In my post of May 6, 2011, I discussed the facts in some detail in this controversial Fed. Cir. decision (611 F.3d 1381 (Fed. Cir. 2010) and concluded that the majority of the Fed. Cir. got this one wrong – the court voted 5-4 to deny rehearing en banc. Although Lilly had prosecution strategies available that would have avoided invalidation of their patent on a newly discovered use of gemcitabine, Lilly picked the wrong one. All practitioners should re-read this decision so as to not fall into the same trap. Ironically, this is an appeal in which Supreme Court review likely would have helped the patent system.
Posts Tagged ‘Lilly’
Supreme Court Denies Cert. In Lilly V. Sun
Tuesday, May 17th, 2011Happy Birthday Patents4Life – We Are 2!
Thursday, March 3rd, 2011
Well almost. The first posts on Patents4Life were dated March 24, 2009. One was on a fairly obscure decision, SRI International (the prior art effect of internet postings), but the other two were on the Fed. Cir.’s summary affirmance of the district court’s finding of invalidity in Classen (applying Bilski as they saw it) and on the Board’s decision ex parte Kubin (that went on to invalidate a DNA patent as obvious to try in the wake of KSR). These decisions were just the first ripples of the tidal wave of judicial decisions at all levels that have limited the scope of patent protection. While the Supreme Court in Festo facially rejected the absolute bar to the application of the doctrine of equivalents endorsed by the Fed. Cir., no one would have picked it as the high water mark of pro-patent case law in our time. The presumptive surrender of access to the DOE has proven daunting to the use of the DOE in practice. But compared to most of the later decisions on central issues of patent law, Festo looks like a beacon of hope. If you have been reading this blog (or any number of others) over the last two years, the number of “anti-patent” decisions that have been handed down is simply overwhelming.
Now some of them are not yet carved in judicial stone, being at various stages of appeal, but the sum of KSR, Bilski (well, I guess it was more pro-patent than the strict M or T test it replaced with a test yet-to-be-determined), Ariad v. Lilly (WDR grows up), Lilly v. Sun,(broadened base for obviousness-type double patenting), Centocor v. Abbott (WDR rules), Microsoft v. i4i (lower evidentiary bar to patent invalidation), Janssen v. Teva (no utility for hypothetical bioactivity), Stanford v. Roche (weakens Bayh-Dole Act), Myriad (DNA and diagnostics are natural phenomena), Therasense v Becton Dickinson (more ways than ever to show inequitable conduct), and the WARF stem cell reexamination (WARF lost at the Board) do not bode well for the system Jefferson hoped would help modernize the young republic. The only bright spot on this judicial trial of tears was the Fed. Cir.’s affirmance in Prometheus v. Mayo in December that methods of medical treatment and monitoring past muster under Bilski. And yet, even this modest decision may be reconsidered by the Supreme Court.
Still, the last time the full court addressed the issue of patentable subject matter was in 2001 in Pioneer v. JEM Ag Supply, in which the patent eligibility of plants was affirmed, and the Court refused to back down from Chakrabarty. The issuance of the Chakrabarty patent was 30 years ago this month and most would agree that granting biotech patents has done our society a lot more good than it has rained evil upon us. Except, perhaps for the folks who are trying to block Obama’s order permitting funding for stem cell research. Or the Myriad plaintiffs. But they are in the minority. Aren’t they?
Centocor v. Abbott Labs. – “Antibody Exception” To Written Description Requirement Under Fire
Monday, March 29th, 2010Abbott Laboratories markets a recombinant human antibody, HUMIRA, as a treatment for rheumatoid arthritis. This antibody binds to a receptor on TNF. NYU and Centocor own US Pat No 7070775 which claims an isolated recombinant anti-TNF-a antibody (Ab) comprising a human constant region, where said Ab competitively inhibit binding of the mouse A2 antibody to human TNF-a and binds to a neutralizing epitope of human TNF-a in vivo with the recited affinity. The A2 mouse antibody is the only species disclosed in the specification, and is not the subject of claim 1.
The string of 13 patent applications that yielded this patent began with an application filed in 1991. The ‘775 patent issued in 2006 and Centocor sued Abbott for infringement. The district court denied Abbott’s motion for JMOL that the specification of the ‘775 patent failed to meet the written description requirement of s.112, and Abbott has appealed to the Federal Circuit. Centocor v. Abbott Labs., No. 2:07CV139-TJW, 2009 U.S. Dist. Lexis 102427 (E.D. Tex. Nov. 4, 2009).
A little bit of history. As pointed out by Lilly in its Amicus Brief supporting Abbott (a PDF is provided at the end of this posting), after years of R&D, antibody-based therapies have come of age: “Rapid growth in the field of antibody research has led to the introduction of nineteen monoclonal antibody [MCA] drugs into the U.S. market since 1994, while only one such MCA drug was approved by the FDA prior to 1994.” When I started prosecuting biotech applications in the early 80’s, MCAs were seen primarily as “research tools,” that might have value in diagnostic assays. If a researcher discovered a new polypeptide that might be useful as a disease marker, broad claims were routinely allowed by the PTO, e.g.: “A purified antibody which specifically reacts with protein x [a possible marker for, e.g., prostate cancer], wherein said antibody does not significantly react with prostate specific antigen.” Put simply, if you knew the structure of the antigen, you could get a claim to any antibody that bound to that antigen. In fact, if you could get a claim to the antigen, the antibody claims pretty much got tossed in gratis. Maybe we have the legal death of In re Durden in 1995 to “blame” for this, but that is a story for another day.
A Look Back at the Roots of the Thorny WDR Problem
Monday, December 7th, 2009As the date for oral argument looms in Ariad v. Lilly, as does an en banc decision as to the existence and/or the role of the written description requirement (WDR) in Section 112, I thought it would be worthwhile to re-visit an article I published in the April 2003 issue of JPTOS. (A copy can be found at the end of this posting.) Please read the concluding part of this article in view of my posts on this site of August 24, 2009 and May 5, 2009. The article is entitled “Do-Over! — The Federal Circuit Takes a Second Look at Enzo v. Gen-Probe.”
Put simply, the debate within the Federal Circuit is between the Judges who want to return the WDR to its role in settling priority disputes, and the Judges who want the WDR to ensure that the specification demonstrates that the inventors had “adequate possession” of the invention – to do something more than simply teach the interested public how to make and use the invention. Even a disclosure of actual reduction to practice (e.g., of actual possession), is not, per se, sufficient for this group. (“While ‘possession’ is a relevant factor in determining whether an invention is described, it is only a criterion for satisfying the statutory written description requirement. Showing possession is not necessarily equivalent to providing a written description.”) The specification must also permit the art to “visualize or recognize the identity of the subject matter of the claim.” Enzo I, 285 F.3d at 1018.
Thus, in late 2002, the legal battle lines are sharply drawn. One camp of Judges, led by Judge Rader, believes that the WDR is no more than a semantic test for the “right to use” the claim language in question. If the claim language is supported by the specification, the WDR is satisfied. Enablement is a separate issue that is to be resolved by application of the very fact-specific Wands factors. In re Wands, 858 F.2d 731 (Fed. Cir. 1988). These eight factors, used for determining whether or not the enablement requirement is met, include the nature of the invention, the breadth of the claims, the level of ordinary skill in the art, the level of predictability in the art and the existence of working examples. See also M.P.E.P. 2164.01(a) (8th ed. 2001). The camp led by Judge Lourie expects a lot more from the WDR; along with the enablement requirement, it now imparts or denies the “right to claim” the invention at issue. That is nearly as equitable a mission as that assigned to the doctrine of equivalents.
The WDR is evolving one fact situation at a time, and without en banc review, entire classes of patents will move in and out of its invalidity shadow. Two hypothetical fact patterns may serve to illustrate the uncertainties in the current WDR. In the first, an inventor isolates a new protein, factor X, from liver cells. The inventor knows nothing about the structure, or even the class of protein, such as an enzyme or a hormone, only that it is not an antibody. However, the protein binds to a receptor site on prostate cancer cells and blocks their division completely. If the inventor files at this point, the court is presented with actual possession and purely functional claiming. If the inventor deposits some of factor X, a step usually not taken with a pure chemical compound, the claim to “factor X” and its functional language could presumably be within the Enzo safe harbor. The American Type Culture Collection does not list “proteins” as materials it will accept for deposit. If the inventor fails to deposit prior to issuance, the specification would not meet the WDR, the claims would be invalid, and a continuation-in-part fully characterizing factor X would not be entitled to the filing date of the parent, since the description of factor X in the parent would not meet the requirements of Section 112. 35 U.S.C. Section 120.
In the second hypothetical case, an inventor uses computational chemistry to identify consensus sequences that are responsible for the enzymatic activity of a protein encoded by a series of related plant genes. The software developed by the inventor then “mixes and matches” the consensus sequences on the inert peptidyl framework to optimize the bioactivity of the enzyme, arriving at a genus of hypothetical high-activity enzymes, all defined by complete sequences. If the inventor files at this point, with adequate directions as to how to assemble the synthetic enzymes, he has produced a presumably enabling specification with complete structural data, but with no actual reduction to practice whatsoever. Is this an example of a specification that should fail the heightened WDR, or one that should meet the precise definition test of the new WDR? Do we need more than the Wands factors to evaluate the ability of the specification to place the invention in the hands of the public? Should this inventor, who never walked into a laboratory receive a patent, while the inventor of factor X be left with nothing but the satisfaction of curing cancer?
If factor X is an antibody, and the target is known, perhaps binding affinity language would meet the WDR. But what if it is a hormone, or a small molecule, or an “anti-inflammatory steroid,” an example of inadequate description given by the Enzo II panel? And is it really the best use of the court’s time to resolve endless fact situations on the basis of five words in the statute that provide no guidance whatsoever as to what they require, beyond some degree of correspondence between the specification and the claims? With the clearly articulated division of opinions within the court, the fate of any patent appealed from a WDR decision below will depend entirely on the panel that appellant draws. Whether or not the interested public all agree with the Wands requirements, they have proved to be a workable test for meeting the make-and-use requirement of Section 112. It is time for the court to deliver Lilly and Enzo (I) to the doctrinal scrap heap where holdings like Durden and Druey ended up, and let the evolution of biotechnology patent law continue in a productive direction. However, we all know that “bad facts make bad law,” and I don’t see how Ariad will be able to move WDR jurisprudence in a direction that will favor patenting early-stage biotechnology.
