Recent Developments in Health Law

World Health Organization, “10 Facts on Essential Medicines,” February 12, 2010, available at <http://www.who.int/features/factfiles/essential_medicines/en/index.html> (last visited March 21, 2011).

World Health Organization, “Essential Medicines,” available at <http://www.who.int/topics/essential_medicines/en/> (last visited March 21, 2011).

Attaran A. , “How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries?” Health Affairs 23, no. 3 (2004): 155–166, at 158 (patents exist for essential medicines a mere 1.4% of the time); World Health Organization and World Trade Organization, Report of the Workshop on Differential Pricing and Financing of Essential Drugs , April 2001, at 9, available at <http://www.wto.org/english/tratop_e/trips_e/hosbjor_report_e.pdf> (last visited March 21, 2011) (“[M]ost essential drugs are not under patent protection anywhere.”).

See, e.g., Universities Allied for Essential Medicines, The Access Gap, available at <http://sandbox.essentialmedicine.org/issues/access-gap> (last visited March 21, 2011); Marriott A. , Your Money or Your Life , Oxfam International, 2009, at 2, available at <http://www.oxfam.org/sites/www.oxfam.org/files/bp-your-money-or-your-life.pdf> (last visited March 21, 2011).

On the theoretical appeal of international drug price discrimination, see Fisher W. W. III , “When Should We Permit Differential Pricing of Information?” UCLA Law Review 55, no. 1 (2007): 1–38, at 28.

See World Health Organization, Revised Procedures for Updating the WHO Model List of Essential Drugs , May 19, 2001, at 1, available at <http://www.searo.who.int/en/Section1257/Section2263/info-kit/who-model-drug_list.pdf> (last visited March 21, 2011).

See, e.g., Atik J. Lidgard H. H. , “Embracing Price Discrimination: TRIPS and the Suppression of Parallel Trade in Pharmaceuticals,” University of Pennsylvania Journal of International Economic Law 27 (2006): 1043–1076, at 1060.

See, e.g., Gilead Sciences, Gilead Sciences Submits New Drug Application to U.S. FDA for Once-Daily Single-Tablet Regimen of Truvada and TMC278 for HIV , Press Release, November 23, 2010, available at <http://www.gilead.com/pr_1499754> (last visited March 21, 2011).

Hornbeck R. , “Price Discrimination and Smuggling of AIDS Drugs,” Topics in Economic Analysis & Policy 5 no. 1, art. 16 (2005): 1–25, at 1 (noting the successful use of price discrimination for vaccines).

Outterson K. , “Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets,” Yale Journal of Health Policy, Law & Economics 5 (2005): 193–291, at 206.

Food & Drug Administration, “Buying Medicines and Medical Products Online FAQs,” available at <http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/BuyingMedicinesOvertheInternet/ucm202675.htm#faqs1> (last visited March 21, 2011) (“The number of Websites [offering pharmaceuticals]… seems to be growing.”).

Liang B. A. Mackey T. , “Searching for Safety: Addressing Search Engine, Website, and Provider Accountability for Illicit Online Drug Sales,” American Journal of Law & Medicine 35, no. 1 (2009): 125–184, at 146; Rosenfield T. A. , “The Counterfeit Drug Invasion: How Drug Reimportation Unjustifiably Poses a Threat to the Health of the U.S. Public,” University of Pennsylvania Journal of International Economic Law 25 (2004): 1047–1077, at 1058 (“The FDA estimates 5 million packages of drugs were imported in 2003 via internet transactions, up from 2 million in 2002 and 1 million in 2001”).

Id. (Liang and Mackey), at 149–50.

See, e.g., Weil E. , “Grumpy Old Drug Smugglers,” New York Times Magazine, May 30, 2004, at 42.

Flaherty M. P. Gaul G. M. , “Millions of Americans Look Outside the U.S. for Drugs,” Washington Post, October 23, 2003.

Id.

U.S. Food & Drug Administration, Regulatory Procedures Manual: Chapter 9: Import Operations and Actions , March 2010, at 9–14, available at <http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf> (last visited March 21, 2011).

Bartfai T. Lees G. V. , Drug Discovery from Bedside to Wall Street (Burlington: Elsevier, 2006): at 294.

See Fisher W. W. Syed T. , “Global Justice in Health Care: Developing Drugs for the Developing World,” University of California Davis Law Review 40 (2007): 581–678, at 603–604.

See generally Kaplow L. Shavell S. , “Why the Legal System Is Less Efficient than the Income Tax in Redistributing Income,” Journal of Legal Studies 23, no. 2 (1994): 667–681.

See Marriott , supra note 4, at 2 (advocating for free, not merely less expensive, drugs).

See Grabowski H. , “Patents, Innovation, and Access to New Pharmaceuticals,” Journal of International Economic Law 5, no. 4 (2002): 849–860, at 857 (“[E] ven the marginal costs of most AIDS drugs…far exceed the total per capita health expenditures of [developing] countries.”).

See Central Intelligence Agency, “World Factbook: Country Comparison: Distribution of Family Income,” 2011, available at <https://www.cia.gov/library/publications/the-world-factbook/fields/2172.html> (last visited March 21, 2011) (indicating Gini coefficients of between 46 and 65). According to the World Health Organization, such disparities can ironically sometimes lead drugs to be priced higher in developing countries than in developed countries, as pharmaceutical companies tailor prices to the wealthy. See Hammer P. J. , “Differential Pricing of Essential AIDS Drugs: Markets, Politics and Public Health,” Journal of International Economic Law 5 (2002): 883–912, at 888.

Danzon P. M. Towse A. , “Differential Pricing for Pharmaceuticals: Reconciling Access, R&D and Patents,” International Journal of Health Care Finance & Economics 3 (2003): 183–205, at 184.

IMS Health, IMS Health Forecasts Global Pharmaceutical Market Growth of 5–7 Percent in 2011, Reaching $880 Billion , Press Release, October 6, 2010, available at <http://www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=119717f27128b210VgnVCM100000ed152ca2RCRD>.

World Health Organization, Neglected Tropical Diseases , 2009, at 18, 30, and 33, available at <http://whqlibdoc.who.int/publications/2009/9789241598705_eng.pdf> (last visited March 21, 2011).

Azar A. M. II , Eating Today and Eating Tomorrow: Competition, Innovation, and Pricing for Modern Medicine , U.S. Department of Health & Human Services, November 9, 2005, available at <http://www.hhs.gov/deputysecretary/depsecspeeches/051109.html> (last visited March 21, 2011) (“When people realize that other consumers are paying much lower prices, they often put pressure on politicians to do something.”); the Pharmaceutical Market Access and Drug Safety Act of 2009, H.R. 1298, 111th Cong. (2009) (“Congress finds that…Americans unjustly pay up to 5 times more to fill their prescriptions than consumers in other countries.”).

Taylor D. , “Importing a Headache for Which There's No Medicine: Why Drug Reimportation Should and Will Fail,” Journal of Law & Policy 15 (2007): 1421–1468, at 1426 (describing a state proposal which would have allowed Wisconsin and Illinois residents to purchase drugs from Canada, Ireland, or the U.K.); Andrisano A. F. , “To the U.S. Government: Whether or Not Reimportation Is the Answer, Something Must Be Done to Help Americans Afford Their Necessary Prescription Drugs!,” Penn State International Law Review 23 (2005): 897–930, at 922 (“A growing number of cities and states have been exploring ways to permit their residents to benefit from the cheaper prescription drugs existing in Canada.”).

The Pharmaceutical Market Access and Drug Safety Act of 2009 , H.R. 1298, 111th Cong. (2009). Similar bills appeared earlier. See, e.g., The Pharmaceutical Market and Drug Safety Act of 2004, S. 2328, 108th Cong. (2004).

A similar problem was created with the Medicaid “best price” provision, under which the price the government pays on behalf of Medicaid beneficiaries is indexed to private market transactions. See 42 U.S.C. § 1396r-8 (2011).

Spitz B. Abramson J. , “When Health Policy Is the Problem: A Report from the Field,” Journal of Health Politics, Policy & Law 30, no. 3 (2005): 327–366, at 342; Stegemann K. , “Chapter 5: International Price Discrimination and Market Segmentation for Patented Pharamceuticals in the EU,” in Govaere I. Ullrich H. , eds., Intellectual Property, Public Policy and International Trade (Brussels: P. I. E. Peter Lang, 2007): at 157.

Baer A. B. , “Price Controls through the Back Door: The Parallel Importation of Pharmaceuticals,” Journal of Intellectual Property Law 9 (2001): 109–135, at 131; Cahoy D. R. , “Patent Fences and Constitutional Fence Posts: Property Barriers to Pharmaceutical Importation,” Fordham Intellectual Property, Media & Entertainment Law Journal 15 (2005): 623–708, at 625, n. 4 (quoting U.S. Senate Republican Policy Commission, Pharmaceutical Price Controls Abroad: An Unfair Trade Policy, at 6–7 [November 6, 2003] [“Importation of pharmaceuticals only treats the symptom, not the cause – it may reduce drug prices temporarily, but it can lead to two devastating scenarios:…second, indirectly imposing pharmaceutical price controls in the United States eventually will lead to reduced spending on R&D and fewer new drugs coming into the market.”]).

On alternative compensation schemes see, e.g., Love J. Hubbard T. , “Prizes for Innovation of New Medicines and Vaccines,” Annals of Health Law 18 (2009): 155–186; Hollis A. Pogge T. , The Health Impact Fund: Making New Medicines Accessible for All , Incentives for Global Health, 2008.

GAVI, Innovative Finance , November 2010, at 1, available at <http://www.gavialliance.org/resources/IF_brochure_11.2010.pdf> (last visited March 21, 2011) (hereinafter GAVI, Innovative Finance).

Global Fund, “Fighting AIDS, Tuberculosis and Malaria,” available at <http://www.theglobalfund.org/en/fighting/?lang=en> (last visited March 21, 2011).

Global Fund, The Global Fund Announces Measures to Enhance Financial Safeguards and Strengthen Fraud Prevention , Press Release, February 4, 2011, available at <http://www.theglobalfund.org/en/pressreleases/?pr=pr_110204>.

Global Fund, Global Fund Third Voluntary Replenishment 2011–2013 , October 5, 2010, available at <http://www.theglobalfund.org/documents/replenishment/newyork/Replenishment_NewYorkMeeting_Pledges_en.pdf> (last visited March 21, 2011).

Id.

GAVI, Advance Market Commitment for Pneumococcal Vaccines Annual Report 12 June 2009 – 31 March 2010 , at 10, available at <http://www.vaccineamc.org/files/AMCannualReport10.pdf> (last visited March 21, 2011) [hereinafter GAVI, Annual Report].

GAVI, Saving Lives and Protecting Health: Results and Opportunities , May 2010, at 12, available at <http://www.gavialliance.org/resources/GAVI_Updated_Results_EN_May2010.pdf> (last visited March 21, 2011) [hereinafter GAVI, Saving Lives].

See GAVI, Annual Report, supra note 39, at 15.

See GAVI, Saving Lives, supra note 40, at 2; GAVI, Pfizer Vaccine Receives AMC Approval by Independent Assessment Committee , September 10, 2010, available at <http://www.vaccineamc.org/updatesept10_10.html> (last visited March 21, 2011); see also GAVI, Part I: Target Product Profile (TPP) for the Advance Market Commitment (AMC) for Pneumococcal Conjugate Vaccines , December 18, 2008, available at <http://vaccineamc.org/files/TPP_Master_Table.pdf> (last visited March 21, 2011) (listing criteria).

GAVI, Kenya Marks the Global Roll Out of Pneumococcal Vaccine against the World's Leading Cause of Child Death , February 14, 2011, available at <http://www.gavialliance.org/media_centre/press_releases/kenya_pneumococcal.php> (last visited March 21, 2011).

Scudellari M. , “Are Advance Market Commitments for Drugs a Real Advance?” Nature Medicine 17, no. 2 (2011): 139 (noting that falling prices are built into the GAVI pneumococcal vaccine model).

Cernuschi T. , “Pricing of Pneumococcal Vaccines under Advance Market Commitments,” The Lancet 374 (2009): 684.

Offit P. A. , “Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?” Health Affairs 24, no. 3 (2005): 622–630, at 623–624.

Sonderholm J. , “Wild-Card Patent Extensions as a Means to Incentivize Research and Development of Antibiotics,” Journal of Law, Medicine & Ethics 37, no. 2 (2009): 240–246; see also Sonderholm J. , “In Defense of Priority Review Vouchers,” Bioethics 23, no. 7 (2009): 413–420.

Anonymous author, “Will Pharma Jump Into the Patent Pool?” Pharmaceutical Representative 40, no. 11 (2010): 8; see also Medicines Patent Pool Foundation, Who We Are: Background: How the Medicines Patent Pool Came About, available at <http://www.medicines-patentpool.org/> (last visited March 21, 2011).

E.g., Orphan Drug Act, Pub. L. No. 97–414, codified at 21 U.S.C. §§ 360aa-360ee (2011) (direct public funding) and 26 U.S.C. § 45C (2011) (tax credits).

Patent Application No. 339/MUMNP/2006, India Patent Office Mumbai, December 30, 2010, available at <http://www.imak.org/storage/339.MUMNP.2006_Decision%20copy.pdf> (last visited February 24, 2011).

Industry Briefing, “India Pharma: Interpreting Innovation, Economist Intelligence Unit,” January 6, 2011, available at <http://viewswire.eiu.com/index.asp?layout=ib3Article&article_id=377713222&country_id=&pubtypeid=1152462500&industry_id=&company_id=70039607&channel_id=&rf=0> (last visited March 22, 2011).

See Patent Application No. 339/MUMNP/2006, supra note 1, at 25.

Doctors Without Borders, India Rejects Patents for Two Key AIDS Drugs: Decision Illustrates Need to Safeguard ‘Pharmacy of the Developing World,’ Press Release, January 7, 2011, available at <http://www.doctorswithoutborders.org/press/release.cfm?id=4949&cat=press-release> (last visited March 22, 2011).

See Industry Briefing, supra note 2.

See Mueller J. , “The Tiger Awakens: The Tumultuous Transformation of India's Patent System and the Rise of Indian Pharmaceutical Innovation,” University of Pittsburgh Law Review 68, no. 3 (2007): 491, at 563–565. See also Gopakumar M. K. , “Product Patents and Access to Medicines in India: A Critical Review of the Implementation of TRIPS Patent Regime,” Law and Development Review 3 (2010): 325.

See generally Mueller , supra note 5.

Id., at 512.

Id.

Id., at 513. See also The Patents Act, No. 39 of 1970; India Code (1999), “84(5), available at <http://ipindia.nic.in/ipr/patent/patents.htm> (last visited February 13, 2011).

Mueller J. , “Taking TRIPS to India – Novartis, Patent Law, and Access to Medicines,” New England Journal of Medicine (February 8, 2007): 541–543.

Id.

See Doctors Without Borders, supra note 4.

See Mueller , supra note 6, at 516–19. See also Koshy S. , “Note: The Effects of TRIPs on Indian Patent Law: A Pharmaceutical Industry Perspective,” Boston University Journal of Science & Technology Law 1 (1995): 4, 14.

See Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994, “Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments – Results of the Uruguay Round,” I.L.M . 33 (1994): 1125, at 1208–1211.

See Mueller , supra note 6, at 519.

See Gopakumar , supra note 6, 326.

See Mueller , supra note 6, at 542–43.

Id. See also Gopakumar , supra note 6, at 335.

See Gopakumar , supra note 6; Mueller , supra note 6, at 563. See also the Patents Act, No. 39 of 1970, § 2(1)(ja) (Universal 2005) (amended 2005).

Initiative for Medicines, Access & Knowledge, Fact Sheet on Abbott Laboratories, HIV and Lopinavir/Ritonavir, Initiative For Medicines, Access and Knowledge, available at <http://www.imak.org/storage/IMAK__FINALAbbottFacts_1-1-2011.pdf> (last visited February 13, 2011).

Slind-Flor V. , “Microsoct, Abbott, Serious Bidness, Intellectual Property,” Bloomberg News, available at <http://www.bloomberg.com/news/2011-01-05/microsoft-abbott-serious-bidness-intellectual-property.html> (last visited March 22, 2011).

See Patent Application No. 339/MUMNP/2006, supra note 1, at 1.

Samal Amarrendra Dr. , Letter Confirming Abandoning of Soft-Gel Patent Application, Government of India Patent Office, available at <http://www.i-mak.org/storage/kaletra%20softgel%20rejection.jpg> (last visited March 22, 2011).

See Patent Application No. 339/MUMNP/2006, supra note 1, at 1.

Id., at 21–25.

See Doctors Without Borders, supra note 4.

See Patent Application No. 339/ MUMNP/2006, supra note 1, at 2–3.

Id.

Id.

See Initiative for Medicines: Access & Knowledge, available at <http://www.I-Mak.org> (last visited March 22, 2011).

See Patent Application No. 339/MUMNP/2006, “Statement of the Opponent In Reply to the Applicant's Response,” February 16, 2009, available at <http://www.i-mak.org/storage/I%20MAK%20Statement%20of%20Reply%20339%20MUM%20NP%202006.pdf> (last visited March 22, 2011).

See Patent Application No. 339/MUMNP/2006, supra note 1, at 1–2.

Id., at 25.

Id.

Id., at 21–25

Id., at 25.

Id.

Initiative for Medicines, Access & Knowledge, India Rejects Sham Patent Application for Lifesaving HIV Drug: Pharmaceuticals in India now free to help HIV Patients Worldwide , Press Release, available at <http://www.imak.org/storage/FINAL%20Press%20Release%201-1-2011.pdf> (last visited March 22, 2011).

See Doctors Without Borders, supra note 4.

U.S. Should Applaud India's Decision to Reject Frivolous Patent on Key AIDS Drug, Health GAP , Press Release, available at <http://www.healthgap.org/press/india_patent_decision.htm> (last visited March 22, 2011).

HIS Global Insight, “Same-Day Analysis: Multinationals Hit by Series of Indian patent Office Rejections,” January 14, 2011, available at <http://www.ihsglobalinsight.com/SDA/SDADe-tail19749.htm> (last visited March 22, 2011).

See Mueller , supra note 11, at 541.

Doctors Without Borders, Fact Sheet, Lopinavir / Ritonavir (LPV/r), available at <http://www.i-mak.org/storage/MSF%20Facts%20on%20Lopinavir-Ritonavir.pdf> (last visited March 22, 2011).

See Economic Intelligence Briefing, supra note 2.

Amin T. , “Third Party Observation under Article 115 of the EPC against European Patent Application NO. 048168207,” Initiative for Medicines Access & Knowledge, available at <http://www.i-mak.org/storage/I-MAK%20Observation%20EPO%2025-10-2010.pdf> (last visited March 22, 2011).

Office of the United States Trade Representative, 2010 Special 301 Report , April 30, 2010, available at <http://www.ustr.gov/webfm_send/1906> (last visited March 22, 2011).