Patent Docs

DuPont & Widener University School of Law IP CLE Seminar

DuPont and the Widener University School of Law will be holding the 2013 Intellectual Property Continuing Legal Education Seminar on October 1, 2013 at The DuPont Country Club in Wilmington, Delaware.  Among the presentations being offered at the seminar will be:

• Learning from the 2013 Supreme Court Decisions -- to be presented by Patent Docs author Dr. Kevin Noonan
• Interface Between IP and Antitrust Laws
• IP Strategies in Emerging Markets -- India, China, Brazil
• Ethics in a Post AIA World
• Patent Highlights
• Post-Grant Proceedings under the AIA
• Proceedings under the ITC -- Recent Developments Post Tianrui
• Estimating Damages -- Which Model to Choose?

Additional information about the seminar, including a program, list of speakers can be found here.  The registration fee for the seminar is $600.  Those interested in registering for the seminar can do so here.

Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2013)

By Andrew Williams --

When assessing the validity of a patent, you cannot ignore the dependent claims.  That was the main takeaway from the recent Federal Circuit case, Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc.  In that case, the lower court had invalidated all of the asserted claims of two particular patents as inherently anticipated in view of several prior art references.  However, three of these claims were dependent claims, and they all had the same additional limitation -- "wherein the tetracycline compound has substantially no anti-microbial activity in said mammal system."  The lower court did not address this limitation, so the Federal Circuit vacated the finding of invalidity of these three claims and remanded for a determination whether the identified prior art references also contained this limitation.  The Court did not, however, fault the lower court for overlooking this limitation, but instead placed the blame squarely on the patent-asserting parties for failing to highlight this issue in the post-trial papers.  The result was somewhat academic, in part because the Plaintiffs also asserted a later-expiring patent that had been found by the lower court to be valid and infringed by Mylan.  The Federal Circuit affirmed the remainder of the lower court's findings, with the result being that the FDA will not be able to approve Mylan's ANDA until the expiration of the infringed patent, which currently will occur on December 19, 2027.

The Federal Circuit opinion did not contain much more detail than the above paragraph.  In fact, without that one issue, this case most likely would have been a Rule 36 affirmance.  Therefore, for the benefit of the readers of this blog, we will provide some context for this case.  The drug at issue is doxycycline, which is sold by Galderma Laboratories, L.P. under the brand name Oracea® for the treatment of acne rosacea.  There were five patents that cover Oracea® that were asserted in this case:  the "Ashley Patents," U.S. Patent Nos. 7,211,267 and 7,232,572; the "Amin Patents," U.S. Patent Nos. 5,789,395 and 5,919,775; and the "Chang Patent," U.S. Patent No. 7,749,532.

In October 2008, Mylan submitted ANDA No. 90-855 to market a generic version of this drug.  Because doxycycline was an old antibiotic, it was not entitled to most of the benefits of the Hatch-Waxman scheme at the time of this ANDA filing.  However, Congress subsequently revised the statute, paving the way for the Orange Book listing of the Ashley and Amin patents.  Nevertheless, the FDA made a determination that these "later-listed" antibiotic patents were not entitled to a 30-month stay.  Because the stay was not available, Galderma requested a preliminary injunction, which the United States District Court for the District of Delaware granted on June 28, 2010.  The FDA then approved Mylan's product on July 1, and the Chang patent issued on July 6, 2010.  In an effort to invalidate the Chang patent, Mylan filed a declaratory judgment action, and the two cases were subsequently combined.

After a trial on the merits, the lower court found that the Ashley patents were not infringed by Mylan because Galderma failed to prove that Mylan's ANDA product contained an amount of doxycycline that does not significantly inhibit the growth of microorganisms.  This outcome was based in part on the construction of two claim terms:  "a sub-antibacterial amount," which was held to mean "an amount that does not significantly inhibit the growth of microorganisms, e.g., bacteria," and "an amount that . . . has substantially no antibiotic activity," which was held to mean "an amount that is effective to treat the papules and pustules of rosacea but does not significantly inhibit the growth of microorganisms, e.g., bacteria."  The District Court also determined that the word "amount" applies to all parts of the human body.  Therefore, the Court concluded, because there are approximately 100,000,00,000,000 bacterial cells in the human body, it would be almost impossible for Galderma to prove infringement of a claim that required no significant inhibition of any of these microorganisms.  Moreover, Mylan had introduced in vivo studies that showed that the administration of its ANDA product significantly inhibited the growth of the bacteria in the oral cavity.  As a result, the District Court held that the claims of the Ashley patents were not infringed.  Mylan did not, however, prove that these same claims were invalid.

With respect to the Amin patents, which were the two patents that were the subject of the Federal Circuit opinion, the Court also found that Galderma failed to prove that the asserted claims were infringed.  Galderma had failed to prove that Mylan's ANDA product would inhibit the production of endogenously produced Nitric Oxide ("NO"), or inhibit the expression of inducible Nitric Oxide synthase ("iNOS").  In addition to the non-infringement finding, the lower court found that the asserted claims were inherently anticipated by several prior art references.  Claim 1 of the '395 patent was representative:

1.  A method for inhibiting nitric oxide production in a mammal system, comprising providing to the mammalian system an amount of a tetracycline compound sufficient to cause a decrease in the amount of nitric oxide produced endogenously by the mammalian-system.

The cited art did not expressly teach that the prior art use of doxycycline inhibited NO production or iNOS expression, but the District Court found these to be inherent properties of these references.  Half of these references taught the use of lower dosages of doxycycline, but the lower court only reviewed the higher dosage references to conclude that they all inherently anticipate all of the claimed methods.  However, as indicated above, because the dependent limitation, which required that the compound also have no anti-microbial activity, was not addressed, the validity finding of these dependent claims was in error.  The Federal Circuit stopped short of reversing this finding, but instead remanded for a determination of not only the teaching of the lower-dosage references, but an analysis of whether any of the references inherently disclosed the lack of anti-microbial activity.

Finally, the lower court did find that the later issued Chang patent was valid and infringed.  However, because the Chang patent was not Orange Book listed, the District Court held a separate hearing regarding remedies on February 17, 2012.  The Court subsequently granted a permanent injunction pursuant to 35 U.S.C. § 283 for many of the same reasons that it had previously granted the preliminary injunction.  It also held that Galderma was entitled to relief under 35 U.S.C. § 271(e)(4)(A), which prevents the FDA from approving an ANDA product prior to the expiration of the patent at issue.  Mylan had questioned whether such a remedy under this section was appropriate because the patent was not listed in the Orange Book.  The District Court pointed out, however, that the Federal Circuit recently addressed the issue whether Section 271(e)(2) was available to non-Orange Book listed patents that cover an ANDA product, concluding that it is the filing of an ANDA that infringes a patent that provides jurisdiction, regardless of whether that patent is listed in the Orange Book.  See AstraZeneca Pharmacetuticals LP v. Apotex Corp., 669 F.3d 1370 (Fed. Cir. 2012).  By extension, the lower court held that the Hatch-Waxman remedy of Section 271(e)(4) is also be available to a patent holder, regardless of whether the patent at issue is Orange Book listed.

The final matter addressed by the lower court was the disposition of the bond that Galderma posted upon entry of the preliminary injunction.  Mylan pointed out that the FDA approved its ANDA product on July 1, 2010, but the Chang patent did not issue until July 6, 2010.  Therefore, Mylan contended, because the District Court found that Mylan's ANDA product did not infringe either the Ashley or Amin patents, it was entitled to be compensated for the time between these few days.  The lower court disagreed, in part because Mylan had not presented its "winning" argument regarding the in vivo data until trial, and therefore to a certain extent was to blame for the harm it suffered.

In the end, the remand to determine the validity of the Amin patents was somewhat academic, in part because Mylan was found not to infringe the Amin patents anyway.  However, Galderma and its co-plaintiffs have filed suit against several other ANDA filers seeking to market generic versions of this drug.  Therefore, because it is possible that one or more of these ANDA products will be found to infringe the Amin patents, the validity of the dependent claim may turn out to be relevant after all.

Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2013)
Nonprecedential disposition
Panel: Circuit Judges Newman, Reyna, and Taranto
Per curiam opinion

NIH Implements New Policy on HeLa Genomic Data

By Donald Zuhn --

On Wednesday, the National Institutes of Health (NIH) announced that the agency had reached an understanding with the family of Ms. Henrietta Lacks regarding access to genomic data for the HeLa cell line, which was derived from cervical cancer cells taken from Ms. Lacks on February 8, 1951.  Ms. Lacks eventually died of cancer on October 4, 1951.  According to the NIH release, "the understanding gives the Lacks family a seat at the table in reviewing applications for controlled access to Henrietta Lacks' whole genome data."

NIH Director Dr. Francis S. Collins indicated that the sequencing and posting of the HeLa genome by researchers in Germany "brought into sharp relief important ethical and policy issues."  In response to concerns from the Lacks family, the German researchers took down the HeLa genomic data.  Dr. Collins noted that the NIH met with members of the Lacks family to listen to their concerns, and "arrived at a path forward that respects their wishes and allows science to progress."

The result of the discussions between the NIH and the Lacks family is a new controlled access policy for full genome sequence data from HeLa cells.  Under the policy, researchers who agree to the terms set forth in the HeLa Genome Data Use Agreement will be able to apply to the NIH for access to HeLa genomic data.  In addition, two representatives of the Lacks family will serve on a six-member working group that will review proposals for access to the HeLa genomic data.  NIH-funded researchers who obtain full genome sequence data from HeLa cells will also have to deposit such data into a single database for future sharing (other researchers are being encouraged to do the same).  Finally, all researchers who use or generate genomic data from HeLa cells will now be asked to include an acknowledgement and expression of gratitude to the Lacks family in their publications.

The NIH announcement also appeared in the journal Nature, where it was accompanied by a paper on a whole genome analysis of the CCL-2 strain of HeLa cells, which identifies an insertion of the human papilloma virus near an oncogene that may explain the aggressiveness of Ms. Lacks' cancer (Adey et al., "The haplotype-resolved genome and epigenome of the aneuploid HeLa cancer cell line," Nature 500: 207–11 (08 August 2013)).

Ambry Responds to Myriad Lawsuit

Asserts Affirmative Defenses and Antitrust Counterclaims and Asks for Declaratory Judgment

By Kevin E. Noonan --

On Monday Ambry filed its Answer to Myriad's complaint for patent infringement, and asserted patent misuse as an affirmative defense.  Ambry also asked the District Court for a declaratory judgment of non-infringement and invalidity of all patents Myriad has asserted, and raised antitrust counterclaims under the Sherman and Clayton Acts.

Procedurally, Ambry raised no challenge to jurisdiction or venue, but denied that the named plaintiffs are the owners or co-owners of the asserted patents, and admitted only that it provides genetic diagnostic testing services including for its BRCAplus, Breastnext, CancerNext, and OvaNext tests as of June 13, 2013.

Substantively, Ambry's Answer denies that any of the patents were duly and legally issued, that the claims are valid or infringed, or that Myriad has suffered any damages.  Ambry contends as affirmative defenses that Myriad fails to state a claim for relief, and that the patents are invalid under §§ 102, 103, 112, that the asserted claims do not recite patent-eligible subject matter under § 101, and that Myriad's asserted claims are unenforceable under the doctrine of patent misuse.  The Answer asserts no factual or legal grounds for any of its affirmative defenses.

It is in Ambry's counterclaims that things get interesting.  Ambry asserts that it is "a CAP-accredited, CLIA-certified commercial clinical laboratory, a recognized leader in diagnostic and contract genomic services specializing in the application of new technologies to molecular diagnostics and genetics research."  Its counterclaims are based on Sections 4 and 16 of the Clayton Act, 15 U.S.C. §§ 15 and 26, and seek treble damages and injunctive relief under the Sherman Act, 15 U.S.C. § 2.  Ambry also seeks a declaratory judgment that all claims of the patents asserted by Myriad are invalid and not infringed, either directly or through inducement (presumably, under 35 U.S.C. § 271(b)).  There are no allegations of unenforceability for inequitable conduct.

In its background facts, Ambry asserts the following allegations:

• Myriad is maintaining its monopoly in violation of the antitrust laws through "bad faith" enforcement of its patents

These assertions are based on Ambry's allegations that Myriad "knows" its patents are invalid under the Supreme Court's AMP v. Myriad and Mayo v. Prometheus decisions and the Federal Circuit's Myriad decision regarding method claims not asserted in this litigation.  Ambry characterizes this litigation as a continuation of "sharp and overreaching practices to wrongfully monopolize the diagnostic testing of human BRCA1 and BRCA2 genes in the United States and to attempt to injure any competitor who dares to challenge Myriad's monopoly."  These "sharp" practices include "(1) using research funded by public money to file patents over alleged inventions that the Supreme Court and the Federal Circuit have confirmed never should have been patented [an ex post facto argument that ignores the University of Utah's obligations to file such patents under the Bayh-Dole Act], (2) using those patents to intimidate and chill competition in the BRCA1 and BRCA2 genetic screening markets in the late 1990s to ensure monopoly profits, (3) taking patients' personal BRCA1 and BRCA2 genetic sequence data and depriving the public of access to that data to inhibit competition, and (4) using sales and marketing tactics with genetic counselors and payors to intentionally misrepresent the accuracy and reimbursement of Ambry's BRCA1 and BRCA2 diagnostic tests."  In Ambry's telling of the tale, the Utah inventors benefited from international efforts to identify breast cancer-specific genes, including identification of chromosome 17 as the site of BRCA1 by Mary Claire King.  This, in Ambry's telling, was the critical observation, after which "standard and well-known techniques could be used to sequence the gene."  This reading minimizes the vast difference between identifying a chromosome, or even a chromosomal region, genetically linked to a disease or disorder and isolating and sequencing the gene, as illustrated below (graphic courtesy of Courtenay Brinckerhoff):

The situation with the BRCA2 gene was similar, according to Ambry, with the Stratton group identifying chromosome 13 as the locus of that gene, and the collaborative nature of work towards its identification.  In addition, Ambry asserts that the Stratton group also isolated and sequenced BRCA2, at about the same time that Myriad announced its isolation of the gene.  Ambry also emphasizes the amount of "public and private" grant monies received by the Skolnick group ("$5 million in 1992, $8 million in 1993, and $9 million in 1994"), and later in their complaint alleges that Myriad attempted to deprive NIH researchers credit for inventorship (later rectified) and royalties (allegedly still owed these inventors).

Following these events, Ambry asserts that Myriad "quickly set out to commercialize its discoveries," inter alia, by applying for patents on the isolated BRCA1 and BCRA2 genes.  According to Ambry:

These patents rest on patenting the isolated DNA sequence of the BRCA1 and BRCA2 genes.  The claims at issue in this case do not cover novel diagnostic tools or methods used in genetic testing.  Nor are they analogous to patents on novel medical instruments.  Rather, these claims attempt to confer upon Myriad the exclusive right to read human BRCA1 and BRCA2 sequences.

(As in the ALCU's lawsuit, Ambry reduces the actual methods used to determine a genetic sequence to merely "reading" a sequence.)  Departing from factual allegations, Ambry proceeds to argue that Myriad's claims "either attempt to assert broad ownership over all human DNA sequences that can be used to amplify and sequence BRCA1 and BRCA2, or merely append routine steps to the patent claims, which would necessarily be conducted while assessing the biological relationships between mutations in the BRCA1 and or BRCA2 genes and the predisposition to cancer."  Further, Myriad's patenting strategy "is an overt attempt to convert these natural biological phenomena into patentable inventions using the patent language of a 'method' or 'process.'"  "In other words, the patent claims are directed to routine biological procedures and correlations generically such that it is effectively impossible for anyone in the United States in any meaningful way to 'make' or 'use' natural forms of isolated DNA molecules encoding the BRCA1 and BRCA2 genes in humans without infringing Myriad's patents," features that, in Ambry's view should apply to any genetic diagnostic method and, indeed, almost all diagnostic method claims.

Returning to its characterization of the facts, Ambry asserts that Myriad "set up $30 million diagnostics laboratory" and provided three tests:  a comprehensive assessment of both BRCA1 and BRCA 2 (costing $2400); a "single site" test for mutations "previously identified in another family member" ($395); and a "multisite" test specific for members of the Ashkenazi Jewish population.  Ambry also sets out Myriad's efforts to assemble "a group of laboratories, health insurers, sales teams and doctors to market and sell its tests," resulting in $20 million in revenue in the first three quarters of 1997 alone.  At the same time, according to Ambry, Myriad was threatening competitors (including those at the Genetic Diagnostic Testing Laboratory at the University of Pennsylvania) with infringement lawsuits for offering BRCA gene testing, and filed such a lawsuit against the University, which settled with an agreement that university laboratories would not offer these tests.  Interestingly, Ambry's allegations of Myriad's malfeasance include a settlement of litigation between Myriad and OncorMed that resulted in Myriad acquiring OncorMed's patents "to extend its monopoly."

• Myriad eschews considerations of affordability, test accuracy and recommendations for genetic testing

These allegations are based on the following facts according to Ambry.  Compared with OncorMed, Myriad offered a comprehensive rather than a "tiered" approach to testing, thus requiring the $2400 test rather than tests of fewer mutations offered by OncorMed costing around $500.  (Of course, when testing a "naïve" patient, i.e., one whose family history with regard to the existence of BCRA gene mutations was unknown, Myriad's testing would provide the best information on whether the patient was at risk for inherited breast cancer.)  Ambry also notes that while OncorMed complied with recommendations of a Federal Task Force on Genetic Testing (issued March 1996, at the dawn of the generic testing era), Myriad did (and does) not.  (A similar situation exists for recommendation from the American Society of Clinical Oncologists, issued May, 1996.)  Also in this section of the complaint are allegations that Myriad "misses" "up to 12%" of certain types of genetic variations (specifically, rearrangements, deletions and insertions), citing Congressional testimony from interested parties (including Wendy Chung, one of the ALCU plaintiffs) attributing delays in this testing to Myriad's "monopoly."

• There exists significant opposition to Myriad's business model of patenting gene sequences and establishing a private database

This portion of Ambry's counterclaims highlights Myriad's decision in 2004 not to contribute additional information on BRCA gene mutations obtained through is testing to a public repository of breast cancer-specific mutations, and the reaction of "[p]oliticians, clinicians, breast cancer advocacy groups and commentators" who oppose this decision (including the "Sharing Clinical Reports Project").  Also mentioned is the ACLU's lawsuit and the Supreme Court's decision invalidating five of nine claims at issue before the Court.

• Myriad is aware that its asserted claims on BCRA1 and BCRA2 genes are invalid under recent Supreme Court and Federal Circuit cases

In this portion of the "factual" background for its counterclaims, Ambry recites the history and outcomes of the ACLU's Myriad litigation, from the District Court through the Supreme Court's June 13th decision, as well as the effects of the Court's Mayo decision on this lawsuit.  (The history of these lawsuits have been extensively discussed and Ambry's characterization thereof will not be set forth here.)  This history is recited here as evidence that "rebuts and presumption [that] Myriad [] brought this suit in good faith."

As a consequence of these litigations, Ambry contends that "[Myriad's] asserted composition claims are not patent eligible, because they are identical to sequences that occur in nature (a variation of the Department of Justice's "magic microscope" test not explicitly relied upon by the Court).  According to Ambry, Myriad's asserted claims reciting BRCA gene-specific primers "on their faces fail to recite patentable subject matter" because the Supreme Court in its Myriad decision "unequivocally excluded from patentable subject matter synthetic DNA 'that may be indistinguishable from natural DNA.'"  (This is probably Ambry's strongest argument.)  Merely being "synthetic" is not enough to render these primers patent eligible, according to Ambry:  "even though the probe or the primer may have been synthesized in a laboratory, [it is not patent eligible] so long as it mirrors, in whole or in part, the genomic DNA of the BRCA1 or BRCA2 genes."

Turning to Myriad's asserted method claims, Ambry's argument is on less firm ground.  According to Ambry, these claims are also invalid under Myriad (and Mayo) because they recite "two biochemical processes [that] were well known in the art."  However, what was "routine, well-understood and conventional" in Mayo was not just the type of methods applied in those claims but the actual application of the recited methods themselves (i.e., testing blood from patients administered 6-thioguanine to determine drug or metabolite levels).  Here, in contrast, Ambry's argument is that these "two biochemical processes" (amplifying and sequencing DNA) were generically known, which it true.  But the application of these methods to the BCRA genes was not "routine, well-understood and conventional" prior to Myriad's patent filing because the subject matter, the BRCA genes, were unknown in the art.  Ambry attempts to overcome this logical deficiency by equating the BRCA genes to be a "law of nature"; while the association of specific mutations with breast cancer may be such a law, the genes themselves are not.  In keeping with the doctrinal laxness of the Court's Mayo decision, Ambry's arguments in this regard include not only subject matter ineligibility but the purported lack of novelty and obviousness of Myriad's methods, ignoring the fact that none of these deficiencies applies to the knowledge of the BCRA genes' existence in the prior art.  Indeed, it is much more consistent with the Supreme Court's Myriad decision that such claims are patent-eligible, in view of the Court's statement that:

Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.  Judge Bryson aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge.  Many of its unchallenged claims are limited to such applications."

Regardless, Ambry contends that Myriad filed its lawsuit "to enforce its invalid patents in bad faith in order to keep competitors from entering the market," citing Myriad's intention to maintain the "status quo" (which, according to Ambry is Myriad's "wrongful monopoly") as set forth in its brief in support of its preliminary injunction motion.  Ambry also asserts as an improper motive for the lawsuit its intention to contribute the results of its BRCA gene testing to public databases.  In Ambry's view, Myriad's failure to do the same constitutes an attempt to use "its invalid patents to maintain as secret patients' gene sequences (which do not belong to Myriad) in an attempt to limit competition."  And Ambry also asserts that Myriad is using the lawsuit to delay market entry by competitors other than Ambry, and to incorporate aspects of its own technology into Myriad's testing, resulting in an expropriation of "Ambry's superior screening services, which utilize more sensitive, efficient and cost-effective next-generation sequencing technologies."

Finally in this portion of Ambry's counterclaims is the allegation that Myriad has "market power" and that its activities have harmed the market.  This portion of Ambry's counterclaims assert that the market is diagnostic genetic testing for BCRA gene mutations in the United States, for which "[t]here are no products that are reasonably interchangeable substitutes for [BRCA] genetic tests."  BRCA testing is also subject to high barriers to entry, including "the various patents Myriad holds, the technological know-how for designing and running genetic tests to identify mutations in BRCA1 and BRCA2, and establishing relationships with genetic counselors and hospitals, many of which are already heavily utilizing Myriad's tests."  Myriad has an "over 90% market share" for BRCA genetic testing and "possesses the power to control prices and exclude competitors."  And the public suffers because Myriad's tests are "nearly 100% higher" in costs than Ambry's.  Additionally, Ambry contends that Myriad's contention that Ambry's testing has "variant of unknown significance (VUS)" rates of 10-30% are false, and that Myriad knowing this falsity has had its employees conduct a campaign of informing genetic counselors of this false VUS rate for Ambry's BRCA testing.  And these allegations (which are used to support Ambry's antitrust counterclaims) extend past Myriad:  "Plaintiffs in this action are aware of the anticompetitive and exclusionary conduct by Myriad [and] that each and every Plaintiff is aware that the claims of the asserted patents are facially invalid [and] that each and every plaintiff was involved in the decision to bring this lawsuit, notwithstanding that the asserted claims are facially invalid."

Count 1 of Ambry's counterclaims is brought under Section 2 of the Sherman Antitrust Act (against Myriad only).  According to this counterclaim:

126.  Myriad is willfully maintaining its monopoly through exclusionary conduct as distinguished from growth or development as a consequence of a superior product, business acumen, or historic accident.  Myriad seeks to maintain its monopoly position through various anticompetitive conducts described above, including through the bad faith enforcement of its facially invalid patents.

127.  Myriad was aware before filing its Complaint in this action that the claims it was asserting are invalid per Myriad and Prometheus.

128.  Through its exclusionary and anticompetitive conduct, Myriad has acquired and maintained its monopoly in the relevant market for genetic testing for patients seeking analysis of their full BRCA1 and BRCA2 gene sequences.  Myriad has operated in this manner free from competition because of the high barriers to entry that exist in the market, including Myriad's invalid patents, the technological know-how to design and run genetic tests, and the actions of Myriad's employees.

Ambry alleges it has suffered "substantial injury to its business and property" as a consequence, and that "[c]ompetition in the relevant market" has similarly suffered "[d]ue to Myriad's anticompetitive conduct."

Count 2 is brought under the Sherman Act for "attempted" monopolization for substantially the same market behavior, Ambry alleging that Myriad acted "with a specific intent to monopolize the relevant market through the assertion of facially invalid patent claims and the anticompetitive conduct of its employees."

Ambry does not expressly assert that the patents were obtained through fraud, or that the litigation is brought as a sham, but rather that the effects of Myriad's assertion of patent claims Ambry asserts are invalid under recent Federal Circuit or Supreme Court precedent should incur antitrust liability.  In this regard no better authority that Chief Justice Roberts may be consulted regarding the relevant legal standard:

The point of patent law is to grant limited monopolies as a way of encouraging innovation.  Thus, a patent grants "the right to exclude others from profiting by the patented invention."  Dawson Chemical Co. v. Rohm & Haas Co., 448 U. S. 176, 215 (1980).  In doing so it provides an exception to antitrust law, and the scope of the patent -- i.e., the rights conferred by the patent -- forms the zone within which the patent holder may operate without facing antitrust liability.

This should go without saying, in part because we've said it so many times.  Walker Process Equipment, Inc. v. Food Machinery & Chemical Corp., 382 U. S. 172, 177 (1965) ("'A patent . . . is an exception to the general rule against monopolies'"); United States v. Line Material Co., 333 U. S. 287, 300 (1948) ("[T]he precise terms of the grant define the limits of a patentee's monopoly and the area in which the patentee is freed from competition"); United States v. General Elec. Co., 272 U. S. 476, 485 (1926) ("It is only when . . . [the patentee] steps out of the scope of his patent rights" that he comes within the operation of the Sherman Act); Simpson v. Union Oil Co. of Cal., 377 U. S. 13, 24 (1964) (similar).

The key, of course, is that the patent holder -- when doing anything, including settling -- must act within the scope of the patent.  If its actions go beyond the monopoly powers conferred by the patent, we have held that such actions are subject to antitrust scrutiny.  See, e.g., United States v. Singer Mfg. Co., 374 U. S. 174, 196–197 (1963).  If its actions are within the scope of the patent, they are not subject to antitrust scrutiny, with two exceptions concededly not applicable here:  (1) when the parties settle sham litigation, cf. Professional Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc., 508 U. S. 49, 60–61 (1993); and (2) when the litigation involves a patent obtained through fraud on the Patent and Trademark Office.  Walker Process Equipment, supra, at 177.

FTC v. Activis (Roberts, CJ, dissenting).

The other asserted counterclaims comprise asking the Court for a declaratory judgment of non-infringement and invalidity of each of the asserted patents.

Ambry asks for a jury trial, declaratory judgment, an injunction under Section 16 of the Clayton Act to prevent Myriad or the other plaintiffs from enforcing the patents-in-suit, treble damages on Ambry's Sherman Act antitrust counterclaims, and costs and attorneys' fees.

NCI Researchers Generate Largest Database of Cancer-specific Genetic Variations

    By Donald Zuhn --

Last month, the American Association for Cancer Research (AACR) announced that researchers at the National Cancer Institute (NCI) had generated a data set of cancer-specific genetic variations, which the researchers were making freely available to the research community.  The data set of coding variants in the NCI-60 panel of cell lines was described in the July 15 issue of the AACR journal Cancer Research (Abaan et al., "The Exomes of the NCI-60 Panel: A Genomic Resource for Cancer Biology and Systems Pharmacology").  The NCI-60 human cancer cell line panel, which consists of 60 different cell lines representing cancers of the lung, colon, brain, ovary, breast, prostate, and kidney, as well as leukemia and melanoma, is used extensively by cancer researchers to discover anti-cancer drugs.  According to the article, the genomic variants identified in the NCI-60 panel are being made available at the NCI DTP, CellMiner, and Ingenuity websites.

Co-author Dr. Yves Pommier, chief of the NCI's Laboratory of Molecular Pharmacology, noted that the data set of coding variants constitutes "the largest database worldwide, containing 6 billion data points that connect drugs with genomic variants for the whole human genome across cell lines from nine tissues of origin, including breast, ovary, prostate, colon, lung, kidney, brain, blood, and skin."  He added that "[o]pening this extensive data set to researchers will expand our knowledge and understanding of tumorigenesis, as more and more cancer-related gene aberrations are discovered."

The comprehensive list of cancer-specific genetic variations was generated by conducting whole-exome sequencing of the NCI-60 human cancer cell line panel.  The genetic variations that were identified consisted of two types:  type I variants corresponding to variants found in the normal population, and type II variants, which are cancer-specific.

Preliminary studies conducted by the researchers indicate that the data set has the potential to enhance our understanding of the relationships between specific cancer-related genetic variations and drug response.  In particular, the researchers were able to predict the sensitivity of cells harboring type II variants to 103 anti-cancer drugs approved by the FDA and an additional 207 investigational new drugs.

One month prior to the release of the NCI-60 panel database, the Genetic Alliance, a network of more than 1,200 disease-specific advocacy organizations, thousands of universities, private companies, government agencies, and public policy organizations, announced the launch of an initiative to fill the public information gap caused by the lack of available genetic information for the BRCA1 and BRCA2 genes (see "Consortium Launches Public Database of BRCA Data").  The Genetic Alliance announcement came on the same day that the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc.

News from Abroad: UK High Court Considers quia timet Injunctions

The UK High Court recently gave its judgment in the case of Merck, Sharp & Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Ltd (collectively referred to in the judgement as BMS) v Teva Pharma B.V. and Teva UK Ltd (Teva) (decision).  The judgement is interesting as it is one of the few so called "quia timet" injunctions that has been issued by the UK High Court on the basis of a contention by a patent proprietor that a generic pharmaceutical company intends to launch its generic drug whilst the patent and SPC under which the drug is protected are still in force.  A quia timet injunction is an injunction to restrain harm which has not yet occurred but what is being threatened is imminent.

The patent

Efavirenz is a drug used to control HIV infections and is protected by the patent EP (UK) 0 582 455 (and its associated SPC) which is owned by Merck.  The patent will expire on 3 August 2013 and the SPC on 20 November 2013.

Interim injunction

Teva obtained a marketing authorisation for Europe for generic efavirenz in early 2012.  From its actions in previous cases, such as the Warner Lambert case concerning generic atorvastatin, Teva had a reputation to launch generic versions of a drug while the patent and SPC protecting the drug were still in force.  BMS therefore asked Teva what its intentions were regarding the launch of generic efavirenz.  Teva replied that its policy was to not divulge commercial information to its competitors.  It also pointed out that the grant of the marketing authorisation for generic efavirenz permits but does not require Teva to market the generic product and that it was Teva's policy to not infringe valid patents.

Dissatisfied with Teva's reply, BMS applied to the UK court for injunctive relief alleging that Teva's actions to obtain a marketing authorisation for Europe at an unusually early time during the patent term and its reluctance to provide details of its intentions concerning the launch of generic efavirenz in the UK indicated an intention to infringe the patent and SPC.

Teva countered that the claim should be struck out because it was not based on the validity of the patent but instead on whether Teva's actions amounted to a threat to infringe.

The judge believed that BMS had reasonable grounds for seeking injunctive relief.  In the judge's view, the fact that Teva went to the trouble of obtaining a marketing authorisation for efavirenz gave a concrete inference that Teva intended to sell efavirenz at some time.  Furthermore, the judge found that the fact that Teva obtained the marketing authorisation almost 22 months before patent expiry, which is unusually early, supported an inference that generic efavirenz was intended to be launched before patent expiry.

An interim injunction was therefore granted on 15 March 2012 against Teva to prevent the launch of generic efavirenz in the UK.

Final trial

At final trial (decision issued on 9 July 2013) the only question that was considered was whether Teva, by its actions, threatened to infringe EP (UK) 0 582 455 and its associated SPC before their expiry and, thus, whether a final injunction for the remaining term of the patent and SPC ought to be granted.

Teva argued that at the time the action was brought (February 2012) it did not intend to launch generic efavirenz before expiry of EP (UK) 0 582 455 and its associated SPC.  Teva presented documentation from its in-house legal and commercial departments which, Teva asserted, supported its position.

The judge summarised the test under UK law for granting quia timet injunctions as whether, in all the circumstances, there is a sufficiently strong probability that an injunction will be required to prevent harm to the claimant occurring that the bringing of proceedings by the claimant is justified.  The defendant's intentions before the action is brought are central to the assessment.  Important considerations are the defendant's subjective intentions and acts and what third parties would perceive the defendant's intentions to be.

In the present case, in considering the "third parties perceptions" arm of the test, the judge held that when the action was brought, third parties would perceive that there was a threat to infringe EP (UK) 0 582 455 and its associated SPC because in the past Teva had launched products before expiry and without notice to the patentee.  In considering the "subjective intentions" arm of the test, during the case Teva had informed BMS that it did not "have any plans to supply pharmaceutical products containing efavirenz" in the UK before SPC expiry.  However, from internal documents disclosed by Teva during the trial, the judge found that Teva was actively considering whether or not to launch its generic drug in the UK before the expiry of the SPC.

The court therefore held that it was appropriate to continue the preliminary injunction to restrain Teva from infringing the patent and the SPC up to their expiry.

The judgement provides useful guidance for pre-action correspondence which seeks to ascertain when a company plans to launch its generic drug.  If generics companies withhold such information from patent proprietors they may face actions for quia timet injunctions.  Therefore, if a generics company is asked by an originator company about its intentions concerning the launch of a generic drug, the generic company should consider supplying assurances that generic drugs will not be launched while patent rights remain in force.  Such assurance may be given under confidence to prevent commercially sensitive information being divulged to competitor generics companies.

This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.

Court Report

By Sherri Oslick --

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

UCB, Inc. et al. v. Sun Pharma Global FZE et al.
1:13-cv-05514; filed August 1, 2013 in the Northern District of Illinois

• Plaintiffs:  UCB, Inc.; UCB Pharma GmbH; Research Corporation Technologies, Inc.; Harris FRC Corp.
• Defendant:  Sun Pharma Global FZE; Sun Pharmaceutical Industries, LTD.; Sun Pharmaceutical Industries, Inc.

Infringement of U.S. Patent No. RE38,551 ("Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of UCB's Vimpat® (lacosamide, used as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy aged 17 years and older).  View the complaint here.

Medical University of South Carolina Foundation for Research Development et al. v. AstraZeneca Pharmaceuticals LP
2:13-cv-02078; filed July 31, 2013 in the District Court of South Carolina

• Plaintiffs:  Medical University of South Carolina Foundation for Research Development; Charleston Medical Therapeutics Inc.
• Defendant:  AstraZeneca Pharmaceuticals LP

Infringement of U.S. Patent No. 6,511,800 ("Methods of Treating Nitric Oxide and Cytokine Mediated Disorders," issued January 28, 2003) based on AstraZeneca's manufacture and sale of its Crestor® product (rosuvastatin calcium, used to treat high cholesterol and atherosclerosis).  View the complaint here.

Alcon Research Ltd. v. Mylan Pharmaceuticals Inc. et al.
1:13-cv-01332; filed July 26, 2013 in the District Court of Delaware

• Plaintiff:  Alcon Research Ltd.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. 8,268,299 ("Self Preserved Aqueous Pharmaceutical Compositions," issued September 18, 2012), 8,323,630 (same title, issued December 4, 2012), and 8,388,941 (same title, issued March 5, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Alcon's Travatan Z® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention).  View the complaint here.

Depomed, Inc. v. Banner Pharmacaps Inc. et al.
2:13-cv-04542; filed July 26, 2013 in the District Court of New Jersey

• Plaintiff:  Depomed, Inc.
• Defendants:  Banner Pharmacaps Inc.; Watson Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,365,180 ("Oral Liquid Compositions," issued April 2, 2002), 7,662,858 ("Method of Treating Post-Surgical Acute Pain," issued February 16, 2010), 7,884,095 (same title, issued February 8, 2011), 7,939,518 (same title, issued May 10, 2011) and 8,110,606 (same title, issued February 7, 2012) following a Paragraph IV certification as part of Banner's filing of an ANDA to manufacture a generic version of Depomed's Zipsor® (diclofenac potassium, used for relief of mild to moderate acute pain).  View the complaint here.

Janssen Pharmaceuticals, Inc. et al. v. Actavis Elizabeth LLC et al.
2:13-cv-04507; filed July 25, 2013 in the District Court of New Jersey

• Plaintiffs:  Janssen Pharmaceuticals, Inc.; Grunenthal GmbH;
• Defendants:  Actavis Elizabeth LLC; Actavis, Inc.; Actavis LLC; Alkem Laboratories Ltd.; Ascend Laboratories, LLC

Infringement of U.S. Patent Nos. RE39,593 ("1-Phenyl-3-Dimethylaminopropane Compounds With a Pharmacological Effects," issued April 24, 2007), 7,994,364 ("Crystalline Forms of (-)-(1R,2R)-3-(3-Dimethylamino-1-Ethyl-2-Methylpropyl)-Phenol Hydrochloride," issued August 9, 2011) and 8,309,060 ("Abuse-Proofed Dosage Form," issued November 13, 2012), licensed to Janssen, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Janssen's Nucynta® and Nucynta®  ER (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults).  View the complaint here.

Nomination Period for 2013 ABA Blawg 100 Closes August 9th

Last month, the ABA Journal began work on its 7th annual list of the 100 best legal blogs (or blawgs) and announced that it is seeking the advice of its readers, via the ABAJournal.com website, on which blogs to include on this year's Blawg 100.  Last year, Patent Docs was honored to be included among five blogs selected in the IP Law category of the Blawg 100 (see "ABA Journal Announces 2012 Blawg 100").

Readers interested in nominating a particular blog should use the blawg 100 amici form provided on the ABA Journal website.  Additional information about the Blawg 100 can also be found on the blawg 100 amici form.  The nomination period for the ABA Blawg 100 closes on Friday, August 9th.

Conference & CLE Calendar

August 5-7, 2013 - Advanced Patent Law Seminar (Chisum Patent Academy) - Seattle, WA

August 8, 2013 - Analyzing and Adapting to the Supreme Court's Myriad Ruling (Technology Transfer Tactics) - 1:00 to 2:00 pm (Eastern)

August 8-11, 2013 - 2013 Annual Meeting (American Bar Association) - San Francisco, CA

August 21, 2013 - Inducement to Infringe in Hatch-Waxman Litigation: Lessons from Commil USA v. Cisco Systems and Bayer Schering v. Lupin for Pharma Patents (Strafford) - 1:00 to 2:30 pm (EDT)

August 22, 2013 - What are the Implications of CLS Bank Int'l v. Alice Corp. on Computer-Implemented Inventions? (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

August 29, 2013 - AIA Impact on Section 102 and Prior Art: Navigating the Expanded Scope of Prior Art and the AIA Exceptions (Strafford) - 1:00 to 2:30 pm (EDT)

September 15-17, 2013 - 41st IPO Annual Meeting (Intellectual Property Owners Association) - Boston, MA

September 16, 2013 - The European Unitary Patent: Strategic Considerations for a New Era (McDonnell Boehnen Hulbert & Berghoff LLP & Nederlandsch Octrooibureau) - Chicago, IL

September 17-18, 2013 - FDA Boot Camp*** (American Conference Institute) - Boston, MA

September 18, 2013 - Conflicts in Patent Prosecution: Avoiding the Ethical Pitfalls Minimizing Risks of Malpractice Liability and Ethics Sanctions (Strafford) - 1:00 to 2:30 pm (EDT)

September 23-24, 2013 - International Congress on Paragraph IV Litigation*** (Momentum) - New York, NY

September 26, 2013 - Supreme Court IP Review (IIT Chicago-Kent College of Law) - Chicago, IL

October 3-4, 2013 - Paragraph IV Disputes*** (American Conference Institute) - Chicago, IL

***Patent Docs is a media partner of this conference or CLE

ACI Paragraph IV Disputes Conference

American Conference Institute (ACI) will be holding its next Paragraph IV Disputes conference on October 3-4, 2013 in Chicago, IL.  The conference will allow attendees to:

• Devise strategies relative to the use of new PTO proceedings such as IPR in Hatch-Waxman litigation;
• Understand how new 271(e)(1) controversies under Claussen and Momenta may undo Roche v. Bolar;
• Decipher the implications of the Watson case for pharmaceutical patent settlements;
• Assess how contradictory findings in the federal courts and PTO relative to obviousness will impact primary compound and composition claims;
• Formulate a plan of action for Markman hearings in view of the ongoing intra-circuit discord at the CAFC on claim construction;
• Identify new challenges to market as well as regulatory exclusivities;
• Appreciate how FDASIA, the GAIN Act, and Generic User Fees Act will influence FDA regulatory redress in Hatch-Waxman matters;
• Evaluate Orange Book-listed method of treatment patents in view of new rulings on inducement and divided infringement; and
• Anticipate damages quantifications for at risk launches vis-à-vis Protonix.

In particular, ACI's faculty will offer presentations on the following topics:

• Identifying patents which may be ripe for challenges of invalidity and non infringement: Offensive and defensive strategies for brand names and generics;
• Use of IPR and other PTO proceedings in a Paragraph IV challenge: Strategies for brand names and generics in navigating new proceedings in alternate and parallel forums which may change the rules of the Hatch-Waxman endgame;
• The start of the Paragraph IV litigation countdown: The Paragraph IV certification and notice letter;
• Obviousness in review: Formulating assertions and defenses in view of new substantive and procedural developments in the Federal courts and PTO;
• Advanced strategies for drafting and perfecting pleadings and effectively using dispositive motions in Paragraph IV disputes;
• Of customs and courts: The importance of mastering the requirements of local patent rules in Paragraph IV disputes;
• A view from the Bench;
• The end of Roche v. Bolar? -- Understanding how new 271(e) (1) controversies may alter the course of brand name and generic strategies in Paragraph IV litigation relative to safe harbor research exceptions;
• Mastering regulatory maneuvers in Paragraph IV disputes: Seeking relief from the FDA in the course of Hatch-Waxman litigation;
• New exclusivity challenges for brand names and generics;
• Pay-for-delay and settlement drafting update;
• Continuing claim construction conundrums impacting Markman strategies;
• Evolving theories of inducement and divided infringement in Paragraph IV litigation concerning method treatment patents;
• Protonix -- Case study of an at risk launch: Pros and cons analysis of launching at risk and survey of new developments in seeking injunctive relief and damages; and
• Inequitable conduct: Ethical considerations for Paragraph IV matters before the PTO and district court.

In addition, two pre-conference workshops will be offered on October 2, 2013.  The first, entitled "Hatch-Waxman and BPCIA Master Class -- Perfecting Your IP and Regulatory IQ of Small and Large Molecules" will take place from 8:30 am to 12:00 pm, and the second, entitled "Post-Grant Review and Inter Partes Review Boot Camp: Essential Considerations for Brand Names and Generics Regarding the Use of These PTO Procedures in Paragraph IV Scenarios" will take place from 2:00 to 5:30 pm.

The agenda for the Paragraph IV Disputes conference can be found here.  More information regarding the workshops and master class can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and one workshop), or $3,495 (conference and two workshops).  Those registering by September 9, 2013 will receive a $200 discount.  Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of the Paragraph IV Disputes conference.

Supreme Court IP Review Conference

IIT Chicago-Kent College of Law will be holding the Supreme Court IP Review (SCIPR) conference on September 26, 2013 at the IIT Chicago-Kent College of Law in Chicago, IL.  The conference will provide intellectual property practitioners, jurists, legal academics, and law students with a review of IP cases from the U.S. Supreme Court's 2012 Term, a preview of cases on the docket for the 2013 Term, and a discussion of cert. petitions to watch.

The conference will cover the six IP cases decided during the 2012 Term:

• Association for Molecular Pathology v. Myriad Genetics, Inc. (patentability of human DNA sequences) -- panel including Patent Docs author Dr. Kevin Noonan
• Bowman v. Monsanto Company (patent exhaustion in second generation of genetically modified seeds)
• Kirtsaeng v. John Wiley & Sons, Inc. (international copyright exhaustion)
• Already, LLC v. Nike, Inc. (impact of covenant-not-to-sue on declaratory judgment jurisdiction in trademark cases)
• Gunn v. Minton (Federal Circuit jurisdiction over patent malpractice claims)
• FTC v. Actavis, Inc. (antitrust and reverse payments to settle patent litigation)

The Honorable Diane Wood, Circuit Judge, U.S. Court of Appeals for the Seventh Circuit will deliver the keynote address.

A complete agenda for the conference, including a list of speakers, can be found here.  Additional information about the conference can be found here.  Those interested in attending Friday's sessions can do so here.  The registration fee is $35 (general public), $15 (outside academics and students), or free (Chicago-Kent faculty and students).

Seminar on European Unitary Patent

McDonnell Boehnen Hulbert & Berghoff LLP will be hosting a live onsite seminar entitled "The European Unitary Patent: Strategic Considerations for a New Era" on September 16, 2013 from 9:30 am to 10:30 am (CT) at its Chicago, IL office.  Nederlandsch Octrooibureau ("NLO") patent attorneys Paul Clarkson and Caroline Pallard will explain the upcoming changes in the European Patent System, explore the consequences such changes may have for U.S. clients with patent portfolios within this jurisdiction, and look at the enforcement possibilities within the new regime and the strategies that U.S. clients may wish to consider in order to maximize the effectiveness of their IP investments.

While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for Illinois.

Consumer Watchdog Argues That WARF Stem Cell Patent Is Invalid under § 101

By Donald Zuhn --

Last month, Consumer Watchdog filed its opening brief in an appeal of a Board decision affirming the patentability of U.S. Patent No. 7,029,913, arguing that the claims of the '913 patent are invalid because they cover ineligible subject matter and were anticipated and obvious.  The appeal arises from an inter partes reexamination of the '913 patent that Consumer Watchdog, which describes itself as a not-for-profit public charity dedicated to providing a voice for taxpayers and consumers in special interest-dominated public discourse, government and politics, filed in 2006.  The '913 patent, which is assigned to the Wisconsin Alumni Research Foundation (WARF), has three claims.  According to the Consumer Watchdog brief, independent claim 1 (as amended by WARF during the reexamination) recites:

1. (Amended) A replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo, wherein the stem cells (i) will proliferate in an in vitro culture for over one year in an undifferentiated state without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.

After the Patent Office granted Consumer Watchdog's request for an inter partes reexamination (Control No. 95/000,154), the Examiner determined that the pending claims were allowable, and Consumer Watchdog appealed to the Board.  The Board reversed, designating four news grounds of rejection (one anticipation rejection and three different obviousness rejections), and WARF responded by filing a request to reopen prosecution along with an amendment and a declaration.  The Examiner determined that the claims were patentable over the Board's rejections, and the Board affirmed.  Consumer Watchdog's appeal to the Federal Circuit followed.

In addition to arguing that the '913 patent is invalid as anticipated or obvious in view of the references on which the Board based its new grounds of rejection, Consumer Watchdog also argues that the claims of the '913 patent are invalid under § 101.  In particular, the brief states:

As a threshold matter, the claims of the '913 patent are invalid under 35 U.S.C. § 101 for claiming subject matter that is not patent eligible.  Specifically, the claimed hES [human embryonic stem] cell culture falls within the "product of nature" exception to statutory subject matter.  It is within the Court's discretion to address this issue despite the fact that the Board failed to address it below, and is especially appropriate in light of the recent Supreme Court ruling on Section 101 in Ass'n. for Molecular Pathology v. Myriad Genetics, Inc.. 2013 U.S. LEXIS 4540 (June 13, 2013).

Noting that "[t]he Supreme Court restated [in June] that discovery and isolation of a product that occurs in nature does not render that product patent eligible under Section 101," the brief attempts to draw analogies between its appeal and the Myriad case.  For example, the brief states that "[a]s in AMP, the '913 patent's claims are drawn to neither a method of preparation nor a scientific application of the claimed composition."  The brief also suggests that:

The '913 patent's requirement that the claimed culture of cells be in vitro is analogous to the claim limitation in AMP that the DNA be "isolated."  But here there is not even a chemical change between ES cells in an in vivo embryo and ES cells in an vitro culture as there is between human DNA in vivo and isolated DNA in vitro.

The brief also notes that "[t]he '913 patent does not in any way distinguish the claimed ES cells from those that exist in nature," adding that "if the claimed ES cells were not the same as natural ES cells, the claimed invention would offer very little benefit for medical research."  As the brief argues, "WARF did not create or alter the properties inherent in stem cells any more than Myriad created or altered the genetic information encoded in the DNA it claimed."

Although "[t]he Board never considered whether the claims to hES cells are patent eligible subject matter," the brief contends that "the Court may still consider whether the claims here are invalid under Section 101 because, 'a court may consider an issue antecedent to . . . and ultimately dispositive of the dispute before it, even an issue the parties fail to identify and brief,'" citing U.S. Nat'l Bank v. Indep. Ins. Agents, 508 U.S. 439, 447 (1993).  With respect to the issue of patent eligibility, the brief states that "[c]onsideration of the 101 question is especially appropriate in light of the fact that the Supreme Court's recent AMP decision came after the Board's decision here."

WARF now has until August 12 to file its opening brief in the appeal.