P.G. Diploma in Patent Laws

P.G. DIPLOMA IN PATENT LAWS NALSAR PROXIMATE EDUCATION NALSAR UNIVERSITY OF LAW

Paper IV - Practical (Abuse of Patents)

MODEL ANSWERS-2005-06

1. What are the types of Infringement in Patents ? Discuss the Doctrine of Equivalents with suitable case illustrations

The major types of Infringment are Literal and DOE-

The doctrine of equivalents is a common law doctrine providing generally that a patent may be infringed even if the literal claims of the patent are not infringed. The most often- quoted definition is from Graver Tank, infra, and provides that a device will infringe the claims of a patent under the doctrine of equivalents if it “performs substantially the same function in substantially the same way to obtain the same result” as the claimed invention. The doctrine of equivalents serves to expand the patent protection beyond the literal language of the claims.

The constitutional purpose of patent law is to “promote the Progress of Science and useful Arts” by granting inventors exclusive rights to their inventions for a limited period of time. The judicially created doctrine of equivalents has long played an important, albeit controversial role in the realm of patent law. It strives to strike a balance between the two competing policies behind the enforcement of patent rights: (1) to protect the inventor’s right to exclude others who might steal the product of his work, and (2) to provide clear notice to the public of the invention’s boundaries.

The doctrine of equivalents is an equitable doctrine established by the courts to protect patented inventions. In order to find that a patent has been infringed (literal infringement), every element of the patented claim must be found in the infringing device. Thus, a copyist can avoid literal infringement by making changes so that his or her device does not have the exact elements disclosed in the patented claim. Any discrepancy between the patented claim and the accused device will negate a finding of literal infringement.

However, in order to protect patent owners from copyists stealing the patented invention by making small or insubstantial changes to the invention, the Supreme Court established the principle of infringement under the doctrine of equivalents. This doctrine allows a court to find infringement if the elements of the accused device are "insubstantially" different from those disclosed in the patent.

Because of the inherent uncertainty in the doctrine of equivalents, courts have exercised their equitable powers to limit the doctrine. An important limit is the principle of prosecution history estoppels. This doctrine relates to the amendments, statements, arguments, and representations made by the patent applicant during the course of obtaining a patent. Any statement that limits the scope of the patent made for "a reason related to patentability" is binding and the applicant will be forbidden (estopped) from later attempting to argue that the limitation does not exist.

The courts are continually struggling with the crucial issue of when should the doctrine of equivalents be applied, and at what point is the claim language of a patent stretched too far; Festo is only the latest case of many on this issue.

Case Illustration • Supreme Court in Graver Tank & Manufacturing Co. v. Linde Air Products Co.: • ‘Courts have recognized that to permit imitation of a patented invention which does not copy every literal detail would be to convert the protection of the patent grant into a hollow and useless thing. Such a limitation would leave room for the unscrupulous copyist to make unimportant changes and substitutions in the patent which, though adding nothing, would be enough to take the copied matter outside the claim, and hence outside the reach of law’ • One who seeks to pirate an invention, like one who seeks to pirate a copyrighted book or play,may be expected to introduce minor variations to conceal and shelter the piracy. Outright and forthright duplication is a dull and very rare type of infringement. To prohibit no other would place the inventor at the mercy of verbalism and would be subordinating substance to form. • Electric welding compositions. The patented composition was a combination of alkaline earth metal silicate and calcium fluoride. The accused composition used silicates that were not of an alkaline earth metal Function/way/result • A patentee may invoke the doctrine of equivalents to proceed against an alleged infringer if his or her device ‘performs substantially the same function in substantially the same way to obtain the same result.’ • The test is necessarily premised on the underlying assumption that each of the "elements" recited in the claim is found somewhere in the accused product or process

Warner-Jenkinson Co. v. Hilton Davis Chem. Co FESTO CORPORATION, v. SHOKETSU KINZOKU KOGYO KABUSHIKI CO., LTD

2) What is a patent equivalent? What is the need of an equivalent?

Patent specifications which have been published; which may be later granted if found patentable; by different patent offices for the same invention are known as Equivalent. These specifications together form the patent family.

Since a patent only gives the owner a territorial right in the country where the patent application is filed and granted – it may be required to file individual patent applications in several countries of interest depending on the commercial interest of the patentee in order to protect the invention. Thus a patent family with a number of equivalents is planned depending on commercial interest. 3) Write short notes on –

a. Pfizer vs Ranbaxy (Lipitor)

Lipitor is the brand name for atorvastatin, which was invented by Warner-Lambert and then acquired by Pfizer. Patents were sought and obtained in many countries for the main active ingredient, with further patents obtained for follow-up developments. Ranbaxy attacked not only the master atorvastatin patent, but also subsidiary patents on the calcium salt.

Although most of the world’s judgments have been in Pfizer’s favor, Ranbaxy has vowed to fight on through the appeal process. Given that each country has a different system for filing and obtaining patents – and also its own standards as to what can be patented, how patent claims should be interpreted, what amounts to infringement and how patents can be attacked – the degree of unanimity between the different courts is interesting and reassuring.

The US case - Pfizer’s US patents are not due to expire until 2010 and 2011. The original term was extended from 2006, on the grant of the marketing authorisation. Ranbaxy applied for an abbreviated new drug application (a request to the FDA for commercial approval based on the approval already given – for example, to the patented medicine) to sell the generic version and was sued by Pfizer for patent infringement. Ranbaxy tried to show that the patents were not enforceable; in the US, it sought to rely on the doctrine of inequitable conduct, claiming that Pfizer had withheld information from the US Patent and Trademark Office when obtaining the patent protection. It also argued that the patents were unenforceable on the grounds of anticipation, obviousness and/or double patenting. These failed and Pfizer’s US monopoly continues.

The UK case - Pfizer’s UK patents will also expire in 2011 and 2010. In this case, Ranbaxy asked the court to state that it did not infringe one of Pfizer’s patents and that the other patent was invalid. Unlike the US position, where there is a presumption that a granted patent is valid, there is no such presumption in the UK. The court will look at whether the invention was patentable; this includes whether it was new and not obvious. Ranbaxy tried to argue that it did not infringe the claims of the master UK patent because they only covered the racemic mixture for the enantiomers of atorvastatin. Ranbaxy said that it should therefore be free to sell a pharmaceutical composition, which only contained one of them. The English court did not agree with this argument and held that the patent claims covered both the racemic mixture and the individual enantiomers.

Ranbaxy then sought to revoke the subsidiary patent, which covered the calcium salt of atorvastatin. This was argued both over the disclosure in Pfizer’s master patent and also over the disclosure in a third Pfizer patent application that related to atorvastatin. This third application was filed after the master patent, but before the subsidiary patent.

In Europe, the patent law provides that where an earlier patent application for the same subject matter has been filed, then it can be used to assess the novelty of a later patent application, even when the earlier application has not been published by the time the later patent application was filed. This applies whether the earlier unpublished patent application is filed by the same inventors or by unrelated inventors. There is no grace period and the chance of self-collision exists. The purpose is to stop the same invention from being patented twice. However, in practice, as long as one can make a difference between the two documents, however slight, the second patent can be granted. The analysis is strictly on novelty and not on how obvious it would be to adapt the earlier invention.

Ranbaxy relied on this to invalidate the subsidiary patent for the calcium salt. They also successfully relied on the fact that this would be an obvious modification of the master patent. Pfizer, predictably, are appealing.

Other jurisdictions - Proceedings have also been taking place on the same patents in at least Norway, Austria and Ireland. The Norwegian courts upheld Pfizer’s patents, but in Austria one patent was overturned. b. Patent Term Extension

 To make up for the time lost in approval  To make up for time lost in prosecution  FDA decides regulatory delay and PTO decides term extension.  Patent Term Restoration- maximum five years  Total extension (Patent term remaining upon approval + restoration =14 years or less.  Under 35 U.S.C. §156 must claim a product, or a method of manufacturing or using a product  A “drug product” means the active ingredient found in the final dosage form prior to administration of the product to the patient  A patent that claimed a metabolite of an approved drug was held not to claim the approved drug, even though the court recognized that use or sale of the metabolite would have infringed the patent claiming the approved drug product- Hoechst- Roussel Pharmaceuticals Inc. v. Lehman, 109 F.3d 756, 759 (Fed. Cir. 1997  A patent is only eligible for one term extension, so term extension is effectively available for only one product per patent  The product must have been subject to regulatory review before its commercial marketing or use, and the resulting permission for commercial marketing or use must be the first granted  A patent can be extended only once  Patent must claim the active ingredient of the approved product  One extension per regulatory review period  Extension only applicable to the approved product, not all the claims of the patent C. Markush Structures

Mainly used in chemistry, a Markush claim or structure is a claim with multiple "functionally equivalent" chemical entities allowed in one or more parts of the compound. According to "Patent Law for the Nonlawyer" (Burton A. Amernick; 2nd edition, 1991),

"In claims that recite... components of compositions, it is sometimes important to claim, as alternatives, a group of constituents that are considered equivalent for the purposes of the invention.... It has been permissible to claim such an artificial group, referred to as a 'Markush Group,' ever since the inventor in the first case... won the right to do so."

If a compound being patented includes several Markush groups, the number of possible compounds it covers could be vast. No patent databases generate all possible permutations and index them separately. Patent searchers have the problem, when searching for specific chemicals in patents, of trying to find all patents with Markush structures that would include their chemicals, even though these patents' indexing would not include the suitable specific compounds. This is where databases that permit searching of chemical substructures are indispensable.

Markush claims were named after Eugene Markush, the first inventor to use them successfully in a U.S. patent, in the 1920s

d. ANDA and certifications.

An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public. Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). Using bioequivalence as the basis for approving generic copies of drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Waxman-Hatch Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.

The different certifications of ANDA include:

1. Paragraph I - that the required patent information relating to such patent has not been filed; 2. Paragraph II - that such patent has expired; 3. Paragraph III - that the patent will expire on a particular date; 4. Paragraph IV - that such patent is invalid or will not be infringed by the drug, for which approval is being sought.

For Paragraphs I or II the statute provides that the FDA may approve the ANDA effective immediately and for Paragraph III the FDA may approve the ANDA effective on the date that the applicant certifies that the patent will expire while for Paragraph IV the statute begins by providing a forty-five-day window during which the patent-holder may bring suit against the applicant. If the patent-holder brings suit during that forty-five-day period - the statute says that the FDA's approval of the ANDA must be delayed for thirty months. Provision that is intended to allow the patent-holder time to vindicate its patent in court. If the court finds that the patent is invalid or is not infringed, the FDA's approval becomes effective as of the date of that ruling.

E. Double Patenting

A double patenting issue may arise between two or more pending applications, between one or more pending applications and a patent, or in a reexamination proceeding. Double patenting does not relate to international applications which have not yet entered the national stage in the United States.

A. Between Issued Patent and One or More Applications Double patenting may exist between an issued patent and an application filed by the same inventive entity, or by an inventive entity having a common inventor with the patent, and/or by the owner of the patent. Since the inventor/patent owner has already secured the issuance of a first patent, the examiner must determine whether the grant of a second patent would give rise to an unjustified extension of the rights granted in the first patent.

B. Between Copending Applications-Provisional Rejections

Occasionally, the examiner becomes aware of two copending applications filed by the same inventive entity, or by different inventive entities having a common inventor, and/or that are filed by a common assignee that would raise an issue of double patenting if one of the applications became a patent. Where this issue can be addressed without violating the confidential status of applications (35 U.S.C. 122), the courts have sanctioned the practice of making applicant aware of the potential double patenting problem if one of the applications became a patent by permitting the examiner to make a "provisional" rejection on the ground of double patenting. In re Mott, 539 F.2d 1291, 190 USPQ 536 (CCPA 1976); In re Wetterau, 356 F.2d 556, 148 USPQ 499 (CCPA 1966). The merits of such a provisional rejection can be addressed by both the applicant and the examiner without waiting for the first patent to issue.

The "provisional" double patenting rejection should continue to be made by the examiner in each application as long as there are conflicting claims in more than one application unless that "provisional" double patenting rejection is the only rejection remaining in one of the applications. If the "provisional" double patenting rejection in one application is the only rejection remaining in that application, the examiner should then withdraw that rejection and permit the application to issue as a patent, thereby converting the "provisional" double patenting rejection in the other application(s) into a double patenting rejection at the time the one application issues as a patent.

If the "provisional" double patenting rejections in both applications are the only rejections remaining in those applications, the examiner should then withdraw that rejection in one of the applications (e.g., the application with the earlier filing date) and permit the application to issue as a patent. The examiner should maintain the double patenting rejection in the other application as a "provisional" double patenting rejection which will be converted into a double patenting rejection when the one application issues as a patent.

Case Illustration

• Eli Lily lost patent protection over it’s blockbuster drug prozac after the federal circuit court of appeals invalidated its patent covering a method of using fluoxitine for treating depression on the grounds of double patenting over Lily’s own earlier patent claiming a method of using fluoxitine for inhibiting seratonin re-uptake 4. a) Does Lucy have an invention? b) Can she get a patent entitled "Anti-eating Face Mask"? What are your suggestions on protecting the brand name "Anti-eating Face Mask"? c) Discuss the novelty, non-obviousness and utility of proposed invention’s claims. d) Will you advice the client to file a patent application? Why? e) Draft a set of claims for the proposed patent application.

4a) Lucy definitely has an invention as disclosed by her. She can get a patent for the instant invention as he satisfies all the needs for an invention to be patentable.

4b) The title "Anti-eating Face Mask" may be apt as it clearly defines and describes the invention and worth trying.

A trademark registration for "Anti-eating Face Mask" should be sought for with the help of an appropriate brand name to distinguish the goods or services offered by Lucy from those offered by another. Moreover, since "Anti-eating Face Mask" is not distinctive and deceptive – it is not a good choice – an alternative and appropriate name should be seeked.

4c) Lucy’ disclosure about their invention satisfy all the needs for a patent. Novelty – The invention "Anti-eating Face Mask" is unique and novel. No indication is available for any such report in prior-art.

Non-obviousness - The invention "Anti-eating Face Mask" is not obvious and has a definite inventive step. The invention can’t be anticipated from prior-art and is not in public domain.

Utility - The invention "Anti-eating Face Mask" has a wide utility and industrial applicability.

Obesity is a basic problem with which many people today are confronted and, as clearly indicated by the variety of diets proposed to conquer overweight, the major contributing factor to overweight is the excessive consumption of food. The temptation to eat which leads one to eat excessively is ever present and the ready availability of attractively prepared, taste-tempting foods makes the temptation to eat and therefore to overeat virtually irresistible. Frequently, this temptation is so great that compulsive eating is not uncommon and many persons are virtually without the strength of will to resist overeating. The average person, therefore, does have a problem as to the over consumption of food but, even worse, when certain individuals are exposed to food constantly such as chefs, cooks, restaurant personnel or the like, it is a foregone conclusion that these individuals will consume far more food than is proper particularly when such food is usually readily available at no cost. During the preparation of such meals not only is there the temptation to nibble on the food being prepared but it is generally necessary that the food be tasted during preparation thereby constantly stimulating the appetite and promoting the consumption of large quantities of food.

4d) Lucy definitely has an invention which she should protect. The only way to protect the invention will be by applying for a patent, prosecuting it through and having it granted in all geographical territories where he visualizes a commercial interest. She can also choose to file a PCT application designating all states and later choosing his counties of interest during National Phase to delay his decision and expense.

4e) I Claim: 1. A face mask for preventing the introduction of substances into the mouth of the wearer comprising in combination; a cup shaped member conforming generally to the shape of the mouth and chin area of the wearer's face below the nose, said cup shaped member formed of rigid material with openings to allow breathing therethrough, means for mounting said cup shaped member over the mouth including plural straps extending from said cup over the head of the wearer, one of said straps provided with a means for separation to allow for placement and removal of said face mask, and a lock at said separation means to prevent removal of said face mask, said mounting means further including a hoop member of rigid material adapted to extend over the user's head and chin and a flexible strap having end portions connected to said hoop member for extending around the back of the user's head and a strap member adapted to extend over the top of the user's head, said strap member being connected at opposite ends to said hoop member and to said strap intermediate the ends of said strap, said separation means including a staple adjacent one end portion of said strap, and an aperture in said strap one end portion in longitudinally spaced relationship with said staple, said strap one end portion arranged to be looped around said hoop member for insertion of said staple in said aperture and said lock engageable with said staple extending through said aperture for locking said strap one end portion to said hoop member, wherein said hoop member is attached to said cup shaped member by plural rods extending there between, two of said rods attached to opposed sides of said cup shaped member, a third said rod attached to a lowermost portion of said hoop member. 2. A face mask in accordance with claim 1 wherein said cup-shaped member comprises a screen formed of a plurality of wires, said wires in said screen defining said openings there between.

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