to renewed questioning from Judge Rader, that the prior art Valiante reference “taught p38 which is NAIL” (the subject matter of the Kubin application was a cDNA encoding human NAIL), she reminded the Court that what Valiante disclosed was “a band on a gel,” i.e., that the Valiante patent disclosed an antibody immunologically reactive to p38, and therefore, that Valiante did not disclose purified p38, but merely its detection on a Western blot (where it would be expected to be in the presence of a multiplicity of other proteins).“
The essential facts and issues of In re Kubin are found online best explained at Coping with Kubin by Kristina Caggiano at PharmaExec.com, where she even includes adaptation strategies for lawyers and law firms for the new legal circumstances. Holman’s Biotech IP Blog has a good technical overview, which in our opinion, however, is too biased on the side of patent protection.
In the case itself, the existence of a protein (P38) on the surface of NK cells and the method of recognition of that protein had already been previously discovered by others. That is the prior art. What the patent claimant had done was to decode this protein, a standard procedure in this field, if also sometimes requiring a time-consuming trial-and-error process, and a task often assigned to lab assistants in the laboratory. The task can be tedious, but it is not what anyone would call “inventive”.
Is that decoding a patentable invention? In fact, the patent claimant did not restrict itself to the decoded nucleotide (of which there can be hundreds of millions in a single DNA strand of the human organism) but sought a patent for the entire genus of similar polynucleotides, a gigantic biotech “land grab” which is common in the patenting of so-called biotechnology “discoveries”.
A legal problem exists here therefore as regards patent enablement and description, to which also see Holman. Essentially, that legal doctrine means that you can patent YOUR mousetrap but not all other conceivable mousetraps, even those that are similar to yours. Courts still do not understand that you can patent YOUR physical invention, but not the idea incorporated in the invention. In fact, it is to the advantage of society that inventions breed imitation and improvement, which are at the root of all progress. Patent claims for entire genuses of things should thus be rejected as a matter of course by courts as spurious. Deterring high fines for such claims should be assessed against claimants. Patents should protect what has been invented (and produced as an invention), not what could be invented (or produced as an invention).
Kubin is a case which provides the Federal Circuit with a golden opportunity to put an end to the mass of biotech patent applications which have flooded the USPTO ever since their disastrous decision in In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), which the Harvard Law Review describes (in a note to In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005) as:
“the Federal Circuit’s heavily criticized decision in In re Deuel.”
In re Deuel : Armageddon for the USPTO
The majority opinion in Deuel is marked by Judge Alan David Lourie’s statement that: ““Obvious to try” has long been held not to constitute obviousness” in a decision holding that:
(1) combination of prior art reference teaching method of gene cloning, together with reference disclosing partial amino acid sequence for a protein that stimulated cell division, did not render claims prima facie obvious; (2) conceived method of preparing some unidentified DNA does not define it with precision necessary to render it obvious over protein it encodes; and (3) patent claims generically encompassing all DNA sequences encoding human and bovine proteins to stimulate cell division were not invalid as obvious.“
In our view of how the law should be, the Federal Circuit was wrong on all counts, as the Deuel decision led to an avalanche of patent applications that is still being felt today by a USPTO that has a backlog of over 1 million patent applications pending, and no end in sight.
As written at the Harvard Law Review case note cited above:
“Deuel held that, despite the existence of a known method for isolating a DNA sequence, obviousness is no bar to the patenting of a sequence as long as the precise nucleotides are not previously known. The ensuing “avalanche of patent applications on ESTs” led to the reinstatement of the requirement of substantial utility in the Utility Guidelines in 1999, but an overwhelming number of costly and complex applications continued to be filed. In addition, in 1997 the Federal Circuit appeared to be attempting to slow the flood of patents by distinguishing biotechnology from other chemical industries and holding, in Regents of the University of California v. Eli Lilly, that an adequate written description of a patent for a DNA sequence required the disclosure of the precise sequence of nucleotides. Although this requirement was seen as a means of delaying patent filing in some instances until the tedious task of sequencing was completed, it also meant that the patent would only cover the exact sequence disclosed. Together, these decisions created a field in which a large number of patents of very narrow scope would be available, inviting concerns that such a regime would produce “too many concurrent fragments of intellectual property rights in potential future products,” and thereby impede innovation in biotechnological research….“
[we go to the paragraph at the beginning of that same Harvard Law Review case discussion]
“The question of patenting expressed sequence tags (ESTs) was first raised in 1991 when Dr. J. Craig Venter of the National Institutes of Health (NIH) filed several applications for EST patents. Although the ensuing controversy ultimately prompted the NIH to withdraw its applications, private companies have since stepped in to lay claim to hundreds of thousands of ESTs. Recently, in In re Fisher, the Federal Circuit denied claims to ESTs by finding that, without knowledge of the function of the genes to which they correspond, their value as research tools did not rise to the level of patentable utility. When combined with policy considerations for furthering agricultural biotechnology, Fisher suggests that the identification of underlying gene function should be regarded as a necessary, but not sufficient, condition of utility.“
What is patentable subject matter and what is non-patentable due to obviousness?
Do recent court decisions deny the patent claims in In re Kubin?
The winds of change are blowing strongly in the direction of a substantial limitation of patents, especially in light of the sensible standards recently issued by the United States Supreme Court in KSR v. Teleflex, 550 U.S. 398 (2007) and by the Federal Circuit in In re Bilski, 545 F. 3d 843 (Fed. Cir. 2008)(en banc).
In KSR, the U.S. Supreme Court, in an opinion by Justice Kennedy for a unanimous court, held that “common sense” was the prevailing standard for obviousness and not some artificial formula, and that something which was “obvious to try” for “a person of ordinary skill in the relevant art” was “obvious” and thus non-patentable. In Bilski, the Federal Circuit, sitting en banc, in a 9-3 decision and via a majority opinion written by Chief Judge Michel, held that a business method which did not involve a machine process or a physical transformation was not patent-eligible subject matter.
KSR International v. Teleflex
In KSR International v. Teleflex, the U.S. Supreme Court overturned the Federal Circuit Court TSM tripartite test of “teaching-suggestion-motivation” to determine the obviousness of a patent. During oral arguments the TSM test was called “three imponderable nouns,” by U.S. Supreme Court Justice Antonin Scalia, who categorized the TSM test as “gobbledygook” and “irrational”, whereas Chief Justice John Roberts called it “Federal Circuit jargon” which was “worse than meaningless because it complicates the inquiry rather than focusing on the statute.”
As Tony Mauro of the Legal Times wrote at Law.com in Justices Slam Nation’s Patent System….:
“In surprisingly blunt terms, Supreme Court justices Tuesday made it crystal clear that they are upset with the nation’s patent system, the lawyers who litigate under it and the appeals court that referees it.
During a lively — bordering on raucous — hour of arguments on what makes an invention so obvious that it does not deserve a patent, justice after justice piled on criticism of the U.S. Court of Appeals for the Federal Circuit’s three-part “teaching-suggestion-motivation” test for determining obviousness, an issue that arises in virtually every patent application and appeal. The test has been criticized as too patent-friendly, resulting in a proliferation of junk patents that stifle competition.
“Three imponderable nouns,” is how Justice Antonin Scalia dismissed the test, also calling it “gobbledygook” for good measure.
Chief Justice John Roberts Jr. called it “Federal Circuit jargon” that is inflexible and “worse than meaningless.”
And when Justice Stephen Breyer said he had read the briefs in the case “15 times” and still could not understand the “motivation” prong of the test, Scalia chimed in, “Like Justice Breyer, I don’t understand.”
The implied message to the Federal Circuit seemed to be: If two of the brainier justices on the Supreme Court don’t have a clue what you are talking about, a new test might be in order.”
In fact, the U.S. Supreme Court threw out the TSM Test altogether.
KSR was applied soon thereafter by the Federal Circuit in Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007).
As noted by Mark Nowotarski at IPToday.com, the Board of Patent Appeals and Interferences is citing KSR in over 60% of its decisions relating to obviousness.
In re Bilski
The holding in Bilski is that patent protection does not extend to business methods which are not tied to a machine process or a physical transformation. This standard has since been applied in the life sciences in Classen Immunotherapies, Inc. v. Biogen IDEC et al. (Fed. Cir. Dec. 19, 2008), which is labeled as a “nonprecedential” disposition, a rather misleading label which attempts to make a nothing out of a something. The notice “This disposition is nonprecedential” should be dropped as contrary to reality. Every disposition has precedential effect on the world and on the subject parties, like it or not. Law does not exist in a vacuum nor can the doctrine of stare decisis be negated by labels. What is done, is done, and it lives on as done.
Bilski casts a possible shadow over In re Kubin since the decoding of a gene is not tied per se to a machine process nor is it a physical “transformation” of the gene. It is a mere method of revealing what is present anyway. Genetic decoding means only that the researcher knows in greater detail “what it is” and “where it is”, but the nucleotides remain unchanged. There is no machine process in the technical sense since the genes are not “processed” and nothing is transformed. All that has happened is that one has gained more knowledge – and the gaining of more knowledge is viz. should not be patentable.
We could understand the patenting of a specific drug that incorporates a proprietary type of method for producing its ingredients, but if these ingredients are genetic materials, then those materials themselves, including their genetic sequences, should be unpatentable per se.
What will the Federal Circuit decide in In re Kubin?
In our opinion, the Federal Circuit has no choice but to affirm the denial of the patent claimed.