Patent Docs

USPTO News: Office Summarizes Feedback on Public PAIR Access

July 17, 2008

By Donald Zuhn —

The U.S. Patent and Trademark Office today released a summary of the feedback it received in response to its April 30, 2008 webcast concerning user access to the Public Patent Application Information Retrieval (PAIR) system. During the webcast, Commissioner for Patents John Doll and Deputy Chief Information Officer Deborah Diaz noted that the Office had implemented a CAPTCHA (Completely Automated Public Turing test to tell Computers and Humans Apart) tool in order to distinguish human users from automated scripts. Commissioner Doll and Deputy CIO Diaz also requested that PAIR users submit comments concerning their use of the system.

Between April 30 and the June 1 deadline for submitting comments, the USPTO received 37 responses. In summarizing the responses, the Office noted that respondents have "a clear interest in being able to receive automatic notification of status changes or other updates, and some interest in receiving packaged deliveries of data (for example, via DVD or ZIP file)." In addition, the Office stated that "[m]any respondents indicated that their work was impeded without volume access to PAIR data, and at least two reported that they were unable to retrieve data at all under the current access restriction." While the Office concluded that it had "no immediate plans to remove the CAPTCHA restriction" at this time, the Office assured users that it was "evaluating a solution that will ease the restriction and permit limited automated access," and recognized "the urgency in implementing support for both interactive and automated access to Public PAIR."
Merck & Co. v. Apotex, Inc. (Fed. Cir. 2008)

July 16, 2008

By Kevin E. Noonan —

Federal Circuit jurisprudence on whether an Article III case or controversy exists continues to evolve regarding the extent to which federal district courts can exercise jurisdiction in patent cases, most recently in Merck & Co. v. Apotex, Inc. (nonprecedential).

The dispute was over Apotex’s ANDA filing for a generic version of Merck’s Fosamax® drug for treating osteoporosis. At issue were Merck’s Orange Book-listed patents for Fosamax®, including U.S. Patent Nos. 4,621,077 (claiming the active ingredient, alendronate sodium), 5,358,941, 5,681,590, 5,849,726, 6,008,207, 6,090,410, and 6,194,004 (claiming various formulations of Fosamax® tablets), and 5,994,329, 6,015,801, and 6,225,294 (claiming Fosamax® dosing schedules). Apotex filed a Paragraph III certification for the ‘077 patent, which expired on August 6, 2007, and Paragraph IV
certifications for Merck’s other Orange Book-listed patents (which expire on different dates from 2012-2018). Merck filed suit within 45 days of Apotex notifying them of its filing, and Apotex counterclaimed for a declaratory judgment of non-infringement. However, before trial, Merck granted Apotex a covenant not to sue on all the patents-in-suit:

Merck unconditionally represents, stipulates, agrees, and covenants that it will not sue Apotex for infringement of, or otherwise assert, enforce, or hold Apotex liable for infringement of any of the ‘941, ‘590, ‘726, ‘207, ‘410, ‘004, ‘329, ‘801, and ‘294 patents based on the importation, manufacture, use, sale, or offer for sale of the alendronate sodium tablets that are the subject of and described in Apotex’s ANDA No. 077-982.

Merck’s acquiescence was not enough for Apotex to be able to market generic Fosamax®, however, because Teva Pharmaceuticals was the first ANDA filer. Although Merck prevailed in its ANDA litigation against Teva, the final judgment in that litigation (limited to the ‘077 patent) permitted Teva’s 180-day market exclusivity term to begin on February 6, 2008, barring Apotex from entering the market until August 5, 2008. Finally, the FDA decided to lift the 30-month approval stay imposed upon Merck’s ANDA litigation filing, originally set to expire on August 24, 2008, to coincide with the end of Teva’s market exclusivity on August 5.

Having given Apotex the covenant not to sue, Merck moved to dismiss on the grounds that there was no longer a case or controversy between the parties. Apotex in response moved to amend its complaint to include a claim for Sherman Act violations. The District Court granted Merck’s motion and denied Apotex’s motion, and the appeal followed.

In their unanimous decision, the panel (Gajarsa, Friedman and Proust) cited the Court’s decision in Caraco Pharm. Labs, Ltd. v. Forest Labs., Inc. at the same time, mentioning that the Court had denied Caraco’s petition for rehearing and rehearing en banc. Judge Gajarsa, writing for the panel, noted that the injury-in-fact alleged by Apotex — delay in marketing generic Fosamax® — was "not fairly traceable" to Merck in view of the covenant not to sue. The existence of the covenant by itself was not enough, according to the opinion citing Caraco. In this case, the Federal Circuit’s decision was based on two factual distinctions with Caraco. First was the FDA decision to lift the thirty-month stay when the District Court dismissed the case. Second, unlike in Caraco, the first ANDA filer in this case — Teva — had triggered the 180-day exclusivity period by entering the market on February 6, 2008. Thus, the delay in entering the market is not (and, once Merck granted its covenant, was not) attributable to Merck, but was a consequence of the statutory exclusivity granted to Teva as the first ANDA filer. Thus, there was no longer a case or controversy between the parties, and the Federal Circuit affirmed the District Court’s dismissal.

The Federal Circuit also affirmed the District Court’s denial of Apotex’s motion to amend its complaint to include its antitrust counterclaim. Applying regional (Third Circuit) law, the CAFC noted that Fed. R. Civ. Pro. 15(a) provides that courts "should freely grant leave [to amend] when justice so requires." Reasons for not granting leave include "undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party by virtue of allowance of the amendment, futility of amendment, etc.," citing Foman v. Davis, 371 U.S. 178, 182 (1962). Here, the panel agreed with the District Court that Apotex "failed to allege facts sufficient to support its antitrust counterclaim, and that Apotex’s antitrust allegations were ‘bald and conclusory.’" The District Court’s denial was thus not an abuse of discretion, according to the Federal Circuit.

Merck & Co. v. Apotex, Inc. (Fed. Cir. 2008)
Nonprecendential disposition
Panel: Senior Circuit Judge Friedman and Circuit Judges Gajarsa and Prost
Opinion by Circuit Judge Gajarsa
Lilly Strattera® Litigation Down to 7 Defendants

July 16, 2008

By Sherri Oslick —

Earlier this month by consent judgment, the Paragraph IV litigation between Eli Lilly and Glenmark Pharmaceuticals over Lilly’s ADHD drug Strattera® was terminated. Per the parties’ stipulation, Glenmark agreed that the patent-in-suit was neither invalid nor unenforceable, and further agreed to a permanent injunction enjoining it from manufacturing or selling its generic version of Strattera® during the lifetime of the patent-in-suit, absent a final judgment that the patent-in-suit is unenforceable or that its claims are invalid.

As we previously reported, the suit was originally filed in the District Court of New Jersey on August 9, 2007 against defendant Actavis Elizabeth LLC for 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 Actavis’ filing of an ANDA to manufacture a generic version of Lilly’s Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder). Shortly thereafter, Lilly amended its complaint to add nine additional ANDA filers: Glenmark Pharmaceuticals, Sun Pharmaceuticals , Sandoz, Mylan Pharmaceuticals, Apotex, Aurobindo Pharma, Teva Pharmaceuticals, Synthon Laboratories, and Zydus Pharmaceuticals (see "Eli Lilly Pursues Additional Strattera® ANDA Filers").

Glenmark is the third defendant to be dismissed from the case. In December, Lilly and Zydus reached an agreement comparable to the Glenmark agreement, and consent judgment was entered on December 12, 2007. On June 27, 2008, Lilly dismissed Synthon Laboratories by stipulation, the details of which remain confidential.
USPTO News: PTO Announces “Triway” Pilot Program

July 15, 2008

By Donald Zuhn —

The U.S. Patent and Trademark Office announced today that it was initiating a pilot program to promote worksharing between the USPTO, European Patent Office, and Japan Patent Office. The pilot program, dubbed "Triway," was first proposed by the USPTO at the 2005 Trilateral Pre-conference; the Trilateral Offices agreed at last year’s Trilateral Pre-conference to undertake a limited pilot program. We first heard of the Triway program at last month’s BIO International Convention when Group 1600 Director Dr. George Elliott briefly described three of the Office’s worksharing initiatives to conference attendees (see "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.").

Under the Triway program, each of the three participating Offices will conduct searches on applications filed in their respective Offices, and the search results will then be shared among the Offices in order to reduce the search and examination workload in each of the Offices. The Trilateral Offices agreed at last year’s Trilateral Pre-conference that the pilot program would be limited to 100 applications in which the USPTO is the Office of first filing, and where the filings are from diverse technologies (i.e., no more than fifteen applications from any one Technology Center). The pilot program will begin on July 28, 2008 and end on July 28, 2009, or upon acceptance of 100 applications, whichever occurs first.

To request participation in the pilot program, interested applicants must:

• File (or have recently filed) a nonprovisional application with the USPTO that was complete (pursuant to 37 C.F.R. § 1.51(b)) at the time of filing;
• File corresponding applications in the EPO and JPO, where the corresponding applications claim priority to the U.S. application and are filed within four months of the filing of the U.S. application;
• Limit all three applications to a single invention and ensure that the claims of each application "sufficiently correspond" (i.e., are of the same of similar scope); and
• File a request to participate in the Triway pilot program and a petition to make the U.S. application special and pay a petition fee under 37 C.F.R. § 1.17(h) (the USPTO will make a sample request/petition form, designated as PTO/SB/12, available here on July 28; the request must be faxed to the Office of the Commissioner for Patents at 571-273-0125, directed to the attention of Magdalen Greenlief).

Applicants will be expected to satisfy several procedural requirements during their participation in the Triway pilot program. Once an application has been accepted into the pilot program, the USPTO will conduct a search and fax a copy of the search report to the applicant within six months of the filing of the U.S. application (to the extent practicable). The applicant must then promptly file a copy of the search report with the EPO and request participation in the pilot program in the EPO. The EPO will consider the USPTO search, conduct its own search, and issue an Extended European Search Report (EESR). The applicant must then promptly file the EESR with the USPTO. With respect to the JPO, the applicant must file a request for examination, a request for accelerated examination, a statement of participation in the Triway program, and copies of the USPTO and EPO searches with the JPO. The JPO will consider the USPTO and EPO searches, conduct its own search, and issue an office action. The applicant must then promptly file copies of the JPO office action with the USPTO and EPO (a translation of the JPO office action and a certification must also be submitted to the USPTO).

Additional details concerning the pilot program can be found here.
Wall Street Journal: Current Patent System Suppresses Innovation

July 14, 2008

By Donald Zuhn —

In an op-ed piece in today’s Wall Street Journal, L. Gordon Crovitz opines that Congress’ failure to enact patent reform this year has undermined the Constitutional mandate to encourage innovation (see "Patent Gridlock Suppresses Innovation"). The fault for our flawed system, according to Mr. Crovitz, rests with Congress, which he believes "[f]or the third year in a row . . . has just given up on passing a law reforming how patents are awarded and litigated."

Mr. Crovitz (at left) leaves little doubt as to which team he backs when he discusses the efforts of the Allied Security Trust, an industry consortium that has begun to buy up patents in order to keep them out of the hands of dreaded "patent trolls" (when Mr. Crovitz notes that the Allied Security Trust includes "[c]ompanies as diverse as Verizon, Google, Cisco and Hewlett-Packard," one wonders what definition of "diverse" he is using). While Mr. Crovitz asserts that our current patent system has become "patently absurd" for most innovations, it is clear that he speaks for the "software and other technology companies" — which he expects "to be the growth engine of the economy" — and not for the biotechnology and pharmaceutical industry. For example, when Mr. Crovitz contrasts the pharmaceutical industry’s self-centered reasons for lobbying against patent reform legislation with pro-reform lobbying conducted by technology companies, he argues that the latter were "worried more about uncertainty in the law than about the value of their patents."

According to Mr. Crovitz, "growing" evidence indicates that "for most industries, today’s patent system causes more harm than good." However, the only evidence Mr. Crovitz cites in his article is James Bessen’s and Michael Meurer’s book "Patent Failure," which Mr. Crovitz contends establishes that the costs of U.S. patent litigation to alleged infringers ($12 billion in 1999) outweighed the profits companies earned from patents ($4 billion in 1999).

Mr. Crovitz enumerates the problems he believes plague our current patent system. In his view, these include an "uncertainty about who owns what rights," "poorly defined property rights for inventions," the issuance of "increasingly broad and vague patents," the inability of companies to know whether or not they are complying with patent law, the perpetuation of a first-to-invent standard over a first-inventor-to-file system, "a still-primitive system for notifying others of the existence of patents," and a squeezing out of small inventors by companies that "only pay for rights they think the system will protect."

A cynic might suggest, after reading this latest attack on the U.S. patent system, that if Mr. Crovitz were forced to choose, he might pick unfettered access to his Blackberry device over access to new pharmaceuticals. And while that might be fine for him, it’s not a choice the rest of us may be willing to make.

Mr. Crovitz served as executive vice-president of Dow Jones, where he launched the company’s Consumer Media Group, integrating the print, online, television, and digital editions of The Wall Street Journal, MarketWatch.com, and Barron’s. He left Dow Jones in December 2007, when Dow Jones was acquired by News Corp.

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

• "The Wall Street Journal’s Problem with the U.S. Constitution," November 14, 2007
• "The Wall Street Journal Gets It Half Right," November 5, 2007
RNAi Patent Revoked by EPO

July 14, 2008

By Kevin E. Noonan —

Last Friday, the European Patent Office revoked (in its entirety) European Patent No. EP 1 230 375, owned by Cancer Research Therapeutics Ltd. of Cambridge, UK and exclusively licensed to Alnylam Pharmaceuticals, Inc. The patent was opposed by several companies involved in commercializing RNA interference (RNAi), including Sanofi-Aventis Deutschland GmbH, Sirna Therapeutics, Nucleonics, Inc., Quark Biotech, and Silence Therapeutics AG.

The patent, commonly referred to as the "Glover patent" based on the name of the first inventor, contained broad claims but were also limited by disclosure of (relatively) long double-stranded RNA species, which have been associated with provoking immune responses and interferon production in mammals. Alnylam retains licenses to patents relating to smaller species (15-21 nucleotides) having more commercial potential as drugs. These include the Crooke Patents (U.S. Patent Nos. 5,898,031 and 6,107,094 and EP 0 928 290) licensed exclusively from Isis Pharmaceuticals; the Kreutzer-Limmer I and II patents (European Patent Nos. EP 1 144 623, EP 1 214 945 and EP 1 352 061); the Tuschl II patents (U.S. Patent Nos. 7,056,704 and 7,078,196) exclusively licensed fom the Max Planck Society; as well as patents on chemically-modified RNAi variants, including U.S. Patent Nos. 5,670,633; 6,005,087; and 6,531,584.

Alnylam downplayed the EPO’s revocation in a press release (see "Alnylam Provides Update on "Glover’ Patent"), asserting its intention to appeal the decision.
Cellectis and Regeneron Resolve Licensing Dispute

July 13, 2008

By Donald Zuhn —

Earlier this month, Cellectis SA, based in Romainville Cedex, France, announced that it had reached an agreement with Regeneron Pharmaceuticals, Inc., of Tarrytown, NY, concerning the use of the French biotech company’s homologous recombination patent estate. Under the agreement, Regeneron would pay the French biotech company $12.45 million for the use the Cellectis patents. Cellectis noted that the agreement resolved a more than four-year-old dispute regarding a licensing agreement the companies entered into in December 2003. According to Cellectis’ press release, the dispute concerned the interpretation of the 2003 agreement, which encompassed patents and patent applications directed to a process for the specific replacement of genes by homologous recombination.

In addition to the $12.45 million payment, Regeneron will also pay Cellectis "a low single-digit royalty" based on revenue received by Regeneron from future licenses or sales of its VelociGene® or VelocImmune® products and services. Under the terms of the agreement, Regeneron will not have to pay royalties with respect to its prior licensing deals with AstraZeneca UK Ltd., Astellas Pharma Inc., and sanofi-aventis, or its commercial sales of antibodies based on Regeneron’s VelocImmune technology. Finally, the agreement between Cellectis and Regeneron calls for Regeneron to purchase of 368,301 ordinary shares of Cellectis stock.

For additional information regarding the agreement, please see:

• A report on the agreement by The Business Review
Court Report

July 13, 2008

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.

Abbott Laboratories v. Dr. Reddy’s Laboratories, Inc. et al.
3:08-cv-03390; filed July 8, 2008 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,511,678 ("Controlled Release Formulation of Divalproex Sodium," issued January 28, 2003), 6,528,090 (same title, issued March 4, 2003), 6,713,086 (same title, issued March 30, 2004), and 6,720,004 (same title, issued April 13, 2004) following a paragraph IV certification as part of Dr. Reddy’s filing of an ANDA to manufacture a generic version of Abbott’s Depakote® ER (divalproex sodium, used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches). View the complaint here.

Enzo Life Sciences, Inc. v. Eiken Kagaku Kabushiki Kaisha
1:08-cv-00692; filed July 3, 2008 in the Eastern District of Virginia

Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Eiken in the interference between U.S. Patent Application No. 10/306,990 ("Novel Methods for Amplifying and Detecting Nucleic Acid Sequences," filed November 29, 2002), assigned to Enzo and U.S. Patent Nos. 6,410,278 ("Process for Synthesizing Nucleic Acid," issued June 25, 2002) and 6,974,670 ("Method of Synthesizing Nucleic Acid," issued December 13, 2005), assigned to Eiken. View the complaint here.

Celgene Corp. et al. v. Barr Laboratories, Inc. et al.
2:08-cv-03357; filed July 2, 2008 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,629,327 ("Methods and Compositions for Inhibition of Angiogenesis," issued May 13, 1997) and 6,235,756 ("Methods and Compositions for Inhibition of Angiogenesis by Thalidomide," issued May 22, 2001) following a paragraph IV certification as part of Barr’s amended filing of an ANDA to manufacture a generic version of Celgene’s Thalomid® (thalidomide, used to treat multiple myeloma and erythema nodosum leprosum). View the complaint here. As reported here and here, Celgene has previously asserted other patents against Barr based on the same ANDA filing.
Conference & CLE Calendar

July 13, 2008

July 16, 2008 – Patent Claim Construction Workshop (Law Seminars International) – Seattle, WA

July 24-25, 2008 – Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

August 11-12, 2008 – Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

August 10-15, 2008 – Advanced Courses (Patent Resources Group) – Washington, DC

September 11, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – New York, NY

September 11-12, 2008 – Current Issues in Complex IP Licensing (Law Seminars International) – Philadelphia, PA

September 15-16, 2008 – Biotech Patents*** (American Conference Institute)

September 21-23, 2008 – 2008 Annual Meeting (Intellectual Property Owners Association) – San Diego, CA

September 22-23, 2008 – USPTO Boot Camp: Patent Edition*** (American Conference Institute) – Alexandria, VA

September 22-23, 2008 – FDA Boot Camp*** (American Conference Institute)

September 22-23, 2008 – Patent Litigation 2008 (Practising Law Institute) – San Francisco, CA

October 6-7, 2008 – Patent Litigation 2008 (Practising Law Institute) – McLean, VA

October 7-8, 2008 – Global Patent Litigation*** (American Conference Institute) – New York, NY

October 15, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

October 15-17, 2008 – Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) – New York, NY

October 23-24, 2008 – Patent Litigation 2008 (Practising Law Institute) – Chicago, IL

November 10-11, 2008 – Patent Litigation 2008 (Practising Law Institute) – Atlanta, GA

November 17-18, 2008 – Patent Litigation 2008 (Practising Law Institute) – New York, NY

***Patent Docs is a media sponsor of this conference or CLE
ACI Global Patent Litigation Conference

July 11, 2008

American Conference Institute (ACI) will be holding its Global Patent Litigation conference on October 7-8 in New York. The conference will allow attendees to:

• Develop a strategic plan for where to file patents based on existing jurisdictional factors;
• Ensure that patent rights will be enforced through a clear assessment of patent filing requirements in different countries;
• Avoid inconsistencies in claim construction, drafting, and translation;
• Decide where to litigate through key jurisdictional decision-making;
• Collaborate with outside counsel to understand foreign patent laws and procedures;
• Navigate international court systems including in the EU and China;
• Craft arguments to obtain adequate relief or damages in foreign jurisdictions;
• Assist emerging foreign companies with navigating the litigation landscape in the U.S.; and
• Align litigation strategies with corporate goals.

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

•
Deconstructing the international legal landscape — Deciding where to file patents to minimize future litigation risks;
• Establishing a strategic enforcement assessment plan determining whether you have the rights to enforce a patent in a particular jurisdiction;
• Ensuring that strategic litigation decisions coincide with international business goals;
• Identifying inconsistencies in claim construction, drafting, and translation across jurisdictions and using them to your advantage in litigation;
• Identifying and assigning outside counsel who have a thorough understanding of the complexities surrounding multi-jurisdictional litigation;
• Developing critical strategies for litigating in Europe based on judicial practices, efficiency, and laws in the different countries;
• The next wave: Assisting emerging foreign companies with navigating the litigation landscape in the U.S.;
• Striking the balance between China’s lucrative potential, its impediment to IP protection, and your litigation risks;
• Mitigating the risks of costly, unnecessary litigation — Choosing a viable yet effective alternative; and
• Assessing the likelihood of obtaining adequate relief or damages in foreign jurisdictions.

An additional pre-conference workshop entitled: "Developing a practical multi-country approach for patent enforcement, litigation management, and execution" will be offered on October 6, 2008. The pre-conference workshop will touch upon all of the factors that arise in multi-country litigation and set the framework for the two-day conference, from choosing the venue, to gathering evidence to obtaining damages. In addition, the pre-conference workshop will use a real world hypothetical to help attendees understand the rules and nuances of the court systems of major jurisdictions and to show attendees how to devise different litigation strategies depending on the countries in which one is litigating.

The agenda for the Global Patent Litigation 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 $2,195 (conference alone) to $2,795 (conference and pre-conference workshop). Those registering on or before August 8, 2008 will receive a $300 discount off the registration fee and those registering on or before September 12, 2008 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 Global Patent Litigation conference.

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