Claims

1.  
   In a patent or patent application, the claimsdefine, in technical terms, the extent, i.e. the scope, of the protection conferred by a patent, or the protection sought in a patentapplication. The claims are of the utmost importance both during prosecution and litigation alike. For instance, a claim could read:
   EXAMPLE

define the invention and are what aspects are legally enforceable. 

The specification must conclude with a claim particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention or discovery. The claim or claims must conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable (clearly understood ) by reference to the description. (See 37 CFR § 1.58(a)).

-- see MPEP 608.01(i) for more

608    Disclosure [R-11.2013]

To obtain a valid patent, a patent application as filed must contain a full and clear disclosure of the invention in the manner prescribed by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. The requirement for an adequate disclosure ensures that the public receives something in return for the exclusionary rights that are granted to the inventor by a patent. All amendments and claims must find descriptive basis in the original disclosure.No new matter may be introduced into an application after its filing date. Applicant may rely for disclosure upon the specification with original claims and drawings, as filed. See also 37 CFR 1.121(f) and MPEP § 608.04.

In a patent or patent application, the claims define, in technical terms, the extent, i.e. the scope, of the protection conferred by a patent, or the protection sought in a patent application. The claims are of the utmost importance both during prosecution and litigation alike.

For instance, a claim could read:

• "An apparatus for catching mice, said apparatus comprising a base, a spring member coupled to the base, and ..."
• "A chemical composition for cleaning windows, said composition substantially consisting of 10–15% ammonia, ..."
• "Method for computing future life expectancies, said method comprising gathering data including X, Y, Z, analyzing the data, comparing the analyzed data results..."

Background

In most jurisdictions, a patent is a right to exclude others from making, using, importing, selling or offering for sale the subject matter defined by the claims when the claim is for a thing (apparatus, composition of matter, system, etc.). If a claim is for a method, the right to exclude would be to exclude any single party from carrying out all the steps of the claim. In order to exclude someone from using a patented invention, the patent owner, or patentee, needs to demonstrate in a court proceeding that what the other person is using falls within the scope of a claim of the patent; therefore, it is more valuable to obtain claims that include the minimal set of limitations that differentiate an invention over what came before (i.e., the so-called prior art). But the fewer the limitations in a claim, the more likely it is that the claim will cover, or "read on," what came before and be rejected during examination or found to be invalid at a later time for lack of novelty or obviousness.

History

Patents have not always contained claims. In many European countries, patents did not contain claims before the 1970s. It was then often difficult to decide whether a product infringed a patent, since the sole basis to know the extent of protection was the description, in view of the prior art. Claims have been necessary parts of U.S. patent applications since the enactment of the Patent Act of 1836.^[1]

However, even among patent legal systems in which the claims are used as the reference to decide the scope of protection conferred by a patent, the way the claims are used may vary substantially. Traditionally, two types of claiming system exist:

• the "central claiming system", according to which the claims identify the "centre" of the patented invention. The exact scope of the protection depends on the actual nature of the inventor’s contribution to the art in the concerned technology.
• the "peripheral claiming system", according to which the claims identify the exact periphery, or boundary, of the conferred protection. In this system, the burden of drafting good claims is much higher on the patent applicant (or on his counsel). The applicant receives the protection he or she requested and almost nothing more, provided that the invention is new and non-obvious. This theoretically makes it easier for third parties to examine whether infringement may exist or not.

No patent system today is a purely either central or peripheral, but the system used in Germany and most of the other countries of continental Europe is considered more central than the system currently used in the United Kingdom, the United States, and especially Japan, which are more peripheral.^{[citation needed]} In recent years, Japan's system has become more peripheral,^[2] while the system used in the United States has become less peripheral.^{[3][dubious – discuss]}

Requirements and structure

In most modern patent laws, patent applications must have at least one claim, which are critical defining elements of the patent and the primary subject of examination. In some patent laws however, a date of filing may be obtained for an application which does not contain any claim.^[4]

European Patent Convention

Main article: Claims under the European Patent Convention

Under the European Patent Convention (EPC), a claim must define the matter for which the protection is sought in terms of technical features.^[5] These technical features can be either structural (e.g. a nail, a rivet) or functional (e.g. fastening means).^[6]

Regarding the structure of a claim, under the European Patent Convention, what is called the "preamble" is different from the meaning the "preamble" has under U.S. patent law. In an independent claim in Europe, the preamble is everything which precedes the expression "characterized in that" or "characterized by" in a claim written according to the so-called "two-part form", and therefore everything which is regarded as known in combination within one prior art document, namely the closest prior art document.^[7] For this reason, in Europe, the preamble of a claim is sometimes also called "pre-characterizing portion".^[8]

United States

A claim may include the following parts:

• A preamble that recites the class of the invention, and optionally its primary properties, purpose, or field: "An apparatus..." "A therapeutic method for treating cancer..." "A composition having an affinity for protein X..." This preamble may also reference another claim and refine it, e.g., "The method of claim 1..." (See "dependent claim" below.).

• A "transitional" phrase that characterizes the elements that follow. The phrases "comprising", "containing" and "including" are most often used and (under some patent laws, specifically US) preferable, as it means "having at least the following elements..." and are therefore open (inclusive) and do not exclude additional limitations. The phrases "consisting of" and "consisting essentially of" are (under some patent laws, specifically US) more limiting, as they mean "having all and only" or "virtually only" and are therefore closed (exclusive). In the US, the phrase "consisting of" excludes additional limitations, while the phrase "consisting essentially of" excludes additional limitations that would "materially affect the basic and novel characteristic(s) of the claimed invention".^[9]

• A set of "limitations" that together describe the invention: "an X, a Y, and a Z connected to the X and the Y." The elements should be described as though they interact or cooperate to achieve the desired result.^[10] The distinction between elements and limitations is explained in the article All elements test.

• Optionally, a purpose clause that further describes the overall operation of the invention, or the goal that the invention achieves ("wherein the Z simultaneously controls the X and Y," or "wherein the Z accomplishes purpose W by controlling X and Y," etc.) 
•  
•  
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Interpretation or claim construction

The claims often use precise language. Certain words commonly used in claims have specific legal meanings determined by one or more court decisions. These meanings may be different from common usage. For instance, the word "comprises", when used in the claims of a United States patent, means "consists at least of". By contrast, the word "consists" means "consists only of", which will lead to a very different scope of protection.

Furthermore, in U.S. patent practice at least, inventors may "act as their own lexicographer" in a patent application. That means that an inventor may give a common word or phrase a meaning that is very specific and different from the normal definition of said word or phrase. Thus a claim must be interpreted in light of the definitions provided in the specification of a patent. The specification of a patent is a written description of how to make and use the invention (see also: sufficiency of disclosure). In U.S. law, a claim is interpreted in a Markman hearing. The Public Patent Foundation has constructed Free Claim Construction Dictionaries.

Construction, whether of a patent or any other document, is of course not directly concerned with what the author meant to say. There is no window into the mind of the patentee or the author of any other document. Construction is objective in the sense that it is concerned with what a reasonable person to whom the utterance was addressed would have understood the author to be using the words to mean. Notice, however, that it is not, as is sometimes said, "the meaning of the words the author used", but rather what the notional addressee would have understood the author to mean by using those words. The meaning of words is a matter of convention, governed by rules, which can be found in dictionaries and grammars. What the author would have been understood to mean by using those words is not simply a matter of rules. It is highly sensitive to the context of and background to the particular utterance. It depends not only upon the words the author has chosen but also upon the identity of the audience he is taken to have been addressing and the knowledge and assumptions which one attributes to that audience.^[11]

Basic types and categories

There are two basic types of claims:

• the independent claims, which stand on their own, and
• the dependent claims, which depend on a single claim or on several claims and generally express particular embodiments as fall-back positions.

The expressions "in one embodiment", "in a preferred embodiment", "in a particular embodiment", "in an advantageous embodiment" or the like often appear in the description of patent applications and are used to introduce a particular implementation or method of carrying out the invention.^[12] These various embodiments may or may not each be claimed with specificity. They might serve as multiple examples of a more general "genus" that is claimed. In some cases the examiner might declare that what the applicant presented as variations of one invention are actually separate inventions that need to be examined individually.

An independent ("stand alone") claim does not refer to an earlier claim, whereas a dependent claim does refer to an earlier claim, assumes all of the limitations of that claim and then adds restrictions (e.g. "The handle of claim 2 where it is hinged.") Each dependent claim is, by law, more narrow than the independent claim upon which it depends. Although this results in coverage more narrow than provided by the independent claim upon which the second claim depends, it is additional coverage, and there are many advantages to the patent applicant in submitting and obtaining a full suite of dependent claims:

• Clarification of the independent claim language: Independent claims are typically written with very broad terms, to avoid permitting competitors to circumvent the claim by altering some aspect of the basic design. But when a broad wording is used, it may raise a question as to the scope of the term itself. For example, does a "base" include a "set of legs"? A dependent claim, including the phrase, "wherein said base comprises a set of legs," if allowed by the patent examiner, clarifies that the word base in the independent claim does not necessarily include legs. This is by the logic of claim differentiation. In the U.S, at least, each claim in an issued patent is presumed to cover different territory than any other claim. If in claim 2 the base must include legs, then the wording of claim 1 must not be taken as requiring the base to include legs. In practice, dependent claims are often used to home in on the inventor's preferred embodiment of the invention (e.g., the actual product design that the inventor intends to use.) The independent claim broadly describes the invention; dependent claim #1 describes the invention in a narrower aspect that more specifically describes the preferred embodiment; dependent claim #2 is narrower still; etc.

• Possible invalidity of base claim: It is impossible to know, when beginning the application process and even at the time of patent issuance, if a patent claim is valid. This is because any publication dated before the application's priority date and published anywhere in any language can invalidate the claim (excluding publications by the inventor published during the grace period in certain countries such as U.S., Canada and Japan). Furthermore, even applications that were not yet published at the time of filling, but have a priority date prior to the priority date of the application, can also invalidate the claim. As it is impossible to gain an absolute and complete knowledge of every publication on earth, not to mention unpublished patent applications, there is always some degree of uncertainty. If the independent claim is determined to be invalid, however, a dependent claim may nevertheless survive, and may still be broad enough to bar competitors from valuable commercial territory.

• Claim differentiation: In United States patent law, under the doctrine of claim differentiation, each claim is presumed to cover a different aspect of the invention than in each other claim. This doctrine may be relied upon to help maintain broad claim scope in the case where a claim standing alone might be construed as having either a broad or a narrow interpretation. If a dependent claim is added that depends from this "parent" claim but is specifically drawn to the narrower interpretation, then the parent claim must necessarily be different - i.e., it must be the broader interpretation.^{[citation needed]} As construed in the courts, the doctrine of claim differentiation dictates that it "is improper for courts to read into an independent claim a limitation explicitly set forth in another claim."Environmental Designs Ltd. v. Union Oil Co. of California, 713 F.2d 693, 699 (Fed. Cir. 1984). This means that if an independent claim recites a chair with a plurality of legs, and a dependent claim depending from the independent recites a chair with 4 legs, the independent claim is not limited to what is recited in the dependent claim. The dependent claim protects chairs with 4 legs, and the independent claim protects chairs with 4 legs as well as chairs having 2, 3, 5 or more legs.

Under the European Patent Convention, when a claim in one particular category (see below), e.g. a process claim, depends on a claim from a different category, e.g. a product claim, it is not considered to be a dependent claim but an independent claim. Under U.S. law, this is still counted as a dependent claim, regardless of the class change.^{[citation needed]}

The rules of claim drafting also permit "multiple dependent claims" that reference more than one other claim, e.g.: "3. Method of claim 1 or 2, further comprising..." The rules for this are quite specific: specific claims must be referenced ("the method of any of these other claims" is incorrect); the claims must be referenced in the alternative ("the method of claims 1 and 2" is incorrect); etc. While still acceptable, this claim style is seldom used in the U.S. because it is counted for filing fee purposes according to the number of claims that it references. Thus, if the claim depends from three former claims, it is counted for fee purposes as three dependent claims. In light of the "excess claim" fees currently imposed by the USPTO, this tactic can quickly become expensive. Multiple dependent claims are, however, very commonly used in other jurisdictions, including Canada and Europe.^[13][14]

Claims can also be classified in categories, i.e. in terms of what they claim. A claim can refer to

• a physical entity, i.e. a product (or material) or an apparatus (or device, system, article, ...). The claim is then called respectively "product claim" or "apparatus claim"; or
• an activity, i.e. a process (or method) or a use. The claim is then called respectively "process claim" (or method claim) or "use claim".

Special types of claims

Main article: List of patent claim types

In addition to the above basic claim types, there are also many special types of claim which are used in different circumstances. Sometimes a particular claim form is required by law if a patent is to be granted for a particular invention, such as for a second medical use of a known substance where the "Swiss-type" claim might be required. Another reason to use a particular claim might be to catch a particular class of infringer.

See also

• Catnic Components Ltd. v. Hill & Smith Ltd. (1982)
• Claims under the European Patent Convention
• Clearance search and opinion
• Disclaimer
• Doctrine of equivalents
• Probatio diabolica, in relation to product-by-process claims

References

1. Jump up^ Patent Act of 1836, Ch. 357, 5 Stat. 117 (July 4, 1836)
2. Jump up^ See Decision of Supreme Court of Japan (Saikou Saibansho), February 24, 1998 Case No. Heisei 6 (o) 10831No. Heisei 6 (o) 1083, first recognizing the doctrine of equivalents.
3. Jump up^ See Warner-Jenkinson v. Hilton Davis, 520 U.S. 17 (Fed. Cir. 1997) (restricting the scope of the doctrine of equivalents.)
4. Jump up^ See for instance Article 11(1) PCT.
5. Jump up^ Article 84 EPC, Rule 43(1) EPC
6. Jump up^ Guidelines for Examination in the EPO, section f.iv.2.1 : "Technical features."
7. Jump up^ Rule 43(1) EPC (previously Rule 29(1) EPC 1973) and, for instance, EPO board of appeal Decision T 13/84, Headnote 1.
8. Jump up^ See for instance "The pre-characterising portion of the claim is based on..." in Decision T 0443/11 of 30 January 2012, item 2.1.
9. Jump up^ USPTO MPEP 2111.03
10. Jump up^ Google Books Jeffrey G. Sheldon, How To Write a Patent Application sec. 6.3.5.3 (1992); see American Choc. Mach. Co. v. Helmstetter, 142 Fed. 978, 980 (2d Cir. 1905) ("The distinction between a combination and an aggregation lies in the presence or absence of mutuality of action. To constitute a combination it is essential that there should be some joint operation performed by its elements, producing a result due to their joint and co-operating action, while in an aggregation there is a mere adding together of separate contributions, each operating independently of the other. Defendant's machine comprises merely an aggregation of two devices. There is no mechanical or functional mutuality of operation. It is not a combination because there is no co-operation between the coating and jarring mechanisms, because the two devices do not unitedly perform their functions, and because they are not necessarily combined in one machine, and do not act together to secure the final result.") (citations omitted).
11. Jump up^ UK House of Lords, Kirin-Amgen Inc & Ors v Hoechst Marion Roussel Ltd & Ors [2004] UKHL 46 (21 October 2004) (paragraph 32)
12. Jump up^ "embodiment = a specific, disclosed example of how an inventive concept, that is more generally stated elsewhere in the disclosure, can be put into practice." in WIPO,International patent classification (Version 2009), Guide, page 33.
13. Jump up^ Rule 43(4) EPC
14. Jump up^ Guidelines for Examination in the EPO, section f.iv.3.4 : "Independent and dependent claims": "(...) a dependent claim may refer back to one or more independent claims, to one or more dependent claims, or to both independent and dependent claims."

Further reading

• The construction of product-by-process claims, 11th European Patent Judges' Symposium, Copenhagen, Official Journal of the EPO 2003, Special Edition, No. 2, p. 20-75 (pdf)

External links

• European Patent Convention
  • Article 69 EPC defining the extent of protection
  • EPC Protocol on the Interpretation of Article 69 EPC
  • Article 84 EPC defining the role of claims
  • Rule 43 EPC (previously Rule 29 EPC 1973) expressing the legal requirements regarding the form and content of the claims
• US patent law (Title 35 of the US Code)
  • 35 USC § 101 patentable subject matter
  • 35 USC § 112 specification and claims
• Studies on patent claims
  • When small is beautiful: measuring the evolution and consequences of the voluminosity of patent applications at the EPO This paper addresses issues in measuring the voluminosity of patent applications (number of claims and pages) and highlights patterns in its evolution.

REF http://www.uspto.gov/main/glossary/index.html

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Firmenich's New Enantioselective Synthesis of (-)-beta-Santalol

...

Charles Fehr and co-workers at Firmenich have designed the "right cat for the desired odor". In WIPO Patent Application WO/2009/141781 (November 26, 2009), they disclose a novel, and seemingly practical, approach to the synthesis of beta-Santalol (the Golden Grail of Sandalwood odor). 

See also - Charles Fehr, Iris Magpantay, Jeremy Arpagaus, Xavier Marquet, Magali Vuagnoux, Enantioselective Synthesis of (-)-beta-Santalol by a Copper-Catalyzed Enynol Cyclization-Fragmentation Reaction, Angewandte Chemie, Volume 121, Issue 39, Date: September 14, 2009, Pages: 7357-7359

β-Santalol is an organic compound that is classified as a sesquiterpene. It comprises about 20% of the oil of sandalwood, the major component being α-santalol. As of 2002, about 60 tons of sandalwood oil are produced annually by steam distillation of the heartwood of Santalum album.^[1]

References

1. Karl-Georg Fahlbusch, Franz-Josef Hammerschmidt, Johannes Panten, Wilhelm Pickenhagen, Dietmar Schatkowski, Kurt Bauer, Dorothea Garbe, Horst Surburg "Flavors and Fragrances" in Ullmann's Encyclopedia of Industrial Chemistry, Wiley-VCH, Weinheim: 2002. Published online: 15 January 2003; doi:10.1002/14356007.a11_141.

Out of the woods 

Woody fragrances such as Iso E Super, a compound known as a 'floraliser' and used in most new fine fragrances, also rate highly, says Gautier. Some people smell a cedarwood note in Iso E Super, while others perceive it to be musky. The male fragrance Fahrenheit  (Dior, 1988) is 25 per cent Iso E Super while Perles de lalique  (Lalique, 2007) is 80 per cent Iso E Super. The commercial Iso E Super owes its woody smell to a 5 per cent impurity which has an odour threshold about 100 000 times lower than that of the main product.  

Alpha- (top) and beta-santalol are constituents of the prized East Indian sandalwood oil

In 1999, Kraft's team at Givaudan isolated this impurity by epoxidation of a commercial Iso E Super and proposed a structure based on NMR spectra. The team came up with a way to synthesise the compound but it was not commercially viable and the structure turned out to be too complex for an alternative synthetic procedure. But out of several synthesised analogues, one had an almost equal odour threshold and smelled even better. What is more, its industrial synthesis is straightforward and it has become a big hit - used by Givaudan as the captive material Georgywood. 

However, on strictly cash terms, the most valuable fragrances are the natural products. For example, East Indian sandalwood oil is one of the most precious and expensive perfumery raw materials.  

Beta-santalol is the main olfactory constituent of sandalwood oil. It wasn't until 1990 that beta-santalol could be prepared in the lab - this took an 11-step reaction that was unsuitable for industrial scale-up. The best sandalwood oil substitutes are derivatives of alpha-campholenic aldehyde, prepared from inexpensive alpha-pinene, most of which is a byproduct of the paper industry.  

'The components in sandalwood oil are not easy to make,' acknowledges Gautier. 'But what Firmenich has done is screened all around that kind of structure to try to find woody notes. We have a lot of substitutes so that perfumers can create something close to sandalwood without needing sandalwood oil.' Kraft agrees that there are 'excellent synthetic substitutes' out there. For example, the campholenic aldehyde derivatives typically have a good sandalwood smell. 'The other olfactory parts of natural sandalwood oil - such as the smokey, cedar-like aspects - can easily be added using, for example, cedarwood oil,' says Kraft. 

Sandalwood was initially quite cheap (Guerlain's Samsara  contained 25 per cent sandalwood) but overharvesting has led to Indian sandalwood trees being listed on the World Conservation Union's threatened species red list. 

'There's still a good market for sandalwood oil and the price has gone, in the past six or seven years, from $1000 [£680] per kg to over $2000,' says Leffingwell. One Australian firm, TFS Corporation, has taken the initiative and planted over 1700 hectares of the endangered Indian sandalwood (Santalum album  ) in plantations in Western Australia.

http://www.google.com/patents/WO2009141781A1?cl=en

A) Preparation of β-santalol (via Wittig and hydroxyalkylation reaction)
A solution of butyllithium in hexanes (1.35 M, 11.7 ml, 15.8 mmol) was added over a 15 minutes period to a stirred suspension of ethyltriphenylphosphonium iodide (6.61g, 15.8 mmol) in THF (125 ml) at 0⁰C. The resultant red solution was cooled to -78°C and 3-(2-methyl-3-methylene-bicyclo[2.2.1]hept-2-exo-yl)-propanal (2.55 g, 14.33 mmol) in solution in THF (16 ml) was added over a 15 minutes period. After further 5 minutes at -78°C, a solution of butyllithium in hexanes (1.35 M, 12.7 mL, 17.2 mmol) was added over a 5 minutes period and the mixture was further stirred for 20 minutes at -78°C before allowing to reach 0⁰C in 2 hours. Dry paraformaldehyde (2.60 g, 86.0 mmol) was added in one portion to the deep red homogeneous solution and the mixture was stirred for 30 minutes at 0⁰C and was allowed to reach room temperature. After 1 hour at room temperature the mixture was poured into 5.2 ml of saturated aqueous solution of NH₄Cl and extracted twice with CH₂Cl₂. The organic layer was washed with water and brine, and dried with Na₂SO₄. The mixture was filtered through a short pad of silica gel with dichloromethane as eluent and solvents were removed under pressure to give a crude. Purification of crude compound was performed by flash chromatography on silica gel with cyclohexane/AcOEt 90/10) as eluent to give pure β-santalol as pale yellow oil. Further bulb to bulb distillation under reduced pressure afforded β-santalol in 50% yield (Z:E=95:5). 1H NMR (CDCl₃, 400 MHz): 5.29 (t, J=7.5, IH), 4.73 (s, IH), 4.45 (s, IH), 4.14 (s, 2H), 2.66 (d, J=3.8, IH), 2.12-1.94 (m, 3H), 1.78 (d, J=I.2, 3H), 1.71-1.60 (m, 3H),
1.44-1.36 (m, 2H), 1.32 (br s, IH), 1.27-1.17 (m,3H), 1.04 (s, 3H). ¹³C NMR (CDCl₃, 125 MHz): 166.2, 133.9, 129.0, 99.7, 61.6, 46.8, 44.7, 44.6, 41.5, 37.1, 29.7, 23.7, 23.2, 22.6, 21.2.
B) Preparation of β-santalol (via [1,4] hydrogenation) i) Preparation of a compound (V): 2-methyl-5-(2-methyl-3-methylene-bicyclo[2.2.1] hept-exo-2-yl)-pent-2-enal
3-(2-Methyl-3-methylene-bicyclo[2.2.1]hept-2-exo-yl)-propan-l-al (274.0 mg,
1.54 mmol) was dissolved in toluene (15.0 ml) at room temperature under nitrogen. The mixture was heated to reflux and propionaldehyde (0.4 ml, 1.96 mmol) and aqueous catalytic solution of hexamethyleneimine and benzoic acid (0.12 ml, 0.616 mmol) was separately added in one portion. Once that addition was finished, the mixture was further heated at reflux for 6 hours. The mixture was cooled down to room temperature and extracted twice with brine, the organic layer was dried over MgSθ₂, filtered off and concentrated to give a crude which was further purified by flash chromatography with cyclohexane/ AcOEt (95/5) to afford the title compound in 80% yield.
¹H NMR: 9.38 (s, IH), 6.48 (dt, J¹=?^, J²=1.2, IH), 4.78 (s, IH), 4.49 (s, IH), 2.69 (d, J=3.9, IH), 2.40-2.29 (m, 2H), 2.12 (d, J=3.1, IH), 1.75 (s, 3H), 1.72-1.64 (m, 3H), 1.59-1.51 (m, IH), 1.47-1.36 (m, 2H), 130-1.21 (m, 2H), 1.09 (s, 3H). ¹³C NMR: 195.2, 165.5, 155.2, 139.1, 100.3, 46.8, 44.8, 44.7, 39.4, 37.1 , 29.6, 24.9, 23.7, 22.6, 9.1.
H) Preparation of a compound (IV): Acetic acid 2-methyl-5-(2-methyl-3-methylene- bicyclo[2.2.1]hept-2-exo-yl)-penta-l,3-dienyl ester To a stirred solution of 2-methyl-5-(2-methyl-3-methylene-bicyclo[2.2.1]hept-2-yl)- pent-2-enal (268.0 mg, 1.23 mmol) in toluene (3.0 ml) were added Ac₂O (0.35 ml, 3.70 mmol), Et₃N (0.70 ml, 5.02 mmol), and a catalytic amount of DMAP (15.0 mg, 0.1 mmol). The resulting mixture was heated to reflux for 22 hours. The mixture was cooled down to room temperature and quenched with brine, extracted twice with Et₂O, dried over MgSO₄, filtered off and concentrated to give a crude which was further purified by flash chromatography with cyclohexane/AcOEt (98/2) to afford the title compound in 82% yield (E:Z=79:21). ¹H NMR: 7.18 (s, IH), 5.99 (d, J=12.4, IH), 5.72 (dt, i^l=\2A, J²=6.1, IH), 4.76 (s, IH), 4.47 (s, IH), 2.68 (d, 3.4, IH), 2.17 (s, 3H), 2.12-2.01 (m, 2H), 1.81 (d, J=I.0, 3H), 1.73-1.63 (m, 3H), 1.43-1.39 (m, 2H), 1.27-1.18 (m, 2H), 1.02 (s, 3H).
¹³C NMR: 167.9, 165.5, 134.4, 130.6, 126.9, 120.7, 100.0, 46.9, 45.3, 45.0, 44.5, 37.0, 29.7, 23.6, 23.0, 20.8, 10.4.
Hi) Preparation of(2Z)-Acetic acid 2-methyl-5-(2-methyl-3-methylene-bicyclo[2.2.1] hept-2-exo-yl)-pent-2-enyl ester (VII)
Acetic acid 2-methyl-5-(2-methyl-3-methylene-bicyclo[2.2.1]hept-2-exo-yl)-penta-l,3- dienyl ester (6.80 g, 93% pure; 24.3 mmol0.18 mmol) was treated with
[(Cp*)Ru(COD)]BF₄ (52 mg, 0.122 mmol) and maleic acid (230 mg, 1.95 mmol) in dry and degassed acetone (20 ml) at 60⁰C under 4 bars of H₂ for 24 hours. The product was extracted with pentane/5% NaOH, washed twice with saturated aqueous NaCl, dried
(Na₂SO₄) and bulb-to-bulb distilled: 6.80 g (81% Z and 5% E by GC; 92%). 1H NMR: 5.38 (t, J=7.1, IH), 4.73 (s, IH), 4.59 (s, IH), 4.45 (s, IH), 2.66 (br s, IH),
2.12-2.04 (m, 4H), 2.07 (s, 3H), 1.73 (d, J= 1.0, 3H), 1.69-1.61 (m, 3H), 1.45-
1.37 (m, 2H), 1.27-1.17 (m, 3H), 1.04 (m, 3H).
¹³C NMR: 171.1, 166.1, 131.4, 129.4, 99.7, 63.2, 46.8, 44.7, 44.6, 41.2, 37.1, 29.7, 23.7,
23.4, 22.6, 21.5, 21.0.

β-Santalol
IUPAC name[hide] (2Z)-2-Methyl-5-[2-methyl-3-methylene-bicyclo[2.2.1]hept-2-yl]pent-2-en-1-ol
Identifiers
CAS number	77-42-9
EC number	201-027-2
Jmol-3D images	Image 1
SMILES [show]
Properties
Molecular formula	C15H24O
Molar mass	220.35 g mol−1
Appearance	Liquid
Density	0.9717 g/cm3
Boiling point	177 °C (351 °F; 450 K)
Solubility in water	Practically insoluble
Solubility in ethanol	Soluble
Solubility in diethyl ether	Soluble
Chiral rotation ([α]D)	−87.1°
Refractive index (nD)	1.5100
Related compounds
Related terpenes	α-Santalol
Except where noted otherwise, data are given for materials in their standard state (at 25 °C (77 °F), 100 kPa)

................
see
http://pubs.rsc.org/en/content/articlelanding/2014/ob/c3ob42174k#!divAbstract
Biocatalyst mediated regio- and stereo-selective hydroxylation and epoxidation on (Z)-α-santalol were achieved for the first time, using a fungal strain Mucor piriformis. Four novel metabolites were characterized as 10,11-cis-β-epoxy-α-santalol, 5α-hydroxy-(Z)-α-santalol, 10,11-dihydroxy-α-santalol and 5α-hydroxy-10,11-cis-β-epoxy-α-santalol. Using Amano PS lipase from Burkholderia cepacia, α- and β-isomers of 10,11-cis-epoxy-α-santalol were resolved efficiently.

 

Data exclusivity for medicinal products in Europe...8+2+1 approach

Data exclusivity for medicinal products in Europe

The pharmaceutical sector is heavily regulated, with significant costs associated with both developing a new medicinal product and generating the data required to get a product to market. Protecting that data is therefore important.  Data exclusivity is a form of product exclusivity right for medicinal products in Europe, and market exclusivity is a related form of additional protection.

These two rights are in addition to any granted patent exclusivity right covering a medicinal product.

Why is data exclusivity granted?

The rationale for granting data and market exclusivity is to compensate the innovator company for the investment it has put in to developing the new medicinal product and to generating the data required to obtain a marketing authorisation.

Regulatory approval for medicinal products requires applicants to provide information about the efficacy and safety of their product to regulatory authorities. The first applicant for approval of a new medicinal product must provide a substantial body of data relating to the product (including the results of pre-clinical tests and clinical trials).

The regulatory regime permits generic companies, who subsequently wish to gain their own approval for the same drug substance, to rely on information filed by the innovator company that made the first application.  In order to be able to benefit from the data provided by the innovator in their regulatory filings for that medicinal product - the "reference medicinal product" - a generic company must show that their product has the same qualitative and quantitative composition as that product and that it is bioequivalent.

So what is the impact of a product enjoying "data exclusivity"?

An innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company(typically a generic company) for the same drug substance. 

For marketing authorisation applications made from November 2005 onwards, the period of data exclusivity in Europe has been harmonised as 8 years from the date of first authorisation in Europe.  For marketing authorisation applications made before November 2005, the period of data exclusivity varies from EU member state to EU member state, and is either 6 years or 10 years.

For marketing authorisation applications made from November 2005 onwards, there is an additional period of 2 years of "market exclusivity".  This is the period of time during which a generic company may not market an equivalent generic version of the originator's pharmaceutical product (although their application for authorisation may be processed during this period, such that they are in a position to market their product on the expiry of this additional 2 year period).

An extra year of protection for new indications

As noted above, the rules determining exclusivity changed in 2005. Under the "old rules" data exclusivity lasted either 6 or 10 years. The "new rules" follow an "8 + 2 + 1" year approach:

"Under the 'old rules' data exclusivity lasted up to 10 years. The 'new rules' follow an '8 + 2 + 1' year approach."

• During the first 8 years from the grant of the innovator company's marketing authorisation, data exclusivity applies.
• After the 8 years have expired a generic company can make use of the pre-clinical and clinical trial data of the originator in their regulatory applications, but still cannot market their product.
• After a period of 10 years from the grant of the innovator company's marketing authorisation, the generic company can also market their product, unless the innovator product qualifies for a further one year of exclusivity. 
• This additional 1 year may be obtained in a number of circumstances, such as where the innovator company is granted a marketing authorisation for a significant new indication for the relevant medicinal product. In such a situation the generic company can only market their product after 11 years from the grant of the innovator company's marketing authorisation.

How to Calculate Data Exclusivity Periods in Europe 

An application for approval of a New Chemical Entity must contain data to allow assessment of the safety and efficacy profile. These data include pharmacological and toxicological tests and the results of clinical trials. 

To avoid repeating such tests and trials, applications for generic pharmaceutical substances are not required to include these data; instead they may rely on the data provided in relation to the NCE application. However, EC directive 2001/83/EC prevents regulatory authorities from accepting applications for approval of generics that rely on this data until a data exclusivity period has expired. 

This period starts on the day of the first marketing authorisation in the European Community (including Liechtenstein/Switzerland), and expires either six or ten years thereafter, depending on the country in which the application is to be filed and the procedure used to file it. 

Data exclusivity relates to the active ingredient per se, new periods of data exclusivity are not applied to later approval of new dosage forms, routes of administration or indications. 1) To calculate the expiry of the data exclusivity period for centralised applications add 10 years to the corresponding European First Marketing Authorisation Date shown in the Pipeline Selector Report. 2) To calculate the expiry of the data exclusivity period for national or mutual recognition procedure applications, add the term from the following table to the corresponding European First Marketing Authorisation  

Exclusivity .......Period ...........Country 

10 Years 

Belgium (BE) France (FR) Germany (DE) Italy (IT) Luxembourg (LU) Netherlands (NL) Sweden (SE) United Kingdom (UK) 

6 years 

Austria (AT) Denmark (DK) Finland (FI) Greece (GR) Iceland (IS) Ireland (IRL) Norway (NO) Portugal (PT) Spain (ES) Other, acceding countries* 

* Poland has a data exclusivity period of 3 years for approvals prior to 1/5/2004 and 6 years thereafter. Hungary, Slovenia, Slovakia and Malta have requested transitional data exclusivity periods. 

New Data Exclusivity Provisions for Europe A New Data protection directive (2004/27/EC) has been introduced in Europe, which provides eight years of protection from the first European Community marketing authorisation date, after which a European regulatory body may accept an application for approval of a generic. However, the product may not be marketed within ten years of the first European Community marketing authorisation date. An additional one year period of data exclusivity is allowed in respect of new indications with ‘significant clinical benefit’ over the existing indications. Approvals for other product line extensions, including different pharmaceutical forms, are regarded as a bundle of approvals for which only one data exclusivity period is available. This new directive applies only to data relating to NCE products submitted for approval after 31 October 2005, hence do not affect any of the current Pipeline Patent Intelligence products. 

Generic applications in the EU, patents and exclusivity

Types of protection on the originator molecule that have to be taken into account by generic drug manufacturers when filing applications for generic drugs in the EU include the following:

• patents at the time of marketing
• supplementary protection certificates at the time of marketing
• data/regulatory exclusivity at the time of regulatory submission
• market exclusivity at the time of marketing.

Patents

Patents in the EU last for 20 years. Pharmaceutical products are normally covered by a number of patents, sometimes by as many as 30 to 40 patents or more. For pharmaceuticals these patents can be extended with a maximum of five years via a supplementary protection certificate.

Evergreening

A patent on a new use or ‘indication’, formulation, salt or ester can block the registration or marketing of a generic medicine for treatments where the original patent has already expired. This strategy is known as ‘evergreening’ aims to prevent or delay competition from generic medicines by extending market protection through patents on minor changes to the original product.

Data exclusivity

Data exclusivity is a separate and additional provision to patent protection for the originator medicine. With data exclusivity, there can be neither disclosure of regulatory data to a competitor nor regulatory reliance upon the data. Data exclusivity is the period during which no generic drug application can take place.

Therefore, generic medicines can only be evaluated and approved by the medicines regulatory authorities after the data exclusivity period has expired.

In the EU there is now an 8+2(+1) formula for data and marketing exclusivity, which means that originator's data is protected for 8 years and they have marketing exclusivity for a maximum of 11 years from first marketing approval in the EU.

Exclusivity period: 8+2(+1)

The 8+2(+1) exclusivity period came into effect in the EU in late 2005.

8 years data exclusivity dating from the European Commission authorisation decision: before that, no generic applications may be filed.

+2 years marketing protection: no generic applications may be approved.

+1 year: new indication(s) if it constitutes a significant clinical benefit.

It applies for all products, regardless of whether they followed a centralised or national approval procedure.

It is not retroactive; it does not affect exclusivity periods for products for which applications were submitted before the effective date—late 2005.

Market exclusivity

With marketing exclusivity, the agency cannot allow a competing product to enter the market during the time period in which an innovator has a right of exclusivity.

Submission of generic applications is only possible after the expiry of the data exclusivity at year 8. However, there is no linkage of patent protection with registration. Approval of the application and launch of the generic can then take place at year 10 if there is no patent protection, and if there is no additional 1 year of marketing exclusivity due to a significant new indication registered for the reference product during the first 8 years of license, see figure below.

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