32. Legal risks

Bayer HealthCare

Product-related litigation

Competition law proceedings

Patent disputes

Further legal proceedings

Bayer CropScience

Proceedings involving genetically modified rice

Limagrain

Asbestos

Premise®

Bayer MaterialScience

Antitrust proceedings in connection with polymers

Proceedings involving propylene oxide

Personal injury litigation

Liability considerations following the Lanxess spin-off

As a global company with a diverse business portfolio, the Bayer Group is exposed to numerous legal risks, particularly in the areas of product liability, competition and antitrust law, patent disputes, tax assessments, and environmental matters. The outcome of any current or future proceedings cannot be predicted with certainty. It is therefore possible that legal or regulatory judgments could give rise to expenses that are not covered, or not fully covered, by insurers’ compensation payments and could significantly affect our revenues and earnings.

Legal proceedings currently considered to involve material risks are outlined below. The legal proceedings referred to do not necessarily represent an exhaustive list.

Bayer HealthCare

Product-related litigation

Lipobay/Baycol: As of February 2, 2009, approximately 236 Lipobay/Baycol cases, 200 of them in the United States, remain pending against Bayer worldwide, claiming economic loss, medical monitoring, and personal injury. We are currently aware of fewer than five pending cases in the United States that in our opinion meet our criteria for potential settlement.

The class-action lawsuit which had been filed by shareholders in connection with Lipobay/Baycol has been resolved for a payment by Bayer of a total of US$ 18.5 million.

Magnevist®: As of February 2, 2009, Bayer has been served in a total of 241 lawsuits in the United States involving the gadolinium-based contrast agent Magnevist®. Three other manufacturers of gadolinium-based contrast agents in the United States also have been named party to the same or similar lawsuits. Additional cases are anticipated.

In the lawsuits, plaintiffs allege that patients developed nephrogenic systemic fibrosis (NSF) as a result of the use of Magnevist® during medical imaging procedures. NSF is a rare, severe condition that can be debilitating and in some cases fatal. Plaintiffs seek compensatory and punitive damages under theories of strict liability and negligence and/or breach of warranty, claiming that the product is defective and unreasonably dangerous, that Bayer knew or should have known of the risks associated with Magnevist®, and has failed to disclose or adequately warn its users.

All cases pending in federal courts have been consolidated in a multidistrict litigation (MDL) proceeding for common pre-trial management. Bayer believes that it has meritorious defenses and intends to defend itself vigorously. Based on the information currently available, Bayer has taken accounting measures for anticipated defense costs.

Trasylol® (aprotinin) is a drug approved for use in managing bleeding in patients undergoing coronary artery bypass graft surgery. As of February 2, 2009, there were 470 lawsuits pending in the United States served upon Bayer on behalf of persons alleging personal injuries, including renal failure and death, and economic loss from the use of Trasylol®. Bayer also has been served with a class action in Canada. Plaintiffs in both the U.S. and Canadian cases seek compensatory and punitive damages, claiming that Bayer knew or should have known of these risks and is liable for having failed to disclose or adequately warn users of Trasylol®. All cases pending in U.S. federal courts have been consolidated in a multidistrict litigation (MDL) proceeding for common pre-trial management. Additional cases are anticipated.

In 2006 and 2007 observational studies reported on a possible correlation between the administration of Trasylol® and severe renal dysfunction, myocardial infarction, stroke and an increase in mortality. In November 2007, Bayer temporarily suspended worldwide marketing of Trasylol® after preliminary results from an independent clinical study in Canada raised concerns about a possible increased risk of mortality in patients who had received Trasylol®. The marketing suspension will remain in effect until the final results from the Canadian study have been analyzed and the benefit-risk assessment for Trasylol® can be re-evaluated together with the health authorities. In some countries, including the United States, Trasylol® continues to be available to certain surgical patients with an established medical need. We are closely cooperating with health authorities to resolve the questions that have arisen.

Bayer believes it has meritorious defenses and intends to defend itself vigorously. Based on the information currently available, Bayer has taken accounting measures for anticipated defense costs.

HIV/HCV: Numerous actions are pending against Bayer in the United States and other countries seeking damages for plaintiffs resident outside of the United States who claim to have become infected with HIV or HCV (hepatitis C virus) through use of blood plasma products sold by Bayer. Additional actions are pending by U.S. residents who claim to have been infected with HCV. Bayer believes it has meritorious defenses.

Competition law proceedings

Diabetes Care investigation: The United States Department of Justice had conducted an investigation into Bayer HealthCare’s Diabetes Care Division regarding the manner in which Bayer provided business development funds from 1998 to 2003 to certain customers who marketed and sold Bayer blood glucose meters and test strips to patients. In November 2008, Bayer agreed to a settlement with the U.S. Department of Justice in order to avoid the time, uncertainty and expense of litigation. Without acknowledging liability, Bayer agreed to pay US$ 97.5 million to the U.S. government, and to enter into a Corporate Integrity Agreement with the Office of Inspector General for the Department of Health and Human Services.

Cipro®: 39 putative class action lawsuits and one individual lawsuit against Bayer involving the medication Cipro® have been pending in the United States since 2000. The plaintiffs are suing Bayer and other companies also named as defendants, alleging that a settlement to end patent litigation reached in 1997 between Bayer and Barr Laboratories, Inc. violated antitrust regulations. The plaintiffs claim the alleged violation prevented the marketing of generic ciprofloxacin as of 1997. In particular, they are seeking triple damages under U.S. law. After the settlement with Barr the patent was the subject of a successful re-examination by the U.S. Patent and Trademark Office and of successful defenses in U.S. federal courts. It has since expired.

All the actions pending in federal courts were consolidated in federal district court in New York in a multidistrict litigation (MDL) proceeding. In October 2008, the Court of Appeals for the Federal Circuit in Washington D.C. affirmed the 2005 ruling of the United States District Court in New York dismissing all lawsuits filed in federal court. The recent appellate decision affirmed the dismissal of various lawsuits brought by indirect purchaser plaintiffs in federal courts. Another appeal remains pending concerning the claims brought by direct purchasers of Cipro®. These claims also were dismissed by the federal district court, but the appellate court in New York has jurisdiction for the appeal of these lawsuits. Further cases are pending before various state courts. Bayer believes that it has meritorious defenses and intends to defend itself vigorously.

Patent disputes

Yasmin®: In April 2005, Bayer filed suit against Barr Pharmaceuticals Inc. and Barr Laboratories Inc. in U.S. federal court alleging patent infringement by Barr for the intended generic version of Bayer’s Yasmin® oral contraceptive product in the United States. In June 2005, Barr filed its counterclaim seeking to invalidate Bayer’s patent. In March 2008, the U.S. federal court invalidated Bayer’s ’531 patent for Yasmin®. Bayer has appealed this ruling.

In June 2008, Bayer and Barr Laboratories Inc. signed a supply and licensing agreement for Yasmin® covering the United States. Bayer supplies Barr with a generic version of Yasmin® which Barr markets solely in the United States. Barr pays Bayer a fixed percentage of the revenues from the product sold by Barr. Bayer continues to pursue its appeal of the court decision that invalidated Bayer’s U.S. patent ’531 for Yasmin®. If Bayer prevails in its appeal, Bayer will receive a larger share of Barr’s revenues from sales of its generic version of Yasmin® in the United States.

In March 2008 Bayer received two notices of an Abbreviated New Drug Application with a Paragraph IV certification (an “ANDA IV”) pursuant to which Watson Laboratories Inc. and Sandoz Inc. each seek approval to market a generic version of Bayer’s oral contraceptive Yasmin® in the United States. Bayer has filed suit against Watson and Sandoz in U.S. federal court alleging patent infringement by Watson and Sandoz for the intended generic version of Yasmin®. In reply, Sandoz has filed its answer and counterclaim alleging, among other things, the invalidity of various Bayer patents and that the agreement reached with Barr is anticompetitive and violates the Sherman Act antitrust law.

YAZ®: In January 2007, Bayer received notice from Barr Laboratories Inc. that it has filed an ANDA paragraph IV application with the U.S. FDA seeking approval of a generic version of Bayer’s YAZ® oral contraceptive. In October 2007 Bayer also received notice from Watson Laboratories Inc. that it has filed an ANDA IV with the U.S. FDA seeking approval of a generic version of YAZ®. In June/July 2008 Bayer further received notice from Sandoz Inc. that it has filed an anda iv with the U.S. FDA seeking approval of a generic version of YAZ®. All three applications claim that Bayer’s patents are invalid and/or that the respective generic product does not infringe them. Bayer has filed patent infringement suits against Watson and Sandoz claiming that certain of Bayer’s patents have been infringed. Originally, Bayer included the ’531 patent in its first suit against Watson. After the court decision in the suit against Barr regarding Yasmin®, Bayer had to exclude the ’531 patent from the suit against Watson. If Bayer prevails in its appeal against the court decision regarding Yasmin®, Bayer will evaluate its options to use the ’531 patent. However, regardless of these patent disputes, Bayer retains data exclusivity for YAZ® as an oral contraceptive in the U.S. until March 16, 2009. No generic manufacturer can lawfully market a generic version of YAZ® for an oral contraceptive indication in the United States until after March 16, 2009.

In June 2008, Bayer and Barr agreed that Bayer will grant Barr a license to market a generic version of YAZ® in the United States starting July 2011. Bayer will supply Barr with the product for this purpose. Should Bayer lose patent lawsuits in the United States against other companies concerning YAZ®, at that time Bayer will begin supplying the product to Barr and Barr will begin marketing generic YAZ® in the United States. Barr will pay Bayer a fixed percentage of the revenues from the product sold by Barr.

Blood glucose monitoring devices: In 2005, Abbott Laboratories commenced a lawsuit in the United States against Bayer and another party alleging infringement of two of Abbott’s patents relating to blood glucose monitoring devices. The devices concerned are sold by Bayer as part of its Ascensia® info

Contour® system and its DEX® and Autodisc® system. The Ascensia® Contour® system is supplied to Bayer by a Japanese manufacturer, who originally designed the product and is contractually obligated to indemnify Bayer. Abbott added a separate claim of infringement against the devices sold by Bayer as part of its DEX® and Autodisc® system. Bayer is not entitled to indemnification on this separate claim. In 2008 the court granted summary judgment in favor of Bayer with regard to one of the two patents and held the patent claims at issue invalid. After a trial on the issue of invalidity, the court also held the second patent invalid. Abbott has appealed both decisions.

In 2007, Roche Diagnostics Operations and Corange International commenced a lawsuit in the United States against Bayer and several other parties alleging infringement of two of Roche’s patents relating to blood glucose monitoring devices. Two of the accused devices are sold by Bayer as part of its info

Breeze® 2 and Contour® systems. Bayer believes that these patents are covered by an existing license agreement between the parties, and the litigation has been dismissed in favor of an arbitration under this earlier license agreement. The arbitration proceeding is currently pending. Roche has added to the arbitration four additional patents which Roche alleges the Bayer Contour® systems infringe.

Kogenate®: In 2008, Novartis Vaccines and Diagnostics Inc. and Novo Nordisc A/S commenced a patent infringement suit in the United States alleging that Bayer’s manufacturing and marketing of the recombinant Factor VIII product Kogenate® infringe a substance patent granted in 2006. The suit primarily seeks damages. Bayer does not believe that it has infringed any valid patent.

Bayer believes it has meritorious defenses in these patent disputes and intends to defend itself vigorously.

Further legal proceedings

Wholesale prices in the U.S.: Bayer and a number of pharmaceutical companies in the United States are defendants in pending lawsuits in which plaintiffs, including states, are alleging manipulation in the reporting of wholesale prices and/or best prices for their prescription pharmaceutical products. The plaintiffs seek damages, including disgorgement of profits and punitive damages. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Bayer Schering Pharma AG former shareholder litigation: In September 2008, the squeeze-out of the former minority shareholders of Bayer Schering Pharma AG became effective. As usual in such cases, several shareholders have initiated special court proceedings to review the adequacy of the compensation payments made by Bayer for the transfer of the shares in the squeeze-out. The adequacy of the compensation and the guaranteed dividend paid by Bayer in connection with the Bayer Schering Pharma AG profit and loss transfer agreement made in 2006 is also being reviewed by the courts. (Please note that Bayer Schering Pharma AG and Schering-Plough Corporation, New Jersey, are unaffiliated companies that have been independent of each other for many years. The names “Bayer Schering Pharma” or “Schering” as used in this Annual Report always refer to Bayer Schering Pharma AG, Berlin, Germany, or its predecessor, Schering AG, Berlin, Germany, respectively).

Bayer CropScience

Proceedings involving genetically modified rice: Since August 2006, Bayer CropScience has been party to multiple lawsuits, including putative class actions, filed in U.S. federal and state courts by rice farmers and resellers. Plaintiffs allege that they have suffered economic losses after traces of genetically modified rice were identified in samples of conventional long-grain rice grown in the U.S. This is alleged to have led to various commercial damages, including a decline in the commodity price for long-grain rice, costs associated with restrictions on imports and exports, and costs to secure alternative supplies. All the actions pending in federal court were consolidated in December 2006 in federal district court in Missouri in a multidistrict litigation (MDL) proceeding. In 2008, this court denied plaintiffs’ request to certify a class action. Plaintiffs’ subsequent request for interim appeal was denied by the appellate court.

In development of the genetically modified rice, field testing was conducted in cooperation with third parties, including a breeding research institute in the U.S. The genetically modified rice was never commercialized.

The USDA and the FDA have stated that the genetically modified rice does not present a health risk and is safe for use in food and feed and for the environment. Additionally, in October 2007, the USDA released its report concerning its investigation into how the genetically modified rice entered the commercial rice supply. The USDA was unable to determine a cause and indicated it would not pursue any enforcement actions against Bayer CropScience or any other party.

Bayer believes it has meritorious defenses in these actions and intends to continue to defend itself vigorously. Bayer has taken accounting measures for anticipated defense costs based on the information currently available.

Limagrain: In France, Limagrain had filed suit against Bayer for indemnity against liabilities to third parties arising from an alleged breach of a 1986 contract. In March 2008 the Commercial Court in Paris as the court of first instance dismissed all claims of Limagrain. Limagrain did not appeal and the court decision has become final.

Asbestos: A further risk may arise from asbestos litigation in the United States. In many cases, the plaintiffs allege that Bayer and co-defendants employed third parties on their sites in past decades without providing them with sufficient warnings or protection against the known dangers of asbestos. Additionally, a Bayer affiliate in the United States is the legal successor to companies that sold asbestos products until 1976. Union Carbide has agreed to indemnify Bayer for this liability. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Premise®: Bayer, among others, had been named as a defendant in a putative nationwide class action filed in federal court in North Carolina, United States, which alleges violations of antitrust laws in the marketing of a certain pest control product (Premise®). In 2007, the court granted summary judgment in favor of the defendants and plaintiffs have appealed. Bayer believes it has meritorious defenses and intends to continue to defend itself vigorously.

Bayer MaterialScience

Antitrust proceedings in connection with polymers

All proceedings by authorities reported in the past relating to rubber, polyester polyols, polyether polyols, urethanes, urethane chemicals and other primary products for urethane end products in which fines were expected have since been terminated.

In addition, subject to few exceptions, all civil law suits for damages relating to proceedings by authorities in North America have been settled. Bayer no longer considers the remaining risks to be material.

In Europe, the European Commission imposed fines upon Bayer or granted Bayer full amnesty in antitrust investigations concerning the products rubber chemicals, butadiene rubber, emulsion styrene butadiene rubber, polychloroprene rubber and nitrile butadiene rubber. However, civil law lawsuits for damages have been filed. In February 2008, a group of plaintiffs who are primarily producers of tires brought an action for damages before the High Court of Justice in the United Kingdom against Bayer and other producers of butadiene rubber and emulsion styrene butadiene rubber based on alleged violations of antitrust law. In June 2008, Bayer filed its defense with the High Court. Due to a parallel proceeding initiated before a court in Milan, to which Bayer joined as intervenient, the question arises as to which jurisdiction is competent to judge the case. In August 2008, The Goodyear Tire & Rubber Company filed an amended complaint in a U.S. federal court alleging that Bayer and other producers of butadiene rubber and styrene butadiene rubber violated antitrust law. The complaint seeks, among other things, treble damages. In September 2008, Bayer filed a motion asking the court to dismiss Goodyear’s complaint for failure to state a cause of action. A class action alleging antitrust violations in connection with rubber products was filed in Australia in 2008. While the Australian action was struck out in October 2008, the plaintiffs filed an amended claim in November 2008. This proceeding is still at a very early stage.

Bayer is defending itself in the European, U.S. and Australian litigation. The financial risk from these proceedings cannot currently be quantified. Therefore, Bayer is unable to take any accounting measures in this regard.

It remains possible that further civil antitrust lawsuits for damages may be filed concerning these products.

Proceedings involving propylene oxide

In 2006, a U.S. arbitration panel issued a final award in favor of Lyondell Chemical Co. in respect of a dispute with Bayer over interpretation of their Joint Venture Agreement for the manufacture of propylene oxide. Subsequently, Bayer sought to vacate the final award and filed additional claims against Lyondell.

In December 2008, Bayer and Lyondell concluded a settlement agreement which disposed of all previous claims among the parties.

Personal injury litigation

MDI: In the United States, Bayer, together with other manufacturers, resellers and applicators, is a defendant in multiple cases, including a putative class action, that seek damages for personal injuries allegedly resulting from exposure to diphenylmethane diisocyanate (MDI) based products used in coal mines. In one case the plaintiffs allege that they were also exposed to info

TDI and

HDI based products. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Baytown: In 2006, a high pressure rupture of a holding tank interrupted operation of the toluene diisocyanate II unit at the Baytown, Texas facility. After the rupture, 61 contractor employees filed a lawsuit against Bayer in Texas state court seeking damages for personal injuries. The claims of 57 of the plaintiffs have been settled. Bayer believes the legal risks remaining are no longer material.

Liability considerations following the Lanxess spin-off

The liability situation following the spin-off of the Lanxess subgroup is governed by both statutory and contractual provisions. Under the German Transformation Act, all entities that are parties to a spin-off are jointly and severally liable for obligations of the transferor entity that are established prior to the spin-off date. Bayer AG and Lanxess AG are thus jointly and severally liable for a time period of five years for all obligations of Bayer AG that existed on January 28, 2005.

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