Patent Docs

Program on Patents and the Public Good

The Greater Washington, DC Chapter of the Licensing Executives Society (LES) will be offering a program entitled "Patents and the Public Good" on November 14, 2012 from 5:30 - 8:00 pm (Eastern) at Sidley Austin LLP in Washington, DC.  Chief Judge Randall Rader of the U.S. Court of Appeals for the Federal Circuit, former Chief Judge Paul Michel of the U.S. Court of Appeals for the Federal Circuit, and Raymond Van Dyke of Van Dyke Law will review the positives of a strong patent system to our nation and the world.  A networking reception will be held from 5:30 - 6:30 pm, and the presentation will be held from 6:30 - 8:00 pm.

The registration fee for the program is $30 (LES members) or $40 (non-members).  Those interested in registering for the program, can do so here.  The online registration deadline is November 13, 2012.

Exelixis, Inc. v. Kappos (E.D. Va. 2012)

Court Overrules PTO Interpretation of B-Delay Calculation

By Kevin E. Noonan --

Judge T.S. Ellis III of the U.S. District Court for the Eastern District of Virginia wrote the latest chapter in the story of judicial review of (and, generally, disagreement with) how the Office has interpreted the patent term adjustment provisions of the 1999 America Inventors Protection Act (AIPA).  This case involves so-called "B delay," corresponding to a date that is three years after an application's filing date and the date on which the Office actually grants a patent pursuant to 35 U.S.C. § 154(b)(1)(B).  The issue was whether the Office had correctly implemented the statute by negating B delay in circumstances where an applicant had responded to a final rejection by filing a request for continued examination (RCE) (also a provision newly added to U.S. patent law by the AIPA).

The case involved an application filed by Exelixis that resulted in grant of U.S. Patent No. 7,989,622 entitled "Phosphatidylinositol 3-Kinase Inhibitors and Methods of their Use."  The application was filed on January 15, 2008 and a first Office Action promulgated by the Office on February 22, 2010, resulting in an "A delay" (the time from the filing date to the first substantive action in a case pursuant to 35 U.S.C. § 154(b)(1)(A)) of 283 days.  The PTO issued Final Rejection on March 9, 2011 (38 months, i.e., 2 months from the three-year date calculated from the filing date), to which the applicants responded on April 11, 2011; this response was filed with an RCE.  "Less than three weeks later" (a time the Court characterized as "commendable, if, with respect to this application, uncharacteristic alacrity"), the Office issued a Notice of Allowance.  Despite payment of the Issue Fee almost immediately (on April 28, 2011), the patent did not grant until August 2, 2011.  At that time, the Office notified Exelixis that the PTA for this patent was a total of 368 days, corresponding to 283 days of A delay, 85 days of B delay, 0 days of C delay under 35 U.S.C. § 154(b)(1)(C) and subtracting 61 days for applicant delay in prosecution ("C reduction" under 35 U.S.C. § 154(b)(2)(C)).  The Office's calculation of the B delay, the issue in the case, credited Exelixis for 85 days from the time between the date that was three years after the application was filed and the date the Final Rejection was mailed; the Office did not give this patent the benefit of another 114 days corresponding from the date the RCE was filed until the grant date, implementing Office policy that filing an RCE stops the accumulation of B delay in the Office's PTA calculation.  These 114 days and the Office's policies that deprived the '622 patent of this additional PTA prompted the lawsuit.  The Court set forth a helpful timeline:

The Court recognized the context of the dispute being based in an assessment of Congressional intent in implementing the provisions of the General Agreement on Tariffs and Trade (GATT), which changed the term of U.S. patents from 17 years from issue to 20 years from the filing (or earliest priority) date, and the provisions of the AIPA apparently aimed at restoring term lost as the result of Patent Office delays in prosecution.  "Taken as a whole," the Court said:

[T]he clear goal and purpose of these provisions is to provide a successful applicant with a patent that can be enforced against putative infringers for approximately 17 years -- 20 years from the date of application less three years for prosecution and examination -- and to reach this goal by providing applicants with day for day patent term extension for delays attributable to the PTO and day for day reductions for the patent term extension for delayed attributable to an applicant's failure to act with alacrity in certain circumstances.

The Court characterizes the provisions of 35 U.S.C. § 154(b) as "guarantees" according to the titles of the three sections of § 154(b) relating to PTO delay, which is significant because the Court notes (in a footnote) that it is permissible for courts to use titles and headings in statutes in interpreting the meaning of the substantive provisions of law.

On summary judgment, the Court ruled against the PTO's interpretation of the statute based on its construction of the statutory provisions and Congressional intent discerned inter alia from how Congress described and characterized those provisions in the statute.  The Court applied the deferential standard that agency action must be upheld unless it is "arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law" under the Administrative Procedures Act (5 U.S.C. § 706(2)(A)), noting that an erroneous interpretation of the law satisfies this standard, citing Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005), and Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004).

The Court's opinion begins with the "plain language of the statute," and the Court found that the meaning of the statute was "clear, unambiguous, and in accord with both the statute's structure and purpose."  Section 154(b)(2) clearly and "simply" is intended by its terms to provide a guarantee of no more than a three-year application pendency, according to the Court's opinion, and this goal is accomplished by "(i) starting a three year clock on the date the application is filed, (ii) tolling the running of this clock if, within the three year period, any of three events occur, including an RCE filing, and (iii) adding a day for day PTA to the patent term for any delay in the issuance of a patent after the three year clock, less any tolling, runs out."

In the Court's view, the provisions of the statute involving RCEs have to do solely with tolling the clock with regard to the three-year date.  The opinion states that the portion of the statute concerning RCEs "clearly and unambiguously modifies and pertains to the three year period and does not apply to, or refer to, the day to day PTA remedy."  The Court characterizes as "[e]specially notable" that the statute "does not address the filing of an RCE after the expiration of the three year clock" (emphasis in original).  The statute "makes [it] clear that once the three year clock has run, PTA is to be awarded on a day for day basis regardless of subsequent events" in the Court's view.  The Court also notes that the filing of an RCE is not contained in the section setting forth the day to day reduction in PTA occasioned by applicant delay in prosecution, and concludes that the statute does not consider the filing of an RCE to be an action that warrants reduction in PTA under the statute.  The Court concludes that "RCE's gave no impact on the PTA after the three year deadline has passed."

The Court rejected PTO arguments in favor of the Office's interpretation.  Specifically, the opinion swiftly dismissed the argument that the statute must be interpreted as if it included the word "then" in such a way that would support its interpretation by simply noting that the word "then" did not appear in the statute and on the grounds that the Office's interpretation would effectively treat the filing of an RCE as a failure to "engage in reasonable efforts to conclude prosecution of the application," i.e., the grounds for applicant delay where the Court had expressly found RCE filings were not included.  If this is the interpretation the Office wants to apply to RCEs, the Court tartly recommends that the Office should be sure to "issue any notice of rejection prior to the expiration of the three year period" as well as require prompt filing of an RCE.  The Court also rejects the Office's position that it should be accorded deference, saying that "deference is unwarranted when [] the statute is unambiguous."  In this regard the Court notes that the Federal Circuit had rejected this level of deference in the last case decided on PTA issues, Wyeth v. Kappos.  Finally, the Court noted that any disparate treatment that might result one application to the next (depending on whether an RCE was filed before or after the 3-year anniversary date) was something within the Office's power to control or minimize.

It is likely that the government will appeal to the Federal Circuit, and thus that the finality of this interpretation of the statute will remain delayed until that review of complete.  This means that there is time for prudent patent practitioners to review the PTA status of their clients' patents to determine where there are instances where the PTA was "improperly" calculated under the interpretation set forth in this opinion.  But time may be of the essence for some because the statute also imposes a 180-day statute of limitations on filing challenges to Office PTA determinations (see "USPTO Posts Notice Regarding Wyeth Decision"), and while an intervening change in the law may permit challenges outside that period it makes better sense to identify important patents and file a lawsuit based on this interpretation of the B delay statutory provisions to best protect both clients and practitioners.

Exelixis, Inc. v. Kappos (E.D. Va. 2012)
Memorandum Opinion by Judge T.S. Ellis, III

Ballot Initiative on Genetically Engineered Food Labeling Defeated in California

By Donald Zuhn --

On Tuesday, while California voters were helping President Obama secure a second term in the White House, picking the President over Republican challenger Mitt Romney by a 59.1% to 38.6% margin, they were also responsible for defeating a ballot initiative, Proposition 37, that would have required raw or processed food to be labeled if such food was made from plants or animals having genetic material changed in specified ways.  The initiative measure, entitled "The California Right to Know Genetically Engineered Food Act," would have amended the California Health and Safety Code such that "any food offered for retail sale in California [would be considered to be] misbranded if it is or may have been entirely or partially produced with genetic engineering and that fact is not disclosed."  The margin of defeat for Proposition 37 was somewhat narrower than that in the Presidential race, with voters rejecting the ballot initiative 53.7% to 46.3%.

According to Proposition 37, "genetically engineered" food was defined as:

[A]ny food that is produced from an organism or organisms in which the genetic material has been changed through the application of:
    (A) In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) techniques and the direct injection of nucleic acid into cells or organelles, or
    (B) Fusion of cells, including protoplast fusion, or hybridization techniques that overcome natural physiological, reproductive, or recombination barriers, where the donor cells/protoplasts do not fall within the same taxonomic family, in a way that does not occur by natural multiplication or natural recombination.

Under the Act, raw agricultural food that was genetically engineered would have to be labeled as "Genetically Engineered," and processed food ("any food produced from a raw agricultural commodity that has been subject to processing such as canning, smoking, pressing, cooking, freezing, dehydration, fermentation, or milling") would have to be labeled as "Partially Produced with Genetic Engineering."

At the California Secretary of State website, arguments in favor of and against the ballot initiative were presented.  In addition, voters were directed by the website to the groups California Right to Know (in favor of the initiative) and NO on 37 (against the initiative) for additional information.

Interestingly, the Ballotpedia webpage for Proposition 37 listed the California Democratic Party and the Green Party of California as supporters of the failed ballot initiative and the California Republican Party as being opposed to the initiative.  Donors to the "No on 37" campaign included Monsanto, E.I. Dupont De Nemours & Co., DOW Agrisciences, Bayer Cropscience, BASF Plant Science, Syngenta Corporation, and the Biotechnology Industry Organization (BIO).

According to a report in the San Jose Mercury News, proponents of the initiative, including California Right to Know, will now turn their efforts towards getting similar initiatives on the ballot in Washington and Oregon.

USPTO Proposes Update to Code of Professional Responsibility

    By Andrew Williams --

Last month, on October 18, 2012, the U.S. Patent and Trademark Office published a notice of proposed rulemaking (77 Fed. Reg. 64190) to finally update its rules of professional conduct by conforming them to the ABA Model Rule of Professional Conduct.  The ABA Model Rules have been adopted in some form by every state (except California) and the District of Columbia.  These USPTO proposed rules are welcome news for patent practitioners that are also attorneys, because currently, such individuals are required to know and abide by the ethics rules of the state in which they practice, as well as the Patent and Trademark Office Code of Professional Conduct, which is based on the former ABA Model Code from 1980.  Of course, there are differences between the ABA Model Rules and the proposed USPTO Rules, just are there are differences between the current USPTO Code and the proposed Rules of professional.  In highlighting any differences, this post will refer to the ABA Model Rules and not to the specific rules of any particular jurisdiction, because to do so would be too onerous (in other words, if you are an attorney licensed in a U.S. jurisdiction, do not rely on any statements found below regarding what ethical rules are required in your jurisdiction, but instead please consult the particular rules of the state in which you practice).  If you would like to provide any comments to the Patent Office regarding these proposed rules, they must be submitted to the Office on or before December 17, 2012.

The Patent Office detailed its reasoning for proposing these rules at this time in the Federal Register notice, and these reasons were reiterated by David Kappos on his Public Blog.  The Office recognized that adopting harmonized rules of ethical and professional conduct is consistent with the mandate of the Leahy-Smith America Invents Act of 2011.  There are almost 42,000 registered patent practitioners, and at least 75% of them are attorneys.  Without the new rules, these patent attorneys are required to go back and forth between the old Model Code and the newer Model Rules.  More importantly, the amount of authority referring to or interpreting the Model Code is, at best, limited.  Instead, a practitioner has the benefit of comments, annotations, and case law interpreting the Model Rules which, even if not binding on the Patent Office, will be useful until a larger body of USTPO-specific precedent is established.  Finally, the Office pointed out that the new rules do not deviate significantly from the current rules of professional conduct, and largely codify obligations or professional and fiduciary duties that already exist.

The differences between the current PTO Code of Professional Conduct, the ABA Model Rules of Professional Conduct, and the proposed USPTO Rules are highlighted in the Federal Register notice, as well as on the Patent Office website.  One of the more significant changes from the current Patent Office rules is the removal of the ability of the Patent Office to collect an annual practitioner maintenance fee, and the removal of the ability of the Patent Office to require continuing legal education reporting of all registered agents or attorneys.  Of course, these provisions were never enforced, but the new rules remove any threat of potential enforcement in the future.  There are also examples of differences between the ABA Model Rules of Professional Conduct and the proposed USPTO Rules that include the inclusion of ex parte proceedings in the section that requires candor towards the tribunal (proposed § 11.303) and the removal of the sections in the ABA Model Rules that deal exclusively with criminal proceedings.  However, probably the most important section to which patent attorneys need to pay attention is proposed § 11.106, dealing with the confidentiality of information.

Confidentiality of Information

One of the most significant changes found in the proposed USPTO Rules in terms of what is currently required by the Patent Office, and in terms of how it differs from the ABA Model Rules, is that relating to the handling of a client's confidential information.  This new rule differs from that currently in place by changing what is defined as confidential information.  The current USPTO Code defines "Confidence" as "information protected by the attorney-client or agent privilege under applicable law," and "Secret" as "other information gained in the professional relationship that the client had requested by held in inviolate of the disclosure of which would be embarrassing or would be likely to be detrimental to the client."  USPTO Code § 10.57(a).  As can be seen, and has been noted by commentators for years, this definition is somewhat limiting.  Most confidential information of a client does not fall under this definition of confidence, and information is only secret under this definition if the client has expressly stated that it is so (or if its disclosure would be embarrassing or detrimental).  Instead, the ABA Model Rules and the proposed USPTO Rules expand the scope of this term, defining confidential information as any "information relating to the representation of a client . . . ."  See, e.g., Proposed USPTO Rule § 11.106(b).  Of course, this definition is provided in the context of what information a practitioner can or cannot (technically may or shall not) reveal, and it is important to note that this information can include information that is publically available.  In fact, the ABA rules have been interpreted to mean that it is possible for an attorney to be prohibited from revealing information related to his or her representation of a client even though such information could have otherwise been obtained from a publically available source.  As a result, it can be a difficult question figuring out whether something is truly "confidential" under this Rule.  Thus, this is a perfect example of a rule for which there is a lot of non-USPTO commentary, and hopefully the Patent Office will either provide its own guidance of the extent of "confidential" information, or will accepted this preexisting (and future) commentary as persuasive on the issue.

The more troubling aspect of the proposed rule is where it deviates from the ABA Model Rules.  As with the Model rule, the proposed USPTO Rule explains what information a practitioner "shall not" reveal without informed consent, implied authorization, or permission under rules.  In addition, both sets of rules explain what information a practitioner "may" reveal, including such things as information that may prevent death, bodily harm, or fraud.  Of note, however, even in the cases where death, bodily harm, or fraud may be result, the practitioner is not required to reveal such information, but rather the practitioner has permission to do so.  The proposed USPTO Rules and the ABA Model Rules nevertheless diverge in one important respect:  the proposed USPTO Rules include a type of information that is mandatory to reveal:  "A practitioner shall disclose to the Office information necessary to comply with applicable duty of disclosure provisions."  In other words, under this proposed rule, a finding that relevant information was intentionally withheld by a practitioner involved in the prosecution of an application will not only cause a patent to become unenforceable, it will result in an ethical violation by the practitioner.

This requirement to disclose information even though it may be confidential also has the possibility to trap a patent practitioner between two ethical obligations.  Importantly, this obligation to disclose information necessary to comply with the duty of disclosure is not limited to confidential information from that particular prosecution client.  Instead, it is possible under the rule that a patent attorney could be aware of confidential information belonging to another client that is nevertheless relevant, and he would therefore be ethically required to submit it with the prosecution client's application.  The Patent Office apparently considered this potential ethical quandary, and as a result, removed this type of disclosure from the types of information that are prohibited from being revealed.  Of course, try explaining to your other client why you revealed its confidential information and made it publically accessible in another client's patent file.  Moreover, any patent attorney in a jurisdiction that has adopted some form of the ABA Model Rules is subject to rules of professional conduct that do not have such a permissive cut-out.  Therefore, such a patent attorney would be required by the proposed USPTO Rules to reveal such third-party confidential information to satisfy the duty of disclosure, but would be prohibited from doing so by the professional rules of conduct of their state.

To be fair, a similar quandary probably already exists, because if a patent attorney is aware of such third-party confidential information, that attorney is already required to disclose it to prevent the patent from becoming unenforceable (and therefore withholding it would violate the duty to act competently for your client).  Nevertheless, the proposed rules would explicitly make such action unethical, and subject to potential disciplinary proceedings.  What is unclear from the proposed USPTO rules is whether an attorney in such an ethical quandary could noisily withdraw from the case, thereby removing the problem.  However, if not, such an attorney would face certain disciplinary proceedings (either in their state or at the Patent Office), because it is impossible to "not reveal" information and, at the same time, submit it to the Patent Office in an information disclose statement.  Yet, this is what the proposed rule, in conjunction with the ABA Model Rules would require.

Anyone wishing to provide comments regarding the new rules regarding confidential information, or provide comments to any other of the proposed rules, can do so by submitting them by e-mail to ethicsrules.comments@uspto.gov; by regular mail addressed to:  Mail Stop OED-Ethics Rules, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of William R. Covey, Deputy General Counsel for Enrollment and Discipline and Director of the Office of Enrollment and Discipline; or via the Federal eRulemaking Portal.  Again, the deadline for submitting comments is December 17, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 64190).

A Genetic Basis for Müllerian Mimicry in Butterflies

By Kevin E. Noonan --

Mimicry is a classic (and classical) biological phenomenon, the appreciation of which dates to the time when biology was more accurately called "natural history" and was more diversion for English country gentlemen than proper science.  Perhaps the most well-known form of mimicry is Müllerian mimicry, and the best example of that is the viceroy butterfly (Limenitis archippus), which although tasty to avian predators displays markings almost indistiguishable from the monarch butterfly (Danaus plexippus), which is not only unpalatable but actually toxic to birds (see below).  Anyone with even a rudimentary appreciation of Linnean classification will recognize another interesting feature of mimicry:  despite their visual similarities, the monarch and viceroy butterflies are not only different species but members of different genera, suggesting that genetic inheritance cannot account for the convergence in wing pattern phenotype.

Recent work employing genomic sequencing and linkage analysis (from the Heliconius Genome Project) has begun to shed light on the genetic bases for Müllerian mimicry.  This work was performed on a South American butterfly species, Heliconius melpomene (at right).  As reported in Nature (doi:10.1038/nature11041), naturally occurring species of Heliconius show significant introgression in regions related to color pattern development.  Heliconius butterflies comprise 43 species and hundreds of races and make up rapidly radiating butterfly species in South America; certain of these species exhibit classic Müllerian mimicry, wherein palatable species adopt the color pattern of other species that are unpalatable to bird predators.  The authors sequenced almost 13,000 genes (12,669 open reading frames) in the 269 megabase (Mb) butterfly genomic DNA and mapped the majority (~83%) of these genes to the 21 Heliconius chromosomes using a modern version of RFLP analysis termed restriction site DNA linkage mapping.  This work found that the chromosomal organization of Heliconius butterfly genomic DNA was "broadly conserved" since the evolutionary split from a common ancestor shared with Bombyx (silkmoth) species in the Cretaceous (~100 million years ago).  Comparison with the Bombyx mori (silkmoth) genome identified 6,010 orthologues and previously unidentified chromosomal fusions in the Heliconius chromosomal complement.  Biologically important expansion was found in families of genes related to chemosensation and body shape and form (homeobox, or Hox, genes).  The Heliconius genome showed an expected increase in ultraviolet opsins (due to the diurnal lifestyle adopted by butterflies) and an unexpected genetic complexity in olfactory genes (33 Heliconius olfaction genes, similar to what was found in monarch butterfly species having 34 olfactory genes).  The researchers also found additional Hox genes related to body shape and form, similar to what is found in other butterflies and related dipteran species.

The researchers compared genomic DNA from three co-mimicry species, Heliconius melpomene, Heliconius timareta, and Heliconius elevatus and produced a genetic tree between 84 individuals from H. melpomene and related species (see below).  In this comparison, the researchers found hybrid exchange especially at two genomic regions that control mimicry pattern based on ~4% (12Mb) of the genome.  The results obtained from Heliconius melpomene amaryllis and H. timareta ssp. were compared and the researchers report evidence of greater hybrid interbreeding between these species when compared with H. melpomene aglaope and H. timareta ssp, which do not have overlapping spatial ranges.  The researchers estimated 2-5% exchange of the genome; the introgression was not uniformly distributed over the 21 chromosomes but seems to be limited to 11 chromosomes with two chromosomes showing the strongest frequency of introgression.  These regions, comprising loci known to be associated with red pattern (B/D) and yellow (N/Yb) pattern loci, showed blocks of sequence (~100 kb in size) that are shared between species and exchanged in hybrids.  The genetic makeup of these shared blocks of sequence were more consistent with hybrid introgression (and fixation) than in other alternatives, such as convergent evolution.

The researchers concluded that these species exchange protective color pattern genes promiscuously and that their evidence of hybrid exchange and fixation indicates that this mode of gene transfer between diverse species may be a more important mechanism for explaining phenomena like mimicry than had been previously appreciated.  The authors propose that hybridization between mimicking species is a plausible explanation for "parallel evolution of multiple mimetic patterns" in these species.

Supplemental experimental details can be found here.

Image of Heliconius melpomene by Greg Hume, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.

Court Report

By Sherri Oslick --

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

Acura Pharmaceuticals Inc. v. Impax Laboratories Inc.
1:12-cv-01371; filed October 31, 2012 in the District Court of Delaware

Acura Pharmaceuticals Inc. v. Par Pharmaceutical Inc.
1:12-cv-01372; filed October 31, 2012 in the District Court of Delaware

Acura Pharmaceuticals Inc. v. Sandoz Inc.
1:12-cv-01373; filed October 31, 2012 in the District Court of Delaware

Acura Pharmaceuticals Inc. v. Watson Laboratories Inc.-Florida et al.
1:12-cv-01374; filed October 31, 2012 in the District Court of Delaware

• Plaintiff:  Acura Pharmaceuticals Inc.
• Defendants:  Watson Laboratories Inc. – Florida; Watson Pharmaceuticals Inc.; Watson Pharma Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 7,510,726 ("Methods and Compositions for Deterring Abuse of Opioid Containing Dosage Forms,"  issued March 31, 2009) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Oxecta® (oxycodone hydrochloride, used for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate, marketed by Pfizer).  View the Impax complaint here.

Esoterix Genetic Laboratories, LLC et al. v. Life Technologies Corp., et al.
1:12-cv-01173; filed October 31, 2012 in the Middle District of North Carolina

• Plaintiffs:  Esoterix Genetic Laboratories, LLC; The Johns Hopkins University
• Defendants:   Life Technologies Corp.; Applied Biosystems, LLC; Ion Torrent Systems, Inc.

Infringement of U.S. Patent Nos. 6,440,706 (" Digital Amplification,"  issued August 27, 2002), 7,824,889 (same title, issued November 2, 2010), and 7,915,015 (same title, issued March 29, 2011) based on defendants' manufacture and sale of products, kits, and devices used in methods for the detection of ratios of genetic sequences in a biological sample and/or for the detection of allelic imbalances in a biological sample.  View the complaint here.

Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc.
2:12-cv-06761; filed October 26, 2012 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,263,650 (" Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy,"  issued September 11, 2012) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.

Conference & CLE Calendar

November 12-14, 2012 - Fall Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) - Charleston, SC

November 15, 2012 - Successful Strategies for Overcoming Obviousness Rejections in the Patent Application Process (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 - 11:15 am (CT)

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

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

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

ACI Conference on Patent Reform

American Conference Institute (ACI) will be offering "The Comprehensive Guide to Patent Reform" from January 23-24, 2013 in New York, NY.  The conference will allow attendees to:

• Adapting to the first-to file regime and developing prosecution techniques to ensure timely filings that result in robust patents;
• Dissecting the new rules covering the usage of declarations and assignments to avoid costly delays and confusion associated with recalcitrant or missing inventors;
• Utilizing the inter partes review process to challenge troubling patents and understanding the discovery rules associated with this procedure;
• Determining when it is appropriate to employ the post-grant review procedure to attack a rival patent and crafting defenses to it;
• Grasping the advantages of supplemental examination, its potential to cure defects in prosecution, and recognizing its risks;
• Maximizing the potential of third party prior art submission in attacking a rival patent pre-issuance and guarding against its effects with smart prosecution;
• Understanding the implications of patent reform for Hatch-Waxman litigation; and
• Demystifying the new standards for prior art encoded in the America Invents Act including discussion of the new "disclosures" definition, the impact on obviousness findings, and more.

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

• USPTO keynote address: The USPTO's efforts to implement AIA provisions impacting patent prosecution -- to be presented by Teresa Stanek Rea, Deputy Director, U.S. Patent and Trademark Office;
• Preparing your company for the looming implementation of the first-to-file regime and preparing strategies to exploit the coming changes for maximum benefit;
• Identifying what constitutes prior art under the AIA and planning a patenting strategy around the new standards;
• Slipping the Gordian knot -- How to avoid ethical conundrums presented by the AIA's inconsistent best mode requirements;
• USPTO address: Detailing the new post grant opposition procedures, how they will impact patenting, and more -- to be presented by Thomas Giannetti, Patent Administrative Judge, U.S. Patent and Trademark Office;
• Learning the sweet science: Win the new boxing match known as inter partes review;
• Preparing for the eventual employment of the post grant review procedure in opposition practice;
• Deciding when to use supplemental examination to cure defects in a patent: Balancing the risks and rewards;
• Gambit: Utilizing third party prior art submissions in the pre-issuance chess match;
• Examining the ramifications of patent reform for Hatch-Waxman litigation and the brand/generic wars; and
• Investigating the changes to declarations and assignments and understanding how these new provisions can be used to keep prosecution on track.

In addition, a pre-conference workshop entitled "Patent Reform 101: A Primer on the Fundamental Provisions of the America Invents Act" will be offered from 9:00 am to 12:00 pm on January 23, 2013, and a post-conference workshop entitled "Interactive Working Group Session: A Hypothetical Invention Being Patented Under the AIA" will be offered from 9:00 am to 12:00 pm on January 25, 2013.

An agenda for the conference can be found here.  More information regarding the workshops 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), $2,995 (conference and one workshop), or $3,495 (conference and two workshops).  Those registering by November 9, 2012 will receive a $300 discount and those registering by December 14, 2012 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 Patent Reform conference.

Court Report Supplement

By Ann Palma --

About Court Report Supplement:  Periodically, we will report on biotech and pharma cases that were inadvertently omitted from our Court Report column.

W.H.P.M., Inc. v. BiotechPharma, LLC et al.
1:12-cv-137; filed February 10, 2012 in the Eastern District of Virginia

• Plaintiff:  W.P.H.M., Inc.
• Defendants:  BiotechPharma, LLC and Raouf A. Guirguis

Infringement of U.S. Patent No. 7,927,562 ("Collection and Assay Device for Biological Fluid," issued April 19, 2011) based on BiotechPharma's manufacture, use, sale, and offers for sale of its products for drug testing and identity verification, including the "BTP tube device" or "DRG-SA06 Drug Testing & Identity Verification System."  View complaint here.

Lonza Walkersville, Inc. v. Hyglos GmbH
1:2012-cv-602; filed February 4, 2012 in the District of Maryland

Infringement of U.S. Patent Nos. 5,716,834 ("Cloned Factor C cDNA of the Singapore Horseshoe Crab, Carcinoscorpius Rotundicauda and Purification of Factor C Proenzyme," issued February 10, 1998), 5,712,144 (same title, issued on January 27, 1998), 5,858,706 ("Expression of Carcinoscorpius Rotundicauda Factor C in Eukaryotes," issued on January 12, 1999), 5,985,590 (same title, issued on November 16, 1999), and 6,645,724 ("Assays for Endotoxin," issued on November 11, 2003) based on Hyglos GmbH's manufacture, use, offers for sale, sale, and importation of products that contain endotoxin detection assays, including EndoLISA®, or that contain an affinity matric for removal of bacterial endotoxins from solutions, including EndoTRAP®.  View the complaint here.

ArcticDX, Inc. et al v. Sequenom, Inc. et al.
2:12-cv-00081; filed February 29, 2012 in the Eastern District of Texas

• Plaintiffs:  ArcticDx, Inc.; ArcticA, Inc.; ArticAx US Ltd.
• Defendants:  Sequenom, Inc.; Sequenom Center for Molecular Medicine, LLC

Infringement of U.S. Patent No. 8,114,592 ("Genetic Markers Associated with Age-Related Macular Degeneration, Methods of Detection and Uses Thereof," issued February 14, 2012) based on Sequenom's use, sale, and offer for sale of genetic diagnostic products, including RetnaGene®.  Declaratory Judgment of noninfringement and invalidity of U.S. Patent Nos. 8,053,190 ("Susceptibility Genes for Age-Related Maculopathy (ARM) on Chromosome 10q26," issued November 8, 2011), 7,867,727 ("Methods and Reagents for Treatment and Diagnosis of Vascular Disorders and Age-Related Macular Degeneration," issued January 11, 2011), 7,695,909 ("Susceptibility Genes for Age-Related Maculopathy (ARM) on Chromosome 10q26," issued on April 13, 2010), 7,351,524 ("Diagnostics and Therapeutics for Macular Degeneration-Related Disorders," Issued on April 1, 2008) or 8,088,579 ("Complement Factor H for Diagnosis of Age-Related Macular Degeneration," issues January 3, 2012) based on Arctic's manufacture, use, or sale of products for genetic diagnostics, including Macula Risk®.  View the complaint here.

XY, LLC v. Trans Ova Genetics, LC
5:12-cv-208; filed March 5, 2012 in the Southern District of Western District of Texas

Infringement of U.S. Patent Nos. 7,820,425 ("Method of Cryopreserving Selected Sperm Cells," issued on October 26, 2010), 6,357,307 ("System and Method of Flow Cytometry and Sample Handling," issued on March 19, 2002), 6,604,435 ("Low Acceleration Method of Flow Cytometry," issued on August 12, 2003), 6,782,768 ("Flow Cytometer Nozzle," issued on August 31, 2004), 6,263,745 ("Flow Cytometer Nozzle and Flow Cytometer Sample Handling Methods," issued on July 24, 2001), 7,713,687 ("System to Separate Frozen-Thawed Spermatozoa Into X-Chromosome Bearing and Y-Chromosome Bearing Populations," issued on May 11, 2010), 7,771,921 ("Separation systems of Frozen-Thawed Spermatozoa into X-Chromosome Bearing and Y-Chromosome Bearing populations," issued on August 10, 2010), 6,149,867 ("Sheath Fluids and Collection Systems for Sex-Specific Cytometer Sorting of Sperm," issued on November 21, 2000), 6,524,860 ("Methods for Improving Sheath Fluids and Collection Systems for Sex-Specific Cytometer Sorting of Sperm," issued on February 25, 2003), and 7,195,920 ("Collection Systems for Cytometer Sorting of Sperm," issued on March 27, 2007) based on Defendant's use of flow cytometers (or other similar apparatuses) for sex selection of sperm cells and the sale of semen produced using such apparatuses, in addition to Defendant's use of flow cytometry-based sex selection protocols and procedures.  View the complaint here.

Proprietary Wellness, LLC v. Primordial Performance, LLC
4:12-cv-11072; filed March 9, 2012 in the Eastern District of Michigan

Infringement of U.S. Patent No. 8,084,446 ("Use of DHEA Derivatives for Enhancing Physical Performance," issued on December 27, 2011) based on Defendant's manufacture, use, offer for sale, sale, and importation of products or processes containing 4-DHEA or Andosterone and its esters, in addition to claims of breach of license agreements, unjust enrichment, quantum merit, and tortious interference. View the complaint here.

Butamax™ Advanced Biofuels LLC v. Gevo, Inc.
12-cv-298; filed March 12, 2012 in the Eastern District of Delaware

Infringement of U.S. Patent No. 8,129,162 ("Ketol-Acid Reductoisomerase Using NADH," issued on March 6, 2012) based on Defendant's manufacture and use of recombinant microorganisms comprising mutant ketol-acid reductoisomerase enzymes.  View the complaint here.