Patent Docs

Supreme Court Grants Cert in AMP v. Myriad

By Kevin E. Noonan --

In a decision that should surprise no one, the U.S. Supreme Court granted certiorari today in Association for Molecular Pathology v. Myriad Genetics, Inc.  The grant was limited to the first question presented, whether human genes are patent-eligible, and the Court denied certiorari on the other two questions (thus letting stand the Federal Circuit's determination that screening methods using genetically transformed cells are patent-eligible under the Court's Mayo v. Prometheus precedent, and that a declaratory judgment plaintiff must cite actual injury to have standing).

The decision is unsurprising in view of the (relative) specificity of the question presented and the overwhelmingly one-sided nature of the amicus briefing (see "AMP v. Myriad Briefed and Distributed for Conference").  Later posts will discuss potential outcomes and stratagems for ensuring that the Court is fully informed on the facts rather than the rhetoric of gene patents. But one thing is certain:  anyone with skin in this game who sits on the sidelines should be ashamed.

Myriad Files Responsive Brief Opposing Certiorari

By Kevin E. Noonan --

On Halloween, Myriad Genetics filed its brief in opposition to plaintiffs' petition for certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. (plaintiffs nominally being the Association for Molecular Pathology et al., but actually the American Civil Liberties Union and the Public Patent Foundation).  In doing so, Myriad no doubt understands the position of the boy encountered by St. Augustine who was trying to empty the ocean into a hole in the sand on the beach; in reality, Myriad faces not only petitioners by the plethora of amici from a variety of academics, patients, doctors, and civil liberties groups clamoring for the Court to grant cert. (see "AMP v. Myriad Briefed and Distributed for Conference").

Petitioners presented three questions to the Court, all countered by Myriad in its respondents' brief:

1.  Are human genes patentable?

2.  Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?

3.  Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally and directly threatened with an infringement action?

Myriad's brief begins by setting out the context in which this case was brought, long (~30 years) after the U.S. Patent and Trademark Office began granting patents on isolated genes.  Citing the PTO's "specific expertise in issues of patent law" (and reminding the Court that it was content to rely on that expertise as recently as its decision in J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred Int'l. Inc.), the brief recites not only a brief history of gene patenting but also instances where the Office established rules to ensure that such claims were properly within the scope of 35 U.S.C. §§ 101 and 112 (i.e., the 2001 Utility Guidelines).  And the brief reminds the Court that the biotechnology industry has relied on the determination that genes are patent-eligible during that time, and the societal benefits that have accrued as a result.  Turning specifically to Myriad, the brief recounts how it was that the company isolated the genes and then determined which mutations were relevant to a breast or ovarian cancer diagnosis, and the extent to which these accomplishments required human ingenuity, effort, and invention.  The brief sets forth the accolades Myriad (rightfully) received for this achievement, and then discusses the extent to which the protection Myriad obtained from its patents was commensurate in scope with its contributions.

Importantly, the brief also rebuts some of the untruths espoused by petitioners and their amici, regarding the effects of the Myriad patents on the field and particularly the efforts of others, unimpeded by Myriad's patents, to undertake genetic experimentation including the Human Genome Project and continuing into the present day with individual genome sequencing.  In so doing, the brief lays to rest another misstatement by petitioners (no doubt motivated by the effect the argument had on Judge Bryson at the Federal Circuit), that Myriad's claims would somehow interfere with such individual genomic sequencing, citing Chris Holman's 2012 law review article, "Will Gene Patents Derail the Next Generation of Genetic Technologies?: A reassessment of the Evidence Suggests Not," 80 UMCK 563, as well as noting alternative technologies by which mutations in the BRCA1 and BRCA2 genes could be detected that would not infringe Myriad's claims (without accentuating for the Court that these technologies could not be so used if Myriad had not identified the mutations in the first place).

Following this introduction, the brief sets forth the proceedings in the District Court and Federal Circuit below before returning to its argument countering petitioners and their amici.  In so doing, the brief highlights for the Court the political motivations behind this case, stating that "[p]laintiffs' counsel hand-selected the challenged claims.  As part of a strategy of 'pick[ing] one case' for a broad assault on all patents covering similar subject matter."  Thereafter the brief provides the Court with "corrections of petitioners' misstatements," necessary not only to prevent the Court from relying on these falsehoods but for provoking in the Justices the question of why plaintiffs' petition is based on such misstatements in the first place.  These include:

1.  The first question presented bears no relation to the uncontroverted facts of this case.  Petitioners seek to present this case as asking whether "human genes" are patent-eligible.  Of course, the genetic material naturally existing in every human being is not an "invention," i.e., it is not the product of human ingenuity.  But this case does not involve claims to such "native" human genes.  The challenged composition claims are instead narrowly drawn to specific, defined DNA molecules, isolated by human scientists in laboratories, that do not naturally occur.  As Judges Lourie and Moore explained, molecules of isolated BRCA1 and BRCA2 DNA are chemical "composition[s] of matter" that are just as deserving of patent eligibility as any other human-made molecule.  Indeed, numerous pharmaceutical and biotechnical inventions are claimed as specified molecules.  This perhaps explains petitioners' insistence on framing their first question as "Are human genes patentable?", instead of addressing the question actually presented to and answered by the lower courts regarding the patent-eligibility of molecules defined, cultivated, and isolated by men and women through the application of human ingenuity.

2.  Petitioners also contend that "[s]tandard isolation results in random DNA fragments that are identical to those that exist naturally in the body."  . . .  By definition, however, an "isolated" DNA molecule has been removed from its naturally occurring environment.  . . .  A molecule cannot simultaneously be "removed from its naturally occurring environment" and "exist naturally in the human body" -- its naturally occurring environment.  As Judge Lourie explained in his lead opinion:  "It is undisputed that Myriad's claimed isolated DNAs exist in a distinctive chemical form -- as distinctive chemical molecules -- from DNAs in the human body," because of "human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA."  . . .  Petitioners' belated factual claim that covalent bonds of DNA molecules may be broken in the body . . . is irrelevant.  This assertion omits critical elements of the definition of "isolated" DNA.  Isolated DNA is not merely DNA that has had bonds broken; the breaking of covalent bonds, while important, is but one part.  Isolation further requires separation of the specific DNA of interest from the rest of the DNA in the body and even the rest of the fragmented DNA that may be present in a test tube outside the body.  Even setting aside the human-engineered initial fragmentation breaking the covalent bonds, such specific, precisely defined (i.e., targeted) separation does not naturally occur in the body.  Thus, it is a contradiction in terms to say that "isolated" DNA exists within the body.  . . .

3.  Contrary to petitioners' cursory and unsupported assertions, neither Myriad nor its patents hinder research of BRCA genes.  One named plaintiff concedes that she "could sequence the BRCA1 and BRCA2 genes for purely research purposes," and has been doing so without impediment.  . . .  The undisputed facts further demonstrate that 18,000 researchers have conducted studies on BRCA1/2 genes, over 8,000 relevant papers have been published on BRCA1/2 genes, and over 130 clinical trials regarding BRCA1/2 genes have commenced since Myriad publicly disclosed its inventions.  . . .  Moreover, multiple laboratories provide "second opinions" regarding BRCA1/2 test results.  In short, Myriad's patents do not hinder research.  . . .

4.  Petitioners allege that Myriad has "stopped other laboratories from creating and offering new and improved testing procedures" and has "the right to exclude the rest of the scientific community from examining the naturally-occurring genes of every person in the United States."  . . .  These statements are false.  The challenged claims do not preempt, preclude, or prohibit others from creating and offering new and improved testing services.  To the contrary, Myriad's composition claims are limited to the precise isolated molecules it created and that are recited in the patents.  These claims do not preempt or preclude other technologies that have been developed and are currently being used to study the human genome and identify genetic mutations to assess a patient's cancer predisposition -- e.g., gene expression profiles, whole-genome sequencing, untargeted single-molecule sequencing, and protein-truncation testing.  . . .  These technologies "sequence" DNA without the need for "isolation."

In fact, earlier in this case (January 2010), petitioners stated:  "It is only humans' inability -- currently -- to sequence DNA while it is in the body that requires scientists to isolate it."  . . .  This falsely suggests there are only two options:  sequence in the body or sequence "isolated" DNA.  While DNA still cannot be sequenced in the body, DNA extracted from the body but not "isolated" can be, and has been, sequenced.  For example, random sequencing and protein-truncation testing have been used for years to identify genomic variations, including BRCA mutations.  More recently, multiple companies, e.g., Oxford Nanopore and Pacific Biosciences, have developed single-molecule technologies that can perform untargeted sequencing of DNA, which may include BRCA genes, without infringing the challenged claims.

5.  Petitioners contend that the challenged composition claims "define[] the gene according to how it functions in the body -- i.e., that it codes for and produces a polypeptide or protein."  . . .  That is untrue.  Each claim is a specific, defined molecule isolated from the body; none is claimed in terms of its "function."  Terms such as "encoding" or "coding for" are commonly used in DNA patent claims to recite physical structure, not function -- they are "structural terms" that define Myriad's human-made molecules.  . . .  Petitioners' contentions to the contrary, like their insistence upon redefining the question presented as "Are human genes patentable?", reflect a misunderstanding of basic scientific principles, well-established case law, and the nature of the composition claims at issue; at a minimum, they demonstrate that the petition is grounded on disputed antecedent facts.

(citations omitted, emphasis added).

Having dispensed with (or at a minimum bringing the Court's attention to these fanciful misstatements, the brief then sets forth Myriad's reasons the Court should deny the writ.  Put simply, Myriad argues that the Federal Circuit has properly applied Supreme Court precedent in Chakrabarty, Mayo, and MedImmune in reaching its decision below and that the case is not in the proper posture for the Court to intervene.  Applying each line of precedent in turn, Myriad argues that the Federal Circuit applied the Court's § 101 jurisprudence regarding the composition of matter claims to isolated genes, specifically the rubrics set forth in the seminal Chakrabarty case.  Myriad argues that "faithfully applying Chakrabarty in view of Mayo," the Federal Circuit came to the correct conclusion that the isolated DNA claims recited patent-eligible subject matter.  The brief characterizes the Court's J.E.M. case as being "on all fours" with this case, because there the Court decided plants were patent-eligible because § 101 should be given "broad scope and applicability" and the PTO have been granting utility patents on plants (~1800 patents) for 16 years (in contrast, the brief notes that the PTO has been granting patents on isolated DNA for 30 years and there are ~40,000 isolated DNA patents).  Citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushki Co. (applicable here through the auspices of Judge Moore's citation of the precedent in her concurring opinion below), "[t]o change so substantially the rules of the game now [] could very well subvert the various balances the PTO sought to strike when issuing the numerous patents which have not yet expired" (covering isolated DNA, an argument that will resonate only insofar as the Court believes that the PTO's decisions deserve some deference).

The brief next argues that the Federal Circuit's decision is not in conflict with any Supreme Court precedent, including Mayo, Chakrabarty, Funk Bros. Seed Co., and American Fruit Growers, Inc.  In distinguishing Mayo, the brief also addresses the "preemption" argument advanced in petitioners' brief, reminding the Court that "all patent claims are preemptive."  The concerns enunciated by the Court in Mayo regarding preemption are not implicated here on the facts, including that diagnosing risk for breast and ovarian cancer based on the presence of BRCA mutations can be accomplished using several alternative, non-infringing methods.  The other three Court decisions are consistent with the Federal Circuit opinion below based on their facts, according to Myriad's brief, and in this regard point to another misstatement by petitioners:

In arguing that the results in Funk Brothers and American Fruit Growers should govern, petitioners mischaracterize the claims here as merely a "blueprint" for "coding for" the genetic material in the body; under this view, petitioners say, the patents claim only a natural function.  . . .  This is factually incorrect and mischaracterizes the claim language.  The patents do not claim the compositions with reference to their functions; and the "coding for" language is a structural, not a functional, limitation in the claims.  See In re Deuel, 51 F.3d at 1557-58.  The composition claims are limited to claims for a specific, precisely defined composition with a specific, non-naturally occurring structure -- a particular, human-defined, isolated DNA molecule.  . . .  As the Federal Circuit ruled, the claims are directed to a specific and new chemical entity that does not exist in nature and that has uses unrelated to how the "code" operates in the body (unlike natural DNA "exist[ing] in the body as one of forty-six large, contiguous DNA molecules," the claims are drawn to "a free-standing portion;" . . . the claims "are truncations" that "are not naturally produced without the intervention of man").

(citations omitted).

Having rebutted petitioners' argument regarding the patent eligibility of the composition of matter claims, the brief then turns to the other two questions presented.  Regarding the screening method claim (claim 20 of U.S. Patent No. 5,747,282), the brief rebuts yet another factual misstatement:  that [petitioners] proclaim -- without record support -- that 'transformed cells containing altered DNA are conventional products widely available for purchase.'"  Rather, the brief properly informs the Court that the cells are "a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer" which is "a new and useful product of human ingenuity," and thus can be distinguished from the Mayo claims because it recites something that is neither a product nor a law of nature and in so doing Claim 20 does "significantly more than describe a natural law."  In addition, the brief corrects the petitioners "overstatement" that this claim would prevent "any researcher from engaging in this science to find a cancer treatment" by noting that the claim "is tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic," reducing the temperature of petitioners hyperbolic arguments to comport with reality (emphasis in original).

Finally, the brief addresses the jurisdictional issue, substantially repeating the evidence that the one plaintiff found to have standing, Dr. Harry Ostrer, may have destroyed that standing by moving from NYU (which supported his for-profit diagnostic activities) to Montefiore Hospital, which does not (or, more properly, petitioners have not presented any evidence that Montefiore would do so).

The brief ends with a section presenting six reasons why this case is not a good "vehicle" for review by the Court.  In truncated versions, these are:

First, this case represents an abstract challenge to Myriad's patents.  Petitioners alone selected the particular claims to challenge, leaving unchallenged several claims that they concede will continue to impede BRCA sequencing and other conduct in which they seek to engage . . . .  Accordingly, there exist significant issues of redressability, yet another antecedent jurisdictional problem with the petition.  See, e.g., Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992).

Second, Myriad was unable to assert counterclaims of infringement because no plaintiff was actually conducting any BRCA-related testing services; accordingly, this Court's review would be inhibited because the exact scope of the challenged claims has not been defined.  The district court performed only limited claim construction, and without infringement assertions the courts had no reason to determine the precise scope of the claims' exclusionary rights.  . . .  Moreover, much of petitioners' effort to obtain this Court's review is premised on their unsubstantiated speculation that Myriad's claims will inhibit those "who want to undertake testing and research involving the patented genes in order to improve diagnosis and treatment for patients" and will "exclude the rest of the scientific community from examining the naturally-occurring genes of every person in the United States."  . . .  Such assertions have never been tested in any adversary proceeding.  And had they been tested, they would have been exposed as false, for several non-infringing technologies for determining a patient's cancer predisposition are currently available.  . . .  Likewise, with no review of the form of testing petitioners might utilize, to determine whether such testing would infringe, there has been no analysis of what the claims do not cover, e.g., whole-genome sequencing.

Third, as to the patent-eligibility of the challenged composition claims, there is not a single opinion for the panel.  Petitioners seek to make this a reason for review.  . . .  But, had there been a true need to reconcile divergent judicial viewpoints, it would have been appropriate for petitioners to first seek en banc review from that court.  . . .  For whatever reasons, they did not.

Fourth, the relevance of patenting isolated human DNA is ever diminishing in light of the publication of the entire human genome in 2001 (several years after the 1994 and 1995 filing dates of the patents-in-suit), thus presenting arguable bars to patentability under other provisions of the Patent Act (such as obviousness under § 103) for any claims to isolated human DNA molecules sought after that date.  Further, such patents issued before the 2001 publication of the entire human genome will soon expire -- Myriad's patents-in-suit all expire by 2015.  Thus, the unique facts of this case, presenting issues unlikely to recur, make it an inappropriate candidate for certiorari.

Fifth and finally, despite over 30 years of isolated DNA patents, this case is the first and still only appellate decision to address the patent-eligibility of such compositions.  In nonetheless challenging these ruling, a change in the settled understanding of § 101 that allows patents on isolated genetic molecules.  . . .  Such efforts, particularly with the deeply settled reliance interests of the technology and investing communities at stake, should be addressed to Congress, not the courts.  . . .  Moreover, any consideration of the settled expectations that isolated molecules are patent-eligible should take into account the consequences of a legal rule that would apply far beyond the realm of human DNA.  Many biotechnology companies' intellectual-property endeavors, and the investors on which those companies rely, depend on patents covering isolated DNA corresponding to non-human genes.  . . .  Altering the expectations that these useful developments will be patent-protected is the role of policymaking, not adjudication.

(citations omitted).

The best that can be said is that Myriad has countered every misstatement and done its best to inform the Court regarding the facts, the law, and the consequences of granting certiorari here.  It remains to be seen whether the Court will be able to resist the siren song of this politically charged question, or will dive headfirst into another foray of trying to be the final arbiter of the scope and direction of American innovation.

USPTO Releases Performance and Accountability Report for FY 2012

By Donald Zuhn --

The U.S. Patent and Trademark Office recently released its Performance and Accountability Report for Fiscal Year (FY) 2012.  The report notes that the Office's 2010-2015 Strategic Plan sets forth three strategic goals and one management goal in support of the Office's mission to foster innovation and competitiveness by providing high quality and timely examination of patent and trademark applications, guiding domestic and international intellectual property policy, and protecting intellectual property rights.

The 2010-2015 Strategic Plan specifies eleven performance outcome measures for which the Office has developed annual performance targets.  According to the report, the Office met its annual performance targets for all eleven performance targets.  Among the patent-related performance targets that the Office met in FY 2012 were average first action pendency (21.9 months versus target of 22.6 months), average total pendency (32.4 months versus target of 34.7 months), and patent applications filed electronically (97.1% versus target of 96.0%).  Table 2 of the report provides data for the patent-related performance targets, as well as FY 2008 to FY 2011 (click on table to expand):

The report also presents data for the following patent-related performance targets:  patent average first action pendency for FY 2000 to FY 2012 (Figure 4), patent average total pendency for FY 2000 to FY 2012 (Figure 5), and patent applications filed electronically for FY 2003 to FY 2012 (Figure 6):

The report notes that the number of applications filed increased from 537,171 in FY 2011 to 565,566 in FY 2012, which constituted a 5.3% increase in filings.  This followed a 5.3% increase in application filings in FY 2011.

Despite accepting more than 500,000 patent applications for the third straight year, the number of applications awaiting action dropped from 690,967 in FY 2011 to 633,812 in FY 2012 (which marked the fourth consecutive year that the number of applications awaiting action has dropped).  The total number of pending applications also decreased, dropping from 1,168,928 in FY 2011 to 1,157,147 in FY 2012.

Utility patent issuances were up significantly in FY 2012, rising from 221,350 in FY 2011 to 246,464 in FY 2012.  It was the third straight year that the Office issued more than 200,000 utility patent issuances (having issued 207,915 in FY 2010), and the fourth straight increase.

With respect to first action and total pendency, the Office will have its work cut out for it if it intends to replicate the success of FY 2012.  For first action pendency, the annual performance target drops from 22.6 months for FY 2012 to 18.0 months for FY 2013 and 15.8 months for FY 2014, and for total pendency, the annual performance target drops from 34.7 months in FY 2012 to 30.1 months in FY 2013 and 26.1 months in FY 2014.

With respect to Patent Prosecution Highway (PPH) participation, the report notes that "[a]s of the end of FY 2012, over 17,400 applications at the USPTO had been received within the PPH program since its inception," and that the Office had "achieved the goal of driving significant increase in [PPH] usage for three years running."

For biotechnology and organic chemistry applicants, average first action pendency dropped from 23.8 months in FY 2011 to 17.8 months in FY 2012, and total average pendency dropped from 33.6 months in FY 2011 to 30.0 months in FY 2012.  Both pendency measures were below the Office's overall averages of 21.9 months and 32.4 months, respectively.  No other Technology Center posted a better first action pendency than TC 1600, and only TC 2800 (semiconductor, electrical, optical systems & components) posted a better final action pendency.

For additional information regarding this and other related topics, please see:

• "USPTO Releases Performance and Accountability Report for FY 2011," November 30, 2011
• "USPTO Releases 2010 Performance and Accountability Report," November 17, 2010
• "USPTO Announces 'Highest Performance Levels in Agency's History' in 2008," November 18, 2008
• "USPTO Announces 'Record Breaking' 2007 Performance," November 15, 2007
• "Patent Office Announces Record-Breaking Year," December 27, 2006

Novartis AG v. Kappos (D.D.C. 2012)

By Donald Zuhn --

In an opinion issued earlier this month, Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia determined that Novartis AG and Novartis Vaccines and Diagnostics, Inc. had not satisfied the 180-day limitation of 35 U.S.C. § 154(b)(4)(A) for timely challenging patent term adjustment (PTA) determinations of the U.S. Patent and Trademark Office with respect to nineteen of twenty-three patents at issue, and further, that the 180-day limitation should not be equitably tolled.  For three of the four patents for which Novartis had timely challenged the Office's PTA determinations, the District Court adopted the rationale in Exelixis, Inc. v. Kappos, and for the lone remaining patent, the Court determined that the Office erred in not applying the Federal Circuit's decision in Wyeth v. Kappos.

In July 2010, Novartis brought suit against U.S. Patent and Trademark Office Director David Kappos under 35 U.S.C. § 154 and the Administrative Procedure Act (APA), alleging that the Patent Office improperly determined the amount of patent term adjustment to which eleven of Novartis' patents were entitled (see "Novartis Challenges USPTO's Interim Procedure for Requesting PTA Recalculations").  In its complaint, Novartis argued that the Patent Office improperly refused to apply the Federal Circuit's decision in Wyeth v. Kappos to patents granted prior to September 2, 2009 (which the opinion refers to as the Wyeth claim).  Novartis also challenged the Patent Office's interpretation of the effect of filing a Request for Continued Examination (RCE) on the determination of B Delay (which the opinion refers to as the RCE claim).  The District Court subsequently consolidated the instant case with three other Novartis cases that raise similar issues, bringing the number of Novartis patents at issue in the consolidated action to twenty-three.

With respect to Novartis' Wyeth claim, the opinion notes that the Patent Office's method of determining the extent of any overlap between A Delay (PTA accrued as a result of the Office's failure to take certain specified actions within fixed windows of time) and B Delay (PTA accrued as a result of the Office's failure to issue a patent within three years of the filing of the application) changed in response to the Federal Circuit's decision in Wyeth v. Kappos.  In particular, the Federal Circuit determined that A Delay and B Delay should be aggregated so long as that aggregation did not require counting the same calendar day twice.  Following the Federal Circuit's decision in Wyeth, the Office announced that it would implement the Court's interpretation of A/B Delay overlap for patents issued on or after March 2, 2010, and that it would permit recalculation of PTA for patents issued within 180 days of the Office's announcement.

With respect to Novartis' RCE claim, the opinion notes that the Office has promulgated two rules (37 C.F.R. §§ 1.702(b) and 1.703(b)) interpreting the proper calculation of B Delay under § 154(b)(1)(B).  The effect of these rules is that patentees cannot accrue B Delay for time consumed by an RCE, regardless of when the RCE was filed, and that the "time consumed by" an RCE includes all of the time from the filing of the RCE to the issuance of the patent.

In assessing the Office's determination of PTA for each of the twenty-three Novartis patents at issue, the opinion begins by noting that challenges of the Office's PTA determinations are governed by 35 U.S.C. § 154(b)(4)(A), which provides that:

An applicant dissatisfied with a determination made by the Director under paragraph (3) shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent.

(In a footnote, the opinion indicates that for complaints filed on or after September 16, 2011, the U.S. District Court for the Eastern District of Virginia now has jurisdiction over actions under 35 U.S.C. § 154(b), a change brought about by passage of the Leahy-Smith America Invents Act.)  For three of the twenty-three Novartis patents at issue (U.S. Patent Nos. 7,807,155; 7,968,518; and 7,973,031), the Office acknowledged that Novartis' complaints were timely filed.  However, the Office argued that for the remaining patents, Novartis' complaints were filed more than 180 days after those patents were issued, and therefore, that Novartis was foreclosed from seeking additional PTA for those patents.  Novartis countered that the 180-day limitation of § 154(b)(4)(A) did not apply to its claims because § 154(b)(4)(A) applies to determinations "under paragraph (3), and therefore only applies to determinations of A Delay.  According to Novartis, determinations of B Delay and A/B overlap can be challenged within the general six-year statute of limitations set forth in the APA (28 U.S.C. § 2401(a)).

In siding with the Patent Office with respect to the 180-day limitation of § 154(b)(4)(A), the District Court states that:

In addition to being consistent with the plain meaning of the statute, [the Patent Office's] interpretation avoids absurd results.  Congress clearly intended to include strict controls on judicial review of PTA determinations.  Under Novartis' interpretation, only Pre-Issuance Determinations [i.e., determinations of A Delay] would be subject to those controls, while the final, complete PTA determinations that accompany an issued patent would not.  Instead, a patentee would have 180 days in which to challenge the calculation of A Delay but six years in which to challenge B Delay and A/B Delay Overlap.

However, while agreeing with the Office on this issue, the District Court disagreed with the Office that Novartis was foreclosed on all of the remaining patents at issue.  In particular, the Court noted that Novartis had filed a petition for PTA reconsideration for U.S. Patent No. 7,470,792 within two months of issuance, as required under 37 C.F.R. § 1.705(d), and had filed a complaint within 180 days of the Office's denial of reconsideration (but more than 180 days after the patent issued).  In response to Novartis' argument that the 180-day limitation period should have been tolled by its filing of a petition for reconsideration, the District Court determined that "[b]ecause the Court holds that the general tolling rule applies, and because Novartis filed its complaint with respect to the ’792 patent within 180 days after the denial of its petition for reconsideration, Novartis' claim with respect to that patent was timely filed."

Novartis next sought equitable tolling of the 180-day limitation of § 154(b)(4)(A) for the remaining nineteen patents at issue.  With respect to its Wyeth claim. Novartis argued that it lacked knowledge of this claim until the Federal Circuit's decision in Wyeth v. Kappos changed the law with respect to A/B Delay overlap, and therefore, that the 180-day limitation should have been equitably tolled until the Office's January 20, 2010 announcement that it would not seek further appellate review of the Federal Circuit's Wyeth decision.  With respect to its RCE claim, Novartis argued that because no court had ruled on the viability of this claim (prior to Exelixis, Inc. v. Kappos), the statute of limitations had not yet begun to run for that claim.

The District Court, however, found Novartis' arguments to be unpersuasive and determined that "the facts in this case do not justify the application of the equitable tolling doctrine to Novartis' nineteen untimely complaints."  Explaining that "[e]quitable tolling is available to a petitioner who has been diligent in pursuing his rights, but for whom some extraordinary circumstance stood in the way and prevented timely filing," the Court noted that "Novartis was free to raise the same issues that Wyeth and Abbott Laboratories raised in their lawsuits within the 180 days after their patents were granted," and stated that "contrary to Novartis' argument, a change in law is not such an extraordinary circumstance as to justify the application of equitable tolling."

Turning to the four patents for which PTA determinations were found to have been timely challenged, the opinion notes that three of the patents concern the same issue decided by the Eastern District of Virginia in Exelixis, Inc. v. Kappos, namely "whether § 154(b)(1)(B) requires that, or even addresses whether, any PTA be reduced by time attributable to an RCE where, as here, the RCE is filed after the expiration of the three year guarantee period specified in that statute."  After discussing the decision in Exelixis, the Court noted that it found "Judge Ellis' well-reasoned opinion to be persuasive," and "therefore adopt[ed] his rationale for concluding that the PTO's interpretation [of the statute] is contrary to the plain and unambiguous language of § 154(b)(1)(B), and that it contravenes the structure and purpose of the statute."

For the lone remaining patent -- the '792 patent -- the District Court determined that the Office "erred in not applying either this Court's or the Federal Circuit's Wyeth decision."  The Court noted that the '792 patent issued on December 30, 2008, two months after the District Court decision in Wyeth, that Novartis sought reconsideration of its PTA determination in February 2009, based in part on the District Court's Wyeth ruling, and that the Office nevertheless declined to apply the Wyeth method of calculating overlap to the '792 patent.  The Court stated that "[t]his was erroneous," and that the Office "abused its discretion by refusing to calculate Novartis' patent consistently with the method adopted in Wyeth"

Novartis AG v. Kappos (D.D.C. 2012)
Memorandum Opinion by Judge Ellen Segal Huvelle

ABA Journal Announces 2012 Blawg 100

Patent Docs Makes List for First Time

The ABA Journal has announced its annual list of the 100 best legal blogs -- or blawgs -- following a nomination process that began in August.  The 100 blogs selected for the 2012 list have been divided into fifteen categories:  News/Analysis, Trial Practice, Business of Law, Niche, For Fun, IP Law, Careers/Law Schools, Labor & Employment, Criminal, Justice, Torts, Legal Technology, Courts, Corporate, and Legal Research/Writing.  Five of the Blawg 100 were selected in the IP Law category, including Patent Docs, which was selected to the Blawg 100 for the first time.  The other blogs selected to the IP Law category were IPWatchdog; Hollywood, Esq., Patently-O, and Rebecca Tushnet's 43(B)log.

An alphabetical list of the 2012 Blawg 100 can be found here and a list of the top blawgs sorted by category can be found here.  In announcing the 2012 Blawg 100, ABA Journal Editor and Publisher Allen Pusey noted that "[e]ach year, our choices become tougher," adding that "[b]logging has become such a staple of professional communication that keeping up with our own directory of more than 3,500 blogs by lawyers, judges, law professors or even law students is more formidable than it's ever been."

Now that the ABA Journal has selected its Blawg 100 for 2012, it is asking readers to choose their favorites from among the top 100.  In order to vote for your favorites, you will first have to register here (registration is free).  Voting will conclude on December 21.

In addition to releasing its 6th annual Blawg 100, the ABA Journal announced its inaugural Blawg 100 Hall of Fame, featuring law blogs the ABA Journal "can't imagine not making our favorites list each year."  The inaugural list of ten blawgs, which includes Patently-O, can be found here.

We would like to thank our readers for nominating Patent Docs for the Blawg 100, and we would like to thank the ABA Journal for making Patent Docs a 2012 Blawg 100 honoree.

News from Abroad: Emerging Practice of the European Patent Office on Stem Cell Inventions

Is There Light at the End of the Tunnel?

By Jenny Donald --

It is clear from an emerging practice of the European Patent Office (EPO) that they were not widely impressed by the controversial Brüstle decision issued by the Court of Justice of the European Union (CJEU).

The EPO has adapted its practice to be consistent with the Brüstle decision.  However, it has also taken a position that will allow companies working in the area of stem cell research to obtain patent protection for their products and methodologies, by indicating that it will allow inventions that utilise human embryonic stem cell lines that have been established using a method that does not destroy the human embryo.

This emerging practice of the EPO could have a great impact on the future of stem cell research in Europe.

EPO previous practice

In Europe, inventions that necessitate the use of human embryos have been excluded from patentability for some time.

Prior to the issuance of the Brüstle decision the EPO's practice was that:

• a product, which could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded from patentability

• a product, which could be obtained from an established human embryonic stem cell line is patentable, provided the product fulfils the other requirements of patentability, because obtaining the product did not directly involve the destruction of a human embryo

Brüstle decision

The main purpose of the Brüstle decision was to clarify the meaning of the term 'human embryo'.  However, the CJEU also stated that the exclusion of human embryonic stem cells, and other products, was relevant to the destruction of a human embryo at any point in history.

EPO current practice

The EPO has stated, when adapting its practice in line with the Brüstle decision, that the exclusion to patentability can no longer be avoided by exclusively obtaining the stem cell/product indirectly from an established human embryonic stem cell line that required the destruction of a human embryo.  At some point in history a human embryo has been destroyed to establish the cell line and any products derived, either directly or indirectly, are now excluded from patentability.

Accordingly, the EPO has changed its practice to:

• a product, which could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded from patentability; the point in time at which such destruction takes place is irrelevant

There have been great concerns that this change in practice will severely limit the scope of protection available in the area of stem cell research and for other products obtained from human embryos.

EPO emerging practice

It appears that all may not be lost!

A new technology, Single Blastomere Biopsy (SBB), published for the first time in 2008 enables stem cells, and other products, to be obtained from a blastocyst that does not result in the destruction of the human embryo.

Based on the existence of this technology, at least one examining division of the EPO has stated that inventions directed to products obtained from cell lines established using this technology are not excluded from patentability.

The reasoning behind this new stance is that the human embryonic stem cell lines have be established using a non-destructive methodology; and the existence of such established cell lines means that the claimed invention does not constitute a new use of a human embryo.

In contrast, any method directed at manufacturing such cell lines would be excluded from patentability because, despite that fact that the methods are non-destructive, the methods are a new use of a human embryo.  Hence, it is only once a cell line has been established that stem cells, products and associated methods that are derived from such established cell lines are not excluded from patentability, provided they meet the other requirements of patentability.

This article was reprinted with permission from Forresters.

Court Report

By Sherri Oslick --

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

Apotex Inc. v. Daiichi Sankyo, Inc. et al.
1:12-cv-09295; filed November 20, 2012 in the Northern District of Illinois

• Plaintiff:  Apotex Inc.
• Defendants:  Daiichi Sankyo, Inc.; Daiichi Sankyo Co., Ltd.

Declaratory judgment of non-infringement of U.S. Patent No. 6,878,703 ("Pharmaceutical Composition," issued April 12, 2005) in conjunction with Aptoex's filing of an ANDA to manufacture a generic version of Daiichi's Benicar® (olmesartan medoxomil, used to treat hypertension).  View the complaint here.

Life Technologies Corp. et al. v. Promega Corp.
2:12-cv-09879; filed November 19, 2012 in the Central District of California

• Plaintiffs:  Life Technologies Corp.; California Institute of Technology
• Defendant:  Promega Corp.

Infringement of U.S. Patent No. RE43,096 ("Tagged Extendable Primers and Extension Products," issued January 10, 2012) based on Promega's manufacture, sale, and offer for sale of certain product lines utilizing fluorescent-tagged oligonucleotides in genetic assays, including its PowerPlex, StemElite, and CellID products.  View the complaint here.

Astellas US LLC et al. v. Akorn Inc.
1:12-cv-01489; filed November 19, 2012 in the District Court of Delaware

• Plaintiffs:  Astellas US LLC; Astellas Pharma US, Inc.; Item Development AB
• Defendant:  Akorn Inc.

Infringement of U.S. Patent No. 5,731,296 ("Selective Vasodilation by Continuous Adenosine Infusion," issued March 24, 1998), licensed to Astellas, following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Astellas' Adenoscan® product (adenosine injection, used as a diagnostic for myocardial reperfusion injury).  View the complaint here.

Millennium Pharmaceuticals Inc. v. Accord Healthcare Inc. et al.
1:12-cv-01490; filed November 19, 2012 in the District Court of Delaware

• Plaintiff:  Millennium Pharmaceuticals Inc.
• Defendants:  Accord Healthcare Inc.; Intas Biopharmaceuticals Ltd.; Intas Pharmaceuticals Ltd.

Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma).  View the complaint here.

Conference & CLE Calendar

November 27, 2012 - Patents and the Written Description Requirement: Navigating Section 112 Disclosure Obligations and Withstanding Invalidity Challenges (Strafford) - 1:00 - 2:30 pm (EST)

November 28-29, 2012 - Biotech Patents*** (American Conference Institute) - Boston, MA

November 28-29, 2012 - Orphan Drugs and Rare Diseases*** (American Conference Institute) - Boston, MA

December 3-5, 2012 - Drug and Medical Device Litigation*** (American Conference Institute) - New York, NY

December 4-5, 2012 - Paragraph IV Disputes*** (American Conference Institute) - San Francisco, CA

December 11, 2012 - Preissuance Prior Art Submissions at the USPTO -- Best Practices for Third-Party Challenges to Patent Applications and Monitoring Competition (Strafford) - 1:00 - 2:30 pm (EST)

December 12, 2012 - Saving the Best for Last: Top 10 Things In-House Counsel Need to Do to Prepare for the AIA's March 2013 Deadline (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

January 23-24, 2013 - The Comprehensive Guide to Patent Reform*** (American Conference Institute) - New York, NY

January 29, 2013 - Combined Customer Partnership Meeting of TC3700 and TC1600 (U.S. Patent and Trademark Office) - Alexandria, VA

January 29-30, 2013 - Biotech & Pharma Patent Litigation*** (C5) - Amsterdam, Netherlands

February 20-22, 2013 - Intensive Patent Law Seminar (Chisum Patent Academy) - New York, NY

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

USPTO to Hold Medical Devices/BioTech Customer Partnership Meeting

The U.S. Patent and Trademark Office will be holding a combined customer partnership meeting of Technology Center 3700 (medical devices) and Technology Center 1600 (biotechnology) on January 29, 2013.  The agenda for the meeting is as follows:

• Sign-in -- 8:30 - 9:00 am
• Introduction -- 9:00 - 9:30 am
• CPC (Cooperative Patent Classification) -- 9:30 - 10:30 am
• 101 (Patentable Subject Matter) -- 10:45 - 11:45 am
• AIA Update -- 1:00 - 2:00 pm
• Open round table discussion -- 2:15 - 3:45 pm

The meeting is being held in the USPTO's Madison Auditorium, 600 Dulany Street, Alexandria, VA.  Those wishing to attend the meeting can register here.  Additional information regarding the customer partnership meeting can be found here.

Happy Thanksgiving from Patent Docs

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 23rd.

Patent Profile: USPTO Issues Patent for Paromomycin-supplemented Turkey Feed for Prophylaxis of Histomoniasis and Improved Weight Gain

By Donald Zuhn --

Last month, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,293,266, entitled "Paromomycin-supplemented feed stuff for turkey and use thereof for prophylaxis of histomoniasis, reduction of the horizontal spreading of histomoniasis, and for improved weight gain and feed conversion," to Huvepharma AD, a pharmaceutical company based in Sofia, Bulgaria.  The '266 patent is directed to a method of preventing the infection with or spread of histomoniasis or increasing weight gain in turkeys using a feed supplemented with paromomycin.

Histomoniasis (or blackhead disease) is a disease of poultry species, particularly chickens and turkeys, due to parasitic infection by a protozoan, Histomonas meleagridis.  The parasite specifically infects the cecum and liver of birds, with symptoms of the infection including depression, reduced appetite, poor growth, increased thirst, sulphur-yellow diarrhoea, listlessness, and dry, ruffled feathers.  Paromomycin (left), also known as monomycin and aminosidine, is an aminoglycoside antibiotic that was first isolated from Streptomyces krestomuceticus in the 1950s.  It is structurally related to neomycin, streptomycin, and kanamycin and has a broad spectrum of activity, including activity against protozoa, bacteria, and cestodes.  Surprisingly, the inventors found that the continuous application of paromomycin in feed in dosages below 1000 ppm, in the range 10-750 ppm, had a significant effect in:  (i) reducing the mortality of infected birds, (ii) significantly reducing the horizontal spread of the disease from infected to healthy birds, and (iii) improving the growth performance of the infected and non-infected animals.

The '226 patent issued on October 23, 2012 from U.S. Application No. 09/967,726, which was a U.S. national stage application of International Application No. PCT/BG2008/000003, which claims priority to Bulgaria Patent Application No. 109831.  Independent claims 1, 4, and 6 of the '226 patent recite:

1.  A method for preventing infection with or spread of histomoniasis in healthy turkey or in a flock of healthy turkey, the method comprising: formulating a feed stuff for turkey comprising feed supplemented with paromomycin in an amount sufficient to provide prophylaxis of histomoniasis; and feeding the feed stuff to the healthy turkey or flock of healthy turkey continuously from day 0 until slaughter or at least for more than one week; whereby infection or spread of histomoniasis in the healthy turkey or in the flock of healthy turkey is prevented.

4.  A method for reducing or preventing horizontal spread of histomoniasis in a flock of turkey, the method comprising: formulating a feed stuff for turkey comprising feed supplemented with paromomycin in an amount sufficient to provide prophylaxis of histomoniasis; and feeding the feed stuff to the flock of turkey continuously from day 0 until slaughter or at least for more than one week; whereby horizontal spread of histomoniasis is reduced or prevented in the flock of turkey.

6.  A method for increasing weight gain and improving feed efficiency in turkey or in a flock of turkey, the method comprising: formulating a feed stuff for turkey comprising feed supplemented with paromomycin in an amount sufficient to provide prophylaxis of histomoniasis; and feeding the feed stuff to the turkey or to the flock of turkey continuously from day 0 until slaughter or at least for more than one week; whereby weight gain is increased and feed efficiency is improved in the turkey or the flock of turkey.

Independent claims 8, 11, and 13 are identical to the above claims with the exception that the term "formulating" is replaced with "providing."

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

By Kevin E. Noonan --

The Federal Circuit made its first attempt to implement the Supreme Court's nearly opaque jurisprudence on the scope of patent eligibility for diagnostic method claims (as set forth in Mayo v. Prometheus) in PerkinElmer, Inc. v. Intema Ltd., decided today.  (The Court's AMP v. Myriad case doesn't really count, as the diagnostic method claims in Myriad had already been held patent-ineligible under the "machine-or-transformation" test set forth in In re Bilski, and the Supreme Court's Mayo decision certainly didn't expand the scope of patent eligibility.)

The case involved claims from U.S. Patent No. 6,573,103 for prenatal diagnostic testing for Down's syndrome, intended to avoid the need for invasive testing like chorionic villus sampling that incurs the risk of miscarriage.  Claims 1 and 20 were set forth by the Federal Circuit panel as being representative:

Claim 1.  A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome, the method comprising the steps of:
    measuring the level of at least one screening marker from a first trimester of pregnancy by:
        (i) assaying a sample . . . ; and/or
        (ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . . ;
    measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:
        (i) assaying a sample . . . ; and/or
        (ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . . ;
    and determining the risk of Down's syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.

Claim 20.  A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome, the method comprising the steps of:
    measuring the level of at least one first screening marker from a first trimester of pregnancy by:
        (i) assaying a sample . . . ; and/or
        (ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . . ;
    determining a first risk estimate of Down's syndrome by comparing the measured level of the at least one first screening marker level from the first trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies;
    comparing the first risk estimate with a predetermined cut-off level to initially classify the pregnant woman as screen- positive or screen-negative based on the comparison;
    and if the pregnant woman is initially classified as screen-negative; measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one
first screening marker from the first trimester of pregnancy, by:
        (i) assaying a sample . . . ; and/or
        (ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . .
    and determining the risk of Down's syndrome by comparing the measured level of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from second trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.

The panel opinion apprehends that the "key difference" between these claims was the segregation of patients into positive or negative groups, wherein only the positive groups are screened in the second trimester, embodied in the "determining step" as the "key limitation."  The District Court had construed this "key limitation" as determining a risk of Down's syndrome by comparing distributions of certain markers in Down's syndrome pregnancies and "unaffected" pregnancies, and then combining the screened markers into a single risk calculation based on the results from the first and second trimester screenings.  The District Court rejected PerkinElmer's summary judgment motion of patent ineligibility under § 101 (and granted Intema's summary judgment motion on patent eligibility) on the grounds that the claims are directed at a data-gathering method comprising measuring steps that satisfied the machine-or-transformation test (assaying a blood sample was transformative in the District Court's view).

The panel opinion written by Judge O'Malley and joined by Judges Bryson and Wallach, reversed the District Court's finding of patent-eligible subject matter (and affirmed summary judgment against Intema on anticipation and obviousness grounds), based on the Supreme Court's Mayo decision and the Federal Circuit's Myriad decision.  "The key distinction," according to the Court, "which bears on our decision today[] is between claims that recite ineligible subject matter, and no more, and claims to specific inventive applications of that subject matter."  The opinion goes on to say that the basis for making this distinction is that claims to specific applications of "patent-ineligible subject matter" (i.e., "laws of nature, natural phenomenon or abstract ideas") "do not risk the broad preemption of 'the basic tools of scientific and technological work,'" citing Benson v. Gottschalk, 409 U.S. 63, 67 (1972).  In the panel's view, the claimed methods do not contain an "inventive concept" (defined as in Mayo as "other elements or a combination of elements [] sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself" and because these claims "contain[] nothing more than 'well-understood, routine, conventional activity previously engaged in by researchers in the field.'"

The opinion then sets forth how it arrived at this conclusion, which in a nutshell was that the panel did not see any distinction between these claims and the Mayo or Myriad claims.  While relying on extensive language from the Court's Mayo decision, the analysis focuses much more closely on the similarities between the claims at bar and the Myriad claims (calling them "indistinguishable" from the claims in Myriad).  The similarities reside completely in the fact that the Intema claims and the Myriad claims involve comparing measured biological information (between wildtype and mutant BRCA genes in Myriad and between Down's pregnancies and unaffected pregnancies here), which the panel characterizes as being merely mental activity regarding a naturally occurring relationship).  These two characteristics of the claims -- that they recite "mental steps" and "natural laws" -- are sufficient to render them patent-ineligible unless, according to the opinion, they also contain that ineffable "something more" required by the Supreme Court's Mayo opinion.  Surveying the claims, the opinion states that the "measuring" steps are insufficient, because (as in Mayo) the method steps encompass any and all methods for measuring the markers.  Here, the patentee's attempts to provide broad support for the invention was held against them, wherein the specification was cited for reciting that "'[t]he individual measurements are obtained through known methods. . . .  Any markers which are effective at each particular stage may be selected.'"  As a result, the panel was able to characterize the measuring steps as encompassing "well-understood, routine, conventional activity previously engaged in by scientists who work in the field."

Similarly, the "determining" step (characterized by the District Court as a "key" limitation) was thought by the panel to comprise merely the "mental step" of comparing marker levels in Down's and unaffected pregnancies, and that the "comparing" methods comprise statistical analysis was not enough:  these are also "well-understood" and "conventional" (although the opinion does not establish that it was conventional to apply Gaussian statistics for such comparisons, the patentee's further recitations in the specification that "Any of the known statistical techniques may be used.  Preferably the multivariate Gaussian model is used, which is appropriate where the observed distributions are reasonably Gaussian. Such multivariate Gaussian analysis is in itself known . . . ." clearly suffices to support the panel's conclusion that the statistical handling of the data was routine and conventional).  Also in this regard the panel recognizes that, as in Myriad, there is no requirement that an actual assay (BRCA gene sequencing in Myriad, taking an ultrasound here) must actually be performed; the claims are satisfied by making the comparison itself (between two printouts of gene sequences in Myriad, or between two ultrasound images here), making it a simple matter to construe the claims as encompassing the merely mental step of "comparing."

The panel gets to the heart of the matter by reaching the preemption issue, wherein "anyone who wants to use this mental step or natural law must follow the claimed process" and the root of the problem, that "there is no requirement that a doctor act on the calculated risk," both because the claims do not recite a treatment step and because the claims purportedly impact the activities of medical doctors treating patients (albeit through the intermediary of a commercial (or at least for-profit) testing laboratory (and the panel goes on to support this conclusion with reference to the different patent-eligibility fates of the claims in Classen v. Biogen Idec, where the presence of an immunization step distinguished patent-eligible from patent-ineligible subject matter).

The Court asserts the most troubling basis for its decision by comparing the claims here with Claim 20 in Myriad's U.S. Patent No. 5,747,282.  The patent-eligible distinction, according to this panel, is that in Claim 20 the cell that was used to compare growth rates in the presence or absence of a test compound was non-naturally occurring (and constituted patent-eligible subject matter, and thus "their inclusion in the process made the claims patent-eligible despite the reference to an otherwise ineligible mental step."

The panel enters into Supreme Court-sanctioned flights of fancy in finding that the claims also fail the machine-or-transformation test, on the grounds that "measuring" marker levels is not transformative because "it could be performed 'without transforming the [sample], should science develop a totally different system for [assaying for a biochemical screening marker] that did not involve such a transformation,'" citing Mayo.

While it is apparent that the point is that the claims are overbroad in this respect, it should not be too much to ask that courts base their opinions (with regard to conventionality) on the conditions and limitations existing in the reality we happen to inhabit at the time they render a decision, not some hypothetical Never-Never Land of their own imagination.

This case stands as the most recent cautionary tale of how diagnostic methods claims must be crafted -- narrow, specific, encompassing particular assaying and detection steps, and encompassing some (any) patentable feature other than the naturally occurring correlation between a marker and disease.  It may be hoped that claims drawn to a novel marker, or to the new appreciation that a known marker was diagnostically relevant to a particular disease, contained in claim language reciting sufficient specificity to recited methods, will be enough to pass muster.  After all, Intema's claims (and the claims of most existing diagnostic method patents granted prior to the Mayo decision) were drafted without foreknowledge of the Supreme Court's return to the Benson/Flook era in Mayo, and its targeting of any claim that may impact medical treatment.  Of course, the lesson from Mayo, and this case, is that such inventions should not be patented, but rather kept in a tight black box where patient data is gathered (including for security some unnecessary data) and a clinically established correlation produced.  This is, of course, the antithesis of a patent regime intended to "Promote the Progress . . . of the Useful Arts" but in a capitalist society, diagnostic assays cannot reasonably be expected to be developed, or distributed, free of charge.  Perhaps the courts, and the medical community, will come to face this reality before it is too late.

PerkinElmer, Inc. v. Intema Ltd. (Fed. Cir. 2012)
Panel: Circuit Judges Bryson, O'Malley, and Wallach
Opinion by Circuit Judge O'Malley

News from Abroad: UK Government Considers Broadening Bolar Exemption

When a generic pharmaceutical company seeks approval for a generic version of a reference product, it must necessarily perform certain tests on its product.  If the product in question is patented, then obtaining the product (e.g., through importation or manufacture) in order to carry out those tests is technically an act of patent infringement.

Historically, therefore, generic companies were prevented from 'day one' launches immediately following patent expiry.  This was because it was only possible to commence the tests necessary to secure approval following patent expiry, meaning that the dates of i) the application for generic approval being filed, ii) approval being obtained, and iii) launch were all pushed back.

To minimise or ideally eliminate the time lag between patent expiry and launch of generic pharmaceutical products, the EU introduced the so-called Bolar exemption into patent law.  Very briefly, this provides a defence to patent infringement to those conducting tests for obtaining data to support applications for the approval of generic pharmaceutical products and also any consequential practical requirements (e.g., importing or manufacturing the pharmaceutical product to be used in those tests).

By relying on the Bolar defence, generic pharmaceutical companies could conduct the tests necessary to obtain approvals for their products prior to patent expiry.  The approvals could then be secured and the product launched immediately following patent expiry.

One drawback with the wording of the Bolar exemption as implemented into UK law is that the nationality of the generic approval for which the data is being obtained is not specified.  Plainly, if the otherwise infringing tests are being conducted to obtain data to support a UK application for generic approval, then the defence does apply.

However, the case is not so clear where the tests are being conducted in the UK to provide data to support an application outside of the UK and especially outside of the EU.  Similarly, in a situation where the data may be used to support both a UK and a non-EU application for approval, confusion exists.

Additionally, the Bolar defence is only currently applicable if the approval which is to be sought is for a generic drug; it does not apply if the tests are being conducted to provide data to support an application for approval of an innovative drug.  A second defence, available to those conducting research done for experimental purposes has been construed narrowly by the UK Court and also does not apply to clinical trials and test involving innovative drugs.  This arguably puts those companies developing innovative drugs in a worse position to those developing generic products.

In order to improve clarity and also make the UK a more attractive jurisdiction for conducting clinical trials, the UK government are now working to reword those sections of the UK Patents Act which provide research-based defences such as the Bolar defence.  It is envisaged that any changes that are made will come into force towards the end of 2013.

This is clearly an important development which will have significant effects on the ability of pharmaceutical companies to conduct tests and trials in the UK.  WP Thompson will report further, once the revised wording of the statute has been finalised.

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.

AMP v. Myriad Briefed and Distributed for Conference - Update

By Donald Zuhn --

Last week, the Supreme Court updated its docket for the Association for Molecular Pathology v. Myriad Genetics, Inc. case to indicate that it has been distributed for conference on November 30.  In response to the Petition for a Writ of Certiorari filed in September by the Public Patent Foundation (PUBPAT) and the American Civil Liberties Union (ACLU) Foundation on behalf of Petitioners Association for Molecular Pathology et al. (see "Plaintiffs (Again) File Certiorari Petition in Myriad Case"), the Court received a brief in opposition from Respondents Myriad Genetics, Inc. et al., a reply from Petitioners, and seven amici curiae briefs.  Thanks to a reader, Patent Docs has now secured copies of four more amici briefs:

• Amici Curiae Brief for Academics in Law, Medicine, Health Policy and Clinical Genetics in Support of Petitioners -- brief

• Brief Amici Curiae of The National Women's Health Network, Reproductive Health Technologies Project, Disability Rights Legal Center, Forward Together, The Center for Genetics and Society, The Pro-Choice Alliance for Responsible Research, Alliance for Humane Biotechnology, G. Michael Roybal, MD, MPH, and Anne L. Peters, MD in Support of Petitioners -- brief

• Brief of Amicus Curiae AARP in Support of Petitioners -- brief

• Brief of Amici Curiae Cancer Council Australia, The Royal College of Pathologists of Australasia, Human Genetic Society of Australasia, National Breast Cancer Foundation, and Luigi Palombi PhD in Support of Petitioner -- brief

• Brief for Canavan Foundation, Claire Altman Heine Foundation, March of Dimes Foundation, Facing Our Risk of Cancer Empowered, National Association for Pseudoxanthoma Elasticum, and Ovarian Cancer National Alliance as Amici Curiae in Support of Petitioners -- brief

• Brief of Amici Curiae American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American Osteopathic Association, American College of Legal Medicine, and The Medical Society of The State of New York in Support of Petition for Writ of Certiorari -- brief

According to the docket, one other amici brief was submitted by:

• Kali N. Murray and Erika R. George

Patent Docs intends to make copies of the remaining amici brief as well as Petitioners' reply brief available to the extent that we can secure copies.  In addition, we plan to summarize in subsequent posts any of the briefs for which we can secure copies.