35 USC 101, machine-transformation test

Whether a patent claim is directed to statutory subject matter is a question of law that we review de novo. AT&T, 172 F.3d at 1355.

Section 101 provides that:
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 thereof, subject to the conditions and requirements of this title.

35 U.S.C.§101. According to§100(b), "[t]he term 'process' means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or materials." 35 U.S.C.§100(b). But, as noted in In re Bilski, this definition of process is "unhelpful" because the definition itself uses the term "process." 545 F.3d 943, 951 n.3 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1, 2009). Thus, we turn to the case law to guide our understanding of what constitutes statutory subject matter under§101.

The Supreme Court has construed§101 broadly, noting that Congress intended statutory subject matter to "include anything under the sun that is made by man." Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). It is well-established, however, that this sweeping statement does not indicate that§101 is unlimited and embraces every discovery:
[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc; nor could Newton have patented the law of gravity. Such discoveries are "manifestations of . . . nature, free to all men and reserved exclusively to none."
Id. (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)). More specifically, the Court has held that a claim to a process is not patent-eligible if it claims "laws of nature, natural phenomena, and abstract ideas." Diamond v. Diehr, 450 U.S. 175, 185 (1981); see also Gottschalk v. Benson, 409 U.S. 63, 67 (1972) ("Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.").

At the same time, it has also been established that "while a claim drawn to a fundamental principle"--i.e., a law of nature, natural phenomenon, or abstract idea--"is unpatentable, 'an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.'" Bilski, 545 F.3d at 953 (quoting Diehr, 450 U.S. at 187). The key issue for patentability, then, at least on the present facts, is whether a claim is drawn to a fundamental principle or an application of a fundamental principle. Although this inquiry is hardly straightforward, following the Supreme Court, we articulated in Bilski a "definitive test" for determining whether a process is patent-eligible under§101: "A claimed process is surely patent-eligible under§101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." Id. The machine-or-transformation test is a "two-branched inquiry," i.e., the patentee "may show that a process claim satisfies§101 either by showing that his claim is tied to a particular machine, or by showing that his claim transforms an article." Id. at 961.

The machine-or-transformation test has two further aspects: "the use of a specific machine or transformation of an article must impose meaningful limits on the claim's scope to impart patent-eligibility," and "the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity." Bilski, 545 F.3d at 961-62 (citations omitted). "This transformation must be central to the purpose of the claimed process." Id. at 962. Thus, in most cases, one cannot ground the transformative nature of a process in a step that is "insignificant extra-solution activity" or merely a "data-gathering step." See id. at 963 ("Further, the inherent step of gathering data can also fairly be characterized as insignificant extra-solution activity."). In other words, if steps of a method are included for the purpose of data-gathering rather than being "central" to the purpose of the process, the patentee likely cannot rely on the data-gathering steps to prove that the claimed process is transformative and thus drawn to patentable subject matter. See id. at 963 (stating that mere data-gathering will not, "at least in most cases, . . . constitute a transformation of any article").

The Supreme Court has also made clear that the patent eligibility of a claim as a whole should not be based on whether selected limitations constitute patent-eligible subject matter. See Bilski, 545 F.3d at 958 (citing Diehr, 450 U.S. at 188; Parker v. Flook, 437 U.S. 584, 594 (1978)). As noted in Diehr, the Court has specifically stated that it is "inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis." 450 U.S. at 188. Moreover, it is improper to consider whether a claimed element or step in a process is novel or nonobvious, since such considerations are separate requirements set forth in 35 U.S.C.§§102 and 103, respectively. Bilski, 545 F.3d at 958 (citing Diehr, 450 U.S. at 188-91). With this understanding of the present state of the law, we now turn to the parties' arguments in the instant action.

The proper inquiry under §101 is whether these methods meet the Supreme Court's machine or transformation test articulated in Benson and Diehr, and applied in Bilski, and, if so, whether the machine or the transformation is central to the purpose of the claims.

"It is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter." See Bilski, 545 F.3d at 962.

We agree with the district court that the final "wherein" clauses are mental steps and thus not patent-eligible per se. However, although they alone are not patent-eligible, the claims are not simply to the mental steps. A subsequent mental step does not, by itself, negate the transformative nature of prior steps.

As we explained in Bilski,
[I]t is inappropriate to determine the patent eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter. After all, even though a fundamental principle itself is not patent-eligible, processes incorporating a fundamental principle may be patent-eligible. Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under§101.
545 F.3d at 958 (citations omitted). Such is the case here. Although the wherein clauses describe the mental processes used to determine the need to change the dosage levels of the drugs, each asserted claim as a whole is drawn to patentable subject matter.

The claims do not preempt natural processes; they utilize them in a series of specific steps. See Diehr, 450 U.S. at 187 ("Their process admittedly employs a well-known mathematical equation, but they do not seek to preempt the use of that equation. Rather, they seek only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process."). Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle. See Bilski, 545 F.3d at 954 (characterizing the machine-or-transformation test as "a definitive test to determine whether a process is tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself"). The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of transformative steps comprising particular methods of treatment. See id. ("[A] claimed process that transforms a particular article to a specified different state or thing by applying a fundamental principle would not pre-empt the use of the principle to transform any other article, to transform the same article but in a manner not covered by the claim, or to do anything other than transform the specified article."). It is clear that these methods of treatment are§101 patentable subject matter.

2008-1403
PROMETHEUS LABORATORIES, INC.,
Plaintiff-Appellant,
v.
MAYO COLLABORATIVE SERVICES (doing business as Mayo Medical Laboratories) and MAYO CLINIC ROCHESTER,
Defendants-Appellees.

Appeal from the United States District Court for the Southern District of California in Case No. 04-CV-1200, Judge John A. Houston.

DECIDED: September 16, 2009

35 USC 121 (divisionals), double patenting, continuations, continuations-in-part, 35 USC 120 (priority), product-by-process claims, indefiniteness, obviousness, infringement, doctrine of equivalents

Section 121, entitled "Divisional applications," provides in its third sentence:
A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.
35 U.S.C.§121. The third sentence of§121 is a safe harbor provision that protects a divisional application, the original application, or any patent issued on either of them from validity challenges based on a patent issuing on an application subjected to a restriction requirement or on an application filed as a result of a restriction requirement. In effect, the third sentence of §121 shields patents that issue on applications filed as a result of a restriction requirement from double patenting invalidation. See Applied Materials, Inc. v. Advanced Semiconductor Materials America, Inc., 98 F.3d 1563, 1568 (Fed. Cir. 1996) ("[W]hen two or more patents result from a PTO restriction requirement, whereby aspects of the original application must be divided into separate applications,§121 insulates the ensuing patents from the charge of double patenting.").

On the definition of "divisional application" in§201.06 of the Manual of Patent Examining Procedure ("MPEP"), which provides:
A later application for an independent or distinct invention, carved out of a pending application and disclosing and claiming only subject matter disclosed in the earlier or parent application, is known as a divisional application or "division."
MPEP§201.06 (8th ed., July 2008 rev.).

We review a court's conclusion on double patenting without deference because "double patenting is a matter of what is claimed, and therefore is treated like claim construction upon appellate review." Georgia-Pacific Corp. v. U.S. Gypsum Co., 195 F.3d 1322, 1326 (Fed. Cir. 1999). "[Obviousness-type] double patenting is a judicially created doctrine adopted to prevent claims in separate applications or patents that do not recite the 'same' invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection." Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1373 (Fed. Cir. 2005).

Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). The Pfizer decision addressed whether a patent that issued from a continuation-in-part application--rather than a divisional application--could receive the protection of the§121 safe harbor. 518 F.3d at 1358--62. Looking first to the statute, the court observed that§121 on its face refers to "divisional application[s]." Id. at 1360. Turning to the legislative history, the court observed that a House Report also referred specifically to "divisional application[s]." Id. Notably absent from the legislative history, in the court's view, was a suggestion "that the safe-harbor provision was, or needed to be, directed at anything but divisional applications." Id. at 1361. From there, the court "conclude[d] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Id. at 1362. Accordingly, the court decided that the§121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.

We are persuaded by the reasoning in Pfizer that the§121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application. See Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990) ("To gain the benefits of Section 121 there outlined, [the patentee] must have brought its case within the purview of the statute, i.e., it must have limited the claims in its divisional application to the non-elected invention or inventions."(emphasis added)).

We recognize that, unlike a continuation-in-part application, a continuation application can satisfy the definition of a "divisional application" in MPEP§201.06. That is because a continuation-in-part application adds subject matter not disclosed in the earlier application, see MPEP§201.08, whereas continuation and divisional applications are limited to subject matter disclosed in the earlier application, see MPEP§§201.06, 201.07. This distinction, however, does not justify departing from a strict application of the plain language of §121, which affords its benefits to "divisional application[s]." See 35 U.S.C.§121 (sheltering from attack "a divisional application or. . . the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application" (emphases added)); see also Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 2003) ("Given the potential windfall [a] patent term extension could provide to a patentee, this court applies a strict test for application of§121." (footnote omitted)).

Our conclusion that the§121 safe harbor protects patents descending from divisional applications, but not from continuation applications exclusively, is consistent with our decisions in Applied Materials and in Symbol Technologies. In both of those cases, we affirmed§121 protection of patents which issued directly from continuation applications. See Applied Materials, 98 F.3d at 1568--69; Symbol Technologies, 935 F.2d at 1579--81. In both cases, however, the continuation applications, from which the protected patents issued, descended from divisional applications that were filed as a result of restriction requirements. See Applied Materials, 98 F.3d at 1568; Symbol Technologies, 935 F.2d at 1580. Our decisions in Applied Materials and Symbol Technologies thus establish that a patent need not have issued directly from a divisional application to receive §121 protection. In other words, intervening continuation applications do not render a patent ineligible for§121 protection so long as they descended from a divisional application filed as a result of a restriction requirement.

Takeda presented the situation where a patent applicant sought to overcome a double patenting rejection of a process patent over a product patent by presenting post-invention evidence of alternative processes of making the product. 561 F.3d at 1375--76. In 1974, Takeda Pharmaceutical Co. ("Takeda") filed a Japanese patent application disclosing a product (cephem compounds) and the process for making the product. Id. at 1373. Takeda obtained a patent on the product in 1981, and a patent on the process in 1996, both of which claimed priority to the 1974 application. Id. at 1373--74. During reexamination of the process patent, the PTO examiner rejected the claims of the process patent as patentably indistinct over the claims of the product patent, and, therefore, invalid for double patenting, a ruling which the Board of Patent Appeals and Interferences affirmed. Id. at 1374. The District Court for the District of Columbia disagreed, however, based primarily on MPEP §806.05(f), which provides that process and product claims are patentably distinct if "the product as claimed can be made by another materially different process." Takeda Pharm. Co. v. Dudas, 511 F. Supp. 2d 81, 96 (D.D.C. 2007), vacated, Takeda, 561 F.3d at 1378. The district court held that, because viable, alternative processes for making the product existed in 2002 and 2005, the process and product were patentably distinct, and, therefore, not invalid for obviousness-type double patenting. Takeda, 511 F. Supp. 2d at 97.

The question on appeal to this court in Takeda was whether, when an issued patent claims a product and discloses, but does not claim, a process for making that product, the patentee, when later seeking a patent on the disclosed process, may present evidence of post-invention, alternative processes that produce the patented product, in order to show that the process and product are patentably distinct. 561 F.3d at 1375--766. The answer was a qualified yes. We concluded that "the relevant time frame for determining whether a product and process are 'patentably distinct' should be at the filing date of the secondary application," which is the later application for the process. Id. at 1377. We reasoned that "[t]he secondary application . . . actually triggers the potential of an 'unjustified extension of patent term,'" which is one of the "policies underlying the double patenting doctrine." Id. That is because the patentee "essentially avers that the product and process are 'patentably distinct'" upon filing of the secondary application. Id. Accordingly, Takeda could "rely on subsequent developments in the art up to January 8, 1990, the filing date of the secondary application, in order to show a patentable distinction between the [product and process for making the product]." Id. at 1378. We thus held that Takeda could rely on alternative processes that were in existence prior to January 8, 1990, the date of the application for the process patent. Id. It could not, however, rely on processes that came into existence after January 8, 1990, which eliminated processes existing in 2002

6 Takeda could overcome a double patenting rejection by presenting evidence that the product could be produced by alternative processes because "double patenting is not sustainable when the product can be fabricated by processes other than that secured by the issued process patent," In re Cady, 77 F.2d 106, 109 (CCPA 1935) (quotation marks omitted). This principle is embodied in MPEP §806.05(f), which states that a product is patentably distinct from the process for making the product if "the product as claimed can be made by another materially different process."

The language in the Takeda opinion stating that "the relevant time frame for determining whether a product and process are 'patentably distinct' should be at the filing date of the secondary application." Id. at 2 (quoting Takeda, 561 F.3d at 1377).

Section 120, entitled "Benefit of earlier filing date in the United States," recites in pertinent part:
An application for patent for an invention disclosed in the manner provided by the first paragraph of section 112 of this title in an application previously filed in the United States, . . . which is filed by an inventor or inventors named in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application.

35 U.S.C. §120 (emphases added). In short, §120 provides that a qualifying "application for patent for an invention . . . shall have the same effect . . . as though filed on the date of the prior application." This court has "repeatedly recognized [the] principle" that the "plain and unambiguous meaning of section 120 is that any application fulfilling the requirements therein 'shall have the same effect' as if filed on the date of the application upon which it claims priority." Transco Prods. Inc. v. Performance Contracting, Inc., 38 F.3d 551, 556 (Fed. Cir. 1994). "The 'effect' described in section 120 is the benefit of the earlier filing date--i.e., the benefit for purposes of priority and section 112 . . . ." Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1342 (Fed. Cir. 2008). Thus, §120 requires continuation applications to receive, at the very least, the benefits provided by the earlier filing date.

The Takeda decision conferred upon the patentee an additional benefit outside the mandate of §120. Nevertheless, the Takeda court understood the interrelationship between §120 and the timing rule it created. It recognized that the rule it crafted could "provide the patentee with the best of both worlds: the applicant can use the filing date as a shield, enjoying the earlier priority date in order to avoid prior art, and rely on later-developed alternative processes as a sword to defeat double patenting challenges." Takeda, 561 F.3d at 1377. Because of §120, we read Takeda to stand for the limited proposition that an applicant can only rely on subsequent developments in the art up to the filing date of the "secondary application" in order to show that alternative processes to make the product render the product and the process for making that product patentably distinct.

Takeda will permit Amgen, if it wishes to do so, to rely on alternative processes for making the products claimed in the '933 and '422 patents up to their filing dates to prove that the claims of those patents and the claims of the '868 and '698 patents are patentably distinct. If Amgen pursues that course, Roche will be free to rely on subsequent developments in the art up to the filing dates of the '933 and '422 patents to prove that any alternative processes put forth by Amgen do not render the claims of the '933 and '422 patents and the claims of the '868 and '698 patents patentably distinct. In other words, Takeda is a two-way street within its own confines.

The obviousness-type double patenting analysis entails two steps: (1) construction of the claims in the earlier patent and the claim in the later patent to identify any differences, and (2) determination of whether the differences in subject matter between the claims render the claims patentably distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001). Accordingly, we begin our obviousness-type double patenting analysis, as the district court's analysis began, by construing the claims and identifying any differences.

Next, we must determine whether the identified difference renders the claims non-obvious to a person of ordinary skill in the art in light of the prior art. See In re Kaplan, 789 F.2d 1574, 1580 (Fed. Cir. 1986). This part of the obviousness-type double patenting analysis is analogous to an obviousness analysis under 35 U.S.C.§103, except that the earlier patent is not considered prior art. See In re Longi, 759 F.2d 887, 892 n.4 (Fed. Cir. 1985) ("[A] double patenting of the obviousness type rejection is analogous to [a failure to meet] the non-obviousness requirement of 35 U.S.C.§103, except that the patent principally underlying the double patenting rejection is not considered prior art." (quotation marks omitted)).

An obviousness determination requires that a skilled artisan would have perceived a reasonable expectation of success in making the invention in light of the prior art. See In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) ("[S]tated in the familiar terms of this court's longstanding case law, the record shows that a skilled artisan would have had a resoundingly 'reasonable expectation of success' in deriving the claimed invention in light of the teachings of the prior art."); In re O'Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988) ("For obviousness under §103, all that is required is a reasonable expectation of success."); see also Longi, 759 F.2d at 896--97 (holding that a patent application was properly rejected for obviousness-type double patenting where the prior art references indicated a reasonable expectation of success).

See Pharmastem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342, 1360 (Fed. Cir. 2007) ("[T]he burden falls on the patent challenger to show by clear and convincing evidence that a person of ordinary skill in the art would have had reason to . . . carry out the claimed process, and would have had a reasonable expectation of success in doing so.").

See Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985) ("[O]ne should not go about determining obviousness under §103 by inquiring into what patentees (i.e., inventors) would have known or would likely have done, faced with the revelations of references.").

In making its anticipation argument, Roche relies on our statement in Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354 n.20 (Fed. Cir. 2003) ("TKT II"), that "a claimed product shown to be present in the prior art cannot be rendered patentable solely by the addition of source or process limitations."

Amgen contends that, because the source limitation imparts both novel structure and function

"A patent is presumed to be valid, and this presumption only can be overcome by clear and convincing evidence to the contrary." Enzo Biochem, Inc. Gen-Probe Inc., 424 F.3d 1276, 1281 (Fed. Cir. 2005) (citation omitted). A patent claim is invalid by reason of anticipation if "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." 35 U.S.C. §102(a). Anticipation under §102(a) generally requires the presence in the prior art of each and every limitation of the claimed invention. Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000).

It has long been the case that an old product is not patentable even if it is made by a new process. See Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 373 (1938) ("Wabash") ("[A] patentee who does not distinguish his product from what is old except by reference, express or constructive, to the process by which he produced it, cannot secure a monopoly on the product by whatever means produced."); Cochrane v. Badische Anilin & Soda Fabrik, 11 U.S. 293, 311 (1884) ("BASF") ("While a new process for producing [the product] was patentable, the product itself could not be patented even though it was a product made [by an artificial process] for the first time."); SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1317 (Fed. Cir. 2006) ("It has long been established that one cannot avoid anticipation by an earlier product disclosure by claiming the same product . . . as produced by a particular process."); In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) ("If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a difference process."); Tri-Wall Containers, Inc. v. United States, 408 F.2d 748, 750 (CCPA 1969) ("It is well established that a product as made by a new process is not patentable unless the product itself is new.").

However, a new product may be patented by reciting source or process limitations so long as the product is new and unobvious. See Wabash, 304 U.S. at 373 ("[I]n some instances a claim may validly describe a new product with some reference to the method of production . . . ."); BASF, 111 U.S. at 311 (determining that "an old article" made by a new process was not patentable); In re Luck, 476 F.2d 650, 653 (CCPA 1973) ("[I]t is well established that product claims may include process steps to wholly or partially define the claimed product."); In re Brown, 459 F.2d 531, 535 (CCPA 1972) ("[I]t is the patentability of the product claimed and not of the recited process steps which must be established."); In re Pilkington, 411 F.2d 1345, 1348 (CCPA 1969) ("[P]atentability of a claim to a product does not rest merely on a difference in the method by which that product is made. Rather, it is the product itself which must be new and unobvious.").

In determining validity of a product-by-process claim, the focus is on the product and not on the process of making it. See Atl. Thermoplastics Co. v. Faytex Corp., 970 F.2d 834, 841 (Fed. Cir. 1992) (explaining that, in BASF, the validity rule "focused on the product with less regard for the process limits"); Brown, 459 F.2d at 535 (focusing on the product claimed and not the process); Pilkington, 411 F.2d at 1348 (noting that the product itself must be new). That is because of the already described, long-standing rule that an old product is not patentable even if it is made by a new process.14 As a result, a product-by-process claim can be anticipated by a prior art product that does not adhere to the claim's process limitation. In determining infringement of a product-by-process claim, however, the focus is on the process of making the product as much as it is on the product itself. See Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1293 (Fed. Cir. 2009) (en banc). In other words, "process terms in product-by-process claims serve as limitations in determining infringement." Id. (quotation marks omitted). As a result, a product-by-process claim is not infringed by a product made by a process other than the one recited in the claim. Id.

The impact of these different analyses is significant. For product-by-process claims, that which anticipates if earlier does not necessarily infringe if later. That is because a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim. Similarly, that which infringes if later does not necessarily anticipate if earlier. That is because an accused product may meet each limitation in a claim, but not possess features imparted by a process limitation that might distinguish the claimed invention from the prior art.

Indefiniteness is a question of law. Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008). Under 35 U.S.C.§112, claims must "particularly point[ ] out and distinctly claim[ ] the subject matter which the applicant regards as his invention." If a claim fails to reasonably apprise one skilled in the art of the boundaries of the claim when read in light of the specification, then the claim is invalid under§112 for indefiniteness. See Miles Labs., Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir. 1993).

See Brown, 459 F.2d at 535 ("[T]he lack of physical description in a product-by process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established.").

Findings of fact that go to the question of validity of product-by-process claims do not automatically become part of claim construction.

Patentees often use process limitations to distinguish their product from prior art products because their product cannot accurately be discriminated from the prior art except by reference to the process by which it is obtained. See, e.g., Pilkington, 411 F.2d at 1349 ("[T]he differences between the [claimed product] and the [product] of the prior art do not appear to us to be particularly susceptible to definition by the conventional recitation of properties or structures."). In those situations, the product-by-process format allows the patentee to obtain a patent on the product even though the patentee cannot adequately describe the features that distinguish it from prior art products. In effect, the process limitation embodies the difficult-to-describe distinctions that render the product patentable. Thus, to call the process limitation indefinite in this situation would defeat one of the purposes of product-by-process claims, namely permitting product-by-process claims reciting new products lacking physical description.

Infringement is a question of fact. Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1159 (Fed. Cir. 2007). To prove infringement, the patentee must show that an accused product embodies all limitations of the claim either literally or by the DOE. TIPS Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364, 1379 (Fed. Cir. 2008); see also Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir. 2008) (stating that, to prove infringement, the patentee has the burden of persuasion by a preponderance of the evidence). If any claim limitation is absent from the accused device, there is no literal infringement as a matter of law. TIPS Sys., 529 F.3d at 1379. We begin our infringement analysis with the product patents.

Materiality is context-dependent. See Biotech Biologische Naturverpackungen GmbH & Co. v. Biocorp, Inc., 249 F.3d 1341, 1352 (Fed. Cir. 2001) ("Whether a change in a product is material is a factual determination, and is properly for the trier of fact."). In the biotechnology context, a significant change in a protein's structure and/or properties would constitute a material change. Cf. Eli Lilly, 82 F.3d at 1573 ("In the chemical context, a 'material' change in a compound is most naturally viewed as a significant change in the compound's structure and properties."). A good source for determining whether a change in a product of a process is material under §271(g) is the patent. Where the specification or asserted claims recite a structure or function for the product of the processes, then significant variations from the recited structure and function are material. What makes a variation significant enough to be a "material change," however, is a question of degree.

("We look . . . to the substantiality of the change between the product of the patented process and the product that is being imported.").

"An accused device that does not literally infringe a claim may still infringe under the doctrine of equivalents if each limitation of the claim is met in the accused device either literally or equivalently." Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1459 (Fed. Cir. 1998) (en banc). An element in the accused product is equivalent to a claim limitation if the differences between the two are "insubstantial" to one of ordinary skill in the art. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 40 (1997). Insubstantiality may be determined by whether the accused device performs substantially the same function in substantially the same way to obtain the same result as the claim limitation. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950).

To support a finding of infringement under DOE, Amgen must have presented, on a limitation-by-limitation basis, "particularized testimony and linking argument as to the 'insubstantiality of the differences' between [the pharmaceutical composition in claim 12] and [MIRCERA�, or with respect to the function, way, result test." Tex. Instruments v. Cypress Semiconductor Corp., 90 F.3d 1558, 1567 (Fed. Cir. 1996). "[E]vidence and argument on the doctrine of equivalents cannot merely be subsumed in plaintiff's case of literal infringement." Lear Siegler, Inc. v. Sealy Mattress Co., 873 F.2d 1422, 1425 (Fed. Cir. 1989); see also Texas Instruments, 90 F.3d at 1567 ("Generalized testimony as to the overall similarity between the claims and the accused infringer's product or process will not suffice."). But see Paice LLC v. Toyota Motor Corp., 504 F.3d 1293, 1305 (Fed. Cir. 2007) ("Our 'particularized testimony' standard does not require [the expert] to re-start his testimony at square one when transitioning to a doctrine of equivalents analysis."). These requirements "ensure that a jury is provided with the proper evidentiary foundation from which it may permissibly conclude that a claim limitation has been met by an equivalent." Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1188 (Fed. Cir. 1998).

2009-1020, -1096
AMGEN INC.,
Plaintiff-Cross Appellant,
v.
F. HOFFMAN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH,
and HOFFMAN-LA ROCHE INC.,

Defendants-Appellants.

Appeals from the United States District Court for the District of Massachusetts
in case no. 05-CV-12237, Judge William G. Young.

DECIDED: September 15, 2009

1. What do the terms "patent pending" and "patent applied for" mean?

They are used by a manufacturer or seller of an article to inform the public that an application for patent on that article is on file in the United States Patent and Trademark Office. The law imposes a fine on those who use these terms falsely to deceive the public.

2. Is there any danger that the USPTO will give others information contained in my application while it is pending?

A. Most patent applications filed on or after November 29, 2000, will be published 18 months after the filing date of the application, or any earlier filing date relied upon under Title 35, United States Code. Otherwise, all patent applications are maintained in the strictest confidence until the patent is issued or the application is published. After the application has been published, however, a member of the public may request a copy of the application file. After the patent is issued, the Office file containing the application and all correspondence leading up to issuance of the patent is made available in the Files Information Unit for inspection by anyone, and copies of these files may be purchased from the Office.

3. May I write to the USPTO directly about my application after it is filed?

The Office will answer an applicant's inquiries as to the status of the application, and inform you whether your application has been rejected, allowed, or is awaiting action. However, if you have a patent attorney or agent of record in the application file the Office will not correspond with both you and the attorney/agent concerning the merits of your application. All comments concerning your application should be forwarded through your attorney or agent.

4. Is it necessary to go to the USPTO to transact business concerning patent matters?

No. Most business with the Office is conducted by written correspondence. Interviews regarding pending applications can be arranged with examiners if necessary and are often helpful.

5. If two or more persons work together to make an invention, to whom will the patent be granted?

If each had a share in the ideas forming the invention as defined in the claims – even if only as to one claim, they are joint inventors and a patent will be issued to them jointly on the basis of a proper patent application. If, on the other hand, one of these persons has provided all of the ideas of the invention, and the other has only followed instructions in making it, the person who contributed the ideas is the sole inventor and the patent application and patent shall be in his/her name alone.

6. If a first person furnishes all of the ideas to make an invention and a second person employs the first person or furnishes the money for building and testing the invention, should the patent application be filed by the first and second persons jointly?

No. The application must be signed by the true inventor, and filed in the USPTO, in the inventor's name. This is the person who furnishes the ideas (e.g. the first person in the above fact pattern), not the employer or the person who furnishes the money.

7. Does the USPTO control the fees charged by patent attorneys and agents for their services?

No. This is a matter between you and your patent attorney or agent in which the Office takes no part. To avoid misunderstanding you may wish to ask for estimate charges for: (a) the search (b) preparation of the patent application, and (c) USPTO prosecution.

8. Will my attorney advise me as to whether a certain patent promotion organization is reliable and trustworthy?

No. We have no control over such organizations. In fact, most if not all such organizations do not provide good value, in our opinion. Generally speaking, it is you, the inventor, who should know the market for your invention.

9. Are there any organizations in my area which can tell me how and where I may be able to obtain assistance in developing and marketing my invention?

Yes. In your own or neighboring communities you may inquire of such organizations as chambers of commerce and banks. Many communities have locally financed industrial development organizations, that can help you locate manufacturers and individuals who might be interested in promoting your idea.

10. Are there any state government agencies that can help me in developing and marketing of my invention?

Yes. In nearly all states there are state planning and development agencies or departments of commerce and industry which seek new product and new process ideas to assist manufacturers and communities in the state. If you do not know the names or addresses of your state organizations you can obtain this information by writing to the governor of your state.

11. Can the attorney assist me in the developing and marketing of my patent?

We generally do not act or advise concerning the business transactions or arrangements that are involved in the development and marketing of products themselves. We are however actively involved in the sale and licensing of patents. The difference is subtle, but important. You will be responsible for marking the invention covered by the patents; we can handle selling and licensing rights to the invention.

12. If I develop my invention using government funding, are my patent rights in any way limited?

First, it is very important that you tell your patent attorney about any government funding that you have received. This funding must be disclosed in the patent application, or the entire patent may revert to the government. The fact that government funding was involved will be shown on the face of the patent when it grants.

If you are a government employee, your patent rights may be proscribed by executive order. Executive Order 10096 provides that the government shall obtain all rights to any invention made by an employee if any one of the following conditions applies: the invention is made during working hours; the invention is made using either government facilities, equipment, etc., or is made with the help of another government employee who is on official duty; or the invention relates to the official duties of the inventor.

The government is not required to take the whole patent if it would be inequitable, but may do so. Even if the government elects not to take it all, it retains a nonexclusive, irrevocable, royalty- free license with the power to grant licenses to others for all government purposes.

The government rights to patents for inventions developed under federally sponsored R&D at universities, nonprofit organizations and small business organizations are determined in accordance with the terms of the funding agreement. In 1980, the Congress passed Bayh-Dole Act to provide uniformity among various government agencies and to make it easier for universities, nonprofit organizations and small business organizations to patent inventions developed with federal funding.

Under the 1980 Bayh-Dole Act, nonprofit institutions and small businesses are allowed to own property developed with government funding. The Act is set forth at 35 USC §200 through §212 and contains various provisions outlining restrictions on a patent owner's normal rights to advance government goals. Most of these restrictions will probably never come into play for a small business. Others, such as restrictions on foreign licensing, are applicable to non-profit institutions such as universities that receive government grants.

Probably the biggest effect on small businesses is the ability of the government to use the technology in its own labs via its nonexclusive license granted by law when government funding is involved in development of the invention.

In accordance with the act, all funding agreements with such organizations must give the organization the right to obtain title to any invention that is conceived or first reduced to practice in performance of work under the funding agreement. There are several exceptions to this requirement, such as inventions made during the operation of a government- owned facility or if the organization is not located in the U.S.

In order to obtain title, the organization must follow the prescribed procedure set forth in the funding agreement. Even if the organization obtains title, the government retains several rights. These rights include a nonexclusive, nontransferable, irrevocable, paid- up license to practice or to have practiced the invention for or on behalf of the U.S. throughout the world. If the organization is not diligently proceeding to commercialization, the government has march- in rights and can force the organization to license the patents upon reasonable terms.

The government has the right to file patent applications anywhere the organization does not file and has the right to acquire any U.S. or foreign patent or application which the organization elects to abandon. The government may also, under certain circumstances, require the licensing of background patents upon reasonable terms. In certain instances, the government may require the organization to include "buy American" clauses in any license agreement. Finally, if the organization is a nonprofit entity, the government can prevent the assignment of the patents, limit the term of any exclusive license and limit the use of royalties obtained from licenses.

The government rights to patents for inventions developed under federally funded R&D at privately owned business organizations (except small businesses) are determined by the terms of the procurement contract. These procurement regulations required to be used by most government agencies closely parallel the provisions used for universities, nonprofit corporations and small business organizations.

Accordingly, the government's rights in patents developed under procurement contracts are very similar to those described above. There is, however, one very important exception. Several governmental agencies (e.g., the Department of Defense, the Department of Energy and NASA) have statutory prohibitions against private business organizations obtaining title to inventions developed with federal funds.

Statute 35 USC §203, provides "march-in rights" for government funded inventions owned by small businesses or nonprofit organizations. Rather than grant the government full access to the patented' technology, march-in rights allow it to request the patent owner or exclusive licensee to grant an appropriate license to another. If the request is refused, the funding agency may even issue its own license. The agency has the capacity to determine the type of license to be granted and the field within it is intended to be used with no restrictions based on the patent owner's actual use. Thus, the agency can even grant a license under the patent to a direct competitor.

March-in rights only apply under extreme circumstances such as a threat to public health that cannot be alleviated by the patent owner's use alone. An agency's judgment on this matter, as well as on the reasonable scope of license and its terms, is reviewable. So far, the government has never used its march-in rights.

13. Once I am granted a patent, do I have to mark my products with the patent number? What if I make software or some other product that is not easily marked?

You don't have to mark your products with the patent number, but you should. If you don't, you won't be able to recover damages for infringement that occured before you found out about it and sent the infringer a letter. There is a specific patent statute, 35 USC 287, that speaks to this:

"Patentees, and persons making, offering for sale, or selling within the United States any patented article for or under them, or importing any patented article into the United States, may give notice to the public that the same is patented, either by fixing thereon the word "patent" or the abbreviation "pat.", together with the number of the patent, or when, from the character of the article, this cannot be done, by fixing to it, or to the package wherein one or more of them is contained, a label containing a like notice. In the event of failure so to mark, no damages shall be recovered by the patentee in any action for infringement, except on proof that the infringer was notified of the infringement and continued to infringe thereafter, in which event damages may be recovered only for infringement occurring after such notice. Filing of an action for infringement shall constitute such notice."

Thus, if possible, you should mark your product with "patent" or "pat" and then list all the patents on inventions that are part of that product. If you can't fit the marking on the product (like for software), you should mark the software packaging - the box, or prominent literature within the box, like the user manual. To be safe, mark software by marking the box it is sold in, if there is one. Otherwise, mark the most prominent document that accompanies the software in a sale - the user manual, the installation manual or screens (in the case of a download).

Even if the patent only covers a method of making the product, you should mark the product or package.

What if you don't mark the product? In that case, you don't lose the patent, and you can still sue to enforce the patent. But you will lose the right to collect money for infringement that occured prior to the marking of the product. You can start marking products at any time, so if you have products that you sell that are covered by one or more patents, start marking them as soon as possible.

14. What are Abbreviated New Drug Applications ("ANDA")?

Abbreviated New Drug Applications ("ANDA") are creatures of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified at 21 U.S.C. §§ 355, 360cc (2003); 35 U.S.C. §§ 156 (2002), 271 (2003) (collectively, the "Hatch-Waxman Act").

The Hatch-Waxman Act strikes a balance between the sometimes-competing policy interests of inducing pioneering research and development of new drugs and enabling production of low-cost, generic copies of those drugs. A manufacturer that seeks to market a generic drug may submit an ANDA for approval by the United States Food and Drug Administration ("FDA"), rather than submitting a full New Drug Application ("NDA") showing the safety and efficacy of the generic drug. Thus, the generic manufacturer may rely on safety and efficacy studies of the pioneer manufacturer upon showing the generic drug's bioequivalence with the previously approved drug product. 21 U.S.C. § 355(j)(2)(A) (2003).

The Hatch-Waxman Act also requires a pioneer drug manufacturer to notify the FDA of all patents that "claim[ ] the drug for which the [NDA] applicant submitted the application." 21 U.S.C. §§ 355(b)(1) & (c)(2) (2003). The FDA lists such patents in its Approved Drug Products With Therapeutic Equivalence Evaluations, known as the "Orange Book". Under 35 U.S.C. § 271(e)(2), a generic manufacturer infringes a patent by filing an ANDA to obtain approval for a generic drug product claimed by a valid and unexpired patent.

As part of the approval process, an ANDA applicant must make a certification addressing each patent listed in the Orange Book that claims the drug. 21 U.S.C. § 355(j)(2)(A)(vii). The Hatch-Waxman Act specifies the certification alternatives, (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is invalid or will not be infringed by the manufacture, use, or sale of the new generic drug for which the ANDA is submitted. 21 U.S.C. § 355(j)(2)(A)(vii)(I-IV) (2003). These are commonly referred to as paragraph I, II, III, and IV certifications.

When an ANDA certifies under paragraph IV, the applicant must provide the patentee a detailed basis for its belief that the patent is not infringed, that it is invalid, or that it is unenforceable. 21 U.S.C. § 355(j)(2)(B) (2003). The patentee then has forty-five days to sue the ANDA applicant for patent infringement. 21 U.S.C. § 355(j)(5)(B)(iii). If the patentee does not sue, the FDA may proceed to approve the ANDA. If the patentee does file suit, the FDA may not approve the ANDA until expiration of the patent, resolution of the suit, or thirty months after the patentee's receipt of notice, whichever is earlier.