Patent Docs

Genzyme Misappropriation Lawsuit

    By Mark Chael --

An intellectual property lawsuit is slated to begin on March 12, 2007, pitting Genzyme Corp. against three executives at a Canadian firm, Cytochroma, which is developing therapies for vitamin D deficiency and chronic kidney disease (CKD).  Genzyme alleges that the executives misappropriated trade secrets and other intellectual property prior to joining Cytochroma.

In early 2005, Genzyme acquired Bone Care International, a spinoff from the University of Wisconsin, for a reported $600 million.  There are 38 U.S. patents and about 22 pending U.S. patent applications that list Bone Care as the assignee.  Later, in September, 2005, a company called Proventiv Therapeutics was founded by former employees of Bone Care.  Thereafter, in 2006, Cytochroma acquired Proventiv.  Cytochroma recently completed a round of venture financing to start human clinical trials on drug compounds for treating vitamin D deficiency in patients with kidney disease.

Genzyme's lawsuit, filed in the U.S. District Court for the Western District of Wisconsin (06-C-0428-S), alleges that the three Cytochroma executives, who were former Bone Care and Proventiv employees, used Bone Care trade secrets while they were working at Proventiv to develop CKD treatments that were later acquired by Cytochroma.  The executives contend that the compounds they were working on at Proventiv were in the public domain.

USPTO News: Revised Procedure Regarding Notice of Omitted Items

    By Christopher P. Singer --

In a January 30, 2007 notice, the U.S. Patent and Trademark Office announced revised procedures relating to what patent applicants and practitioners must do in response to the dreaded Notice of Omitted Items.  This Notice is what every practitioner fears, as it reflects a determination by the Office of Initial Patent Examination (OIPE) that the application has a defect that, potentially, cannot be corrected.

Under the new procedure the Office allows for three types of responses: (1) petition for filing date of deposit under 37 C.F.R. § 1.53(e) (i.e., that the alleged missing item was in fact deposited); (2) petition for a later filing date (i.e., petition under 37 C.F.R. § 1.182, supplemental oath/declaration referring to omitted item); and (3) accept the application as deposited by filing an appropriate amendment.  Appropriate amendments include substitute specifications that renumber pages, drawings, claims, and/or remove references to the omitted matter (see additional examples and explanations here).  Such amendments should comply with 37 C.F.R. §§ 1.121 and 1.125.  An indexed PDF version of 37 C.F.R. can be downloaded here (however, it is large and may take time depending on your network connection).

The change in procedure is only reflected in the third course of action.  Formerly, applicants and practitioners did not have to file any response in order to accept the application as filed.  If the Office received neither petition under options (1) or (2), the applicant was deemed to have constructively elected the third option.  However, because there existed no required time for response, the Office would receive amended applications after examination and/or publication which hindered prosecution.  Now there must be an active election of one of the three options by filing a response with the Office.

The Notice of Omitted Items now has a due date for response, which is extendable under 37 C.F.R. § 1.136.  Therefore, in order to toll the date a response must be filed with the Office within the extended period for response.  As an added bonus, and to exacerbate further the gnashing of teeth, the Office considers the Notice of Omitted items a notice or action under 35 U.S.C. § 154(b)(2)(C)(ii) or 37 C.F.R. § 1.704(b).  Therefore, extensions of time taken for the reply to the Notice will reduce patent term adjustment under 35 U.S.C. § 154(b)(2)(C)(ii) or 37 C.F.R. § 1.704(b).

Patent Profile: EvoGenix Announces Grant of U.S. Patent No. 7,166,697

    By Christopher P. Singer --

In a January 24, 2007 press release, EvoGenix Ltd announced that U.S. Patent No. 7,166,697, titled "V-like domain binding molecules" has been granted by the U.S. Patent Office.  According to EvoGenix, the patent covers a protein technology termed "Evibodies®," which are similar to antibodies and are useful in treatments and diagnostics, but are about one tenth the size of an antibody.  EvoGenix envisions that Evibodies® technology can be developed and applied to the current antibody drug market, particularly for diagnostic imaging and because the technology allows for more economical manufacture of protein active agents.  The '697 patent claims priority to an international patent application (published as WO 99/45110), filed March 5, 1999.  In brief, the claims of the '697 patent relate to a non-antibody ligand V-like domain (VLD) comprising modifications to at least one CDR (complementary determining region) loop structure and compositions thereof.  Representative independent Claim 1 recites:

1.  A modified monomeric non-antibody ligand V-like domain (VLD) comprising within the VLD at least one CDR loop structure or part thereof that is modified or replaced such that (i) the size of the CDR loop structure or part thereof is increased by at least one amino acid residue when compared with the corresponding CDR loop structure or part thereof in an unmodified VLD; and/or (ii) the modification or replacement results in formation of a disulphide bond within or between one or more of the CDR loop structures, wherein the CDR loop structure is a surface polypeptide loop structure corresponding to a complementarity determining region of an antibody V-domain, and wherein the non-antibody ligand is selected from the group consisting of CTLA-4, CD28 and ICOS.

More information regarding this technology as well as EvoGenix Ltd. related technologies can be found here.

USPTO News: EFS-Web Document Indexing and Priority Document Exchange

    By Christopher P. Singer --

The U.S. Patent and Trademark Office today (January 30, 2007) presented a webinar that detailed certain issues relating to document indexing and descriptions of filings submitted with the USPTO via EFS-Web.  The seminar provided helpful explanations and tips regarding how to describe submissions properly so that they are more quickly processed and available on private PAIR.  The USPTO provides summary documents, tutorials, and training for EFS Web, document indexing tips, as well as document indexing tips and helpful informational links here.  In particular, document descriptions can be found here.

In addition, the Priority Document Exchange (PDX) program between the U.S. and European Patent Offices is now in full swing.  The Japanese Patent Office is expected to integrate into this program sometime this coming summer.  Applicants wishing to request that the USPTO either provide or request a priority document to or from the EPO are advised to use forms provided by the Office.  Applicants should use form PTO/SB38 for documents coming from the EPO to the USPTO, and form PTO/SB39 for documents going to the EPO from the USPTO.

For additional information regarding the PDX program, please see our previous reports (January 18 and January 19).

Innogenetics, N.V. v. Abbott Laboratories (W.D. Wis. 2007)

Innogenetics Appeals Its Win over Abbott

    By Robert Dailey --

In two earlier posts (January 8 and January 12), we reported on Innogenetics' $7 million victory after a jury found that Abbott had infringed Innogenetics' patent covering methods for HCV genotyping.  The jury also found that Abbott's conduct had been willful.  However, in a post-verdict ruling, the District Court held that Abbott's conduct had not been willful as a matter of law.  Innogenetics is now appealing that portion of the judge's ruling.

On first glance, this appeal may seem to be a long shot.  At trial, Innogenetics proffered no evidence of actual copying, instead showing only that it would have been possible for Abbott to copy.  Moreover, Abbott obtained multiple opinions as to the invalidity of the Innogenetics patent.

Thus, the appeal appears to rest on the assertion that Abbott proceeded in bad faith after learning of the Innogenetics patent.  This argument has some merit.  At trial, Abbott relied heavily on a non-infringement argument, even though it had only sought legal opinions on an anticipation defense.  Abbott's failure to gather opinions on non-infringement may indicate that its solicitation of the opinion was merely a ceremonial act carried out to avoid treble damages.  Judge Crabb, however, rejected this as a "red herring" since "one cannot infringe an invalid patent."  Abbott had made full disclosure to outside counsel and had made an anticipation argument at trial that tracked with outside counsel's opinion.  According to the Court, that is sufficient to avoid a charge of willfulness.  In other words, a defendant need not bankrupt itself seeking opinions on every potential legal defense.

The District Court may have overstated the rule on willfulness a bit, but it seems unlikely that the Federal Circuit will deem this reversible error.  In that event, Innogenetics may simply be trying to beat Abbott to the punch on filing an appeal.  Abbott lost the case, after all.  We'll have to wait and see how Abbott responds to this aggressive strategy.

Innogenetics, N.V. v. Abbott Labs., No. 05-C-0575-C (W.D. Wis.)

Click here for Judge Crabb's opinion rejecting the jury's willfulness finding.

Click here for the Reuters news report.

Robert Dailey, Ph.D., is a physical chemist and a third-year law student at the University of North Carolina at Chapel Hill.  Dr. Dailey was a member of MBHB's 2006 class of summer associates.

Anti-Patent ("Sullivan?") Malice by the New York Times

    By Kevin Noonan --

The New York Times continued its recent campaign against patents this week, running an Op-Ed piece by Denise Caruso on gene patenting.  Perhaps this attack is rooted in the Times loss before the Supreme Court a few years ago when it tried to usurp copyright from authors for online versions of articles.  New York Times Co. v. Tasini, 533 U.S. 483 (2001).  Or perhaps the Times takes the European view that patents are just the way "big business" frustrates entrepreneurship (despite plenteous evidence to the contrary).  Whatever its motivation, the latest Times jeremiad is full of the usual falsehoods and half-truths.

This begins with the title of the piece, "Re: Framing:  Someone (Other Than You) May Own Your Genes."  Readers of this space will recognize the falsity of this statement:  no one (other than you) owns your genes.  Patent offices around the world, including in the U.S., require that a gene be "isolated and purified" by a scientist before patent rights will attach.  Moreover, this is but the threshold for patenting in the U.S.; in addition, the nucleic acid sequence of the gene must be new (meaning that it wasn't disclosed previously by anyone), and the function of the gene product must be known (or the gene lacks utility).  No one would probably wish to own "your" genes, since it is highly likely that at least one of the copies of any particular one of "your" genes is a variant, or even a mutant, that would not perform as does the genetically "wildtype" version of the gene.  Finally, the title implies that someday a patent holder will knock on your door and ask for royalties because they "own" the gene for alcohol dehydrogenase, and since there is a bottle of wine in your garbage, the patent holder knows your liver must be busy using this gene to make the enzyme that detoxifies the alcohol in the wine.  Hogwash, to quote our current Vice-President.

The subtitle is in some ways worse:  "Is it time to consider an alternative to patenting life forms."  This is part of a new "vitalism" expressed by some writers (such as Lori Andrews (at right) of Chicago-Kent College of Law) when it comes to DNA patenting.  DNA "is a chemical, albeit a complex one" according to the Federal Circuit, and as such is no different than other biological substances such as vitamins and proteins that are non-controversial subjects of patent protection.  But there is something about DNA, perhaps because its status as the "genetic material" that is so compelling, that renders irrational otherwise sober discussion.  Western science rejected the concept of vitalism -- that biological molecules or processes are not subject to the chemical and physical laws that govern other matter -- late in the 19th century when Pasteur and Wohler and others showed that there was no scientific basis for the concept.  Rapid progress in biology and biochemistry followed.  Yet the framing of the issues in the new vitalism seems to revive these simply incorrect views for political rather than scientific reasons (since there are no scientific reasons to support them).

The body of the piece discusses the ideas of an academic (notably, not one with any scientific or legal background) who believes that there is an "acceptable" level of intellectual property, by analogy to an "acceptable" level of risk.  The semantic implications are clear, since most readers will not think of risk as a good thing; of course, there would be little money made in a reader's 401(k) account without it.  Professor Stephen Hilgartner (at left), according to the author, suggests somehow that intellectual property rights need to be restricted much like real property rights are restricted, for example, by zoning ordinances.  A review of his paper reveals much talk about the crisis in patenting "life" but little critical thinking about whether there is, in fact, a crisis that needs correcting.

Conflated throughout the Times article are issues surrounding genetically modified foods; rights of indigenous societies when traditional flora, fauna, or methods are expropriated; and how corporations own 20% of the human genome.  A prominent example cited in the piece is Canavan disease, where a group of parents of children carrying a mutation that caused the disease challenged the researchers who patented their identification of the mutation (for use in a diagnostic test).  What the piece downplays is that the parents were able to get the patent holder to settle, in view of their unique financial and biological contributions to the discovery.  All of which could have been avoided by having a good patent attorney involved on the parents' behalf in the first place.

And nowhere in any of this discussion is there a mention of the fundamental qualities of patents:  limited rights for limited times.  Limitations in scope arise from the duality of DNA as both chemical and information.  As a chemical, DNA can be protected by patent rights.  However, as part of the quid pro quo of the patent system, the nucleotide sequence of a patented gene must be disclosed, and that information is not patentable.  So even while a patent is in force, every researcher in the world can work to "design around" the gene sequence to avoid infringement.  Limitations in time result from the Constitutional mandate that the "exclusive rights" granted to inventors for their discoveries not be perpetual:  currently the patent term is 20 years from filing, and for many patents the effective term is much less.  Thereafter, of course, the patent "monopoly" is done, and the researcher's work is freely available to all.

There is a great deal to be discussed about patents and their application to the life sciences, but most of what is current is political not rational.  An article (usually from the popular press) about this "crisis" is used as a reference to support another article about that "crisis," and soon everyone is shouting fire in a crowded theatre without knowing what caused the "crisis" in the first place.  Biotech patenting has allowed a generation of (predominantly) U.S. companies to bring diagnostic tests and therapeutic agents to market and to attack diseases that were death sentences just a few short years ago.  As Professor Hal Wegner (at right) notes in his recent Patently-O piece, it is just those parties that have provided these benefits (universities, small start-up biotech companies, and pharma) that have the most need for the limited exclusivity provided by patents.  Political Cassandras do us no service with their misinformed cries that the sky is falling; we listen to them at our peril.

For additional information on this topic, please see:
• "In Support of Gene Patents," December 7, 2006

Vanderbilt and Michigan Join Sigma-Aldrich RNAi Program

    By Jason Derry --

PharmaLive has reported that Vanderbilt-Ingram Cancer Center and the University of Michigan added their names to the list of members currently involved in Sigma-Aldrich's RNAi Partnership Program.  The Program was set up by Sigma-Aldrich to provide members with access to its functional genomics portfolio, which comprises shRNA libraries that target over 30,000 human and mouse genes.  Sigma-Aldrich hopes the Program will enhance RNAi-related research at select academic institutions by offering its members access to background information, search tools, workshops, and techniques relating to RNAi technology.  The Program also provides its members with special pricing on RNAi products.  Other members of the Program include the Cleveland Clinic, Washington University of St. Louis, Princeton University, the Wistar Institute, and Rutgers University.  Those interested in becoming members of the RNAi Partnership Program can check out this link.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.

Conference & CLE Calendar

Monday & Tuesday - Biotechnology 2007 (Law Seminars International) - San Francisco, CA

Monday & Tuesday - BIO-Asia Partnering Conference (Biotechnology Industry Organization) - Tokyo, Japan

February 27-28, 2007 - Patent Portfolio Management (American Conference Institute) - New York, NY

March 25-29, 2007 - American Chemical Society National Meeting - Chicago, IL

April 16-18, 2007 - Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman (Patent Resources Group) - Orlando, FL

EFS-Web Document Indexing Online Training

    By Christopher P. Singer --

On January 30, 2007 at 1:00pm (EST) the USPTO will provide online training regarding proper document indexing when submitting filings using EFS-Web.  Proper indexing of documents is important for minimizing potential errors and delays in the Patent Office's processing of submissions by EFS-Web.

Since enrollment for this event was closed in a little more than an hour, at the conclusion of the event, Patent Docs will provide highlights of the broadcast as well as links to supplemental information that the Office may provide.

ACS National Meeting in Chicago

The American Chemical Society is holding its Spring 2007 meeting on March 25-29 in Chicago, Illinois.  According to the ACS website, over 12000 attendees are expected.  We note that our colleagues Steve Sarussi and Brad Crawford will be giving presentations at the meeting on March 28th during a session entitled: "Ensuring the Effective Patent Protection of Innovative Molecular Technology."  In particular, Mr. Sarussi will be speaking about: "Threshold intellectual property issues for the V.P. of R&D at small pharmaceutical companies," and Mr. Crawford will be speaking about: "International patent protection and strategy."

For more information, visit the ACS website by clicking here.

Roche Announces Positive Phase III Results for Actemra

    By Christopher P. Singer --

In a January 24, 2007 press release, Roche announced that its multinational phase III study of Actemra (tocilizumab) for treatment of rheumatoid arthritis has met its endpoint.  The study focused on patients with rheumatoid arthritis that had poor response to treatment with methotrexate.  Over the course of the 24 week study, patients receiving Actemra (i.v.) plus methotrexate reported improvements in symptoms relative to patients receiving placebo plus methotrexate.  Additional Actemra-rheumatoid arthritis phase III trials are ongoing with results expected later this year.

Actemra is a humanized interleukin-6 (IL-6) receptor monoclonal antibody being developed by Roche in collaboration with Chugai.  Actemra was initially launched in Japan in 2005 as a therapy for Castleman's disease.

Changes to USPTO Electronic Filing Rules

        By Christopher P. Singer --

In a rule change that is sure please patent practitioners living in Hawaii, the U.S. Patent and Trademark Office (USPTO) announced several amendments to Title 37 of the Code of Federal Regulations (C.F.R.) relating to EFS-Web correspondence.  In particular, the following sections of 37 C.F.R. have been amended:  §§ 1.4 (signature requirement; form usage/modification), 1.6 (U.S. national stage correspondence; filings; follow-on communications), 1.8 (certificate of transmission by EFS-Web, local time of filer controls timeliness of response), and 1.33 (e-mail acknowledgement of correspondence between the USPTO and correspondence address).  To review the Federal Register notice regarding these rules changes consult this link. 

The most significant change is introduced by new sections 1.8(a)(1)(i)(C) and 1.6(a)(4), which effectively allow a practitioner to use EFS-Web Certifications like Certificates of Mailing under 37 C.F.R. § 1.8.  Thus, correspondence as described in § 1.8 and the EFS-Web "Legal Framework" can be submitted with the proper certification statement and will be considered timely filed as long as such correspondence is "transmitted prior to expiration of the set period of time by being: transmitted via the Office electronic filing system in accordance with §1.6(a)(4)" (37 C.F.R. § 1.8(a)(1)(i)(C)).  Accordingly, the filer needs to include a certificate for each piece of correspondence stating the date of transmission.  NOTE:  The "receipt date" stamp will still reflect the date and time of the submission at the USPTO.  Therefore, for example, applications having critical bar dates should be submitted by EFS with respect to the time and date at the USPTO, not the practitioner's particular local time, or by Express Mail under 37 C.F.R. § 1.10.

For information regarding and clarification of this procedure, the USPTO encourages practitioners to review the "Legal Framework" for EFS-Web at this link.

The USPTO advises that filers should be generally cautious regarding e-filings.  For example, when using EFS-Web to file correspondence with the Office, the filer should make sure to receive (and save) the USPTO-generated E-filing acknowledgement.  Should the filer be unsure about the whether the filing was received by the USPTO, he or she should review the application on Private PAIR to confirm the filing, and retrieve a copy of the e-filing acknowledgement.  Additionally, if a practitioner attempts a transmission when the electronic filing system is inactive (repair, maintenance, etc.), alternative methods of filing should be used (e.g., Facsimile, Express Mail-Post Office to Addressee, First Class Mail).

Federal Circuit Proposes New Rules for Electronic Filing

    By Donald Zuhn --

On January 22, 2007, the Federal Circuit announced a proposal to amend its rules by adopting Federal Circuit Rules 28(a)(15) and (16), 28(j), 30(k), and 31(b), (e), and (f); and by deleting Federal Circuit Rule 32(e).  According to the Court's announcement, the rule changes would require parties represented by counsel to file a digital version of every brief and appendix, unless counsel could certify that such submission would not be practical or would constitute a hardship.  The Court's requirements for the filing of paper copies of the briefs and appendices would continue unchanged.  Proposed Rule 30(k) would result in the posting of digital versions of all briefs and appendices on the Federal Circuit's website, provided that such briefs and appendices are not redacted, sealed, or otherwise restricted by court order.  In conjunction with the adoption of the proposed rules, the Court has also proposed to withdraw Federal Circuit Rule 32(e), which at present permits the filing of briefs on CD-ROM media.  Comments regarding the proposed rules changes should be sent to the Office of the Clerk of the United States Court of Appeals for the Federal Circuit, and must be received by the close of business on February 16, 2007.

Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2007)

    By Donald Zuhn --

In an appeal from a District Court decision granting summary judgment in favor of Defendant-Appellee Caraco Pharmaceutical Laboratories, Ltd. (Caraco), the Federal Circuit concluded that the District Court did not err in construing the term "about 1:5" or in finding no literal infringement or infringement under the doctrine of equivalents, and thus, affirmed the District Court's grant of summary judgment of non-infringement.

Plaintiff-Appellant Ortho-McNeil Pharmaceutical, Inc. (Ortho) owns U.S. Patent No. 5,336,691 (the '691 patent), which relates to a pharmaceutical composition comprising certain weight ratios of the analgesics tramadol and acetaminophen (Ortho sells this composition under the trademark Ultracet®).  The '691 patent discloses that "[c]ertain ratios [of tramadol and acetaminophen] result in a composition which exhibits synergistic analgesic effects," and that "[t]he most preferred ratios are from about 1:19 to 1:50."  The '691 patent also discloses that ratios of "about 1:1 and about 1:5 are encompassed by the present invention."

Seeking approval to market a pharmaceutical composition containing tramadol and acetaminophen having a weight ratio of no less than 1:7.5 and an average weight ratio of 1:8.67, Caraco filed an Abbreviated New Drug Application (ANDA) with the FDA.  In response, Ortho filed suit against Caraco, alleging that the filing of the ANDA infringed claim 6 of the '691 patent.  The asserted claim recites a pharmaceutical composition comprising tramadol and acetaminophen in a weight ratio of "about 1:5."  Caraco then moved for summary judgment of non-infringement.

The threshold issue in this case involves the proper construction of the term "about 1:5."  Before the District Court, Ortho argued that "about 1:5" means "approximately 1:5, and . . . encompasses a range of ratios of at least 1:3.6 to 1:7.1," and Caraco countered that the term means "approximately 1:5, subject perhaps to minor measuring errors of, say, 5 or 10%."  Relying on Ortho's experts, who testified that those of ordinary skill in the art would understand that the term "about 1:5" encompasses a range of ratios between 1:3.6 and 1:7.1, the District Court construed the term "about 1:5" to mean "approximately 1:5, encompassing a range of ratios no greater than 1:3.6 to 1:7.1."

Based on its construction of the term "about 1:5," the District Court concluded that the composition described in Caraco's ANDA did not literally infringe the '691 patent.  In addition, the District Court determined that Caraco's composition - having an average weight ratio of 1:8.67 - did not infringe the '691 patent under the doctrine of equivalents, since such a finding would render the "about 1:5" limitation meaningless.

With regard to the District Court's construction of the term "about 1:5," the Federal Circuit considered the intrinsic and extrinsic evidence in the case, and determined that the District Court had not erred in construing the term "about 1:5" to mean "approximately 1:5, encompassing a range of ratios no greater than 1:3.6 to 1:7.1."  In reaching this determination, the Federal Circuit noted that "[t]he intrinsic evidence points to a meaning for the term 'about 1:5' that is narrow because the 1:5 weight ratio, along with the 1:1 weight ratio, is distinctly claimed and distinguished from other broader weight ratios in the patent."  In particular, the Court noted that because some of the claims in the '691 patent recite a single weight ratio and some claims recite ranges of weight ratios, "one of ordinary skill in the art would understand the inventors intended a range when they claimed one and something more precise when they did not."  The Court also noted that while the inventors tested ratios of 1:1, 1:3, 1:5, 1:5.7, and 1:15, "the patentees chose to specifically claim ratios of 1:1 and 1:5" rather than "claim[] a ratio range of 'about 1:1 to about 1:5,' or even a ratio range of 'about 1:3 to about 1:5.'"

With regard to the District Court's decision to grant summary judgment of non-infringement, the Federal Circuit first determined that under the District Court's claim construction, "there can be no literal infringement because Caraco's formulation must have a weight ratio of tramadol to acetaminophen of no less than 1:7.5."  Turning to the issue of infringement under the doctrine of equivalents, the Federal Circuit agreed with the District Court that to expand the weight ratio of "about 1:5" to encompass a composition having an average weight ratio of 1:8.76 "would eviscerate the limitation."  The Federal Circuit, therefore, concluded that the District Court properly granted summary judgment of non-infringement in favor of Caraco.

Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Lab., Ltd. (Fed. Cir. 2007)
Panel: Circuit Judges Schall and Gajarsa and Chief Judge McKinney
Opinion by Chief Judge McKinney