PATENT RIGHTS

III. PATENT RIGHTS

A. Right to Exclude

A U.S. patent gives the inventor the right to exclude others from making, using, selling, or offering for sale his claimed invention within the United States or importing the invention into the United States. If the U.S. patented invention is a process, the right to exclude also prevents others from using, offering for sale, or selling in the United States, or importing into the United States, products made by that process. These infringing acts are sometimes referred to as ‘‘practicing’’ the invention. In this chapter, the terms ‘‘prac- tice’’ or ‘‘use’’ of the patented invention are used as shorthand for any and all of the statutory infringing acts. Along with this exclusionary right is the right to bring legal action in the courts when others practice the patented invention prior to its expiration without permission from the patent owner.

Patent Considerations 697 The right to exclude (a negative right) means that the inventor may in

some cases be excluded from practicing his own patented invention. This occurs when there exists an unexpired U.S. patent that is broader in claims than the inventor’s patent. The concept of ‘‘freedom to practice’’ or domi- nant/subservient patent claims is important for the drug delivery researcher to understand, since he may consider incorporating patented drugs into his new delivery system to improve their therapeutic benefits. The owner of the unexpired drug patent can exclude others from using the drug and therefore has a dominant exclusionary right over subsequent patents that include the drug as part of their claimed invention. Also, patentable improvements may in some cases be subservient to the original invention’s patent claims. On the other hand, the inventor of the drug or earlier delivery system cannot use the drug in the separately patented delivery system or use the improved version without permission.

B. Right to Assign The inventor is the owner of the patent rights, and he or she may assign, i.e.,

transfer his or her interest in the patent, either the exclusive rights to the whole patent or an undivided part or share of these rights. Employers may require their employees (inventors) to assign their exclusive rights to inven- tions conceived as part of their employment. The assignment is recorded in the United States Patent and Trademark Office (USPTO). Upon assign- ment, the employer owns the property rights inherent in the patent.

C. Right to License The patent owner may license, i.e., transfer some or all of the patent rights;

however, title is retained by the patent owner. A license may be exclusive or nonexclusive, and the licensee may be given the right to sublicense. The commercial value of a drug delivery system patent often involves the ability to license the technology to owners of patented drugs with limitations in their pharmacokinetics or duration of effect. Companies such as Alza have become successful using this corporate strategy.

IV. PATENT TERM The patent grant is for a limited term, which in the United States is now 20

years from the earliest effective filing date for applications filed beginning June 8, 1995. Prior to the new law, patents had a term of 17 years from issue. In the transition to the new patent term, there are issued patents in effect

698 Roehrs with expiration dates of 17 years from issue, or 20 years from the earliest

effective filing date, or various dates depending on certain patent term extensions that have been enacted by Congress. Patent maintenance fees are required at 3.5, 7.5, and 11.5 years after issuance (subject to a grace period), and failure to pay the required fee will result in premature expira- tion of the patent term.

Patent expiration dates for FDA-approved drugs are published in the FDA ‘‘Orange Book.’’ These dates are provided to FDA by the company submitting the NDA and are not validated by FDA or the USPTO. (Patent term extensions for FDA-approved drugs are discussed in Chapter 20.) Patent terms may also be extended by the USPTO in certain cases where delays in patent application review would provide the inventor with less than a 17-year patent term. The new minimum patent term guarantee applies only to delays by the USPTO during examination of the application and not to delays caused by the applicant.

V. PATENTABLE INVENTIONS Congress has defined patentable inventions in four broad categories:

‘‘Whoever invents or discovers any new and useful process, machine, man- ufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and require- ments of this title.’’

Ophthalmic drug delivery systems (ODDS) typically are claimed in a patent as compositions of matter and/or processes. Compositions of matter include chemical compounds and physical mixtures. Drug delivery system dosage forms are usually a combination or association of ingredients that cooperate to produce a unitary result exhibiting properties different from those possessed by the individual ingredients. One of the ingredients may be

a drug molecule, which, in association with the ingredients of the delivery system (vehicle), is delivered in a new or improved manner to the eye. Drug molecules sometimes are developed specifically for ocular drug delivery purposes, i.e., prodrugs such as dipivefrin or the carbonic anhydrase inhi- bitors dorzolamide and brinzolamide, and are claimed as compositions of matter.

A patentable process consists of an act, operation, step, or series of steps performed upon specified subject matter to produce a physical result.

A patentable process includes the method of making and method of using a substance, e.g., a pharmacologically active ingredient. Method of use or treatment claims often are recited in drug delivery patents. These so-called ‘‘use patents’’ also can include new uses for old products.

Patent Considerations 699

A patentable invention must contain claim(s) to statutory subject mat- ter that are novel (new), useful (utility), and nonobvious among other require- ments for specificity of the claims and adequacy of disclosure of the invention.

A. Utility This is perhaps the easiest of the three statutory requirements to satisfy for

patentability, particularly for most pharmaceutical inventions. Only useful inventions may be patented, i.e., inventions providing a beneficial use in society. A useful invention does not have to provide an advantage or an advance in the art to be considered to meet the utility requirement, nor does it have to necessarily provide the best or even a commercially feasible pro- duct or process. Issues of utility may arise if the usefulness is not apparent or credible. A patent usually states under the objectives of the invention one or more intended purposes for the invention. These statements of specific uti- lity are usually sufficient unless there is a reason for one skilled in the art to question the truth of the statement of utility or its scope. The invention must

be operable for at least one of the intended purposes to meet the utility requirement. For pharmaceutical inventions, issues can arise if the utility alleged has never before been demonstrated or there are no in vitro tests that correlate with a practical utility or animal tests with recognized relevance to human utility. If human use is not alleged, it need not be proved, veterinary utility being sufficient. Also, FDA requirements for safety and efficacy are not patent law requirements for utility. Indeed, patent protection is often obtained prior to completion of human clinical trials, and it is the patent rights that provide the economic incentive to complete FDA’s marketing requirements.

B. Novelty and Loss of Right to Patent Useful statutory subject matter may be patented if it meets the legal require-

ments of novelty and nonobviousness, and these two requirements essen- tially define the limits of what may be protected for a particular invention. Novelty is relatively straightforward, i.e., if the claimed subject matter has been done before in exactly the same manner, then it is old (lack novelty) and is not patentable. However, even if the invention is new, further inquiry is required to determined whether it is nonobvious, i.e., not obvious to one of ordinary skill in the art to which it pertains. The patent law also defines certain circumstances where acts by the inventor or others may prevent a patent from being obtained, i.e., so-called statutory bars, even though the invention may meet all other requirements.

700 Roehrs The novelty provisions of patent law prevent an inventor from obtain-

ing a patent for subject matter that was known, used, patented, described, or made by another prior to the applicant’s invention. The novelty requirement is one of strict identity, i.e., a single reference must contain all the limitations of the claimed subject matter and in the same order (steps) in which they are arranged in the claim. This is termed ‘‘anticipation,’’ and for meeting the novelty requirements, the USPTO cannot combine more than one reference to show anticipation of the claimed subject matter.

Patent law prescribes the following conditions, which if are found to have occurred prior to the invention prevent a patent from issuing for lack of novelty:

1. The invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country

2. The invention was described in a patent granted on an applica- tion for patent by another filed in the United States or on an international application by another fulfilling certain require- ments

3. The invention was made in this country by another who had not abandoned, suppressed, or concealed it

Note that knowledge or use by others outside of this country does not prevent a patent unless the invention has been published or patented any- where in the world. Knowledge or use in this country refers to that which is accessible to the public. The terms ‘‘others’’ and ‘‘another’’ refer to any entity different from the so-called inventive entity, i.e., single inventor or joint inventors.

Certain acts by the inventor may cause a loss of rights and bar the issuance of a patent:

1. The invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the filing date of the U.S. patent application.

2. The invention was abandoned.

3. The invention was first patented or caused to be patented in a foreign country prior to the filing date of the U.S. patent appli- cation on an application in the foreign country filed more than 12 months before the filing of the U.S. patent application.

United States patent law provides a 1-year grace period for filing a patent application in this country when the invention has been patented or published anywhere in the world or for public use or sale in this country.

Patent Considerations 701 Thus it is important that the inventor recognize when the 1-year grace

period may be triggered and keep the patent legal specialist informed of all potential public disclosures, uses, and offers for sale of the invention so that a timely application may be filed to prevent a statutory bar. It is also important that the inventor not try to second-guess the meaning of these legal conditions since they have been and are subject to various legal inter- pretations by the courts based on specific set of facts and circumstances. For example, what is considered ‘‘printed’’ is certainly now more complex than when it was first promulgated and has been interpreted to mean all material accessible to the public in tangible form, including a single copy of a thesis indexed and catalogued in a university library. The conduct of tests in the public eye to perfect an invention or the sale of an invention for the sole purpose of experimental use may or may not trigger the 1-year grace period, and legal advice should be obtained in advance.

C. Nonobviousness

A new and useful invention must also meet the statutory requirement for nonobviousness. The patent law states that ‘‘if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which the subject matter pertains,’’ then the invention is considered obvious and a patent cannot be granted.

The determination of whether a particular invention is or is not obvious is largely subjective, although the courts have established some guidelines and tests for its determination as a matter of law. Obviousness does not hinge on the manner in which the invention was made, i.e., there is no requirement for ‘‘a flash of genius.’’ Many inventions are made after considerable experimentation or even by error or accident and rarely by revolutionary imagination. The test of obviousness of an invention is not whether it would have been ‘‘obvious to try’’ the combination of steps or elements that led to the invention. In hindsight, it may seem like it would have been obvious to try certain experiments leading to the claimed subject matter, but the focus of the patent law is on the level of knowledge and skill in the art at the time the invention was made.

To ascertain if the nonobviousness requirement has been met, the USPTO and the courts examine the following:

1. The scope and content of the prior art

2. The differences between the art and the claims at issue

702 Roehrs

3. The level of ordinary skill in the art

4. Whatever objective evidence may be present The prior art is the body of knowledge or information that is publicly

available or accessible at the time of the invention. Patent law presumes that the inventor and the person of ordinary skill have full and comprehen- sive knowledge of the prior art pertinent to the invention. For determining obviousness, reference is made to the scope and content of the art relevant to the subject matter of the invention as well as to so-called analogous art. This is different from the requirement for novelty where anticipation is not restricted to the prior art of the invention but includes all prior art. Analogous prior art is that art that may be outside the field of the invention but that the inventor would examine to solve a problem or obtain a result leading to the invention. Analogous art is said to be art that is reasonably pertinent to the particular problem the inventor was involved with, and there is a similarity of elements, problems, and purposes.

The content of the prior art is examined for what it teaches about the claimed subject matter. Does the prior art teaching render it obvious to one of ordinary skill in the art, or does it teach away, i.e., discourage one of ordinary skill from following the path taken by the inventor or suggest that it would be unlikely to be productive? Prior art that ‘‘teaches away’’ can be evidence of nonobviousness.

If the invention is novel, then there must exist some difference from that found in the prior art, and it is this difference that has sometimes been termed the ‘‘invention’’ or ‘‘inventive step.’’ What matters is not necessarily the degree of difference, but whether or not the difference is obvious to the one ordinarily skilled in the art at the time the invention was made. However, the degree of difference can be a factor, particularly if it causes disproportionate, unexpected, surprising, or unusual results. The difference from the prior art is examined for the invention’s ‘‘subject matter as a whole.’’ This means that the inherent properties of what is claimed and disclosed in the patent’s specification are also part of the comparison to the teachings of the prior art. If the invention produces certain advantages or unexpected results and these might be crucial to a determination of nonobviousness, they should be included in the patent specification.

The person of ordinary skill in the art is a hypothetical person and is usually considered to be one who follows conventional wisdom in the art rather than one who is an innovator in the art. The level of ordinary skill is ascertained at the time the invention was made, not at a later time when advances in the art could have made the original invention obvious, parti- cularly if the advances were made possible by the claimed invention. Certain factors may be considered in determining the level of ordinary skill, includ-

Patent Considerations 703 ing the education level of active workers in the art, the types of problems

encountered and the prior art solutions to those problems, the sophistica- tion of the technology, and the rapidity with which innovations are made.

Objective evidence of nonobviousness usually comes as proof or evi- dence of what are called ‘‘secondary considerations.’’ The most common type of secondary considerations include the commercial success of the invention, the satisfaction of a long-felt need, the failure of others to find

a solution to the problem the invention addresses, copying of the invention by others, unexpected results, and expression of disbelief or praise by experts. While the absence of such secondary considerations does not neces- sarily indicate that an invention is obvious, their presence in an invention is not always conclusive of nonobviousness.

VI. INVENTORSHIP AND PRIORITY OF INVENTION Only the true and original inventor may obtain a U.S. patent. The inventor

cannot have derived the invention from someone else. If more than one independent inventor applies for a patent on the same invention, it will be awarded to the first inventor. Although we speak of the inventor, it is more correct to speak of the ‘‘inventorship entity’’ since there may be more than one inventor. Where there is more than one inventor, the inventorship entity is spoken of as joint inventors or co-inventors. Joint inventorship is quite common in the pharmaceutical field where several scientists collaborate on a project. A patent can be invalidated if more or fewer than the correct num- ber of co-inventors is named in an application, but the law presumes that the listing of inventors in an issued patent is correct. Legal remedies are avail- able to correct a mistake in the inventorship entity as long as it was made without intent to deceive.

Each inventor owns an equal and undivided interest in the patent rights and, absent an agreement to the contrary, can individually assign or license their property rights to different parties. In most cases the joint inventors work for the same organization and assign their patent rights to their employer. However, if a project involves collaboration with scientists outside of the organization and there is the possibility of joint inventorship, the question of the ownership of property rights between the two organiza- tions should to be addressed prior to applying for a patent.

A joint invention occurs when more than one person contributes something meaningful to the conception of the claimed invention. The con- tribution must be more than a mere suggestion of a desired result or must do more than merely follow the instructions of another. Someone preparing a composition provided by his or her supervisor and submitting it for testing

704 Roehrs does not rise to the level of an inventor. However, if in so doing he or she

makes a contribution, such as a modification in the composition that allows it to achieve its intended purpose, then he or she could become a joint inventor. According to U.S. patent law, joint inventors may obtain a patent even though they did not physically work together or at the same time, each did not make the same type or amount of contribution, or each did not make a contribution to the subject matter of every claim of the patent.

United States patent law is a ‘‘first-to-invent’’ system, as opposed to other countries, which have ‘‘first-to-file’’ systems. The priority of invention is an issue when more than one inventorship entity submits a patent applica- tion for the same claimed subject matter. The priority contest (interference) is invoked to determine who was the first to invent. Invention is considered the acts of conception and reduction to practice. The patent will be awarded to the first to conceive the invention even if last to reduce it to practice as long as

he or she was reasonably diligent in pursuing the reduction to practice from the time prior to conception by the other inventorship entity. Conception is considered the mental part of inventing. The inventor forms in his or her mind the complete form of his or her part of the invention. In some cases, conception may not be complete until after some experimentation has taken place. Reduction to practice is the demonstration that the invention works for its intended purpose, but the act of filing a patent application is recog- nized in patent law as a constructive reduction to practice. Scientists are taught to keep records of their experimental work, and it is important to record the conception of an invention in a timely manner and keep timely records of the acts taken to reduce it to practice. The conception and reduc- tion to practice records should be witnessed by someone other than another co-inventor. The witness should have sufficient knowledge or qualifications to understand the technical information regarding the invention records.