BOOK REVIEW: Janice M Mueller, Patent Law, Third Edition, Aspen Publishers (2009), 613 pages, paper.

Posted on May 11, 2009 by Warren Woessner

I thought I would take time out from my rants about the written description requirement, and patentable subject matter, to let you know about this important addition to IP education tools. In 2003, Professor Mueller, now at the University of Pittsburgh Law School, published the first edition of An Introduction to Patent Law, which was intended to fulfill a need she perceived for an introductory textbook for patent law students that was also rigorous in its analysis of the law, while being manageable in length. The first edition was a mere 398 pages, and a marvel of compression. I used it regularly and felt that, when asked a question, I could confirm or deny my “first impression” of almost any part of 35 U.S.C. with remarkable ease. The new edition has been held to 614 pages, and should be on every patent prosecutor’s shelf, in between Chisum’s (now) three volume Patent Law Digest and, if you are a chem/biotech practitioner, John L. White’s Chemical Patent Practice (a case law summary I still call “The Bible”).

Before issuing this rave review, I thought I would test out the book’s currency in four “hot’ areas of IP law – patentable subject matter, inherent anticipation, obviousness, and the written description requirement. Patent Law is up-to-date in all these areas. Bilski is discussed thoroughly, though Lab. Corps. v. Metabolite Laboratories only rates a footnote. Anticipation by Inherency gets its own subsection in the excellent discussion of section 102, as does KSR in the chapter on obviousness. I need not have worried about the treatment of section 112 issues like enablement and WDR. Professor Mueller has published extensively on WDR and there is a lengthy subsection on what she properly terms “The Written Description of the Invention Requirement.” I would have liked to have seen a bit more on how to logically resolve the “scope of claims” issue under enablement and the WDR but, as I have discussed in an earlier post, the Federal Circuit has just begun to deal with that issue.

A disclaimer is in order, Professor Mueller was “my” law clerk a generation or so back, but, as Patent Law demonstrates, she learned her lessons from me and from my elders (e.g., Judge Giles S. Rich, for whom Mueller also clerked) very well. I would like to close with a quote from her introduction to section 102:

Deceptively straightforward at first reading, when applied, the seven subsections (a) through (g) of 35 U.S.C. s. 102 may seem a rather bewildering Pandora’s box of arcane conventions and obscure terms of art…. First, here are some general recommendations for readers who seek a better understanding of the intricacies of s. 102. It is important to get comfortable with the statute. Post a copy of 35 U.S.C. s. 102 on the wall next to your desk or computer and copy its text into your laptop or PDA. Read the language over every day until you know it by heart.

I think I said something like that 20 years ago, but I can’t be sure. I know I could not have said it better.

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Ariad: “The Future Ain’t What It Used To Be!” Judge Linn’s Concurrence and the Abuse and Neglect of the Enablement Requirement at the Federal Circuit

Posted on May 5, 2009 by Warren Woessner

In my post of April 13, 2009, I concluded with a brief summary of Judge Linn’s cogent concurrence, and noted that I would revisit it. Judge Linn does not believe that it was ever necessary for the court to graft “a separate written description requirement [WDR] onto section 112, paragraph 1.” He noted his dissents in U. of Rochester v. Searle and in Enzo Biochem.v. Gen-Probe, leading decisions in which the Fed. Cir. used the WDR to invalidate biotech claims (at least initially in Enzo, see W. D. Woessner, “Do-Over! The Federal Circuit Takes a Second Look at Enzo v. Gen-Probe,” JPTOS, 85, 275 (April 2003)). Judge Linn wants a claim to be tested against section 112(1) as follows:

The question is, “Does the written description describe the invention recited in the claims – themselves part of the specification – in terms that are sufficient to enable one of skill in the art to make and use the invention and practice the best mode contemplated by the inventor?” That is the mandate of the statute and is all our precedent required, prior to [UC v. Lilly].”

Judge Linn chastised his colleagues for using the WDR to invalidate the claims-in-suit in Ariad that “broadly claim any method for reducing NF-kB activity in cells, including both known and unknown methods,” and ducking the question of whether or not claims written broadly enough to cover any method for achieving a particular result can ever meet the enablement requirement. Lilly had argued that the specification cannot enable unknown methods, but is that always true (or simply a tautology – e.g., if you enable it, it is no longer unknown)? Judge Rader apparently thinks so. See Chiron v. Genentech, 363 F.3d at 1254. But then what are the consequences for a “pioneering” method of treatment claim?

Before even starting to address this question, it is worthwhile, I think, to take a step back and review when the Federal Circuit seems comfortable when faced with affirming or reversing the invalidation or refusal to allow claims due to their failure to meet the WDR and when they do not. Federal Circuit panels seem to be comfortable invalidating claims as failing the WDR when there is essentially no support for claimed subject matter in the specification. This was the factual situation in the U. of Rochester decision (358 F.3d 916), in which no non-steroidal COX-2 inhibitors were disclosed and, of course, in Ariad, discussed in detail in my post below, in which workable NF-kB inhibitors were not disclosed. Of course, it is clear, at least to me, that the claims in both cases would not have been found to meet the enablement requirement either, so why waste a lot of time going through all those messy Wands factors. See also Chiron, 363 F.3d at 1255.

Interestingly, the Fed. Cir. panel in Capon v. Eschar, 418 F.3d 11349 (Fed. Cir. 2005) reversed the Board and found that the highly functional claims of both parties met the WDR (and did not reach enablement). The claims of both parties in the interference were to chimeric genes made up of at least two segments, e.g., a first gene segment encoding a single-chain Fv domain of a specific antibody and a second gene segment encoding the cytoplasmic and extracellular domain of an endogenous protein. (This is a gloss on claim 1 of Eshchar). Why did these claims survive initial scrutiny for adequate description in the specification of the recited claim elements under the hanging sword of the WDR? Because both parties put in evidence that (a) their specifications taught the art how to make such constructs and, more importantly, that (b) representative pieces of DNA useful to make these chimeric genes were available to the art, e.g., were known as of their respective filing dates.

Even before U.C. v. Lilly, the CCPA, the Board, and the Fed. Cir. had held that that which is known to the art need not be described in detail in the specification. Although the Capon, panel addressed this issue as if they had never seen it before, in fact, they were following precedent from the 80’s and early 90’s, that simply makes common sense. (In fact the PTO Written Description Examination Guidelines state: “Information that is well known in the art need not be described in detail in the specification.” citing Lockwood v. Amer. Airlines, 107 F.3d 1565 (Fed. Cir. 1997). In biotech prosecution, I prefer Hybritech Inc. v. Monoclonal Antibodies, Inc., 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. (947) (1987).

How could it be otherwise? Without such real-world pronouncements, applicants would face WDR rejections for using functional terms like “surfactant” or “insulating layer.” Of course, this type of erroneous WDR rejection remains remarkably common in biotech prosecution, but that is the subject for another post.

To return to Capon, the panel then had to decide “the question of whether the specifications adequately support the breadth of all of the claims that are presented… The inventors…state that biological properties typically vary, and that their specifications provide for evaluation of the effectiveness of their chimeric combinations.” 418 F.3d at 1358. Here is where the panel’s struggle is manifest. What standards should be used in such a case (and to test a method claim such as Judge Linn envisions)? If the court is called upon to test enablement, it has before it the Wands factors, all eight of them, by which to resolve the question of whether or not the claimed invention can be practiced without “undue experimentation.” See Wands, 858 F.2d at 737. These factors overlap and use vague language (“nature of the invention”) but they at least guide the inquiry.

But what happens when a panel tries to evaluate whether or not the written description of the invention justifies the scope of the claims? As the panel states in Capon at 1360: “Although the legal criteria of enablement and written description requirement are related and are often met by the same disclosure, they serve discrete legal requirements.” Oh really? And how are those requirements to be tested when failure to meet the WDR due to “overclaiming” is alleged?

Lacking the “easy button” of specifications with no support for generic claims (read U. of Rochester), or in which only one embodiment of a generic claim is disclosed (UC v Lilly), the panel remanded to the Board to “explore the support for each of the claims of both parties,” noting that there were working examples and general teachings in the specifications as well as “known science” with application of precedent to guide review of the scope of the claims.” I bet this is one case the Federal Circuit never wants to see again!

So the tension between the application of the tests for an enabling disclosure and for an adequate written description is palpable. In Capon, the panel came close to creating a WDR test but punted at the last minute. I was going to end with a statement like “If the facts in Capon do not support a finding of sufficiency of the descriptions of largely functional biotech product claims, I cannot imagine what would be sufficient,” but in fact, I began this post with the idea of testing a broad functional method of treatment claim that has substantial support in the specification against the Wands factors, and for adequacy under the WDR, so that will be the subject of the next post. We will see that Judge Linn is appropriately concerned about the fate of method claims, including ones that enjoy much more support than the “Hail Mary” claims dispatched in Ariad.

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

Posted on April 27, 2009 by Warren Woessner

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?

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

Posted on April 22, 2009 by Warren Woessner

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.

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