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Bearish AMRN Report (part 3): by Medical Research

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Vascepa® Granted Priority Review Status from Health Canada GlobeNewswire Inc. - 3/29/2019 5:45:15 PM
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Bearish AMRN Report (part 3): by Medical Research Collaborative, LLC (sample pages)

https://medicalresearchcollaborative.com/reports?product_id=51



2. The Assailability of Amarin Corp.’s Patent Portfolio


2.1 Obviousness and Prior Art


Title 35 (pre-AIA) of the U.S. Code lists the following as conditions for patentability, giving at the same time a working definition of “prior art” relevant to all patent applications filed before March 16, 2013 (or pre-Sept. 16, 2012 for § 112):

Quote:
35 U.S.C. 101 Inventions patentable.

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

35 U.S.C. 102 (pre-AIA) Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless —

(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or

(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.

35 U.S.C. 103 (pre-AIA) Conditions for patentability; non-obvious subject matter.

(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.

35 U.S.C. 112 (pre-AIA) Specification.

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.



In patent law, “prior art” constitutes all relevant reference materials that can show the claimed invention is not novel or is obvious due to it being publicly knowable or in use more than one year prior to the submitted patent application in which the claims reside. This includes, but is not limited to, published studies as well as prior patent applications—whether assigned or not—that are reasonably accessible.[1] It is essential for a claimed invention to be novel, nonobvious, and “useful” (in this instance meaning usable/executable/functional) for it to be valid/enforceable.[2] And so, it is essential there be no relevant prior art showing a patent claim to be obvious or lacking novelty.

The United States Patent and Trademark Office (USPTO) Guidance details a rejection for obviousness as: “An invention that would have been obvious to a person of ordinary skill at the time of the invention is not patentable.”[3] This “person” is defined as, “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention.” It includes those with a professional degree of knowledge of the subject matter in question. For example, a clinical researcher in the field of gene therapy with a degree of acumen normal for that profession (PhD, involved in multiple studies, etc.), would be a person of ordinary skill in the art of DNA sequencing.

However, USPTO Guidance further clarifies that obviousness can include open-ended concepts:

Quote:
“ ‘The obviousness analysis cannot be confined by overemphasis on the importance of published articles and the explicit content of issued patents. In many fields it may be that there is little discussion of obvious techniques or combinations, and it often may be the case that market demand, rather than scientific literature, will drive design trends.’ [KSR, 550 U.S. at 419, 82 USPQ2d at 1396.]

Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations. However, Office personnel must explain why the difference(S) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art. The “mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness.” Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976). The gap between the prior art and the claimed invention may not be “so great as to render the [claim] nonobvious to one reasonably skilled in the art.”Id. In determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.



And so, a claimed invention (contained in the “Claims” section of the patent application) need not be shown to be explicitly described in the prior art for it to be invalidated—it may also be invalidated if it is shown to be inherently described in the prior art.


2.2 The Doctrine of Inherent Disclosure

Patent law terms a disclosure from a prior art reference an “enabling disclosure” if it can be relied upon by one skilled in the art to anticipate the claimed invention, regardless of the particular source or country of origin.[4]

Quote:
II. WHAT CONSTITUTES AN “ENABLING DISCLOSURE” DOES NOT DEPEND ON THE TYPE OF PRIOR ART THE DISCLOSURE IS CONTAINED IN

The level of disclosure required within a reference to make it an “enabling disclosure” is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. There is no basis in the statute (35 U.S.C. 102 or 103) for discriminating either in favor of or against prior art references on the basis of nationality. In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961).

III. EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENT

A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm.Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). See also MPEP § 2122.



Part 2122 expounds:

Quote:
2122 Discussion of Utility in the Prior Art [R-08.2017]

UTILITY NEED NOT BE DISCLOSED IN REFERENCE

In order to constitute anticipatory prior art, a reference must identically disclose the claimed compound, but no utility need be disclosed by the reference. In re Schoenwald, 964 F.2d 1122, 1124, 22 USPQ2d 1671, 1673 (Fed. Cir. 1992) (The application claimed compounds used in ophthalmic compositions to treat dry eye syndrome. The examiner found a printed publication which disclosed the claimed compound but did not disclose a use for the compound. The court found that the claim was anticipated since the compound and a process of making it was taught by the reference. The court explained that “no utility need be disclosed for a reference to be anticipatory of a claim to an old compound.” It is enough that the claimed compound is taught by the reference.). See also Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (“[P]roof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.”).



A breakdown of the various phrases used to describe types of enabling disclosures in a prior art reference that can invalidate the claims of a patent application[5] are as follows:

Express (Explicit) Obviousness: This is the most apparent and easily identifiable form of enabling disclosure. For example, if a proposed invention claims a compound identical to aspirin in the year 2019, it would be invalidated as obvious due to express disclosures in prior art (many sources and publications describe the use of aspirin and the chemical makeup of aspirin well before 2019). In the sections that follow we show the vast majority of patent claims covering Vascepa to be explicitly disclosed by prior art, serving as the primary basis for our argument against the validity of Amarin’s Orange Book listed patents.

Inherent Obviousness: This type of enabling disclosure is not as directly observable in the prior art, but is implied—in other words, inherently disclosed as obvious. This could entail a scientific principle, or readily assumed result of the combination of two or more things, even if the result of the combination is not explicitly stated in the prior art. However, it cannot be termed “obvious” under § 103 if not known or understood by one of ordinary skill in the prior art at the time of the claimed invention.

Inherent disclosure (for obviousness) may in part be relied upon to refute Amarin’s method of use patent claims, which involve the absorption of eicosapentaenoic acid (EPA) to reduce serum triglyceride levels, something anyone that has ever eaten fish or taken a fish oil supplement has wittingly or unwittingly done. If Amarin were to rebut that their version of EPA is not naturally derived due to the ethyl ester form (which they did not invent), we can show this to be irrelevant, as all forms of fish and fish oil supplements have a meaningful impact on triglycerides, and importantly, ethyl ester EPA has been a known prodrug of EPA since well before the priority date of any of their patents; ethyl-EPA is acted upon by esterases in the small intestine to release free EPA, which is then incorporated into triglycerides, cholesterol esters and phospholipids. Therefore, the consumption of a highly purified ethyl ester EPA product will convert to EPA and only then be absorbed, having a lowering effect on serum TG levels. But it is the EPA itself that is actually having any effect. Thus, the enabling disclosure (“ethyl ester EPA can reduce serum triglyceride levels”) is inherently obvious to one skilled in the art.

Inherent Anticipation: In this instance, the claimed invention is found invalidated by enabling disclosure for “lacking novelty” under § 102 where a prior art reference implies the claimed use or composition, although not expressly stating it, and regardless of the knowledge of one skilled in the art. A prior art reference may inherently anticipate the claim(S) of an invention if it is necessarily present in, or the natural result of, the elements explicitly disclosed in the prior art (though not itself explicitly disclosed). For example, it may be the penultimate step that would naturally result from all prior steps, and that naturally leads to the final step that results in a product or outcome—but was not expressly stated in the literature. This anticipated disclosure invalidates a claim’s patentability for lack of novelty. And once again, it is not required that one of ordinary skill could have recognized the claimed invention (penultimate step, in our example) from the prior art disclosure.[6] That is only a requirement for an “obviousness” rejection under § 103. However, a claim can be rejected as both lacking novelty under § 102 and as obvious under § 103.

USPTO Guidance elaborates on the above, citing numerous examples from case law:

Quote:
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION

There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also:

Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”); …

Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) (“Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known.”);

SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound “inherently” anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound “inherently results in at least trace amounts of” the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate);

In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. “The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable.”)



An amusing example of the above comes from Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. 529 F. Supp. 2d 106 (D. Mass. 2007), in which Ariad was rebuffed by the examiner for trying to claim a use of resveratrol for the regulation of gene expression:[7]

Quote:
In short, any time someone, over the last several hundred or thousand years, drank even a moderate amount of red wine with food containing significant fats (e.g., the typical French diet) they were reducing NF-kB activity (and concomitant NF-kB mediated gene expression) that had been induced by the fat content in the food.



A rejection under inherent anticipation could be applied to Amarin’s patents, finding them wanting for novelty. The simplest of these being that ethyl ester EPA having a triglyceride-lowering effect in human subjects with severe hypertriglyceridemia was anticipated by one or more prior art references (for a novelty rejection, parts of multiple prior art references that form a whole cannot be relied upon; each must be able to stand alone as proof) showing an ethyl ester EPA + DHA formulation to have a dramatic triglyceride-lowering effect in subjects with severe hypertriglyceridemia. Although the isolation and dosing of ethyl ester EPA alone (with very little DHA) having a TG-lowering effect isn’t explicitly shown in such a reference, the TG-lowering effect of its isolated use is inherently anticipated by it, being prominently included in the compound, and thus such a use is lacking novelty.

(Please note that the courts’ definition of what is novel and nonobvious is separate from and more stringent than FDA regulation on what is entitled to 5-year NCE status, where a one-to-one active ingredient to active moiety is required for refusal.[8])

As we will further prove in the sections that follow, there is much compelling evidence that very little that is novel can be claimed from ethyl ester forms of purified fish oil, regardless of the ratio of EPA to other fatty acids contained therein (since the early ‘90s), and regardless of the indications for use (since the mid-late ‘90s).

______________________________________

[1] https://www.uspto.gov/web/offices/pac/mpep/s2128.html

[2] https://www.uspto.gov/patents-getting-started/general-information-concerning-patents

[3] 2141-Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103

[4] 2121-Prior Art; General Level of Operability Required to Make a Prima Facie Case

[5] 2141-Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103

[6] 2112-Requirements of Rejection Based on Inherency; Burden of Proof

[7] https://e-foia.uspto.gov/Foia/RetrievePdf?system=FCA&flNm=08-1248_1

[8] Amarin Pharms Ireland Ltd. v. FDA, 106 F.Supp.3d 196 (Dist. Court, Dist. of Columbia, 2015).





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