Issues to preserve intellectual property of inventions for Material drug Manufacturing Formulations

1. Subject matter Identify area in which the invention fits.

2. Utility

Establish invention has real value to humans, and show how it is to be used.

3. Obviousness Demonstrate the inventor took more than

"the next obvious step".

4. Novelty Document invention is different and not known or previously published in the "prior art".

5. Disclosure Publish enough information to allow one skilled in the art to repeat invention.

Fig. 3.24. Product & Process Patents makes the key organizational, staffing, and operational decisions. One easy way to tell the predominant company is to look at the chairman of the board and CEO positions and which company filled them.

Challenges to the combined operations are substantial and manifold, related to the staff's worries about job loses with loss of productivity, integration of two different staffs with same responsibilities, co-mingling of two business cultures that impacts operations and even communications, and integration of two different sets of operating procedures. Office and research buildings in disparate locations may be a bane or boon. Restraint of trade needs to be addressed with the U.S. Securities and Exchange Commission and European equivalent, such that a monopoly of products in one therapeutic area is avoided. The merged company often must out-license one of their products to avoid this problem. Merger costs at the beginning are huge (e.g., severance packages to managers, golden parachutes to senior management being pushed out, closing of some offices, labs, or operations, and moving people to new locations). Several years often are required for the combined company to assimilate the costs of merging and return to a level of profitability above the added profits from each company. The slide also notes the number of alliances in the industry, intended to produce a symbiosis between two separate companies, usually a smaller one and a large FIPCO to better perform the research and marketing of a product [51-55].

The last outcome, but certainly not least in importance, to discuss involves the staff members in R&D, that is, the scientists and clinicians. What outcomes do these staff and managers receive? Six areas include financial, the research work, scientific advancement, public good (health care), education, and philanthropy (Fig. 3.26). Most of these researchers have come out of academia to the pharmaceutical industry, often harboring questions about scientific integrity, independence, loss of collegiality with their university brethren, and an inordinate focus on products. These concerns will be

Public Good & Patient Health r Merger mania (1980-2005):

o Pfizer-Warner/Lambert-ParkeDavis-Pharmacia-Upjohn = Pfizer o Glaxo-BurroughsWelcome-SmithKline-Beachum = GSK o Amgen-Immunex-Tularik-Synergen-Kinetix-Abgenix = Amgen c Marion-Merrill Dow-Aventis-Sanofi-Synthelabo = Sanofi-Aventis o Sandoz-Ciba-Geigy-Chiron = Novartis c Yamanouchi-Fujisawa = Astellas r Alliances & Licensing (2003): [Focuses: Technology, Molecules, & Products] [Areas: Research, Clinical Development, & Marketing/Sales] o Pharma-Biotech = 383 c Biotech-Biotech = 435

Fig. 3.25. Mergers & Acquisitions

Philanthropy

Education

Public Good & Patient Health

Philanthropy

Education

Research Work

Advancing Science

Financial Its more than a Job & Salary!

Research Work

Advancing Science

Financial Its more than a Job & Salary!

Fig. 3.26. Staff Members addressed with the many benefits received by industry researchers. Financial reward is usually the first outcome for industry staff that is recognized. Salaries basically need to be competitive with the private sector, and they are. In addition, scientists can receive a bonus in the forms of cash and stock options, based on exceeding their objectives, which is product advancements, publications, and product approvals. Two significant professional benefits, not related to any compensation of any kind, are twofold; helping patients by developing new products to improve their care, thus advancing public good; advancing science by their novel product-related work that is shared with all scientists through presentations at scientific meetings and publications. Another intangible reward to research scientists in the employ of a company is the philanthropy that companies provide to their community, institutions, and patient groups through donations, in the millions of dollars per year per company. Their research work is yet another personal reward; the opportunity to perform research on novel products during their career, present and publish their discoveries and findings, and work with thought leaders from around the world. Some academician may look with a jaundiced eye at industry-based research, both basic and clinical, but the work stands on its own merit based on its scientific quality and innovation. Educational opportunities abound for industry scientists who can learn and then use the latest technologies, attend educational conferences, and for those interested and capable take on management and leadership development.

In this chapter, we have discussed many outcomes of research for a company beyond the ultimate outcome, new products. Company-based research is measured by a company's ability to be successful with all these interim outcomes, all of which essentially are steps, the building blocks, that lead up to product approvals and a successful company.

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