Patent Docs

Court Report

    By Sherri Oslick --

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

Teva Pharmaceutical Industries Ltd. et al. v. Apotex, Inc. et al.
3:07-cv-04897; filed October 10, 2007 in the District Court of New Jersey

Declaratory judgment of infringement of U.S. Patent Nos. 6,699,997 ("Carvedilol," issued March 2, 2004), 6,710,184 ("Crystalline Solids of Carvedilol and Processes for Their Preparation," issued March 23, 2004), 7,056,942 ("Carvedilol," issued June 6, 2006), and 7,126,008 (same title, issued October 24, 2006) based on Apotex's filing of an ANDA to manufacture and sell a generic version of GSK's Coreg® (carvedilol, used to treat congestive heart failure).  View the complaint here.

Cornerstone BioPharma, Inc. et al. v. Vision Pharma, LLC et al.
5:07-cv-00389; filed October 8, 2007 in the Eastern District of North Carolina

Infringement of U.S. Patent No. 6,270,796 ("Antihistamine/Decongestant Regimens for Treating Rhinitis," issued August 7, 2001) based on defendants' manufacture and sale of VisRx, allegedly a "generic" version of Cornerstone's AlleRx® Dose Pack Products (used to treat allergies and symptoms of the common cold).  View the complaint here.

Celgene Corporation et al. v. Intellipharmaceutics Corp.
3:07-cv-04854; filed October 5, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), and 6,635,284 (same title, issued October 21, 2003), all licensed exclusively to Novartis in certain fields of use, following a paragraph IV certification as part of Intellipharmaceutics' filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Sanofi-Aventis et al. v. Mylan Pharmaceuticals Inc.
1:07-cv-00139; filed October 5, 2007 in the Northern District of West Virginia

Infringement of U.S. Patent Nos. 4,661,491 ("Alfuzosine Compositions and Use," issued April 28, 1987) and 6,149,940 ("Tablet with Controlled Release of Alfuzosine Chlorhydrate," issued November 21, 2000) following a paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Sanofi-Aventis' Uroxatral® (alfuzosin hydrochloride, used to treat benign prostatic hyperplasia).  View the complaint here.

Celgene Corporation et al. v. KV Pharmaceutical Company
2:07-cv-04819; filed October 4, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998) and 6,635,284 (same title, issued October 21, 2003) (both assigned to Celgene and licensed exclusively to Novartis in certain fields of use) following a paragraph IV certification as part of KV's filing of an ANDA to manufacture a generic version of Novartis' Ritalin® LA (methylphenidate hydrochloride extended release capsules, used to treat attention deficit hyperactivity disorder/attention deficit disorder).  View the complaint here.

Eli Lilly and Company v. Synthon Laboratories, Inc.
2:07-cv-00450; filed October 3, 2007 in the Eastern District of Virginia

Infringement of U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/ Hyperactivity Disorder," issued August 19, 1997) following a paragraph IV certification as part of Synthon's filing of an ANDA to manufacture a generic version of Lilly's Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder).  View the complaint here.

Adams Respiratory Therapeutics, Inc. et al. v. Perrigo Company et al.
1:07-cv-00993; filed October 2, 2007 in the Western District of Michigan

Infringement of U.S. Patent No. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002) following a paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Adams' Mucinex® (guaifenesin, used to treat chest congestion).  View the complaint here.

Conference & CLE Calendar

October 10-12, 2007 - Stem Cells European Business Summit - Edinburgh, Scotland

October 12, 2007 - Intellectual Property Law Summit 2007 (West LEGALWorks and Intellectual Property Law Association of Chicago) - Chicago, IL

October 16, 2007 - New Patent Rules Update: Implications of Compliance (World Research Group)

October 25-26, 2007 - Biotech and Pharma Public-Private Partnerships Forum (American Conference Institute) - Washington, D.C.***

October 25-27, 2007 - Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman (Patent Resources Group) - Palm Springs, CA

November 13-15, 2007 - Pharma and Biotech Collaborative Agreements (American Conference Institute) - New York, NY***

January 30-February 1, 2008 - Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NY***

***Patent Docs is a media sponsor of this conference or CLE.

ACI Pharma/Biotech IP Due Diligence Conference

American Conference Institute (ACI) will be holding the 5th National Conference on Pharma/Biotech IP Due Diligence: Your Complete Guide for M&As, Licensing, and Other Collaborations on January 30-31, 2008 in New York, NY.  The conference will provide information about current changes to patent practices, including patent reform efforts that have occurred in the courts, legislature, and U.S. Patent and Trademark Office.  In particular, ACI's faculty will offer presentations on the following topics:

• Factoring patent reform, PTO rulemaking, and new case law into due diligence analyses.
• Repositioning diligence strategies in light of recent court decisions.
• Reassessing the strength of the patent portfolio in light of the USPTO rules and the Patent Reform Act of 2007.
• Determining what diligence is due in light of new and increasingly complex multi-party transactions.
• Extracting from the diligence review the factors that will impact valuation.
• Drafting the checklist and selecting/managing the due diligence team based on the structure and business goals of the deal.
• Ferreting out the target's prior contractual obligations, licensing and third party obligations.
• What a company must know to prepare for the diligence review when approached by venture capitalists.
• Managing due diligence when dealing with industry/university collaborations and licenses.
• Evaluating the scope, validity, and enforceability of the target's patents.
• Protecting confidentiality, trade secrets, and attorney client privilege during a diligence review.
• Uncovering issues with ownership rights and Inventorship.
• Freedom to operate: Ensuring the purchaser/licensee has the right to commercialize the IP at issue.
• FDA regulation of small molecule drugs and biologics: Understanding how this affects the diligence review.
• The deliverable: Ascertaining and communicating the results of the analysis.

An additional master class entitled: "Drafting an Effective Due Diligence Report" will be offered on February 1, 2008.  The master class will provide strategies and solutions - as well as the advice and tools that practitioners need - to draft a comprehensive report of findings.

The agenda for the Pharma/Biotech IP Due Diligence conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee ranges from $1,995 (conference alone) to $2,595 (conference and master class).  Those registering on or before November 15, 2007 will receive a $200 discount off the registration fee.  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 sponsor of ACI's Pharma/Biotech IP Due Diligence conference.

Hooray! - (Finally) the Big Dogs Have Joined the Hunt

    By Kevin E. Noonan --

On October 9th, SmithKline Beecham Corp., SmithKline Beecham PLC, and Glaxo Group Ltd. (d/b/a/ collectively as GlaxoSmithKline) filed a verified complaint in the U.S. District Court for the Eastern District of Virginia against John Dudas and the U.S. Patent and Trademark Office, asking for preliminary and permanent injunctions staying implementation of the PTO's new continuation and claims rules entitled "Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably-indistinct Claims and Examination of Claims in Patent Applications; Final Rule" (New Rules).  The Complaint also asks the Court for a permanent injunction enjoining Defendants from issuing new regulations relating to the number of continuations, request for continuing examination (RCEs), or claims permitted in an application, to vacate the New Rules and declare them arbitrary, capricious, an abuse of agency discretion, contrary to law, constitutional right, power privilege or immunity, and in excess of the Office's statutory authority.  Writs of mandamus necessary to effectuate the Court's decision are also requested.

The Complaint asserts eight Counts supporting its prayer for relief:

1.  That the New Rules are ultra vires because the PTO lacks the statutory authority to issue substantive rules relating to continuations, RCEs, and claims;
2.  That the PTO "especially" lacks the authority to limit the number of continuation applications an applicant can file;
3.  That the New Rules are beyond the PTO's power because they are to be applied retroactively and change the legal consequences and prosecution strategies of already-filed applications;
4.  That the PTO lacks the authority to limit the number of claims an applicant can file in an application;
5.  That the New Rules limiting the number of continuing applications than can be filed are contrary to the Patent Act;
6.  That the PTO violated the provisions of the Administrative Procedures Act by violating the notice and comment provisions regarding the revised limitations on the number of claims filed in an application;
7.  That the New Rules are vague and fail to provide sufficient notice for GSK to comply with them;
8.  That the New Rules are an unconstitutional taking of GSK's patent and patent application property rights.

GSK addresses in its complaint some of the concerns that have been raised in discussions of legal action against the Office, including standing, ripeness, and irrevocable harm.  Regarding the standing issue, the Complaint asserts than GSK has identified more than 100 applications that have two or more continuations, and another 30 that have two or more continuations or continuation-in-part applications as well as at least 1 RCE, establishing that GSK is at risk for judicially-recognized injury.  As for whether the issue is ripe, the Complaint cites the two-part ripeness test of Abbott Labs., Inc. v. Gardner, 387 U.S. 136 (1967).  According to GSK, the issue is fit for judicial review and would pose a hardship on regulated parties.  The fitness prong is established as presenting the question of whether the New Rules exceed the PTO's statutory authority.  The Complaint alleges that the regulated parties would suffer the hardship of complying with the New Rules, requiring GSK "either to expend non-recoverable resources in complying with the potentially invalid regulation or to risk subjection to costly enforcement processes," citing Seegers v. Gonzales, 396 F.3d 1248, 1253 (D.C. Cir. 2005).  In this regard, GSK benefited from the assertions in the PTO's answer to the complaint in Tafas v. Dudas (see "Rules Challenger Amends Complaint and Withdraws PI Motion"), the only other effort to forestall implementation of the New Rules; the Complaint uses the Abbott standard to refute the Office's position on ripeness.  As it does at several points in the Complaint, included in the hardship is the loss of life-saving drugs that GSK will not be able to pursue in the absence of robust patent protection.

The Complaint cites the provisions of H.R. 1908, the patent "reform" act, that would amend Title 35 to add § 2(c)(6) to grant the PTO "the authority to promulgate regulations to insure the quality and timeliness of applications and their examination, including specifying circumstances under which an application for patent may claim the [priority] benefit under sections 120, 121 and 365(c) of the filing date of prior filed applications for patent" (see "Patent 'Reform' Bill Passes House of Representatives").  GSK further cites the provisions of the legislation requiring a 60-day review period during which Congress can pass a joint resolution of disapproval which would prevent the regulation from becoming effective, and the fact that the Senate bill (S. 1145) does not contain provisions granting such rulemaking authority to the PTO.  The Complaint contends that if the PTO had the authority it asserts in promulgating the New Rules this legislation would be unnecessary and redundant, and that the disapproval provisions indicate that Congress has not, and is not contemplating granting unlimited authority to the PTO to change provisions of substantive law.  The PTO's actions in promulgating the New Rules is characterized in the complaint as an attempt to bypass the political process and overstepping the authority granted to it by Congress.

Interestingly, the Complaint alleges that the examination support document provisions of 37 C.F.R. § 1.265 are impermissibly vague and fail to put GSK on notice of how to comply with the regulation, because the rule does not define the metes and bounds of the extent of the search required, whether electronic or manual searches are required, whether these searches be limited to domestic databases or ones in other countries, and what libraries must be searched for non-patent art.  This objection is important not only as it applies to the New Rules that the Office has promulgated, but in view of the provisions of the House bill that grant the Director the authority to require searching and other prior art information in all applications.

The Complaint also identifies as a "regulatory 'trap'" the provisions of the New Rules that purport to provide additional continuation applications and claims upon the filing of a petition and a showing.  This portion of the Complaint is important because it addresses the counter-allegations of the Office that it has not abridged any substantive rights.  The Complaint alleges that the petition and showing provision set forth in the New Rules is an illusion, since the requirement that the amendment, evidence, or argument "could not have been" earlier presented is interpreted by the Office to require that the earlier submission was "physically impossible," a standard impossible to meet.  The Complaint also alleges that the mere submission of such a petition would put a practitioner at risk under the Office's ethical proscriptions against filing false statements.

The Complaint provides extensive supporting information for the Court, including the economic costs of drug discovery investment and how that investment is put in jeopardy by the New Rules, the reduction in drug discovery and development that the New Rules will induce, and the harm brought upon the public as a consequence.  (Indeed, the Complaint identifies protecting the public health as "[t]he highest public interest.")  Included in the Complaint is a review of Congressional and Court sanction of unlimited continuing application practice, and prior court rejection of the PTO's assertion of the power to restrict an applicant from filing an unlimited number of continuing applications under the patent statute.  The lack of Congressional intent that the Office have the authority they assert under the New Rules is evidenced by the failure to pass legislation in 2005 granting that authority to the PTO.

There are two additional aspects of the complaint.  First, the complaint was filed as a Verified Complaint, that is, it was sworn to under penalty of perjury by Sherry M. Knowles Senior Vice President and Global Head of Corporate Intellectual Property of GSK.  Second, the complaint was sent to John Dudas (at left) over a cover letter inviting the Office to discuss the merits and (presumably) delay implementation of the New Rules until these discussions could take place.

After a protracted (and perhaps stunned) silence following publication of the New Rules (see "Breaking A Very Long Silence"), those parties whose interests are most threatened by the New Rules are beginning to act.  In addition to this Complaint, reliable sources have informed Patent Docs that efforts are continuing before the Office of Management and Budget (OMB), particularly in view of the contradiction between the Office's representation that the New Rules would not have "significant economic impact" and the evidence, provided by the Intellectual Property Owners (IPO) and others (see "Is the Patent Office Starting to Blink?") that compliance with even the reporting provisions of the New Rules will be accompanied by significant costs (perhaps even as "clarified" by the PTO yesterday; see "USPTO Issues Notice to 'Clarify' Certain Provisions of the New Rules").  In view of the evident disdain the Patent Office has shown toward patent owners and the patent bar throughout the rulemaking process, experience suggests that additional efforts by even more important actors should be brought to bear if there is any hope that the New Rules will not be implemented.

For additional information regarding specific provisions of the New Rules, please see:

• "USPTO Issues Notice to 'Clarify' Certain Provisions of the New Rules," October 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(a)(2): Divisional Dilemma?" October 9, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142(c): Increasing the Chances of Submitting a Successful Suggested Restriction Requirement (SRR)," October 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.145: "Provoking a Restriction Requirement," October 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1)(i) & (vi): PCT Practice," September 23, 2007
• "An Analysis of the New Rules: USPTO Releases ESD Guidelines," September 17, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
• "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
• "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

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

• "Changes to New Rules to Be Published in Early November," October 11, 2007
• "'Impact' of New Continuation and Claims Rules," October 8, 2007
• "Is the Patent Office Starting to Blink," October 5, 2007
• "Breaking A Very Long Silence," October 1, 2007
• "It Ain't Necessarily So," September 28, 2007
• "Commissioner Doll Addresses ACI Biotech Patents Conference," September 26, 2007
• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

CAFC Reissues Opinion Affirming Denial of PI to Force Interim Patent Term Extension as Precedential

Somerset Pharm., Inc. v. Dudas (Fed. Cir. 2007) (reissued as precedential)

    By Sherri Oslick --

The Federal Circuit has now reissued its earlier Somerset opinion as precedential; a summary of the original, non-precedential opinion can be found in our earlier post here.  In view of the CAFC's recent reissue of the identical opinion as precedential, a brief revisit is in order.

Somerset had applied for a patent term extension on U.S. Patent No. RE34,579, covering methods of using Emsam®, a transdermal patch containing selgline, to treat depression.  Six months prior to the expiration date of the patent, with no ruling yet on their original patent term extension application, Somerset applied for an interim patent term extension, a discretionary solution where a patent expiration is imminent.  One month later, Somerset filed suit in the District Court of Delaware to compel the Director to act on - and to grant - the interim extension.  Somerset also moved for a preliminary injunction for the same relief.  The District Court denied the preliminary injunction and Somerset appealed.

While on appeal and prior to briefing, both Somerset's application for interim patent extension, as well as their original application for extension, were denied.  Somerset withdrew its appeal as moot insofar as it pertained to compelling the Director to act on the application for interim extension, but moved forward with the appeal as it pertained to compelling the Director to grant the request for interim extension.

The CAFC affirmed the District Court's denial of the PI based on the inability of Somerset to show reasonable likelihood of success on the merits.  The statute authorizing interim patent term extension, reasoned the CAFC, only provided for such an extension where a certificate of extension could not be granted or denied prior to expiration of the patent.  Because Somerset's certificate has already been denied, a petition for interim patent term extension was not statutorily authorized and as such, Somerset had no reasonable likelihood of success.

Changes to New Rules to Be Published in Early November

    By Donald Zuhn --

Yesterday, we reported on the Patent Office's release of a pre-OG notice describing four significant changes to the new continuation and claims rules.  Those wondering when the changes would be published in the Official Gazette (OG) did not have to wait long.  In a USPTO e-Commerce e-Alert notice sent to EFS-Web users today, Commissioner of Patents John Doll stated that the clarifications to the new rules would be published in the Official Gazette on November 6, 2007.

Commissioner Doll also took the opportunity to "remind" recipients of the e-mail notice that the new continuation and claims rules would go into effect on November 1, 2007.  In what has become a routine refrain, the Commissioner concluded by acknowledging the "significant role" applicants and their representatives play "in providing the USPTO with quality applications which allow examiners to provide better quality examinations resulting in high quality patents."

USPTO Issues Notice to "Clarify" Certain Provisions of the New Rules

    By Jason Derry* and Donald Zuhn --

The U.S. Patent and Trademark Office has made four significant changes to the new continuation and claims rules, which appear to ease at least some of the new burdens applicants are now facing as the effective date of the new rules approaches.  In particular, the changes apply to:

(1)  The "one more" continuing application provision (see 72 Fed. Reg. 46,717);
(2)  The CIP identification requirement of 37 C.F.R. § 1.78(d)(3);
(3)  The identification requirement of 37 C.F.R. § 1.78(f)(1); and
(4)  The meaning of the term "examined" in 37 C.F.R. § 1.78(d)(1)(ii)(B).

The full explanation of the changes can be found here.  The practical effects of these changes are described below:

(1)  The "one more" continuing application provision set forth in the new rules notice (see 72 Fed. Reg. 46,717) allows an applicant who has filed two or more continuation or continuation-in-part applications of an initial application before August 21, 2007 to file "one more" continuing application on or after August 21, 2007 without submitting a petition and showing.

In today's notice, the Patent Office acknowledged a not so minor problem with the "one more" provision, whereby an applicant could turn a proper "one more" continuing application into an improper one by simply filing a continuing application that satisfies Rule 78(d)(1)(ii), (iii), or (vi) after November 1, 2007.  In particular, because the "one more" provision requires that there be "no other application filed on or after August 21, 2007 that also claims the benefit under 35 U.S.C. 120, 121, or 365(c) of [priority applications filed before August 21, 2007]," a proper divisional application, for example, which claims the benefit of such prior-filed applications would destroy the benefit claim of the "one more" continuing application.

To eliminate this unintended consequence of the "one more" provision, the Patent Office has suspended the provisions of Rule 78(d)(1), pursuant to Rule 183, to the extent that a continuing application that satisfies the conditions set forth in Rule 78(d)(1)(ii), (iii), or (vi) would have been considered an "other application filed on or after August 21, 2007 that also claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such prior-filed nonprovisional applications or international applications.'"

(2)  For CIP applications pending before November 1, 2007 in which a first Office Action on the merits has been mailed before November 1, 2007, applicants DO NOT have to comply with 37 C.F.R. § 1.78(d)(3).  Thus, in these situations, applicants do not have to identify the claim or claims in the CIP that are supported by the prior application, unless specifically asked to do so by an Examiner pursuant to 37 C.F.R. § 1.105(a)(1)(ix).

Applicants still must identify support in the prior application in CIP applications where a first Office Action on the merits has not been mailed before November 1, 2007.  However, the date for compliance with this requirement is now February 1, 2008 (previously, the new rules notice was silent as to any compliance date).

(3)  For applications filed before November 1, 2007, the Patent Office is waiving the "within two months" provision in 37 C.F.R. § 1.78(f)(1)(i)(A), which required applicants to identify commonly-owned applications and patents having a filing or priority date within two months of a subject application.  Therefore, applicants no longer have to worry about scouring their patent portfolios for pending applications and issued patents that happen to be commonly owned, have a common inventor, and have a filing or priority date that, while not the same, falls within a two month window.  It is important to note that applicants must still identify commonly-owned applications or patents sharing a common inventor which have the same filing or priority date as the subject application.

In addition, the Patent Office is also waiving the "within two months" provision in certain instances for applications filed on or after November 1, 2007.  While the intent of the Office may have been to simplify the identification requirement, the provision for applications filed on or after November 1, 2007 is anything but simple.  In particular, the PTO notice states that under the new version of the new rule, applicants are:

not required to identify any other pending or patented application that has an actual filing date or benefit or priority filing date before November 1, 2007, unless: (1) the subject application has a benefit or priority filing date that is the same as the actual filing date or the benefit or priority filing date of the other application; or (2) the subject application has an actual filing date or benefit or priority filing date on or after November 1, 2007 that is the same as or within two months of the actual filing date or the benefit or priority filing date of the other application.

In other words, for subject applications filed on or after November 1, 2007, an applicant need only identify (1) applications and patents having a filing or priority date that is the same as a priority date of the subject application, when the subject application's priority date is before November 1, 2007, or (2) applications and patents having the same filing or priority date OR a filing or priority date that falls within two months of the subject application's filing or priority date, when the subject application's filing or priority date is on or after November 1, 2007 [NOTE: This paragraph has been updated since this article was originally posted.]

(4)  Finally, it appears that the Patent Office has finally resolved an issue that has caused a recent uproar in the patent community.  As discussed in this space yesterday (see "An Analysis of the New Rules: 37 C.F.R. § 1.78(a)(2): Divisional Dilemma?"), the Patent Office's interpretation of the phrase "examined in any prior-filed application" in Rule 78(a)(2) - as well as in Rule 78(d)(1)(ii)(B) - created (perhaps) a situation in which applicants would have to file all of their divisional applications before November 1, 2007 if an International application and Demand had been previously filed on the claim set.  As we reported, even Commissioner Doll was stumped by the effect of this rule on an applicant's ability to file proper divisional applications on or after November 1, 2007 (see "It Ain't Necessarily So").

With respect to the Patent Office's revised interpretation of the term "examined," the notice states that:

The term “examined” in 37 CFR 1.78(d)(1)(ii)(B) does not include the international phase examination under PCT Article 31 that occurs as a result of the filing of a Demand for international preliminary examination.  Therefore, if an applicant files an initial application which is an international application designating the U.S. and the International Searching Authority determines that the international application lacks unity of invention under PCT Rule 13, the filing of a Demand and the examination of all the inventions in Chapter II would not preclude the applicant from filing a divisional application for each invention not elected for examination in the application after entry into the national stage, assuming that such divisional application or applications otherwise meet the conditions set forth in 37 CFR 1.78(d)(1)(ii).

The Patent Office has indicated that the relevant questions added to its Frequently Asked Questions on September 26, 2007 (i.e., C8 and C11) will be revised accordingly.  [In fact, the Office has already revised the responses to questions C8 and C11.]

While the Patent Office's new interpretation of "examination" provides some relief to anxiety-stricken applicants who have been debating whether to file a boatload of divisional applications before November 1st, the new interpretation does seem to conflict with the express language of Rule 78(a)(2), which precludes the filing of a divisional application where an invention or inventions has been "subject to a requirement to comply with the requirement of unity of invention under PCT Rule 13" (and where the other three requirements of Rule 78(a)(2) have been met).  [Rule 78(d)(1)(ii)(B) contains a similar requirement.]

For additional articles in this series, please see:

• "An Analysis of the New Rules: 37 C.F.R. § 1.78(a)(2): Divisional Dilemma?" October 9, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142(c): Increasing the Chances of Submitting a Successful Suggested Restriction Requirement (SRR)," October 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.145: "Provoking a Restriction Requirement," October 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1)(i) & (vi): PCT Practice," September 23, 2007
• "An Analysis of the New Rules: USPTO Releases ESD Guidelines," September 17, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
• "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
• "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

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

• "'Impact' of New Continuation and Claims Rules," October 8, 2007
• "Is the Patent Office Starting to Blink," October 5, 2007
• "Breaking A Very Long Silence," October 1, 2007
• "It Ain't Necessarily So," September 28, 2007
• "Commissioner Doll Addresses ACI Biotech Patents Conference," September 26, 2007
• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

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

Patent Office Issues Examination Guidelines Regarding Obviousness after KSR

    By Kevin E. Noonan --

The U.S. Patent and Trademark Office promulgated today its long-awaited guidelines for Examiners in making obviousness determinations in view of the U.S. Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc.

The guidelines generally follow the Patent Office's public comments on the decision (see "The Patent Office Reacts to KSR: A First Look"), to the effect that KSR merely reinforced the primacy of the analytical framework provided in the Supreme Court's Graham v. John Deere Co. decision.  This analysis remains, as the Office contends it always has been, the proper basis for an Examiner's obviousness determinations.

One important feature of the guidelines, however, is an explicit requirement that an Examiner provide articulated reasons for the factual determinations underlying an asserted prima facie case of obviousness.  This focus is consistent with the rule set down in the KSR decision that a factfinder must provide "reasons" why an invention would have been obvious to one of ordinary skill in the art.  In explicating this aspect of the Supreme Court's decision, the Notice sets forth the following "rationales" for asserting an obviousness rejection, and sets forth explicit factual findings that an Examiner must articulate to support an obviousness rejection made using any of these rationales:

(A) Combining prior art elements according to known methods to yield predictable results;

(1) a finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference;

(2) a finding that one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely would have performed the same function as it did separately;

(3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable; and

(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

(The fourth "prong" is a "catch-all" provision contained in all the rationales.)  This rationale is illustrated by the factual posture of Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57 (1969) and in Ruiz v. A.B. Chance Co., 357 F.3d 1270 (Fed. Cir. 2004).  The Notice cites KSR for the proposition that, under this rationale, ''it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does."  But this rationale also notes that unexpected results can be used to overcome a prima facie case of obviousness on these fact patterns, citing U.S. v. Adams, 383 U.S. 39, 51-52 (1969).

(B) Simple substitution of one known element for another to obtain predictable results;

(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;

(2) a finding that the substituted components and their functions were known in the art;

(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and

(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

This rationale is illustrated by the factual posture of In re Fout, 675 F.2d 297 (C.C.P.A. 1982); In re O'Farrell, 853 F.2d 894 (Fed. Cir. 1988); Ruiz v. A.B. Chance Co. 357 F.3d 1270 (Fed. Cir. 2004); and Ex parte Smith, 83 U.S.P.Q.2d 1509 (B.P.A.I. 2007).  Proper application of this rationale in finding obviousness is that "the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention."

(C) Use of known technique to improve similar devices (methods, or products) in the same way;

(1) a finding that the prior art contained a ''base'' device (method, or product) upon which the claimed invention can be seen as an ''improvement;''

(2) a finding that the prior art contained a ''comparable'' device (method, or product that is not the same as the base device) that was improved in the same way as the claimed invention;

(3) a finding that one of ordinary skill in the art could have applied the known ''improvement'' technique in the same way to the ''base'' device (method, or product) and the results would have been predictable to one of ordinary skill in the art; and

(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

This rationale is illustrated by the factual posture of In re Nilssen, 851 F.2d 1401 (Fed. Cir. 1988) and Ruiz v. A.B. Chance Co. 357 F.3d 1270 (Fed. Cir. 2004).  This rationale requires that the prior art teach:

a method of enhancing a particular class of devices (methods, or products) [that] was made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations.  One of ordinary skill in the art would have been capable of applying this known method of enhancement to a 'base' device (method, or product) in the prior art and the results would have been predictable to one of ordinary skill in the art.

(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;

(1) a finding that the prior art contained a ''base'' device (method, or product) upon which the claimed invention can be seen as an ''improvement;''

(2) a finding that the prior art contained a known technique that is applicable to the base device (method, or product);

(3) a finding that one of ordinary skill in the art would have recognized that applying the known technique would have yielded predictable results and resulted in an improved system; and

(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

This rationale is illustrated by the factual posture of Dann v. Johnston, 425 U.S. 219 (1976) and In re Nilssen, 851 F.2d 1401 (Fed. Cir. 1988).  The Notice defines the terms "base device," "known technique," and "improved system" with regard to this rationale.  In applying this rationale to specific facts, a particular known technique that was recognized by one of ordinary skill in the art can be considered "as part of the ordinary capabilities" of the skilled worker.  Thus, if the worker of ordinary skill would have been able to apply the known technique to a known "device" (a method or product) that was "ready for improvement" and yielded a predictable result, the resulting invention would have been obvious.

(E) ''Obvious to try'' - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;

(1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;

(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;

(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and

(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

This rationale is illustrated by the factual posture of Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007); Alza Corp. v. Mylan Laboratories, Inc., 464 F.3d 1286 (Fed. Cir. 2006); and Ex parte Kubin, 83 U.S.P.Q.2d 1410 (B.P.A.I. 2007) (Patent Docs will have more on the latter application of the rule in a related post).  Citing KSR, the Notice requires for this rationale that an Examiner articulate facts supporting the conclusion that:

a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art;

(1) a finding that the scope and content of the prior art, whether in the same field of endeavor as that of the applicant's invention or a different field of endeavor, included a similar or analogous device (method, or product);

(2) a finding that there were design incentives or market forces which would have prompted adaptation of the known device (method, or product);

(3) a finding that the differences between the claimed invention and the prior art were encompassed in known variations or in a principle known in the prior art;

(4) a finding that one of ordinary skill in the art, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable to one of ordinary skill in the art; and

(5) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

This rationale is illustrated by the factual posture of Dann v. Johnston, 425 U.S. 219 (1976); Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007); Ex parte Catan, 83 U.S.P.Q.2d 1569 (B.P.A.I. 2007); and KSR Int'l Co. v. Teleflex Inc. itself.  The Examiner must articulate facts supporting the existence of "design incentives or other market forces could have prompted one of ordinary skill in the art to vary the prior art in a predictable manner to result in the claimed invention."

(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.

(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings;

(2) a finding that there was reasonable expectation of success; and

(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

This, of course, is a recapitulation of the Federal Circuit's "teaching-suggestion-motivation" test, supplemented with the Graham-derived catch-all provision this rationale shares with all the rest.  The Notice cites DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006), for the application of this rationale where the "motivation" is "technology-independent," such as the "desire to enhance commercial opportunities" by making a product or process "stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient," calling this motivation "universal" and "almost common-sensical."

The guidelines impose these enumerated requirements on Examiners to provide the articulated reasons set forth above when making the factual findings relating an obviousness determination.  The guidelines also remind Examiners of the requirements of 37 C.F.R. 1.111(b) that applicants rebut these factual determinations by "distinctly and specifically point[ing] out the supposed errors in the Office's action and reply to every ground of objection and rejection in the Office action," as well as the burden to "present arguments pointing out the specific distinction believed to render the claims patentable over any applied references."  Applicants evidence can include factual evidence that "(1) one of ordinary skill in the art could not have combined the claimed elements by known methods (e.g., due to technological difficulties); (2) the elements in combination do not merely perform the function that each element performs separately; or (3) the results of the claimed combination were unexpected," as well as evidence relating to the secondary considerations enunciated in Graham (long-felt need, commercial success, and failure of others).  The Examiner must then reconsider the question of non-obviousness in light of all the evidence of record.

The guidelines generally comport with the Office's assertions in the immediate wake of the KSR decision that its obviousness determinations were "business as usual," "status quo," and had always been based on the Graham factors.  Although this stance was belied by the perceived need to promulgate explicit guidelines to inform Examiners to continue what was purportedly their conventional practice, the guidelines generally remain true to the conventional Graham analysis, supplemented when necessary by the Federal Circuit's TSM test.  Clearly gone from the analysis is the traditional assertion that an obviousness determination would be deficient merely because it was not supported under the TSM analysis.  This result was not dependent on these new guidelines, however; the Office's position in this regard has been clear for months, as evidenced by this excerpt from the prosecution history of U.S. Patent Application No. 11/436775:

[I]n response to Applicant's argument that the references do not provide that a specific teaching, suggestion, or motivation to support a finding of obviousness, KSR forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness.  See the recent Board decision Ex parte Smith, USPQ2d, slip op. at 20 (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR International Co. v. Teleflex Inc. (KSR), 82 USPQ2sd at 1396).

The ultimate impact of the Supreme Court's KSR decision will only be evident after Examiners have had a chance to apply the guidelines to actual claims.  Whether KSR evinces a sea change in how the Office determines obviousness will depend in large part on the extent to which Examiners are required to provide articulated reasons for the factual determinations that are not explicitly required.

For additional information regarding the new guidelines, please see:

• Examination Guidelines for Determining Obviousness under 35 U.S.C. 103 in View of the Supreme Court Decision in KSR International Co. v. Teleflex Inc., 72 Fed. Reg. 57,526 (2007)
• USPTO Press Release

An Analysis of the New Rules: 37 C.F.R. § 1.78(a)(2): Divisional Dilemma?

    By Donald Zuhn --

On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice regarding the new rules, the Patent Office's nearly two hour webcast on August 23, 2007 (and the webcast's accompanying 113-page presentation), and the Office's 63-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.

37 C.F.R. § 1.78(a)(2):

Recently, we discussed an aspect of the new continuation and claims rules that even had the Commissioner of Patents initially stumped (see "It Ain't Necessarily So").  In particular, Commissioner John Doll (at left), when speaking at the ACI Biotech Patents Conference last month, informed the audience that an examination during International phase did not constitute an "examin[ation] in any prior-filed application" under Rule 78(a)(2).  The next day, the Commissioner reversed course by acknowledging that he had been mistaken.  That same day, the Patent Office added two new questions (C8 and C11) that somewhat addressed the situation to its "Frequently Asked Questions" document.

Commissioner Doll's initial reply came in response to the following hypothetical:  an applicant files an International application and a U.S. nonprovisional, which presumably contain the same claim set, and which claim the benefit of the same provisional; the applicant files a Chapter II Demand in the International application; and the applicant receives a Restriction Requirement in the nonprovisional application.  Ultimately, the Commissioner stated that the applicant would not be permitted to file a "proper" divisional application off of the nonprovisional application because the claims - despite being restricted by a U.S. Examiner in the nonprovisional application - had been examined in the International application as a result of the applicant's filing of a Demand.  Thus, the claims of the divisional application would contravene the prohibition in Rule 78(a)(2) that the claims in a divisional "not [be] examined in any prior-filed application."

Depending on the particular circumstances, the Patent Office's interpretation of Rule 78(a)(2) could create some rather bizarre outcomes.  For example, if an applicant sought examination of the International application in Europe, the European Examiner and the U.S. Examiner could take entirely different positions with respect to the restriction of the same claim set, but the European Examiner's position would trump the U.S. Examiner's position.

Potentially more troubling would be a situation in which the European Examiner finds that "there is a technical relationship among [a group of inventions claimed in a single international application] involving one or more of the same or corresponding special technical features," and therefore, determines that the requirement of unity of invention has been fulfilled (see Rule 13 of Patent Cooperation Treaty), but the U.S. Examiner determines that restriction is necessary in the nonprovisional application.  [We note that one comment submitted in response to the Patently-O article "Rule Changes Triage" raises this issue.]  Is the applicant still precluded from filing a divisional application off of the nonprovisional application?  If so, would the applicant also be precluded from pursuing claims to independent and distinct inventions in the nonprovisional application because such claims would be directed to non-elected inventions, or would the applicant have to use a valuable continuation application to secure such claims?  What if the Examiner restricted the claims into more than three inventions?  What if the applicant only had "one more" continuation left in the application family?

As with many of the new rules, Rule 78(a)(2) - and the Patent Office's interpretation of this rule - raise questions for which there do not seem to be any easy answers.  So what should applicants do before November 1, 2007 to protect themselves?  [As we noted in our previous article, for International applications that have not yet been filed, or which have only recently been filed, applicants would be wise not to file a Demand.]

Assuming that the mere filing of a Demand creates the problem described above, an applicant could file a divisional application covering each independent and distinct invention before November 1, 2007.  By doing so, the potential problems created by Rule 78(a)(2) could be avoided, since this rule only applies to applications filed on or after November 1, 2007 (see 72 Fed. Reg. 46716).

However, is the mere filing of a Demand sufficient to create the problem described above?  Rule 78(a)(2) appears to specify four requirements for a "proper" divisional application:

(1) the application must "disclose[] and claim[] only an invention or inventions that were disclosed and claimed in a prior-filed application,"
(2) the invention or inventions must have been "subject to a requirement to comply with the requirement of unity of invention under PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121 in the prior-filed application,"
(3) the invention or inventions "were not elected for examination," and
(4) the invention or inventions "were not examined in any prior-filed application."

Only the last requirement would seem to be related to the filing of the Demand.  With respect to the second requirement, M.P.E.P. § 1850(V) states that:

The search fee which the applicant is required to pay is intended to compensate the International Searching Authority for carrying out an international search (and for international applications having a filing date on or after January 1, 2004, for preparing a written opinion), but only where the international application meets the "requirement of unity of invention".  That means that the international application must relate to only one invention or must relate to a group of inventions which are so linked as to form a single general inventive concept (PCT Articles 3(4)(iii) and 17(3)(a)).

If the International Searching Authority finds that the international application does not comply with the requirement of unity of invention, the applicant will be informed of the lack of unity of invention by a communication preceding the issuance of the international search report (and for international applications having a filing date on or after January 1, 2004, a written opinion of the International Searching Authority), which contains an invitation to pay additional search fees.  (Form PCT/ISA/206 or USPTO/299 (telephone practice), see below).  This invitation specifies the reasons the international application is not considered to comply with the requirement of unity of invention, identifies the separate inventions, and indicates the number of additional search fees and the amount to be paid (PCT Rules 40.1, 40.2(a) and (b)).

Thus, one could argue that if an applicant did not receive an invitation to pay additional search fees, the invention claimed in a divisional application (and disclosed and claimed in a prior-filed International application) had not been "subject to a requirement to comply with the requirement of unity of invention under PCT Rule 13."  Moreover, one could also argue that in the absence of such an invitation, the applicant could not have made a decision to pay (or not pay) additional fees, and therefore, did not satisfy the third requirement of Rule 78(a)(2), i.e., not having elected the invention claimed in the divisional application.

Therefore, with respect to divisional applications filed off claim sets that have been presented in International applications in which a Demand was filed, the new rules present applicants with a choice:

(1) play it safe and file your divisional applications before November 1, 2007, or
(2) rely on an interpretation of Rule 78(a)(2) that excludes International applications in which (a) no invitation to pay additional search fees was issued, (b) additional search fees were not paid (and thus, only one invention was examined), OR (c) a Demand was not filed, and file your divisional applications after November 1, 2007.

As always, we would appreciate your comments regarding this potential new rules dilemma.

For additional articles in this series, please see:

• "An Analysis of the New Rules: 37 C.F.R. § 1.142(c): Increasing the Chances of Submitting a Successful Suggested Restriction Requirement (SRR)," October 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.145: "Provoking a Restriction Requirement," October 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1)(i) & (vi): PCT Practice," September 23, 2007
• "An Analysis of the New Rules: USPTO Releases ESD Guidelines," September 17, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
• "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
• "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

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

• "'Impact' of New Continuation and Claims Rules," October 8, 2007
• "Is the Patent Office Starting to Blink," October 5, 2007
• "Breaking A Very Long Silence," October 1, 2007
• "It Ain't Necessarily So," September 28, 2007
• "Commissioner Doll Addresses ACI Biotech Patents Conference," September 26, 2007
• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don't Get It - 'Patent Reform' at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

Changes to Rule 78(a)(2):

(a) Definitions --

(1) Continuing application. A continuing application is a nonprovisional application or an international application designating the United States of America that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed nonprovisional application or international application designating the United States of America. An application that does not claim the benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed application is not a continuing application even if the application claims the benefit under 35 U.S.C. 119(e) of a provisional application, claims priority under 35 U.S.C. 119(a)- (d) or 365(b) to a foreign application, or claims priority under 35 U.S.C. 365(a) or (b) to an international application designating at least one country other than the United States of America.

(2) Divisional application. A divisional application is a continuing application as defined in paragraph (a)(1) of this section that discloses and claims only an invention or inventions that were disclosed and claimed in a prior-filed application, but were subject to a requirement to comply with the requirement of unity of invention under PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121 in the prior-filed application, and were not elected for examination and were not examined in any prior-filed application.

(3) Continuation application. A continuation application is a continuing application as defined in paragraph (a)(1) of this section that discloses and claims only an invention or inventions that were disclosed in the prior-filed application.

(4) Continuation-in-part application. A continuation-in-part application is a continuing application as defined in paragraph (a)(1) of this section that discloses subject matter that was not disclosed in the prior-filed application.

GSK and Anacor to Collaborate

    By Jason Derry --

Anacor Pharmaceuticals and GlaxoSmithKline have announced an agreement relative to discovery, development, and commercialization of therapeutics for viral and bacterial diseases.  Anacor develops small molecule therapeutics based on a boron chemistry platform.  The agreement provides GlaxoSmithKline the option to select up to four targets for drug candidate development, with further options to select up to eight targets.  Under the terms of the agreement, Anacor will develop certain boron-based drug candidates, and GlaxoSmithKline will have the option to license the candidates for further development.  GlaxoSmithKline will also receive exclusive, worldwide rights for commercialization of the selected candidates.  Anacor has the option to develop any of the candidates not selected by GlaxoSmithKline.  The agreement also provides that Anacor will receive $12 million upfront and a commitment of $10 million equity financing from GlaxoSmithKline.  Each licensed candidate could be worth up to $331 million for Anacor if certain milestones are reached.

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

"Impact" of New Continuation and Claims Rules

Patent Docs received an e-mail today that contained some interesting information about the impact the new continuation and claims rules might have had if only the Patent Office had promulgated the new rules a "little earlier."  We were unable to identify the author online, so if you know who originally penned these two paragraphs, please let us know [UPDATE: We have been informed that the authors of this piece are Gregory E. Upchurch of LegalMetric, LLC and Bryan K. Wheelock of Harness, Dickey & Pierce, PLC; Additional UPDATE: We just received a copy of LegalMetric's e-mail, which can be obtained here].  In addition, due to the number and age of the patents described in the piece, we were unable to confirm the accuracy of the figures presented [UPDATE: A table of the authors' analysis is available for download at the LegalMetric's webpage or here].

As most of you know the new Patent Office rules will take effect November 1st.  Before the new rules, one New Jersey inventor amassed 394 patents with more than 5 independent claims, 21 of which had more than 25 total claims.  This will be prohibited by new 37 CFR 1.75(b)(1).  Furthermore, this same inventor slid by without filing any of the 7,326 separate statements about co-pending applications that will now be required by 37 CFR 1.78(f)(1)(i), or any of the 243 terminal disclaimers under 37 CFR 1.78(f)(2)(ii)(A) or explanations under 37 CFR 1.78(f)(2)(ii)(B) for the applications filed on the same day with the exact same title.  This inventor obtained more than three patents with identical titles 67 times - once obtaining 37 different patents with the exact same title, with a total of 188 claims.  286 times he obtained patents with the same titles with more than 15 total independent claims, and 53 times he obtained patents with the same titles with more than 75 total claims, which would now be nearly impossible under 37 CFR 1.75(b)(1).

THANK GOODNESS that the Patent Office has put a stop to the likes of Thomas Alva Edison.  What would become of us if we had more like him?

These figures don't include applications Edison filed that did not issue, or the rejected claims in the patents that did issue.  Even with a lot more work, Edison probably could not have obtained equivalent protection.  Because he violated the 5/25 rule on at least 394 occasions, he would have had to file and prosecute at least that many more applications.  He also would have had to file 7,326 statements under 1.78(f)(1), as many as 72 on a single day, and 243 terminal disclaimers under 37 CFR 1.78(f)(2)(ii)(A) or explanations under 37 CFR 1.78(f)(2)(ii)(B).  He doubtless would have lost at least some of his protection in the 67 instances where he had four or more patents with the same title, and in the 286 patents in patent families where the total number of independent claims exceeded 15, and in the 53 patents in patent families where the total number of claims exceeded 75.  Destroying the incentive to invent such trifles as the electric lamp, the stock ticker, the phonograph, movies is a small price to pay for the convenience of the Patent and Trademark Office.

Undoubtedly the Patent and Trademark Office will now remove the 2,108 references on its web site to Edison, now that it has identified him as a serial patent abuser.

For a copy of the spreadsheet from which these figures were obtained, go to www.legalmetric.com and click on Edison Patent Spreadsheet under Resources.

The True Tragedy of the Anti-Commons

    By Kevin E. Noonan --

The term "the tragedy of the anti-commons" assumed a cache of avant-garde radicalism since its coining by Heller and Eisenberg in 1998.  That cache was less alluring the more the listener knew of either patent law or academic science practices, but it certainly attracted "progressive" pundits and policymakers and supported the idea that the U.S. patent system was somehow "broken."

There has been precious little evidence for any tragedy, as evidenced by a report in Nature Biotechnology last year (see "The 'Anti-Commons' Aren't So Tragic, After All").  More recently, Ronald Bailey of Reason magazine posted an article updating the evidentiary status of the tragedy (see "The Tragedy of the Anticommons: Do Patents Actually Impede Innovation?").  And as Patent Docs reported last year, there isn't much of a tragedy after all.  Mr. Bailey cites the Nature Biotechnology report, as well as other studies by the National Academy of Science.  In a 2003 study, the Academy found that drug discovery had not been "substantially impeded" by patent proliferation in the area (see "Effects of Research Tool Patents and Licensing on Biomedical Innovation").  Moreover, the report found little evidence that use of research tools had been negatively affected.  A more recent Academy study found that the number of projects abandoned or delayed was "extremely small" (see "Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health").  Indeed, the more common reasons for project abandonment or delay included "lack of funding, conflict with other priorities, a judgment that the project was not feasible, not scientifically important, or not that interesting, and the perception that the field was too crowded with competing investigators," i.e., the traditional concerns of the academic scientist (not the unrealistically altruistic scientific shaman conjured by those trying to use such a chimera to support their efforts to restrict patenting).

This year, a report by the Association for the Advancement of Science (AAAS), entitled "International Intellectual Property Experiences: A Report of Four Countries" provided a survey of the experiences of thousands of scientists in the U.S., Europe (Germany and the U.K.), and Japan with regard to "acquiring, using, or creating" intellectual property.  Again, little evidence of anticommons tragedies were reported, and according to Stephen Hansen, the director of the AAAS study, "[a]ll four studies suggest that intellectual property rights had little negative impact on the practice of science."

Researchers into the anticommons tragedy are catching on.  As Mr. Bailey reports, "[i]t is interesting that we rarely, if ever, hear from the researchers themselves about these issues.  The issues have been brought to public attention instead by academic lawyers, sociologists and economists," noted Hansen.  What has happened is that a handful of cases - including Myriad Genetics BRCA1/BRCA2 breast cancer diagnostic test and the Cavanan lawsuit brought by Chicago attorney Lori Andrews - have been used extensively in the popular press to create a false impression that the anticommons problem is systemic and widespread, when in fact it is not.  Mr. Bailey's report notes that the impetus for patent "reform" stems mostly from the information technology sector, as a consequence of the differences in investment costs, obsolescence timing, and "patent thicket" propensities of that industry.  Even in this arena the evidence is that there is no anticommons tragedy, as reported by workers at the London School of Economics (see "Strategic Patenting and Software Innovation").  Citing the study, these authors report that "expansion of patentability over software during the 1980s and early 1990s was not associated with any major changes in R&D investment" by software innovator firms.  This evidence has not prevented other authors, notably Boston University visiting law professor James Bessen and the Federal Reserve Bank of Philadelphia's Robert Hunt, from suggesting that "the over-proliferation of software patents was reducing software research and development and slowing down innovation" (see "An Empirical Look at Software Patents").

Thus, the empirical evidence establishes that there is no tragedy in the IT or biotechnology anticommons.  The real tragedy, of course, is the uncritical acceptance of such theoretical contingencies by politicians and policy-makers.  Perhaps stated more directly, it is the use of the work of these academic theoreticians by anyone with a political agenda to support, regardless of whether there is any evidence that the risk is real.  As Patent Docs noted in reporting on the Nature Biotechnology report a year ago, the principal proponents of the anti-commons theory had no evident experience or expertise in either patent law or academic science.  This should have engendered caution if not open skepticism to their ideas, but instead they were used by novelists, bureaucrats, and pundits to support the notion that the patent system in the U.S. was broken.  As has been evidenced by the recent rule-making activities of the U.S. Patent and Trademark Office, as well as the witness lists of Congressional hearings regarding patent "reform," the one group consistently ignored (except those who sing from the anti-patent hymn book such as Dan Ravicher) are patent attorneys, who at a minimum are conversant with the competing interests and practices as they exist before "reform," and who have a much better understanding of what works and what is "broken" in U.S. patent law and practice.  The evident disdain for patent attorneys exhibited by the Patent Office and others actively working to retract the protections of U.S. patent law suggests the reason for ignoring patent lawyers:  their plans are not supported by the facts, and so those who know the facts cannot be permitted to be heard.  This by itself should be a clarion call for patent attorneys to make themselves heard in this debate, by all means necessary.

Monsanto Co. v. Syngenta Seeds, Inc. (Fed. Cir. 2007)

    By Kevin E. Noonan --

The Federal Circuit last week clarified two frequently-disputed areas of patent prosecution:  how to claim progeny of inventions that inherently self-replicate, and how to appropriately fulfill both the written description and enablement requirements of 35 U.S.C. § 112, first paragraph, and at the same time disclose broadly enough to support claims of appropriate breadth.

Monsanto Co. and its wholly-owned subsidiary, DeKalb Genetics Corp., sued Syngenta Seed Co. for infringing patents relating to transgenic corn seed, specifically corn resistant to Monsanto's RoundUp®-brand insecticide (glyphosate) by expressing Agrobacterium 5-enolpyruvoyl-shikimate-3- phosphate synthetase (EPSPS).  The patents at issue were U.S. Patent No. 4,940,835, claiming a chimeric plant gene that confers glyphosate resistance; U.S. Patent No. 5,538,880, claiming methods for producing herbicide-resistant and insect-resistant corn (Zea mays) plants; and U.S. Patent No. 6,013,863, claiming methods for producing glyphosate-resistant transgenic corn using a screenable marker gene.  The alleged infringing acts were producing transgenic corn using seed harvested from transgenic corn obtained from Monsanto under a license that precluded harvesting seed for replanting (said licenses were to Monsanto licensee companies acquired by Syngenta, at least some of whom were named as defendants).

Claim 1 of the '835 patent reads:

1.  A chimeric plant gene which comprises:
    (a) a promoter sequence which functions in plant cells;
    (b) a coding sequence which causes the production of RNA, encoding a chloroplast transit peptide/5-enolpyruvylshikimate-3- phosphate synthase fusion polypeptide, which chloroplast transit peptide permits the fusion polypeptide to be imported into a chloroplast of a plant cell; and
    (c) a 3' non-translated region which encodes a polyadenylation signal which functions in plant cells to cause the addition of polyadenylate nucleotides to the 3' end of the RNA;
    the promoter being heterologous with respect to the coding sequence and adapted to cause sufficient expression of the fusion polypeptide to enhance the glyphosate resistance of a plant cell transformed with the gene.

Claim 4 of the '880 patent reads:

4.  A process comprising obtaining progeny from a fertile transgenic plant obtained by the process of claim 1 which comprise said DNA.

Claim 5 of the '863 patent reads:

5.  The process of claim 1 further comprising obtaining transgenic glyphosate resistant progeny plants of subsequent generations from said fertile transgenic plant.

The District Court granted summary judgment to Syngenta on invalidity of the '835 patent and non-infringement of the '880 and '863 patents.  The District Court found the '835 invalid for failing to satisfy the enablement requirement, because the asserted claims encompassed all plant cells, and while the patent enabled genetic transformation of dicotyledonous plants it was filed prior to the time that methods were known in the art for genetically-transforming monocots.  The patent specification not providing methods for transforming monocots, while the claims encompassed monocots, rendered the specification non-enabling throughout the scope of the asserted claims.

With regard to infringement, the District Court found that the asserted claims of the '880 and '863 patents required not merely the step of obtaining transgenic progeny but also the process of producing the transgenic plant in the first place, based on the dependent-claim structure of the asserted claims of these patents.  It was undisputed that DeKalb had produced the transgenic plants initially and had thus performed these steps recited by the claims.  In addition, the District Court found that Syngenta had lawfully obtained the disputed seed through acquisition of the named defendant subsidiaries, and that part of that right included the right to further produce progeny transgenic plants comprising the resistance gene.

The Federal Circuit unanimously affirmed in an opinion by Judge Rader.  The CAFC rejected both of Monsanto's theories of infringement:  first, that claim 4 of the '880 patent was an independent claim and did not require performance of the steps recited in earlier claims; or second, that performance of the transgenic plant production steps by DeKalb did not preclude a finding of Syngenta's infringement by performing the ultimate step of obtaining the progeny transgenic plants.  Regarding Monsanto's first theory, the Federal Circuit stated that claim 4 of the '880 patent and claim 5 of the '863 patent were cast in the conventional form of dependent claims.  This is not sufficient, according to the Federal Circuit, and the CAFC analyzed these claims with regard to whether they not only referenced at least one earlier claim but further limited the referent claim (pursuant to 35 U.S.C. § 112, fourth paragraph).  In this analysis, the Federal Circuit held that claim 4 fulfilled the statutory requirements of a dependent claim, and further stated that while Monsanto could have presented claim 4 as merely requiring the product of process claim 1 as a starting material, it had not.  The prosecution history supported this interpretation, as the claim as originally presented was "unquestionably" a dependent claim, and the patentees had asserted that amendments made to cast the claim into the form that issued as claim 4 were "directed to matters of form not affecting the scope of the invention" and did not introduce new matter.  The Federal Circuit also rejected Monsanto's contention, made during oral argument, that claim 1 was a product-by-process claim and thus merely provided a starting material for the process of claim 4.

Having affirmed the District Court's determination that claims 4 (of the '880 patent) and 5 (of the '863 patent) were dependent claims, the Federal Circuit held that Syngenta's performance merely of the ultimate step of the properly-construed process claim was not infringement as a matter of law.  The principle is simple:  although an independent claim may be infringed while its dependent claim is not, the converse is not true.  Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1552 (Fed. Cir. 1989).  Here, it was undisputed that the steps comprising the independent claims of both asserted patents were performed not by the accused infringer Syngenta, but by Monsanto or DeKalb.  Thus, since Syngenta did not infringe these independent claims, it could not infringe the asserted dependent claims.  Moreover, the steps of the corresponding independent claims were practiced by Monsanto or DeKalb prior to grant of either of the asserted patents.  Accordingly, this activity did not support Monsanto's infringement claims (made under both § 271(a) and § 271(g)).

Turning to the District Court's invalidity decision, the Federal Circuit focused, as had the District Court, on the term "plant cells" in claim 1 of the '835 patent.  The CAFC adopted the lower court's construction of this term to include both monocots and dicots as "plant cells."  Analogizing to the factual circumstances of In re Vaeck, the Federal Circuit agreed with the District Court that there was no basis in the patent specification to limit the term "plant cells" and thus both monocots and dicots properly fell within the scope of the claims.  Unfortunately for Monsanto, however, it was undisputed that genetic transformation of monocotyledonous plants was not known in the art, nor disclosed in the patent specification, at the '835 patent's filing date.  Thus, the practice of the invention claimed in the '835 patent throughout its entire scope, as required by the statute, would require undue experimentation.  The Federal Circuit affirmed this conclusion despite the fact that the claims in dispute were not directed to plant cells per se, but to chimeric genes and constructs comprising them.  The CAFC stated that this distinction was not dispositive, since the capacity to be expressed in "plant cells" was a required feature of the claimed chimeric genes.

What lessons can the biotechnology patent practitioner take from this decision?  First, it is evident that extreme caution should accompany claim drafting dependent on process steps, even should those process steps be necessary to overcome prior art or to fulfill the requirements of § 112.  As noted by the Federal Circuit, the outcome might have been different had claim 4 of the '880 patent recited a claim such as:  "A process comprising obtaining progeny from a fertile transgenic plant comprising a chimeric gene encoding a chloroplast transit peptide/5-enolpyruvylshikimate-3-phosphate synthase fusion polypeptide expressed at a level sufficient to increase the plant's resistance to glyphosate," or even better, "Progeny of a fertile transgenic plant comprising a chimeric gene encoding a chloroplast transit peptide/5-enolpyruvylshikimate-3- phosphate synthase fusion polypeptide expressed at a level sufficient to increase the plant's resistance to glyphosate."  Either of these claims would be free of any process steps that could raise issues with regard to performance of any steps other than the steps Syngenta certainly performed in this case, i.e., producing progeny of Monsanto's transgenic plants.

Second, attempts made during claim drafting to accommodate the Federal Circuit's focus on the written description requirement over the past decade, coupled with the desire to provide a sufficiently broad disclosure to encompass the broadest scope of the invention, must be balanced by a consideration of whether such scope is enabled either explicitly in the specification or by the skill of one having ordinary skill in the art.  In the Monsanto case the issue was one of technique:  monocots could not be genetically transformed, so claims not limited to dicots could not be enabled.  It is foreseeable that in other instances unknown reagents or genes could be implicated, particularly for unrecognized members of known multigene families.  In any event, it behooves patent claim drafters to consider carefully the relationship between what is described and what is enabled to avoid the outcome suffered by Monsanto.

Monsanto Co. v. Syngenta Seeds, Inc. (Fed. Cir. 2007) 
Panel: Circuit Judges Rader and Gajarsa and District Judge O'Malley
Opinion by Circuit Judge Rader

Additional information regarding this case can be found at Patently-O.

Court Report

    By Sherri Oslick --

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

 Elan Corporation PLC v. Intellipharmaceutics Corporation et al.
1:07-cv-00603; filed October 1, 2007 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a paragraph IV certification as part of Intellipharmaceutics' filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Warner Chilcott Company, Inc. v. Watson Pharmaceuticals, Inc. et al.
2:07-cv-04697; filed October 1, 2007 in the District Court of New Jersey

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

Eli Lilly and Company v. Aurobindo Pharma Ltd.
1:07-cv-05488; filed September 28, 2007 in the Northern District of Illinois

Infringement of U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/ Hyperactivity Disorder," issued August 19, 1997) following a paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Lilly's Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder).  View the complaint here.

Hoffmann-La Roche Inc. v. Genpharm Inc. et al.
2:07-cv-04661; filed September 28, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007) and 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic Acid or Salt Thereof," issued September 25, 2001) following a paragraph IV certification as part of Genpharm's filing of an ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis).  View the complaint here.

Sanofi-Aventis et al. v. Torrent Pharma Inc. et al.
1:07-cv-00969; filed September 27, 2007 in the Western District of Michigan

Infringement of U.S. Patent Nos. 4,661,491 ("Alfuzosine Compositions and Use," issued April 28, 1987) and 6,149,940 ("Tablet with Controlled Release of Alfuzosine Chlorhydrate," issued November 21, 2000) following a paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Sanofi-Aventis' Uroxatral® (alfuzosin hydrochloride, used to treat benign prostatic hyperplasia).  View the complaint here.

Sepracor Inc. et al. v. Orchid Chemicals & Pharmaceuticals Ltd. et al.
3:07-cv-04623; filed September 26, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,211,582 ("Methods for treating urticaria using descarboethoxyloratadine," issued May 1, 2007), 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007), and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough, following a paragraph IV certification as part of Orchid's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex® (desloratidine, used to treat allergies).  View the complaint here.