PATENTS AND MEDICINE.
Right to Health
International Statutes
-Article 25 of the UDHR
-Article 12 of the ICESCR
-Article 12 and 14 of CEDAW
-Article 16 of ACHPR
-Article 24 of CRC
-All the above provide for every person’s right to health.
Domestic Statutes
-Objective 14; all Ugandans enjoy rights and opportunities and access to education, health services, clean and
safe water, work, decent shelter, adequate clothing, food security and pension and retirement benefits.
-Objective 22: The state shall encourage and promote proper nutrition through mass education and other
appropriate means in order to build a healthy State.
-Winnie Asege v AG; Court found that the right to access medicines should be balanced with IP rights, and held
that the Anti-Counterfeit Act which prohibited importation of counterfeit/generic ARVs violated the right to
health of the people.
-P.A.O and others v AG (Kenyan Case); The petitioners were all HIV positive adults who had been living with
HIV for periods ranging between eight and 19 years, who, with the exception of the second petitioner, had been
on generic anti-retroviral drugs (ARVs) for about ten years.
-The petitioners submitted that they have continued to receive their drugs free of charge by virtue of the Industrial
Property Act which permits the importation of generic drugs.
-They challenged the constitutionality of sections 2, 33, and 34 of the Anti-Counterfeit Act. The petitioners
contended that the impugned provisions were inconsistent with the provisions of the Kenyan Constitution as they
potentially hindered access to life-saving medications for HIV positive persons. In particular, the petitioners
contended that the Anti-Counterfeit Act will have negative effects on the manufacturing and accessibility of
cheaper generics drugs, thereby infringing their rights to life, dignity and health guaranteed under articles 26(1),
28 and 43 of the Constitution of Kenya.
-Court found that sections 2, 32 and 34 of the Anti-Counterfeit Act were inconsistent with articles 26(1), 28 and
43 of the Kenyan Constitution. The court further found that the Anti-Counterfeit Act threatened to limit access to
affordable and essential drugs and medicines, including generic medicines for HIV and AIDS. (The definition of
counterfeit was so broad as it might be seen to encompass generic medicines)
Herceptin v Hoffman La-Roche
-The issue was he excessive prices of the drug which was used in the treatment of breast cancer which is an
essential medicine by World Health Organization (WHO)
-Hoffman La-Roche had a license to the patents
-Court held that the drug was overpriced. Court realized that the rights to the patent of the drug cannot be infringed
its expiry in 2028.
Factors that allow access to medicine.
1) Methods of Treatment
-S.13 IPA provides that inventions contrary to public order, morality, public health and safety, public policy,
principles of humanity and environmental conservation cannot be patented.
-S.8 (3) (c) IPA diagnostic, therapeutic and surgical methods for the treatment of humans or animals (Can’t be
patented)
-Art. 27(3) of the TRIPS Agreement; diagnostic, therapeutic and surgical methods for the treatment of humans or
animals
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-UpJohn Company (Roberts) Application; Russell J stated that it was a well-established principle that a method
of treatment of a human ailment with a known substance was not capable of being an invention under the law.
(This is in line with public health and safety as people shouldn’t be prevented from getting surgeries merely
because it’s patented)
-Exparte Brinkerhoff; The patent Office Board of Appeal stated that methods of treatment of physicians of
certain diseases are not patentable on the rationale that to grant a patent for a particular method of treatment would
deceive the public that the method will deliver results in all cases.
-Article 8 of the TRIPS Agreement; Members may, in formulating or amending their laws and regulations, adopt
measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital
importance to their socio-economic and technological development, provided that such measures are consistent
with the provisions of this Agreement. (This allows generic drug importation)
2) Compulsory Licensing
-S.58 IPA After the expiration of four years from the filing date of an application or three years from the grant of
a patent, whichever last expires, a person may apply to the Minister for a licence to exploit the patented invention
on the grounds that the market for the patented invention is not being supplied, or is not being supplied on
reasonable terms, in Uganda.
-S.59 IPA if the invention constitutes an important technical advance of considerable economic significance in
relation to the invention claimed in the earlier patent the minister can grant a compulsory license to infringe on
the rights of the earlier patent
-Bayer Corporation v Natco Pharmacy: The reason for the dispute between the two companies was a drug
named Nexavar which is used to treat kidney cancer.
-Natco pharma filed an appeal for the grant of compulsory licence for the drug “Nexavar” of Bayer Corporation
before the Intellectual Property Appellate Board (‘IPAB’) and after a long range of disputes at the end, India’s
first compulsory licence was granted to Natco pharma.
Lee Pharma v Astra Zeneca; Lee Pharma, a Hyderabad based Indian pharmaceutical company, filed an
application for compulsory licence under Section 84(1) of the Act, for the patent covering AstraZeneca's diabetes
management drug ‘Saxagliptin’
-The grounds were that the patentee had failed to meet the requirements of the public and it is not available at a
reasonable price. However court declined at it was held noted that the Applicant failed to demonstrate and
establish concretely its allegations and thus, rejected all grounds raised by the Applicant and refused the
application for Compulsory licence.
-Art. 31 of the Trips Agreement provides that where law of a member allows for use of a patent without the
owner’s consent the following should be observed; that such use shall be non-assignable, non-exclusive, if the
user has attempted to get authorization before and it was not successful, supply is for the domestic market,
adequate remuneration shall be paid to the right holder among others.
3) Parallel Importation
-Parallel importation refers to the practice of importing genuine, branded products from one market to another
market where they are sold without the consent of the manufacturer. (Therefore they can be sold at lower prices)
-Patricia Ochieng and Others v AG; The Court expressed the view that Section 2 of the Act is likely to be read
as including generic products and would thus affect the availability of generic drugs in Kenya and threaten the
petitioners' constitutional rights to life and health.
-S.44(1)(e) of the IPA it is not an infringement to manufacture and export to another country a patented healthcare
invention where the export of the invention addresses a health need identified by the other country, where—
(i) The product is either not patented in the third country; or
(ii) The government of another country has authorised use of the patent without the consent of the patent owner
and the production for export of the patent is intended only for the market of the third country.
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Class International BV v Colgate Palmolive, Court held that parallel importation of genuine trademarked goods
are generally allowed within the European Union
-Bristol Myers Squibb Co v Mylan Pharms Inc. It concerned whether a parallel importer could rebrand the
generic medicine with the original brand name. And the ECJ held that such rebranding was not allowed as it
would mislead patients and potentially harm public health. Court held there has to be a balance between parallel
importation and patent security.
4) Scientific Research/Education/Experimental Use
-Madey v Duke University: Case recognized the common law exception in the United State permitting the use
of patented invention solely for research, academic or experimental purposes. But declined to apply it so broadly
so long as the act is in furtherance of the alleged infringer's legitimate business and is not solely for amusement,
to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the experimental use
defense.
-S. 43 IPA, so long as the act is in furtherance of the alleged infringer's legitimate business and is not solely for
amusement, to satisfy idle curiosity, or for strictly philosophical, inquiry, the act does not qualify for the
experimental use defense.
-S.44; states that it is not an infringement of patent to carry out the works for experimental purposes, education
-Whittemore v Cutter; Case considered the foundations for the experimental use exception. The court ruled that
using a patented machine solely to understand its functionality or verify its effectiveness wouldn’t be an
infringement.
-Integra Lifesciences Limited v Merck KGA; Plaintiff sued claiming that the defendant had used its patented
compound on another drug for clinical research. Court held that the use of patented compounds in clinical research
is exempted from patent infringement.
5) Bolar Exception
-S.43 (1) the rights under the patent extend only to acts which are done for industrial or commercial purposes but
do not extend to acts which are done for scientific research.
-Article 30 of the TRIPS Agreement Members may provide limited exceptions to the exclusive rights conferred
by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent
and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate
interests of third parties.
Roche Products Incorporation v Bolar Pharmaceutical Company
-Bolar was a generic drug manufacturer. Roche was a brand-name pharmaceutical company which made and sold
a sleep aid Dalmane, the active ingredient of which Flurazepam was protected by patent.
-Before patent expiration, Bolar used the patented chemical in experiments to determine if its generic product was
bioequivalent to Dalmane in order to obtain FDA approval for its generic version of Dalmane. Bolar argued that
its use of the patented product was not infringement under the experimental use exception to the patent law. (The
District Court accepted this argument and Roche appealed)
-The Court of Appeals for the Federal Circuit rejected Bolar’s contention holding that the experimental use
exception did not apply because Bolar intended to sell its generic product in competition with Roche’s Dalmane
after patent expiration and, therefore, Bolar’s experiments had a business purpose.
-Bolar also argued that public policy in favor of availability of generic drugs immediately following patent
expiration justified the experimental use of the patented chemical because denying such use would extend Roche’s
monopoly beyond the date of patent expiration. The court rejected this argument, stating that such policy decisions
should be made by Congress.
-Likewise, the court decided that apparent policy conflicts between statutes such as the Food and Drug Act and
the Patent Act should be decided by Congress and not the courts.
-Shortly After this case, Congress did pass a law permitting use of patented products in experiments for the
purpose of obtaining FDA approval (Hatch-Waxman Act)
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Apotex Inc v Wellcome Foundation Limited
-Court defined the scope of the Bolar Exception, only in the use of obtaining approval and not for commercial
purposes.
Flexibilities of the TRIPS Agreement
-Article 30
-Article 31:
-Article 27: patents shall be available and patent rights enjoyable without discrimination as to the place of
invention, the field of technology and whether products are imported or locally produced.
-Also provides exclusions as to patentability
-Article 32: opportunity for judicial review of any decision to revoke or forfeit a patent shall be available.
-Article 8:
Clash between Patents and Right to Access Medicine.
1) Pricing
-Article 28 of TRIPS; patent shall confer on its owner the following exclusive rights:
To prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling,
or importing.
-Article 15(1) (b) of the ICESCR, Rights of everyone to enjoy the benefits of scientific programs.
-Article 27(2) of the UDHR; Everyone has the right to the protection of the moral and material interests resulting
from any scientific, literary or artistic production of which he is the author.
-These all give rights to the people making the patented drug (pharmaceutical companies) to overprice as they
have rights to the drug. (We already saw the exceptions but we also saw situations where court is reluctant to
grant them)
PATENTS AND ICT
Alice Corporation v CLS Bank International;
-Whether a business implemented business method could be patented (computerized trading program)
-Supreme Court ruled that the abstract idea of using to organize and manage things in a financial services context
was not patentable itself
-However court left the door open for patents on inventions that applied the abstract idea to a specific solution
with practical application.
-Court held that patent law should not restrain abstract ideas that are the building blocks of human ingenuity and
held all of Alice’s claims ineligible for patent protection
-Court went on to state that any claim that merely describes a way of doing business should not be patentable.
Apple Inc v Samsung Electronics Co.
-Apple sued Samsung, and Samsung counter sued.
-They alleged patent infringement of various design features of smartphones and tablets while Samsung argued
that the features were not functional and therefore not patentable.
-The jury decided for Apple in 2012 and awarded 1 billion in damages (This case shows patent protection in ICT)
eBay v Merc Exchange
-Online auction site eBay uses practices in its online auction technology for which MercExchange owns patents,
including eBay's "Buy it now" function – over 30 percent of the company's business.
-The MercExchange sought an injunction to prevent the continued use of the application by EBay.
-Court held that in the grant of an injunction they had to follow the four part test which entails irreparable injury,
inadequate remedies to compensate, public interest would not be disserved.
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-By the time of the judgement it’s important to note that MercExchange had reduced its staff from 40 to 3 and
was basically a patent troll (people who threaten injunctions in order to get money from big corporation)
-The injunction was not awarded.
Positives of ICT
-Increases Innovation
-Eases Application Process
-Improves access to patent information
-Eases patent management in giving licenses
-Eases collaboration at a global level.
Interfirm Company v Law Society of New South Wales
-Court stated that in case of invention, that state offers a monopoly for a period of time in return for a disclosure
of the specifications in that invention.
Quanta Computer v LG Electronics
-Quanta purchased intel microprocessor products and manufactured computers containing them.
- LG had sold to Intel and then sued Quanta claiming that the methods were patented.
-Court held that the doctrine of patent exhaustion applies to methods and once a product is unconditionally
authorized for sale, the patent owner can no longer invoke patent law in an attempt to receive additional loyalties.
Definition of ICT (UNESCO)
-A device set of technological tools used to transmit, store, create, or exchange information.
Negatives
1) Increases infringement on patents. -Article 27 of Trips; Suggests that a person only has patent protection
within their territory where they registered the patent.
-In Menashe Business Limited v William Hill Organization Limited, court held that there cannot be patent
infringement if the used patent occurs beyond where claimant has patent protection.
-Since ICT can easily be moved around the world, limited protection.
2) Creates patent thickets: Patent thickets refer to a situation where numerous patents, often overlapping, cover
a particular technology or product (For instance on a smartphone there might be many patents on one smartphone,
covering the different parts of it) (Use the case of Apple v Samsung)
3) Makes patents outdated at a fast pace
4) Creates Patent Trolls (Use the EBay v Merc Exchange)
-Diamond v. Diehr, was a United States Supreme Court decision which held that controlling the execution of a
physical process, by running a computer program did not preclude patentability of the invention as a whole.
-The high court reiterated its earlier holdings that mathematical formulas in the abstract could not be patented,
but it held that the mere presence of a software element did not make an otherwise patent-eligible machine or
process patent ineligible.
-In Aerotel Ltd v Wavecrest Group Enterprises Ltd, the claimant was an Israeli company with a patent for a
method of making telephone calls and a telephone system. The company did not make or sell anything but
exploited the present and other patents by litigation and the threat of litigation against others, principally in the
United States.
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PATENTS AND DISABILITY RIGHTS
-Art. 27 of the UDHR; everyone has the right freely to participate in the cultural life of the community, to enjoy
the arts and to share in scientific advancement and its benefits.
-Art. 32 of Constitution Notwithstanding anything in this Constitution, the State shall take affirmative action in
favour of groups marginalised on the basis of gender, age, disability or any other reason created by history,
tradition or custom, for the purpose of redressing imbalances which exist against them.
-Art. 35 Persons with disabilities have a right to respect and human dignity, and the State and society shall take
appropriate measures to ensure that they realize their full mental and physical potential.
-Art 27 TRIPS; patents shall be available and patent rights enjoyable without discrimination as to the place of
invention, the field of technology and whether products are imported or locally produced.
-Article 30 TRIPS: Members may provide limited exceptions to the exclusive rights conferred by a patent,
provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not
unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of
third parties.
Marrakesh Treaty
-Article 4: Work shall be allowed to be put in an accessible format for the beneficiary persons without the
necessary consent from the rightful owner of the work.
Article 5: Accessible format copy may be distributed to a beneficiary person or authorized entity in another
contracting party’s country
Article 6: Importation of an accessible format copy for the benefit of the beneficiary person shall be permitted
without the authorization of the right holder.
Assistive Technology
-It’s an item, system, equipment or product acquired off-shelf or customized that is used to increase/ maintain/
improve functional capabilities of individuals with disabilities.
-It includes mobility aids like wheelchairs, voice recognition and various physical modifications.
-All of this information can be patented, which promotes innovation and in turn helps out persons with disabilities.
Exceptions to Patentability which favor PWDs (Already deliberated on above)
1) Refusal to grant patents for surgeries and all that (Helps access medical care?
2) Granting of Licenses (Compulsory Licensing) (Allows furtherance in fields that will help, access of
information)
3) Experimental Exception (Allows development in fields)
4) Parallel Importation (Access to Medical Care)
Cases
National Federation of the Blind v Scribd
-Case was challenging Scribd, Inc.’s failure to design its digital reading subscription service to work with software
used by the blind.
-Scribd said it was exempted because it was an internet based business.
-Court stated that Now that the internet plays such a critical role in the personal and professional lives of
Americans, excluding disabled persons from access to covered entities that use it as their principal means of
reaching the public would defeat the purpose of this important civil rights legislation.
National Federation of the Blind v Target Corp.
-They sued Target Corp under the Americans with Disabilities Act that their online website was inaccessible to
people with disabilities.
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-Target said that the act only applied to physical retail stores and did not extend to websites or the internet.
-Court ordered that a retailer may be sued if its website is inaccessible to the blind. (The parties however settled
the suit)
National Association of the Deaf v Netflix
-Plaintiff sued Netflix because the closed captioning feature of Netflix made it difficult for persons with hearing
impairments to access their features.
-The matter was settled however court declined the motion to dismiss tabled by Netflix and maintained that even
websites have a duty under the ADA.
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