- 1. Stephanie Nishi Spencer Lee Andrew Walnum Gurmeet Marwaha
Period 5, Biotechnology
2. The Scenario What can Biotex offer this scientist in order to
avoid going out of business? 3. Biotex: Question 1 Is the MA
Scientists patent legitimate?
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- Patents fallibility different types of patents are available
(as recognized in previous charts).Depending on the type of patent
the scientist filed for, and exactly when, Biotex may not be
required to pay royalties to the scientist
- Viewpoint of Social Conscience Groups:
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- Biotexs refusal to pay royalties is a sign of disrespect and
disregard for basic human rights
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- The patent for the cancer-curing protein is for the next 20
years, he can legally demand a compromise.
4.
- FDA isnot in charge of patents , but IF the scientist decides
to put the drug on the market,he/she must follow FDA guidelines in
order to approve the drug .
- FDAs expectations concerning the investigators
responsibility
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- Ensuring that a clinical investigation is conducted according
to the signed investigator statement forclinical investigations of
drugs, including biological products, or agreement for clinical
investigations of medical devices, the investigational plan, and
applicable regulations
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- Protecting the rights, safety, and welfare of subjects under
the investigators care
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- Controlling drugs, biological products, and devices under
investigation
Biotex: Question 1 FDA POINT OF VIEW has the scientist been
investigated? 5.
- The patients only want the drug; they do not really care
whether Biotex or the scientist has rights over the drug.
- They, however, place importance in the clinical trials for the
drug.The drug must be carefully tested and confirmed on what side
effects there are when taking the treatment.
Biotex: Question 1 Patient Advocacy Group Opinion 6. Biotex:
Question 2 Is there any way to fight the patent and get out of
paying the $20 million?
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- Biotex simply wants to coast through the FDA testing without
any conflict. In order to quell the protest by the scientist, and
to further investigate the legitimacy of the scientists patent,
Biotex intendsto file a lawsuitto fight the scientists patent.
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- Paying the 20 million will greatly reduce the companys profit,
but a monetary settlement might be better than risking the longterm
success of the company.
- Viewpoint of Social Conscience Groups:
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- Social conscience groups that support private research believe
that the scientist has every right to demand payment. A patent is a
legal document which gives its owner the rights to the production
and use of his research therefore cannot be violated by Biotex
7. Biotex: Question 2 Is there any way to fight the patent and
get out of paying the $20 million?
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- Viewpoint of FDA: The FDA cant intervene in any legal matters
between Biotex and the scientist. However, if Biotex files a
lawsuit, theFDA cant allow the drug in question to go on the market
for at least 30 months .
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- Plus side for Biotex: Biotex can still continue to develop the
drug and take it through the standard FDA testing though.
- Viewpoint of Patient Advocacy Groups:
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- Patients or potential consumers of the drug who have cancer
will be upset by the legal battle, and willinsist on a monetary
settlementbetween Biotex and the scientist because the agreement
will be more efficient and immediate.
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- Ramon, and patients in his village will become upset by the
delay of progress by Biotex to mass produce the cancer-curing drug,
and perhaps will take part in the legal battle suing Biotex.
8. 9.
- Patent protects inventor of drug from copy-cat-ing
Drug Inventor has the right to charge buyers directly for using
his drug However, as you will see in the following slide, there
areMANY types of patentsthat protect specific parts of the
inventors research e.g. method/process of drug creation, specific
components of drug, etc. 10. Type Description/Regulations When is
it used? Applicable to Dilmena #6? Composition
- Drug Composition (acceptable)
- 1 + pharmaceutically acceptable carriers (e.g. binders,
buffers, solvents)
To form drugs by combining 2 ingredients, known or unknown, and
claiming that specific combination as ones own research Maybe. MA
Scientist could have patented his specific combination of the
protein and other materials used to extract the protein as his OWN
research. He MUST have stated the specific application and function
of the protein to receive this patent Formulation
- Patents for specific effects of the drug
- Patents for rights over drug creation, allows/disallows use of
drug in other forms (e.g. capsules, pills, creams)
Allows inventor to control means of manufacturing his
drug/research No. There is no evidence at this time that the MA
Scientist PRODUCED a drug based on his research of the
cancer-curing protein.Biotex cannot be held responsible for the
production of the drug, but the rights of usage of the protein
remain unclear. Method or Process Protects the process or method
used to PRODUCE the drug Patents method of harvesting,
extracting,or fabricating specific components of a product of
research Yes. MA Scientist could patent the way he extracted the
cancer-curing protein 11. Type Description/Regulations When is it
used? Applicable to Dilemna #6? Use or Application Patents the
effect of the compound, composition, or drug product on specific
living organisms (e.g. humans, pets, etc.) Patents rights of usage
of component for specific causes Yes. This is a worst-case
scenario.MA Scientist, if he stated that this protein cures cancer,
patented rights over the application of this protein as a cure for
cancer. Compound
- IDENTIFICATION of new chemical, biological, herbal or drug
molecule
- New molecules form some sources (biological/herbal)
- Nature of compound (physical form, particle size)
Allows inventor to claim rights over discovery of the leaves
with the cancer-curing protein Yes. This is also the worst-case
scenario.MA Scientist has full legal control over the usage of
these leaves. 12. Solution 1: Patent on Method
- If the scientist filed for amethod or processpatent then this
is good news for Biotex.
- The MA scientist could have patented the way the cancer-curing
protein is extracted.
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- Biotex can continue to produce the drug without paying
royalties if the company finds a different method of harvesting the
protein, or their method differs from that of the scientist. E.g.
use of different restriction enzymes, solvents, etc to
extract.
- ** Recap: A method or process patent is a patent for how the
drug is produced.
13. Solution 2: Patent on Composition
- If the scientist filed for a composition patent, then that
means he has a patent for the new protein and any other elements he
has combined it with.
- CONDITION:the scientist MUST have combined this protein with
other elements either to create a product, or to enhance the
effects of the protein.
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- Biotex must appeal to the scientist with both a monetary
settlement and request for the rights over his creation of the
specific combination of elements and protein.
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- The company must halt all research and production.
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- Recommended monetary offer: 15 million to start.
- ** Recap: A method or process patent is a patent for how the
drug is produced.
14. Solution 3: Possibility of Formulation Patent
- Product Form: Lets say the scientist patented the way the drug
is administered, for instance in a pill.
- Biotex would only have to change the way the drug is
administered. For example, instead of in pill form, the
cancer-curing protein could be administered in an aqueous solution
that can be injected.
- Drug Release: Although it is highly unlikely the scientist
filed for this product, it would be easy for Biotex to combat.
- Biotex would only have to change the release of the drug into
the system, making it release faster or slower.
15. Solution 4: Patent on Compound
- Patent on the actual cancer-curing leaves found in Ramons
village.
- Biotex would have to settle with the scientists demands. Biotex
would legally not be able to use that protein because the scientist
owns the exclusive rights to that product.
16. Other Suggestions
- Science has shown that some molecules have enantiomeres, or
mirror-images of the same molecule.
- They could be thought of as left- and right-handed
molecules.
- They are technically thesame drug but are recognized as having
a different orientation . If Biotex could develop a mirror image of
its cancer-curing drug, then it may be able to claim that its drug
is different from the scientists.
If Biotex cannot find a way to win a lawsuit against the
scientist, it may be better to develop a mirror-image of the drug
molecule.
- Although a mirror-image drug may be able to prevent Biotex from
paying the scientist, there are many complications with
development.
- If the scientist has acomposition, formulation, or compound
patent , then it will not matter if a new mirror-image drug is
made.
- Mirror-images of drugs have been known to be less effective
than their originals, and, in some cases, cause severe
complications. A whole new round of expensive FDA testing would be
needed.
17. 18. Works Cited
- "Guidances, Information Sheets, and Notices."FDA U.S. Food and
Drug Administration . 28 May 2010.
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm>.
- Singh, Vinod. "How to Read and Understand Drug Patents."Ezine
@rticles . 28 May 2010. .