Archive for April, 2009

IN SEARCH OF CHAKRABARTY, “NATURAL PHENOMENA” AND WHERE BILSKI WENT BAD, WITH A GLANCE BACK AT ARIAD.

Monday, April 27th, 2009

I was finishing up my recent comment on the reexamination proceedings involving the Baltimore et al. patent, when a fragment of one of the Office Actions caught my eye and stuck in my mind. The Examiner is trying to explain why inherent anticipation does not require recognition by the art of the underlying mechanism of action involved in, say, prior art reporting the bioactivity of a drug:

Similarly, theoretical mechanisms or rules of natural law that are recited in a claim, that themselves are not patentable, do not need to be recognized by one of ordinary skill in the art for a finding of inherency. A person of ordinary skill does not need to recognize that a method or structure behaves according to a law of nature in order to fully and effectively practice the method or structure. …EMI Group North America, Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342 (Fed. Cir. Sept. 21, 2001).
The EMI Court used the following hypothetical example to clarify this principle:
Humans lit fires for thousands of years before realizing that oxygen is necessary to create and maintain a flame. The first person to discover the necessity of making a fire by lighting a flame in the presence of oxygen could not have obtained a valid patent claim for “a method of making a fire by lighting a flame in the presence of oxygen.” …[U]nderstanding this law of nature would not give the discoverer a right to exclude others from practicing the prior art of making fires.

I think that this is an example of the hoary maxim: “That which literally infringes if later in time anticipates if earlier than the date of the invention”. Making fires would infringe a claim to lighting a flame in the presence of oxygen, but making fires preceded the discovery of oxygen’s role in flames and so would inherently anticipate the hypothetical claim the court discussed above.

Where the panel In re Bilski “went bad” happens early in the exhaustive opinion. In re Bilski, 545 F.3d 943 (Fed. Cir. 2008). Like Justice Breyer in his Lab. Corp. of Amer. Holdings dissent, the Fed. Cir. panel was struggling to define a “natural phenomena” or a “fundamental principle” in order to decide if the claims before them were unpatentable subject matter (along with “laws of nature and abstract ideas”. See Diamond v. Diehr, 450 U.S. 175 (1981)). Justice Breyer admitted that this has never been easy:

I concede that the category of non-patentable “phenomena of nature’ like the categories of “mental processes” and “abstract intellectual concepts,” is not easy to define. See Flook, …98 S. Ct. 2511 (“The line between a patentable ‘process’ and an unpatentable ‘principle’ is not always clear”)[Lab. Corps. of Amer. V. Metabolite Labs., 126 S. Ct. 2921, 2926 (2006)].

The Federal Circuit in Bilski saw the “line” but simply jumped over it, and then spent pages explaining why their legal short-cut was completely justified by precedent. Let’s review how they cut this corner:

The Court in Diehr thus drew a distinction between those claims that “seek to pre-empt the use of” a fundamental principle, on the one hand, and claims that seek only to foreclose others from using a particular application of the fundamental principle, on the other… Patents, by definition, grant the power to exclude others from practicing that which the patent claims. Diehr can be understood to suggest that whether or not a claim is drawn only to a fundamental principle is essentially an inquiry into the scope of that exclusion, i.e., whether the effect of allowing the claim would be to allow patentee to pre-empt substantially all uses of that fundamental principle. If so, the claim is not drawn to patent-eligible subject matter.

A few paragraphs later, the panel also admits that this inquiry can be difficult to resolve;

Unfortunately, this inquiry is hardly straightforward. How does one determine whether a given claim would pre-empt all uses of a fundamental principle?

Yes, that is the question, but it is never answered. In the next paragraph, one sentence later, the panel lays the issue to rest, with the dreaded test:

The Supreme Court, however, has enunciated a definitive test to determine whether a process claim is tailored narrowly enough to encompass only a particular principle rather than to pre-empt the principle itself. A claimed process is surely patent-eligible under s. 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.

This is a handy test, but it does not do justice to our obligation to wrestle with the larger questions and concepts we have been discussing. Let’s go back to the Ariad reexamination, which is much more interesting than the Fed. Cir. opinion that invalidated the claims based on insufficient description in the specification. I submit that the quote from the reexamination I presented above provides a workable test for deciding whether or not a process claim “pre-empt[s] the principle itself”. How about a test like this:

Claims are drawn to unpatentable natural phenomena would always be inherently or explicitly anticipated by fundamental natural phenomena.

Not elegant, but let’s test it out. In his Lab. Corps. dissent, Justice Breyer concedes that “many a patentable invention rests upon its inventor’s knowledge of natural phenomena; many ‘process’ patents seek to make abstract intellectual concepts workably concrete; and all conscious human action involves a mental process.”

Darn right! But two paragraphs later, the Justice starts out his opinion with “[t]here can be little doubt that the correlation between homcysteine and vitamin deficiency set forth in claim 13 is a “natural phenomenon.” No doubt? The claim in question must be a lot like the hypothetical claim discussed by the Ariad Examiner; allow it to stand, and we won’t be able to light a fire. Here is claim 13 of the Lab. Corps. patent:

A method for detecting a deficiency of cobalamine or folate in warm-blooded animals comprising the steps of:
Assaying a bodily fluid for an elevated level of total homocysteine; and
Correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamine or folate.

Well, this looks like a diagnostic assay that is a “product of human ingenuity” carried out by “the hand of man”, not like any universal or fundamental principle of nature. So what manifest law of nature, abstract idea or fundamental principle inherently anticipates this claim? It is a law of nature that animal blood has homocysteine in it. So a hypothetical unpatentable claim would be “Human blood comprising homocysteine”. But this “claim” would not anticipate claim 13 if it was prior art. Also, issuance of claim 14 would not permit patentee to collect a royalty from any person, simply because their blood must contain some homocysteine. Taking this analysis a bit further, let’s consider a claim to a natural internal relationship: “Human blood that comprises x amount of homocysteine and y amount of cobalamine.” This claim would not anticipate claim 13 either, and claim 13 could not be read to prohibit a person from having blood containing both substances. (This is why my proposed test is not circular; the claim is a constant and you test various principles or phenomena against it.)

Justice Breyer, I respectfully submit that nature may contain correlations but it does not analyze, much less correlate, anything. Nature doesn’t care if your homocysteine is low or high and what the consequences may befall you if it is too high or too low. Just like nature doesn’t care what your PSA level is, even though it
is certainly a natural phenomenon that men have PSA in their blood. But a claim: “Human blood containing PSA” does not anticipate a claim to a method of detecting prostate cancer by assaying blood for PSA and correlating an elevated PSA level to the presence of prostate cancer.” Good thing those patents have expired; they yielded workable life-saving tests before they faced invalidation.

The “human factor” is strangely absent from Bilski, but it is in almost every paragraph of Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), which affirmed the patentability of a “human-made microorganism” and effectively founded the biotech industry. The Justices spent a paragraph discussing precedent holding that “laws of nature, physical phenomena, and abstract ideas have been held not patentable….Such discoveries are ‘manifestations of … nature, free to all men and reserved exclusively to none.’”

But in 1980, these Justices took a different road than the one mapped in Justice Breyer’s dissent. In the next paragraph, they conclude that “[j]udged in this light, respondent’s micro-organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomena, but to a non-naturally occurring manufacture or composition of matter – a product of human ingenuity ‘having a distinctive name, character [and] use.”…His discovery is not nature’s handiwork, but his own; accordingly it is patentable under s. 101. I think it is no accident that Chakrabarty is not cited once in the main Bilski opinion, but it cited in both Newman’s and Rader’s dissents (“Natural laws and phenomena can never qualify for patent protection because they cannot be invented at all” 545 F.3d at 1013).

Of course I am aware that Chakrabarty addresses patentability of a composition of matter, not a process, but I submit that my test applies to both. Try it out. To close, I quote from Dennis v. Pitner, 106 F.2d 142 (7th Cir.1939). cert. denied 308 U.S. 606. The claims in suit were to an “extract of cube root” with a statement of intended use of it as an insecticide. Today, this would be considered a claim for a new use of a known compound. The court rebuffed the defendant’s argument that the claim was simply the “revelation of an existing law of nature”. In the formal language of the day, the court proceeded:

The discoveries that a cube root would act as an insecticide, that copper and iron when properly mixed in predetermined proportions [WARF v. Breon, 85 F.2d 166] would increase the red corpuscles in the human blood…necessitated the co-acting of two or more things. The insecticide needed the breath of an insect upon which the powdered cube root could act before it became an effective insecticide. The copper and iron mixture needed contact with the human blood before a change in red corpuscle count occurred. Seldom is there any discovery of a new phenomenon of an old chemical product that does not call for the old product’s contact with a material to which it must be applied by human agencies before the phenomenon occurs. In all such cases the discoverer is well outside of the rule which excludes the issuance of patents to those who have merely discovered a law or principle of nature or fundamental truth.

If a process carried out by “human agencies” is deemed somehow injurious to society (read “commerce”), Congress can, and has, legislated so as to protect the interested public. (We will consider patents on methods of conducting surgery in the future.) Please consider that precious few patent attorneys are even asked to write claims on fundamental principles of nature these days. They just don’t come along that often anymore. Cold fusion, anyone?

Patent Office Bats Down Ariad’s ‘Hail Mary Claims’ In Reexamination

Wednesday, April 22nd, 2009

In my earlier post on Ariad v Lilly, there is a detailed discussion of the Federal Circuit’s recent decision that invalidated all of the claims-in-suit for failure to meet the written description requirement. The Federal Circuit rejected Lilly’s attempts to establish inequitable conduct, in part based on the failure of Dr. Baldwin to submit papers he published on the mechanism-of-action of NF-kB after the effective filing date of the ‘516 patent. The panel stated: “Lilly did not show that Dr. Baldwin appreciated the inherent anticipation theory to which the references allegedly pertained.” I would like to spend a little time discussing the inherent anticipation theory and the meaning of the title of this post.

Two requests by third parties (Lilly and Merck?) for reexamination of the ‘516 patent were filed in 2005 and merged as reexamination no. 90/007,503 on May 4, 2006. The reexamination proceedings have continued since then, and the Patent Office has rejected every claim that Ariad has proposed as inherently anticipated by various references. Whether or not the parties will continue this reexamination in view of the verdict, the proceedings make it crystal clear that the Patent Office does not feel it needs to use section 112 to dispose of “mechanism of action” claims such as those that were in suit.

A composite dependant claim 80 was set forth in first my Ariad post. It is a good example of a “Hail Mary” claim, but so is claim 12, which is shorter:

12. A method for reducing the effects of bacterial infection on mammalian immune cells comprised reducing NF-kB activity in mammalian immune cells so as to reduce bacterial [LPS]-mediated stimulation of the immune cells.

Apart from section 112 issues, why do I call this a “Hail Mary claim”? In football, a “Hail Mary” pass is a long throw that the quarterback makes, usually in the last seconds of the game, hoping that one of his receivers, by some miracle, will be there to catch it.

A “Hail Mary claim” is a broad claim that a patent attorney proposes, usually containing broad functional language that, while presumed valid when and if issued, is vulnerable to attack due to non-prior art publications that explain why prior art publications in fact anticipate the claim.

There is no room here to more than begin to summarize the hundreds of pages of rejections, amendments and counterarguments presented by the requestor, patentees’ attorneys, and the Patent Office in the reexamination, but they have stayed focused on this “principle” since the first office action. Put another way, the Patent Office has asserted (and I think that they are correct under the prevailed precedent):

(A) Method claims whose only recited steps are altering biological mechanisms of action are invalid as anticipated, under principles of inherency, by a prior use of a biologically active compound that meets two requirements:
1. More than one year prior to the effective filing date of the claim at issue, an “old compound” was administered so as to treat a condition or achieve a result encompassed by the condition or result recited by the claim at issue; and
2. At any time, it is shown that the mechanism of action of the “old compound”, when used to treat the condition or achieve the result, is the mechanism of action recited in the claim.

To get back to the Ariad reexamination, claims 1 and 12 were found to be inherently anticipated by the 1970 Physicians’ Desk Reference, which provides detailed information about currently marketed drugs, taken with later, non-prior art publications, showing that certain drugs found in the PDR in fact work by inhibiting NF-kB. For, example, the Examiner cited the PDR as teaching the administration of antibiotics such as erythromycin to treat gram negative bacterial infections. The PDR, of course, did not mention NF-kB; it had not been discovered yet. Next, later-generated “intrinsic evidence” was cited to establish that, e.g., erythromycin inhibits LPS and NF-kB activation of cytokine expression (Yasutomi et al., J. Immunol., 175, 8069 (2005)). This is a case where an “inherent species” is anticipating a later generic claim “of vast scope,” to quote the Federal Circuit.

If this seems unfair, consider Eli Lilly & Co. v. Barr Labs., 251 F3d. 955 (Fed. Cir. 2001), where a claim to a method of blocking serotonin uptake by administration of fluoxetine was held to be inherently anticipated by a prior art claim to a method of treating anxiety by administering fluoxetine. The court stated that the later claim “simply describes the process by which fluoxetine hydrochloride physically acts on individuals who receive the drug.” Thus, the later claim does not represent a new use of an “old compound.” Consider that this decision has only been buttressed by more recent decisions relating to inherent anticipation, such as Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir 2003), which invalidated a claim to a metabolite of an “old drug” because evidence not in existence when the old drug and its use were patented showed that the metabolite formed in the patient’s body when the drug was ingested. This case has been cited by the Examiner throughout the reexamination proceedings for the principle that “inherent anticipation does not require a person of ordinary skill in the art to recognize the inherent disclosure in the prior art at the time the prior art was created.” Citing SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005), the Examiner has taken the position of the court that “what was actually done, or possible to do, in the prior art was “irrelevant since disclosure, not practice, is necessary for anticipation.” To make the Patent Office’s burden of rejected “Hail Mary” claims even lighter, the Examiner noted that the threshold “for enabling a prior art reference is lower for enablement under [section 112] required for a patented invention insofar that the prior art reference need not demonstrate efficacy or utility.”

Patentee’s attorneys’ counter-arguments have mostly involved the requirement for certainty in the art to support an inherency rejection and that the claims – that have been cancelled or amended to some extent – now contain claim elements not present in the prior art or the intrinsic evidence.

Section 112 issues aside, can the legal prayer of a “Hail Mary” claim ever be answered? I think the answer is a qualified “Yes.” What if a cellular signaling pathway – the mechanism of action – is associated with a condition untreatable with any agent prior to the effective filing date of the claims? For example, consider a claim to a method of halting progression of ALS by administering an agent that inhibits the induction of NF-kB in a mammalian subject. What if a third party discovers an effective “old drug” in 2008 and finds that it works by NF-kB inhibition? Now the claim would not be expressly or inherently anticipated, and there is no need to protect anything in the public domain. This analysis only works if the old drug was not tried prior to the effective filing date of the claim and if no drug that was tried in fact had any efficacy. Perhaps a really thorough search could answer both these questions. Perhaps.

In Search of University Patents

Monday, April 20th, 2009

Technology Transfer Tactics, in conjunction with FreePatentsOnline, has created a site (link below) which they state can allow the visitor to view all of a given university’s patents by just clicking on the name of the institution. However, while this is an interesting tool to get a snapshot of a university’s recent activity, it does not include “all of their patents, from the most recent to the oldest.” For example, clicking on the University of Minnesota (a client of SLW) shows 296 documents, mostly published patent applications, back to about 2002, plus some older reissues and plant patents. If you search for their in-force pharmaceutical patent U.S. Pat. No. 5,567,703, you can find it via FreePatentsOnline, but it is not listed as a University of Minnesota patent under “University of Minnesota.” Click on Iowa State and there are only eight patents that are not in the 7 million series; this does not comprise all of their unexpired patents. A more minor quibble is that many non-profit research institutions with substantial portfolios, such as RCT and Scripps, are not included. Also, it would have been helpful to show the legal name of the assignee of the patent documents, not just the popular name. A number of universities don’t have inventors, they simply assign applications to “The University of X,” or have changed the name of the entity that holds their patents. In summary, this is an interesting site to visit, but it is not ready for prime time analyses quite yet.

www.technologytransfertactics.com/university-patents
www.freepatentsonline.com
Technology Transfer Tactics Partners with Patents Online

Federal Circuit Throws a Wrench into “Mechanism of Action” Claims

Monday, April 13th, 2009

A three-judge panel of the Court of Appeals for the Federal Circuit recently decided Ariad Pharmaceuticals, Inc. et al. v. Eli Lilly & Company, appeal no. 2008-1248 (Fed. Cir. April 3, 2009), involving Blatimore et al. (U.S. Pat. No. 6,410,516). The “et al.” is M.I.T., The Whitehead Institute and Harvard University. Despite the impeccable scientific credentials of the inventors, that included two Nobel Prize winners, the panel reversed the district court’s denial of Lilly’s motion for JNOV of a jury verdict finding of validity and infringement of the claims in suit. A representative “composite” claim (80) reads as follows:

A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-kB-mediated intracellular signaling, the method comprising reducing NF-kB activity in the cells by reducing binding of NF-kB to NF-kB recognition sites on genes which are transcriptionally regulated by NF-kB, such that NF-kB-mediated effects on external influences are modified.

Claims 144-145 are similar but recite a more specific effect – that the method reduces bacterial LPS induced expression of cytokines in mammalian cells. Since Patents4Life began a few days before this decision, the reader is respectfully requested to refer to the helpful commentary in Nature/Biotechnology, 24, 737 (Jul 2006), in which I am extensively quoted.

The jury found that the drug Evista infringed claims 80 and 95 and that the drug Xigris infringed claims 144 and 145. The plaintiff’s victory was in jeopardy from the start, as the panel recited the principles of law controlling the written description requirement (WDR) of 35 U.S.C. 112 for three pages of the slip opinion. Lilly had argued that the claims are not supported by an adequate written description of the method, since the patent does not teach how to reduce the activity of NF-kB. The specification only disclosed three functionally-named classes of inhibitor compounds, e.g., “decoy molecules”. Ariad argued that the claims could not fail the WDR since they did not recite any inhibitor compounds (in the claims), and the patent did not purport to claim any such molecules.

The Federal Circuit made short work of Ariad’s argument, essentially finding less description than they found to be inadequate in the U. of Rochester decision (the “COX-2” patents) in which the claims-in-suit recited a “non-steroidal compound” possessing certain activity, but provided no examples of such compounds.

Ariad also advanced a procedural argument – that they had presented the jury with “substantial evidence” of adequate description via an expert’s interpretation of the specification at trial. The panel found that much of the evidence was directed to the state-of-the art as it was after the 1989 date chosen by the jury as the effective filing date of the patent. The panel went on to carefully examine the specification, and found a lack of substantial evidence to support the verdict that the patent’s written description showed possession of the inhibitors by the inventors. The panel noted that the only inhibitor named was the “I-kB” molecule that binds to NF-kB to hold it in an inactive state in vivo until signals are received to release it. The panel found that the I-kB sequence was not disclosed in the 1989 application and, adding insult to injury, found that the inventors had inadequately described the sequence when they added it in a figure (43) in a later filing.

The panel reviewed the Federal Circuit’s recent (post-UC v. Lily) WDR jurisprudence, seemingly with relish when they wrote that the putative disclosure of one class of inhibitor in the patent “just represents a wish or arguably, a plan for future research” to obtain it. The panel noted that the specification contained examples of DNA sequences that were disclosed to be useful as “decoy molecules” but was unconvinced that the specification adequately taught how to use them. The panel found that the specification did not even disclose a “hypothetical example” of how to use them. The panel’s comment that hypothetical examples “certainly can be sufficient to satisfy the written description requirement,” could be a backhanded attempt to shore up the Kubin decision, in which the primary prior art, the Valiente patent, contained a hypothetical example of how to isolate the protein that Kubin et al. actually characterized. In any case, the ‘516 patent had no such examples, and the panel found “gaping holes” in its disclosure that rendered it insufficient to support “the vast scope of these generic claims.”

The panel upheld the district court’s finding on no inequitable conduct on the basis that there was no clear and convincing evidence of intent to deceive by the attorneys who handled the application. The attorneys had deleted erroneous figure 43 in a number of applications, and their failure to do so in the application that issued as the ‘516 patent did not rise to the level of “purposeful concealment.” This was the case even though materiality was considered to be high. The court had also dismissed Lilly’s attempt to demonstrate inequitable conduct due to the failure of one inventor to disclose his later work on NF-kB inhibitors to the PTO. The court felt that the inventor probably did not understand the relevance of the work to an inherent anticipation theory that Lilly had advanced. The panel restated the standard that some amount of intent must be established by clear and convincing evidence, no matter how great the materiality of the omitted information [citing Star Scientific v. R. J. Reynolds, 537 F.3d 1537 (Fed. Cir. 2008) repeatedly].

In his concurrence, Judge Linn reiterated his view as set forth in Rochester, that establishing a separate WDR in 112 was unnecessary, when the enablement requirement was adequate to test patents such as the ‘516 patent. Judge Linn also urged the Federal Circuit to address the issue of whether a specification can enable “unknown methods … an important issue that we have left unresolved.” Indeed it is. This cogent concurrence will be a subject of future posts, as will be reexamination procedure that Merck initiated to advance the inherent anticipation arguments the panel also did not consider