Patent Docs

Conference & CLE Calendar

September 21-22, 2009 - 2009 World Stem Cell Summit*** - Baltimore, MD

September 21-22, 2009 - Patent Litigation 2009 (Practising Law Institute) - San Francisco, CA

September 23-25, 2009 - 10th Annual Generic Drugs Summit on the Business of Biosimilars (Institute for International Research) - Boston, MA

September 30-October 1, 2009 - Biotech Patents*** (American Conference Institute) - Boston, MA

October 5-6, 2009 - Patent Litigation 2009 (Practising Law Institute) - McLean, VA

October 7-8, 2009 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY

October 14, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA

October 15-16, 2009 - Patent Litigation 2009 (Practising Law Institute) - Chicago, IL

October 20-21, 2009 - 17th Forum on Biotech Patenting (C5) - London, United Kingdom

October 22-23, 2009 - Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) - Philadelphia, PA

October 26-28, 2009 - Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) - Washington, DC

October 28-29, 2009 - Patent Opinion Writing Boot Camp*** (American Conference Institute) - Philadelphia, PA

November 9-10, 2009 - Patent Litigation 2009 (Practising Law Institute) - Atlanta, GA

November 9-11, 2009 - Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) - London, England

November 10, 2009 - The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) - Baltimore, MD

November 12-13, 2009 - Paragraph IV on Trial*** (American Conference Institute) - New York, NY

November 13, 2009 - The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) - Las Vegas, NV

November 16-17, 2009 - Patent Litigation 2009 (Practising Law Institute) - New York, NY

November 17-18, 2009 - Structuring, Negotiating, and Managing Pharma/Biotech Collaborative Agreements (American Conference Institute) - New York, NY

December 7-8, 2009 - Foreign Patent Law & Regulation*** (American Conference Institute) - New York, NY

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

ACI Foreign Patent Law & Regulation Conference

American Conference Institute (ACI) will be holding a conference on Foreign Patent Law & Regulation for the U.S. Life Sciences Patent Practitioner from December 7-8, 2009 in New York, NY.  The conference will allow attendees to:

• Develop a strategic plan for deciding when and where to file life sciences patents abroad;
• Prosecute and file life sciences and pharmaceutical patents in emerging Asian markets;
• Navigate unique issues that arise in the context of seeking supplementary protection certificates (SPCs) and method of use/treatment claims in life sciences patents;
• Address cultural idiosyncrasies and technical requirements in various jurisdictions when developing international patent litigation strategy;
• Select and manage a multi-jurisdictional patent litigation team;
• Seek damages and pursue available remedies abroad -- knowing what you can (and cannot get) and where you can get it; and
• Assess the impact of the EC Sector inquiry on global pharmaceutical patent life cycles.

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

• Why now?  Understanding the importance of developing a global strategy for a life sciences patent portfolio;
• Evaluating advantages and limitations of foreign filing conventions and treaties;
• Foreign patent offices:  Exploring filing and prosecution protocols;
• Filing and prosecuting life sciences & pharmaceutical patents in emerging Asian markets;
• Guidelines for evaluating standards of patentability and selecting the best jurisdictions in which to file an international life sciences patent;
• Strategies for successfully obtaining method of use/treatment claims;
• Navigating the "ins" and "outs" of opposition practice in Europe and Asia;
• Supplementary protection certificates (SPCs):  Strategies for successfully extending the patent term on a life sciences invention;
• Balancing competing antitrust and IP interests:  Assessing the impact of the EC Pharmaceutical Sector Inquiry on the exercise and defense of patent rights;
• Considerations for U.S. life sciences companies when filing patent suits abroad and selecting foreign litigation counsel;
• Successfully seeking injunctive relief for a life sciences patent:  Strategies for the EU and Asia;
• Organizing and managing a foreign patent litigation team and strategy;
• Understanding the mechanics of conducting and seeking discovery in foreign jurisdictions;
• Obtaining, calculating, and evaluating the scope of available damages abroad; and
• Caselaw update:  Emerging trends in foreign life sciences patent litigation.

An additional post-conference workshop entitled "Mastering the Interplay between Foreign Patent Law and Regulatory Requirements for Life Sciences Companies in the EU and Asia" will be offered from 9:00 am to noon on December 9, 2009.  During the workshop, ACI faculty will provide a comprehensive overview of the basics of patent protection and regulatory approval required for the commercial viability of life sciences products in the EU and emerging Asian jurisdictions.

According to an ACI release, the Foreign Patent Law & Regulation conference has been designed to provide in-house patent and IP counsel within the pharmaceutical, biopharmaceutical, biotechnology, and medical device industries with a working knowledge of the current status of patent law in key foreign jurisdictions, including the EU and emerging Asian markets.  A leading faculty comprised of experienced in-house counsel representing such multi-national companies as Allergan, Boehringer Ingelheim, GlaxoSmithKline, Medtronic, Novartis, Novo Nordisk, Purdue Pharma, sanofi-aventis, Sanofi Pasteur, and Schering-Plough, as well as patent prosecution attorneys and litigation counsel from Australia, Belgium, China, India, Germany, Japan, Korea, Netherlands, Switzerland, and the United Kingdom will provide attendees with an in-depth overview of the unique issues that arise in the context of both prosecution and litigation outside the U.S.

The agenda for the Foreign Patent Law & Regulation conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee for the conference is $2,195 (conference alone) or $2,795 (conference and workshop).  Those registering on or before October 2, 2009 will receive a $300 discount off the registration fee and those registering on or before November 6, 2009 will receive a $200 discount off the registration fee.  ACI will also provide a $200 discount off the standard price to all Patent Docs readers who reference the discount code "Patent Docs" when registering.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Foreign Patent Law & Regulation conference.

Tech Companies Send Letter on Patent Reform to Secretary Locke

    By Donald Zuhn --

On Monday, a group of 56 companies sent a letter to Secretary of Commerce Gary Locke (below) urging the Secretary "to push for improvements" to the post-grant and inter partes examination provisions of patent reform legislation currently before Congress.  The Seattle PI's Microsoft blog published a copy of the letter on Wednesday in an article entitled "Tech cos. protest patent reform in letter to Locke."

In the letter, the group acknowledges that "some versions of the legislation have been improved this Congress," but asserts that "additional improvements are in order to ensure that the end product avoids serious unintended consequences."  According to the signatories, the "two most contentious issues in the patent reform debate relate to patent damages and the expansion of administrative challenges to patent validity."  With respect to the first issue, the letter commends the Senate for resolving the patent damages issue by introducing a "gatekeeper" provision, and urges Secretary Locke to support that approach (see "Senate Judiciary Committee Holds Hearing on Patent Reform" and "Senate 'Patent Reform' Bill (S. 515) Voted out of Judiciary Committee").  The group states that "[a]ny effort to go back to previous [damages] proposals will, in our view, endanger the entire patent reform effort."

With respect to the second issue, however, the group predicts that post-grant review and inter partes examination provisions in the current legislation "will have serious negative consequences which must be considered."  The letter notes that these provisions will put additional strain on an already burdened Patent Office, and contends that "[a]dding new obligations to the agency at this time seems extraordinarily unwise."  If the current provisions are passed into law, the group foresees "longer patent pendency and lower patent quality."  In addition, the signatories contend that such provisions would be "vulnerable to a high level of abuse" by "allow[ing] infringers to subject valid patents to lengthy and repeat challenges."  In support of its contentions, the group cites a November 2007 article co-authored by Yongshun Cheng (former Senior Judge and Deputy Presiding Judge of the Intellectual Property Division of Beijing High People's Court) and Li Lin, which concluded that the patent reform bill passed by the House in September 2007 "is friendlier to the infringers than to the patentees in general as it will make [U.S.] patent[s] less reliable, easier to be challenged and cheaper to be infringed" (see "Chinese IP Judge Discusses Implications of U.S. Patent Reform Bill and Two Congressmen Heed Warning").

The group contends that abuse of the post-grant review and inter partes examination provisions "will be harmful to American innovators who rely on strong patents," and therefore, urges Secretary Locke "to push for improvements to these provisions which will limit the ability of infringers to undermine the very system the legislation attempts to strengthen."

The 56 signatories to the letter include:  Abbott Medical Optics Inc.; Acclarent, Inc.; Acorn Cardiovascular, Inc.; Allergan Inc.; Applied Medical; ARCH Venture Partners; Ardian, Inc.; Asthmatx, Inc.; ATS Medical; Aware, Inc.; Biomerix Corporation; Calibra Medical; Carticept Medical, Inc.; Conceptus, Inc.; Corning Inc.; Cryptography Research, Inc.; Cummins-Allison; Cyberonics; Digimarc Corp.; Dolby Laboratories; Dynatronics Corp.; Elemé Medical Inc.; Evalve, Inc.; ExploraMed Development, LLC; Fallbrook Technologies Inc.; The Foundry, LLC; ForSight; ForSight VISION3; ForSight VISION4; GeneEx, Inc.; Ikaria Holdings, Inc.; InterDigital, Inc.; Intermolecular; Medigroup Inc.; Miramar Labs, Inc.; Mohr Davidow Ventures; Monsanto; Moximed, Inc.; NeoTract, Inc.; NeoVista, Inc.; Neuro Resource Group, Inc.; NeuroPace, Inc.; Nims, Inc.; Novasys Medical; Optimum Performance Solutions LLC; OsteoMed; Paracor Medical, Inc.; PolyRemedy, Inc.; Qualcomm Inc.; Streamline; Tessera; TherOx; Transonic Systems Inc.; Urovalve Inc.; U.S. Venture Partners; Venture Investors; The Vertical Group; Vibrynt, Inc.; and Viryd Technologies Inc.

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2009)

Medical Diagnostics Claims Are Patentable Subject Matter

    By Kevin E. Noonan --

Over the past few years, Federal Circuit decisions in In re Bilski and Classen Immunotherapeutics, Inc. v. Biogen Idec, combined with Justice Breyer's dissent in Laboratory Corp. v. Metabolite Labs., Inc. ("LabCorp"), have created more than a frisson of anxiety in the biotechnology and medical diagnostics community, due the apprehension that medical diagnostics claims might generally be deemed not to be patent-eligible subject matter under 35 U.S.C. § 101.  These fears may be alleviated to some degree by the decision today in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, where the Court held that a diagnostics claim satisfies the machine-or-transformation test enunciated in Bilski.

The case relates to U.S. Patent Nos. 6,335,623 and 6,680,302, which were exclusively licensed by Prometheus.  Defendants Mayo Collaborative Services and Mayo Clinic Rochester used the technology covered by these patents, until Mayo unilaterally announced that it intended to use its own test internally and to sell the test to other hospitals.  Prometheus brought suit and the District Court granted summary judgment in Prometheus' favor that Mayo's test literally infringed claim 7 of the '623 patent.  All of the patent claims relate to methods for identifying metabolites of thiopurine, a drug used to treat various gastrointestinal disorders such as Crohn's disease and ulcerative colitis.  Claim 1 of the '623 patent was cited in the Federal Circuit opinion as being representative:

A method of optimizing therapeutic efficacy for treatment of an immune- mediated gastrointestinal disorder, comprising:
    (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
    (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
    wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
    wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The District Court granted summary judgment in favor of the defendants that the claims of the '623 and '302 patents were invalid under 35 U.S.C. § 101 for failure to recite patent-eligible subject matter, stating that merely because the inventors:

have framed the claims as "treatment methods" does not make the claims patentable.  Indeed, "one can reduce any process to a series of steps.  The question is what those steps embody."  Lab. Corp. of Am. Holdings v. Metabolite, Inc., 548 U.S. 124 (2006) (Breyer, J., dissenting from dismissal of certiorari) (emphasis in original); see also In re Grams, 888 F.2d 835, 839 (Fed. Cir. 1989) (explaining that the critical question is: "What did applicants invent?") (quoting In re Abele, 684 F.2d 902, 907 (C.C.P.A.1982)) . . .  [T]he "administering" and "determining" steps are merely necessary data-gathering steps for any use of the correlations.  However, an "unpatentable principle" will not transform into a "patentable process" simply by adding conventional method steps.  . . .  [The [wherein or] "warning" step [in a mental step that] does not require that dosage be adjusted, or any other action.  . . .  [I]t is the metabolite levels themselves that "warn" the doctor that an adjustment in dosage may be required.

The District Court held that "the patents claimed the correlations between certain thiopurine drug metabolite levels and therapeutic efficacy and toxicity."  These correlations were "natural phenomena" according to the District Court, and thus unpatentable "because the correlations resulted from a natural body process."  The inventors of the '623 and '302 patents did not invent the correlation, according to the lower court's invalidity opinion, because the metabolites detected according to the patent claims "are products of the natural metabolizing of thiopurine drug, and the inventors merely observed the relationship between these naturally-produced metabolites and therapeutic efficacy and toxicity."  Moreover, having determined that the claims encompass the correlations themselves, the District Court held that the claims "wholly preempt" the correlations.  The recited process steps, of administering a thiopurine drug and determining the levels of thiopurine metabolites in a patient's blood, were "merely necessary data-gathering steps," and the final step constituting the "wherein" clause of claim 1 of the '623 patent (for example) is merely a "mental step," according to the District Court, since it did not recite any action mandating that a physician adjust the administered dosage of the thiopurine drug.

The Federal Circuit reversed, in an opinion by Judge Lourie joined by Chief Judge Michel and the Honorable Ron Clark, District Judge of the U.S. District Court for the Eastern District of Texas, sitting by designation.  The opinion cited as context the Supreme Court's expansive definition of patentable subject matter in Diamond v. Chakrabarty and its limits, as in Diamond v. Diehr and Gottschalk v. Benson, as well as how methods were defined broadly by Congress under 35 U.S.C. § 100(b), but the analytical framework of the decision was the machine-or-transformation test in In re Bilski.  Citing Bilski, the Court framed the issue before it as follows:

The key issue for patentability, then, at least on the present facts, is whether a claim is drawn to a fundamental principle or an application of a fundamental principle.

The CAFC turned to Bilski to address this "key issue," with one additional caveat in guiding its application.  The Supreme Court, said Judge Lourie, "has also made clear that the patent eligibility of a claim as a whole should not be based on whether selected limitations constitute patent-eligible subject matter . . . [I]t is "inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis," citing Diehr, and that "it is improper to consider whether a claimed element or step in a process is novel or nonobvious, since such considerations are separate requirements set forth in 35 U.S.C. §§ 102 and 103, respectively," citing Bilski and Diehr.

Turning to the claims at issue, the Federal Circuit held that the administering and determining steps, dismissed by the District Court as constituting mere "necessary data-gathering steps," were instead transformative and thus satisfy the transformation prong of the Bilski machine-or-transformation (for convenience, MOT) test.  The CAFC opined that "[t]he transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug's metabolites that enable their concentrations to be determined."  The Court found that these steps were essentially "method of treatment" steps, "which are always transformative when a defined group of drugs is administered to a body to alleviate the effects of an undesired condition" (emphasis added).  A human body to which drugs such as thiopurines are administered "necessarily undergoes a transformation," since "the drugs do not pass through the body untouched without affecting it," which the Court characterized as "the entire purpose of administering the drugs."  The Court rejected Mayo's contention that the transformations are the result of "natural processes" because "quite literally every transformation of physical matter can be described as occurring according to natural processes and natural law."  But the transformation encompassed by the administering step of the asserted claims are not "natural processes" according to the Court:  "[i]t is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter (emphasis in the original text).  Ironically noted in a footnote, the Court dismissed Justice Breyer's Metabolite dissent, upon which the District Court "relied heavily on," summarily:  "[t]hat dissent is not controlling law."

The considerations that guided the panel in deciding that the administration steps were transformative also apply to the metabolite-determining steps, according to the Court, since metabolite levels "cannot be determined by mere inspection."  The Court cited in this regard Prometheus' expert, to the effect that "at the end of the process [of metabolite-determining], the human blood sample is no longer human blood; human tissue is no longer human tissue," i.e., these samples have been transformed.

The Court's opinion also rejected any characterization of the administering and metabolite-determining steps as being "insignificant extra-solution activity."  Failure to recognize this was "the crucial error" made by the District Court, according to Judge Lourie.  In this analysis, the Federal Circuit applied the teachings of In re Grams, a case cited by the District Court in coming to its "extra-solution activity" conclusion.  The Federal Circuit distinguished the claims at issue here, which recite patent-eligible subject matter, from the claims in Grams, which did not, because in Grams "the essence of the claimed process was [a] mathematical algorithm, rather than any transformation of the tested individuals," being "merely an algorithm combined with a data gathering step."

The opinion also asserted that, even if the "warning" step encompassed in the "wherein" clause of claim 1 of the '623 patent was merely a mental step, it "does not detract from patentability" (or, more properly, patent-eligibility).  Looking at the claim "as a whole":

The data that the administering and determining steps provide for use in the mental steps is obtained by steps well within the realm of patentable subject matter.  The addition of the mental steps to the claimed methods thus does not remove the prior two steps from that realm.

And citing Bilski:

[I]t is inappropriate to determine the patent eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter.  After all, even though a fundamental principle itself is not patent-eligible, processes incorporating a fundamental principle may be patent-eligible.  Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under § 101.

Finally, the Federal Circuit opined that the District Court erred in deciding that Prometheus' asserted claims "wholly preempted" the use of correlations between metabolites of thiopurine drugs and their toxicity and efficacy.  Rather, according to the Court, the claims utilize, not preempt, the correlations of natural processes "in a series of specific steps" that are patent-eligible subject matter according to the statute, citing Diehr and its analogous use of the Arrhenius equation for curing rubber (a transformative step).  "Regardless," according to the Court, of this issue, satisfaction of the MOT test renders the claims patent-eligible and thus "they do not preempt a fundamental principle."

The decision in the Prometheus case comes as at least a temporary balm to the diagnostics industry, since similar claims in Classen had been summarily (and tersely) rejected by the Federal Circuit as failing the Bilski MOT test (see Patent Docs post).  The Court's recognition in this case of the transformative nature of method claim steps reciting administering, or assaying, or determining, or immunizing thus reconciles the application of the Court's Bilski precedent with physical reality (not to mention common sense).  It also provides inventors and their counsel with tools to adapt their diagnostic method claims to satisfy the test, and precedent to defend patent-eligibility when challenged at the Patent Office or in litigation.  Diagnostic methods companies can now breathe a cautious sigh of relief, at least until the Supreme Court decides Bilski later this year.

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2009)
Panel: Chief Judge Michel, Circuit Judge Lourie, and District Judge Clark
Opinion by Circuit Judge Lourie

Interactive Graphic Illustrates How U.S. Patent System Has Driven American Economy

    By Donald Zuhn --

Last month, the Milwaukee Journal Sentinel published two articles documenting the current state of the U.S. patent system (see "The Milwaukee Journal Sentinel Gets It Right about Patents").  The authors of those pieces, John Schmid and Ben Poston, have now compiled an interactive graphic that shows how the U.S. patent system has shaped American history and innovation.  The graphic contains a number of elements, including a timeline of key patents and significant events in American history, a comparison of domestic and foreign patents issued between 1790 and 2009, and charts showing the top countries and states in which U.S. patents originated, the number of pending applications between 1981 and 2009 and average application pendency between 1983 and 2008, fee diversion between 1992 and 2004, and rapid growth of the Chinese patent system between 1999 and 2008.

Among the patents making the Journal Sentinel's timeline are the issuance in 1928 of U.S. Patent No. 1,680,818 to Harry Steenbock, the issuance in 1948 of U.S. Patent No. 2,442,141 to Andrew Moyer, and the issuance in 1998 of U.S. Patent No. 5,843,780 to James Thomson.  The '818 patent, which is directed to an antirachitic product and process (i.e., a process for enhancing Vitamin D in "organic substances of dietary value").  Dr. Steenbock secured a Nobel nomination in 1929 for the work leading to the '818 patent, and the success of the patent helped launch the Wisconsin Alumni Research Foundation (WARF).  The '141 patent is directed to a method a producing penicillin, and the '780 patent is the first embryonic stem cells patent.  The timeline also includes the Diamond v. Chakrabarty decision, which the authors state spurred an "unprecedented growth in biotechnology," among its significant events.

Amgen Inc. v. F. Hoffman-La Roche Ltd. (Fed. Cir. 2009)

Something for Everyone, but the Injunction Stands

 

    By Kevin E. Noonan --

Amgen has several times successfully defended its erythropoietin (EPO) franchise, the company's first commercial success and in many ways the crown jewel of its (or anyone's) biologics drug pipeline.  That string of successes continued today with a decision by the Federal Circuit against its latest challenger, Hoffman-La Roche.  But the decision also put several of the patents protecting Amgen's EPO at risk, making this a mixed victory at best for the biotechnology company.

The case involved the most recent challenge, Roche's Mircera® product, a pegylated derivative of human EPO.  Amgen sued Roche in a declaratory judgment action in Massachusetts asserting six patents:  U.S. Patent Nos. 5,547,933 (the '933 patent), 5,441,868 (the '868 patent), and 5,618,698 (the '698 patent), U.S. Patent Nos. 5,955,422 (the '422 patent, claim 1) and 5,756,349 (the '349 patent, claim 7) and U.S. Patent No. 5,621,080 (the '080 patent).  On October 23, 2007, a jury found that Mircera® infringed the '933 patent, the '868 patent and the '698 patent, and that these patents as well as the '422 patent and the '349 patent were not invalid.  (The jury reached neither infringement nor validity of the '080 patent).  Specifically, the jury found that Roche's Mircera® infringed claims 3, 7, and 8 of the '933 patent (claim 12 was found not to be literally infringed but infringed under the Doctrine of Equivalents); claims 1 and 2 of the '868 patent; and claims 6 through 9 of the '698 patent.  On October 1, 2008, Massachusetts District Court Judge William Young ruled (in Amgen's favor for each) on several post-trial motions, including:  1) affirming the jury's infringement decision by denying Roche's motion for judgment as a matter of law (JMOL); 2) reaffirming its pretrial decision to grant summary judgment regarding infringement of claim 1 of the '422 patent; 3) "explaining" its reasoning for ruling, also pretrial, that the claims of Amgen's patents-in-suit are not invalid for obviousness-type double patenting (despite the intervening Federal Circuit decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.); 4) denying Roche's motion for JMOL that claim 1 of the '422 patent and claims 3, 7, and 9 of the '933 patent are not invalid for indefiniteness for reciting the term "human erythropoietin"; and 5) granting Amgen a permanent injunction barring "Roche, its agents, servants, employees, counsel, and all persons and entities acting in concert therewith" from infringing the claims of the patents-in-suit for the remaining life of those patents.

The Federal Circuit's decision, written by Judge Schall and joined by Judges Mayer and Clevenger, affirmed most of the determinations by the District Court and the jury.  These will be discussed more extensively in future posts, but can be summarized simply here:  the panel vacated Judge Young's decision on whether the '933 (claims 3, 7, and 8), '349 (claim 7) and '422 (claim 1) patents are not invalid under obviousness-type double patenting and remanded this issue to the trial court; vacated the judgment that claim 7 of the '349 patent was not infringed and remanded for a new trial on that issue; affirmed the judgments that the asserted claims of the '868 patent (claims 1 and 2) and the '698 patent (claims 6-9) are not invalid and were infringed, and that claims 3, 7, and 8 of the '933 patent and claim 1 of the '422 patent were infringed; and finally that claims 9, 11, 12, and 14 of the '933 patent are not infringed by Mircera®.

Because of the number claims asserted and the status of these various claims under the CAFC's opinion, a scorecard seems in order:

The following claims of the '933 patent are infringed but may be invalidated by the trial court for obviousness-type double patenting:

3.  A non-naturally occurring glycoprotein product of the expression in a mammalian host cell of an exogenous DNA sequence comprising a DNA sequence encoding human erythropoietin said product possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells.

7.  The glycoprotein product according to claim 3 . . . wherein the host cell is a non-human mammalian cell.

8.  The glycoprotein product according to claim 7 wherein the non-human mammalian cell is a CHO cell.

The following claim is infringed by Mircera® under the doctrine of equivalents, but its status with regard to the obviousness-type double patenting question is uncertain (it does not fall within the CAFC's remand):

12.  A pharmaceutical composition comprising an effective amount of a glycoprotein product effective for erythropoietin therapy according to claim 7 and a pharmaceutically acceptable diluent, adjuvant or carrier.  [Infringed under the doctrine of equivalents.]

The following claims of the '868 patent are both not invalid and are infringed:

1.  A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
    (a)  growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and
    (b)  isolating said glycosylated erythropoietin polypeptide therefrom.

2.  The process according to claim 1 wherein said host cells are CHO cells.

The following claims of the '698 patent are not invalid and are infringed:

6.  A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
    a) growing, under suitable nutrient conditions, vertebrate cells comprising amplified DNA encoding the mature erythropoietin amino acid sequence of FIG. 6; and
    b) isolating said glycosylated erythropoietin polypeptide expressed by said cells.

7.  The process of claim 6 wherein said vertebrate cells further comprise amplified marker gene DNA.

8.  The process of claim 7 wherein said amplified marker gene DNA is Dihydrofolate reductase (DHFR) gene DNA.

9.  The process according to claims 2, 4 and 6 wherein said cells are mammalian cells.

Claim 1 of the '422 patent is infringed but may be invalidated for obviousness-type double patenting:

1.  A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.

Finally, infringement of claim 7 of the '349 patent will be decided in a new trial, but may be invalid under obviousness-type double patenting:

7.  A process for producing erythropoietin comprising the step of culturing, under suitable nutrient conditions, vertebrate cells according to claim 1, 2, 3, 4, 5 or 6.

Wherein claims 1 through 6 of the '349 patent related to vertebrate cells encoding recombinant EPO:

1.  Vertebrate cells which can be propagated in vitro and which are capable upon growth in culture of producing erythropoietin in the medium of their growth in excess of 100 U of erythropoietin per 10⁶ cells in 48 hours as determined by radioimmunoassay, said cells comprising non-human DNA sequences which control transcription of DNA encoding human erythropoietin.

The significance of the Federal Circuit's decision, and the consequences of an adverse decision on remand for the '933, '349 and '422 patents are illustrated by the respective expiration dates of the five patents at issue in the litigation:

*term shortened by terminal disclaimer

Thus, invalidation of the '933, '349 and '422 patents would reduce Amgen's patent protection on its various EPO products (including Aranesp® and Epogen®) from May 2015 to August 2012 (more than 3 years), which would have a significant (negative) effect on the corporate bottom line.  Accordingly, Amgen can be expected to continue this litigation.

The CAFC's opinion did not disturb the permanent injunction imposed by Judge Young, preventing Roche from marketing Mircera® in the U.S. despite obtaining FDA approval in November, 2007, giving Roche more than sufficient incentive to continue as well.

The substance of the Federal Circuit's opinion, including its reasoning on the standards for obviousness type double patenting, will be the subject of later posts.     

Amgen Inc. v. F. Hoffman-La Roche Ltd. (Fed. Cir. 2009)
Panel: Circuit Judges Mayer, Clevenger, and Schall
Opinion by Circuit Judge Schall

Biotech/Pharma Docket

    By Suresh Pillai --

Purdue Files Appeal in Ultram® Suit against Par

Purdue Pharma Products Inc. has filed an appeal with the U.S. Court of Appeals for the Federal Circuit seeking to overturn an earlier federal court decision that invalidated Purdue's patents (U.S. Patent Nos. 7,074,430 and 6,254,887 covering their product, Ultram ER®.

Purdue originally filed suit in August 2007 in the wake of Par Pharmaceutical's filing of an Abbreviated New Drug Application (ANDA) with the FDA, claiming that Par infringed Purdue's Ultram® patents.  In August, the District Court concluded that, though Par infringed the patents-in-suit, the patents themselves were invalid in view of certain prior art references.  In that decision, the District Court reasoned that under 35 U.S.C. § 103, both pre- and post-KSR, Purdue's selection of tramadol as the active ingredient for Ultram® would have been obvious (see "Biotech/Pharma Docket," August 18, 2009).  At the time, Purdue argued that the existence of numerous other eligible analgesics at the time of patenting would have rendered the choice of tramadol nonobvious to a person having ordinary skill in the art.

Navinta Appeals District Court Ruling in Naropin® Case

Earlier this month, Navinta LLC filed notice in the U.S. District Court for the District of New Jersey announcing its intent to appeal the District Court's finding of infringement with respect to three patents covering Abraxis BioScience's pain drug Naropin®, U.S. Patent Nos. 4,870,086, 5,670,524, and 5,834,489.  At the conclusion of an eight-day bench trial, the District Court ruled that the proposed generic described in Navinta's 2006 Abbreviated New Drug Application (ANDA) fell within the asserted claims of the patents-in-suit.  The Court ordered that Navinta be denied permission to market and manufacture its generic version of Naropin® until after the expiration of the patents-in-suit in September 2014.

The original lawsuit was filed in March 2007 following Navinta's entrance into a collaboration with Sandoz AG that provided Sandoz's U.S. subsidiary with the exclusive rights to make, market, and distribute their generic form of Naropin® within the United States (see "Court Report," March 26, 2007).  Abraxis' lawsuit claimed that Navinta's 2006 ANDA filing evidenced infringement of the three patents currently in suit.  Navinta countersued, claiming that Abraxis' suit was a sham litigation designed to extend Abraxis' monopoly on the drug through a conspiracy between Abraxis and AstraZeneca.

Endo Files Motion to Intervene in Renegal® Infringement Dispute

Endo Pharmaceuticals Inc. has filed a motion in the U.S. District Court for the District of Maryland seeking permission to intervene in the Renegal® patent infringement dispute between Genzyme Corp. and Impax Laboratories, Inc.  In its motion, Endo argued that the only reason Impax challenged a second patent's validity in the case was for the sole purpose of forcing Endo, the first-filer of an ANDA based upon the patent, to forfeit its exclusivity period.  The patents-in-suit, U.S. Patent Nos. 6,733,780 and 5,667,775, cover formulations of sevelamer hydrochloride, the active ingredient in Renegal®.

Genzyme originally filed suit in April 2009, alleging that Impax's filing of an ANDA seeking permission to market and manufacture generic versions of Renegal® infringed the '775 patent (see "Court Report," April 6, 2009).  Genzyme had also previously granted Impax a covenant not to sue over the '780 patent.  Based on this covenant, Endo and Genzyme have argued that the absence of a justiciable case or controversy creates a lack of subject matter jurisdiction over Impax's attempt to have the '780 patent declared invalid and noninfringed.  Although both Endo and Genzyme seek to have Impax's challenged dismissed, Endo still seeks to intervene, as Endo has argued that Genzyme has no direct interest in helping Endo retain its 180-day exclusivity period for manufacturing generics based upon the '780 patent.

ChemBridge Makes Chemical Libraries Available Via Public Access Database

    By Donald Zuhn --

Last month, ChemBridge Corp. announced that it would make ten of its most popular chemical screening libraries available to researchers via the Collaborative Drug Discovery (CDD) Public Access database.  The CDD Public Access database, a collection of public data from leading vendors, researchers, scientific literature, and patent resources, is hosted by Collaborative Drug Discovery, Inc. as a service to the research community.  Collaborative Drug Discovery provides web-based software for organizing preclinical research data to help scientists more effectively advance new drug candidates.  Researchers can register for free read-only access to the CDD public data sets here; read-and-write access, including the ability to archive, mine, and collaborate around private data and to import and export both private and public data is also available.  Compounds from the ten ChemBridge libraries being added to the Public Access database can be obtained from the San Diego-based discovery chemistry company.

The libraries being offered by ChemBridge include its DIVERSet, a 50,000 diverse small molecule dataset covering a broad range of pharmacophore space; and CNS-Set, which contains 56,000 molecules with an increased probability of blood brain barrier penetration.  ChemBridge noted that more than 600,000 molecules would be available through the CDD database.  CDD CEO Barry Bunin stated that both the CDD community for private access and the entire researcher community for public access would benefit from the addition of the ten ChemBridge libraries.  Prior to the addition of the ChemBridge molecules, the CDD database contained over a million compounds.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Warner Chilcott C. LLC v. Lupin Limited et al.
1:09-cv-00673; filed September 9, 2009 in the District Court of Delaware

• Plaintiff:  Warner Chilcott Co. LLC
• Defendants:  Lupin Limited; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent No. 5,552,394 ("Low Dose Oral Contraceptives with Less Breakthrough Bleeding and Sustained Efficacy," issued September 3, 1996) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Warner Chilcott's Loestrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, and ferrous fumarate tablets, used for oral contraception).  View the complaint here.

Warner Chilcott Co. LLC v. Lupin Limited et al.
1:09-cv-00672; filed September 9, 2009 in the District Court of Delaware

• Plaintiff:  Warner Chilcott Co. LLC
• Defendants:  Lupin Limited; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive," issued December 23, 2003) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Warner Chilcott's Femcon Fe® (formerly Ovcon® 35 Fe, norethindrone and ethinyl estradiol tablets, and ferrous fumarate tablets, used for oral contraception).  View the complaint here.

Purdue Pharma Products LP et al v. Paddock Laboratories Inc.
1:09-cv-00666; filed September 4, 2009 in the District Court of Delaware

• Plaintiffs:  Purdue Pharma Products LP; Napp Pharmaceutical Group Ltd.; Ortho-McNeil-Janssen Pharmaceuticals Inc.
• Defendant:  Paddock Laboratories Inc.

Purdue Pharma Products L.P. et al v. Paddock Laboratories, Inc.
0:09-cv-02411; filed September 4, 2009 in the District Court of Minnesota

• Plaintiffs:  Purdue Pharma Products LP; Napp Pharmaceutical Group Ltd.; Ortho-McNeil-Janssen Pharmaceuticals Inc.
• Defendant:  Paddock Laboratories Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,254,887 ("Controlled Release Tramadol," issued July 3, 2001) and 7,074,430 ("Controlled Release Tramadol Tramadol [sic] Formulation," issued July 11, 2006) following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of plaintiffs' Ultram® ER (tramadol hydrochloride, used to treat moderate to moderately severe chronic pain).  View the Delaware compliant here.

Hospira Inc. et al v. Sandoz International GmbH et al.
1:09-cv-00665; filed September 4, 2009 in the District Court of Delaware

• Plaintiffs: Hospira Inc.; Orion Corp.
• Defendants: Sandoz International GmbH; Sandoz Inc.

Hospira, Inc. et al v. Sandoz International GmbH et al.
3:09-cv-04591; filed September 4, 2009 in the District Court of New Jersey

• Plaintiffs: Hospira, Inc.; Orion Corp.
• Defendants: Sandoz International GmbH; Sandoz, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 4,910,214 ("Optical Isomer of an Imidazole Derivative Medetomidine as an Alpha-2-Receptor Agonist," issued March 20, 1990) and 6,716,867 ("Use of Dexmedetomidine for ICU Sedation," issued April 6, 2004), both licensed to Hospira, following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of plaintiffs' Hospira's Precedex® (dexmedetomidine hydrochloride injection, used for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting).  View the New Jersey compliant here.  [NB: The Delaware action was voluntarily dismissed by plaintiffs on September 11, 2009.]

Conference & CLE Calendar

September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL

September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD

September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA

September 17, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY

September 21-22, 2009 - 2009 World Stem Cell Summit*** - Baltimore, MD

September 21-22, 2009 - Patent Litigation 2009 (Practising Law Institute) - San Francisco, CA

September 23-25, 2009 - 10th Annual Generic Drugs Summit on the Business of Biosimilars (Institute for International Research) - Boston, MA

September 30-October 1, 2009 - Biotech Patents*** (American Conference Institute) - Boston, MA

October 5-6, 2009 - Patent Litigation 2009 (Practising Law Institute) - McLean, VA

October 7-8, 2009 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY

October 14, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA

October 15-16, 2009 - Patent Litigation 2009 (Practising Law Institute) - Chicago, IL

October 20-21, 2009 - 17th Forum on Biotech Patenting (C5) - London, United Kingdom

October 22-23, 2009 - Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) - Philadelphia, PA

October 26-28, 2009 - Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) - Washington, DC

October 28-29, 2009 - Patent Opinion Writing Boot Camp*** (American Conference Institute) - Philadelphia, PA

November 9-10, 2009 - Patent Litigation 2009 (Practising Law Institute) - Atlanta, GA

November 9-11, 2009 - Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) - London, England

November 10, 2009 - The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) - Baltimore, MD

November 12-13, 2009 - Paragraph IV on Trial*** (American Conference Institute) - New York, NY

November 13, 2009 - The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) - Las Vegas, NV

November 16-17, 2009 - Patent Litigation 2009 (Practising Law Institute) - New York, NY

November 17-18, 2009 - Structuring, Negotiating, and Managing Pharma/Biotech Collaborative Agreements (American Conference Institute) - New York, NY

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

Analyst Lists Five Biotech Companies to Watch

    By Donald Zuhn --

Last week, Dr. Simos Simeonidis, a Senior Biotechnology Analyst for Rodman & Renshaw, LLC, provided FierceBiotech with a list of five biotech companies to watch in the coming months ("Five Biotech Companies to Watch").  On Dr. Simeonidis' list were Poniard Pharmaceuticals, GTx, OncoGenex, MannKind Corp., and Rigel Pharmaceuticals.

Dr. Simeonidis noted that he liked the chances of South San Francisco-based Poniard announcing the successful completion of a clinical trial of its platinum compound, picoplatin, for the treatment small cell lung cancer.  He believed that a successful trial would allow the company to secure a worldwide partnership for picoplatin, or alternatively, make Poniard an attractive target for acquisition.

GTx, headquartered in Memphis, made the list because of the possibility that the company could receive an approvable letter requiring additional data with respect to its compound, Toremifene, for preventing bone fractures in men with prostrate cancer on androgen deprivation therapy (ADT).  Dr. Simeonidis, however, did express some skepticism regarding the prospects of Toremifene.

Dr. Simeonidis believed that on the strength of recent efficacy data, Vancouver-based OncoGenex could find a partner for its molecule, OGX-011, for treating prostrate and lung cancer.  Aternatively, he thought the whole company could be acquired, noting that OncoGenex is valued at a fraction of the $894 million Johnson & Johnson recently paid for Cougar Biotechnology.  Earlier this week, Patent Docs reported on a patent OncoGenex recently obtained for using OGX-011 to enhance cancer cell chemo- or radiation-sensitivity (see "OncoGenex Announces Issuance of Patent for Antisense Cancer Therapeutic").

According to Dr. Simeonidis, MannKind, which has been developing Afresa, an inhalable form of insulin, has been in active discussions with pharmaceutical partners for the co-development and commercialization of Afresa.  He expects MannKind, based in Valencia, CA, to secure a partner sometime this fall.

Finally, South San Francisco-based Rigel made the list for demonstrating strong efficacy in one of two trials of its compound, R788, for treating rheumatoid arthritis.  The other trial, however, yielded inconclusive results.  Nevertheless, Dr. Simeonidis believed Rigel's shares were undervalued, and suggested that Rigel could secure a partner for R788 sometime this fall.

WIPO to Offer Seminars on PCT

The World Intellectual Property Organization (WIPO) will hold a one-day seminar on the Patent Cooperation Treaty (PCT) for small and medium-sized enterprises and independent inventors on November 10, 2009 in Baltimore, MD and on November 13, 2009 in Las Vegas, NV.  During each session, WIPO staff will provide an overview of the PCT, outline its advantages, and discuss aspects of the PCT with attendees.  In addition, attendees will have a chance to offer suggestions as to how the PCT can be further improved and enhanced to make it more accessible to small and medium-sized enterprises and independent inventors.  The seminar will address the following topics:

• Overview of the PCT system;
• International Search and Preliminary Examination;
• Effective use of patent information -- PATENTSCOPE® service;
• Costs for filing a PCT application;
• PCT filing strategies;
• PCT and licensing activities; and
• Electronic filing of PCT applications.

While no registration fee will be charged for either session, those wishing to attend one of the seminars must complete a registration form here (Baltimore) or here (Las Vegas).  Additional information regarding the seminar can be found here (Baltimore) or here (Las Vegas).

Sanofi-Aventis U.S. LLC v. Sandoz, Inc. (Fed. Cir. 2009)

More Claim Construction Confusion from the Federal Circuit

    By Kevin E. Noonan --

The Federal Circuit demonstrated once again the quagmire that can exist when lower courts attempt to apply the CAFC's rather quixotic jurisprudence on claim construction.

The case, Sanofi-Aventis U.S. LLC v. Sandoz, Inc.⁽¹⁾, arose as the result of ANDA filings by several Defendants for oxaliplatin, the active ingredient in Sanofi's Eloxatin® colorectal cancer drug.  Two claims of the patent at issue, U.S. Patent No. 5,338,874, were asserted against the Defendants:

1.  Optically-pure cis-oxalato(trans-l-1,2-cyclohexanediamine) Pt(II) having the general formula of Formula (1).

(Dependent claim 2 merely added a melting point limitation and was not further at issue in the case.)  The question decided by the Federal Circuit on appeal was whether the claim term "optically pure" included an affirmative limitation that "optically pure oxaliplatin" had been "resolved by means of the HPLC method described" in the specification of the '874 patent.

The District Court had decided that this term did include the limitation.  While admitting that "[t]here was no dispute that nothing on the face of the claims of the '874 patent limit[ed] the claims to 'optically pure oxaliplatin that is produced through the use of HPLC," the District Court identified statements in the prosecution history and disclosure in the specification that supported its interpretation.  Specifically, the District Court was persuaded that Sanofi had distinguished an asserted prior art reference (Kidani et al.) that purported to disclose "a single isomer [of oxaliplatin] useful as an antitumor agent" by arguing that the optical purity of the oxaliplatin in the reference was only 90%.  According to the District Court, Sanofi stated during prosecution that "[o]nly after HPLC resolution (in accordance with the teachings of the present application) was optical purity obtained."  In addition, the District Court pointed to portions of the specification that compared the optical purity of oxaliplatin prepared according to prior art methods contained in the asserted reference with the optical purity of Sanofi's molecule after resolution by HPLC.  To the District Court, these distinctions were sufficient to require that the claim term "optically pure oxaliplatin" describe only oxaliplatin resolved to optical purity by HPLC.  Accordingly, since the Defendants did not use HPLC to resolve oxaliplatin to optical purity, the District Court granted summary judgment of non-infringement.

The Federal Circuit disagreed with the lower court's claim construction.  In a unanimous (albeit nonprecedential) opinion by Judge Moore, joined by Judges Linn and Prost, the Court found that the patentee had not disclaimed all embodiments of optically pure oxaliplatin except those resolved by HPLC.  The Court opined as follows:

We have repeatedly warned of "the danger of reading limitations from the specification into the claim."  See, e.g., Phillips, 415 F.3d at 1323.  "Absent a clear disavowal or contrary definition in the specification or the prosecution history, the patentee is entitled to the full scope of its claim language."  Home Diagnostics, Inc. v. Lifescan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004).  To narrow the plain language of a claim, a disclaimer must be clear and unmistakable.  Cordis Corp. v. Boston Scientific Corp., 516 F.3d 1319, 1329 (Fed. Cir. 2009).  We see no such disclaimer in the specification or prosecution history of the '874 patent.

The Court also disagreed that claim 1 of the '874 patent was a product-by-process claim:

The district court relied on Andersen Corp. v. Fiber Composites, L.L.C., 474 F.3d 1361 (Fed. Cir. 2007), when construing claim 1 as a product-by-process claim.  In Andersen, this court held that claims to composite structures included a pelletizing process limitation where the patentee relied on that process both to define the invention and to distinguish the prior art.  . . .  We determined that the specification attributed the claimed physical properties to the process and that the specification indicated that the pelletizing step was a requirement, not a preference, of the invention.  . . .  We further determined that the patentee had clearly disavowed other processes during prosecution.  . . . [emphasis added]

By contrast, here, the patent specification and prosecution history focus on the property of the composition (optical purity) and not the process used to obtain that property.  . . .  The specification never asserts that HPLC is required to obtain optically pure oxaliplatin.  It characterizes HPLC as an "illustrative method" and a "representative process" by which the claimed compound "may be prepared".  . . .  Moreover, the specification does not define the property (optical purity) by reference to the process of purification by HPLC.  Thus nothing in the specification limits the invention to optically pure oxaliplatin purified using HPLC.

The prosecution history also illustrates that it is the optical purity of oxaliplatin that distinguished it from the prior art, not the process used to obtain that purity.  The Examiner rejected the initially filed claims to oxaliplatin "of optically high purity" as anticipated or rendered obvious by Kidani.   The Examiner stated that Kidani disclosed "a single isomer [oxaliplatin] useful as an antitumor agent.  Note that since the single isomer complex was prepared, the optical purity of such material is very high or almost pure isomer."  In response, the applicant . . . explained that it had repeated Kidani's process "using identical reactant materials and the subsequent testing thereof. . . . The resultant material was tested and found to be 90% [oxaliplatin] not optically pure . . . ."  Sanofi explained that "[o]nly after HPLC resolution (in accordance with the teachings of the present application) was optical purity obtained."  Sanofi further asserted that the products prepared using Kidani's method "do not have the presently claimed optical purity."  Therefore, Sanofi argued that the claimed oxaliplatin "having high optical purity[] is not found or taught in the prior art either by inherency or by being obvious thereover."  Following a telephone interview, Sanofi agreed to amend the claims to "optically pure" oxaliplatin, rather than oxaliplatin "of high optical purity."  The Examiner entered the amendment and allowed the claims, stating that "[t]he Examiner agrees with applicants that Kidani et al. does not teach[] the cis-oxalato(trans-l-1,2-cyclohexanediamine)Pt(II) as an optically pure isomer.  It is clear from Kidani et al. that also other isomers can be in the final product."  Thus, Sanofi argued that the defining feature of the claimed oxaliplatin was its optical purity, not the HPLC process.  Nothing in the prosecution history amounts to a clear and unmistakable disclaimer of optically pure oxaliplatin prepared using other (non-HPLC) processes.  [emphasis added].

The Federal Circuit vacated the District Court judgment of non-infringement and remanded the case to the lower court.

The panel's opinion illustrates how difficult it is for a district court to implement supposedly straightforward rubrics such as those enunciated by the en banc court in Phillips v. AWH Corp.  The District Court's reasoning was based on understanding the plain meaning of the term "optically pure," a phrase that has no plain meaning outside its specialized meaning in the chemical arts.  The District Court looked to the specification and the prosecution history to identify how the patentee defined the term, and in the absence of an express definition used the examples in the specification and the arguments and amendments made during prosecution to construe the claim term "optically pure" to require that optical purity must be achieved using HPLC.  The Federal Circuit disagreed and substituted its judgment for the lower court's, a commonplace occurrence.

The outcome brings to mind the dissenting opinion of District Court Judge Vaughn R. Walker, Chief Judge, U.S. District Court for the Northern District of California, sitting by designation, in Medegen MMS, Inc. v. ICU Medical Inc. (Fed, Cir. 2008) (see "Claim Construction at the Federal Circuit: A District Court Judge's View").  In that case, Judge Walker asserted that claim construction presented "a conundrum" to district courts.  This conundrum arose from these "twin axioms" of claim construction:  "[o]n the one hand, claims 'must be read in view of the specification'," citing Markman, while "[o]n the other hand, it is improper to read a limitation from the specification into the claims," citing Arlington Indus. Inc. v. Bridgeport Fittings, Inc.  The problem with these axioms, according to Judge Walker, is that "the axioms themselves seldom provide an answer, but instead merely frame the question to be resolved."  While recognizing the sound policy reasons for a patent drafter to be required to include "all claim limitations in the claims of a patent," he also admonished that "patents must be read as well as written."  Citing Phillips, he asserted that this analysis must be performed with due consideration of a term's "ordinary and customary meaning" informed by the "context of the entire patent, including the specification."

Judge Walker's dissent raised the essential paradox of the Federal Circuit's practice under Cybor Corp. v. FAS Technologies, Inc. of giving no deference to claim construction by district courts:  "[a]s a jurist more accustomed to working on the front lines of patent litigation than reviewing decisions from above, it is my experience that claim construction -- determining how one of ordinary skill in the art would understand the patent at the time of invention -- often requires making fact-like determinations not well suited to appellate review."  The "uniformity and predictability" desired by the CAFC as a general, guiding principle is not always best served in the individual determinations necessary to construe claim terms.  In this he cited with approval Judge Lourie's point in Phillips, that while there is (and perhaps cannot be) formal deference by the CAFC to a district court's claim construction, it is better policy for the Federal Circuit to affirm "in the absence of a strong conviction of error."

Current academic research suggests that Federal Circuit affirmance rates of district court claim construction has "improved" to from 60-70%.  However, each Federal Circuit panel addresses, and resolves, specific claim construction issues in any particular case in its own way, introducing the kind of uncertainty that the Federal Circuit was created to curtail.  The inconsistencies resulting from the Federal Circuit's "no deference" standard of review can be expected to continue to produce the type of results decried by Judge Walker in Medegen and, arguably, that were obtained in Sanofi-Aventis v. Sandoz.

⁽¹⁾ Additional defendants included Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc., and Pharmachemie BV; Mayne Pharma Ltd., Mayne Pharma (USA) Inc,, Hospira Australia Pty Ltd., and Hospira, Inc.; W.C. Heraeus GMBH; APP Pharmaceuticals, Inc. and Abraxis Bioscience, Inc.; Actavis Totowa LLC, Actavis, Inc. and Actavis Group HF; Fresenius Kabi Oncology PLC and Fresenius Kabi Pharma Ltd.; Sun Pharmaceutical Industries Ltd. and Caraco Pharmaceutical Laboratories, Ltd.; Ebewe Pharma GES.M.B.H. NFG HG; and Mustafa Nevzat Ilac Sanayii A.S., Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc.

Sanofi-Aventis U.S. LLC v. Sandoz, Inc. (Fed. Cir. 2009)
Nonprecedential disposition
Panel: Circuit Judges Linn, Prost, and Moore
Opinion by Circuit Judge Moore

BIO Top Brass Meet the Press

    By Kevin E. Noonan --

The Biotechnology Industry Organization (BIO) held a media briefing on Federal policy issues today, with most of BIO's executive staff assembling at BIO headquarters in Washington, D.C.  In addition to the media present on site, BIO hosted several more members of the press by teleconference.

Jim Greenwood (at left), BIO's President and CEO, started the meeting with prepared remarks concerning healthcare reform, patent reform, and the energy bill.  With regard to healthcare reform, Mr. Greenwood reiterated BIO's support, provided that any healthcare bill recognize four fundamental objectives:  access for all ("every man, woman and child"), cost containment, quality, and innovation.  Mr. Greenwood also mentioned biosimilars legislation, where he expressed pride that BIO had "played it straight" with legislators "from the beginning."  BIO's position was consistently that a 14-year data exclusivity period was the right length, and didn't advocate for longer terms of 16-18 years as a negotiating ploy.  He said that BIO had done "quite well" against a "well-organized coalition" of generics companies, the AARP, the White House, and other factions.  He also said that BIO was willing to accept the Senate bill's compromise of 12 years if that was what it takes to get a bill passed.  He also voiced BIO's support for "comparative effectiveness" as a tool for making medical decisions but not for reimbursement.  On energy, Mr. Greenwood maintained that there was no way to significantly reduce greenhouse gases without contributions from biotechnology, including cellulosic ethanol technology, algae, and other methods of energy production.  Mr. Greenwood ended his remarks with patent reform, which he characterized as a "long, hard fight" contested "at a great disadvantage" against an IT industry that supported "reforms" that would make it "easier to infringe patents."  He voiced BIO's support for the compromise that had produced a bill in the Senate.

Also addressing the press was Dr. Stephen Sherwin (at right), BIO's chairman and also the Chairman of Cell Genesys, Inc.  Dr. Sherwin, a biotech entrepreneur throughout his career, spoke on the economic climate for biotechnology.  He mentioned the obvious -- that it had been an "extremely difficult and challenging time" for biotech over the past 18-24 months, with almost half of the organization's member companies having enough cash for 12 months and a quarter having less than 6 months of cash reserves.  He also mentioned that there has been no significant IPO activity in the biotech sector in almost two years.  The reason is that investors are nervous about the regulatory environment if there is a follow-on biologics bill and the effects any FOB bill may have on the timing of product development.  (In response to a question, Dr. Sherwin said that Wall Street hates uncertainty, even when it is uncertainty Wall Street has created.)  On the bright side, Dr. Sherwin mentioned that there had been "some thawing" in the capital markets in the face of "good news" from clinical trials, etc.  He also noted that he had met with the new FDA commissioner, Dr. Hamberg, and was pleased with her "science-based" approach.  He also noted that there was progress on reauthorizing SBIR grant legislation that would permit companies having venture capital funding to compete for such grants.  He said that he was optimistic, but that "we have our work cut out for us."

In the question-and-answer portion of the meeting, Mr. Greenwood responded to a question from Reuters on healthcare reform that certain revenues for smaller companies -- like royalties and milestone payments -- should be exempt from the fees (or taxes) that the Obama administration proposed on drug sales revenues in an agreement with the pharma industry announced earlier this summer.  Mr. Greenwood also reminded listeners that predictions such as a recent one by BioWorld, that biotech drugs would represent 50% of all new drugs by 2015 and 71% by 2025, might not come to pass if a shortened data exclusivity period drove investment away from the biotech sector.  The 12-year period is the minimum required to maintain the incentives for investment in new biologic drugs, which is why BIO supports this number.  Investors have other opportunities that are less risky that they will take if there isn't a sufficient data exclusivity period to support such investment, Mr. Greenwood said.

Business Week asked about BIO's position on the "politics" of 'partisan gridlock" over the healthcare and energy bills, where Republicans might oppose the bills merely to hand the Obama administration a political defeat.  Mr. Greenwood said it wasn't BIO's role to try to "change the playbook" for the parties, and that the "big picture" required healthcare reform.  BIO has been (and by implication, will continue to be) "religiously non-partisan" on the healthcare issue, resulting in strong bipartisan support (with 28 of 38 Democratic members and all but one Republican member of the Energy and Commerce committee voting for the biosimilars amendment supported by BIO).  There is nothing partisan about using biotechnology in reducing greenhouse gases, he said.  Brent Erickson (at left), BIO's Executive Vice President, Industrial and Environmental Section, chimed in that opposition to the energy bill was not partisan so much as regional, reflecting differences in the reliance of different sections of the country on fossil fuels.  It has been "a bit of an uphill battle" in educating Congress about the contributions of biotechnology in addressing climate and energy problems, he said.

Mr. Greenwood had another opportunity to remind his listeners that BIO had played the role of honest broker in the healthcare debate, in response to a question from the Pink Sheet about whether BIO would need to "cut a deal" with the Obama administration like PhRMA did (according to the Pink Sheet reporter).  Mr. Greenwood said there had not been any horse-trading or quid pro quo in BIO's position -- he said that BIO's success in pursuing its agenda regarding FOB legislation was the result of old-fashioned "shoe leather" politics, by meeting with "scores" of Congressional leaders and explaining BIO's position.  He mentioned that he carried two things to these meetings:  a model of the aspirin molecule and a DVD showing the structure of erythropoietin (see image at right).  Mr. Greenwood also said that BIO's success makes getting a bill passed even more important, since BIO's "enthusiasm for the package [will be] dramatically diminished" if the bill undergoes major changes in the House.

Dr. Sherwin addressed a question about the priorities BIO would advocate for the FDA.  He mentioned that he was "encouraged' by the new FDA commissioner's (science-driven) approach, which he says he expects to be characterized by "efficiency" and "clarity."  He said there will be an effort to strike a balance between safety and efficacy, a balance he said was familiar to all physicians in assessing risks and benefits of any course of treatment.  While acknowledging that a single meeting could not address complex issues, he said he was "encouraged" by having someone with her background in her position early in the Obama administration.

Andrew Noyes from Congress Daily asked about patent reform, and Brent Delmonte, BIO's Vice President for Governmental Relations said that BIO hopes for support for the Senate bill, a "fair, responsible compromise," and that contentious bills (like H.R. 1908 from the previous Congress) could slow patent reform.  He mentioned "great ideas" from both sides of the Hill, including re-examination and the "second window," and the "gatekeeper" function of judges on the damages issue.  On balance, BIO remains "hopeful" for a patent reform bill in this Congress, but doesn't see any "date certain" for the bill coming to the floor.

A reporter from Scripps News asked the panel about the SBIR bill, and Mr. Greenwood said that BIO was very pleased with the result of the vote on the reauthorization bill in the House, which passed the bill 386-41.  Alan Eisenberg, BIO's Executive Vice President Emerging Companies and Business Development, mentioned that the SBIR program is funded by a 2.5% set-aside from other departments and Federal agencies (the Department of Defense, the Department of Energy, the National Institutes of Health), and that the bill was an attempt to overturn "fairly arbitrary" administrative agency (Small Business Administration) decisions that prevented venture capital-funded companies -- the majority of BIO's small company members -- from participating.  BIO is confident that Congress will be able to resolve differences between the House and Senate versions of the bill.

Hans Sauer, BIO's Associate General Counsel for Intellectual Property, fielded a question on the Bilski case, specifically why BIO was interested in the case.  Mr. Sauer provided a brief synopsis of the case, mentioning that the Federal Circuit had fashioned a rule on patent eligibility of method claims that was far broader than necessary to answer the question of whether the business method claims in the Bilski patent should be patent-eligible.  This broader rule put at risk the patentability of claims to important methods, such as biomarkers and biological correlations with disease, and personalized medicine, that made the issue one important to BIO.  He noted that biotech methods, not business method cases, were some of the first cases affected by the Federal Circuit's new rule.  He expressed confidence that the Supreme Court would understand these distinctions when it fashions a different rule in deciding Bilski.

A reporter from the Journal of Commercial Biotechnology and Scientific American brought the discussion back to the economy, and Mr. Eisenberg provided some additional sobering statistics.  He said that the total number of public companies has been reduced, some by mergers and acquisitions, and others by bankruptcy, with more than 20 biotech member companies having declared bankruptcy under Chapter 11.  He also mentioned that the statistics were more certain for public companies, which are under an obligation to report bankruptcies, and that privately-held companies may be able to just "sell their assets" and disappear.  The number of public biotech companies has decreased from 370 to less than 330, and "well over" 100 companies have laid off employees (with a total of 10,000 to 12,000 employees being laid-off throughout the industry).  The most ominous and telling fact, according to Mr. Eisenberg, is that companies were "shelving" projects having positive clinical data, simply because the companies don't have the money to continue funding these projects, and the capital markets have not recovered their interest in the sector.

Finally, Mr. Greenwood reiterated that BIO is in favor of healthcare reform, but that it was just as important that any healthcare reform bill doesn't disincentive innovation.  As it is, investors are sufficiently concerned about FOB legislation that it is an impediment to investment, and it would help investment, and be favorable to innovation, to get a bill passed and end the uncertainty that is inhibiting investment in the industry.  Mr. Greenwood said that the slogan "heat, heal and feed the world" reflects BIO's view that you cannot address these problems in a sustainable way without contributions from biotechnology.

A podcast of the media briefing can be obtained here.