Patent Docs

Re-examination Ordered on "Expired" Harvard Oncomouse Patent

    By Kevin E. Noonan --

On Monday, the U.S. Patent and Trademark Office granted an ex parte reexamination request for U.S. Patent No. 5,925,803, the latest-filed and last-granted member of the Harvard Oncomouse patent family.  Remarkable about the petition is that the third party requester (TPR), Ellen Gonzales of Gonzales Patent Services, contends that the '803 patent has expired by operation of a terminal disclaimer filed in an earlier-filed application, but maintains that despite the putative expiration, the Office retains jurisdiction to consider the re-examination request.

There are three claims in the '803 patent, all directed to methods for testing a compound suspected to be a carcinogen:

1.  A method of testing a material suspected of being a carcinogen, comprising exposing a transgenic mouse to said material and detecting neoplasms as an indication of carcinogenicity, wherein the germ cells and somatic cells of said mouse contain an activated oncogene sequence introduced into said mouse, or an ancestor of said mouse, at an embryonic stage.

2.  A method of testing a material suspected of conferring protection against the development of neoplasms, said method comprising
    (1) providing a first and a second transgenic mouse, the germ cells and somatic cells of which contain an activated oncogene sequence introduced into said mice, or an ancestor of said mice, at an embryonic stage,
    (2) treating said first mouse with said material, and
    (3) detecting, as an indication of said protection, a reduced incidence of development of neoplasms in said first mouse, compared to the incidence in said second mouse, which is not so treated.

3.  The method of claim 1, further comprising exposing said first and second mice to a carcinogen prior to, after, or simultaneously with treating said first mouse with said material.

The TPR asserted six substantial new questions (SNQ) of patentability against these claims:

• SNQ1:  Claim 1 of the '803 Subject Patent is obvious in view of Claims 1, 11, and 12 of [grandparent U.S. Patent No. 4,736,866] in view of Ward et al. or Schach et al. under the doctrine of judicially-created obviousness-type double patenting.

• SNQ2:  Claims 1-3 of the '803 Subject Patent are unpatentable in view of the Claims 1-12 of the '866 Grandparent Patent under the doctrine of judicially-created obviousness-type double patenting.

• SNQ3:  Claims 2-3 of the '803 Subject Patent are obvious in view of the claims of the '866 Grandparent Patent in view of the Proctor Patent, under the doctrine of judicially-created obviousness-type double patenting.

• SNQ4:  Claims 1-3 of the '803 Subject Patent are obvious under 35 U.S.C. 103(a) in view of Schwab et al.

• SNQ5:  Claims 2-3 of the '803 Subject Patent are obvious under 35 U.S.C. 103(a) over Jaenisch et al. in view of the Proctor patent.

• SNQ6:  Claim 1 of the '803 Subject Patent is obvious under 35 U.S.C. 103(a) over Jaenisch et al. in view of the either Ward et al. or Schach et al.

TPR contends that the following describes the priority chain and the relationship between the grandparent '866 patent, parent U.S. Patent No. 5,087,571, and the '803 patent.  The '866 patent, according to the TPR, contained claims 1-12 directed to the Harvard oncomouse; claims 13-19 directed to methods for testing a compound suspected of being a carcinogen; and claims 20-22 directed to plasmid constructs; claim 1 is representative:

1.  A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.

The TPR contends in her request that the applicant cancelled the claims to the testing methods and let claims to the Harvard Oncomouse proceed to grant as the '866 patent.

The application that gave rise to the parent '571 patent, the TPR contends, was improperly designated as a "divisional application," despite the fact that no restriction requirement was raised against any of the claims of the '866 patent and that the patentee voluntarily cancelled the testing method claims in the '866 patent as part of their patenting strategy.  This application was filed initially with original claims 13-24 that had been cancelled during prosecution of the '866 patent.  Prosecution of the '571 patent resulted in two granted claims:

1.  A method of providing a cell culture comprising
    (1) providing a transgenic non-human mammal, all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage; and
    (2) culturing one or more of said somatic cells.

2.  A cell derived from a somatic cell obtained from a transgenic non-human mammal, all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage which cell contains said recombinant activated oncogene sequence.

Significantly, applicants filed a terminal disclaimer over the claims of the '866 patent in order to overcome an obviousness-type double patenting rejection raised against these claims.  The following language in the terminal disclaimer is important for the arguments successfully raised in the request (with emphasis added):

Your petitioner, President and Fellows of Harvard College, hereby disclaims any portion of an patent granted on the above-identified application or on any application which is entitled to the benefit of the filing date of this application under 35 U.S.C. 120 not extending the term of any patent granted on that application beyond the term of issued U.S. Patent No. 4,736,866 issued April 12, 1988.

The TPR contended that this language was not required in a terminal disclaimer and the patentees were bound by it (i.e., that it cannot be rescinded by certificate of correction, reissue, or reexamination, even if it was filed in error).  As in the '866 patent, patentees cancelled the testing method claims in the application that granted as the '571 patent.

The application that granted as the '803 patent was the first member of the priority chain having a restriction requirement, which was filed with claims 1-13 and 15-24 of the grandparent application.  This restriction requirement identified three groups:  claims 1-12 and 15-17, directed to a transgenic animal and methods for producing such an animal; claims 13, 18 and 19, drawn to suspected carcinogen testing methods; and claims 20-24 being drawn to plasmids; applicants elected to prosecute the testing method claims.  During prosecution the applicants overcame an obviousness rejection based on the '866 patent and the Ward and Schah references on the grounds that 35 U.S.C. § 121 "prohibits the USPTO from rejecting a later divisional application 'where (as here) the divisional application is filed as the result of a restriction requirement in the original case.'"  The TPR contended that this statement is inaccurate, insofar as there was no restriction requirement issued during prosecution of either the grandparent '866 patent or the '571 patent.

The TPR argued in the request that the '803 patent expired by operation of the terminal disclaimer filed in the '571 patent on July 12, 2005, the expiration date of the '866 patent.  Reexamination is still proper, she contended, because a reexamination "may be declared for an expired patent at any time during the enforceability of the patent" (emphasis in original), which will run until July 12, 2011 (i.e., six years after the patents expiration date; M.P.E.P. § 2211).  Moreover, a question arising as a result of obviousness-type double patenting is appropriate for raising a substantial new question of patentability in a reexamination (M.P.E.P. § 2217).  Finally, the TPR argued that public policy concerns supported the Office granting her request for reexamination:

TPR respectfully requests that a Reexamination nonetheless be declared to serve the public notice function of Reexaminations (i.e., to make it clear on the record that the '803 Subject Patent is only avoiding the double-patenting rejections because of the terminal disclaimer in the '571 Parent Patent, which likewise informs the public that the patent expired on July 12, 2005).  In such a case, even if a Reexamination is not declared, to serve the public notice function, TPR respectfully requests that the Patent Office indicate in writing that the terminal disclaimer in the '571 Parent Patent application insulates the '803 Subject Patent from obviousness type double patenting rejections, and further, affirmatively state that the '803 Subject Patent therefore expired on July 12, 2005.  This public notice function is particularly important in this case as the Patentee is publicly advertising that the '803 Subject Patent does not expire until July of 2016, which is 11 years past the actual expiration date.

The Office agreed.  As set forth under Reexamination Control No. 90/010,955, the Office granted the reexamination based on all six substantial new questions of patentability.  Although the paper granting the request cited revisions to the reexamination statute (35 U.S.C. § 301 et seq.) enacted by Congress in 2002 in response to the Federal Circuit's decision in the In re Portola Packaging case, which permit a reexamination request to be granted on art considered by the Office during ex parte prosecution provided that a substantial new question of patentability is raised, the paper also notes that all of the art cited by the TPR (except for the Ward reference) had not been considered by the examiner during prosecution of the '803 patent.  Moreover, the Office did not separately address the standing issue raised by the TPR, apparently agreeing that a reexamination is properly granted on an expired patent during the period where the patent right can be enforced.

The reexamination will be considered by Primary Examiners Brenda Brumback, Padmashri Ponnaluri, and SPE Deborah Jones.

Biotech/Pharma Docket

    By James DeGiulio --

Endo Settles with Impax and Sandoz in Opana Patent Suits

Endo Pharmaceuticals Inc. has settled patent infringement suits against Sandoz Inc. and Impax Laboratories Inc. over generic versions of painkiller Opana ER.  The agreement allows Impax to begin selling a version of the drug on January 1, 2013, and allows Sandoz to enter the market on September 15, 2012.

In January 2008, Endo brought suit against Impax and Sandoz after their ANDA filings, alleging infringement of two of Endo's patents (U.S. Patent Nos. 5,662,933 and 5,958,456), which cover Opana.  Endo further alleged that Impax abused the regulatory system for resolving patent disputes over ANDAs, arguing that Impax violated FDA rules by continuing to send Paragraph IV notices even though the agency rescinded its initial acceptance of Impax's ANDA.

The settlements were announced shortly after a bench trial in the District of New Jersey in front of Judge Katharine S. Hayden.  Additional details on the licensing agreements with Impax and Sandoz were not disclosed.

Sanofi, Abbott Unable to Block Glenmark's Launch of Generic Tarka

Sanofi and Abbott have failed to block Glenmark's launch of a generic version of Tarka after the U.S. District Court for the District of New Jersey denied their motion for preliminary injunction and a temporary restraining order.

In October 2007, Glenmark notified Abbott and Sanofi that it had filed an ANDA with the FDA to make a generic drug containing trandolapril and verapamil hydrochloride, the active ingredients in Tarka.  Sanofi and Abbott responded by filing the current lawsuit in December 2007, alleging Glenmark was planning to infringe the 5,721,244 patent which covers Tarka (see "Court Report," December 16, 2007).  On May 14, Abbott and Sanofi asked the court to preliminarily enjoin and temporarily restrain Glenmark from selling generic versions of Tarka, arguing that denying this action would cause the plaintiffs irreparable harm due mostly to market loss.

Judge Dennis M. Cavanaugh of the District Court for the District of New Jersey denied the preliminary injunction due to public interest and Glenmark's likelihood of success on invalidating the '544 patent due to obviousness.  Glenmark presented strong prior art, including ten references and a 1992 patent held by the plaintiffs.  Judge Cavanaugh noted the commercial success of Tarka, but found the prospective harm to Glenmark would be too great to grant the preliminary injunction.

Judge Cavanaugh's opinion can be read here.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law student at the Northwestern University School of Law.  Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at [email protected].

CAFC Sets Date for Oral Argument En Banc in Inequitable Conduct Appeal

    By Donald Zuhn --

Last week, the Court of Appeals for the Federal Circuit issued an order setting a date for oral argument en banc in Therasense, Inc. v. Becton, Dickinson & Co.  The order indicates that oral argument will take place on November 9, 2010 at 10:00 am in courtroom 201.

In April, the Federal Circuit granted a petition for rehearing en banc submitted by Plaintiffs-Appellants Abbott Diabetes Care, Inc. (formerly Therasense, Inc.) and Abbott Laboratories (see "Federal Circuit Grants En Banc Review in Therasense v. Becton Dickinson").  Last month, the Court extended the deadline by which Plaintiffs-Appellants need to file their brief to July 26 (see "Therasense, Inc. v. Becton, Dickinson & Co. -- Briefing Schedule Update").  According to the Court's original order, Defendants-Appellees must file their response 30 days from the date of service of Plaintiffs-Appellees' brief.  Pursuant to Rule 29(e) of the Federal Rules of Appellate Procedure, amicus curiae briefs must be filed no later than 7 days after the principal brief of the party being supported is filed, or no later than 7 days after the Plaintiffs-Appellants' principal brief is filed when an amicus curiae does not support either party.

For additional information regarding this topic, please see:

• "Therasense, Inc. v. Becton, Dickinson & Co. -- Briefing Schedule Update," May 16, 2010
• "Therasense, Inc. v. Becton, Dickinson & Co. Briefing," May 13, 2010
• "Federal Circuit Grants En Banc Review in Therasense v. Becton Dickinson," April 28, 2010

AMP v. USPTO: What Everyone Else Is Saying - Part II

    By Donald Zuhn --

In March, the District Court for the Southern District of New York found the claims of several of Myriad Genetics patents (directed to the BRCA1 and BRCA2 genes) invalid, ruling in favor of the plaintiffs in Association of Molecular Pathology v. U.S. Patent and Trademark Office (see "Round One Goes to the ACLU").  Following the decision, we discussed the parties' reaction to the outcome (see "AMP v. USPTO: What the Parties Are Saying About the Decision"), and then examined what others were saying or reporting about the decision (see "AMP v. USPTO: What Everyone Else Is Saying").  With the deadline for appealing the lower court's decision less than two weeks away (defendants have until June 18 -- or 60 days after judgment was entered on April 19 -- to file a notice of appeal), we take a second look at what others have been saying about the decision over the past two months.

• In "IP Position Critical to Biotech Investment: Looming Battle over Gene Patenting Could Jeopardize Medical Advances," Genetic Engineering & Biotechnology News contends that:

Whether patents are for genes encoding therapeutic proteins such as insulin and growth hormones, antibodies such as Herceptin® and Rituxan®, or mutated genes that are indicative of breast or ovarian cancer, precluding patents on this subject matter will halt the forward progress that has been made in the biotech industry over the past 30 years since [Diamond v.] Chakrabarty was decided.

The article suggests that "[i]n essence, the lawsuit challenges the entire field of gene patenting when it seems that the true question is whether our healthcare system provides access to specific genetic tests (or therapeutics)."  If plaintiffs ultimately prevail, the article asks whether the plaintiffs "next go after Genentech because it has patents and a market for Herceptin for Her2 positive breast cancer; Pfizer and AstraZeneca, for their patents on statins; Biogen-Idec for Rituxan for the treatment of certain types of B-cell non-Hodgkin lymphoma; or Bristol-Myers Squibb, which sells Erbitux?"  With respect to the impact the case might have on investment, Robert More of Frazier Healthcare Ventures observes that he has "seen quite a few technologies over the years that would be of potential great benefit to patients, but the intellectual property was simply not there to support protecting the product from fast followers in the market place," adding that "because of the enormous sums of money required to discover, develop, test, and approve anything in the healthcare sector, quite aside from the time it takes, IP is critical."  Mr. More also suggests that "20 years or less of exclusivity . . . is a small price for us to pay for innovation."

• In "How Gene Patents Harm Innovation," Forbes.com declares that the decision marks "the first battle in which the future of medicine confronted the past -- and the future won."  The article argues that:

Far from hurting biotech innovation, eliminating pure gene patents will greatly speed innovation in the biotech sector.  Instead of tying up basic genetic information with patents, the biotech industry will have to become more like computer industry.  It will compete on the quality of its machines and software algorithms, not by making scientific discoveries and locking up the information for decades with a patent. Numerous high-tech gene companies will be able to flourish thanks to superior technology.

• In "Who owns your genes?" a San Francisco Chronicle editorial predicts that the case will eventually reach the Supreme Court and advises that "[t]he high court should strike it down," arguing that "[g]enes are the common property of humanity, not the private fiefdoms of individual companies."

• In "End of Gene Patents Will Help Patients, Force Companies to Change," WIRED opines that "[w]hen you went to sleep last Sunday night [March 28th], 20 percent of your genome belonged to a researcher or company[, and o]ne day later, following federal district court judge Robert Sweet’s ruling, it belonged to you."  Discussing the plaintiffs' case, the article states that:

Beyond the absurdity of gene patents -- imagine patenting gold, the human arm, or gravity -- [plaintiffs] said that patents had hurt patients, stifled business and stunted research.  Myriad’s monopoly prevented women from getting second opinions on their breast-cancer gene tests.  More broadly, existing gene patents dissuaded researchers from studying sections of the genome that were already claimed, and high licensing fees discouraged would-be entrepreneurs.

In the article, 23andMe CEO Linda Avey states that "[m]y hope is that this ruling stands and companies will need to actually innovate and create new advances based on genetic findings, not depend[] on sole access to them."  If the decision stands, she predicts that "[r]ather than relying on obscure patent language and legal strategies, companies will need to develop products that are competitively positioned."

• In "The absurdity of patenting genes," The Guardian offers a few reasons "why gene patents like [Myriad's] are stupid."  While acknowledging that "[p]atents are a sensible idea, because people are more likely to invest in innovation if they believe it will give them a competitive advantage over other people, and because patents allow people to share their discoveries safely, instead of monetising their advantage by keeping a discovery secret," the article states that "patents also act as a barrier to innovation, and gene patents bring these disadvantages [sic] into stark relief."  On the "chilling effect" gene patents alledgedly have on clinical activity and research, the article states that:

Almost all basic science research on the BRCA1 breast cancer gene over the past 12 years has infringed Myriad's patent, and although the company has tended not to go after basic science researchers, they have never promised that they won't in the future, so this academic research on a major risk factor for a major killer -- the most common cancer in women worldwide -- continues only with Myriad's indulgence, making it risky work.

• In "Gene Patenting: Biotech Can Blame Itself for this PR Nightmare," BNET refers to the "60 Minutes" report on the case back in April (see "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story"), and asks:

[W]hy didn’t Myriad explain how much money they’ve spent developing life-saving diagnostics?  Why didn’t they produce patient spokespersons who’ve been saved from cancer and think $3,200 is a pretty reasonable price to pay for it?

• In "Myriad elicits a genetics tempest," The Salt Lake Tribune quotes Myriad executive vice president and in-house legal counsel Richard Marsh as stating that:

In my mind I just cannot fathom the time, effort and cost it took us to try to get the testing to where it is today.  Most of the plaintiffs in this case are academic centers, and I just cannot see an academic center spending hundreds of millions of dollars employing a thousand people all to try to promote the science.

• Finally, in "Elements of humanity should not be patented," a St. Petersburg Times editorial states that "for years companies have been turning our genes into products, patenting them and keeping people from accessing their own genetic information," and opines that "[t]hese patents on nature should never have been granted."  The article notes that "[t]he [District Court's] ruling has thrown the biotech industry into a tizzy," but declares that "the judge's reasoning is airtight."  On the issue of innovation, the piece states that:

Biotech firms argue that they need the patents to spur investment in study.  But this is a red herring.  There are all sorts of ancillary parts of genetic research that are subject to patent and hugely profitable.  Instead, the ruling will be a boon to genetic science and public health.  Competition in the field of genetic testing will bring costs down, giving access to more people to know what disease proclivities they carry.

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

• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Apporaches to Covering Gene Patenting Story," April 5, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "Debating Gene Patents - Round Four," February 10, 2010
• "Newsweek = Newspeak on Gene Patenting," February 8, 2010
• "Everybody Knows -- The Boston Globe Weighs in on Gene Patenting," February 1, 2010
• "The USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
• "Top Stories of 2009: #4 to #1," January 4, 2010
• "Gene Patenting: Australian Potpourri," December 28, 2009
• "Science Progress Article Examines Impact of Gene Patents on Research," December 21, 2009
• "Gene Patenting Debate Continues - Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "The Tragedy of a Bad Idea," August 25, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009

News from Abroad: Australian Senate to Release Gene Patenting Findings Next Week

    By Damian Slizys --

Following the discussion in Patent Docs of the Australian Senate's gene patent inquiry last December (see "Gene Patenting: Australian Potpourri"), we now expect the findings of the Senate enquiry to be set down on 17 June 2010, following two extensions of time.  The inquiry was allegedly initiated, in part, because of the attempts to enforce the Myriad Genetics patents in Australia which relate to the use of BRCA1/BRCA2 genes in breast cancer screening and as isolated products per se.  In light of the recent decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office (09cv4515, U.S. District Court for the District of New York), the report will be of major interest.  This is particularly the case as many of the proposals put forward to the Senate committee will increase the burden on patentees significantly and/or exclude more than naturally-occurring genes from patentability.  For instance, one proposal requires that a patentee must publicly disclose sufficient information to enable the replication of the invention to the same standard as its closest commercial competitor before the payment of each renewal fee.  We will provide a report on the enquiry's finding once it has been handed down.

In addition, on 8 June 2010, plaintiff law firm Maurice Blackburn, initiated proceedings in the Australian Federal Court directed to invalidating the Myriad Genetics patents in Australia.  Although we have yet to review the pleadings, public statements by Maurice Blackburn indicate that the main legal argument against the patents was one of discovery over invention, but there were also big ethical and philosophical questions about whether the body could be privatised.  ''It's a healthcare rights issue and an issue of freedom of research into the fundamental building blocks of our being,'' the lawyers stated.  The progress of this case will clearly be of marked interest, particularly as the legal arguments proposed do not sit easily within the established grounds of invalidity under Australian law.

Dr. Slizys is a Partner at FB Rice & Co in Melbourne, Australia.

Purdue Pharma Products L.P. v. Par Pharmaceutical, Inc. (Fed. Cir. 2010)

Further Adventures in Obviousness and Inequitable Conduct

    By Kevin E. Noonan --

In Purdue Pharma Products L.P. v. Par Pharmaceutical, Inc., the Federal Circuit exercised its prerogative to illustrate its fractured jurisprudence on two issues, obviousness and inequitable conduct, in a (fortunately) nonprecedential decision.  Contrary to its Congressional mandate to bring jurisprudential consistency to U.S. patent law, on these matters at least the outcome is highly dependent on the constitution of the panel rather than a consistent application of the law.  In view of the fact-intensive nature of the issues involved it is perhaps inevitable, but that does little to help the patent community understand what behavior does (and does not) fit within the statutory standard.

This case arose after Par filed an ANDA for Purdue Pharma's Ultran ER® product, a sustained release formulation of the opiate analgesic tramadol, with a Paragraph IV certification that Purdue Pharma's Orange Book-listed, U.S. Patent Nos. 6,254,887 and 7,074,430 were invalid and/or unenforceable.  The District Court held that Par's generic tramadol formulation infringed claims 3, 13, 27, and 29 of the '887 patent and claims 5, 7, and 11 of the '430 patent.  However, the Court also found that these claims were invalid for obviousness over the disclosure of U.S. Patent No. 5,580,578 ("the Oshlack patent") but that the patents were not unenforceable for inequitable conduct.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Linn and Dyk.  The panel's grounds for affirming the obviousness determination was that the Oshlack patent disclosed tramadol as one of 14 opiate drugs that could be formulated in an extended-release formulation, dosing to encompass a bioavailability profile of from 10 to 33 hours, and a "controlled release coating" comprising water-insoluble polymethacrylate and polyvinylpyrrolidone.  Purdue's patents disclosed alternative, water-insoluble coatings.  The Court held that the Oshlack patent selected tramadol as one of 14 opiate drugs (out of the "myriad other possible active ingredients" that could have been used to prepare an extended-release formulation), and that this disclosure rendered Purdue's claimed formulations obvious "regardless of whether or not the patent lists tramadol as a preferred embodiment."  (The Court helpfully cited another case, Perricone v. Medicis Pharm. Corp., that "reject[ed] the notion that one of [14 listed] ingredients cannot anticipate because it appears without special emphasis in a longer list," relying it seems on the maxim that "anticipation is the epitome of obviousness," In re Kalm, 378 F.2d 959, 962 (CCPA 1967).)  The Court also found that the Oshlack reference expressly taught "once-daily" tramadol formulations albeit without necessarily enabling production thereof (citing Symbol Technologies Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991)).  The panel held that Purdue had waived arguments relating to the non-obviousness of formulations having bioavailability profiles disclosed and claimed in the '887 and '430 patents, as well as (and perhaps more importantly) the argument that the Oshlack patent was not prior art under 35 U.S.C. § 102(e), because these arguments were not raised before the District Court.  A review of Patent Office records indicates that the Oshlack patent was assigned to Purdue in December 1997, suggesting that Purdue's argument was that this patent was not available as prior art under § 102(e) pursuant to the provisions of 35 U.S.C. § 103(c).  This argument, properly made, should have been enough to overcome Par's obviousness defense.  Finally, the Court continued its recent pattern of disregarding the "secondary considerations" of non-obviousness under the Supreme Court's Graham v. John Deere precedent, agreeing with the District Court that evidence of copying was irrelevant in an ANDA context (an argument of apparently first enunciation), and that Purdue had not provided sufficient context (or perhaps sufficient "nexus") for its commercial success evidence to rebut the District Court's legal conclusion of obviousness.

Turning to inequitable conduct, the panel agreed with the District Court that Purdue had withheld material information from the Office in the form of experimental data, and indeed had submitted a "misleading" affidavit during prosecution:  the declaration contained "more favorable" experimental data than the data that Purdue withheld.  Par reasonably contended that this constituted inequitable conduct, since Purdue could provide "no credible explanation" for these actions.  In finding no inequitable conduct, the District Court found insufficient evidence of deceptive intent.  For example, the Court characterized the declaration as being "an overly aggressive attempt to put a positive spin on the data."  Par also contended that the District Court erred in relying on "evidence" of good faith, which included that the declarant failed to recall why the less-favorable data was not submitted to the Office, "that the formulators did not recognize the data's import to patentability when the evidence showed that they did," and that patentees had later submitted "similar" (presumptively negative) data to the Office.

The Federal Circuit affirmed the District Court's finding of no inequitable conduct based on several factors that are consistent with the deference that the "abuse of discretion" standard is intended to produce, as well as others that are less reasonably related to the conclusion.  These include witness credibility, but also include that the declaration was "prepared" to overcome a rejection on inherent anticipation before the European Patent Office (but if it wasn't submitted to the USPTO it could not have been used to support an inequitable conduct defense).  The panel also seemed to sanction as a factor related to deceptive intent the later submission of "more pertinent experimental results," which the Court noted had been "generated for a foreign litigation."  Also impliedly sanctioned was the "credible excuse" proffered by Purdue, that "[t]he omitted data did not reproduce conditions from the prior art and revealed dissolution rates outside those claimed in the asserted patents."  The panel stated that "[e]ven assuming that the applicants withheld material data and submitted a materially misleading declaration, as the district court found" in affirming the District Court's decision, a statement that seems to stretch to the breaking point the principle that intent to deceive cannot be inferred from materiality alone.  And the fact that Purdue later disclosed "similar" experimental data seems equally inadequate to overcome the behavior the District Court found, and the panel agreed, was exhibited by Purdue in not only withholding material information but filing a misleading affidavit (compare, for example, different panel holdings in Aventis Pharma S.A. v. Amphastar Pharma, Inc. and Ferring B.V. v. Barr Laboratories, Inc.).  In making this determination, the panel seems to distinguish an earlier panel's decision in Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359 (Fed. Cir. 2007) on the grounds that in Cargill, the patentees consistently submitted misleading information to the Office.  And the panel found that "the reasonableness of inferring that any omission or misleading statement in the preparation of the declaration was made with the specific intent of deceiving the PTO" was diminished because the declaration was prepared for an EPO proceeding (ignoring the fact that the issue was the intent in submitting the declaration to the USPTO during prosecution of the '887 and '430 patents).  For this panel, at least, the District Court's decision of no inequitable conduct was affirmed "[b]ecause intent to deceive is not the single most reasonable inference that can be drawn from the evidence."

Perhaps the en banc court's decision in Therasense v. Becton, Dickenson & Co. will bring some consistency to the Court's inequitable conduct jurisprudence.

Purdue Pharma Products L.P. v. Par Pharmaceutical, Inc. (Fed. Cir. 2010)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Linn, and Dyk
Opinion by Circuit Judge Lourie

Venter Denies Synthetic Cell Discovery Is Artificial Life, Vatican Agrees

    By James DeGiulio --

Last week, we reported that a research team led by Dr. Craig Venter had developed a "synthetic cell" controlled by purely synthetic DNA (see "Dr. Craig Venter Creates First Cell Controlled Entirely by Synthetic DNA")  Dr. Venter and co-author Dr. Daniel Gibson have written an op-ed piece that was recently published in The Wall Street Journal, entitled "How We Created the First Synthetic Cell," which describes their scientific advance and addresses some of the ethical issues involved.  Perhaps fearing a bioethical backlash, the two researchers vehemently deny that they have created life, instead suggesting that they "transformed existing life into new life."  Drs. Venter and Gibson describe their research process as using digitized information to synthesize a modified version of the "naturally occurring" Mycoplasma mycoides genome.

As a historical example, Drs. Venter and Gibson reference the 1967 discovery by Nobel prize winner Dr. Arthur Kornberg (at left), who successfully copied the phiX174 virus DNA.  The authors note that President Lyndon Johnson, at that time, hailed Dr. Kornberg's work as "a very spectacular breakthrough," yet accurately predicted "[i]f you think about some of these decisions the present president is making -- it is going to be a kindergarten class compared to the decisions some future president is going to have to make."  Indeed, President Obama, in a letter last week to the chair of his new bioethics commission, wrote:  "This development raises the prospect of important benefits, such as the ability to accelerate vaccine development.  At the same time, it raises genuine concerns, and so we must consider carefully the implications of this research."  Drs. Venter and Gibson close the piece by welcoming and encouraging such review and dialogue.

The Vatican, after evaluating the methodology of Dr. Venter's creation of the "synthetic cell," has reached the same conclusion put forth by the researchers:  that the discovery is not "creating life" and thus does not move beyond the church's bioethical boundaries.  Furthermore, perhaps surprising to some, the Vatican has publicly praised the discovery.  The Vatican newspaper L'Osservatore Romano published an article calling it an "interesting result" and was optimistic that the development could help cure disease.  Importantly, rather than considering the development as creating life, the article considered that the researchers instead had merely "replaced one of its motors," and that "the DNA, even though it is an excellent engine, is not life."

Though the Vatican's response may appear surprising, the church actually does not officially oppose genetic engineering, so long as the science avoids embryonic stem cells, cloning, or anything else that dabbles in the re-creation of human life.  Nonetheless, the Vatican recognizes that the Venter discovery has taken a substantial step closer to creating life.  Despite the praise in the article, the Venter research team was encouraged to "join courage with caution," when moving forward into such delicate territory.

Patent Docs will report on the scientific community's response to Dr. Venter's "synthetic cell" discovery in a later post.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law student at the Northwestern University School of Law.  Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at [email protected].

Court Report

    By Sherri Oslick --

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

Shire LLC et al. v. Anchen Pharmaceuticals Inc. et al.
1:10-cv-00484; filed June 2, 2010 in the District Court of Delaware

• Plaintiffs:  Shire LLC; Supernus Pharmaceuticals Inc.; Amy F.T. Arnsten PhD; Pasko Rakic MD; Robert D. Hunt MD
• Defendants:  Anchen Pharmaceuticals Inc.; Anchen Inc.

Infringement of U.S. Patent Nos. 5,854,290 ("Use of Guanfacine in the Treatment of Behavioral Disorders," issued December 19, 1998), 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001), and 6,811,794 (same title, issued November 2, 2004) based on Anchen's filing of an ANDA to manufacture a generic version of Shire's Intuniv (guanfacine, used to treat attention-deficit hyperactivity disorder).  View the complaint here.

Teva Pharmaceuticals USA, Inc. et al. v. Bayer Schering Pharma AG et al.
1:10-cv-04340; filed June 1, 2010 in the Southern District of New York

• Plaintiffs:  Teva Pharmaceuticals USA, Inc.; Barr Laboratories, Inc.
• Defendants:  Bayer Schering Pharma AG; Bayer Healthcare Pharmaceuticals Inc.

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. RE37,564 ("Composition for Contraception," issued February 26, 2002), RE37,838 (same title, issued September 10, 2002), and RE37,253 (same title, issued September 16, 2003) based on Teva's filing of an ANDA to manufacture a generic version of Bayer's Yaz® (drospirenone & ethinyl estradiol, used for oral contraception).  View the complaint here.

Bayer Schering Pharma AG et al. v. Teva Pharmaceutical Industries Ltd. et al.
1:10-cv-00474; filed June 1, 2010 in the District Court of Delaware

• Plaintiffs:  Bayer Schering Pharma AG; Bayer HealthCare Pharmaceuticals Inc.
• Defendants:  Teva Pharmaceutical Industries Ltd.; Teva Pharmaceuticals USA Inc.; Barr Pharmaceuticals LLC; Barr Laboratories Inc.

Infringement of U.S. Patent Nos. RE37,564 ("Composition for Contraception," issued February 26, 2002), RE37,838 (same title, issued September 10, 2002) and RE37,253 (same title, issued September 16, 2003) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Bayer's Yaz® (drospirenone & ethinyl estradiol, used for oral contraception).  View the complaint here.

Medicines Co. v. APP Pharmaceuticals LLC et al.
1:10-cv-00476; filed June 1, 2010 in the District Court of Delaware

• Plaintiff:  Medicines Co.
• Defendants:  APP Pharmaceuticals LLC; APP Pharmaceuticals Inc.

Infringement of U.S. Patent No. 7,598,343 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued October 6, 2009) following a Paragraph IV certification as part of APP's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the complaint here.

Biogen Idec MA Inc. v. EMD Serono, Inc. et al.
2:10-cv-02760; filed May 28, 2010 in the District Court of New Jersey

• Plaintiff:  Biogen Idec MA Inc.
• Defendants:  EMD Serono, Inc.; Pfizer Inc.; Bayer Healthcare Pharmaceuticals Inc.; Novartis Pharmaceuticals Corp.

Infringement of U.S. Patent No. 7,588,755 ("DNA Sequences, Recombinant DNA Molecules and Process for Producing Human Fibroblast Interferon-like Polypeptides," issued September 15, 2009) based on defendants' manufacture and sale of IFN-β products (Rebif®, Betaseron®, Extavia®).  View the complaint here.

Novo Nordisk Inc. et al. v. Paddock Laboratories, Inc.
0:10-cv-02199; filed May 28, 2010 in the District Court of Minnesota

• Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk A/S
• Defendant:  Paddock Laboratories, Inc.

Infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of Novo Nordisk's Prandin® (repaglinide, used to treat non-insulin dependent diabetes mellitus in combination with metformin).  View the complaint here.

Bayer Healthcare Pharmaceuticals Inc. v. Biogen Idec Inc.
2:10-cv-02734; filed May 27, 2010 in the District Court of New Jersey

Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 7,588,755 ("DNA Sequences, Recombinant DNA Molecules and Process for Producing Human Fibroblast Interferon-like Polypeptides," issued September 15, 2009) based on Bayer's manufacture and sale of its Betaseron® product.  View the complaint here.

Magnachem International Laboratories, Inc. v. Kappos
1:10-cv-00892; filed May 26, 2010 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,323,495 ("Synthetic Lactone Formulations and Method of Use," issued January 29, 2008).  View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. Actavis Inc. et al.
2:10-cv-02795; filed May 24, 2010 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventisub II INC.; Carderm Capital L.P.
• Defendants:  Actavis Inc.; Actavis Mid Atlantic LLC

Infringement of U.S. Patent Nos. 6,399,632 ("Method of Providing an Antihistaminic Effect in a Hepatically Impaired Patient," issued June 4, 2002), 6,187,791 (same title, issued February 13, 2001), and 6,037,353 (same title, issued March 14, 2000), following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Aventis' Allegra® Oral Suspension (fexofenadine hydrochloride oral suspension, used to treat allergies).  View the complaint here.

Conference & CLE Calendar

June 10, 2010 - "Patents and the Written Description Requirement: Meeting Section 112 Disclosure Obligations After Ariad v. Lilly" (Strafford) - 1:00 - 2:30 PM (EST)

June 11, 2010 - "The Future of U.S. Patent Law: An In-Depth Discussion on the Congress, the Courts, and the USPTO" (Patent Resources Group) - Alexandria, VA

June 15, 2010 - Patent Reform 2010: What Shape Will It Finally Take? (Analysis Group, Georgetown University's Center for Business and Public Policy, and McKool Smith) - Washington, DC

June 16-18, 2010 - Fundamentals of Patent Prosecution 2010: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

June 21-22, 2010 - Follow-on Biologics (American Conference Institute) - New York, NY

June 20-22, 2010 - IP Business Congress (Intellectual Asset Management (IAM) magazine) - Munich, Germany

June 23, 2010 - Regulatory and Intellectual Property Opportunities and Challenges for Life Science Companies Entering the U.S. Market (American Bar Association) - 12:00 - 1:30 PM (EST)

June 23-24, 2010 - Maximising Pharmaceutical Patent Life Cycles (C5) - London, England

June 29, 2010 - Navigating the U.S. Biosimilar Pathway (American Bar Association) - 1:00 - 2:30 PM (EST)

June 30, 2009 - Markman Hearings and Claim Construction in Patent Litigation 2010 (Practising Law Institute) - New York, NY (with groupcasts in Atlanta, GA; Mechanicsburg, PA; Philadelphia, PA; and Pittsburgh, PA)

July 7, 2010 - Prior Art & Obviousness 2010: Current Trends in Sections 102 & 103 (Practising Law Institute) - New York, NY

July 7-9, 2010 - Fundamentals of Patent Prosecution 2010: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

July 19-20, 2010 - Hatch-Waxman Boot Camp*** (American Conference Institute) - Boston, MA

July 29-31, 2010 - Intensive Patent Law Training Workshop (Chisum Patent Academy) - Seattle, WA

August 18-19, 2010 - The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions*** (American Conference Institute) - New York, NY

September 15, 2010 - Prior Art & Obviousness 2010: Current Trends in Sections 102 & 103 (Practising Law Institute) - San Francisco, CA

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

ACI Patent Term Adjustment and Patent Term Extension Conference

American Conference Institute (ACI) will be holding a conference entitled "The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions" on August 18-19, 2010 in New York, NY.  ACI faculty will help attendees:

• Understand the unique role of PTE and PTA in patent life cycle management for the life sciences industry;
• Master the essentials of PTA from questions of eligibility and calculation to the application process to procedures for redress;
• Decipher the mysteries of A, B and C-delays;
• Learn to solve the A and B-delay overlap dilemma and B-delay National Stage queries vis-à-vis Wyeth v. Dudas and Japan Tobacco;
• Avoid applicant delays and circumvent "failure to engage" findings by the PTO;
• Navigate the complexities of PTE in terms of substance and procedure;
• Comprehend how the key challenges in Wyeth Holdings, Photcure, Lupin, and The Medicine Company will affect PTE determinations in the future;
• Appreciate how second generation patents and regulatory exclusivities factor into patent term extensions; and
• Examine the significance of Supplemental Protection Certificates (SPCs) in patent term restoration in the EU.

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

• Exploring the role of PTA and PTE in patent life cycle management in the life sciences industry;
• PTA 101:  Mechanics, essentials and conundrums;
• Using A-delays, B-delays and C-delays to your advantage;
• Wyeth v. Dudas:  Analyzing and solving the A and B delay overlap dilemma;
• Japan Tobacco:  Remedying B-delay errors in national stage applications under 35 U.S.C. § 371;
• Strategies for avoiding applicant PTA delays and other pitfalls;
• PTE:  Laying the groundwork for patent term restoration;
• New trends and challenges in PTE litigation:  Key cases to watch;
• Supplementing PTE through the use of second generation patents;
• Understanding the interplay of PTE and certain regulatory exclusivities; and
• Exploring patent extensions and exclusivities in the EU.

A complete brochure for this conference, including an agenda, list of speakers, and registration form can be obtained here.

The registration fee for this conference is $2,195.  Attendees registering by June 18, 2010 will receive a $300 discount and attendees registering by July 23, 2010 will receive a $200 discount.  ACI will also be offering a special rate of $1,795 to all Patent Docs readers who reference the discount code "Patent Docs - PTA" 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 Patent Term Adjustment and Patent Term Extension conference.

USPTO Director Announces New Examination Options

    By Kevin E. Noonan --

Undersecretary of Commerce and U.S. Patent and Trademark Office Director David Kappos today announced a three tiered patent prosecution regime, termed "Three Track" to be instituted in the Office.  The scheme will be implemented as rulemaking pursuant to 35 U.S.C. § 2 and after a Notice and Comment period under the Administrative Procedures Act, although the Director noted that Congress would (under current law) need to set fees for the different prosecution options (or enact legislation providing the Office with fee-setting authority; see "New USPTO Fee-Setting Bill Introduced in House").  The Director's announcement was made to a group of about a dozen reporters on a conference call this afternoon, as well as a press release published on the Patent and Trademark Office website.

The Directed explained the three tiers as follows.  The first tier, "Fast Track" or "Track One," constituting an accelerated examination procedure, is aimed at having a first Office Action issue within four months after filing, with final disposition (defined as allowance or Final Rejection) in no more than twelve months.  Notably, there will be no requirement for an Examination Support Document (ESD), due to the "resistance of the patenting community" over this requirement in current accelerated examination procedures and the response to this requirement in earlier-proposed patent "reform" bills and the infamous "claims and continuations" rules finally rescinded by the Director last fall (see "'New Rules' Officially Rescinded").  In response to a question, the Director explained that this first tier examination was not intended to replace existing accelerated examination (which does contain an ESD requirement).  The Director said the Office did not want to take away applicant options, but did say that if applicants abandoned existing accelerated examination procedures in favor of the "Fast Track" approach, he could see the Office eliminating these other existing protocols.  He also said that the Office would take advantage of its experience and infrastructure with these other accelerated examination schemes.  In response to another question, the Director said that there had been 3,714 applications that have used existing accelerated examination procedures since 2005.  Answering yet another question, the Director predicted that the time required to examine applications in certain arts (making these arts less amenable to accelerated examination), and the costs would be an impediment to large corporations requesting this accelerated "Fast Track" examination.  The Director said that the fee would not be trivial, but that in the absence of independent fee-setting authority (something which the Director took the time to mention was in a presently-pending bill in the House of Representatives introduced by Rep. Conyers and Smith (H.R. 5322) and that was supported by the Obama administration), fees to be imposed for first tier Fast Track examination would need to be set by Congress.  The Director also noted that any reduction in fees for traditional small entities (50%) or (even smaller) "microentities" (75%), constituting individual inventors and others (as defined in the current Senate patent "reform" bill, S. 515) would likewise require Congressional implementation.  The Director cited small entities and microentities as components of the economy that create the most innovation and new jobs, saying the Office "really wants to help them."  The Director also commented on the Patent Prosecution Highway (PPH) as a way to accelerate examination, conserve Office resources, and reduce the backlog.

The second tier ("Track Two") constitutes the status quo, and would be the "default" mode for examination, according to the Director.  Applicants would need to do nothing to elect this examination mode different from what is done currently.  The Director also noted his hope that the pendency under this track will be reduced to 10 months to first action and 20 months to final disposition.

The "Track Three" third tier is an extended or delayed examination, which would permit an applicant to defer examination for up to 30 months from the earliest priority date.  Analogizing this tier to the current Patent Cooperation Treaty timetable, the Director asserted that discussions with many constituencies ("small entities, large entities, pharma, information technology, and everybody in between") tell him "regularly" that applicants wanted a way to defer examination as a way to reduce costs.  The Director also noted that he envisions a system where the Office's actions were tied to payment of the fee for that action, and to provide a way to "exit" the process when an application is no longer desired (such as when a search shows anticipating prior art).  The Director conceded that this tier was expected to address, in part, the current application backlog.  The Director's hope is that by deferring examination some applications would be abandoned and thus not contribute to the backlog or consume Office resources.  (This behavior is observed in foreign patent offices, albeit where application pendency requires a yearly annuity payment.)  This is particularly important in view of reductions in the examiner corps occasioned by attrition not counterbalanced by new hiring.  Unaddressed was the effect (if any) of electing this third tier on patent term adjustment; in view of the current statutory provisions and Office rules that reduce such adjustments for applicant "failure to diligent prosecution" it is likely that deferring examination will incur such costs.  This can be expected to make the third tier much less attractive for arts, such as biotechnology and pharmaceuticals, where reduced term has real-world economic consequences.  As with first-tier examination, the costs for deferring examination, including delayed payment of search fees or examination fees, will depend on Congressional authorization unless the Office is granted independent fee-setting authority.

In another Office initiative, the Office will delay examination until a first Office Action is issued by a foreign patent office (including for example the Japan Patent Office) for applications arising from a first foreign filing.  The USPTO will treat this Action as a "first office action" on the merits and require an applicant to file a paper addressing the rejections contained in such a foreign action.  The Director hypothesized that in some instances this will be a perfunctory response, such as those occasions where the basis of the rejection does not have a counterpart in the U.S. ("absolute novelty"-based rejections are one example).  For other grounds of rejection in common between the U.S. and the foreign patent office (such as § 102(b) rejections, for example), the applicant would be required to address the rejection in the form of a preliminary amendment, which the Director contended would thus advance prosecution of the U.S. application by overcoming rejections before substantive examination by a U.S. examiner, as well as avoiding RCE practice and get the application in condition for final disposition.  While this proposal certainly has benefits for the Office, the requirement that an applicant with a first foreign-filed application wait until the applicant receives an action from a foreign patent office can be expected to delay U.S. examination (since there is typically a much longer delay to first action in foreign offices compared with the U.S.; the Director suggested applicants can take steps to reduce this delay).  This suggests that foreign filers may benefit from the practice (which already is advantageous for creating § 102(e) prior art) of filing a U.S. provisional application on the same day that the foreign application is filed.  This would provide such applicants with a first U.S. filing that would enable them to avoid such delay.

Finally, in response to a question from a Reuters reporter, the Director stated that the Office expects to collect between $146-242 million more than was appropriated to the Office (and likely, he said, to be towards the high end).  Thus, the rationale for a 15% surcharge in fees (and fee-setting authority generally) seems to have evaporated, but the Director notes that the Office has needs (like increased hiring and IT infrastructure improvements) that have not been addressed.  (He did not mention that the problem seems most easily resolved by preventing Congress from diverting these funds from the Office by the appropriations process.)  He also noted that another use for the monies would be to fund a reserve mandated by the Office of Management and Budget.

This proposal incorporates features either instituted (accelerated application) or earlier proposed (delayed examination) intended to address both the backlog and arguments that the backlog is harming innovation.  The Director expressed the opinion that the proposal would provide the circumstances for "gobs of jobs" to be created based on more a efficient patent application system.  Clearly, the Director has the correct attitude (helping applicants get patents under the law efficiently and effectively) and recognizes the relationship between a properly-functioning patent system, innovation, and the economy.  It is an attitude that remains refreshing in view of recent history of the Office.

In the Office's press release announcing the "Three Track" initiative, the Office noted that it was seeking input from the patent community regarding the proposal.  As part of that effort, the Office will be holding a public meeting on July 20 at 1:30 pm (EDT) at the USPTO’s Madison building, 600 Dulany Street, Alexandria, Virginia.  Those interested in attending the meeting must register by 5:00 pm (EDT) on July 16.  The Office is also seeking written comments, which must be submitted by August 20.  A June 4 Federal Register notice will provide additional details regarding the initiative.

Biotech/Pharma Docket

    By James DeGiulio --

Celgene, Barr Resolve Patent Dispute over Generic Thalomid

Celgene Corp. and Barr Laboratories Inc. have resolved their patent dispute over the multiple myeloma cancer drug Thalomid, with Celgene agreeing to drop its patent infringement claims and Barr dropping its invalidity and antitrust claims.

Celgene initiated the dispute in January 2007, after Barr filed an ANDA for generic thalidomide in September 2006 (see "Court Report," February 28, 2007).  Celgene claimed that Barr's product infringed seven of its patents, and then added another asserted patent in a second lawsuit against Barr in August 2007 (see "Court Report," September 3, 2007).  Barr responded in October 2007 by filing its own suit, alleging that Celgene failed to disclose material information to the U.S. Patent and Trademark Office and that Celgene interfered with its attempts to get the raw material needed for studies required to file its ANDA.  Celgene filed a third lawsuit before the District Court consolidated these actions in July 2008.  Finally, in December 2008, Celgene filed an amended complaint alleging infringement of the three patents currently at issue: U.S. Patent Nos. 5,629,327; 6,235,756; and 7,435,745.

On May 26, Judge Wigenton of the U.S. District Court for the District of New Jersey approved the parties' stipulation of dismissal without prejudice of all claims and counterclaims asserted in the case.  Barr's antitrust claims were dismissed with prejudice.  Each party agreed to bear its own costs and attorneys' fees in the matter.

The parties' approved stipulation can be found here.

GlaxoSmithKline and Teva Reach Settlement in Combivir Dispute

GlaxoSmithKline PLC unit Glaxo Group Ltd. has settled with Teva Pharmaceuticals USA Inc. in its patent infringement suit over the HIV drug Combivir.

GSK sued Teva in November 2007, alleging that Teva's proposed generic product would infringe U.S. Patent No. 5,859,021 patent over Combivir (see "Court Report," November 11, 2007).  Teva's ANDA for its generic drug was tentatively approved in 2009, after which Teva said it planned to release the generic product May 17, about two years before the expiration of the '021 patent.  Teva had already stipulated that its generic version would infringe the '021 patent, so the only issue remaining for trial was the validity of the patent.

On May 26, Magistrate Judge Leonard Stark of the U.S. District Court for the District of Delaware approved the parties' stipulation dismissing the case.  Prior to the dismissal order, GSK had asked the District Court for a preliminary injunction barring Teva from launching a generic version in May.  However, the case was settled before the Court ruled on the motion.

Terms of the settlement were not available.  Judge Stark's order and the parties' stipulation dismissing the case can be found here.

Sandoz Counterclaims for Two Patents Dismissed in Merck's Emend Suit

Sandoz's counterclaims against Merck relating to two patents were dismissed in an infringement suit over Emend, a drug used to suppress nausea resulting from chemotherapy drugs and surgery.

The dispute began January 15, 2009 when Sandoz notified Merck in a letter that it had filed an ANDA seeking approval for a generic version of Emend.  Merck filed a complaint in February 2009 alleging infringement of four patents:  U.S. Patent Nos. 5,719,147; 6,048,859; 6,096,742; and 6,235,735 (see "Court Report," March 8, 2009).  In its answer, Sandoz included counterclaims for declaratory judgment of noninfringement, invalidity and/or unenforceability of the four patents listed, and additional patents, U.S. Patent Nos. 5,538,982 and 7,214,692.  The counterclaims state that if Sandoz were to prevail, it would still be faced with the threat of litigation over the additional patents, which cover the same products.

In April 2010, the counterclaims relating to the original four allegedly infringed patents were dismissed.  On May 19, Sandoz sent a proposed order of dismissal to Judge Mary Cooper of the U.S. District Court for the District of New Jersey, but included no further details.  The next day, May 20, Judge Cooper dismissed Sandoz's counterclaims related to the '982 and '692 patents.

The May 20 dismissal order can be found here.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law student at the Northwestern University School of Law.  Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at [email protected].

Biotech/Pharma Issuances on the Rise

    By Donald Zuhn --

Last week, a post on Patently-O presented some interesting results regarding the percent of utility applications that had issued as patents as compared to the total number of issued patents and abandoned applications for eight technology centers (see "USPTO Grant Rate by Technology Center").  The post indicated that the results had been obtained from an analysis of about 25,000 utility applications filed over the past few years.  According to the post, TC 1600 (biotechnology and organic chemistry) had produced the lowest percent of issuances (less than 45%).

For a presentation at last month's BIO International Convention on the impact of the recession on biotech patent prosecution, we looked at the number of biotech/pharma patents that had issued between 2000 and 2010 and the number of biotech/pharma applications that had published over this same time frame.  The results of this analysis are shown in the graph below (note: figures for 2010 are projected based on issuances and publications through June 1):

In the graph above, the blue bars represent the number of patents designated as belonging to classes 424, 435, 436, 504, 506, and/or 514 that issued in the specified year.  The red line represents the number of patent applications designated as belonging to one of the above classes that published in the specified year (because the AIPA mandated publication of certain U.S. applications filed after November 28, 2000, no biotech/pharma applications were published in 2000 and only 3,920 biotech/pharma applications were published in 2001).

If the numbers through May hold up during the remainder of the year, biotech/pharma patent issuances could return to levels not seen since 2003, indicating that the Patent Office may indeed be putting the days (years?) of "reject, reject, reject" behind them.

Dr. Craig Venter Creates First Cell Controlled Entirely by Synthetic DNA

    By James DeGiulio --

After a 15-year effort, the team of Daniel Gibson (at right), Hamilton Smith, and Craig Venter (below left) have created the first cell controlled by a purely synthetic genome.  In a press release and accompanying press conference, Dr. Venter described the converted cell as "the first self-replicating species we've had on the planet whose parent is a computer."

As reported in the May 20 issue of Science, in an article entitled "Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome," the research team at the J. Craig Venter Institute in Rockville, Maryland designed 1,078 specific cassettes of DNA that were 1,080 base pairs long and ordered them from DNA synthesis company Blue Heron Biotechnology.  To ensure that the assembled genome would be recognizable as synthetic, four of the ordered DNA sequences contained strings of bases that, in code, spell out an e-mail address, the names of the people involved in the project, and a few famous quotations from James Joyce and other authors.  The team then assembled the shorter lengths into a complete Mycoplasma mycoides genome.  The researchers transferred the synthetic genome into a recipient cell from a different bacterial species, replacing the endogenous DNA, and the cell became entirely controlled by the new synthetic genome.  The cell was essentially converted into a different species, for the finished product was capable of replication and had all the expected properties of a Mycoplasma mycoides bacterium.

The cost of the project was $40 million, most of it paid for by Synthetic Genomics, a company Dr. Venter founded.  Not surprisingly, Venter has applied for several patents covering the work, assigning them to his company.  Synthetic Genomics has a contract from Exxon to generate biofuels from algae.  However, the bacterium used by the Venter group is unsuitable for biofuel production, and Dr. Venter said the team would move on to more suitable organisms.  Dr. Venter and his colleagues hope to design new bacteria that will perform useful functions, such as production of new fuel molecules, new food oils, and new biologically derived sources of plastic and chemicals.  Dr. Venter predicted that the first application the world may see could be as soon as next year.

Dr. Venter's "synthetic cell" has the potential to rejuvenate nagging questions of ethics, law, and public safety about artificial life that bio-ethicists have been debating for more than a decade.  However, some scientists downplayed the development, finding it as merely a technical accomplishment, since the new cell can be viewed as an organism with a synthetic genome, not as a synthetic organism.

President Obama has asked the White House bioethics commission to report back to him on the significance of this development, and Nature has published a series of opinions on Dr. Venter's article from synthetic biology experts.  Patent Docs will address the commentary and additional reactions to Dr. Venter's discovery in future posts.

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

• "Playing the Bioterror Card in the Synthetic Biology Debate," December 19, 2007
• "The Synthetic Biology Sky Is Not Falling," December 16, 2007
• "Patenting Life (Really)," June 11, 2007

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law student at the Northwestern University School of Law.  Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at [email protected].