Top Banner
Stephanie Nishi Spencer Lee Andrew Walnum Gurmeet Marwaha Period 5, Biotechnology
18
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
  • 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?

  • Viewpoint of Biotex:
      • 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:
      • Biotexs refusal to pay royalties is a sign of disrespect and disregard for basic human rights
      • 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
    • 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
    • Protecting the rights, safety, and welfare of subjects under the investigators care
    • 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?

  • Viewpoint of Biotex:
      • 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.
      • 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:
      • 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?

  • Viewpoint of FDA:
      • 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 .
      • 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:
      • 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.
      • 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.

  • Basic Law:
  • 20 years duration
  • approvalNOTrequired
  • 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 + active ingredient
  • 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

  • Drug Release:
  • Patents for specific effects of the drug
  • Product Form:
  • 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)
  • New chemical entity
  • 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.
  • Result:
    • 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.
  • Result:
    • 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.
    • The company must halt all research and production.
    • 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.
  • Result:
  • 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.
  • Result:
  • 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.
  • Worst-case scenario.
  • Result:
  • 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.
  • **Payment: 20 million

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. .