Avoiding Antitrust Issues

The Interface of America's Antitrust and Intellectual Property Laws

The Antitrust Laws

Congress passed the Sherman Antitrust Act in 1890.¹ Since then, America's antitrust laws have sought to protect the integrity of our free enterprise syst8em by outlawing various restraints of trade that threaten "free and unfettered competition."^{2 (p5)} In discussing the objectives of the Sherman Act, the US Supreme Court has explained, "the unrestrained interaction of competitive forces will yield the best allocation of our economic resources, the lowest prices, the highest quality and the greatest national progress."³ Today, America's basic antitrust statutes include the Sherman Act (1890), the Clayton Act (1914)⁴ and the Federal Trade Commission Act (1914),⁵ and the Robinson-Patman Act (1936).⁶

Restraints of trade that are potentially illegal under Section 1 of the Sherman Act include price fixing, boycotts, and market allocations by horizontal competitors, as well as some potentially anticompetitive agreements among companies in vertical relationships, including price-fixing, exclusive dealings, and boycotts.¹ According to the American Bar Association (ABA), "Violations of §1 may be enjoined pursuant to §16 of the Clayton Act . . . and persons injured in their business or property by reason of a violation may recover treble damages under §4 of the Clayton Act."^7(p1) While Section 1 of the Sherman Act requires concerted action, ^2(p9) Section 2 forbids attempts to monopolize and actual monopolization by single persons or companies, as well as combinations and conspiracies to monopolize.

The Clayton Act regulates additional potentially anticompetitive acts, such as tying arrangements, exclusive dealing agreements, and requirements contracts. ^2(p11) Section 3 of the Clayton Act generally forbids sales or leases of goods "on the condition, agreement, or understanding that the lessee or purchaser thereof shall not use or deal in the goods, wares, merchandise, machinery, supplies, or other commodities of a competitor or competitors of the lessor or seller, where the effect of such lease, sale, or contract for sale or such condition, agreement, or understanding may be to substantially lessen competition or tend to create a monopoly in any line of commerce." The Clayton Act also regulates mergers and acquisitions. Section 7 of the Clayton Act generally forbids stock or asset acquisitions. (While pharmaceutical company mergers are subject to Clayton Act review, a full discussion is beyond the scope of this chapter.)⁸ In addition, the Clayton Act regulates interlocking directorates and officers (Section 8).^2(p25) The Robinson-Patman Act of 1936 was designed in part to amend and supplement the Clayton Act. "In general, the [R-P] Act makes it unlawful . . . to discriminate in price, services, or facilities, when the effect of such discrimination may be substantially to lessen competition or tend to create a monopoly in any line of commerce." ^2(p25)

The Robinson-Patman Act is generally referred to as Section 2 of the Clayton Act, (that being the specific section that the R-P Act amends).

The Federal Trade Commission Act of 1914 established the Federal Trade Commission (FTC), which today has the sole responsibility for enforcing the FTC Act and shares responsibility with the Justice Department's Antitrust Division for enforcing the Clayton and Robinson-Patman Acts. The ABA states, "[A]lthough the Federal Trade Commission may not directly enforce the Sherman Act, it may prohibit as an unfair method of competition under Section 5 of the FTC Act conduct that violates the Sherman Act. Thus, the scope of Section 5 is at least as broad as that of the combined Sherman, Clayton and Robinson-Patman Acts."^{7(pp727, 607)} Section 5 of the FTC Act broadly prohibits "unfair methods of competition in or affecting commerce and unfair or deceptive acts or practices in or affecting commerce."^5(§45)

The penalties for violating the antitrust laws can be severe. Violations of Sections 1 and 2 of the Sherman Act can be prosecuted as felonies, punishable by large fines and imprisonment. However, the majority of cases prosecuted criminally under the Sherman Act have involved allegations of per se violations of Section 1, including horizontal price-fixing, bid rigging, and market allocation.^7(pp729-731) Private parties also may enforce Sections 1 and 2 of the Sherman Act, as well as the Clayton and Robinson-Patman Acts, and if successful, may recover treble damages, as well as reasonable attorneys' fees and costs. Furthermore, many states have adopted supplementary antitrust legislation. Consequently, complying with the complex regulatory thicket of antitrust legislation is critical to a biopharmaceutical company's long-term economic health.

The Patent Laws

A patent is a grant from the US government assuring an inventor the sole right to make, use, and sell an invention for a limited number of years. The primary purpose of patents is to encourage inventors by rewarding their heavy expenditures of time, money, and energy. Shortly before he became President, Abraham Lincoln opined that patent laws were among the most valuable new inventions and discoveries in the history of the world "on account of their great efficiency in facilitating all other inventions and discoveries."⁹ Several of America's key constitutional framers, including Thomas Jefferson and James Madison, believed that protecting inventions would spur scientific discovery. For example, James Madison contended in The Federalist that strong patent laws would enhance "the public good."¹⁰ With the average research and development costs for a new Food and Drug Administration (FDA) approved pharmaceutical continuing to spike above $800 million, biopharm companies must be able to recoup their substantial investments through patents without undue interference from the antitrust laws.¹¹

Reconciling Intellectual Property and the Antitrust Laws

Courts and commentators have questioned at times whether the temporal and limited "monopolies" bestowed by America's patent laws are consistent with the antitrust laws.^12,13 The ineluctable conclusion is that they are. By spurring innovation and new developments, the patent laws catalyze enhanced competition, which ultimately results in increased output and consumer choice, as well as greater efficiencies and lower prices to consumers. Biopharm companies must therefore be permitted to maximize the values of their intellectual property portfolios (in 2002 "pharmaceutical companies derived an average 20 percent of their total sales from in-licensed products"),¹⁴ without crossing the antitrust laws' boundaries. The good news is that with careful and ongoing antitrust counseling, biopharm companies can enjoy the fruits of their discoveries without violating the antitrust laws.

Antitrust Issues in Acquiring, Listing, and Enforcing Biopharmaceutical Intellectual Property Rights

Obtaining Pharmaceutical Patents

In rare circumstances, obtaining a pharmaceutical patent by a grant to the inventor may potentially create antitrust liability. According to the ABA, citing Automatic Radio Mfg. Co. v Hazeltine Research, Inc., "In the context of the challenge to acquisition by grant, the Supreme Court has stated that 'mere accumulation of patents, no matter how many, is not in and of itself illegal.'"^7(p1035),¹⁵ However, such liability may only be imposed if the patent is obtained by fraud, and the patent holder attempts to enforce it with knowledge that the patent is invalid.

Allegations such as those involved in Walker Process v Food Machinery and Chemical Corp., and Nobelpharma AB v Implant Innovations, Inc.,^{16, 17} formed the basis of an antitrust suit under Section 1 of the Sherman Act by the US against Ciba-Geigy in 1969, based on alleged misrepresentations to obtain a patent for hydrochlorothiazide, "a very useful diuretic and antihypertensive agent." The government contended that Ciba presented affidavits to the United States Patent and Trademark Office (PTO) containing material omissions. Holding for Ciba, the US District Court ruled, "The government ha[d] not demonstrated by clear and convincing evidence that Ciba omitted the allegedly misleading facts intentionally and in bad faith. Furthermore, the omitted facts were immaterial to the issuance of the patent."¹⁸

As stated by the Federal Circuit, "Walker Process antitrust liability is based on the knowing assertion of a patent procured by fraud on the PTO, very specific conduct that is clearly reprehensible." ^17(p1071) Consequently, such potential liability can be avoided by not making fraudulent misrepresentations or omissions to the United States Patent Office. In Bristol-Myers Squibb Co., the FTC charged Bristol-Myers Squibb with procuring two Taxol (anti-cancer drug) patents "through inequitable conduct." The FTC observed in part, "When pursuing a patent, an applicant has a duty of candor and good faith in dealing with the PTO. This duty includes a requirement to disclose all information, of which the applicant is aware, that a reasonable examiner would find material in determining patent ability. The failure to satisfy this duty is inequitable conduct that renders the patent unenforceable."¹⁹

In other rare circumstances, obtaining an extensive portfolio of competitive patents through purchase or assignment "may violate the Sherman Act where the assignment [or purchase] constitutes unlawful monopolization or is part of an agreement by competitors to restrain trade."^7(p1036) So the ABA has pointed out, citing United States v Singer Manufacturing Co. ("in the context of a broader monopolistic scheme, the transfer of a patent from a Swiss manufacturer to its US licensee to facilitate bringing enforcement actions against Japanese competitors violated Sherman Section 1"),²⁰ and citing Kobe, Inc. v Dempsey Pump Co. ("the acquisition, nonuse and enforcement of 'every important patent' in the field with a purpose to exclude competition, together with other anticompetitive acts, constituted a violation of Section 2 of the Sherman Act").²¹

Sham Pharmaceutical Patent Litigation

Potential antitrust liability may attach for filing "objectively baseless" sham litigation to enforce a patent. For example, in Nobelpharma AB v Implant Innovations, Inc, the Federal Circuit, citing Professional Real Estate Investors Inc. v Columbia Pictures Indus, Inc. (PRE)²² and Eastern RR Presidents Conference v Noerr Motor Freight, Inc. (Noerr),²³ explained, "An antitrust claim can also be based on a PRE allegation that a suit is baseless; in order to prove that a suit was within Noerr's 'sham' exception to immunity, an antitrust plaintiff must prove that the suit was both objectively baseless and subjectively motivated by a desire to impose collateral, anti-competitive injury rather than to obtain a justifiable legal remedy."^{17(p1071-1072)} In the consent order issued against Bristol-Myers Squibb (BMS) on April 14, 2003 (cited earlier), the FTC charged that BMS had filed sham patent litigation relating to its anti-cancer drug Platinol and its anti-anxiety drug BuSpar in order to delay the market entry of potential generic competitors. The FTC alleged, "The intent and effect of BMS's multiple patent infringement lawsuits was to prevent generic buspirone manufacturers from marketing their products for as long as possible, through wrongful trigger of the 30-month stay."^19(¶60) Once again, however, the standard of proof required for making such a claim is high, so potential liability can be avoided through careful diligence and good-faith conduct.

Misleading Orange Book Listings

A "principal focus" of the FTC's recent enforcement activities against pharmaceutical companies "has been improper Orange Book listings."^{24, 25} (The FDA's Orange Book is formally known as Approved Drug Products With Therapeutic Equivalence Evaluations.) From the FTC's perspective, "an improper Orange Book listing strategy involves unilateral abuse of the Hatch-Waxman process itself to restrain trade."

In 2003, the Commission stated that it "has challenged conduct by firms that allegedly have 'gamed' the Hatch-Waxman framework to deter or delay generic competition. Our 'first generation' of such matters involved agreements through which a brand-name drug manufacturer allegedly paid a generic drug manufacturer not to enter and compete. . . .Our 'second generation' of enforcement activities has involved allegations that individual brand-name manufacturers have delayed generic competition through the use of improper Orange Book listings that trigger a Hatch-Waxman provision prohibiting the FDA from approving a generic applicant for 30 months."²⁵ In a number of recent complaints, the FTC charged that pharmaceutical companies have filed erroneous or misleading information with FDA to delay the potential entry of generic competition.

For example, such charges were filed against Biovail Corporation by the FTC in October of 2002, as part of a consent order regulating Biovail's use of its antihypertension drug Tiazac.²⁶ In its subsequent actions, the FTC alleged that Biovail had wrongfully acquired an exclusive license to a patented formulation of dilitiazem (the same active pharmaceutical ingredient as in Biovail's Tiazac), and then listed the patent in the Orange Book as claiming Tiazac — even though Biovail allegedly was aware that the "patent did not cover the formulation of Tiazac it was marketing."^26(¶36) The FTC similarly charged Bristol-Myers Squibb in 2003, with "efforts to extend its monopoly by providing to the FDA false and misleading information concerning its [BuSpar anti-anxiety drug] patent," as well as its Taxol and Platinol anticancer drugs. ^{19(¶¶34-58,90-93,110-122)}

To avoid such potential attacks, pharmaceutical companies must avoid filing false or misleading information with either the US PTO or FDA, and ensure that statements to FDA and PTO are consistent. Such advice comports with the general maxim that in dealing with the government, "credibility counts," and that one may well find oneself dealing with the same regulators again in the future.

Antitrust Issues in Exploiting Intellectual Property

Agreements Not to Compete or to Raise Prices or Reduce Output

Market Allocation Agreements

Following a long line of cases, the US Department of Justice's Antitrust Division and the FTC have jointly stated that "agreements of a type that always or almost always tends to raise price or reduce output are per se illegal,"²⁷ citing Broadcast Music Inc. v Columbia Broadcasting Svs.²⁸ The "per se" rule allows restraints of trade to be "condemned without further analysis."²⁸ In Broadcast Music Inc. v Columbia Broadcasting Svs., the Supreme Court stated that where a "practice facially appears to be one that would always or almost always tend to restrict competition and increase output" rather than "one designed to 'increase economic efficiency and render markets more, rather than less competitive,"' it is considered to be "per se illegal" and may be condemned without further analysis. ^7(p50) Moreover, citing Palmer v BRG of Georgia, Inc.²⁹ (market allocation) and United States v Trenton Potteries Co.³⁰ (price-fixing), the US Department of Justice and the FTC have declared, "Types of agreements that have been held per se illegal include agreements among competitors to fix prices or output, rig bids, or share or divide markets by allocating customers, suppliers, territories or lines of commerce."²⁷

In 2002, the FTC alleged that Biovail Corporation and Elan Corporation had entered into an agreement to split the market for the sales of 30 mg and 60 mg generic Adalat, a prescription drug used to treat hypertension.³¹ The FTC asserted that Elan had obtained a monopoly over the 30 mg generic Adalat, and that Biovail had obtained one over the 60 mg product. The FTC added that through a series of distribution agreements, the companies avoided direct competition and split their profits. The FTC complaint charged that the agreement resulted in consumers and others having "to pay artificially high prices for generic Adalat products." ^31(¶27) In recent remarks on the subject of the Federal Trade Commission v Perrigo Co. and Alpharma Inc.,³² FTC Chairman Deborah Platt Majoras noted that the FTC had attacked an alleged "conspiracy between Alpharma, Inc. and Perrigo Company to limit competition for over-the-counter store-brand children's liquid Ibuprofen." Chairman Majoras also stated, "Perrigo and Alpharma had signed an agreement allocating to Perrigo the sale of the product for seven years. In exchange for agreeing not to compete, Alpharma received an up-front payment and a royalty on Perrigo's sales of children's liquid Ibuprofen. Perrigo then, not surprisingly, raised prices."³³

Because the stakes are so high, any potential non-competition agreement between biopharm companies must be reviewed carefully by antitrust counsel.

Pharmaceutical Patent Settlement Agreements

Payments by brand pharmaceutical patent holders to generic companies to settle patent litigation have garnered intense antitrust regulatory scrutiny and spawned substantial antitrust litigation in recent years. A generic abbreviated new drug application (ANDA) holder may note its intention to market a generic product prior to the expiration of a patented new drug application (NDA) drug by certifying to FDA that a patent or patents listed by a brand manufacturer in FDA's Orange Book are either invalid or not infringed by the generic version. The generic company also must notify the holder of the approved NDA, and the owner of the patent, of the filing of the ANDA. Generally, a patent infringement suit will then be filed against the ANDA filer within 45 days to prevent the FDA review and approval process from proceeding. Such a suit automatically stays FDA approval of the ANDA until the patent expires, a court determines that the patent is invalid, or 30 months pass.

According to the FTC, under the Hatch-Waxman Act, "the first applicant to submit an ANDA with a Paragraph IV Certification for a generic version of a brand name drug is entitled to a 180-day period of marketing exclusivity before the FDA may grant final approval of any other generic manufacturer's ANDA regarding the same brand name drug. This period does not begin to run until either the generic drug is commercially marketed or a court enters final judgment that the patents subject to the Paragraph IV Certification are invalid or not infringed." ^{34, 35(¶¶8-9)} The complaints accompanying several FTC consent decrees have charged that such settlements effectively allocated markets and injured competition "by preventing or discouraging the entry of competition in the form of generic versions of [pharmaceuticals] into the relevant market[s]."^{35(¶34), 36} For example, in May 2000, the FTC charged that Abbott Laboratories paid Geneva Pharmaceuticals $4.5 million per month to delay bringing to market a generic alternative to Abbott's brand-name hypertension and prostate drug Hytrin. The companies entered into a consent decree with the Commission. ³⁵

NDA patent holders have complained vigorously that the FTC's aggressiveness has effectively prevented them from settling patent infringement suits against generic ANDAs, and has effectively held them hostage to generics. On March 8, 2005, the Eleventh Circuit Court of Appeals agreed and reversed an earlier FTC decision. In that decision, the FTC had found Schering-Plough Corporation liable under Section 5 of the FTC Act and Section 1 of the Sherman Act for making payments to Upsher-Smith Laboratories as part of a settlement involving K-Dur 20 (a supplement generally taken in conjunction with prescription medicines for the treatment of high blood pressure or congestive heart disease) in return for Upsher agreeing to license certain products to Schering and promising not to enter the K-Dur 20 market.³⁷ The court rejected the FTC's finding that Schering's payments to Upsher and ESI Lederle, Inc. did not represent "legitimate consideration for the licenses granted by Upsher or ESI's ability to secure FDA approval of its generic." ^38(p1062) Noting that "U.S. patent litigation costs [over] $1 billion annually," and that there "is no question that settlements provide a number of private and social benefits as opposed to the inveterate and costly effects of litigation," the court ruled that "[t]he Commission's inflexible compromise-without-payment theory neglects to understand that reverse payments are a natural by-product of the Hatch-Waxman process." The Eleventh Circuit added, "Consequently, the Commission prohibited settlements under which the generic receives anything of value and agrees to defer its own research, development, production, or sales activities."^38(p1074)

The recent Schering decision may conflict with a 2003 ruling by the Sixth Circuit holding that quarterly $10 million payments by Hoechst Marion Roussel, the manufacturer of prescription drug Cardizem CD, to Andrx Pharmaceuticals to refrain from marketing a competitive generic drug violated the antitrust laws. Regarding In Re Cardizem CD Antitrust litigation, the court noted that Andrx's generic Cardizem CD had received FDA approval.³⁹ In addition, in In Re Terazosin Hydrochloride Antitrust litigation, the court applied a per se analysis and found a settlement agreement to be illegal,⁴⁰ following a remand from the Eleventh Circuit in Valley Drug Co. v Geneva Pharmaceuticals, Inc.⁴¹ Given the high stakes and continuing uncertainty, any settlements of generic drug patent litigation must be carefully reviewed by antitrust counsel and the court.

In Schering, the Eleventh Circuit was impressed by the "settlement [having been] signed in Judge Rueter's presence on January 23. 1998."^38(p1061) By contrast, the FTC charged in Abbott Laboratories and Geneva Pharmaceuticals that "[t]he court hearing the patent litigation was not made aware of the respondents' Agreement."^35(¶28)

Tying Arrangements

In certain circumstances, it may be illegal to tie the sale of a patented pharmaceutical to another product.⁴² For example, in 1992 the FTC charged that Sandoz Pharmaceuticals unlawfully required purchasers of its schizophrenia drug clozapine, the first new drug for the treatment of schizophrenia in twenty years, to also purchase distribution and patient-monitoring services from Sandoz. The FTC asserted that Sandoz's "'tying' arrangement raised the price of clozapine and prevented others — such as private laboratories, the Veterans Administration, and state and local hospitals — from providing the related blood tests and necessary patient monitoring."⁴³

Antitrust Issues In Pharmaceutical Licensing Relationships

From a competition standpoint, biopharm licenses can be procompetitive and efficiency enhancing.⁴⁴ An excellent example is "the successful collaboration between Genentech and IDEC pharmaceuticals that resulted in the drug Rituxan, the first monoclonal antibody granted market approval in the United States." ^45(pp1,18)

"Unfortunately, poorly drafted or executed licenses can be perceived as potentially reducing fair competition or market efficiencies," and lead to antitrust liability. ^44(p50) For example, in 1999, the FTC and several states successfully pursued antitrust claims based on a series of licensing arrangements involving Mylan Laboratories and three other companies designed "to monopolize the markets for two generic and anti-anxiety drugs, lorazepam and clorazepate."⁴⁶ Mylan was able to dramatically increase the prices of the drugs through exclusive licensing arrangements for the raw material necessary to produce them.

A host of other potential antitrust issues can arise through licensing relationships, including illegal resale price maintenance. The 1995 Antitrust Guidelines for the Licensing of Intellectual Property (IP Antitrust Guidelines) sternly warn, "the Agencies will enforce the per se rule against resale price maintenance in the intellectual property context."^47(§5.2) Thus, a license which requires the licensee to sell a product for a minimum stated price could subject the licensor to potential antitrust liability. Another potential basis for antitrust issues involves Hart-Scott-Rodino filing obligations,^44(n50) and illegal territorial and field-of-use restrictions.^44(n50) Therefore, all licensing relationships should be carefully reviewed by antitrust counsel paying close attention to the 1995 IP Antitrust Guidelines.^{47, 7(1537)}

Conclusion

The penalties for violating the antitrust laws can be severe. However, through careful diligence and proactive antitrust counseling, biopharm companies can exploit their intellectual property in a diverse variety of potentially profitable ways without violating the antitrust laws.

References

1. 15 USC §1-7 (1890).

2. von Kalinowski J. Antitrust Laws and Trade Regulation: Desk Edition. Vol. 1. 2nd ed. Newark, NJ: Matthew Bender & Co Inc; 2004.

3. Northern Pacific Railway Co v United States, 356 US 1 (1958).

4. 15 USC §12-27 (1914).

5. 15 USC §41-58 (1914).

6. 15 USC §13 (1936).

7. ABA Section of Antitrust Law. Annual Review of Antitrust Law Developments. 5th ed. Chicago, IL: American Bar Association; 2002.

8. FTC File No. 021-0192, Docket No. C-4075 (2003). In the Matter of Pfizer Inc and Pharmacia Corporation. 2003 May 30. Available at: http://www.ftc.gov/os/caselist/c4075.htm

9. Lincoln A. Second Lecture on Discoveries and Inventions. In: Basler RP, ed. The Collected Works of Abraham Lincoln. Vol. 3. Piscataway, NJ: Rutgers Univ. Press; 1953:361.

10. Madison J. Federalist No. 43. In Hamilton A, Madison J, Jay J.The Federalist Papers. Rossiter C, ed. New York: New America Library; 1961:271-272.

11. Drug Development: Alliances Essential in Reducing Pharmaceutical Costs, Study Shows. Biotech Bus Wk. 2004 Feb:108. Cited in: Horton TJ. Protecting Your Life Sciences and Biotech Licenses from the Specter of the Antitrust Laws. Licensing J. 2005 March:1.

12. Tom WK, Newberg JA. Antitrust and Intellectual Property: From Separate Spheres to Unified Field.66 Antitrust Law J. 1997; No. 1:167.

13. Symposium: Antitrust Issues in the Pharmaceutical Indus. 71 Antitrust Law J. 2003; No. 2:577.

14. Cutting Edge Information. Pharmaceutical Alliances, Licensing, and Deal-Making (PH56) (Partial Summary). 2003 October. Available at: http://www.pharmadealmaking.com.

15. Automatic Radio Mfg Co v Hazeltine Research, Inc, 339 US 827, 834 (1950).

16. Walker Process v Food Machinery and Chemical Corp, 382 US 172 (1965).

17. Nobelpharma AB v Implant Innovations, Inc, 141 F3d 1059, 1070-1072 (Fed Cir 1998).

18. United States v Ciba-Geigy Corp, 508 FSupp, 1157, 1162, 1175 (DNJ 1981).

19. FTC File Nos. 001-0221, 011-0046, and 021-018, Docket No. C-4076. In the Matter of Bristol-Myers Squibb Company. Complaint. 2003 April 18. Available at: http://www.ftc.gov/os/caselist/c4076.htm.

20. United States v Singer Manufacturing Co, 374 US 174 (1963).

21. Kobe, Inc v Dempsey Pump Co, 198 F2d 416 (10th Cir), cert denied, 344 US 837 (1952).

22. Professional Real Estate Investors, Inc v Columbia Pictures Indus, Inc, 508 US 49, 60-61 (1993).

23. Eastern Railroad Presidents Conference v Noerr Motor Freight, Inc, 365 US 127, 144 (1961).

24. Prepared Statement of the FTC before the Committee on Energy and Commerce Subcommittee on Health. US House of Representatives. 2002, October 9:9. Available at: http://www.ftc.gov/os/2002/10/generictestimony021009.pdf.

25. Prepared Statement of the FTC Before the Committee on Judiciary. US Senate. 2003 June 17:3. Available at: http://www.ftc.gov/os/2003/06/030617pharmtestimony.htm.

26. FTC File No. 011-0094, Docket No. C-4060. In the Matter of Biovail Corporation. Consent Order and FTC Commission Actions. 2002 October 2 and 4. Available at:http://www.ftc.gov/os/caselist/c4060.htm.

27. US Department of Justice and Federal Trade Commission. Agreements Challenged as Per Se Illegal. Guidelines for Collaborations Among Competitors . Washington, D.C. 2000 April 7: §3.2. Available at: http://www.ftc.gov/os/2000/04/ftcdojguidelines.pdf.

28. Broadcast Music Inc v Columbia Broadcasting Svs, 441 US 1, 19-20 (1979).

29. Palmer v BRG of Georgia, Inc, 498 US 46 (1990).

30. United States v Trenton Potteries Co, 273 US 392 (1927).

31. FTC File Nos. 011-0132, Docket No. C-4057. In the Matter of Biovail Corporation and Elan Corporation, LLC. Consent Order and Complaint. 2002 August 15, 20. Available at: http://www.ftc.gov/os/2002/08/index.htm.

32. FTC File No. 021-0197. Federal Trade Commission v Perrigo Co. and Alpharma Inc. District of the District of Columbia. Complaint. 2004 August 12. Available at: http://www.ftc.gov/os/caselist/0210197/040812comp0210197.pdf.

33. Majoras, DP. Recent Actions At The Federal Trade Commission. Remarks before the Dallas Bar Association's Antitrust and Trade Regulation Section; 2005 January 18; Dallas, TX. Available at: http://www.ftc.gov/speeches/majoras/050126recentactions.pdf.

34. 21 USC §355 (1984).

35. FTC Docket No. C-3945. In the Matter of Abbott Laboratories and Geneva Pharmaceuticals, Inc. Complaint. 2000, May 26. Available at: http://www.ftc.gov/os/2000/05/c3945complaint.htm.

36. FTC Docket No. 9293. In the Matter of Hoechst Marion Roussel, Inc, Carderm Capital LP, and Andrx Corp. Consent Order and FTC Commission Actions. 2001, May 8, 11. Available at: http://www.ftc.gov/os/2001/05/hoechstdo.htm and http://www.ftc.gov/opa/2001/05/fyi0130.htm.

37. FTC Docket No. 9297. In the Matter of Schering-Plough Corp, Upsher-Smith Laboratories, and American Home Products Corp. 2001 November 20. Available at: http://www.ftc.gov/os/adjpro/d9297/011109stip.pdf

38. Schering-Plough Corp v FTC, 402 F3d (11th Cir 2005 March 8).

39. In Re Cardizem CD Antitrust Litigation, 332 F3d 896 (6th Cir 2003).

40. In re Terazosin Hydrochloride Antitrust Litigation, 164 F Supp 2d 1340 (SD Fla 2000).

41. Valley Drug Co. v Geneva Pharmaceuticals, Inc, 344 F3d 1294 (11th Cir 2003).

42. Jefferson Parish Hospital Dist No. 2 v Hyde, 466 US 2 (1984).

43. Sandoz Pharmaceuticals Corp, 115 FTC 625 (1992) (consent order). Summarized at: http://www.ftc.gov/bc/rxupdate021108.htm.

44. Horton TJ. Protecting Your Life Sciences and Biotech Licenses from the Specter of the Antitrust Laws. Licensing J. 2005 March:1.

45. Carson P, Jackson M, Mandrgoc M. Maximizing prosperity through strategic licensing. Paper presented at: American Conference Institute Conference on Pharma and Biotech In-Licensing Co-Development and Co-Promotion Agreements; 2002 October 21; New York, NY.

46. Federal Trade Commission v Mylan Laboratories, 62 FSupp 2d 25 (DDC 1999).

47. US Department of Justice and Federal Trade Commission. Antitrust Guidelines for the Licensing of Intellectual Property (IP Antitrust Guidelines). Washington, D.C. 1995, April 6. Available at: http://www.usdoj.gov/atr/public/guidelines/ipguide.htm.

Thomas J. Horton, J.D., is an antitrust and litigation partner at Thelen Reid & Priest LLP, 701 Eighth Street, NW, Washington, DC 20001, 202.508-4025, fax 202.508.4321, thorton@thelenreid.com