CAPSULE HOLDER FOR SAFE AND EFFICIENT LIQUID MEDICATION

CAPSULE HOLDER FOR SAFE AND EFFICIENT LIQUID MEDICATION EXTRACTION Leonel Garcia Jr. , Pharm. D Candidate 2018 Western University of Health Sciences Preceptor Sam Shimomura, Pharm. D 4/20/17

DISCLOSURE • I have no conflict of interest with anything in this presentation

OBJECTIVES • Discuss Dr. Betageri and his invention process • Discuss Leonel Garcia Jr. and my invention process • Discuss the clinical and financial benefit to my device • Explain the government’s role in protecting intellectual property • Explain the different types of patents • Explain the steps of how to get a utility patent

DR. GURU BETAGERI • He is currently Associate Dean in the Western. U Graduate College of Biomedical Sciences • He was the FIRST person at Western. U to apply for and receive a full patent • He has had Western. U help with a total of 4 U. S. patents

DR. BETAGERI’S U. S. PATENTS • Proliposomal Testosterone Formulations • Coated Drug Delivery Formulations • Liposome Drug Delivery • Enteric-Coated Proliposomal Formulations for Poorly Water Soluble Drugs • Ternary Mixture Formulations

DR. BETAGERI’S PATENT PATHWAY • Getting his education was key • He stated “When you construct a building, you need a strong foundation, then you build upon it. ” • Western. U helped him make his ideas into reality

DR. BETAGERI’S PATENT PATHWAY • When I asked how do you come up with an original idea, he responded: • See the problem and go about solving it • It should be in an area of you expertise • Read literature and talk to people about the problem • “If I have a problem with a computer, I know the problem, but I can’t solve it. If someone does something, I will use it. ”

DR. BETAGERI’S PATENT PATHWAY • Western. U put a provisional patent on his ideas first • Teso. Rx was formed by Dr. Betageri and his colleague • Teso. Rx now has the idea licensed to their company and is currently making partnerships with other countries

LEONEL GARCIA JR. • Graduated from Cal State Fullerton (2013) • Employed by UCI Medical Center (2012) • Attending Western University of Health Sciences College of Pharmacy (2013)

LEONEL GARCIA JR. ’S IDEA • Capsule Holder for Safe and Efficient Liquid Medication Extraction in Pharmacy Setting • Owned by the UC reagents • Protected under provisional patent • Originally made for the drug nimodipine

INTRODUCTION • About 800, 000 people in the United States have a stroke per year • Subarachnoid Hemorrhage (SAH) accounts for 10% of all strokes • SAH is when the bleeding goes to the Cerebrospinal fluid

GUIDELINES AND TREATMENT AHA/ASA Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage • Class 1; Level of Evidence A • Oral nimodipine should be administered to all patients with a. SAH • Improves neurological outcomes, but not cerebral vasospasm Up. To. Date • Nimodipine 60 mg every four hours is given to patient with a. SAH within 4 days of hemorrhage • Must be given orally or by nasogastric tube • Treatment is continued for 21 days

NIMODIPINE • Comes in 2 forms • Liquid Filled Capsules (30 mg / 1 m. L) • Liquid (60 mg/ 20 m. L) • For NPO patients, the liquid must be extracted from the capsule • Directions for extraction involve poking two holes into the capsule using a needle and syringe • This has been proven troublesome as the capsule is hard and the liquid is extremely slippery • Needle sticks have been reported

COST 30 mg/ 1 m. L Liquid Filled Capsule • Lowest costing manufacture- SUN Pharmaceuticals 60 mg/20 m. L Nymalize ® Oral Solultion • Made by Arbor Pharmaceuticals • $287. 43 per 30 capsules • $1, 070. 20 per pack of 12 • Assuming a 66. 7% yield • $ 89. 13 per 60 mg dose • $28. 74 per 60 mg dose

COST CONTINUED • According to Up. To. Date, the patient should be given a 60 mg dose every four hours during hospitalization • According to the CDC website, the average length of stay per stroke patient is approximately 5 days • With a saving of $60. 44 per dose, the amount of money saved per patient would be about $1, 800

LEONEL GARCIA JR. ’S IDEA PATHWAY • On IPPE II, I was given the opportunity to practice IV preparations and noticed the Chemolock TM devices • That day, I started drawing many concepts of the device I wanted • Then, I immediately went to The Home Depot to get supplies and created my first prototype with the help of my dad

LEONEL GARCIA JR. ’S IDEA PATHWAY • Many prototypes were made • I spoked to the UCI Invention Transfer Group and gave the idea to them • There I was able to use their Cove lab and interact with biomedical engineers who helped me create a model through 3 -D printing

GOVERNMENT PROTECTION U. S. Constitution Article 1 Section 8 Clause 3 U. S. Constitution Article 1 Section 8 Clause 8 • Congress shall have power … to regulate commerce with foreign nations and among the several states and with Indian Tribes • Congress shall have power … to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writing and discoveries

GOVERNMENT PROTECTION- PATENTS Utility Patent Design Patent Plant Patent may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof may be granted to anyone who invents a new, original and ornamental design for an article of manufacture may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant

HOW TO GET A PATENT: PATENT SEARCH • Perform a Patent Search • USPTO. gov • 7 step U. S. patent search strategy guide • patents. google. com • Legalzoom. com • Legal Attorney • “Americans Invents Act” 2011 - Section 32: Directs the Director to support intellectual property law associations in establishing pro bono programs to assist financially under-resourced independent inventors and small businesses.

HOW TO GET A PATENT: APPLICATION Provisional Patent • Only good for a Utility or Plant patent • Quick and inexpensive while holding a filing date for the inventor’s idea • Good for one year and is not evaluated Utility Patent • Includes same requirements of Provisional: • Background of the invention • Brief summary of the invention • Brief description of several views of the drawing • Detailed description of drawings • Claim or Claims • Abstract of the Disclosure • Drawings • Oath or Declaration

HOW TO GET A PATENT: RECEIVING THE PATENT • Once the USPTO reviews and accepts the patent, the inventor is issued a Notice of Allowance which list all the fees. • Then once the fees are collected, the USPTO will send a patent grant mailed on the issue date. • The patent grants comes with references to prior patents, the inventor’s name, specification and claims. • Comes with a gold seal and a red ribbon.

QUESTIONS?

REFERENCES • Alexandria, Virginia. (2015, October) General information concerning patents. United States Patent and Trademark Office. Retrieved on 4/13/17 from https: //www. uspto. gov/patents-getting-started/general-information-concerning-patents#heading-2 • Capsule Holder For Safe and Efficient Liquid Medication Extraction in Pharmacy Setting. Retrieved from https: //techtransfer. universityofcalifornia. edu/NCD/26018. html • Connolly, E. S. , Jr. , Rabinstein, A. A. , Carhuapoma, J. R. , Derdeyn, C. P. , Dion, J. , Higashida, R. T. , Vespa, P. (2012). Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage. Stroke, 43, 1711 -1737. doi: 10. 1161/STR. 0 b 013 e 3182587839 • Dr. Guru Betageri, personal interview. 4/12/17 • Hospitalization for Stroke in U. S. Hospitals, 1989– 2009. (2012, May 09). Retrieved February 04, 2017, from https: //www. cdc. gov/nchs/products/databriefs/db 95. htm • H. R. 1249 - Leahy-Smith America Invents Act. Congress. gov. Retrieved on 4/13/17 from https: //www. congress. gov/bill/112 thcongress/house-bill/1249 • March 2017 Patents Data, at a Glance. United States Patent and Trademark Office. Retrieved on 4/13/17 from https: //www. uspto. gov/dashboards/patents/main. dashxml • Nimotop ® (nimodipine) capsules for oral use [package insert]. West Haven, CT: Bayer Health. Care; 2005

REFERENCE CONTINUED • Nymalize ® (nimodipine oral solution) Formulary Information. 2016. http: //nymalize. com/doc/Formulary_Kit. pdf. Accessed 3 February 2017 • Oyler D, Stump S, Cook A. Accuracy of Nimodipine Gel Extraction. Neurocrit Care 2015; 22: 89 -92 • Patent process overview. United States Patent and Trademark Office. Retrieved on 4/13/17 from https: //www. uspto. gov/patents-getting-started/patent-process-overview#step 1 • RED BOOK. (n. d. ). Retrieved February 04, 2017, from http: //micromedex. com/products/product-suites/clinicalknowledge/redbook • Singer, R. J. , Ogilvy, C. S. , & Rordorf, G. (2013, September 26). Clinical Manifestations and Diagnosis of Aneurysmal Subarachnoid Hemorrhage. Retrieved February 04, 2017, from http: //www. uptodate. com/contents/clinical-manifestations-anddiagnosis-of-aneurysmal-subarachnoid-hemorrhage • Singer, R. J. , Ogilvy, C. S. , & Rordorf, G. (2014, October 7). Treatment of aneurysmal subarachnoid hemorrhage. Retrieved February 04, 2017, from http: //www. uptodate. com/contents/treatment-of-aneurysmal-subarachnoid-hemorrhage • The Constitution of the United States: A Transcription. National Archives. Retrieved on 4/13/17 from https: //www. archives. gov/founding-docs/constitution-transcript