Patent Docs

Celera to Acquire Atria Genetics

    By Sherri Oslick --

On Thursday, Celera of Rockville, MD and Alameda, CA, an Applera Corporation business, announced that it would acquire Atria Genetics, Inc. of San Fransisco, CA for approximately $33 million cash.  Atria Genetics is a private company that has developed a line of human leukocyte antigen (HLA) testing products that are used for identifying potential donors in the matching process for bone marrow transplantation.  The acquisition is expected to be completed during the second quarter of Celera's fiscal 2008.  Abbott Molecular, a division of Abbott Laboratories, markets and distributes Atria Genetics' current HLA sequencing-based typing products through its alliance with Celera.

For additional information regarding the acquisition, please see:

• Celera's press release

Patent Profile: CODA Genomics Announces Issuance of Synthetic Gene Production Patent

    By Donald Zuhn --

Earlier this month, CODA Genomics, Inc. announced that it had been granted U.S. Patent No. 7,262,031.  CODA Genomics, Inc., which derives its name from its Computational Optimized DNA Assembly technology, has exclusively licensed the '031 patent from the University of California, Irvine (UCI) Office of Technology Assessment (OTA).  The founders of the Laguna Hills, California-based biotech company, Dr. Richard H. Lathrop (left) and Dr. G. Wesley Hatfield (right), are professors at UCI and named inventors on the '031 patent.

According to the statement released by CODA Genomics, the '031 patent relates to the use of a global optimization method for the choice of DNA code to make a given protein, wherein properly chosen DNA enables thermodynamically controlled self-assembly of a desired DNA product.  CODA CEO Dr. Robert J Molinari noted that the '031 patent provided "broad protection of CODA's breakthrough technology" which "will allow the company to aggressively market its high-yielding Hot-Rod genes, and other optimized gene variant sets."  According to CODA's website, the company's Hot Rod genes are designed to express high levels of protein by removing major pauses in the gene's open reading frame (ORF) and by improving tRNA codon usage.

The '031 patent issued from U.S. Application No. 10/851,383, filed May 21, 2004, and claims the benefit of U.S. Provisional Application No. 60/472,822, filed May 22, 2003.  Independent claims 1 and 42 of the '031 patent recites:

1.  A method of synthesizing a DNA sequence encoding a polypeptide, comprising:
    (i) dividing the DNA sequence recursively into small pieces of DNA, wherein adjacent pieces comprise overlapping regions, wherein the division results in at least 3 pieces of DNA;
    (ii) optimizing the sequences of the pieces of DNA resulting from each recursive division in silico by silent codon permutation to strengthen correct hybridizations between adjacent pieces of DNA and to disrupt incorrect hybridizations between all other pieces of DNA resulting from that division;
    (iii) obtaining the optimized small pieces of DNA, wherein the overlapping regions of any adjacent pieces of single-stranded DNA are complementary;
    (iv) combining the pieces of DNA derived from the division of the next-larger piece of DNA;
    (v) allowing the pieces of DNA to self-assemble to form a DNA construct comprising single-stranded DNA segments connected by double-stranded overlap regions;
    (vi) producing the next-larger piece of DNA from the DNA construct; and
    (vii) repeating steps (iv), (v), and (vi) in reverse order of the recursive division in step (i) to produce the DNA sequence.

42.  A method for identifying a set of smaller DNAs suitable for assembly into a larger DNA, where the larger DNA encodes a desired polypeptide, comprising:
    optimizing in silico a set of at least 6 smaller DNAs for assembly together to create the larger DNA, wherein adjacent smaller DNAs comprise overlapping regions, wherein the optimizing comprises permuting silent codons to strengthen correct hybridizations between adjacent pieces of the smaller DNAs and to disrupt all incorrect hybridizations between members of the set, to create a gap between melting temperatures of the lowest melting correct hybridization and the highest melting incorrect hybridization.

PHOSITA Case Reissued as Precedential

Daiichi Sankyo Co. v. Apotex, Inc. (Fed. Cir. 2007) (reissued as precedential)

    By Robert Dailey --

Much of patent law depends on the attributes of the hypothetical "person having ordinary skill in the art" (PHOSITA).  Particularly, claim construction and obviousness determinations depend on how the court defines PHOSITA for the patent-in-suit.

Nevertheless, Federal Circuit case law provides little guidance.  The 1983 Orthopedic Equipment case articulates six non-exclusive factors that courts may use in determining the characteristics of PHOSITA: (1) education level of the inventor; (2) problems encountered in the art; (3) prior art solutions to the problem; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) education level of active workers in the field.  But subsequent case law has added little nuance to this assessment rubric.

An earlier posting on Patent Docs summarizes the holding of the original non-precedential Daiichi Sanko case, issued this July.  Now that the CAFC has reissued the identical opinion as precedential, it's probably worth considering what the implications might be.

The case involved ofloxacin (at left), a topical antibiotic used for treating ear infections.  Although many antibiotics can cause damage to the ear when applied topically, specialists in the field knew that ciprofloxacin (below) showed no such damage.  Since ofloxacin and ciprofloxacin are antibiotics having similar molecular structures, those aware of ciprofloxacin's success would have possessed the requisite motivation to use ofloxacin in similar ways.

But the District Court had included pediatricians and general practice physicians within the class of those having ordinary skill in the art.  Since these non-specialist medical practitioners rarely, if ever, use ciprofloxacin to treat ear infections, the court ruled that ofloxacin's success would not be obvious to PHOSITA.  The Federal Circuit reversed, holding that the District Court should have limited PHOSITA to otologists and persons who develop pharmaceutical formulations.  Since this narrower class of experts would have been aware of ciprofloxacin's success, the use of ofloxacin to treat the same ailment is obvious.

In this instance, the CAFC probably reached the best result.  After all, PHOSITA's art field is determined by the nature of the invention.  Non-specialist physicians are not generally in the business of developing and testing new pharmaceutical products.  If we include them within the class of skilled artisans, then almost no pharmaceutical invention would be obvious.  Thus, this case illustrates the dangers of setting the level of ordinary skill too low.

On the other hand, the law bids us look to the person of ordinary skill in the art.  By focusing too much on the skill set of the inventor, we run the risk of defining PHOSITA as a kind of super-skilled artisan.  In fact, PHOSITA is even less bright than the average artisan; otherwise, half of the practitioners in the art field would fall below the standard.  In other words, he's like the B- student who barely met the minimum qualifications for graduation.

As the CAFC points out, persons included as PHOSITA should at least be capable of carrying out the experiments necessary to create and test the invention.  But if we adorn PHOSITA with too many attributes (i.e., give him the same skills as the inventor), then we create someone for whom everything is obvious.

Final Rule Regarding April 2007 Revision of PCT Procedures

    By Christopher P. Singer --

In the Federal Register published Monday, September 10, 2007 (available here), the U.S. Patent and Trademark Office published its Final rules regarding certain changes the Office made in order to conform with changes introduced in the April 1, 2007 Revisions to the Patent Cooperation Treaty Procedures.  As previously reported on Patent Docs, the PCT Assembly of the World Intellectual Property Organization (WIPO) amended portions of its Regulations which took effect on April 1, 2007.  The USPTO implemented interim procedures to authorize certain portions of these changes until the Final Rules could be enacted.  Importantly, the Final Rules provide: (a) a way for an applicant to request that the right to claim priority be restored in applications that meet specific requirements; (b) a way to insert a missing portion of an international application without losing the international filing date; (c) a clarification about the circumstances in which an obvious error in an international application can be corrected; and (d) revising the search fee for international applications.

September 10, 2007 is the effective date for the changes to 37 C.F.R. §§ 1.57 (incorporation by reference), 1.437 (drawings), and 1.465 (application processing based on corrected/added/withdrawn priority date), while November 9, 2007 is the effective date for the changes to 37 C.F.R. §§ 1.17 (fee for unintentionally delayed priority claim, $1,370) and 1.445 (search fee, $1,800; and supplemental search fee, per additional invention, $1,800), as well as the addition of 37 C.F.R. § 1.452 (restoration of right of priority).

Anyone with questions regarding the notice and these procedures is directed to contact Mr. Richard R. Cole, Senior Legal Examiner with the Office of PCT Legal Administration by telephone (571.272.3281) or fax (571.273.0459).

BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform

    By Donald Zuhn --

Earlier today, Patent Docs participated in a conference call with Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO).  Mr. Greenwood, who represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005 prior to his BIO appointment, had invited a handful of biotech and pharma bloggers to participate in the conference call, where he provided a briefing on the Biologics Price Competition and Innovation Act of 2007 (see "Senate Committee Passes Biologics Legislation"), which the Senate Committee on Health, Education, Labor & Pensions passed on June 27, 2007, and the Patent Reform Act of 2007 (see "Patent "Reform" Bill Passes House of Representatives"), which the House of Representatives passed on September 7, 2007.

On the issue of patent reform, Mr. Greenwood (at left) stated that the House bill was "largely inspired" by the information technology industry, which relies on a business model that is quite different from that of the biotech/pharma sector.  Mr. Greenwood predicted that if the House bill were passed into law, it would be "easier and less costly to infringe patents."  While noting that the bill which the House approved by a 220-175 margin was better than the legislation the House had started out with, Mr. Greenwood believed the House bill was "still bad."  As a result, Mr. Greenwood said that BIO would continue to oppose the House bill and work with the Senate to pass a bill more favorable to the 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations comprising BIO.

With regard to those portions of the House bill that BIO finds to be most problematic, Mr. Greenwood began by criticizing the bill's apportionment of damages provision, which allows a court in an infringement action to calculate a reasonable royalty based on the "economic value attributable to patent's specific contribution over prior art."  When asked if BIO could offer an acceptable middle ground between the current system and the House's apportionment of damages provision, Mr. Greenwood replied that the current system "beats anything we have seen in the legislation."

Mr. Greenwood also found the inequitable conduct and enhanced rulemaking authority provisions of the House bill to be lacking.  With respect to the latter provision, Mr. Greenwood expressed dissatisfaction with the differences between the House and Senate bills (the House bill would retroactively authorize the Patent Office's new continuation and claims rules and the Senate bill would only grant the Office some fee-setting authority).  While acknowledging that USPTO officials may have been "well intentioned" in passing the new continuation and claims rules, Mr. Greenwood believed that such decisions "should be left to Congress, and not to administrators."  Nevertheless, Mr. Greenwood stressed that BIO was "trying to work amicably with the PTO" with respect to the new rules, and observed that a number of BIO-supported changes to the proposed continuation and claims rules had made their way into the final rule.  Mr. Greenwood concluded by stating that BIO had not taken a position with respect to any legal challenges to the new rules, such as Dr. Tafas' action (see "Rules Challenger Amends Complaint and Withdraws PI Motion").

Orange Book Blog, which also participated in the conference call, has reported on Mr. Greenwood's comments concerning the Biologics Price Competition and Innovation Act of 2007.

Eli Lilly Pursues Additional Strattera® ANDA Filers

    By Sherri Oslick --

As reported here, on August 9, Eli Lilly filed suit in the District Court of New Jersey against Actavis Elizabeth in answer to Actavis' filing of an ANDA (and concomitant Paragraph IV certification) to manufacture a generic version of Lilly's Strattera®.  Earlier this month, Lilly filed an amended complaint in the case, adding additional ANDA/Paragraph IV filers Glenmark Pharmaceuticals, Sun Pharmaceuticals, Sandoz, Mylan Pharmaceuticals, Apotex, Aurobindo Pharma, Teva Pharmaceuticals, Synthon Laboratories, and Zydus Pharmaceuticals.  Sandoz, as reported here, had previously filed suit against Lilly seeking declaratory judgment of non-infringement and invalidity of the patent at issue.

Strattera®, or atomoxetine hydrochloride, a norepinephrine reuptake inhibitor, is a non-stimulant medication used in the treatment of Attention-Deficit/ Hyperactivity Disorder (ADHD) in children, adolescents, and adults.  The method of treatment is covered by U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/ Hyperactivity Disorder," issued August 19, 1997).  The '590 patent is set to expire on May 26, 2017.

An Analysis of the New Rules: USPTO Releases ESD Guidelines

    By Kevin E. Noonan --

Review of the new "examination support document" rule promulgated in 37 C.F.R. § 1.265 on August 21, 2007 strongly suggested that the purpose of the rule was not to facilitate submission of relevant prior art as an improvement over current Information Disclosure Statement provisions, but rather to provide strong encouragement (coming close to coercion) for applicants to file no more than 5 independent and 25 total claims (see previous post on Rule 265).  The bases for this were the stringent requirements not only for information but for applicants to characterize the information with regard to patentability, coupled with a complete lack of any effort by the Patent Office to modify the duty of disclosure to permit an applicant or counsel to submit an ESD without the certainty of being accused of inequitable conduct.  This impression was reinforced by the guidelines issued from the Patent and Trademark Office on September 6, 2007.

The guidelines are directed to the requirements of the rule and explicate (generally) what will (and what will not) satisfy the rule.  Some highlights:

1.  The Office suggests that the preexamination search be performed giving the limitations in each of the independent and dependent claims their "broadest reasonable interpretation."  Moreover, the limitations in dependent claims should be searched independently of their combination with the limitations or elements of the independent claims.  For means-(or step-)plus-function claims, the search must encompass the embodiments explicitly-disclosed in the specification and, of course, "equivalents thereof"; it can be contemplated that any such search will be available during litigation to assert an estoppel of the embodiments satisfying the means-plus-function claim.

2.  The Office also suggests that applicants (and their representatives) include "disclosed but unclaimed features" that the applicant may wish to incorporate in their claims, in order to avoid the need to perform a supplemental search.  Thus, the extent of this search effectively extends past the scope of the claims to encompass whatever is disclosed in the specification.  Unmentioned is whether the search must also encompass all that is know to one of ordinary skill in the art (also unmentioned is the crystal-ball, tea-leaf-reading character of this requirement).

3.  Foreign patent office searches "may" not "automatically" satisfy the requirement, but it is clear from what is required for such a search to affirmatively satisfy the requirement that such a search will never suffice.  Of course, the rule does not abrogate an applicant's duty of candor in disclosing whatever a foreign patent office issues in a search report.  And an earlier search on a non-provisional application will not necessarily suffice, either; the guidelines do not state whether Examiner-conducted searches in earlier-filed applications are deemed to be insufficient by this rule.

4.  The rule requires a large amount of detail with respect to identifying the field of search and the search terms used; reliance on the M.P.E.P. standards may be (but are not necessarily) sufficient.  The guidelines refer applicants to M.P.E.P. §§ 904-904.03, and to a web-based search template (which can be found here).

5.  The Office can also deem a search insufficient if it determines that there is closer prior art than what was provided by the applicant.  It is unclear from the guidelines how an applicant could cure the deficiency, other than performing the patentability analysis using this newly-cited art, but it certainly increases the inequitable conduct exposure.  This is particularly true if the art is applicant's own art; the existence of a genuine dispute between the applicant and the office over the scope of any said art will disappear during a post-hoc inequitable conduct accusation.

6.  While providing a number of web-based resources for applicants trying to comply with the search rules (for example, the Manual of Classification, the guidance provided for ESD's with regard to accelerated examination, and a more extensive review of the classification system), the guidelines also suggest that the search be extended to "all probable classes and subclasses relevant to the subject matter of each claim," with no guidance on determining the metes and bounds of what is "probable."

7.  Classification and text searches are recommended, however, classification searches cannot be limited by any text query.  This requirement appears to require an entire class and subclass be reviewed and references eliminated one by one from the search after review.  Text searches for PCT documents should encompass the standards set forth here.

8.  "Other sources" of art outside the scope of the searches set forth in the guidelines include:

• Applicant's own work including references by at least one of the inventors.
• References cited in any prior-filed application in which a benefit or priority is claimed.
• References cited in an international search report of a national stage application.

9.  Turning to the requirement that the ESD identify references "most closely related" to the claims, the Office asserts that these references will be those that disclose the most number of limitations in an independent claim; or a limitation in an independent claim not found in any other reference; or a limitation in a dependent claim not shown in any other reference.  However, if such a reference has a priority or publication date less than one year before the applicant's filing or priority date, additional references should be identified that have a publication or priority date more than one year before the applicant's filing or priority date, even if that disclosure is "less closely related" to the claims.  However, the duty of disclosure requires that other art, "less closely related" to the claims, be submitted in an IDS, including inter alia art cited in foreign or International search reports.

10.  The Office suggests the applicant "map" (presumably using a claim chart) the portions of any reference cited in an ESD that discloses any limitation in an independent or dependent claim.  Only one portion of a reference need be recited, unless any second or other reference would not be "apparent" to the Examiner.  A requirement that the Examiner read the reference is not contained in the guidelines.

11.  With regard to the detailed explanation of patentability, the guidelines suggest that:

The ESD must set out with particularity, by reference to one or more specific claim limitations, why the claimed subject matter is not described in the references, taken as a whole.  The applicant must explain why a person of ordinary skill in the art would not have combined the features disclosed in one reference with the features disclosed in another reference to arrive at the claimed subject matter.  The applicant must also explain why the claim limitations of the independent claims render the claimed subject matter novel and non-obvious over the cited prior art.

It is unclear what evidence is required to establish what one of ordinary skill in the art would not have considered in the motivation to combine vel non, or what would be considered novel or non-obvious.

12.  The guidelines also make plain that, where an application claims priority to an earlier application, the requirement for showing explicit support for limitations in all independent and dependent claims extends to all such priority applications.

13.  The duty to file an ESD, and all its requirements, is ongoing and arises when new art is uncovered and when amendments are made to the claims.  A supplemental ESD can be required under these circumstances.

These guidelines are clearly intended to more fully explain how an applicant can comply with the ESD rules.  Whether intentional or not, what they most clearly explain is that an applicant should avoid filing an ESD under any circumstances.  This may be the intended consequence after all.

For additional articles in this series, please see:

• "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:

• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 207
• "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

USPTO News: Swedish Patent Office to Help USPTO Reduce Application Backlog

    By Donald Zuhn --

The U.S. Patent and Trademark Office announced today that it has begun a pilot project with the Swedish Patent and Registration Office (PRV) in an attempt to reduce the USPTO's growing backlog of U.S. national applications waiting to be examined.  The pilot program will test the feasibility of having the PRV process international applications filed with the USPTO under the Patent Cooperation Treaty.  In particular, the PRV will search and examine 50 PCT Chapter I applications covering a range of technologies, and the USPTO will then review the PRV's work to ensure that it meets USPTO standards.

The USPTO noted in its release that each year it receives more than 50,000 PCT international applications and more than 400,000 national applications.  The Patent Office hopes that by outsourcing the search and examination of international applications, the Office can redirect resources to its backlog of approximately 750,000 U.S. national applications.

USPTO News: BPAI Decisions Now Text Searchable

    By Donald Zuhn --

On August 30, 2007, the U.S. Patent and Trademark Office announced that publicly available final decisions of the Board of Patent Appeals and Interferences (BPAI) posted on the BPAI's Final Decision FOIA web page will now be text searchable.

Alligator Bioscience and SARomics to Collaborate

    By Jason Derry --

Alligator Bioscience has announced that it has entered a collaborative agreement with SARomics.  SARomics is a research company that provides its partners with in silico drug discovery platforms in the fields of structural biology, computational chemistry, and biostatistics.  In particular, SARomics offers many services that help its partners in the drug discovery process, including protein homology modeling, structure-based drug design, virtual screening, ligand-based drug design, QSAR analysis, experimental design, and high throughput data processing and data mining.  Alligator Bioscience focuses on developing and optimizing therapeutic and diagnostic proteins using its proprietary in vitro protein evolution technology.

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

Purdue Pharma LP et al. v. Apotex Inc. et al.
1:07-cv-00549; filed September 12, 2007 in the District Court of Delaware

Infringement of U.S. Patent No. 5,508,042 ("Controlled Release Oxycodone Compositions," issued April 16, 1996) following a paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Hoffmann-La Roche Inc. v. Gate Pharmaceuticals et al.
2:07-cv-04285; filed September 7, 2007 in the District Court of New Jersey

Hoffmann-La Roche Inc. v. Teva Pharmaceurticals USA, Inc. et al.
2:07-cv-04284; filed September 7, 2007 in the District Court of New Jersey

Hoffman-La Roche Inc. v. Mutual Pharmaceutical Company, Inc. et al.
2:07-cv-04350; filed September 11, 2007 in the District Court of New Jersey

The complaints in these cases are substantially similar.  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 defendants' filing of an ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis).  View the Gate Pharmaceuticals complaint here.

Conference & CLE Calendar

September 18, 2007 - Trying a Patent Validity Case in a Post-KSR World (Practising Law Institute)

September 18-19, 2007 - Pharma/Biotech Patent Boot Camp (American Conference Institute) - San Francisco, IL***

September 19, 2007 - Final USPTO Rules on Claims and Continuations (Practising Law Institute)

September 20, 2007 - KSR International Co. v. Teleflex, Inc.: Where Do We Stand Five Months Out? (West LEGALworks)

September 24-25, 2007 - Biosimilars 2007 (Scherago International, Inc.) - George Washington University, Washington, D.C.

September 26-27, 2007 - Advanced Forum on Biotech Patents (American Conference Institute) - Boston, MA***

September 27-28, 2007 - Biotechnology: Business and Legal Developments (Law Seminars International) - Seattle, WA

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 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***

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

USPTO News: USPTO and UK IPO to Collaborate on Patent Prosecution Highway

    By Donald Zuhn --

On September 4, 2007, the U.S. Patent and Trademark Office announced that it has initiated a Patent Prosecution Highway (PPH) pilot program with the United Kingdom Intellectual Property Office (UK IPO).  The two offices are now accepting applications for participation in the pilot PPH, which permits an applicant having an application whose claims have been allowed by one office to fast track the examination of an application in the other office, such that the latter application would be examined out of turn.  In particular, an applicant receiving a ruling from either the UK IPO or the USPTO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application.

According to the USPTO announcement, the pilot PPH will "leverage fast-track patent examination in both offices to allow applicants in both countries to obtain corresponding patents faster and more efficiently," and "permit each office to benefit from work previously done by the other office, in turn reducing examination workload and improving patent quality."  UK Intellectual Property Office Ian Fletcher labeled the program "a further step towards a global patent prosecution highway network."

The USPTO-UK IPO initiative parallels a similar pilot PPH involving the Japan Patent Office and the USPTO, which was begun in July 2006.

The pilot program is scheduled to run until September 4, 2008.  Additional information regarding the USPTO-UK IPO pilot PPH program, including the conditions for eligibility, can be found at the USPTO website and at the UK IPO website.

For additional information regarding this topic, please see:

• "USPTO News: Patent Prosecution Highway Pilot Program to Be Extended," June 28, 2007

Teva and Dr. Reddy's Reach Agreement in Zoloft Suit

    By Sherri Oslick --

On Tuesday, Teva Pharmaceuticals and Dr. Reddy's Laboratories filed a joint stipulation of dismissal in their pending lawsuit over generic sertraline hydrochloride (the API in Pfizer's Zoloft®, used to treat depression).  The suit, originally filed on February 1, 2007 in the District Court of New Jersey, was dismissed without prejudice, with the stipulation of dismissal noting that Dr. Reddy's is not selling, and has no current intention to sell, generic Zoloft® to anyone other than Teva, and that Dr. Reddy's will provide Teva with 30 days advance notice of any importation, sale, offer to sell, or use of sertraline hydrochloride finished product or API.

The settlement of Teva's suit against Dr. Reddy's ends just one of many pending actions filed by Teva earlier this year surrounding the manufacture of generic Zoloft®.  Information on these actions can be found in our previous reports of February 25, March 4, April 15, and June 3, 2007.  At issue in each of these cases, including the action against Dr. Reddy's, are four U.S. patents:  6,600,073 ("Methods for Preparation of Sertraline Hydrochloride Polymorphs," issued July 29, 2003), 6,500,987 ("Sertraline Hydrochloride Polymorphs," issued December 31, 2002), 6,495,721 ("Sertraline Hydrochloride Form II and Methods for the Preparation Thereof," issued December 17, 2002), and 6,897,340 ("Processes for Preparation of Polymorphic Form II of Sertraline Hydrochloride," issued May 24, 2005), all directed to methods of manufacturing crystalline forms of sertraline hydrochloride.