Patent Docs

Biotech/Pharma Lobbying Scoreboard - Third Quarter Update - Part II

    By Donald Zuhn --

Earlier this month, we reported on the lobbying efforts of nine biotech/pharma companies and organizations in the third quarter of 2008 (see "Biotech/Pharma Lobbying Scoreboard - Third Quarter Update; BIO Lobbies for Biotech 'Bailout'").  Recent news reports have allowed us to add thirteen biotech/pharma companies and a trade group to the list:

• The Pharmaceutical Research and Manufacturers of America (PhRMA), which has more than 30 members including Bristol-Myers Squibb Co., GlaxoSmithKline PLC, Johnson & Johnson, Merck & Co., Novartis Corp., Pfizer Inc., and Sanofi-Aventis SA, spent more than $5.4 million on third quarter lobbying (see Forbes.com report).  According to organization's October 20 filing with the House clerk's office, the trade group's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.  The group's filing also indicates that current PhRMA president and chief executive, and former Louisiana Representative, Billy Tauzin; Mimi Kneuer, former chief of staff to Rep. Tauzin; Amy Efantis, former legislative director for Rep. Artur Davis (D-AL); Valerie Jewett, former legislative director for Rep. Rodney Frelinghuysen (R-NJ); and Matt Sulkala, former senior legislative assistant to Rep. Allen Boyd (D-FL), lobbied on behalf of the PhRMA.

• Eli Lilly and Co. spent more than $3.3 million on third quarter lobbying (see Yahoo! Finance report).  According to Lilly's October 14 filing with the House clerk's office, the drugmaker's lobbying efforts were directed in part at patent reform legislation and international patent enforcement.

• Pfizer Inc. spent almost $3.1 million on third quarter lobbying (see Forbes.com report).  According to Pfizer's October 27 filing with the House clerk's office, the drugmaker's lobbying efforts were directed in part at patent reform legislation, free trade issues, and tax credits for companies investing in drug research and development.

• GlaxoSmithKline spent nearly $2 million on third quarter lobbying (see Forbes.com report).  According to GSK's October 20 filing with the House clerk's office, the drugmaker's lobbying efforts were directed in part at patent reform and follow-on biologics legislation as well as patent provisions of free-trade agreements with Peru, Colombia, Panama, and South Korea.  The company's filing also indicates that Jeffrey Ringer, former legislative aide for Rep. Mary Fallin (R-OK), Sen. Elizabeth Dole (R-NC), and former Sen. Conrad Burns (R-MT), lobbied on behalf of GSK.

• Abbott Laboratories spent almost $1.8 million on third quarter lobbying (see Forbes.com report).  According to Abbott's October 20 filing with the House clerk's office, the drug and medical device maker's lobbying efforts were directed in part at patent reform legislation.  The company's filing also indicates that Karen Hauda, former senior director with the U.S. Trade Representative's office, lobbied on behalf of Abbott.

• Johnson & Johnson spent $1.5 million on third quarter lobbying (see Motley Fool report).  According to Johnson & Johnson's October 17 filing with the House clerk's office, the health care company's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.

• Novartis AG spent nearly $1.4 million on third quarter lobbying (see Netscape Money & Business report).  According to Novartis' October 17 filing with the House clerk's office, the pharmaceutical company's lobbying efforts were directed in part at patent reform and follow-on biologics legislation as well as patent provisions of free-trade agreements with Peru, Colombia, and South Korea.

• Merck & Co. Inc. spent $1.11 million on third quarter lobbying (see Forbes.com report).  According to Merck's October 17 filing with the House clerk's office, the drugmaker's lobbying efforts were directed in part at patent reform legislation and international protection of drug patents.

• Bristol-Myers Squibb Co. spent $840,000 on third quarter lobbying (see Forbes.com report).  According to BMS' October 16 filing with the House clerk's office, the pharmaceutical company's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.

• Wyeth spent $756,650 on third quarter lobbying (see Forbes.com report).  According to Wyeth's October 20 filing with the House clerk's office, the drug and medical pharmaceutical company's lobbying efforts were directed in part at follow-on biologics legislation.

• Emergent BioSolutions Inc. spent $575,000 on third quarter lobbying (see Forbes.com report).  According to Emergent's October 17 filing with the House clerk's office, the biopharmaceutical company's lobbying efforts were directed in part at government stockpiling of biodefense vaccines.

• Allergan Inc. spent $460,000 on third quarter lobbying (see Forbes.com report).  According to Allergan's October 19 filing with the House clerk's office, the biotech company's lobbying efforts were directed in part at follow-on biologics legislation.

• Covidien Ltd. spent $450,000 on third quarter lobbying (see Forbes.com report).  According to Covidien's October 20 filing with the House clerk's office, the health care products company's lobbying efforts were directed in part at patent reform legislation.

• Gilead Sciences Inc. spent $240,000 on third quarter lobbying (see MSN Money report).  According to Gilead's October 27 filing with the House clerk's office, the biotech drug maker's lobbying efforts were directed in part at global health and international trade issues.

In addition, a report indicates that the U.S. Chamber of Commerce, which represents more than three million businesses in a wide array of industries, spent $20.6 million on third quarter lobbying (see Forbes.com report).  According to organization's October 20 filing with the House clerk's office, the group's lobbying efforts were directed in part at health care and labor issues.  The Chamber of Commerce filing also indicates that Kai Hirabayashi, a former special assistant in the Labor Department; Jennifer Osika, former senior legislative assistant to Rep. Don Manzullo (R-IL); and Becky Fraser, former senior legislative assistant to Rep. Cass Ballenger (R-NC), lobbied on behalf of the group.

In response to our most recent report on biotech/pharma lobbying, a Patent Docs reader inquired about the lobbying costs of IT companies and organizations, which unlike their biotech/pharma counterparts, have favored more "radical" patent reform.  An online search revealed that a number of IT companies and organizations disclosed significant third quarter lobbying expenditures, including:

• Comcast Corp. -- $3.2 million (see Forbes.com report)
• Microsoft Corp. -- $2 million (see Forbes.com report)
• SAP AG -- $880,000 (see Yahoo! Finance report)
• Google Inc. -- $720,000 (see Yahoo! Finance report)
• Yahoo Inc. -- $570,000 (see International Business Times report)
• Consumer Electronics Association (CEA), a trade group that includes Dell Inc., Microsoft Corp., and Best Buy Co. -- $440,000 (see Yahoo! Finance report)
• Digital Media Association, a trade group that includes Apple Inc., Viacom Inc., and Microsoft Corp. -- $251,413 (see Forbes.com report)

Among the IT entities specifically disclosing that their third quarter lobbying expenses were directed in part at patent reform legislation were Microsoft, Google, and Yahoo.

For additional information regarding this topic, please see:

• "Biotech/Pharma Lobbying Scoreboard - Third Quarter Update; BIO Lobbies for Biotech 'Bailout'," December 19, 2008
• "Biotech/Pharma Lobbying Scorecard - Second Quarter Update - Part II," September 12, 2008
• "Biotech/Pharma Lobbying Scoreboard - Second Quarter Update," August 21, 2008
• "Biotech/Pharma Lobbying Scoreboard - Part II," June 30, 2008
• "Biotech/Pharma Lobbying Scoreboard" June 6, 2008
• "Lobbying Spending Spree Continues," May 20, 2008
• "Abbott's First Quarter Lobbying Tab Hits $880,000," May 2, 2008

Acumed LLC v. Stryker Corp. (Fed. Cir. 2008)

    By Kevin E. Noonan --

There are the inklings of a stratagem taking shape in certain of the Federal Circuit's decisions since the spate of Supreme Court rejections of large portions of its jurisprudence.  That stratagem involves refusing to overturn district court decisions based on applying an abuse of discretion standard, as evidenced in the Federal Circuit's decision to affirm grant of a permanent injunction in Acumed LLC v. Stryker Corp.

The case involved a patent to an orthopedic nail used to reconstruct and stabilize a broken humerus.  The CAFC previously vacated a permanent injunction granted prior to the Supreme Court's decision in eBay Inc. v. MercExchange, L.L.C., which mandated that the traditional "four factor" test for granting injunctions was to be applied in patent cases.  This mandate overruled the Federal Circuit's "general rule [in patent cases] that an injunction will issue, once infringement and validity have been adjudged . . . unless there are some exceptional circumstances that justify denying injunctive relief."  Thus, the District Court revisited the issue based on a proper application of the law and arrived at the same conclusion.

In making its determination that a permanent injunction was permissible in this case, the District Court considered together the four-factor test prongs of whether there was irreparable harm to patentee Acumed and whether the remedy at law (money damages) was adequate compensation as a remedy.  Stryker presented evidence that Acumed previously had granted licenses for the patent-in-suit (U.S. Patent No. 5,472,444) to two other competitors, Smith & Nephew and Zimmer.  The District Court distinguished this behavior on the grounds that, first, Acumed had granted the Smith & Nephew license to settle litigation, and second, that Zimmer was not direct competitor when Acumed granted it a license.

The Federal Circuit, in a unanimous opinion written by Judge Lourie and joined by Judges Mayer and Gajarsa, found none of this to be an abuse of discretion.  The Court asserted that eBay itself stated that a patentee's willingness to license patents to others was not sufficient by itself to preclude a determination that a patentee would be irreparably harmed or that money damages would be an insufficient remedy.  The Court asserted that prior licenses were but one factor a court could consider in deciding whether the evidence favored vel non grant of a permanent injunction.  "Adding a new competitor to the market may create an irreparable harm that the prior licenses did not," according to the Court.  In a footnote, the Court noted that it did not consider whether an injunction would be appropriate in other circumstances where a patentee had granted licenses to third parties, thus avoiding creation of any per se rules in this regard.

Regarding the balance of the hardships, the District Court was persuaded by Acumed's evidence that Stryker had available a non-infringing alternative (a straight rather than a curved humeral nail), and that Stryker was the world's largest orthopedic implant company (so sales of its infringing humeral nail were only a small portion of its sales, whereas the Acumed nail was its flagship product).  The District Court rejected Stryker's argument that a permanent injunction would cause harm to itself, its customers and patients, as well as Stryker's argument that Acumed would benefit from receiving a royalty, since it would gain access to Stryker's "otherwise inaccessible" customers.  The Federal Circuit found none of the District Court's reasoning to be error or an abuse of discretion.  Stryker's evidence of the expense incurred in designing and marketing were irrelevant to the hardships determination, according to the CAFC, because "[o]ne who elects to build a business on a product found to infringe cannot be heard to complain if an injunction against continuing infringement destroys the business so elected," citing Windsurfing Int'l. Inc. v. AMF, Inc., 782 F.2d 995, 1003 n.12 (Fed. Cir. 1986).  The Federal Circuit also found no abuse of discretion in the District Court's determination that Stryker's failure to introduce into the U.S. a straight-nail embodiment of its humeral nail was a business decision that did not tip the balance of hardships in Stryker's favor. 

For the fourth factor, the public interest, the District Court found that this factor did not mitigate against the permanent injunction.  Stryker argued that its infringing humeral nail was "demonstrably safer and superior" to Acumed's product, citing trial testimony from five expert witnesses.  Stryker also contended that Acumed's product had specific deficiencies compared with its infringing product.  The District Court found that Stryker had not established "sufficient objective evidence of any public health issue" that would turn the public interest prong of the four-factor test in its favor.  The lower court also noted that "there was 'considerable dispute at trial' whether Stryker's evidence was the product of biased experts."  Finally, the District Court found that there were non-infringing alternatives to Acumed's product (ironically, the Zimmer and Smith & Nephew licensed products) available to satisfy any portion of the market Acumed was incapable of serving, so that patients would not be harmed by the injunction.  The Federal Circuit credited all these decisions as being within the sound discretion of the trial court, and found none of them to be an abuse of discretion.

Perhaps it is the proper role of an appellate court to defer so assiduously to the decisions made by a district court that rely heavily of factual determinations depending on the demeanor and believability of witnesses, live testimony, and trial advocacy relating thereto.  And perhaps it has been the tendency of the Federal Circuit in many areas, most notably claim construction, to refuse to so defer, or to provide reasoning supporting its lack of deference (such as its Congressionally-mandated role of providing consistency and harmony to patent law) that makes it appear unusual that the Federal Circuit is so compliant with regard to the district court's assessment and balancing of the evidence in granting the injunction.  An inescapable consequence of this compliance, however, is that Federal Circuit also avoids any substantive decision-making in affirming the injunction, based on an abuse of discretion standard it defines as "a clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings."  Using this standard makes it less likely that there will be any readily-reviewable basis for the Supreme Court to grant certiorari in a case like this.  Avoiding another opportunity for its jurisprudence to be overruled may be all the justification the CAFC needs to be deferential for a while.

Acumed LLC v. Stryker Corp. (Fed. Cir. 2008)
Panel: Circuit Judges Mayer, Lourie, and Gajarsa
Opinion by Circuit Judge Lourie

BIO Says CBO Estimate of Follow-on Biologics Savings Is Based on "Troubling Assumption"

    By Donald Zuhn --

Earlier this month, the Congressional Budget Office (CBO) issued a report, entitled "Budget Options, Volume I, Health Care," that presents 115 options for changing U.S. health care policy.  In the Preface to the report, the CBO states that "[t]he inclusion or exclusion of a particular policy change does not represent an endorsement or rejection" by the CBO, and that the report provides arguments for and against each option.  The report's Preface also notes that in keeping with the CBO's mandate to provide objective analysis, the report makes no recommendations.

Option 68 of the report provides a discussion regarding the establishment of an abbreviated regulatory pathway for approving follow-on biologics under the Public Health Service Act.  Under such a regulatory scheme, manufacturers seeking FDA approval for generic biologic drugs (often referred to as follow-on biologics or biosimilars) would be allowed to rely on clinical data and information submitted by manufacturers of brand-name biologics during the approval process of the brand-name biologic.  The report states that:

By streamlining the approval process, multiple manufacturers of follow-on biologics would be likely to enter the market, particularly for top-selling products; such competition would put downward pressure on prices and help lower expenditures on biologic products for both the federal government and private purchasers of health insurance.

Interestingly, despite the controversy between generic and brand-name manufacturers concerning the issue of data exclusivity, the CBO report simply states that its follow-on biologics option "would grant brand-name biologics 12 years of exclusivity during which time no follow-on biologic could be approved."  The report also indicates, not surprisingly, that data exclusivity periods of more than 12 years would reduce estimated savings, and data exclusivity periods of less than 12 years would increase estimated savings.  

The CBO report also outlines a modified version of its follow-on biologics option in which the Centers for Medicare and Medicaid Services would be required to place follow-on biologics in the same billing code as their brand-name counterparts for making payments under Medicare Part B.  The report notes that such a modification "would financially penalize physicians who did not dispense follow-on biologics, when available, to patients enrolled in Medicare Part B," explaining that because reimbursements to physicians would be based on the average cost of the brand-name drug and all follow-on biologic counterparts, physicians would not receive full reimbursement for prescribing brand-name drugs (assuming that such drugs would be priced higher than their generic counterparts).  Moreover, under such a scheme, "physicians would benefit financially from using follow-on biologics because they would be less expensive and physicians would be allowed to retain the difference between the acquisition cost of the biologic and Medicare's payment."

The report predicts that implementation of a follow-on biologics regulatory scheme would save health programs such as Medicare and Medicaid about $8.1 billion over the 2010–2019 period, as well as reduce costs for private health insurance plans and lower insurance premiums for employers by almost 0.2% by 2019.  However, if the modification discussed above was also implemented, the report indicates that Medicare and Medicaid savings would increase to $10.6 billion over the 2010-2019 period.

The report lists the reduction in health care expenditures for both government programs and private payers as an advantage of the follow-on biologics option, and a reduction in returns associated with the development of new biologics, and resulting reduction in investment in the research and development of new biologics, as a "potential" disadvantage.  The report notes, however, that after a regulatory pathway was established for small molecule drugs in 1984, investment in such drugs continued to grow.

On December 19th, the Biotechnology Industry Organization (BIO) released a statement regarding option 68 of the CBO report, and in particular, the proposal to modify payments for biologic drugs under Medicare Part B.  According to the BIO release "[t]he CBO estimate is based on a troubling assumption that reimbursement rules for biologics would be changed in a way that would financially incentivize physicians to switch patients to a cheaper follow-on version of a product at the potential expense of patient safety and therapeutic efficacy."  Concluding that "[t]he change would establish a perverse incentive to prescribe the lower-cost biosimilar regardless of efficacy or safety concerns," the BIO release notes that while the industry trade group supports the establishment of a follow-on biologics regulatory pathway, any regulatory scheme "must place ensuring patient safety -- not potential cost savings -- as the central concern."

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

• "Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient," November 20, 2008
• "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation," September 18, 2008
• "Congressional Fact-finding on Follow-on Biologics," August 13, 2008
• "CBO Releases Report on Senate Follow-on Biologics Bill; BIO Calls for Congress to Pass Biologics Bill in 2008," July 1, 2008
• "Follow-on Biologic Drugs and Patent Law: A Potential Disconnect?" March 25, 2008
• "New Follow-on Biologics Bill Introduced in the House," March 18, 2008
• "Dr. Robert Shapiro Discusses Follow-on Biologics Report," February 19, 2008
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part II," February 14, 2008
• "Biologics Legislation Faces Unresolved Issues," December 28, 2007
• "Senate Committee Passes Biologics Legislation" July 5, 2007

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.

Bayer HealthCare LLC v. Abbott Laboratories et al.
6:08-cv-00507; filed December 24, 2008 in the Eastern District of Texas

Infringement of U.S. Patent No. 5,654,407 ("Human Anti-TNF Antibodies," issued August 5, 1997) based on Abbott's manufacture and sale of its Humira ® (adalimumab, used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis).  View the complaint here.

Eli Lilly and Company v. Lupin Pharmaceuticals, Inc. et al.
3:08-cv-06261; filed December 22, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Sun Pharmaceutical Industries, Inc. et al.
3:08-cv-06266; filed December 22, 2008 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,023,269 ("3-Aryloxy-3-Substituted Propanamines," issued June 11, 1991) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Lilly's Cymbalta® (duloxetine hydrochloride, used to treat depression and generalized anxiety disorder and for the management of diabetic peripheral neuropathic pain and fibromyalgia).  View the Lupin complaint here.

Sanofi-Aventis U.S. LLC et al. v. Ebewe Pharma GES.M.B.H. NFG.KG
3:08-cv-06243; filed December 19, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 5,338,874 ("Cis oxalato (trans 1-1,2-cyclohexanediamine) PT(II) Having Optically High Purity," issued August 16, 1994) following a Paragraph IV certification as part of Ebewe's filing of an ANDA to manufacture a generic version of plaintiffs' Eloxatin® (oxaliplatin for injection, used to treat colorectal cancer).  View the complaint here.

Novartis Corp. et al. v. Teva Parenteral Medicines Inc. et al.
1:08-cv-00952; filed December 18, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 4,939,130 ("Substituted Alkanediphosphonic Acids and Pharmaceutical Use," issued July 3, 1990) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Reclast® (zoledronic acid injection, once-yearly treatment for postmenopausal osteoporosis).  View the complaint here.

Novartis Corp. et al. v. Cobalt Laboratories, Inc. et al.
2:08-cv-06223; filed December 18, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,162,802 ("Synergistic Combination Therapy Using Benazepril and Amlodipine for the Treatment of Cardiovascular Disorders and Compositions Therefor," issued December 19, 2000) following a Paragraph IV certification as part of Cobalt's filing of an ANDA to manufacture a generic version of Novartis' Lotrel® (amlodipine besylate/benazepril hydrochloride, used to treat hypertension).  View the complaint here.  [As previously reported in Court Report, Novartis filed suit against Cobalt earlier this year on this same patent based on an ANDA directed to different dosage forms.]

Conference & CLE Calendar

January 3-7, 2009 - 26th Annual National CLE Conference (Law Education Institute) - Vail, CO

January 12-13, 2009 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - San Diego, CA

January 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MD

January 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, England

January 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC

January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NY

January 29-30, 2009 - Commercialization of Life Sciences Inventions (Law Seminars International) - Phoenix, AZ

January 29-30, 2009 - Fourth Annual Conference on Best Practices in Patent Monetization (Law Seminars International) - San Francisco, CA

February 13, 2009 - Fourth Annual Workshop on Patent Claim Construction (Law Seminars International) - Chicago, IL

February 17-18, 2009 - Pharma/Biotech Patent Litigation (C5) - Amsterdam, Netherlands

February 23-24, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - Palo Alto, CA

February 25-26, 2009 - Optimizing Patent Strategies at Patent Forum 2009 (World Research Group) - San Francisco, CA

March 9-10, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - Research Triangle Park, NC

March 30-31, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - New York, NY

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

LSI Patent Claim Construction Workshop

Law Seminars International (LSI) will be holding its Fourth Annual Workshop on Patent Claim Construction on February 13, 2009 in Chicago, Illinois.  The workshop will provide information on:

• Review of recent Federal Circuit Court decisions;
• Evidentiary hearings:  Successful summary judgment motions;
• Patentee and defendant concerns and strategies in litigation;
• What is persuasive and what is not in a view from the bench;
• Ethics rules and practical tips of particular importance in patent claims.

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

• The claim construction game;
• Claim construction issues on appeal to the Federal Circuit;
• Litigation strategies from plaintiff and defendant perspectives;
• Adapting to the changes in the law:  Tips for successful claim and specification drafting to avoid undesired or unpredictable results;
• View from the bench;
• The development of claim construction theory and practice;
• Using demonstrative evidence to help win claim construction disputes; and
• Ethics.

The agenda for the Patent Claim Construction workshop can be found here.  A complete brochure for this workshop, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee is $447.50 for students and new employees, $695 for government employees, or $895 for all other attendees.  Those interested in registering for the workshop can do so here, by calling 1-800-854-8009, or by faxing a registration form to 1-206-567-5058.

WRG Patent Forum 2009

World Research Group (WRG) will be holding its Optimizing Patent Strategies at Patent Forum 2009 on February 25-26 in San Francisco, California.  The conference will provide instruction regarding the best practices for creating a comprehensive patent strategy while maintaining a strong IP portfolio, avoiding litigation pitfalls, and managing case law changes.

Among the presentations to be offered by WRG faculty are:

• Establishing a comprehensive patent strategy from start to finish;
• Examining your patent strategy to avoid litigation pitfalls;
• Identifying changes with patent reform in the Supreme Court and the Federal Circuit;
• Addressing best practices for patent prosecution;
• Avoiding IP licensing pitfalls;
• Leveraging involvement in patent pools:  When to do it and when to avoid it;
• Collaborating with all parties in building a strong patent portfolio;
• Looking outside the U.S. -- Implementing a successful international patent strategy;
• Redefining obviousness in the post-KSR period:  The implications and impact on litigation; and
• Understanding Chinese patent strategies.

The agenda for WRG's Patent Forum 2009 can be found here (Day One; Day Two).  A complete brochure for this conference, including an agenda and list of speakers, can be downloaded here.

The registration fee for the conference ranges from $1,895 (corporate rate) to $2,195 (law firm rate).  Those registering by January 9, 2009 will receive a $300 discount off the registration fee.  Those interested in registering for the conference can do so here, by sending an e-mail to [email protected], by calling 1-800-647-7600 or 1-781-939-2500, or by faxing 1-781-939-2543.

Happy Holidays from Patent Docs

The authors and contributors of Patent Docs wish their readers a Happy Holidays.  Publication of Patent Docs will resume on December 26th.

USPTO News: Patent Prosecution Highway Pilot with CIPO Is Extended

    By Donald Zuhn --

Yesterday, the U.S. Patent and Trademark Office announced that the USPTO and Canadian Intellectual Property Office (CIPO) will be extending the Patent Prosecution Highway (PPH) pilot program between the Offices for an additional two years to January 28, 2011.  The USPTO and CIPO will evaluate the results of the PPH pilot program at the end of the two-year period to determine whether and how the program should be fully implemented.

As we reported earlier this year (see links below), the USPTO and CIPO initiated the one-year PPH pilot on January 28, 2008.  The objective of the PPH is to share the results of each Office's searches in order to make examination more efficient.  The PPH allows an application that has allowable/patentable claims as determined in the Office of first filing (OFF) to have a corresponding application in the Office of second filing (OSF) to be advanced out of turn for examination, and give the OSF access to the search and examination results from the OFF.  Thus, the applicant can enjoy accelerated examination in the OSF, which is based on the art and examination already dealt with in the OFF.

Inquiries regarding the PPH pilot program should be directed to Magdalen Greenlief at 571-272-8800 or via e-mail (Magdalen.greenlief@us~to.gov).

For additional information regarding this topic, please see:
• "Patent Prosecution Highway Network Expands to Canada & Korea," January 29, 2008
• "USPTO Announces Two Additional Partners in the Patent Prosecution Highway Pilot Program," January 17, 2008

USPTO News: Patent Office Closed on December 26th

    By Donald Zuhn --

Yesterday, the U.S. Patent and Trademark Office (USPTO) announced that the USPTO will be closed on Friday, December 26, 2008.  The USPTO notice states that because December 25th is a federal holiday, the Office will consider December 26th to be a "Federal holiday within the District of Columbia."  As a result, any action or fee due on December 25th or December 26th will be considered timely if the action is taken or the fee is paid on Monday, December 29, 2008 (i.e., the next business day on which the Office is open).  Applicants are reminded that any correspondence sent to the USPTO via United States Postal Service (USPS) Express Mail will be considered filed on the date of deposit with the USPS, and any correspondence transmitted electronically to the USPTO will be considered filed with the USPTO on the date the USPTO received the electronic transmission.

Classen Immunotherapies, Inc. v. Biogen Idec (Fed. Cir. 2008)

    By Kevin E. Noonan --

The Federal Circuit engaged in judicial parsimony last week, in affirming the decision below that the asserted claims of U.S. Patent No. 5,723,283 are invalid for failure to encompass statutory subject matter.  The opinion, written by Judge Moore and joined by Judge Newman and District Court Judge Joseph Farnan of the District of Delaware, sitting by designation, reads in its entirety as follows:

In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court's grant of summary judgment that these claims are invalid under 35 U.S.C. § 101.  Dr. Classen's claims are neither "tied to a particular machine or apparatus" nor do they "transform[] a particular article into a different state or thing."  Bilski, 545 F.3d at 954.  Therefore we affirm.

The opinion is 69 words.  At 89 words, the claim at issue is longer:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

The result is also anomalous because the Classen case was widely viewed as foreshadowing how the Federal Circuit will address the issues raised by Laboratory Corp. v. Metabolite Labs., Inc. (LabCorp), and Justice Breyer's criticism of the scope of that claim under a patentability analysis.

The following is the claim at issue in the Labcorp case:

13.  A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:  assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

There are parallels between the structure of this claim and the Classen claim.  Each recites a preamble directed to identifying a biological phenomenon (a vitamin deficiency in Labcorp, a chronic immune-related disorder related to a acute immunization schedule in Classen), comprising an unambiguous diagnostic/tangible step (assaying a bodily fluid to detect elevated homocysteine levels in Labcorp, immunizing mammals with one or more doses of one or more immunogens, according to an immunization schedule in Classen), followed by an interpreting step (correlating elevated homocysteine with the vitamin deficiency in Labcorp, comparing the incidence, prevalence, frequency or severity of chronic immune-mediated disorders in mammals immunized according to the immunization schedule in Classen).

Now it cannot be the case that all diagnostic claims are per se invalid, suggesting that the claims in both Labcorp and Classen are particularly deficient, in reciting limitations to "correlate" or "compare" results of assays or actions clearly falling within the scope of 35 U.S.C. § 101 as statutory subject matter.  It may be (although it is not clear from the reasoning in Bilski) that the Federal Circuit would consider the claim to be patent-eligible if the comparing or correlating steps were "tied to a particular machine or apparatus" (such as a clinical diagnostic computer); it is clear that such claims would be significantly more narrow and less valuable.

What these claims have in common is that they use the results of a tangible step (assaying or immunizing) to provide the raw material, information, used in the second part of each claim.  This is the relevance of Bilski, and the only apparent rationale for the court's decision in Classen:  what is at issue is whether methods for using, interpreting, or manipulating information, from financial markets or clinical results, can be patented.  The informational component bedevils the analysis, because it removes claims like the claims in Labcorp and Classen from the comfort of typical chemical/pharma claims.

But the Federal Circuit's rote application of Bilski to the Classen claims raises the question of whether diagnostic claims should be patentable.  That the diagnostic methods in Labcorp and Classen are biological/medical methods should not be dispositive, under the Federal Circuit's "technology-neutral" approach to patent law and the Supreme Court's decision in Diamond v. Chakrabarty.  It is thus interesting to speculate on whether the court would come to the same conclusion with regard to claim 1 of U.S. Patent No. 7,464,002:

A diagnosis method for boiler degradation, comprising:  calculating a first thermal transmission rate from a difference in thermal quantity of gas or steam between an entrance and exit of a heat exchanger with respect to at least one heat exchanger constituting the boiler; calculating a second thermal transmission rate based upon a thermal conductivity rate of pipes and thermal conductivity transfer rate of steam and gas of the heat exchanger; comparing the first and second thermal transmission rates; and carrying out diagnosis of the progress of degradation, wherein the diagnosis is displayed on a display device, wherein the boiler is a heat recovery boiler for recovering heat from a gas turbine.

While we are at a far remove from Sadie Carnot and Lord Rumsford, could it not be said that this claim has the very same problems as the Labcorp and Classen claims, provided the relationships between the thermal transmission rates and thermal conductivity are fundamental properties of thermodynamics?  And is this claim, from U.S. Patent No. 7,435,551, patentable under Classen?

A method for diagnosing type II diabetes, which comprises measuring a level of adiponectin (GBP28) having a trimer structure of GBP28 and/or a structure of aggregated GBP28 trimers in its natural state in a sample wherein a level of monomeric GBP28 is not measured, and correlating the level of GBP28 having a trimer structure and/or a structure of aggregated GBP28 trimers to diagnose type II diabetes and wherein a decrease in the level of said GBP28 is indicative of type II diabetes.

The answer to these questions await further developments.  The decision is non-precedential, and so the judicial impact is minimal.  But as of last week, the Court seems to have decided to address patentable subject matter questions using a mechanical application of the Bilski test, pending eventual Supreme Court review.

Classen Immunotherapies, Inc. v. Biogen Idec (Fed. Cir. 2008)
Nonprecedential disposition
Panel: Circuit Judges Newman and Moore and District Judge Farnan
Opinion by Circuit Judge Moore

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.

Pfizer Inc. et al. v. Apotex Inc. et al.
1:08-cv-00948; filed December 17, 2008 in the District Court of Delaware

Pfizer Inc. et al. v. Apotex Inc. et al.
1:08-cv-07231; filed December 17, 2008 in the Northern District of Illinois

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,273,995 ("[R-(R*R*)]-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, its lactone form and salts thereof," issued December 28, 1993) based on Apotex's filing of an ANDA to manufacture a generic version of Pfizer's Lipitor® (atorvastatin calcium, used to treat high cholesterol and heart disease).  View the Delaware complaint here.

Medimmune, LLC v. PDL Biopharma, Inc.
5:08-cv-05590; filed December 16, 2008 in the Northern District of California

Declaratory judgment of invalidity and non-infringement of U.S. Patent Nos. 5,585,089 ("Humanized Immunoglobulins," issued December 17, 1996), 5,693,761 ("Polynucleotides Encoding Improved Humanized Immunoglobulins," issued December 2, 1997), 5,693,762 ("Humanized Immunoglobulins," issued December 2, 1997), 6,180,370 ("Humanized Immunoglobulins and Methods of Making the Same," issued January 30, 2001), and 7,022,500 ("Humanized Immunoglobulins," issued April 4, 2006), based on Medimmune's manufacture and sale of its Synagis® (palivizumab, for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease) and Medimmune's manufacture of motavizumab (a next-generation anti-RSV antibody).  View the (amended) complaint here.

Monsanto Co. et al. v. Mason
3:08-cv-00886; filed December 15, 2008 in the Southern District of Illinois

Monsanto Co. et al. v. Thacker
3:08-cv-00885; filed December 15, 2008 in the Southern District of Illinois

Monsanto Co. et al. v. Thoroughman
4:08-cv-01931; filed December 12, 2008 in the Eastern District of Missouri

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendant's use of soybean seed produced from earlier planted Roundup Ready® soybean seed.  View the Mason complaint here.

Schering Corp. v. Orgenus Pharma Inc. et al.
3:08-cv-06102; filed December 12, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 7,405,223 ("Treating Allergic And Inflammatory Conditions," issued July 29, 2008) following a Paragraph IV certification as part of defendants' amendment of their ANDA to manufacture a generic version of Schering-Plough's Clarinex® (desloratidine, used to treat allergies) prior to the expiration of the '223 patent.  View the complaint here.

Eli Lilly and Company v. Wockhardt USA, Inc. et al.
3:08-cv-06135; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Actavis Elizabeth LLC
3:08-cv-06136; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Aurobindo Pharma USA, Inc. et al.
3:08-cv-06137; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Cobalt Laboratories, Inc.
3:08-cv-06138; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Sandoz, Inc.
3:08-cv-06124; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Impax Laboratories, Inc.
3:08-cv-06139; filed December 12, 2008 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,023,269 ("3-Aryloxy-3-Substituted Propanamines," issued June 11, 1991) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Lilly's Cymbalta® (duloxetine hydrochloride, used to treat depression and generalized anxiety disorder and for the management of diabetic peripheral neuropathic pain and fibromyalgia).  View the Wockhardt complaint here.

Gilead Sciences, Inc., v. Teva Pharmaceuticals USA, Inc. et al.
1:08-cv-10838; filed December 12, 2008 in the Southern District of New York

Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003) and 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate, used for the treatment of HIV-1 infection in adults).  View the complaint here.

Intervet Inc. v. Merial Ltd.
1:08-cv-02162; filed December 11, 2008 in the District Court of the District of Columbia

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 6,224,882 ("Insect Cells or Fraction as Adjuvant for Antigens," issued May 1, 2001) based on Intervet's manufacture and sale of its Circumvent® PCV (porcine circovirus vaccine).  View the complaint here.

Conference & CLE Calendar

January 3-7, 2009 - 26th Annual National CLE Conference (Law Education Institute) - Vail, CO

January 12-13, 2009 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - San Diego, CA

January 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MD

January 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, England

January 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC

January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NY

January 29-30, 2009 - Commercialization of Life Sciences Inventions (Law Seminars International) - Phoenix, AZ

January 29-30, 2009 - Fourth Annual Conference on Best Practices in Patent Monetization (Law Seminars International) - San Francisco, CA

February 17-18, 2009 - Pharma/Biotech Patent Litigation (C5) - Amsterdam, Netherlands

February 23-24, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - Palo Alto, CA

March 9-10, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - Research Triangle Park, NC

March 30-31, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - New York, NY

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

Biotech/Pharma Lobbying Scoreboard - Third Quarter Update; BIO Lobbies for Biotech "Bailout"

    By Donald Zuhn --

Patent Docs periodically reports on the lobbying efforts of various players in the biotech/pharma industry (see links below for reports on first and second quarter lobbying this year).  Our interest in the lobbying expenditures of these companies and organizations stems from the push by Congress over the past two years to pass patent reform and follow-on biologics legislation.  With both houses of Congress expected to renew their efforts to pass patent reform and follow-on biologics bills in 2009, we provide the following update on third quarter biotech/pharma lobbying activities:

• Amgen Inc. spent $2.4 million on third quarter lobbying (see Forbes.com report).  According to Amgen's October 20 filing with the House clerk's office, the biotech drugmaker's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.

• The Biotechnology Industry Organization spent more than $1.9 million on third quarter lobbying (see Forbes.com report).  According to the organization's October 20 filing with the House clerk's office, BIO's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.  The organization's filing also indicates that Patrick Carroll, a former legislative assistant to Representative Ray LaHood (R-IL); Tooshar Swain, who was a legislative correspondent to former Senator Rick Santorum (R-PA); and Bill Olson, a former legislative assistant to Representative John Shimkus (R-IL), lobbied on behalf of BIO.

• Genzyme Corp. spent $770,000 on third quarter lobbying (see Forbes.com report).  According to Genzyme's October 20 filing with the House clerk's office, the drugmaker's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.

• Baxter International Inc. spent $720,000 on third quarter lobbying (see Forbes.com report).  According to Baxter's October 20 filing with the House clerk's office, the drug and medical device maker's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.  The company's filing also indicates that Deborah Williams, a former House Ways and Means Committee staffer, lobbied on behalf of Baxter.

• Genentech Inc. spent $570,000 on third quarter lobbying (see Forbes.com report).  According to Genetech's October 20 filing with the House clerk's office, the biotech company's lobbying efforts were directed in part at follow-on biologics legislation.

• Amylin Pharmaceuticals Inc. spent $540,000 on third quarter lobbying (see Forbes.com report).  According to Amylin's October 17 filing with the House clerk's office, the biotech drugmaker's lobbying efforts were directed in part at follow-on biologics legislation.

• The Generic Pharmaceutical Association spent $506,976 on third quarter lobbying (see Forbes.com report).  According to the trade group's October 20 filing with the House clerk's office, the GPhA's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.

• Cephalon spent $476,543 on third quarter lobbying (see Forbes.com report).  According to Cephalon's October 20 filing with the House clerk's office, the biotech drugmaker's lobbying efforts were directed in part at patent reform legislation.

• Biogen Idec Inc. spent $180,000 on third quarter lobbying (see Forbes.com report).  According to Biogen's October 16 filing with the House clerk's office, the biotech drugmaker's lobbying efforts were directed in part at patent reform and follow-on biologics legislation.  The company's filing also indicates that Kathleen Weldon, a former House Ways and Means Committee staffer; and Adam Gluck, a former Senate Committee on Health, Education, Labor, and Pensions staffer, lobbied on behalf of Biogen.

In addition to the lobbying efforts described above, the Baltimore Business Journal and The Motley Fool recently reported that BIO has begun lobbying for government financial relief for certain members of the biotech industry (see "Biotech Companies Want Bailout Too" and "Drug Developers Want a Bailout, Too").  According to the Baltimore Business Journal, BIO is seeking a change in the tax laws to financially assist small companies, which have struggled to raise cash as a result of the year-long recession.  BIO contends that 25% of the 370 publicly traded U.S. biotech companies now have less than six months of cash on hand.

For additional information regarding this topic, please see:

• "Biotech/Pharma Lobbying Scoreboard - Second Quarter Update - Part II," September 12, 2008
• "Biotech/Pharma Lobbying Scoreboard - Second Quarter Update," August 21, 2008
• "Biotech/Pharma Lobbying Scoreboard - Part II," June 30, 2008
• "Biotech/Pharma Lobbying Scoreboard" June 6, 2008
• "Lobbying Spending Spree Continues," May 20, 2008
• "Abbott's First Quarter Lobbying Tab Hits $880,000," May 2, 2008