Patent Docs

CyberSource and the Tragedy of Bad Analogies

August 24, 2011

Is DNA patent-ineligible because it is like software?

By Kevin E. Noonan —

Recently, in CyberSource Corp. v. Retail Decisions, Inc., a panel of the Federal Circuit invalidated claims to software directing the performance of a process for preventing fraud in Internet purchases. While this type of decision is generally not germane to the topics discussed on Patent Docs, the majority's rationale for its decision affirming the District Court, and its make-up (comprising author Judge Dyk and Judge Bryson), in view of their views on the patent-eligibility of DNA, suggest that a closer look at this decision is warranted. This is particularly the case in view of the penchant for pundits, commentators, and advocates (particularly the ACLU) to take literally the metaphor that DNA is like software, ignoring the many ways in which it is not.

The case involves U.S. Patent No. 6,029,154, containing inter alia the following method and software ("Beauregard") claims:

2. A computer readable medium containing program instructions for detecting fraud in a credit card transaction between a consumer and a merchant over the Internet, wherein execution of the program instructions by one or more processors of a computer system causes the one or more processors to carry out the steps of:
    a) obtaining credit card information relating to the transactions from the consumer; and
    b) verifying the credit card information based upon values of plurality of parameters, in combination with information that identifies the consumer, and that may provide an indication whether the credit card transaction is fraudulent,
    wherein each value among the plurality of parameters is weighted in the verifying step according to an importance, as determined by the merchant, of that value to the credit card transaction, so as to provide the merchant with a quantifiable indication of whether the credit card transaction is fraudulent,
    wherein execution of the program instructions by one or more processors of a computer system causes that one or more processors to carry out the further steps of:
        obtaining information about other transactions that have utilized an Internet address that is identified with the credit card transaction;
        constructing a map of credit card numbers based upon the other transactions; and
utilizing the map of credit card numbers to determine if the credit card transaction is valid.

3. A method for verifying the validity of a credit card transaction over the Internet comprising the steps of:
    a) obtaining information about other transactions that have utilized an Internet address that is identified with the credit card transaction;
    b) constructing a map of credit card numbers based upon the other transactions and;
    c) utilizing the map of credit card numbers to determine if the credit card transaction is valid.

The District Court granted summary judgment of invalidity that the claims were patent-ineligible under Bilski, based on the method claims reciting, in the Court's opinion, "an unpatentable mental process for collecting data and weighing values [which did] not become patentable by tossing in references to [I]nternet commerce." Claim 2 was patent-ineligible, according to the District Court, because "simply appending 'A computer readable media including program instructions . . .' to an otherwise non-statutory process claim is insufficient to make it statutory."

Considering the lower court's decision on the method claim first, the panel agreed that this claim was patent-ineligible because it failed the Bilski "machine-or-transformation" test. Relevant to this determination was the patentee's concessions that "the 'Internet address' recited in step (a) of claim 3 'may be, for example, an Internet protocol (IP) address or an e-mail address for the particular credit card transaction;'" the "'map of credit card numbers' recited in step (b) can be as simple as a list of credit card transactions relating to a particular IP address;" and that "step (c) does not limit claim 3 to any specific fraud detection formula or mathematical algorithm, but rather broadly purports to encompass any means of 'utilizing the map of credit card numbers to determine if the credit card transaction is valid.'" As in Bilski, the panel found that the claimed methods were merely directed to "obtain[ing] and compar[ing] intangible data pertinent to business risks." The claims "plain language" did not involve any machine, and "[t]he mere collection and organization of data regarding credit card numbers and Internet addresses is insufficient to meet the transformation prong of the test," said the Court. And the recitation of "the Internet" as a limitation was a "mere data-gathering step" according to the panel that did not render the claim patent-eligible.

At this point in the opinion, there is little that is surprising to anyone following the Federal Circuit and Supreme Court decisions in Bilski. Claims such as claim 3 in the '154 patent have been at risk since the Federal Circuit's en banc Bilski decision, since such claims recite neither a transformation of an article into a different state or thing nor reciting a particular machine. The panel extends this analysis by considering whether this claim recites an invention that is patent-eligible, despite failing the machine-or-transformation test, pursuant to the Supreme Court's holding that the test is not exclusive. The panel concludes that this claim does not fall into that exceptional category; rather, the claim recites "an unpatentable mental process — a subcategory of unpatentable abstract ideas," citing Gottschalk v. Benson, 409 U.S. 63 (1972), and Parker v. Flook, 437 U.S. 584 (1978). "[M]ethods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas — the 'basic tools of scientific and technological work' that are open to all," in the panel's opinion, citing Benson at 67. To the panel, it was "clear that unpatentable mental processes" are what is claimed in claim 3 of the '154 patent ("[a]ll of claim 3's method steps can be performed in the human mind, or by a human using a pen and paper"), and hence the claim was not patentable.

The panel then turned to the "computer-readable medium" claim, which it characterized as a "Beauregard" claim (derived from In re Beauregard, 53 F.3d 1583 (Fed. Cir. 1995)) that is "a claim to a computer readable medium . . . containing program instructions for a computer to perform a particular process." The panel considers this claim to be "nothing more than a computer readable medium containing program instructions for executing the method of claim 3." CyberSource contended that an important distinction between claims 2 and 3 of the '154 patent was that claim 3 was directed to a process and claim 2 was directed to a manufacture. The panel rejected this distinction as being meaningless for patent-eligibility, despite the fact that claim 2 clearly does not claim a "law[] of nature, physical phenomenon or abstract idea[]." Instead, the opinion says that the Court "looks to the underlying invention for patent-eligibility purposes . . . [r]egardless of what statutory category . . . a claim's language is crafted to literally invoke" (a statement seemingly at odds with the principle that a patentee is free to claim an invention in any language that satisfies the requirements of 35 U.S.C. § 112, second paragraph. In re Steppan, 394 F.2d 1013 (CCPA 1967). In this case, the Court based its decision on In re Abele, 684 F.2d 902 (CCPA 1982), where a claim directed to "an apparatus for displaying data" was equivalent to held to be an unpatentable method claim. And the panel distinguishes its decision in this case with the extensive line of cases, represented by In re Alappat, 33 F.3d 1526, 1545 (Fed. Cir. 1994), to the effect that programming a general-purpose computer to perform a specific algorithm "creates a new machine, because a general purpose computer in effect becomes a special purpose computer once it is programmed to perform particular functions pursuant to instructions from program software." Further, the panel imposes the machine-or-transformation test on claim 2 of the '154 patent, a test heretofore only used to determine the patent-eligibility of method claims.

But as with method claims, at least part of the panel's difficulty with determining that claim 2 was patent-eligible is that it recites no specific algorithm and thus does not "impose meaningful limits on the claims scope." "[M]erely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test," the opinion concludes, citing Benson as controlling authority. The opinion also distinguished its own precedent, including SiRF Tech., Inc. v. Int'l Trade Comm'n, 601 F.3d 1319 (Fed. Cir. 2010), and Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010), on the grounds that, unlike in those cases the use of a computer was not required to practice the method ("the method could not, as a practical matter, be performed entirely in a human's mind").

The relevance of the Court's decision in CyberSource to the question of the patent-eligibility of DNA is rooted in two aspects of that decision: first, that the Court is empowered to look to the "underlying invention" untethered to the expressly recited claim language, and to the argument that DNA is nothing more than information, essentially the software that directs protein production in a cell. To develop the analogy, here the "computer" would be a cell that produces a protein according to the instructions contained in the DNA, so that a claim such as Myriad's claim to the BRCA 2 gene in U.S. Patent No. 5,837,492 could be cast in the following language:

An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2, wherein said molecule is capable of directing a cell to execute a genetic program comprising the steps of:
    a) transcribing the DNA molecule to produce mRNA; and
    b) translating the mRNA to make the BRCA2 polypeptide.

The fact that such a claim is not asserted (or even contained) in the Myriad patents-in-suit in AMP v. USPTO is unavailing to preclude such an analysis, since the "underlying invention" is isolation of a gene that has the capacity to direct the production of a BRCA polypeptide in a cell. This capacity is another one of the essential biological features inherent in any nucleic acid encoding a complete BRCA polypeptide; indeed, the same arguments that have been made regarding the requirement for the "information" in an isolated DNA to be identical to the "information" in the gene in situ in a chromosome could be made for the capacity to direct production of the encoded protein. And the same argument that the distinctions recognized by the majority opinion in the Myriad case should be ignored, substantially because the information is the "underlying invention" (or perhaps more in the language of patent law, provides the molecule's utility) could be made here.

DNA is not a software program, of course: the information content is not patented (as opposed to the patenting of a program) and said information is embodied in a biological molecule having a distinctive structure that is different from its structure as found in nature (including the difference that useful quantities of the isolated DNA can be specifically made). Perhaps the analogy can be extended by treating the specific disclosed sequence (SEQ ID NO. 2 for BRCA 2 in the '492 patent as a specific algorithm, and thus limiting the scope of the claim to be sufficiently definite and specific to avoid the conclusion the Court reached for the software claims in the '154 patent in CyberSource.

But the metaphor/analogy between DNA and software is not something that will go away, especially in view of 50 years of molecular biologists presenting the metaphor as a way to explain to the layman the significance of the discoveries and inventions that have resulted from this still relatively new science. If the Myriad and CyberSource decisions have taught us anything, it is that it is time to move past facile and inapt analogies in making decisions on patent eligibility.
Is Claim Construction the Key to Patent-eligibility of Isolated DNA?

August 23, 2011

By Kevin E. Noonan —

Judge Giles Sutherland Rich famously said that, in patent law, "the name of the game is the claim." One of the weaknesses in the "gene patenting" debate, as well as in the District Court's opinion in AMP v. USPTO (the Myriad case), is the lack of clarity about the scope and meaning of the claims of the challenged patents. The District Court did not bother to hold a Markman hearing to construe the claims, and thus neither that Court nor the Federal Circuit in reviewing Judge Sweet's decision brought any clarity to what the parties were arguing about, instead drawing generally inapt analogies to what other claims in other patents might claim. The type and number of claims at issue are sufficiently similar, having generally the same structure and using the same language that claim construction might help, and the language used is certainly no more arcane than in any other patent case.

Construing claim language to determine the scope and meaning of the claims is a matter of law for the district court in the first instance (Markman v. Westview Instruments, Inc., 52 F.3d 1321 (Fed. Cir. 1995) (en banc), aff'd 517 U.S. 370 (1996)). The Federal Circuit reviews claim construction de novo, giving no deference to either the district court's ultimate construction of claim terms or any factual determinations underlying the court's legal determination of claim scope (Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)). The way courts are to perform claim construction was set forth (most recently) by the en banc Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). This procedure can be summarized in a few simple rules. First, claim terms are to be given their "ordinary and customary" meaning as understood by those with skill in the art. Id. at 1313. Next, the specification is consulted to determine whether the patent applicant has acted as his or her own lexicographer, a capacity recognized as black letter patent law (see Autogiro Co. Amer. v. U.S., 384 F.2d 391 (Ct. Claims 1967). This ability to define terms is limited only insofar as the applicant attempts to define a commonly accepted term in a way that is "repugnant" to its meaning in the art. In re Hill, 161 F.2d 367 (CCPA 1947). In the event that there is any ambiguity about the "ordinary and customary" meaning of a claim term, resort to the specification is preferred under Phillips as "the single best guide to the meaning of a disputed term." Id. at 1315 (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Finally, the prosecution file history should be consulted to ensure that a patentee cannot advance a narrow construction of a term during patent prosecution, only to argue a broader construction in an infringement action. Phillips at 1317.

With these concepts and principles in mind, generally two types of claims were at issue in the Myriad case:

1. Isolated DNA claims (as well as claims to oligonucleotides); and
2. Diagnostic method claims.

(The one other claim at issue, claim 20 of U.S. Patent No. 5,474,282, is in some ways sui generis to the other claims, being directed to methods for screening chemical compounds for anti-cancer properties.) Claim 1 of U.S. Patent No. 5,837,492 is representative of the first type of claim:

An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.

(Claims 1 and 7 of the '282 patent; claims 6 and 7 of the '492 patent; and claim 1 of U.S. Patent No. 5,693,473 are variants of this general claim type.) The italicized words and phrases in the exemplary claim need construing, the other terms being expressly defined with regard to other terms in the claims (e.g., the amino acid sequence of the BRCA2 polypeptide is defined as SEQ ID NO: 2; as a consequence, any ambiguity in the meaning of this term devolves to any ambiguity in the nature of the expressly recited sequence).

Of the italicized terms, the parties and the Federal Circuit focused most attention on the term "isolated." This term has a meaning accepted by the Patent Office (and in the biotechnology arts) with regard to nucleic acids, wherein the term means "isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it." Utility Examination Guidelines, 66 Fed. Reg. 1094 (2001). An associated definition is found in the specification of the patents in suit:

"Isolated" or "substantially pure". An "isolated" or "substantially pure" nucleic acid (e.g., an RNA, DNA or a mixed polymer) is one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins. The term embraces a nucleic acid sequence or protein which has been removed from its naturally occurring environment, and includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems.

Some in the gene patenting debate have characterized this meaning as encompassing isolation of total genomic DNA as falling within the scope of the claim; indeed this interpretation is one of the bases for the argument that Myriad's claims may inhibit "whole genome sequencing" methods, as Chris Hansen of the ACLU argued during oral argument in Myriad (see "AMP v. USPTO: Oral Argument at the Federal Circuit"). This interpretation is only persuasive, however, if the phrase "many other human genome sequences" is eliminated from the list of cellular components from which the BRCA-encoding DNA is separated. Thus, the ordinary and customary meaning of the term "isolated" is reinforced by the express meaning of the term as recited in the specification. And as interpreted using this meaning, the distinctions drawn in the majority and concurring opinions in Myriad, between what is isolated and what is "merely" purified, become less relevant, since DNA is understood both to be "purified" from other cellular components and "isolated" from other human genome sequences.

In addition, since claims must be construed as a whole, giving each limitation meaning and avoiding surplusage, what is "isolated" is a nucleic acid encoding an amino acid sequence "set forth" in the specification as SEQ ID NO: 2. Thus, properly interpreted, the claim is limited to DNA molecules that encode the BRCA 2 polypeptide. The only other claim term that could expand the scope of these claims to extend to nucleic acids other than those encoding the BRCA proteins (and only those having the specifically recited amino acid sequences) is the word "comprising." However, using another well-recognized rubric of claim construction, this word cannot be used to expand the scope of the claim to extend to human genomic DNA per se: first, because "claims should be so construed, if possible, as to sustain their validity," Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed Cir. 1999); see also Klein v. Russell, 86 U.S. (19 Wall.) 433, 466, 22 L. Ed. 116 (1873), but also because claims are interpreted in light of the specification, United States v. Adams, 383 U.S. 39, 49, 15 L. Ed. 2d 572, 86 S. Ct. 708, 174 Ct. Cl. 1293 (1966). The specification of the Myriad patents claiming DNA encoding BRCA1 and BRCA2 disclose the patentees' efforts to identify, isolate, and purify BRCA-encoding DNA. Thus, the proper interpretation of these claims is directed to DNA (and in particular, cDNA) encoding the BRCA proteins.

Turning to the diagnostic method claims, claim 1 of U.S. Patent No. 5,753,441 is representative:

A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

(Claims 1 of U.S. Patent No. 5,709,999; claim 1 of U.S. Patent No. 5,710,001; and claims 1 and 2 of U.S. Patent No. 6,033,857 are variants of this general claim type.) Here, the claim term "comparing" has no specific definition in the specification; however, Example 9, entitled "Analysis of BRCA 1 Mutations" sets forth the general method for extracting DNA from blood or tumor samples from patients with breast or ovarian cancer to detect mutations. The relevant claim term to be construed is thus from a tissue sample from said subject, and whether this implies a necessary transformation step to ascertain the individual patient's BRCA gene sequence. Both the District Court and the Federal Circuit treated this claim as if it had been construed to encompass mere inspection of and comparison between two sequences (i.e., printouts of the germline and patient sample sequences) that did not require a patient sample to be assayed to obtain the sequence. While not a necessarily unreasonable interpretation (since these claims do not expressly recite limitations drawn to obtaining a sample and determining the BRCA gene sequence therefrom), it is not the only interpretation. What is missing from any judicial analysis of the diagnostic method claims at issue is whether the skilled worker would understand the claim not to require these steps, and whether the specification mandates interpretation of the claim to include these steps. (The prosecution file history may also be informative as to what the patentee understood the invention to be and, more importantly, represented that understanding to the patent examiner, with regard to the scope of these claims.)

The danger in ignoring and failing to perform the fundamental and threshold exercise of construing the claims at issue in patent litigation is clearly illustrated in the briefs (both from the parties and the amici) and the decisions of both the District Court and the Federal Circuit. The Courts' analyses are understandably adrift without the anchor of having decided what the claims mean, turning them into a "nose of wax" to be susceptible to whatever argument is being advanced. Although it is perhaps too late to do so now, if the Federal Circuit grants rehearing or en banc review, it would be well if the Court mandated that the parties provide the equivalent of their Markman briefs, to enable the Court as a threshold matter to determine what the claims mean as a matter of law. Without that, it is hard to see how the Federal Circuit, or the Supreme Court if it grants certiorari, will have any reasoned basis for coming to a decision as to whether these claims recite patent-eligible subject matter. That outcome may be good for arguments based on emotion and rhetoric, but it won't be good for deciding this fundamental question of patent law.
WFU Law Professor Says Federal Circuit Failed as “Keeper of the Constitution” in AMP v. USPTO

August 22, 2011

By Donald Zuhn —

In an article published in The Huffington Post on Sunday, Wake Forest University Law Professor Simone Rose accuses the Federal Circuit of failing in its duty as "keeper of the Constitution" with respect to the Court's July 29 decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office. Noting her background as a former registered patent attorney, Professor Rose writes that one question came to mind as she read the majority and concurring opinions, namely "[h]ow can the court allow chemical differences to supersede biological equivalence when the specific utility of the invention, namely detecting mutations linked to breast and ovarian cancer, depends on biological identity?" She argues that "[c]hemically modifying an isolated gene [i.e., "breaking . . . chemical bonds during the isolation process"] does not alter its biological heart (nucleotide sequence)," and that "[a]ccurately detecting BRCA mutations would be impossible without this biological identity."

As for the focus by the majority and concurring opinions on long-standing USPTO practice in issuing gene patents and on the impact an affirmance would have had on the biotech industry, Professor Rose (at left) contends that while "promoting innovation is a laudable goal, the Federal Circuit's broadening of what constitutes patent-eligible subject matter missed the bigger Constitutional target." According to the Professor, the Constitution's Patent Clause requires that the granting of exclusive rights under the patent system be balanced against providing access to basic knowledge. She therefore concludes that "[p]atenting products of nature such as isolated genes and gene sequences prevents access to these basic research tools during the term of the patent," and "[t]his impedes rather than promotes progress and is therefore in direct violation of the IP clause."

Professor Rose argues that federal courts have an obligation, as "keepers of the Constitution," to ensure that their analysis of 35 U.S.C. § 101 and controlling case law is "in harmony with the Constitutional mandate to promote progress of the useful arts." She contends that in AMP v. USPTO, "[t]he Federal Circuit should have taken this role seriously and upheld the lower court's invalidation of the BRCA isolated genes and gene sequence patents as patent-ineligible subject matter."

Interestingly, for Professor Rose, the end result of the invalidation of Myriad's patents would be Congress weighing in on the issue of gene patenting. Unlike the majority and concurring opinions, which state that if the law is to be changed, it is up to Congress and not the courts to change it, Professor Rose believes that a finding by the Federal Circuit of invalidity would have permitted (or encouraged) Congress to step in and "legislate a new 'Constitutional' framework of exclusive rights for this subject matter." Looking forward, the Professor says that she remains "hopeful" that the Federal Circuit sitting en banc or the Supreme Court "will be mindful of its role as the keeper of the Constitution and interpret the Patent Act's subject matter limitation to exclude the BRCA genes as patent-ineligible products of nature." She argues that an "appropriate legislative dialogue" on a solution that balances access and innovation can only begin after the courts determine that gene patents should be excluded as patent-eligible subject matter.
Court Report

August 21, 2011

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Sandoz Inc. v. Novo Nordisk, Inc. et al.
2:11-cv-13594; filed August 17, 2011 in the Eastern District of Michigan

• Plaintiff: Sandoz Inc.
• Defendants: Novo Nordisk, Inc.; Novo Nordisk A/S

Declaratory judgment of invalidity, unenforceability, and non-infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) in conjunction with Sandoz's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novo Nordisk's Prandin® (repaglimide, used to treat non-insulin dependent diabetes mellitus in combination with metformin). View the complaint here.

Allergan, Inc. et al. v. Hi-Tech Pharmacal Co., Inc.
1:11-cv-00650; filed August 17, 2011 in the Middle District of North Carolina

• Plaintiffs: Allergan, Inc.; Duke University
• Defendant: Hi-Tech Pharmacal Co., Inc.

Infringement of U.S. Patent Nos. 7,351,404 ("Method of Enhanced Hair Growth," issued April 1, 2008), 7,388,029 ("Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins," issued June 17, 2008), and 6,403,649 (""Non-Acidic Cyclopentane Heptanoic Acid,2-Cycloalkyl Or Arylalkyl Derivatives As Therapeutic Agents, issued June 11, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Allergan's Latisse® (bimatoprost topical solution/drops, 0.03%, used to treat inadequate or not enough eye lashes). View the complaint here.

Endo Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. et al.
1:11-cv-00717; filed August 16, 2011 in the District Court of Delaware

• Plaintiff: Endo Pharmaceuticals Inc.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.; Matrix Laboratories Ltd.; Matrix Laboratories Inc.

Infringement of U.S. Patent Nos. 5,464,864 ("Use of Tetrahydrocarbazole Derivatives As 5HT₁ Receptor Agonists," issued November 7, 1995), 5,637,611 ("Medicaments," issued June 10, 1997), and 5,827,871 ("Medicaments 1,2,3,4,-Tetrahydrocarbazoles and 5-HT1 Agonist Use Thereof," issued October 27, 1998), assigned to Endo, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Endo's Frova® (frovatriptan succinate, used to treat migrane attacks with our without aura). View the complaint here.

Pfizer Inc. et al. v. MSP Singapore Co. LLC
1:11-cv-00713; filed August 15, 2011 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Pfizer Ireland Pharmaceuticals; Warner-Lambert Co.; Warner-Lambert Company LLC
• Defendant: MSP Singapore Co. LLC

Pfizer, Inc. et al. v. Macleods Pharmaceuticals LTD
1:11-cv-05662; filed August 15, 2011 in the Southern District of New York

• Plaintiffs: Pfizer Inc.; Pfizer Ireland Pharmaceuticals; Warner-Lambert Co.; Warner-Lambert Company LLC
• Defendant: Macleods Pharmaceuticals LTD

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 5,969,156 ("Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)," issued October 19, 1999) following a Paragraph IV certification as part of MSP's filing of an ANDA to manufacture a generic version of Pfizer's Lipitor® (atorvastatin calcium, used to treat high cholesterol and heart disease). View the MSP complaint here.

Abbott Laboratories et al. v. Teva Pharmaceuticals USA Inc. et al.
1:11-cv-00712; filed August 12, 2011 in the District Court of Delaware

• Plaintiffs: Abbott Laboratories; Abbott Respiratory LLC
• Defendants: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000), and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia). View the complaint here.
Conference & CLE Calendar

August 21, 2011

August 31, 2011 – Expert Analysis of Federal Circuit's Ruling in Myriad Appeal (Technology Transfer Tactics) – 1:00 – 2:00 PM (Eastern)

September 6-7, 2011 – Pharmaceutical Law Academy (IBC Legal Conferences) – London, UK

September 8, 2011 – Patents and the Written Description Requirement: Lessons Learned Since Ariad v. Lilly (Strafford) – 1:00 – 2:30 PM (EDT)

September 11-13, 2011 – 2011 Annual Meeting (Intellectual Property Owners Association) – Los Angeles, CA

September 13, 2011 – Biotechnology/Chemical/ Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – Alexandria, VA (and webcast)

September 14, 2011 – Compulsory Licensing as an Emerging Global IP Issue (Intellectual Property Owners Association) – Los Angeles, CA

September 14-16, 2011 – 85th Annual Meeting (Intellectual Property Institute of Canada) – Chicago, IL

September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa*** (South African Department of Science and Technology) – Cape Town, South Africa

September 19-20, 2011 – Tech Transfer Summit Europe*** (Tech Transfer Summit Ltd.) – Paris, France

September 19-21, 2011 – Business of Biosimilars & Biobetters*** (Institute for International Research) – Boston, MA

September 21-22, 2011 – Forum on European Pharmaceutical Regulatory Law*** (C5) – Brussels, Belgium

September 22-23, 2011 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

September 26-27, 2011 – Biosimilars and Biobetters*** (SMi Group) – London, UK

September 26-27, 2011 – Life Sciences Business Development & Acquisitions in Emerging Markets (American Conference Institute) – New York, NYNew York, NY

October 3-4, 2011 – Tech Transfer Summit North America*** (Tech Transfer Summit Ltd.) – Bethesda, MD

October 4-5, 2011 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) –

October 5-6, 2011 – Biotech Patenting*** (C5) – London, UK

October 24-26, 2011 – Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) – London, UK

October 25-26, 2011 – FDA Boot Camp Devices Edition*** (American Conference Institute) – Chicago, IL

***Patent Docs is a media partner of this conference or CLE
Webinar on AMP v. USPTO

August 19, 2011

Technology Transfer Tactics will be offering a webinar providing "Expert Analysis of Federal Circuit's Ruling in Myriad Appeal" on August 31, 2011 from 1:00 – 2:00 PM (Eastern). Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP will discuss the Federal Circuit's "fractured" decision in the AMP v. USPTO ("Myriad") case, and what it means for technology transfer offices and university researchers with gene-based innovations, in terms of both patenting and licensing. In particular, the webinar will cover:

• Patentability of composition of matter claims (where the Federal Circuit reversed the District Court's finding that "isolated DNA" was not patent-eligible under the "products of nature" exception);
• Impact on method claims — both diagnostic methods and screening method claims;
• The decision's creation of a new categorical rule of patent-ineligibility;
• Rejection of the "magic microscope" analysis by the government;
• Likely outcome of future appeals;
• Impact on patent prosecution decisions and claim drafting; and
• "Isolation" vs. "purification" — what’s the difference?

The registration fee for the webinar is $197 ($247 for registration plus CLE processing). Those interested in registering for the webinar, can do so here.
USPTO Announces Agenda for Next BCP Customer Partnership Meeting

August 19, 2011

The U.S. Patent and Trademark Office has announced the agenda for the next biotechnology/chemical/ pharmaceutical (BCP) customer partnership meeting to be held on September 13, 2011. The proposed agenda is as follows:

Morning Session

• Greetings, TC Update, and Overview (10:00 – 10:15 am EDT): Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

• PCT Sequence Rule Compliance in U.S. National Phase Applications (10:15 – 11:15 am): Sue Wolski, Office of PCT Legal Administration

• Break (11:15 – 11:30 am)

• Enhancing Compact Prosecution at BPAI (11:30 am – 12:30 pm): Joe Mallon, Knobbe, Martens, Olson and Bear, LLP

• Lunch (12:30 – 1:30 pm)

Afternoon Session

• Supplemental 112/2 Examination Guidelines (1:30 – 2:30 pm): Kathleen Fonda, Office of Patent Legal Administration

• Break (2:30 – 2:45 pm)

• The Myriad case (Association for Molecular Pathology v. USPTO) and Its Implications for Patent Practitioners and the Biotech Industry (2:45 – 3:45 pm): Robert Makowski, Ph.D., J.D., Connolly Bove Lodge & Hutz LLP

• Common Issues Examiners Face Regarding PLT and Plant Utility Patents (3:45 – 4:30 pm): Anne Marie Grunberg, SPE, Art Unit 1638/1661

• Closing Remarks/Discussion (4:30 – 4:45 pm): Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

The meeting can be attended in person at the USPTO's Auditorium in Madison East, 600 Dulany Street, Alexandria, VA, or viewed online here (select the "enter as guest" option). The Patent Office asks that non-USPTO employees login using their e-mail addresses. Those wishing to attend the meeting should contact Cecilia Tsang by phone at 571-272-0562, by fax at 571-273-0562, or by e-mail at Cecilia.Tsang@uspto.gov by September 8, 2011 to confirm their attendance. Additional information regarding the BCP customer partnership meeting can be found here.
IPO Program on Compulsory Licensing

August 19, 2011

The Intellectual Property Owners Association (IPO) will be holding a one-day CLE program entitled "Compulsory Licensing as an Emerging Global IP Issue" on September 14, 2011 in Los Angeles, CA. The one-day program follows the IPO Annual Meeting, which takes place on September 11-13. The conference will address compulsory licensing from both geographical and industry perspectives. Conference sessions directed to compulsory licensing in the United States and Asia (Japan, Taiwan, and China) will consider whether we are beginning to see a convergence in how countries apply compulsory licensing to patent enforcement and what this may mean to national and international IP rights. The conference will offer presentations and panels on the following topics:

• Introduction — Compulsory Licensing as a Global IP Issue;
• Standards and Compulsory Licensing;
• Compulsory Licensing in the Pharmaceutical Industry;
• Luncheon address by Willard Tom, General Counsel of the Federal Trade Commission;
• Compulsory Licensing in Asia; and
• Compulsory Licensing in the U.S.

Information about the one-day program, including an agenda and list of speakers, can be found in the brochure for the IPO Annual Meeting, which can be obtained here.

The registration fee for the conference is $550 for IPO members or $800 for attendees who are not IPO members. Those registering for both the conference and the 2011 Annual Meeting will receive a $50 discount off the registration fee for the conference. Those interested in registering for the meeting can do so here.
Biotech/Pharma Docket

August 18, 2011

By James DeGiulio —

Medicis and Nycomed Settle Vanos Patent Dispute

Medicis and Nycomed have reached a licensing agreement to settle a patent dispute over a generic version of the psoriasis treatment Vanos. In May 2010, Medicis filed the suit in the Southern District of New York in response to Nycomed's ANDA seeking approval from the FDA to make and sell 0.1% fluocinonide cream before the expiration of Medicis' U.S. Patent Nos. 6,765,001, 7,220,424, and 7,217,422 (see "Court Report," May 23, 2010). Nycomed's ANDA included a Paragraph IV certification asserting that the three patents would not be infringed by its generic version of Vanos. According to the complaint, Nycomed was required to amend its ANDA to provide certification relating to U.S. Patent No. 7,794,738, at issue in another Medicis-Nycomed dispute, but Medicis had yet to receive notification of any such amendment.

On August 16, U.S. District Judge Denise L. Cote signed off on a stipulation and order of dismissal dismissing the suit with prejudice after the two parties notified the Court that they had agreed on a licensing agreement. Nycomed admitted that Medicis' patents covering Vanos were valid and enforceable, and that its ANDA for a generic version of Vanos would infringe Medicis' patents outside of the licensing agreement. The Court noted the public interest in judicial economy in dismissing the suit, and both parties waived any right to appeal the stipulated order. Medicis will grant Nycomed a license to make and sell generic versions of Vanos products beginning December 15, 2013. In return, Nycomed will pay Medicis a royalty based on product sales.

Pfizer Successfully Defends Viagra Patent Against Teva

Pfizer has prevailed in its patent infringement action against Teva over a generic version of Viagra, securing a ruling that the Pfizer patent for the blockbuster drug remains valid and enforceable. On March 24, 2010, Pfizer sued Teva in U.S. District Court for the Eastern District of Virginia, challenging the generic drug maker's contention that U.S. Patent No. 6,469,012 is invalid or would not be infringed by Teva's proposed generic (see "Court Report," April 4, 2010). The '012 patent represents an important holding for Pfizer, as it does not expire until 2019. During a 12-day bench trial in July, Teva conceded that its proposed generic drug would infringe the '012 patent. However, Teva raised a series of challenges to Pfizer's patent, including the validity and enforceability of the patent, as well as Pfizer's standing to sue.

On August 15, U.S. District Judge Rebecca Beach Smith, in a lengthy opinion, found that the decision to try an orally administered version of the active ingredient, sildenafil, to treat erectile dysfunction was not obvious. Judge Smith distinguished the standard of "obvious to try" with a mere "motivation to try." She also ruled against Teva with respect to its claim of double patenting, finding the compound to be sufficiently different from a similar version protected by an earlier Pfizer patent, noting that even small changes in chemical structure could significantly affect how the drug worked in the body.

In a significant portion of the opinion, Judge Smith cited Therasense and chastised Teva for wasting judicial resources by trying to have the patent declared unenforceable by accusing Pfizer and one of its attorneys of engaging in inequitable conduct by not submitting information related to the Canadian version of the patent during prosecution. Judge Smith found that the material was not relevant to the prosecution of the U.S. patent because the patent examiner had already asked the company not to submit further foreign references similar to what had already been provided. Teva also lost a bid to amend its answer to flesh out inequitable conduct claims against the company and some of its attorneys. Judge Smith ruled that not only did Teva unnecessarily delay in seeking to amend its counterclaims, but that Pfizer and the accused individuals would be prejudiced by such a late change.

The Court's decision prevents Teva from receiving approval for a generic form of Viagra until October 2019. Litigation on the same patent remains pending against other generic companies, but no trials have been scheduled in those other cases.

Lilly and Hospira Settle Gemzar Patent Suit

Eli Lilly and Hospira have reached a settlement dismissing Hospira's declaratory judgment action over the patent covering the ovarian, breast, lung, and pancreatic cancer treatment Gemzar. On September 30, 2010, Hospira filed suit against Lilly in the Northern District of Illinois, seeking a declaratory judgment that its plans to sell several versions of a generic version of Gemzar, also known as gemcitabine, would not infringe Lilly's U.S. Patent No. 5,606,048, which protects a "stereoselective glycosylation process for preparing" the drug (see "Court Report," October 3, 2010). Hospira filed an ANDA seeking regulatory approval to sell three versions of the drug in late 2009, and was making preparations to sell the product immediately upon approval. Hospira asserted non-infringement of the '048 patent, but claimed reasonable apprehension that Lilly would assert the '048 patent against Hospira to block the marketing and sale of Hospira's competing product. Hospira contends that Lilly's foreign lawsuits over the drug in Denmark and the United Kingdom gave it a reasonable apprehension that Lilly intended to file a lawsuit to block a generic drug release in the U.S.

On August 10, U.S. District Judge Milton I. Shadur affirmed the parties' stipulation regarding dismissal with prejudice. The settlement brings to an end the U.S. litigation over Gemzar, which has arisen between the two parties in five different countries. Each side is to bear its own costs and attorneys' fees. Additional terms of the settlement were not immediately available.
Patent Reform News Briefs

August 17, 2011

By Donald Zuhn —

Sen. Reid's Cloture Motion Brings Senate Closer to Vote on H.R. 1249

On August 2, Sen. Harry Reid (D-NV) (at right) presented a cloture motion to bring to a close the debate on the House version of the Leahy-Smith America Invents Act (H.R. 1249) so that the Senate can proceed to vote on the bill. The Senate cloture rule (Rule XXII) provides the only process for imposing limits on further consideration of an issue, and requires that a cloture motion (or petition) be supported by at least sixteen Senators. In the case of Sen. Reid's motion, Senators Patrick Leahy (D-VT), Thomas Carper (D-DE), Joseph Lieberman (I-CT), Richard Blumenthal (D-CT), Charles Schumer (D-NY), Amy Klobuchar (D-MN), Robert Menendez (D-NJ), Jeanne Shaheen (D-NH), John Kerry (D-MA), Mark Udall (D-CO), Mark Warner (D-VA), Ben Nelson (D-NE), Jeff Bingaman (D-NM), Max Baucus (D-MT), Mark Begich (D-AK), and Robert Casey, Jr. (D-PA) joined Sen. Reid in signing the cloture petition. Sen. Reid's motion calls for a vote to invoke cloture on Tuesday, September 6, which requires a three-fifths majority of the Senate. If cloture is invoked, debate on H.R. 1249 will be limited to thirty hours, no Senator will be allowed to speak on the legislation for more than one hour, and only amendments to the bill presented prior to the cloture vote will be permitted.

Rep. Rogers: Fees Collected by USPTO "Reserved Only for Use By the PTO"

On June 22, the day before the House passed H.R. 1249, Rep. Harold Rogers (R-KY) (at right), the Chairman of the House Committee on Appropriations, sent a letter to the Speaker of the House and the House Majority Leader addressing the USPTO funding provisions of H.R. 1249. Rep. Rogers, along with Rep. Paul Ryan (R-WI), the Chairman of the House Committee on the Budget, was primarily responsible for convincing the House to change the USPTO funding provisions of H.R. 1249 so that the Patent Office would require Congressional approval in order to spend all of the fees it collects. In his letter, Rep. Rogers notes that (emphasis added):

The language [in H.R. 1249] ensures: the PTO budget remains part of the annual appropriations process; all PTO collected fees will be available only for PTO services and activities in support of the fee paying community; and finally, this important agency will continue to be subject to oversight and accountability by the Congress on an annual basis.

To assure that all fees collected for PTO remain available for PTO services, H.R. 1249 provides that if the actual fees collected by the PTO exceed its appropriation for that fiscal year, the amount would continue to be reserved only for use by the PTO and will be held in a "Patent Trademark Fee Reserve Fund".

At the same time, consistent with the language included in H.R. 1249, the Committee on Appropriations will also carry language that will ensure that all fees collected by PTO in excess of its annual appropriated level will be available until expended only to PTO for support services and activities in support of the fee paying community, subject to normal Appropriations Committee oversight and review.

However, the resolution to the debt ceiling crisis may make it difficult (if not impossible) for Rep. Rogers to keep his promise. Under the legislation that raised the debt ceiling, which was signed into law on August 2, a joint committee of Congress will have to produce debt reduction legislation with at least $1.2 trillion in cuts by November 23, 2011 or face across-the-board cuts of spending, equally split between defense and non-defense programs. How the joint committee's proposal (or automatic spending cuts) will ultimately impact the funding provisions of H.R. 1249 (if passed by the Senate in September and signed by the President) is yet to be determined.

Washington Post Supports Patent Reform Legislation

In an op-ed piece appearing in Sunday's Washington Post, the newspaper says that President Obama is right when he states that patent reform will allow inventors and entrepreneurs to "cut the red tape" that prevents them from "quickly turning new ideas into thriving businesses." Arguing that "the patent system has become creaky" since the 1952 Patent Act was passed, the article contends that the Patent Office "struggles under an enormous backlog, takes far too long to approve legitimate patents, and paradoxically at times blesses weak ones that undermine serious innovation and expose legitimate inventors to costly damages after their products have gone to market." According to the Post, the Leahy-Smith America Invents Act will "go a long way toward curing these problems." While conceding that H.R. 1249 "unfortunately weakens an important funding change that would have ensured needed resources for the perennially beleaguered U.S. Patent and Trademark Office," the Post says "[t]he change is unfortunate, but it is a small price to pay for passage of a broad package of changes that should lift burdens that for far too long have stood in the way of innovation and economic growth."

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