Patent Docs

Eli Lilly & Co. v. Zenith Goldline Pharm., Inc. (Fed. Cir. 2006)

    By Donald Zuhn --

In an appeal from a District Court judgment of validity and infringement, the Federal Circuit affirmed the District Court's finding of validity, holding that U.S. Patent No. 5,229,382 (the '382 patent) was not anticipated by Chakrabati et al., 1980, J. Med. Chem. 23:878-84 (Chakrabati) or the patentee's clinical trials, or rendered obvious by the prior art.

Plaintiffs-Appellees Eli Lilly and Co. and Lilly Industries Ltd. (Lilly) own the '382 patent, which relates to olanzapine (sold under the trademark Zyprexa®) and the use of olanzapine to treat schizophrenia.  Prior to discovering olanzapine, Lilly had identified a number of drugs in the same family of compounds, including clozapine, flumezapine, ethyl flumezapine, and ethyl olanzapine.  Of these prior art compounds, clozapine had been shown to be effective in treating some forms of schizophrenia - but not without potentially fatal side-effects as one percent of patients treated with clozapine would suffer from the blood disorder agranulocytosis.

Until the discovery of olanzapine, the efficacy of clozapine (and other antipsychotics) had been attributed to the presence of an electron-withdrawing group such as a fluorine or chlorine atom.  However, while clozapine has a chlorine atom on its benzene ring, olanzapine has a hydrogen atom, which is not an electron-withdrawing group.

Seeking approval to market generic olanzapine, Defendants-Appellants Zenith Goldline Pharmaceuticals, Inc. (now known as IVAX Pharmaceuticals, Inc.), Dr. Reddy's Laboratories, Ltd., and Teva Pharmaceuticals USA, Inc. (IVAX) filed an Abbreviated New Drug Application (ANDA) with the FDA.  In response, Lilly filed suit against IVAX, alleging that the filing of the ANDA infringed the '382 patent.  Following a bench trial, the District Court determined that the '382 patent was valid and infringed, and found no inequitable conduct.  IVAX appealed the District Court's determinations of validity and no inequitable conduct.

With regard to its anticipation defense, IVAX argued that Chakrabati anticipated claim 1 of the '382 patent because that reference identified compounds from the family of compounds - thienobenzodiazepines - to which olanzapine belonged.  IVAX cited In re Petering, 301 F.2d 676 (C.C.P.A. 1962) and In re Schaumann, 572 F.2d 312 (C.C.P.A. 1978) in support of this argument.

In distinguishing Petering, the Federal Circuit noted that "in contrast to this case, the prior art in Petering did more than make a broad disclosure.  In Petering, the prior art disclosed a limited number of specific preferences from a specifically defined group of [compounds]."  With respect to Schaumann, the Court observed that "the prior art patent [in that case] embraced a very limited number of closely related compounds and specifically described the claimed compound."  The Court also noted that while "the prior art in both Petering and Schaumann expressly spelled out a definite and limited class of compounds that enabled a person of ordinary skill in the art to at once envisage each member of this limited class . . . , the number of compounds actually disclosed by [Chakrabati] numbers in the millions."

The Federal Circuit further noted that while Chakrabati discloses several preferred compounds, none of these preferred compounds resembles olanzapine.  In addition, the Court observed that because Chakrabati "always expressed a preference for halogen-containing compounds (fluorine or chlorine), [and] not hydrogen," one of ordinary skill in the art "would have to depart from the teaching of the article and recombine the components of the specific illustrative compounds with hindsight."  The Federal Circuit, therefore, concluded that Chakrabati did not place olanzapine in the public's possession, and thus, the District Court did not err in finding no anticipation.

With regard to IVAX's argument that Lilly's clinical trials of olanzapine constituted a public use, the Federal Circuit cited TP Labs., Inc. v. Prof'l Positioners, Inc., 724 F.2d 965 (Fed. Cir. 1984), as standing for the proposition that "[e]ven a use that occurs in the open may not invoke a bar when undertaken to experiment on or with the claimed invention."  The Federal Circuit noted that the instant case satisfied several indicia of experimental use set forth in TP Labs., and therefore concluded that the District Court did not err in finding no public use.

Eli Lilly & Co. v. Zenith Goldline Pharm., Inc. (Fed. Cir. 2006)
Panel: Circuit Judges Rader, Schall, and Gajarsa
Opinion by Circuit Judge Rader

For a discussion of the Federal Circuit's decision on the issue of obviousness, readers are encouraged to turn to Kevin Noonan's article on the Lilly case.

Merck and Crucell Cross-License

     By Jason Derry --

Crucell N.V. has announced a cross-licensing agreement with Merck & Co. relating to Crucell's vaccine technology.  The deal allows Merck to use Crucell's technology in certain vaccine fields that have yet to be publicly disclosed, while Crucell will be able to manufacture its Advac®-based vaccines on a larger scale using Merck's large scale manufacturing technology.  Merck already has a license to Crucell's PER.C6® cell line, which can be used for vaccine and protein production.

Crucell is a biotechnology company headquartered in The Netherlands, and focuses its research and development efforts on vaccines and antibodies for preventing or treating infectious diseases.

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

Article About Intellectual Property Issues Relating to Nanotechnology

    By Jason Derry --

If you are interested in intellectual property issues involving nanotechnology, you might want to check out this paper published by the National Cancer Institute Alliance for Nanotechnology in Cancer.  The paper was published in October 2006.

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

Eli Lilly & Co. v. Zenith Goldline Pharm., Inc. (Fed. Cir. 2006)

    By Kevin Noonan --

With the Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc. on the horizon, the Federal Circuit continues to tiptoe around the standards for obviousness.  The most recent example can be found in it opinion affirming a decision of no invalidity in Eli Lilly & Co. v. Zenith Goldline Pharmaceuticals, Inc.

The case involved an ANDA filing by Zenith (now IVAX Pharmaceuticals, Inc.), Teva Pharmaceuticals, and Dr. Reddy's Laboratories for a generic version of Lilly's Zyprexa® antischizophrenia drug.  Having stipulated to infringement by filing the ANDA, the issues before the trial court were invalidity for anticipation or obviousness, and inequitable conduct.  The trial court found in Lilly's favor on both validity and no inequitable conduct (in an opinion whose 221 page length was noted by the Federal Circuit), and the Federal Circuit affirmed.

The interesting aspect of this case was the way the Federal Circuit set forth its de novo review of the district court's application of the legal standard for obviousness.  The Court was careful to first explicate the Supreme Court's rubrics from Graham v. John Deere (being careful to cite its compliance with this standard in Panduit Corp. v. Dennison Mfg.):

The factual underpinnings are: (1) the scope and content of the prior art, (2) the differences between the prior art and the claimed invention at the time of invention, (3) the level of ordinary skill in the art, and (4) the objective indicia of nonobviousness.  See Graham v. John Deere Co., 383 U.S. 1, 17 (1966); Panduit Corp. v. Dennison Mfg., 810 F.2d 1561, 1566-67 (Fed. Cir. 1987).

The Court next cited In re Dillon for the applying this standard to a chemical compound:

For a chemical compound, a prima facie case of obviousness requires "structural similarity between claimed and prior art subject matter . . . where the prior art gives reason or motivation to make the claimed compositions.  In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc).

Finally, the Court made mention of the (putatively) non-controversial potion of its TSM jurisprudence:  "'[A] reasonable expectation of success, not absolute predictability' supports a conclusion of obviousness. In re Longi, 759 F.2d 887, 896 (Fed. Cir. 1985)."

The Federal Circuit's TSM test did make a cameo appearance, where the Court cited In re Rouffet, 149 F.3d 1350, 1355 (Fed. Cir. 1998), for the proposition that "to establish a prima facie case of obviousness based on a combination of elements in the prior art, the law requires a motivation to select the references and to combine them in the particular claimed manner to reach the claimed invention."

However, the Court did not rely on this analysis for affirming the district court's judgment of non-obviousness.  Rather, the Court turned to the "objective indicia" (otherwise known as the "secondary considerations") of long-felt need, industry acceptance, failure of others and unexpected results, by which it said Lilly had rebutted "any prima facie case" of obviousness based on the cited art.

The Federal Circuit nicely sidestepped the critical issue of KSR, namely how to apply the Supreme Court's generic rubrics on obviousness to individual cases while at the same time avoiding contaminating the analysis with hindsight.  The Court's TSM test has been a reliable (if inexact) standard for fulfilling the Court's Congressional mandate of bringing uniformity to U.S. patent law regarding the obviousness question.  No matter how the Supreme Court rules in the coming months, it will be the Federal Circuit's responsibility to craft from that decision workable rules for making an obviousness determination, whether in litigation or before the Patent Office.  This case provides a potentially fruitful route around the doctrinal issues surrounding obviousness, so long as the facts in a particular case fit within one of the objective indicia.

Eli Lilly & Co. v. Zenith Goldline Pharm., Inc. (Fed. Cir. 2006)
Panel: Circuit Judges Rader, Schall, and Gajarsa
Opinion by Circuit Judge Rader

For a discussion of the Federal Circuit's decision on the issue of anticipation, readers are encouraged to turn to Donald Zuhn's article on the Lilly case.

Patent Office Announces Record-Breaking Year

    By Donald Zuhn --

In a press release posted last Friday, the Patent Office announced that 2006 has been a record-breaking year for the USPTO.  In particular, the Patent Office noted that it received a record number of patent applications (440,000) and hired a record number of patent examiners (1,218) in 2006.  The Patent Office also stated that despite completing a record number of patent applications (332,000), the Office achieved its lowest patent allowance error rate in the past twenty years (3.5%).  The Patent Office noted, however, that the patent allowance rate dipped to an all-time low of 54% (see chart below).  With respect to electronic filings, the Office observed that as a result of its implementation of the Electronic Filing System-Web (EFS-Web), electronic filing of patent applications rose dramatically from 1.5 percent per month to 33 percent per month.

A full presentation of the Patent Office's 2006 performance can be found in the USPTO 2006 Performance and Accountability Report.  Of interest to biotech and pharma patent prosecutors are the report's findings with respect to application pendency and examination costs.  In particular, the report indicates that in 2006, the average pendency to a first Office Action in Tech Center 1600 (biotechnology and organic chemistry) was 23.5 months, and the average total pendency was 34.4 months.  Both figures were slightly more than the overall averages of 22.6 and 31.1 months.  In addition, the report states that in 2006, more than seventeen percent of the Patent business group's total costs had gone to the prosecution of biotechnology (7.8%) and chemical (9.5%) utility patents.

BASF Agrochem. Prods. v. Unkel (W.D. La. 2006)

BASF Prevails in Seed-Saving Infringement Case

    By Robert Dailey --

A federal district court held that a farmer who saved rice seed in violation of BASF's standard Stewardship Agreement infringed the patents covering the seed and its use.  The buyer of the saved seed, however, had never actually signed the Stewardship Agreement covering the relevant seed purchase.  But in granting BASF's motion for summary judgment, the court held that the farmer's knowledge of the terms of such agreements was sufficient to subject his purchase to its limitations.

BASF accused a Louisiana rice farmer of saving seed from his 2004 and 2005 plantings of Clearfield®, an herbicide-tolerant rice-growing system.  The Clearfield® seed is protected under the Plant Variety Protection Act (PVPA) and by three U.S. Patents: 6,211,438; 6,211,439; and 6,222,100.  BASF generally sells the seed subject to a Stewardship Agreement that forbids the purchaser from saving the seed for subsequent growing seasons.  Yet the farmer had signed no Stewardship Agreement covering his 2004 seed purchase.  According to BASF, the farmer saved some seed from the 2004 crop and re-planted it during the 2005 growing season.  (Incidentally, a regional seed supplier had signed the farmer's name to a 2004 Stewardship Agreement, but the court never resolved whether the supplier had authority to sign the farmer's name to the agreement. At summary judgment, the court must assume this disputed fact in the farmer's favor.)

The farmer argued that the "first sale doctrine" provides an affirmative defense to any infringing conduct.  The first sale doctrine provides that a patent holder exhausts all rights in an article upon the sale of that article.  In B. Braun Medical v. Abbott Labs, the Federal Circuit notes that this general rule does not prevent a patentee from making conditional sales or granting use-restricted licenses.  The farmer argued that the rule of B. Braun has no relevance since he signed no agreement relating to BASF's use restrictions.  BASF argued that the farmer's notice of the terms of its Stewardship Agreement provided sufficient evidence for the court to infer that the farmer agreed to the use restrictions.  The court wasted little ink in agreeing with BASF's argument on this point.

This begs the question as to what quantum of evidence is necessary for the court to imply conditions that carve out exceptions to the first sale doctrine.  The court cites B. Braun, yet that case resolves a different question. B. Braun addresses whether conditional sales or use restrictions, when expressly agreed upon by the parties, are enforceable.  The case says nothing about what a court is to do when the parties never expressly agreed to the restrictions, i.e., when the restrictions are only implied from the circumstances surrounding the sale.

Federal Circuit precedent provides that state law controls the express and implied terms of patent licenses.  Power Lift v. Weatherford Nipple-Up, 871 F.2d 1082, 1085 (Fed. Cir. 1989).  In similar seed-saving cases, district courts have conducted extensive analyses under state contract law of the conditions implied from the sale of the seed. See, e.g., Pioneer Hi-Bred v. Ottawa Plant Food, 283 F. Supp. 2d 1018 (N.D. Iowa 2003) (finding an implied use restriction based on marking of seed bags with terms of restriction). But the court conducted no such analysis in this case.  Moreover, the facts give no indication that BASF had even marked its bags with a standard notice of its use restrictions.  The court inferred the farmer's agreement to the restrictions simply based on his attendance at a growers meeting and his role as owner of a farm supply store that had been authorized to sell the seed.

Bag marking is sufficiently analogous to shrinkwrap licensing to permit courts to hold farmers to the terms printed on the exterior of the seed bags.  Yet it remains unclear whether a court should read licensing restrictions into a contract based only on whether a farmer would have known about the limitations.  In other words, can widespread publicity serve as a suitable substitute for product marking in the absence of an express agreement?

BASF Agrochem. Prods. v. Unkel, No. 2:05CV1478 (W.D. La. Dec. 7. 2006)

Robert Dailey, Ph.D., is a physical chemist and a third-year law student at the University of North Carolina at Chapel Hill.  Dr. Dailey was a member of MBHB's 2006 class of summer associates.

Court Report

    By Sherri Oslick --

About Court Report: Each week we will report briefly on recently filed biotech and pharma patent cases.  A few interesting cases will be selected for periodic monitoring, providing our readers with an opportunity to follow the progress of these cases.

Novartis Corp. et. a. v. Lupin Ltd. et al.
2:06-cv-05954; filed December 12, 2006 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 Lupin'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.

Ortho-McNeil Pharmaceutical, Inc. v. Barr Laboratories, Inc. et. al.
3:06-cv-06012; filed December 15, 2006 in the District Court of New Jersey

Infringement of U.S. Patent No. 7,125,560 ("Pharmaceutical Composition of Topiramate," issued October 24, 2006) following a paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Ortho-McNeil's Topamax® (topiramate used to treat migraines and epilepsy).  View the complaint here.

Reliant Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
1:06-cv-00774 ; filed December 19, 2006 in the District Court of Delaware

Infringement of U.S. Patent No. 5,681,588 ("Delayed Release Microtablet of ß-phenylpropiophenone Derivatives," issued October 28, 1997) following a paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Reliants's Rythmol® SR (propaphenone hydrochloride extended release; used to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease).  View the complaint here.

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.

The Demise of Enantiomer Patenting?

    By Kevin Noonan --

On December 19th, the European Patent Office decided to revoke European Patent EP 0 652 872, owned by AstraZeneca for its blockbuster drug Nexium® ("the little purple pill").  This action was undertaken by German generic drug manufacturer, Ratiopharm International GmbH, and was unexpected in light of Ratiopharm's earlier failure to invalidate the patent under European opposition rules.  The decision, by the EPO's Technical Board of Appeals, cannot be appealed either in the EPO or in the European Union's Court of Justice, which lacks jurisdiction over the EPO's decisions.

This decision by the European Patent Office raises questions about the validity of so-called enantiomer patents, which are directed to the "active" ingredient in drug formulations comprising a racemic mixture of stereoisomers.  Since most biological molecules are stereo-specific (i.e., one of the pair of "left-handed" or "right-handed" stereoisomers is active and the other is not), patents specifically claiming the active form have provided a means for extending effective patent protection on popular (and lucrative) drugs.  Typically, and most successfully for Nexium®, the initial patent is directed to the racemic mixture of both the biologically active and inactive forms.  Later, claims are presented for the purified active form, which is chemically-distinct and thus (the argument goes) independently patentable.  Additional arguments in favor of patentability are that there is (usually) no reliable way to predict which enantiomer will be the "active" one, and the inventors do not know the identity of the active species when the earlier application on the racemic mixture is filed.

The EPO's surprising decision upsets the conventional rationale on separately patenting enantiomeric species.  Although the EPO will not publish its formal opinion containing the reasoning behind their decision until some time next year, Ratiopharm had argued that Nexium® was not novel and failed to satisfy the European inventive step requirement, analogous to obviousness in the U.S.  While these arguments were not persuasive during the earlier opposition proceedings, they carried the day before the Technical Board of Appeal.

Similar arguments were specifically rejected by the U.S. Patent and Trademark Office, which was apprised during prosecution of the U.S. counterpart (now U.S. Patent No. 6,875,872) of the earlier opposition proceedings and the arguments presented therein.  The U.S. Examiner found that the earlier disclosure of omeprazole (by AstraZeneca) did not anticipate nor render obvious the U.S. claims to the specific chemical compound comprising Nexium® (S-omeprazole magnesium).

Unlike in Europe, there are no administrative procedures before the Patent Office in the U.S. for challenging an issued patent.  However, at a minimum, it can be expected that the arguments raised by Ratiopharm will arise in AstraZeneca's patent infringement lawsuit in the U.S. against the Indian generic drug manufacturer Ranbaxy, and separately against Teva and its subsidiary, IVAX, who filed an ANDA for Nexium® with the Food and Drug Administration.

The case has relevance not only for Nexium® but for a host of other drugs, including Plavix (Sanofi-Aventis) and Lexapro (Lundbeck/Forest Labs, the purified stereoisomer of Celexa), that have used this strategy to extend effective patent protection for drugs having active and inactive stereoisomers.

This adverse decision is not the end of troubles for AstraZeneca over its Nexium® patent portfolio.  A process patent for Nexium® (EP 0 773 940) is under opposition with an oral hearing scheduled in the EPO on March 7, 2007.  In the U.S., a number of pharmacies, including Walgreen Co., Eckerd Corp., Maxi Drug Inc., the Kroger Co., New Albertson's Inc., Safeway Inc., Hy-Vee Inc., and American Sales Co. Inc., have asserted antitrust claims against AstraZeneca, the most recent of which threatens to become a class action initiated by Meijer Inc.  In addition to merely obtaining patents on Nexium®, these suits allege additional anticompetitive behavior, including the company's making sales-related representations on the effectiveness of Nexium® that the plaintiffs allege AstraZeneca specifically disavowed to the FDA.

Pharmaceutical companies are always in the cross-hairs of a variety of groups whose sole goal is lowering drug prices and for whom pharma companies are obvious targets.  There is nothing nefarious or illegal about obtaining enantiomer patents per se, and the arguments in opposition ignore the fact that omeprazole, the racemic mixture sold for years by AstraZeneca as Prilosec®, is not only off-patent but is available over-the-counter, at significantly reduced costs.  The fight here is not (or should not be) about patents, because under U.S. law (and, until the other day, in Europe) AstraZeneca fulfilled the requirements for patenting Nexium®.  Policymakers should beware of upsetting the patent applecart for short-term political goals, or instead addressing behavior, if any, proscripted by more relevant provisions of the antitrust laws.

Article Discusses Premature Licensing of Biotech Products

    By Jason Derry --

Nature Reviews Drug Discovery has published an article relating to potential pitfalls associated with licensing deals between pharmaceutical companies and biotechnology companies.  In particular, the authors discuss the financial considerations of trying to in-license a biotech product in the early stages of clinical development.  The article reviews strategies that biotech and big pharmaceutical companies should consider when thinking about licensing biotech products that have not entered late stage (e.g., Phase II or III clinical trials) development.

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

Reliance Life to Acquire Controlling Interest of GeneMedix

    By Jason Derry --

Reliance Life Sciences has announced that it will buy a controlling share of GeneMedix Plc.  UK-based GeneMedix is a biopharmaceutical company whose core technology involves "protein development scale-up and manufacture" (see link).  Reliance Life Sciences, based in India, "is developing business opportunities in the domains of medical biotechnology, plant biotechnology, industrial biotechnology, clinical research services and contract manufacturing" (see link).  Reliance's investment is reported to be $63.2 million.

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

USPTO News: Private PAIR 7.0 and PDX Presentation

    By Christopher P. Singer --

The USPTO presented a seminar today, December 20, 2006, that provided an overview of the new features now available on Private PAIR and announced the new Priority Document Exchange program (PDX).  The presentation has been recorded and will be available within 48 hours at http://webex.client.ninesystems.com/pair122006.

Private PAIR 7.0

Some of the new features highlighted during the presentation included:

• Pending non-published PCT application search.  A new button has been added for a search based on PCT application number.  PAIR provides application data, transaction history, attorney address, and an image file wrapper.  It is important to remember to associate a customer number with your PCT application.  This can be done through EFS-Web or by submitting a form letter to EBC.

• XML Application Data Download provides for downloadable bibliographic application data, which can be used for document mapping and integrated into many docketing and document management systems.  The XML download is presented as an orange button usually next to "search" button.

• Self-administration of Customer Number allows for on-line changing of correspondence information or a list of attorneys associated with the customer number.  Further, practitioners can search for application status changes by customer number (as far back as 180 days).

• Self-administered Attorney Docket Number allows practitioners to edit a docket number on PAIR's bibliographic application data page.

• Ordering certified copies of pending applications and certified file histories.

• Cited reference display enhancements provide a list of cited references in three sections: U.S. Patent Documents, Reference Forms (e.g., PTO1449 forms), and Foreign Patents and NPLs.  All cited references are downloadable.

Priority Document Exchange (PDX)

The USPTO indicates this program will allow for the free electronic exchange of documents between the U.S. and European Patent Offices.  The request can be made using a PTO form (PTO/SB/38), which provides a release for non-published U.S. Applications.  After placing the request, you should monitor Private PAIR for confirmation of the application transmission.  Request instructions can also be found at the EPO's website.  The request can be made through EFS-Web, through U.S. Mail, or by fax to the USPTO's Central Fax Number (571-273-8300).  You can request additional information regarding this program by e-mail to [email protected].  The PDX program is expected to expand to include the Japanese Patent Office in June 2007.

Pfizer's Australian Patent Covering Atorvastatin Upheld; Patent Covering Atorvastatin Calcium Salt Held Invalid

    By Christopher P. Singer --

In a December 19, 2006 press release, Pfizer Inc. announced that its Australian patent AU 601,981 covering atorvastatin (the active ingredient in Lipitor®) was upheld by the Australian Federal Court in Victoria.  The ruling concluded Ranbaxy's 2005 lawsuit and imposes an injunction against Ranbaxy's generic product.  The 601,981 patent is in effect through May 2012.

The court ruled against Pfizer concerning its AU 628,198 patent covering the atorvastatin calcium salt, holding that patent to be invalid.

Each decision can be appealed.

 

MedImmune and Biowa Agree to License

    By Jason Derry --

MedImmune, Inc. and Biowa, Inc. have announced a licensing and collaboration deal relating to development and commercialization of therapies for inflammatory diseases.  In particular, the agreement relates to treatments that target interleukin-5 receptor.  The companies have indicated that the initial focus will be on a monoclonal antibody, BIW-8405, which is in Phase I clinical trials with asthma patients.  BIW-8405 is a humanized monoclonal antibody that binds to the IL-5 receptor.  Biowa has developed the antibody using its POTELLIGENT® technology.

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