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Monsanto Announces New Policy Regarding Roundup Ready® Seeds

    By Kevin E. Noonan --

In what may be considered a softening (or at least a change) in its approach to protecting its patented technology, Monsanto announced that it would not enforce any contractual provisions regarding its Roundup Ready® transgenic seed (that preclude growers from replanting genetically-engineered seeds) once the patents on that technology expire in 2014.  Monsanto also announced that the company would stop collecting royalties from licensees at the same time.  These actions, by a company renowned for stringently enforcing its intellectual property rights, may reflect a sober and prudent conformity with the current political and regulatory climate.

The announcement addresses, and alleviates, what farmers have expected (if not feared) regarding Monsanto's recombinant seeds, particularly soybeans.  The situation facing Monsanto after 2014 is similar to one that has faced pharmaceutical companies when a company's main product goes off-patent.  Generally the answer has been further innovation, which has sometimes taken the form of providing an improved version of the original drug.  Examples include AstraZeneca's Nexium® that took the place of the related Prilosec® (S-omeprazole rather than racemic omeprazole), and several other drugs that have used this strategy for their drugs (albeit perhaps none so successfully).

Monsanto has pursued a similar strategy for its Roundup Ready® transgenic seed products.  These seeds contain an exogenous bacterial gene, encoding an enol pyruvate shikimate-3-phosphate synthase (EPSPS) gene from the microbe Agrobacterium tumefaciens that confers resistance to glyphosate, an herbicide sold by Monsanto under the name Roundup®.  Over 90% of all soybean acres planted in the U.S. use this herbicide to increase yield and as a consequence are planted with Roundup Ready® seed.  For its soybean embodiments, Monsanto has developed a second-generation seed, termed Roundup Ready 2®, having a 7-11% higher yield per planted acre.  The same gene has been introduced into these seeds but the transgene has integrated into a different chromosomal site.  Until Monday's announcement, farmers feared that Monsanto would force them to switch to Roundup Ready 2® seeds, at a higher cost, in part by preventing them from using the original Roundup Ready® transgenic seeds.

The announcement was more significant than it might be otherwise (since a patentee's right to royalties typically ends with the expiration of its patents) because, in addition to its patent rights, Monsanto has also staunchly enforced contractual provisions protecting its seeds.  Recombinant seed purchasers have been required to sign a "Technology Agreement" ("the Agreement"), agreeing to pay a one-time license fee of $6.50 per bag, and agreeing not to plant themselves, or supply to others, "saved" seeds, i.e., seeds produced from the originally purchased seeds.  This system ensures that farmers purchase and license Roundup Ready® soybean seeds each planting seasons.

Over the past 10 years, Monsanto has filed suit 125 times against individual farmers it accused of infringing its patents, including U.S. Patent Nos. 5,352,605 and No. 5,633,435 (RE39,247) related to its recombinant seed technology.  Only eight of these lawsuits have gone to trial, while in the remainder, the accused infringer agreed to settlements that generally included an admission of liability.  Monsanto has been awarded $21.6 million in its victorious lawsuits, and The Center for Food Safety estimates that Monsanto has received between $85 million and $160 million in settlements, which remain confidential.  Monsanto has said that it has donated these monies to charity.

One remaining concern are licenses required by certain countries to permit importation of recombinant grain and other foodstuffs, licenses maintained at present by Monsanto.  The company has announced that it will maintain these until 2017, but should they be permitted to expire thereafter, these countries may not permit importation of Roundup Ready® soybeans.

Monsanto's actions come on the heals of a Department of Justice investigation into "potential anti-competitive conduct," due in part to allegations by DuPont in counterclaims asserted in lawsuits between the companies, to the effect that Monsanto has committed antitrust violations.  The American Antitrust Institute has also recommended federal investigation of Monsanto's "anti-competitive" conduct.  With the change of administration has come a more stringent attitude regarding investigation if not prosecution of such alleged conduct, even by patentees (whose exclusive rights are, by nature, anti-competitive); the current DOJ antitrust division no longer subscribes to the more patent-friendly (or at least patent-accommodating) stance taken by the Bush administration (see "U.S. FTC and DOJ Release Report on Relationship between Patent Law and Antitrust Law").

Or perhaps Monsanto is aware that, even if they are lawfully exercising the patent franchise, an argument can be made that at present patentees must tread lightly, since the tide (of public perception, Congressional understanding, and jurisprudential consistency) has turned against them.  Every 30 years or so (the 1940's, 1970's, and today) we seem to forget the nature, value, and utility of patenting.  We are in such a period now, which is ironic since the economy depends on patent protection today more than ever before, to protect nascent technology while at the same time promoting its disclosure.  As things now stand, if Monsanto's actions prevent another distracting episode of patent-bashing it may be worth it for the company and the rest of us.

For additional information regarding this topic, please see:

• "Monsanto Announces Latest Lawsuit Settlement over Roundup Ready Soybean Seed," September 8, 2008
• "Monsanto Co. v. David (Fed. Cir. 2008)," February 6, 2008
• "Court Report," February 3, 2008
• "Court Report," January 28, 2008
• "Court Report," January 13, 2008
• "Court Report," January 7, 2008
• "Supreme Court Fails to Grant Certiorari in Monsanto Co. v. McFarling," January 7, 2008
• "Court Report," December 16, 2007
• "Court Report," November 18, 2007
• "Court Report," October 21, 2007
• "Court Report," July 1, 2007
• "Monsanto Co. v. McFarling (Fed. Cir. 2007)," June 4, 2007
• "Court Report," May 20, 2007
• "Court Report," May 7, 2007
• "Court Report," April 15, 2007
• "Court Report," March 11, 2007
• "Court Report," March 4, 2007
• "Court Report," February 28, 2007

Amgen and Hoffman-LaRoche Settle Mircera® Litigation

    By Kevin E. Noonan --

The latest challenge to Amgen's erythropoietin (EPO) franchise ended today, when Hoffman-La Roche agreed to keep its pegylated derivative of human EPO, Mircera®, off the market until July 1, 2014.  The U.S. Food and Drug Administration granted approval for Roche to market Mircera® in November, 2007 (it has already been approved in Europe and is sold in Austria, Sweden, Germany, the United Kingdom, and Norway) but the company has been under an injunction issued by Federal District Court Judge William G. Young pursuant to a judgment of infringement against Roche at trial (see "Victory for Amgen in District Court Decision" - Part I, Part II, Part III).  While the terms of the settlement are not public, according to Amgen there will be no payments from either company.

The parties stipulated to final judgment and a permanent injunction against Roche in a paper filed jointly with the District Court on Monday.  In the stipulation, Roche agreed that the following claims of the patents-in-suit are "valid, enforceable and infringed by Roche's Mircera® product":

(i)   U.S. Patent No. 5,756,349 (the '349 patent) claim 7,
(ii)  U.S. Patent No. 5,547,933 (the '933 patent) claims 3, 7-8,
(iii)  U.S. Patent No. 5,955,422 (the '422 patent) claim 1,
(iv)  U.S. Patent No. 5,441,868 (the '868 patent) claims 1 and 2, and
(v)  U.S. Patent No. 5,618,698 (the '698 patent) claims 6-9.

Roche also agreed to dismissal with prejudice of its "claims, defenses and counterclaims."  The stipulation was entered by the court as an order, to which it appended the following:

Except as allowed under any license agreement reached between the parties, Roche, its agents, servants, employees, counsel, and all persons and entities acting in concert therewith, are hereby permanently enjoined for the life of U.S. Patent No. 5,441,868, U.S. Patent No. 5,547,933, U.S. Patent No. 5,618,698, U.S. Patent No. 5,955,422 and U.S. Patent No. 5,756,349 from infringing said patents by the manufacture, importation, sale, offer for sale or non-exempt use of pegylated Epoetin beta (otherwise referred to as "MIRCERA" or "CERA") in the United States.

Settlement eliminates risks for both parties.  Amgen sued Roche in a declaratory judgment action in Massachusetts, asserting six patents:  U.S. Patent Nos. 5,547,933; 5,441,868; 5,618,698; 5,955,422 (claim 1); 5,756,349 (claim 7); and 5,621,080 (the '080 patent)  On October 23, 2007, a jury found that Mircera® infringed the '933 patent, the '868 patent, and the '698 patent, and that these patents, as well as the '422 patent and the '349 patent, were not invalid.  (The jury reached neither infringement nor validity of the '080 patent).  Specifically, the jury found that Roche's Mircera® infringed claims 3, 7, and 8 of the '933 patent (claim 12 was found not to be literally infringed but infringed under the Doctrine of Equivalents); claims 1 and 2 of the '868 patent; and claims 6 through 9 of the '698 patent.  On October 1, 2008, Massachusetts District Court Judge William Young ruled (in Amgen's favor for each) on several post-trial motions, including:  1) affirming the jury's infringement decision by denying Roche's motion for judgment as a matter of law (JMOL); 2) reaffirming its pretrial decision to grant summary judgment regarding infringement of claim 1 of the '422 patent; 3) "explaining" its reasoning for ruling, also pretrial, that the claims of Amgen's patents-in-suit are not invalid for obviousness-type double patenting (despite the intervening Federal Circuit decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.); 4) denying Roche's motion for JMOL that claim 1 of the '422 patent and claims 3, 7, and 9 of the '933 patent are not invalid for indefiniteness for reciting the term "human erythropoietin"; and 5) granting Amgen a permanent injunction barring "Roche, its agents, servants, employees, counsel, and all persons and entities acting in concert therewith" from infringing the claims of the patents-in-suit for the remaining life of those patents.

The Federal Circuit affirmed most of the determinations by the District Court and the jury, including that the asserted claims of the '868 patent (claims 1 and 2) and the '698 patent (claims 6-9) are not invalid and were infringed, that claims 3, 7, and 8 of the '933 patent and claim 1 of the '422 patent were infringed, and that claims 9, 11, 12, and 14 of the '933 patent are not infringed by Mircera®.  However, the panel opinion vacated Judge Young's decision that the '933 (claims 3, 7, and 8), '349 (claim 7), and '422 (claim 1) patents are not invalid under obviousness-type double patenting and remanded this issue to the trial court.  The Federal Circuit also vacated the judgment that claim 7 of the '349 patent was not infringed and remanded for a new trial on that issue.  This decision put several of Amgen's patents at risk for invalidation under the Federal Circuit's recent jurisprudence interpreting the scope of the "safe harbor" of 35 U.S.C. § 121 (Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008) and Takeda Pharmaceutical Co. v. Doll (Fed. Cir. 2009)).  Invalidation of the '933, '349, and '422 patents would have reduced Amgen's patent protection on its various EPO products (including Aranesp® and Epogen®) from May 2015 to August 2012 (more than 3 years), which would have a significant (negative) effect on the corporate bottom line.  Thus, by settling, Amgen has avoided invalidation of these three patents, and Roche has avoided any damages or attorneys' fees Amgen may have pursued.  Roche also has obtained a date certain for entering the U.S. market with its pegylated EPO product.

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

• "Obviousness-type Double Patenting after Amgen v. F. Hoffman-La Roche," September 27, 2009
• "Amgen Inc. v. Hoffman-La Roche Ltd. (Fd. Cir. 2009)," September 15, 2009
• "Amgen v. Hoffmann-LaRoche: Remaining Issues," October 13, 2008
• "Amgen v. Hoffmann-LaRoche: Back to the District Court," October 10, 2008
• "Victory for Amgen in District Court Decision - Part III," October 9, 2008
• "Victory for Amgen in District Court Decision - Part II," October 8, 2008
• "Victory for Amgen in District Court Decision - Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "How to Avoid a Permanent Injunction: The Lessons of Amgen v. Hoffmann-LaRoche," April 28, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008

Science Progress Article Examines Impact of Gene Patents on Research

    By Donald Zuhn --

Gene patenting has been a hotly debated topic for at least the past three years.  The subject moved back to the forefront when Chicago-Kent College of Professor of Law Lori Andrews and the late Michael Critchton published an article in the November 11, 2006 issue of Parade magazine, in which the two advocated for a Genetic Bill of Rights that would have included a prohibition on gene patents (see "Gene Patenting in the News Again").  The anti-gene patent baton was next passed to Rep. Xavier Becerra (D-CA), who in February 2007 introduced a bill (H.R. 977) in the House that would have prohibited patents from being granted for "a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies" (see "The Continuing Threat to Human Gene Patenting").  And the debate was renewed last May when a group of patients, physicians, academic researchers, and medical societies filed suit against the U.S. Patent and Trademark Office and Myriad Genetics, among others, over several patents claiming human BRCA1 and BRC2 genes and methods for detecting mutations in these genes to diagnose a predisposition to breast and ovarian cancer (see "Association for Molecular Pathology v. U.S. Patent and Trademark Office").

In a recent article in Science Progress entitled "Do Gene Patents Hurt Research?" Timothy Caulfield, the Canada Research Chair in Health Law and Policy and a Professor in the Faculty of Law and School of Public Health at the University of Alberta, added his voice to the discussion.  Mr. Caulfield begins the article by asking what the controversy is all about, and responds that:

While the concerns associated with gene patents are varied, one has had the most policy traction:  the idea that patents on sequences of genetic information hurt research, especially upstream, basic research.  The worry is that patents will hurt science by making it difficult to acquire the rights to all necessary research inputs.  Research will slow, become more inefficient and expensive -- or researchers will simply avoid doing research on patented, yet scientifically valuable, genes.

While Mr. Caulfield (at right) acknowledges that "[a]t first blush, all this [anti-gene patenting] policy activity seems to make sense:  a logical response to a profound social problem [i.e., the impact of patent tickets or the anti-commons on research]," he quickly concludes that there is one hitch -- in particular, that "[t]here is little evidence that the problem exists."  Thus, he writes that while "[t]here is lots of social angst," there is "no good data showing a widespread patent thicket/anti-commons phenomenon."

In support of his conclusion, Mr. Caulfield points to a 2007 study by the American Association for the Advancement of Science, which found "very little evidence of an 'anticommons problem'"; a 2005 study for the National Academy of Sciences, which found that only 1% of scientists surveyed reported suffering a project delay of more than one month due to patents; his own 2009 study of the Canadian genetic research community, which revealed "lots of researcher concern about gene patents, but little evidence that they are actually having a detrimental impact on the research environment"; and Prof. Chris Holman's 2007 paper on the impact of gene patents on innovation and access ("The Impact of Human Gene Patents on Innovation and Access:  A Survey of Human Gene Patent Litigation").

Instead of a patent thicket/anti-commons problem, Mr. Caulfield finds that:

While the apparent disconnect between policy concern and evidence is a significant dilemma on its own, I think there is a bigger problem.  By focusing on gene patents, we seem to be downplaying other concerns associated with the commercialization ethos that increasingly permeates the research environment.

Thus, he asserts that the real problem is "[c]ommercialization pressure, not patenting," adding that "at the current time, we need to recognize that despite all the noise, there is still no solid evidence that gene patents hurt basic research."  Mr. Caulfield does not discount the possibility that such evidence may be generated in the future.  But he insists that "arguments for reform must be based on an honest assessment of available evidence -- not on assertions that conflict with the facts."  Thus, he sees a need for "more methodologically robust research on the true benefits and harms of patents," which he believes "will allow for a more informed debate on the fundamental patent tradeoff:  that is, the granting of a limited-term monopoly for the benefit of society."

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

• "Gene Patenting Debate Continues - Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009
• "Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
• "Genetic Diagnostic Testing: The "Anti-Commons" Revisited?" March 25, 2009
• "Science Article Should Help Allay Gene Patenting Fears," December 17, 2008
• "The Continuing Threat to Human Gene Patenting," October 16, 2007
• "Science Fiction in The New York Times," February 13, 2007
• "The Continuing Value of Biotech Patenting," February 4, 2007
• "Anti-Patent (Sullivan?) Malice by The New York Times," January 29, 2007.
• "In Support of Gene Patents," December 6, 2006
• "Gene Patenting in the News Again," December 5, 2006

USPTO Announces Changes to PKI Certificate Usage Policy

    By Christopher P. Singer --

In a Notice published in the December 17, 2009 Federal Register (74 Fed. Reg. 66955), the U.S. Patent and Trademark Office announced changes to its previously published procedures (October 27, 2009 Federal Register Notice, 74 Fed. Reg. 55200) relating to usage of public key infrastructure (PKI) certificates.  According to the Notice, the revised procedures are effective as of December 17, 2009.

As background, the PKI certificate is the unique electronic code that is provided by the PTO's Electronic Business Center to registered practitioners and allows for access to Private PAIR and the filing of applications and follow-on documents through the EFS-Web.  The prior PKI subscriber agreement allowed certificate holders to designate only a single employee or contractor to use the certificate "under the direction and control" of the holder.  By the letter of this rule, it seemed that if more than one person other than the certificate owner and the single designee were using the certificate, such usage would be in violation of the user agreement.  For practitioners employed by organizations of any size, or having a limited number of registered agents/attorneys, this could potentially present a significant bottleneck in EFS-Web and/or Private PAIR usage, or create an inadvertent violation of terms of the agreement.  In response to the October publication, the Office received a number of responses, inquiries, and comments from current users of EFS-Web and Private PAIR.  The Office, in response to the outcry, has decided to expand the PKI usage procedures to allow for the designation of more than one user other than the certificate holder.

In particular, the newly published procedures allow for a "reasonable number" of authorized users to have access to and use a single PKI certificate as long as the usage is under the direction and control of the PKI certificate holder.  The Notice notes that designated users "should be paralegals or support staff of the certificate holder" specifying that the designee "must be either an employee of the holder's organization or an employee of a contractor."  The overall motivation for the change in procedures arises from the desire to "provide users more flexibility and meet users' needs for multiple concurrent usage of the USPTO electronic systems."  Nevertheless, it is important that each PKI certificate holder directs the usage of his or her individual certificate, as any submission associated with a PKI certificate is treated as though it was made by the holder.

One important consideration to keep in mind relates to restriction on technology export.  Particularly technology and software in unpublished patent applications may be subject to export controls outlined in the Export Administration Regulations (15 C.F.R. §§ 730-774).  The agreement explicitly states, "[i]f a designated employee is not a U.S. citizen, I understand that the designated employees' access to the technology and software constitutes an export" and that "[a]ccess to such technology and software by any person located outside the United States or by a foreign national inside the United States constitutes an export that may require a license from the U.S. Commerce Department's Bureau of Industry and Security ("BIS").  I agree not to use (and to make sure that each designated employee will not use) or permit the use of the USPTO certificate in a manner that would violate or circumvent the Export Administration Regulations."

The Federal Register Notice includes thirteen FAQs that describe certain hypothetical user arrangements and whether those arrangements are appropriate under this usage agreement.  The Notice concludes by presenting the actual revised PKI subscriber agreement in full (about one and a half pages).

USPTO Proposes New Procedure for Treating Rejected Claims That Are Not Appealed

    By Sarah Fendrick --

Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register (74 Fed. Reg. 66097) proposing changes in the procedure for handling notices of appeal and appeal briefs that identify fewer than all of the rejected claims as being appealed.  Under the change, rejected claims that are identified as not appealed in a notice of appeal or appeal brief will automatically be deemed canceled.

Under current procedures, an applicant is not able to appeal only part of an examiner's decision.  Under 37 C.F.R. § 1.113(c), a reply to a final Office action must include cancellation of each rejected claim or appeal from the rejection of each rejected claim.  Similarly, a reply to a non-final action must cancel each rejected claim subject to any ground of rejection not addressed in the reply.  See 37 C.F.R. § 1.111(b).  Therefore, in order to comply with either provision, an applicant must file an amendment canceling the non-appealed claim separately from a notice of appeal or appeal brief.  Failure to file an amendment separately will result in an appeal of the entire examiner's decision.

The change in procedure would allow applicants to appeal only some of the rejected claims without filing a separate amendment to cancel the non-appealed claims.  The non-appealed rejected claims would be deemed canceled as of the date on which the notice of appeal or appeal brief was filed.

To have claims automatically canceled, an applicant must clearly limit the appeal to fewer than all of the rejected claims.  If an applicant fails to clearly limit the appeal to only identified claims or there are inconsistencies regarding whether all of the rejected claims are appealed, the appeal will be treated as an appeal of the entire examiner's decision.

The proposed change will be applicable to any notice of appeal or appeal brief filed under 37 C.F.R. §§ 41.31 and 41.37.

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.

Eli Lilly and Company v. APP Pharmaceuticals, LLC et al.
1:09-cv-01551; filed December 16, 2009 in the Southern District of Indiana

• Plaintiff:  Eli Lilly and Company
• Defendants:  APP Pharmaceuticals, LLC; APP Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 5,464,826 ("Method of Treating Tumors in Mammals with 2',2'-difluoronucleosides," issued November 7, 1995) following a Paragraph IV certification as part of APP Pharmaceutical's filing of an ANDA to manufacture a generic version of Lilly's Gemzar® (gemcitabine hydrochloride for injection, used to treat non-small cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer).  View the complaint here.

Syngenta Seeds, Inc. v. Bayer Bioscience N.V.
1:09-cv-02370; filed December 15, 2009 in the District Court of the District of Columbia

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 5,866,784 ("Recombinant Plant Expressing Non-Competitively Binding Insecticidal Crystal Proteins," issued February 2, 1999), 5,908,970 ("Recombinant Plant Expressing Non-Competitively Binding BT Insecticidal Crystal Proteins," issued June 1, 1999), and 6,172,281 (same title, issued January 9, 2001) based on Syngenta's development and anticipated sales of corn containing combinations of insect resistance derived from the bacterium Bacillus thuringiensis.  View the complaint here.

Cephalon France et al. v. Mylan Pharmaceticals, Inc. et al.
1:09-cv-00165; filed December 14, 2009 in the Northern District of West Virginia

• Plaintiffs:  Cephalon France; Cephalon, Inc.
• Defendants:  Mylan Pharmaceticals, Inc.; Mylan Inc.; Matrix Laboratories Ltd.; Matrix Laboratories Inc.

Cephalon Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:09-cv-00954; filed December 11, 2009 in the District Court of Delaware

• Plaintiffs:  Cephalon Inc.; Cephalon France
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.; Matrix Laboratories Ltd.; Matrix Laboratories Inc.

Cephalon, Inc. et al. v. Actavis Group et al.
2:09-cv-06239; filed December 10, 2009 in the District Court of New Jersey

• Plaintiffs:  Cephalon, Inc.; Cephalon France
• Defendants:  Actavis Group; Actavis Pharma Manufacturing Pvt. Ltd.; Actavis Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. RE37,516 ("Acetamide Derivative Having Defined Particle Size," issued January 15, 2002) and 7,132,570 ("Method for the Production of Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder).  View the Delaware Mylan complaint here.

Wyeth Holdings Corp. et al. v. Sandoz Inc.
1:09-cv-00955; filed December 11, 2009 in the District Court of Delaware

• Plaintiffs:  Wyeth Holdings Corp.: Wyeth-Ayerst Lederle LLC
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent No. RE40,183 ("7-Substituted-9-Substituted Amino-6-Demethyl-6-Deoxytetracyclines," issued March 25, 2008), licensed to Wyeth-Ayerst Lederle, following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Wyeth's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia caused by susceptible strains of designated microorganisms).  View the complaint here.

Seattle Children's Hospital et al. v. Teva Parenteral Medicines Inc. et al.
1:09-cv-00949; filed December 10, 2009 in the District Court of Delaware

• Plaintiffs:  Seattle Children's Hospital; Novartis AG; Novartis Vaccines and Diagnostics Inc.; Novartis Pharmaceuticals Corp.
• Defendants:  Teva Parenteral Medicines Inc.; Teva Pharmaceutical Industries Ltd.; Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 5,508,269 ("Aminoglycoside Formulation for Aerosolization," issued April 16, 1996) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' TOBI® (tobramycin inhalation solution, used in the management of cystic fibrosis patients with Pseudomonas aeruginosa).  View the complaint here.

Conference & CLE Calendar

January 6-10, 2010 - 27th Annual National CLE Conference (Law Education Institute, Inc.) - Vail, CO

January 20-21, 2010 - Life Sciences IP Due Diligence (American Conference Institute) - New York, NY

January 25-26, 2010 - European Pharmaceutical Regulatory Law Boot Camp (American Conference Institute) - New York, NY

January 26-27, 2010 - Advanced In-House Counsel Forum on China IP Law (C5) - Shanghai, China

January 27-28, 2010 - Pharma & Biotech Patent Litigation (C5) - Amsterdam, Netherlands

February 9, 2010 - Patent Prosecution: Best Practices for Reducing Costs While Improving Patent Quality (Technology Transfer Tactics) - 1:00 - 2:30 PM (EST)

February 24-25, 2010 - 2nd Expert Forum on ITC Litigation & Enforcement (American Conference Institute) - New York, NY

March 2-4, 2010 - 6th Annual Biosimilars Conference (Visiongain) - Boston, MA

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

ITC Litigation & Enforcement Conference

American Conference Institute (ACI) will be holding its 2nd Expert Forum on ITC Litigation & Enforcement from February 24-25, 2010 in New York, NY.  The conference will offer practical advice for seizing the opportunities and meeting the challenges offered by fast-paced ITC litigation and allow attendees to:

• Evaluate and compare the potential benefits of selecting ITC or another venue;
• Navigate the ITC's complex procedural rules;
• Understand and resolve questions relating to "domestic industry" standards;
• Meet the demands of accelerated motion practice and discovery;
• Implement effective defense and intervention strategies in a Section 337 action; and
• Enforce ITC exclusion orders.

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

• Evaluating where to litigate international IP disputes;
• Positioning complainants, respondents and intervenors in Section 337 cases;
• Successfully working the logistics of Section 337 litigation;
• Keynote address by Chief Judge Paul R. Michel of the U.S. Court of Appeals for the Federal Circuit;
• Coordinating related parties & proceedings;
• Managing litigation through discovery, claim construction, summary determination and trial;
• Meeting the challenge of the ITC’s unique trial procedures;
• View from the Bench -- Chief Administrative Law Judge Paul J. Luckern, Administrative Law Judge Theodore R. Essex, and Administrative Law Judge Robert K. Rogers of the U.S. International Trade Commission;
• Seeking commission review and modification of ALJ decisions;
• The year in review -- Commission and Federal Circuit decisions in Section 337 cases;
• Understanding and maximizing the available remedies in Section 337 ITC cases;
• Seeking enforcement of exclusion orders;
• Successfully appealing Section 337 determinations;
• A view from the ITC General Counsel's office;
• Keynote address by Shara Aranoff, Chairman of the International Trade Commission;
• Handling ITC ancillary proceedings and parties;
• Addressing downstream remedy strategies post-Kyocera;
• Meeting the challenges faced by in-house counsel in Section 337 cases; and
• Meeting the challenges raised when assisting foreign companies in the ITC with focus on Asian companies.

Two breakout sessions will be offered from 9:00 am to 12:00 pm on February 26.  The first will address Section 337 complaints and responses, and the second will address enforcement of ITC exclusion orders.

A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.  The registration fee for the conference ranges from $2,195 (conference alone) to $2,795 (conference and breakout session).  Those registering by January 5, 2010 will receive a $300 discount off the registration fee and those registering by January 29, 2010 will receive a $200 discount off the registration fee.  Those interested in registering for the conference can do so here, by calling 888-224-2480, or by faxing a registration form to 877-927-1563.

Audioconference on Patent Prosecution Cost Reduction

Technology Transfer Tactics will be offering an audioconference entitled "Patent Prosecution: Best Practices for Reducing Costs While Improving Patent Quality" on February 9, 2010 from 1:00 - 2:30 PM (EST).  Dr. Jean Baker and Jack Cook of Quarles & Brady will provide specific prosecution strategies that Technology Transfer Offices can adopted to significantly reduce legal bills while improving overall patent quality.  The audioconference will address the following topics:

• Disclosure evaluation:  Strategies for distinguishing what TTOs can patent from what TTOs should patent to avoid unnecessary filing costs;
• Strategies for increasing the probability of successful licensing at the disclosure stage
• Ten proven tips for TTOs to reduce patent preparation costs;
• Working with researchers to enhance disclosures and claims construction;
• Reducing unnecessary paperwork and associated attorney costs; and
• Structuring patent prosecution:  Practical strategies for TTOs and licensees to increase the efficiency of prosecution, while reducing the cost and staff burden.

The registration fee for the seminar is $197.  Those interested in registering for the seminar, can do so here.