“Scientific discoveries are not the same as inventions” #M. Pharmacy Notes IPR Material

#M. Pharmacy Notes IPR Material

Scientific discoveries are not the same as inventions Do you agree? Substantiate your answer.

Invention makes or develops something that did not exist. Discovery finds real (non-abstract) things that are already exsistant Patentable inventions must — under conventional patent law — be new, useful and involve an ‘inventive step’. In contrast, it is generally accepted that utilizing something that already exists in nature is a ‘discovery’, and is therefore not patentable.

Drawing an appropriate boundary between un-patentable natural phenomena and patentable inventions is crucial in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued that purport to claim a novel product or process but that, in effect, encompass any practical application of a fundamental biological principle.

#M. Pharmacy Notes IPR Material
Examples include gene patents, which Congress is considering banning, and patents relating to biological correlations and pathways, such as the patents at issue in the headlinegrabbing LabCorp v. Metabolite and Ariad v. Eli Lilly litigations. In view of the mounting concern, it seems likely that government and/or the courts will address the issue, and perhaps substantially shift the boundary.
The question of what should and should not be patentable subject matter has spawned a number of battlegrounds in recent years, setting against each other those in each area supporting patentability, claiming that patents would cause increased innovation and public good, against opponents with views that patentability was being sought only for private good but would do public harm.

Flashpoints have included the patenting of naturally occurring biological material; genetic sequences; stem cells; “traditional knowledge”; programs for computers; business methods.

In March 2010, a federal district court judge in the Southern District of New York ruled that purified DNA sequences and the inventions using them are unpatentable. As has been discussed Judge Sweet relied entirely upon Supreme Court precedent and ignored contrary case law of the Federal Circuit Court of Appeals to conclude that isolated DNA is of the same fundamental quality as natural DNA and is thus unpatentable under section 101 of the Patent Act; and that the method claims of the patents were abstract mental processes that were also unpatentable. His rationale is controversial and his ruling has been appealed to the Federal Circuit.
In the process, different jurisdictions have come to different views as to what should be allowed and what should not.

Types of Patents – All about Patents – Intellectual Property Rights & Regulatory Affairs notes

Patents on business methods have proven to be a particularly controversial type of statutory subject matter. They have been criticized because the patents granted are perceived as being too broad, perhaps due to the difficulty in searching for prior art and recruiting suitably qualified patent examiners who have historically had a science background rather than a business background. Patent applications for business methods are also subject to delays in prosecution at the United States Patent and Trademark Office and other patent office

What is Intellectual Property? Intellectual Property Rights & Regulatory Affairs-2

What is Intellectual Property?

The inventor of a machine, the author of a book, or the writer of music somehow usually ‘own’ their work. From this ownership, certain consequences flow and you probably have been made aware of the fact that we cannot just copy or buy a copy of their works without consideration of their rights. Equally, original industrial designs of furniture, wallpaper and the like seem naturally to be owned by someone or some organization.
Each time we buy such ‘protected’ items, a part of what we pay goes back to the owner as recompense for the time, money, effort and thought they put into the creation of the work. This has resulted over the years in the  development of industries such as the music industry growing worldwide and encouraging new talent to produce more and more original ideas and articles.

What is Intellectual Property? Intellectual Property Rights & Regulatory Affairs-2

The following suggests some of the things that are entitled to protection as intellectual property under national intellectual property laws and / or various international treaties:


  • Performances
  • Videos
  • Computer games
  • Broadcasts
  • Computer programs

Designs for objects

  • Images
  • Logos
  • Trademarks
  • Integrated circuits
  • Inventions

Geographical indications of origin for certain types of products

  • Chemical formulas
  • Companies’ names
  • Perfumes
  • Industrial processes
  • Materials

The outstanding features that most types of property share are that the owner of the property is free to use it as she/he wishes, provided the use is not against the law, and to exclude others from so using that owned item of property. Now the term “intellectual property” is reserved for types of property that result from creations of the human mind, the intellect. Interestingly, the term intellectual property in the Convention Establishing the World Intellectual Property Organization, or “WIPO”, does not have a more formal definition. 
The States that drafted the Convention chose to offer an inclusive list of the rights as relating to:
“Literary artistic and scientific works; performances of performing artists, phonograms, and broadcasts; inventions in
all fields of human endeavor; scientific discoveries; industrial designs; trademarks, service marks, and commercial names and designations; protection against unfair competition; and “all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.”

Intellectual property is usually deals with the following:

1) Literary, artistic and scientific works
e.g. books.
Protection of this property is governed by laws concerning Copyright.
2) Performances, broadcasts e.g. concerts.
Protection of this property is governed by laws concerning Copyright’s Related Rights.
3) Inventions
e.g. a new form of jet engine. Protection of inventions is covered by laws concerning Patents.
4) Industrial designs
e.g. the shape of a soft drinks bottle.
Industrial Designs may be protected by its own specialized laws, or those of Industrial Property or Copyright.
5) Trademarks, service marks and commercial names and designations e.g. logos or names for a product with unique geographical origin, such as Champagne.
Protection is normally available under various laws. In this course the laws are covered within the Trademark module.
6) Protection against unfair competition.
e.g. false claims against a competitor or imitating a competitor with a view
to deceive the customer. This is a theme that occurs in many of the modules in this course and is in fact the subject of a separate module.


Common to all of the areas are two principles:
• The creators of intellectual property can acquire rights as a result of their work.
• The rights to that work may be assigned or licensed to others.

Importance of Intellectual Property Rights:

Intellectual Property Rights really matter. Do you know why?The first reason is that it is both just and appropriate that the person putting in the work and effort into an intellectual creation has some benefit as a result of this endeavor. The second reason is that by giving protection to intellectual property many such endeavors are encouraged and industries based on such work can grow, as people see that such work brings financial return. Intellectual property rights may also help to extend protection to such things as the unwritten and unrecorded cultural expression of many developing countries, generally known as folklore. With such protection they may be exploited to the benefit of the country and cultures of origin.

The reason for States to enact national legislation, and to join as signatories to either (or both) regional or international treaties governing intellectual property rights include:
• to provide incentive towards various creative endeavors of the mind by offering protections;
• to give such creators official recognition;
• to create repositories of vital information;
• to facilitate the growth of both domestic industry or culture, and international trade, through the treaties offering multi-lateral protection.

Source: World Intellectual Property Organization, or “WIPO“4

Intellectual Property Rights {IPR} & Regulatory Affairs 1 SUPAC

Intellectual Property Rights {IPR} & Regulatory Affairs 1 SUPAC


The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become known as Scale-Up and post approval Changes, or SUPAC.

Intellectual Property Rights {IPR} & Regulatory Affairs

In the process of developing a new drug product, the batch sizes used in the earliest  human studies are small. As one proceeds through Phase 1 testing (i.e., the first introduction of a new chemical entity to humans), Phase 2 (discovering an indication for use), and Phase 3 (determining dose, side-effect profile, etc.), the size of the batches is grSadually increased. When a New Drug Application (NDA) is approved by the Food and Drug Administration (FDA), the drug product is scaled up to a significantly larger batch size to meet the demands of the anticipated market.

Intellectual Property Rights {IPR} & Regulatory Affairs 1 SUPAC

Similarly, in the development of a generic version of an already approved marketed product, a small batch is produced and tested for, among other things, bioequivalence to the FDA reference listed drug product. When the generic product meets FDA approval criteria, the Abbreviated New Drug Application (ANDA) or generic antibiotic application (AADA) is approved for marketing. It, too, is then scaled up to meet the demands of its anticipated market. Whether a new chemical entity being brought to market for the first time or an approved generic version of previously marketed product, the size of the batch is almost inevitably scaled up to a significantly larger batch. In the process of scaling up, certain changes in the formula (composition) and/or in the manufacturing process and/or in the equipment may be necessary. In addition, the site at which the product will be manufactured may differ from where the smaller (pilot) batches were manufactured. The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become known as Scale-Up and post approval Changes, or SUPAC. The FDA has issued various guidance for SUPAC changes designated SUPAC-IR1 (for immediate-release solid oral dosage forms), SUPAC-MR2 (for modified-release solid oral dosage forms), and SUPAC-SS3 (for non-sterile semisolid dosage forms including creams, ointments, gels, and lotions).

SUPAC – Pharmacy Assignments Projects PPT’s

Although scale-up may occur at any point in the lifetime of a product, it most often occurs after the firm has been notified that the drug product is approvable, i.e., it meets all the conditions required by the FDA for marketing. With the submittal of Final Printed Labeling, a showing that the marketed product will meet the conditions for marketing as approved by the FDA (and in the case of generics, production of three consecutive scaled-up batches), and satisfactory completion of a pre-approval inspection by the local FDA district office, the product is formally approved to be manufactured and sold in the United States. At this point, SUPAC begins to exert its effect.

Pharma Assignments Projects PPT’s Power Point Presentation PDF:

Although SUPAC is a means of decreasing regulatory burden by empowering industry to make regulatory decisions, it does not affect any compliance or inspection requirement. It also is limited to scale-up and post-approval changes, even though the underlying science applies to pre-approval changes as well. The major affect of SUPAC is a significant decrease in the time required to implement changes.

Download Intellectual Property Rights IPR & Regulatory Affairs Material SUPAC 1



The premise of the consensus White Papers was that if:
1) The source of the drug substance for the smaller and larger batches was the same;
2) The drug substance particle size (both mean and distribution) was the same;
3) The excipients were the same;
4) The excipient particle size (both mean and distribution) was the same;
5) The order of addition was the same;
6) The equipment was the same;
7) The processing was the same; and, most important,
8) A surrogate test for bioequivalence testing (dissolution) was the same, the two batches were indeed the same. Over the previous 20 years the FDA, Bio-pharmaceutics Program had established that with indefinable limits, dissolution was predictive of in vivo bioequivalence, for the same formulation, processed under the same conditions, on the same equipment. These criteria became the fundamental principle of the SUPAC initiative. (The percutaneous diffusion testis similarly used as a surrogate bioequivalence test for non-sterile, semisolid formulations.)To establish the validity of the approach recommended by the three consensus papers, the FDAcontracted the College of Pharmacy of the University of Maryland to study several drug products chosen on the basis of their solubility and permeability. The data revealed that the workshop recommendations were conservative and could be safely implemented. In fact, the studies showed that even broad differences in in vitro dissolution that resulted from major compositional changes failed to translate into bioavailability differences. Subsequently, the FDA published its SUPAC Guidance for Immediate Release Solid Oral Dosage Forms and followed with guidances for modified-release (controlled-release) and non-sterile semisolid dosage forms. In November 1999 (modified slightly in December 1999), the FDA extended the SUPAC
concept to address changes in analytical methodology, packaging, and Labeling and sterile semi solid dosage forms. This last guidance also updated the previously published guidances on immediate-release, modified-release, and non-sterile,
semisolid dosage forms. In particular, the issue of multiple post approval changes(which had been addressed differently in the previously published guidances) were now the same. The FDA now allowed multiple post approval changes for every solid oral dosage form, using the same requirements a sits SUPAC Semisolid Guidance. The SUPAC Guidances published by the FDA define various levels of change and for each level of change specifies the
1) Recommended chemistry, manufacturing, and control tests;
2) In vitro dissolution testing and/or in vivo bioequivalence tests; and 3) Documentation that the FDA requires to be filed in the NDA, ANDA, or AADA to support the change. These guidances do not affect other compliance or inspection documentation required by the FDA Centre for Drug Evaluation and Research Office of Compliance (CDER-OC) or the FDA field investigation units.