Intellectual Property Law Primer

Intellectual Property Law Primer

C H A P T E R 39 Intellectual Property Law Primer Joseph A. Fuchs 39.1 INTRODUCTION processes or machinery that is not known to the public, and is ...

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C H A P T E R

39 Intellectual Property Law Primer Joseph A. Fuchs

39.1 INTRODUCTION

processes or machinery that is not known to the public, and is carefully maintained in secrecy. Knowhow refers to information relating to how to do something in an efficient and reliable manner. These terms are often confused by persons who will say things such as, “you should trademark that idea” or you should “patent that saying.” The misuse of these terms can be humorous to those of us who know their definition. Because this text is focused on addressing technical issues surrounding oral dosage forms we thought it most appropriate, with the brief space available to us, to dedicate our focus on obtaining and enforcing patents.

This chapter will present an overview of intellectual property law, with a principal focus on United States Patent Law. The chapter is divided into two parts. The first part focuses on the process of filing a patent application, corresponding with a patent office to place the claims in a condition for allowance, and obtaining patent grant or issuance. This process is generally referred to as patent prosecution. The second part of this chapter will provide an overview of how patent owners enforce their patents through a lawsuit filed in a US Federal District Court. The enforcement of patents is generally referred to as patent litigation.

39.2.1 Types of United States Patent Applications

39.2 PATENT PROSECUTION

There are four basic types of patent applications in the US:

The term “intellectual property” is an umbrella term encompassing patents, trademarks, copyrights, trade secrets, and knowhow. Patents are used to protect inventions or discoveries of “… any new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof…” 35 U.S.C. §101. Trademarks are used to protect words, phrases, and logos that are used in the sale of a good or service in interstate commerce, and serve to identify the source of the goods or services. Copyrights are used to protect works of authorship fixed in a tangible medium, such as written materials, visual arts, performances, sound recordings, music, and computer software to name a few. Trade secrets are used to protect formulations (such as the Coca Cola recipe),

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice

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provisional, utility, plant, and design.

A provisional patent application allows for the filing of a patent application in a form that is less formal than other types of applications. The provisional patent application is not examined by a patent examiner, but allows an inventor to establish a date of invention for what is disclosed in the application. A utility patent application and international patent application counterparts should be filed within twelve months from the provisional filing date, to claim priority to

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the provisional patent application filing date. 35 U.S.C. § 119 (e): Upon expiry of the twelve month period the provisional patent application lapses and no further action is taken in the provisional application. Design patent applications cover the non-functional, ornamental features of an article of manufacture. 35 U.S.C. § 171: A design patent application includes figures showing the ornamental features from all sides. The design application will typically include a single claim such as “The ornamental design for a [insert article of manufacture] as shown and described.” Plant patent applications can be obtained by “[whoever] invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than tuber propagated plant or a plant found in an uncultivated state …” 35 U.S.C. § 161. This is all I can tell you about plant patent applications, so I will move on to utility patent applications. I apologize to the gardeners and botanists who are reading this.

39.2.2 Standards for Patentability Utility patent applications are the most common type of patent application, and can cover a wide variety of inventions including processes, machines, and compositions of matter. For an invention to be patentable it must be novel, non-obvious, and have utility. The legal standards for determining whether these standards are met can be quite complicated, so we will limit our discussion to a brief overview, and will urge readers if they have questions relating to this matter to consult a patent attorney. Novelty Generally speaking, the novelty standard in the United States requires that, for an invention to be patentable, the invention has not been used in the public in the United States or disclosed in a written publication in the United States or elsewhere for more than one year prior to the filing of the subject patent application. Novelty can also be destroyed, if the invention is known or used by others in the United States or appears in a written publication anywhere in the world before the invention by the applicant. Take note that the invention date can be, and in most cases is, different from the filing date of the patent application. An invention date is the date when an inventor has conceived of an invention, and has put it into practice. The publications and public uses, referenced above, are referred to as “prior art.” If a single textual

prior art reference or public use discloses every element of the invention claimed, the claim is said to be “anticipated.” The US novelty standard is unique to the US. Most other countries of the world require that a patent application be on file prior to the date of any public disclosure of the invention anywhere in the world. This is known as “absolute novelty.” Also, if there is a dispute between or among parties who have applied for a patent on the same invention, the party who filed first is the party who wins the dispute. This is known as “the first to file rule.” Because the United States allows inventors one year from their invention date to file a patent application, written references and public uses that occur less than one year before the filing date of an application may not necessarily be novelty-destroying. If such a reference or use is cited by a patent examiner to reject claims, it may be possible for the inventors to “swear behind” the cited reference, by providing proof in the form of a sworn statement that the inventors conceived of their invention prior to the date of the reference, and used diligence from the date of the reference to the date of reduction to practice. In the case of a patent reference, diligence must be shown from the earliest effective filing date of the application that includes claims of priority to domestic patent references, but not to foreign patent references. However, if the cited reference or public use has occurred more than one year before the filing date, the inventors cannot swear behind such reference. This type of reference is known as a “statutory bar,” and can be the death knell to a patent application. Another interesting consequence of the United States allowing inventors one year from their invention date to file their patent applications is that disputes can arise between or among individual inventors or groups of inventors over who invented first. The United States, therefore, is known as a “first to invent” country, as opposed to a “first to file” country. In order for such disputes to occur, none of the party’s patent applications can be statutory bars to the other patent applications. The United States Patent Office is capable of resolving these disputes in an interference proceeding. An interference can occur between parties having pending patent applications or it can involve a patent and one or more patent applications. The United States legislators are considering amending the US patent laws to move to a firstto-file system, which would put an end to interference proceedings. The US novelty requirements also require, you may be surprised to know, that the inventors identified in the application are the actual inventors.

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39.2 PATENT PROSECUTION

Non-Obvious A patent claim is deemed obvious, and, therefore, not patentable, “… though the invention is not identically disclosed or described … 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 of the invention was made to a person of ordinary skill in the art to which such subject matter pertains.” 35 U.S.C. § 103 (a): A patent examiner can cite to a single reference or a combination of prior art references to make an obviousness rejection. Obviousness rejections can be attacked in numerous ways. For example, a patent applicant can argue that there must be a motivation within the references to combine them together. Recent case law from the United States Supreme Court has stated that the motivation to combine the references does not have to appear in the references. It is enough that one of ordinary skill facing the wide range of needs created by the developments in the field of endeavor would see the benefit in combining the references. KSR v. Teleflex, 550 U.S.____, 127 S.Ct. 1727 (2007). Thus, US patent examiners may find it easier, and less subject to a legal challenge, to combine references after this case. A patent applicant can also argue against an obviousness rejection by proving that the claimed invention has met with commercial success, has solved a long-felt need, has provided a solution where others have failed, and that the cited reference or combination of references teaches away from the claimed invention. A patent applicant can support such arguments by providing sworn statements known as §132 Affidavits. Utility Article 1, § 8, of the United States Constitution, grants Congress the power to “promote the Progress of Science and Useful Arts.” The patent law under Title 35 was drafted in accordance with the constitution and requires that, for an invention to be patentable, it must fall into one of four statutory categories of invention. It also requires that only one patent be granted for an invention, and that the patented invention be “useful.” The four statutory categories of invention are: 1. 2. 3. 4.

useful process; machine; manufacture; or composition of matter. 35 U.S.C. § 101.

To be “useful” an invention does not have to be an improvement over what is disclosed in the prior art.

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It need only have to offer a practical and positive benefit to society. Applying the “useful” standard to the mechanical arts area is relatively simple. For example, an assembly for providing fluid access to a container clearly is beneficial. However, biochemical and bioscience inventions can meet with stiff resistance from the patent office, unless the patent application contains proof that the invention provides some benefit. Patent examiners seem to have shifted rejections for lack of utility to rejections based on a lack of written description or failure to provide an enabling disclosure. Regardless of the statutory construct of the examiner’s rejection, such arguments can be overcome by disclosures and proof in the application of the benefit to society of the practical use of the invention. This is not as easy as it may seem in many complex bioscience patent applications, where the practical utility of the invention may be difficult to discern.

39.2.3 The United States Utility Patent Application A US utility patent application usually has two principal parts, a specification followed by a claim or a set of claims. The Specification The specification must disclose in clear, concise, and exact terms to enable one of ordinary skill in the art to practice the invention. If necessary, the specification will make reference to figures. The specification must also disclose the best mode for practicing the invention. The grant of patent rights allows one to exclude others from practicing the claimed invention. These rights are granted by the US government to the inventor, as a quid pro quo for the inventor making a sufficiently detailed invention disclosure. The requirement to disclose the best mode can sometimes lead to a bone of contention between a patent attorney and the inventor. Frequently, inventors are initially reluctant to disclose the best mode, as they believe they are giving away too much information. However, when inventors are advised that their patent can be invalidated by a court for failure to provide sufficient disclosure, they usually concede by providing an adequate disclosure. The Claims The claims portion of the patent application is where patent applicants define what they believe to be the patentable features of their inventions. Patent examiners will review the claims for clarity purposes, and

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determine whether the claims are allowable in view of prior art patents and publications. Patent examiners conduct a search of the prior art and then prepare an office action allowing or rejecting the pending claims. Office actions should include a detailed reason for allowing or rejecting the claims, and if the rejection is based on a prior art reference or a combination of references, the examiner needs to provide the legal basis for the rejection, and the patent number or other identifying information for the prior art, and the location within the document that discloses the invention being rejected. Applicants will file a reply to the office action, where they can amend the claims and explain why the amendments place the claims into allowable form or they submit arguments without claim amendments. When the claims are in acceptable form to the examiner and the applicant, the examiner will notify the applicant the claims are allowable. The applicant must then pay an issuance fee. Several months later the patent will issue. A US utility patent will typically have a term of twenty years from the earliest effective filing date. Claims come in numerous different varieties including, for example: compositions of matter; formulations; processes; articles of manufacture; product by process; product by physical property; and means plus function. A claim in US format will typically have a preamble, followed by a transitional phrase or term, followed by the body of the claim. The preamble introduces the general subject matter that is to be claimed such as “an assembly” or “a device.” The transitional phrase or term can be critical to determining the scope of the claim. There are three commonly used transitional phrases or terms, “comprising” or “including,” “consisting of,” and “consisting essentially of.” The transitional terms “comprising” and “including” are interpreted as being open-ended. This means that the claim recites the minimum elements of an invention, and that as long as a party uses the recited elements, even if they add additional elements, they will infringe the claim. The transitional phrase “consisting of” is interpreted as being close-ended. This means that in order to infringe such a claim an accused product must include only the recited elements, and nothing more. Such a claim is typically more narrowly interpreted when compared to an open-ended claim. Close-ended claims are useful to claim inventions, such as a process, where the inventive aspect is the removal of a step required in the prior art. The transitional phrase “consisting essentially of” is interpreted as open-ended for some purposes and close-ended for other purposes. The claim is interpreted as open-ended for accused products that include what is recited in the claim and additional

components that do not materially affect the basic and novel characteristics of the invention. Say, for example, you claim a transparent film “consisting essentially of” components A, B, and C. Say a competitor produces a film having components A, B, C, and carbon black. The claim will be interpreted as close-ended because the inclusion of carbon black will destroy the transparency of the film, a basic and novel characteristic of the invention.

39.2.4 Representative Pharmaceutical Related Patent Subject Matter and Claims Some of the first patent applications applied for by innovator drug companies will be for the compositions of matter of new drug discoveries. Because the time to obtain FDA approval for the sale and use of a new drug in the United States can be quite lengthy, the twenty-year term of the patent remaining after receiving approval may be substantially diminished. Accordingly, it is critical for competitors in the pharmaceutical industry to have a well-planned succession of patents to protect forms of the drug being developed for later use. It is a common patent filing strategy employed by pharmaceutical companies to file what are known as patent line extension patent applications. These extension patent applications are designed to present additional hurdles to competitors to create competing drug products. The subject matter for patent line extension patent applications can include, for example, modification of the chemical structure of the patented drug, formulations to deliver the drug, new indications, delivery devices, in combination with the drug, and new routes of delivery. Patents covering modifications to chemical structures can be directed to, for example, chiral isomers of the drug, differing polymorphic forms of the claimed drug, prodrugs, metabolites, and pediatric studies. Chiral Isomers Patents directed to a specific chiral isomer of a drug may disclose that the specific chiral isomer of the drug provides benefits, such as improved pharmacological profiles, when compared to a racemic mixture of the drug. One example of a claim to a specific isomer of a drug is in US Patent No. 5 362 755, directed to (R)-albuterol and recites as follows: ●

Claim 1. A method of treating asthma in an individual with albuterol, while reducing side effects associated with chronic administration of racemic albuterol, comprising chronically

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administering to the individual a quantity of an optically pure R() isomer of albuterol sufficient to result in bronchodilation, while simultaneously reducing undesirable side-effects, said R isomer being substantially free of its S() isomer. Polymorphic Forms Products containing varying polymorphic forms of drugs include, for example, Ranitidine (Zantac), Cedadroxil (Duricef), Tertenadine (Seldane), and Omeprazole (Prilosec). An example of a patent claim to a specific polymorphic form is found in US Patent No. 4 521 431, and specifically claims form 2 of Ranitidine. ●

Claim 1. Form 2 ranitidine hydrochloride characterized by an infrared spectrum as a mull in mineral oil showing the following main peaks: 3260 3190 3100 2560 2510 2470 1620 1590 1570 1263 1230 1220 1195 1163 1075 1045 1021 1006 991 972 958 810 800 760 700 660 640 620 cm1.

Prodrugs Patents directed to prodrugs are directed to the precursor of an active ingredient, which can be designed for targeted delivery or to reduce toxicity. For example, US Patent No. 6 486 182, provides an example of a claim to a prodrug of amlodipine and atorvastin. ●

Claim 1. A compound which is a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof.

from about 100 mg to about 1000 mg, and tramadol or its salts of from about 15 mg to about 150 mg comprising: 1. an immediate-release portion comprising from about 25%–75% of the total effective amount of the acetaminophen and tramadol, in the form selected from pellets, beads, granules, and mini-tablets; 2. a sustained-release portion comprising: a. from about 25%–75% of the total effective amount of the acetaminophen and tramadol, in the form selected from pellets, beads, granules, and mini-tablets; and b. a gelling polymer in an amount by weight of the capsule of about 6% to about 50%; and 3. the capsule releases about 25%–60% of the acetaminophen and the tramadol in the first hour in a simulated gastric fluid dissolution media, about 50%–90% of the acetaminophen and the tramadol in the first four hours, and not less than 80% of the acetaminophen and the tramadol in the first 12 hours in a simulated intestinal fluid dissolution media using USP dissolution method II at 50 rpm. Improved Shelf Life An example of a patent disclosing an improved shelf life formulation for a premixed famotidine formulation is disclosed in US Patent No. 5 650 421. Claim 1 recites as follows: ●

New Formulations and Delivery Technologies There are numerous patenting opportunities pertaining to drug-containing formulations, and delivery technologies. Formulation patents are typically directed to reducing adverse effects of the drug, simplifying dosing regimen and administration, extended-release of the drug, chronotherapeutic release, improved shelf life of the drug formulation, improved dissolution and aqueous solubility (especially for parenteral administration), fast absorption, pediatric formulations, and combo-drug formulations. Controlled-release US Patent Application No. 2004/0131671 A1 discloses a controlled-release form of tramadol and acetaminophen having a combination of a sustained-release and an immediate-release. Allowed claim 1 recites as follows: ●

Claim 1: A capsule for sustained release of drugs, including a combination of acetaminophen of

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Claim 1. A pharmaceutical composition suitable for administration parenterally and through injection, comprising a solution having an effective amount of famotidine or at least one physiologically acceptable salt of famotidine, between about 0.1 mg/ml to about 0.8 mg/ml, the solution having a pH adjusted by an acid to be in the range of 5.7 to about 6.4.

Pediatric Formulation Claim US Patent No. 5 698 562 is directed to a palatable formulation of trimethoprim oral solution. Claim 1 recites as follows: ●

Claim 1. A palatable pharmaceutical oral solution formulation for pediatric dosing consisting of: ● about 1.25 to 8 mg trimethoprim per mL (wt./vol.) of purified water; ● hydrochloric acid (HCl) in sufficient concentration with purified water to permit said trimethoprim to dissolve at the appropriate concentration, wherein

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the solution of dissolved trimethoprim has a pH of between 4.0 and 6.0; and sucrose and flavoring, other than sucrose, in an amount sufficient to overcome the bitterness of said trimethoprim.

39.3 PATENT ENFORCEMENT/ LITIGATION An owner of a patent has the right to exclude others from practicing the claimed invention. A patent does not provide the right for the owner of a patent to practice the claimed invention. It is common for people to confuse the concepts of patentability, and freedom to operate. Whether an invention is patentable, which is discussed in some detail above, depends on what is disclosed in the prior art. Whether a party is free to practice an invention depends on what is claimed in patents that are in their enforceable term. An operating example may help clarify these two concepts. If you find yourself confusing these concepts, try to remember the following example, which should help clarify your thinking.

39.3.1 Example: Patentability Versus Freedom to Operate Thomas Edison conceives of, and reduces to practice, a first generation light bulb. He files a patent application describing the light bulb in complete detail. He discloses in the specification that his light bulb has a sealed glass envelope surrounding an iron filament, which has opposed ends in communication with a source of electricity, and the filament provides light when electrical current is applied to the filament. Claim 1 of the Edison patent recites: 1. A light bulb comprising: a sealed glass envelope defining a chamber, a filament positioned in the chamber and having first and second ends in electrical communication with a source of electricity, wherein when current is applied to the filament it provides light, and when the current is removed it becomes dark. The patent examiner reviewing the Edison patent application searches the prior art, and when he is unable to find any prior art to reject Claim 1 he deems the claim to be in a condition for allowance, and the patent issues. Thus, the patent examiner has determined that Edison’s invention is patentable. Continuing with this example, say a second inventor, who has seen an Edison light bulb, decides to

attempt to develop an improved light bulb. After great effort the second inventor finds that when he uses a tungsten filament, instead of an iron filament, that his new light bulb lights for many days longer than the Edison light bulb. The second inventor prepares a patent application, disclosing his improved light bulb with a tungsten filament. Claim 1 of the second inventor’s patent application recites as follows: 1. A light bulb comprising: a sealed glass envelope defining a chamber, a tungsten filament positioned in the chamber and having first and second ends in electrical communication with a source of electricity, wherein when current is applied to the filament it provides light, and when the current is removed it becomes dark. The patent examiner reviews Claim 1 and he conducts a search of the prior art, and finds the Edison patent on the light bulb. The examiner reviews the specification of the Edison patent, and finds no disclosure of a tungsten filament. The examiner also concludes the use of a tungsten filament and the inclusion in a light bulb is novel, and non-obvious in view of the Edison patent, and has utility. Thus, Claim 1 reciting a light bulb with a tungsten filament is found to be in allowable form, and the second inventor’s patent issues. Now, the second inventor decides that he would like to make his improved light bulb. He consults his local patent attorney to inquire if he would be taking a business risk if he were to make the improved light bulb, and sell it in the United States. The patent attorney conducts a search of US Patents, and finds the Edison patent. Assuming, for the sake of this example, that the Edison patent is still within its enforceable life span, the patent attorney concludes that because the improved light bulb meets every limitation of Claim 1 of the Edison patent, the second inventor does not have freedom to operate. Thus, if the second inventor makes, uses, offers for sale, sells or imports the improved light bulb, he may be sued by Edison for patent infringement. Continuing further with this example, say that Edison hears of the improved light bulb with the tungsten filament, and decides he would like to replace the light bulbs he is making and selling with iron filaments with a tungsten filament. Edison visits his patent attorney and asks him if he is taking any business risk if he makes and sells the improved light bulb with a tungsten filament. Edison’s patent attorney conducts a search of US patents, and finds the second inventor’s patent, which is still within its enforceable life span. Edison’s patent attorney concludes that Edison would be taking a risk of being sued for patent infringement by the second inventor if he were to make the

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improved light bulb with the tungsten filament, because such a light bulb would include every element recited in Claim 1 of the second inventor’s patent. This may seem to be a strange outcome, but it is a common occurrence. Edison’s patent is referred to as a dominating patent, and the second inventor’s patent is referred to as a blocking patent. If Edison or the second inventor would like to sell the improved light bulb during the term of the two patents, they will have to enter into a cross-licensing agreement.

39.3.2 Patent Infringement Litigation Patent infringement lawsuits must be first brought in a United States Federal District Court. All appeals from patent lawsuits on patent-related issues are taken to the United States Court of Appeals for the Federal Circuit (CAFC), located in Washington, DC. There are several different types of infringement allegations including: ● ● ●

direct, contributory, and inducement.

For the sake of brevity, we will discuss infringement in terms of a claim to a product, but it should be understood that this discussion applies equally to claimed methods. Direct infringement can be alleged against a single entity who makes, uses, offers for sale, sells or imports into the United States (infringing acts) a product that has all of the elements of a single claim of a patent. Contributory infringement can be alleged against a party who does not directly infringe a patent, but who supplies a product to another party who directly infringes a patent. Inducing infringement can be alleged against a party who does not directly infringe, but encourages another party to infringe a patent. Patent infringement can occur by literally infringing a claim of a patent or by infringing the claim under the doctrine of equivalents. Literal infringement occurs if every element of a single claim is present in an accused product. A product that does not literally infringe upon the express terms of a patent claim may, nonetheless, be found to infringe under the doctrine of equivalents if there is “equivalence” between the elements of the accused product or process, and the claimed elements of the patented invention. The essential inquiry under the doctrine of equivalents is whether the accused product contains elements identical or equivalent to each claimed element of the patented invention. An infringement analysis entails two steps. The first step, commonly known as claim construction or

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interpretation, is to determine the meaning and scope of the patent claims asserted to be infringed. Once a construction has been made, the second step is to compare the properly construed claims to the device accused of infringing. If an accused product meets all of the limitations of the claim, either literally or under the doctrine of equivalents, the product infringes the claim. For a proper claim construction, the words of the claims are construed in light of the specification, the prosecution history, and the prior art, but independent of the accused device. Claim terms are given their ordinary and accustomed meaning, unless examination of the specification, prosecution history, and other claims indicates that the inventor intended otherwise. For claim construction purposes, the written description contained in the specification may act as a dictionary to explain the invention, and to define terms used in the claims. The interpretation of claims is a matter for a judge to decide, as opposed to a jury. A proceeding to interpret claims is conducted in what is known as a Markman hearing. During a Markman hearing, both the patent owner and accused infringer urge the court to interpret the claims in their favor. After the hearing, the court issues an order stating how the claims are to be interpreted. During a Markman hearing, the patent owner must walk a fine line between urging a claim interpretation broad enough to read on the accused product, so that it may prove its case for infringement, while at the same time being careful not to urge such a broad reading that the claim reads on the prior art, thereby presenting an argument to the accused infringer that the claims are invalid. The accused infringer will urge either a narrow or a broad reading. The accused infringer can argue a narrow claim reading, such that the claims do not read on the accused product and, therefore, the accused product does not infringe the asserted claims. The accused infringer can also urge a broad reading, so that the asserted claims read on the prior art and, therefore, provide an argument that the claims are invalid. Patent infringement actions can be won or lost at an early stage in the proceedings if a party gets an unfavorable claim construction order from the court. The CAFC has held that a finding of infringement under the doctrine of equivalents requires proof of insubstantial differences between the claimed and accused product or processes. The vantage point of one of ordinary skill in the relevant art provides the perspective for assessing the substantiality of the differences. There are limitations placed on the use of the doctrine of equivalents, namely prosecution history estoppel. Prosecution history estoppel limits the range of equivalents available to a patentee by preventing

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recapture of subject matter surrendered during prosecution of the patent. For example, if a patent applicant amends a claim in view of prior art or for other reason pertaining to patentability, from reciting a formulation having 20–35% of component A to reciting 25–35% of component A to obtain issuance of the claim, the patentee cannot then allege that a product having 24% of component A infringes under the doctrine of equivalents. The patentee is said to be estopped from making such an allegation. Another limitation of the application of the doctrine of equivalents can be found if a patentee is deemed to have dedicated subject matter to the public. A certain court opinion rendered by the CAFC held that subject matter disclosed by an applicant in a patent application, but that was not claimed was dedicated to the public, the applicant could not resort to the doctrine of equivalents to prove infringement, even where the specification explicitly taught the equivalence of the subject matter. In yet another limitation, the doctrine of equivalents may not be used to expand the scope of the patentee’s right to exclude, so as to encompass the prior art. This ruling, of course, makes sense since a patent applicant should not be allowed to obtain a claim reading in court that it could not obtain during the prosecution of the patent application.

39.3.3 Remedies for Patent Infringement A party who succeeds in proving a claim for patent infringement will typically have two types of remedies available, including monetary damages and injunctive relief. There are numerous theories for calculating monetary damages, some of which include: a reasonable royalty; actual damages; lost profits from lost sales; convoyed sales; and price erosion. If an infringer is found to have willfully infringed the patent, the amount of damages can be multiplied by a factor up to three times damages. Also, in certain exceptional cases, the court can order the losing party to pay the prevailing party’s attorneys’ fees. This is a departure from the normal situation in the United States, where each party is responsible for paying its attorneys’ fees regardless of whether a party prevails or not. Injunctive relief can be a potent weapon against a party found to be infringing. An injunction is an order from a court that the party found to be infringing must cease all infringing acts relating to the asserted patent.

39.3.4 Defenses to Patent Infringement Defenses to patent infringement can be divided into three categories, non-infringement, invalidity,

and unenforceabilty. A defense of non-infringement will be sustained if the party asserting its patent fails to show that the accused product has every element of the asserted claim, either literally or under the doctrine of equivalents. Patents are entitled to a presumption of validity. The courts defer to the skill and experience of the US Patent Office to issue valid patents, and will upset the grant of a patent only upon a strong showing by the party moving to prove invalidity or unenforceability. Thus, a party moving to invalidate a patent must prove its case by clear and convincing evidence. Clear and convincing evidence requires greater proof than that commonly used in most civil cases, such as breach of contract actions. The clear and convincing standard, however, requires less proof than the beyond a reasonable doubt standard required of the government in criminal cases. Using a baseball analogy, which may not mean anything to some readers, clear and convincing evidence is like hitting a baseball off an outfield wall. Beyond a reasonable doubt would be a home run, and a mere preponderance would be an infield hit. The arguments made by the defending party that a patent is invalid are essentially the same arguments made by a patent examiner in rejecting claims. The defending party can rely on a single reference to anticipate the claims or a single reference or a combination of references, to prove the asserted claims are obvious. Invalidity defenses are usually based on prior art documents that were not before the patent office during the prosecution of the patent application that issued as the patent being asserted. Invalidity can also be proven by showing that the patent does not provide sufficient disclosure for one of ordinary skill in the art to practice the invention. A patent can also be invalidated for failure by the patent applicant to have disclosed the best mode known to it for practicing the invention. A defending party can also defend itself by proving the patent is unenforceable due to “inequitable conduct.” Inequitable conduct usually means the patent was procured by the patent applicant using improper means, such as failing to disclose material prior art to the patent office during the prosecution of the patent application that could impact the scope of the claims, and filing an affidavit including statements known to be false. This chapter was not intended to discuss all aspects of intellectual property in depth. Rather it was meant to expose the reader to certain fundamental concepts of intellectual property law, without getting into too much detail.

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