shutterstock_543922183The Federal Circuit in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. held that U.S. district courts have specific jurisdiction over an ANDA filer in any state they intend to market.1

The court reviewed two interlocutory appeals from separate rulings by the U.S. District Court for the District of Delaware regarding Mylan’s Rule 12(b)(6) motion to dismiss for lack of personal jurisdiction. Mylan filed Abbreviated New Drug Applications (ANDAs) for Ampyra®, Onglyza® and Kombiglyze™, submitting with each a paragraph IV certification – stating that the Orange Book listed patents covering the drugs were invalid or would not be infringed by Mylan’s marketing of its proposed drug.

As a paragraph IV certification constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A), both Acorda and AstraZeneca sued Mylan for infringement in the District of Delaware.2 Both Judges Stark and Sleet ruled that Delaware does have specific personal jurisdiction over the respective case; however; the judges ruled separately on the matter of general personal jurisdiction. Judge Stark ruled that Delaware had general personal jurisdiction while Judge Sleet ruled that they did not. Specific jurisdiction arises from the result of a specific incident while general jurisdiction arises when a court has jurisdiction over a defendant regardless of the type of claim.

The Federal Circuit granted both appeals and ruled only on the specific personal jurisdiction question. Although the court had the opportunity to address the question of whether Delaware also has general personal jurisdiction over Mylan – by way of registering to do business in and appointing an agent to accept service in Delaware – it punted the question for a later case.

In deciding the specific personal jurisdiction issue, the court looked to the ‘minimum contacts requirement’ set out by the Supreme Court in 1945.3 Under this requirement, a court may exercise specific personal jurisdiction without violating the Due Process Clause when the defendant has certain minimum contacts with the forum and no traditional notions of fair play and substantial justice are offended.

The true issue remained how Mylan established minimum contacts when they had performed no marketing to date for their proposed ANDA drug. The court looked to Congress intention when enacting § 271(e)(2), noting that “Congress deemed the ANDA filing to have a non-speculative casual connection to the ANDA filer’s future infliction of real-world market injury on the patent holder.”4

The court looked to multiple factors in deciding that Mylan “undisputedly” intended to market in Delaware. The court put most emphasis on the ‘economic realities’ – i.e. massive costs, estimated between $250,000 to $25 million – of getting an ANDA granted coupled with Mylan’s extensive market presence and sales throughout the U.S. The court also noted that Mylan is registered to do business in Delaware and with the Delaware Board of Pharmacy as well as having an appointed agent to receive service of process. The court noted, however, that even if Mylan did not intend to directly market the ANDA drug in Delaware, it would direct its wholesalers and distributers to do so thereby meeting the minimum contacts requirement.

1 Acorda Therapeutics, Inc. v. Mylan Pharm. Inc., No. 2015-1456 (Fed. Cir. March 18, 2016).
2 See Del. Acorda Therapeutics, Inc. v. Mylan Pharm., Inc., 78 F. Supp. 3d 572 (D. Del. 2015) (decided by Judge Stark); and AstraZeneca AB v. Mylan Pharm., Inc., 72 F. Supp. 3d 549 (D. Del. 2015) (decided by Judge Sleet).
3 Int’l Shoe Co. v. Washington, 326 U.S. 310 (1945).
4 See Acorda c. Mylan at 12.

shutterstock_538215208In Warner Chilcott v. Teva, the Federal Circuit used the appellant’s claim limitation, as defined in the specification, to uphold the district court’s finding that the claims of two patents were invalid as obvious.1 The claims at issue covered the osteoporosis drug Atelvia®. Warner Chilcott, the holder of the patents, filed suit in November 2011 following Teva’s ANDA application to make and sell a generic version of the drug.

Warner Chilcott owns the ’459 and ’460 patents, which are directed to oral dosage forms comprising risedronate (a bisphosphonate) and disodium ethylenediaminetetraacetic acid (“EDTA”), and methods of treating diseases characterized by abnormal calcium and phosphate metabolism, e.g., osteoporosis. Warner Chilcott’s commercial product, Atelvia®, is an oral formulation for treating osteoporosis comprising 35 mg risedronate and 100 mg EDTA. According to Warner Chilcott, Atelvia® solved the problem of prior osteoporosis drugs that were rendered ineffective when taken with or soon after a meal by utilizing a chelating agent to prevent calcium binding.2 The active ingredient, a bisphosphonate, forms an undesirable complex with calcium ions present in food that inhibits absorption of the drug.3 By using a chelating agent, the bisphosphonate can be freed for absorption, however, the chelating agent can also cause undesirable effects when used in a fasted state.4

During prosecution, the claims were rejected as obvious over a prior art patent application.5 The drugmaker overcame the rejection by amending the claims, adding the limitation, “pharmaceutically effective absorption.”6

The district court found the claims invalid, stating that a person of ordinary skill in the art would have recognized the problem caused by interacting bisphosphonate with food and the solution of using chelators to bind a metal ion, because it had been well explored in literature.7 The district court believed that although Warner Chilcott defined the limitation, “pharmaceutically effective absorption” such that it is not equivalent to merely overcoming the food effect, “the pharmaceutically effective absorption would have been a logical and obtainable goal for a drug with bioavailability that is significantly affected by co-administration with food.”8

Warner Chilcott appealed, arguing that the district court misinterpreted the meaning of “pharmaceutically effective absorption,” and that the limitation wasn’t applicable only to food consumption while taking the drug.9 Warner Chilcott argued,

the district court misinterpreted “pharmaceutically effective absorption” and erroneously equated the invention with overcoming the food effect. . . the limitation requires similar fed and fasted absorption of the drug, not merely absorption of an effective amount in either fed or fasted state. . . the specific amounts of risedronate and EDTA are critical, as only the claimed formulation has been shown to achieve such absorption.10

The Federal Circuit affirmed the district court’s obviousness holding. According to the Federal Circuit, the broad disclosure of [the prior art] nearly anticipates, and the only claim limitation it lacks is “pharmaceutically effective absorption.” According to the Federal Circuit,

Although common sense tells us that any pharmaceutical composition entitled to a patent would have to be pharmaceutically effective, as would any such formulation approved by the FDA, the fact is that, without that limitation specifically referring to the fed/fasted absorption defined in the specification, the asserted claims would not have issued from the original prosecution.”11

The Federal Circuit affirmed the district court’s obviousness holding stating, “it would have been obvious in view of the prior art to use a chelating agent to bind calcium ions to mitigate the food effect for risedronate and thereby achieve similar fed/fasted absorption.”12

1 See Warner Chilcott Co., LLC v. Teva Pharm. USA, Inc., No. 2015-1588 at 10 (Fed. Cir. Mar. 18, 2016).
2 Id. at 2.
3 Id.
4 Id.
5 Id. at 3.
6 See Warner Chilcott Co., LLC v. Teva Pharm. USA, Inc., 89 F. Supp. 3d 641, 646 (D.N.J. 2015). This was the only additional limitation to the patents over the prior art. Id.
7 Id. at 661.
8 See No. 2015-1588, at 8
9 Id.
10 Id.
11 Id. at 9-10
12 Id. at 10

shutterstock_514586758A patent has a term of twenty years from the patent application’s effective filing date.1 To compensate inventors for any undue delays in patent examination caused by the U.S. Patent and Trademark Office (“USPTO”), Congress established a system to adjust patent term. In Pfizer v. Lee, the Federal Circuit examined whether certain errors caused by the USPTO give rise to Patent Term Adjustment (“PTA”).2

The Patent Term Guarantee Act provides for the restoration of patent term in three circumstances: (i) an “A-Delay,” which awards PTA for delays arising from the USPTO’s failure to act by certain examination deadlines; (ii) a “B-Delay,” which awards PTA for an application pendency exceeding three years; and (iii) a “C-Delay,” which awards PTA for delays due to interferences, secrecy orders, and appeals. The USPTO calculates PTA by adding the A-, B-, and C-Delays, subtracting any overlapping days, and then subtracting any days attributable to applicant delay.3

When a patent is ready to issue, the USPTO determines whether any PTA delay has accrued and informs the applicant regarding the length of any term to be restored to the issued patent. An applicant can appeal the USPTO’s determination of PTA by filing an action in the United States District Court for the Eastern District of Virginia.4 With respect to A Delay, the Act provides for restoration of patent term “if the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to provide at least one of the notifications under section 132 or a notice of allowance under section 151 not later than 14 months after” – (I) the date on which an application was filed or (II) the date of commencement of the national stage in an international application.5 It is “A Delay” that is at issue in Pfizer.

On May 2, 2003, Wyeth filed U.S. patent application number 10/428,894 (“’894 application”). The statutory deadline for the USPTO to issue its first office action expired on July 2, 2004 (i.e., 14 months from the date the application was filed). On August 10, 2005, 404 days after the July 2, 2004 deadline, the PTO mailed a restriction requirement. Generally, a restriction requirement would be considered an office action under Section 132 because it informs the applicant of reasons why its claims are considered to be directed to separate inventions. The deadline for Wyeth to reply to the restriction requirement was February 10, 2006. On February 6, 2006, Wyeth participated in a telephone interview with the Examiner and explained that the restriction requirement had omitted claims 75, 76, and 103-106 from its categorization of the various claims in the application. During the interview, the Examiner acknowledged that the restriction requirement was not complete and agreed to withdraw it and issue a corrected restriction requirement. The PTO issued a corrected restriction requirement on February 23, 2006, 601 days after the July 2, 2004 deadline.

On April 10, 2012, the ’894 application issued and was awarded PTA of 1291 days, of which 684 days were attributed to A Delay. The PTO did not award A Delay for the 197 days that elapsed between the issuance of the first restriction requirement and the mailing of the corrected restriction requirement. It is that 197 days which are at issue.

Wyeth appealed the district court’s judgment declining to award Wyeth restoration of the patent term for the extra 197-day period in question. Wyeth argued that the USPTO’s original restriction requirement failed to satisfy the notice requirement of Section 132 because it failed to classify six dependent claims into the examiner’s defined invention groups, and thus failed to place the applicants on notice of the restriction requirement as to those dependent claims.

The Federal Circuit disagreed with Wyeth citing, inter alia, Chester v. Miller, wherein the court held that “Section 132 is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.”6 Section 132 merely requires that an applicant “at least be informed of the broad statutory basis for [the rejection of] his claims, so that he may determine what the issues are on which he can or should produce evidence.”

The Federal Circuit stated, the restriction requirement provided adequate grounds on which the applicants could “recogniz[e] and seek[] to counter the grounds for rejection.” Therefore, because the examiner clearly defined the invention groups available for election and further prosecution, the applicants were placed on sufficient notice of the reasons for the examiner’s restriction requirement. The court further stated, the process of patent prosecution often involves changes in both the applicant’s and examiner’s positions, an examiner’s reissuance of an office action in response to an applicant’s suggestion does not automatically mean that an application has been delayed” for purposes of patent term adjustment.

Judge Newman dissented, stating that the issue is simply whether the delay that necessarily ensued is an “‘A Delay” subject to inclusion in the term adjustment. Judge Newman would have granted Wyeth additional PTA, reasoning that the statutory purpose is clear: when patent issuance is delayed because of proceedings that are not the fault of the applicant, the patent term is extended to compensate for the delay.

1 35 U.S.C. § 154(a)(2)
2 Pfizer, Inc. v., Michelle K. Lee, No. 2015-1265, (Fed. Cir. January 22, 2016).
3 35 U.S.C. § 154(b)
4 35 U.S.C. § 154(b)(4)
5 35 U.S.C. § 154(b)(1)(A)
6 Chester v. Miller, 906 F.2d 1574 (Fed. Cir. 1990).

shutterstock_170688149For the first time, the Federal Circuit addressed the requirement of “actual notice” of a published patent application in order for a patent holder to obtain damages before issuance of a patent.1 The case arose from the appeal of a district court’s grant of summary judgement that Adobe Systems was not liable for patent pre-issuance damages under 35 U.S.C. § 154(d), because it had no knowledge of the published U.S. Patent Application that matured into the asserted U.S. Patent No. 8,578,820.

Section 154(d) provides an exception to the general rule that damages for patent infringement can only accumulate during the term of the patent, allowing for damages to accrue beginning on the date of publication of an application that matures into an issued patent. In order to obtain these damages, a patent holder must demonstrate that 1) the asserted claims were “substantially identical” in the publication and in the ultimately issued patent and 2) that the accused infringer had “actual notice” of the published patent application.2

In addressing the meaning of “actual notice” in 35 U.S.C. § 154(d), the court concluded that this term included knowledge of the published application, but this knowledge did not have to come as a result of actions by the owner of the published application.3. Thus, the court dismissed Adobe’s argument that “an affirmative act” by the patent holder is required to give “actual notice” to the potential infringer of the published application. However, they did agree with Adobe that “constructive knowledge” is not “actual notice” of the published application.4

In an attempt to demonstrate that Adobe had “actual notice” of the publication that preceded the ‘820 patent, Rosebud presented three different rationales to the court. First, Rosebud asserted that because the parties were involved in two prior law suits over patents in the same family as the ‘820 patent, and Adobe knew of a grandparent patent to the ‘820 patent, it therefore also knew of the publication of the ‘820 patent application. Secondly, Rosebud argued that because Adobe followed Rosebud and its product, it would have become aware of publication of the ‘820 patent application. Finally, Rosebud suggested that it is standard practice when defending against a charge of patent infringement to search for patents and applications related to the asserted patent, and thus, Adobe surely would have discovered the publication of the ‘820 patent application.5

The court rejected each of Rosebud’s assertions. The court noted that even though the ‘280 patent shares a specification with the patents involved in prior lawsuits between Rosebud and Adobe, there was no evidence that Adobe had knowledge of the published application, and specifically, the claims of the published application.6 Knowledge of related patents does not equate to actual notice of the published patent application.7 With regard to Rosebud’s assertions that Adobe followed Rosebud and its products, the court found no evidence suggesting that Adobe or its employees were monitoring Rosebud and its products, and specifically there was no evidence that suggested that Adobe actively sought out Rosebud’s published patent applications.8 Finally, the court disagreed that it was standard practice during litigation to review related patents, or applications during litigation, particularly because the prior lawsuit between Rosebud and Adobe never reached the claim construction stage.9

Based on the Federal Circuit’s ruling, two potential practice tips emerge for companies prosecuting in the biotech space. The first is to consider including picture claims directed to a desired product in an application, such that claims of a published application may be in a form that meets the “substantially identical” requirement of 35 U.S.C. § 154(d) when they ultimately issue as a patent. While the requirement for similarity of the claims was not specifically addressed in Rosebud, the court did highlight the importance of a potential infringer having actual knowledge “of the claims of the published patent application and the fact that the applicant is seeking a patent covering these claims.”10

The second tip relates to whether to institute a “competitor monitoring” policy within a company, or for a client. Certainly the court in Rosebud indicated that simply being aware of related patents or applications, or even monitoring a client’s products, would probably not rise to the level of the required “actual notice” of the published application.11 The answer to this question certainly includes weighing the value of following a competitor with the risk that this process may result in “actual notice” of a competitor’s published patent application.12 Most likely each company, and potentially each technology sector in the biotech space, may have a different answer to this balance.

1 Rosebud LMS Inc., v. Adobe Sys. Inc., No. 2015-1428 (Fed. Cir. Feb 9, 2016).
2 35 U.S.C. § 154(d) (2006).
3 Id. at page 7.
4 Id. at page 5.
5 Rosebud, No. 2015-1428 at pages 7-8.
6 Id. at page 8.
7 Id.
8 Id. at pages 8-9.
9 Id. at page 9.
10 Id. at page 8.
11 Id. at pages 8-9.
12 Id. at page 5 (“the ordinary meaning of “actual notice” also includes knowledge obtained without an affirmative act of notification.”)

shutterstock_558540649Another layer of complexity has been added to patent prosecution under the District Court of Michigan’s expanded interpretation of the obviousness type double patenting (“ODP”) doctrine.1 The district court held that a continuation application can, in certain circumstances, invalidate its earlier filed and earlier issued parent under ODP. If upheld, patent prosecutors must carefully consider the scope of the claims in a continuation application especially when the parent application/patent receives patent term adjustment (“PTA”) extending its expiration date.

Citing the Federal Circuit’s Gilead2 decision, the district court stated “a court should look to the expiration dates not issuance dates to determine whether a patent can be used as the prior art patent under the [ODP] doctrine.”3 The patent at issue (U.S. 7,339,149) is the parent of the reference patent (U.S. 7,402,786), i.e., the patent asserted against the ‘149 patent. Absent patent term extension (“PTA”), the ‘149 patent would be expected to expire at the same time as the continuation application, and the doctrine of ODP would not necessarily be implicated. The ‘149 patent, however, had 418 days of PTA, and thus, expired after its continuation application:

blog-picture.jpg.4

The diagram above implies that the ‘149 patent and the ‘786 patent only have a common parent application, but in fact the ‘786 patent is a continuation of the ‘149 patent.

In explaining its holding, the district court quoted heavily from Gilead, which stated that “looking to the earliest expiration date [as opposed to the issuance date] of all the patents an inventor has on his invention and its obvious variants best fits and serves the purpose of the doctrine of double patenting.”5 But the facts in Gilead were different from the fact pattern in this case because, in Gilead, the target patent was filed later than the reference patent. However, in this case, the target patent, i.e., the ‘149 patent, was filed earlier than the reference patent. The Federal Circuit did not discuss the possibility of using filing dates for the purposes of determining whether a reference patent is properly used against a target patent in its Gilead decision.

The district court’s decision, if upheld, will mean patent prosecutors must think twice before filing a continuation application that could be used to later invalidate the parent application that contains PTA. Interestingly, during prosecution of the parent application, the continuation application will likely not be cited in an ODP rejection by the USPTO. Indeed, if the continuation application is filed after the parent application is allowed (but not issued), an information disclosure statement citing the continuation application may be necessary. But even then, the ODP rejection will necessarily be provisional because the continuation would not have been allowed at that point. In some scenarios, the continuation application may be filed after issuance of the parent application, in which case not even a provisional rejection will be made against the parent application. Thus, although the district court’s decision may be overruled, in the meantime, patent prosecutors must carefully consider claim scope in any continuation applications, particularly when the parent application contains PTA.

1 Magna Electronics, Inc. v. TRW, Case No. 1:12-cv-654 (D. Mich. Dec. 10, 2015).
2 Gilead Sciences Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014).
3 Magna at 6.
4 Id.
5 Gilead at 1216.

shutterstock_430169764The Federal Circuit recently denied Dow Chemical’s request for rehearing and rehearing en banc of Dow Chem. Co. v. Nova Chems. Corp. decided on August 28, 2015.1 The panel decision found that when multiple methods of measurement for a claimed parameter exist, a patentee must designate which method is being used. For a review of the court’s decision in the Dow Chem case, see our previous article here.

Although the Order gave no explanation for the denial, the opinion contained two concurrences and one dissent.
Chief Judge Prost, in a concurrence with Judges Dyk and Wallace joining, stated:

that clear and convincing evidence is the standard for patent invalidation; that the burden to establish indefiniteness rests with the accused infringer; that findings of fact by juries are entitled to deference; and that knowledge of someone skilled in the art may be pertinent to the indefiniteness question. In particular, we agree that if a skilled person would choose an established method of measurement, that may be sufficient to defeat a claim of indefiniteness, even if that method is not set forth in haec verba in the patent itself.

Judge Moore’s concurrence (with Judges Newman, O’Malley, and Taranto joining and Judge Chen joining in part) stated that the panel’s opinion in the case did not change any case law that has been created by the Supreme Court or the Federal Circuit. Judge Moore highlighted that extrinsic evidence can be relied upon to determine whether a patent’s specification is sufficiently definite, that fact finding made incident to the ultimate legal conclusion of indefiniteness receive deference on appeal, and the burden of proving indefiniteness lies ultimately with the party challenging validity. Judge Moore’s concurrence acknowledged that she “may disagree with and even find troubling” the panel’s resolution of the case, this alone was not a sufficient reason for en banc review.2

Judge O’Malley, in a dissent with whom Judge Reyna joined, theorized that the Dow Chem case should not have been heard by the Federal Circuit in the first instance as there was no jurisdiction under the Federal Rules of Civil Procedure. Judge O’Malley highlighted that the Federal Circuit had already affirmed the district court’s Rule 54(b) (partial final judgment) ruling on validity, infringement, and damages. She also noted that the only judgment appealed to the Federal Circuit in this instance pertained to a calculation of damages for infringement but not the indefiniteness issue itself. Therefore, Judge O’Malley asserted that the issue decided upon was not in the jurisdiction of the court.

1 Dow Chem. Co. v. Nova Chems. Corp., 14-1431, (Fed. Cir. August 28, 2015)(order denying request for panel rehearing and rehearing en banc).
2 Id. (Moore, J., concurring).

shutterstock_90590239In companion cases related to the generic version of enoxaparin marketed by Momenta and Sandoz, the CAFC decided:1

1. Neither Teva’s nor Amphastar’s enoxaparin products infringe under 35 U.S.C. § 271(g)2 because they are not “made by” Momenta’s patented process, and
2. Amphastar’s use of Momenta’s patented method is not protected by the 35 U.S.C. § 271(e)(1) safe harbor.

Momenta brought suit against Teva and Amphastar asserting that (i) Teva’s importation into the U.S. of an enoxaparin product would infringe Momenta’s ‘886 patent under 35 U.S.C. § 271(g), (ii) Amphastar’s manufacture in the U.S. of enoxaparin infringes the ’886 patent under 35 U.S.C. § 271(a), and this infringement does not fall within the safe harbor of 35 U.S.C. § 271(e)(1)3, and (iii) Amphastar’s sale of enoxaparin in the U.S. infringes the ‘886 patent under 35 U.S.C. § 271(g).4

The decision explains that Teva does not manufacture enoxaparin in the U.S., but rather imports the product into the United States.5 Unlike Teva, Amphastar manufactures its enoxaparin product within the United States, and Momenta asserted that Amphastar uses its patented method as an intermediate step in the multi-step process of manufacturing its drug.6

The crux of the decision relating to infringement under Section 271(g) lies in whether Teva’s and Amphastar’s enoxaparin products are “made by” Momenta’s patented “method of analyzing.”

Claim 1 of US ’886 recites (in part) “A method for analyzing an enoxaparin sample for the presence or amount of a non naturally occurring sugar …” In deciding non-infringement under Section 271(g), the Court noted7 that:

1. “All of the asserted claims of the ‘886 patent are directed to ‘[a] method for analyzing an enoxaparin sample.’”
2. “Use of the word ‘analyzing’ indicates practicing the claimed invention requires that the enoxaparin already be ‘made.’”

In considering Momenta’s arguments8, the court concluded that the ordinary meaning of “made” as used in § 271(g) means “manufacture” and extends to the creation or transformation of a product, such as synthesizing, combining components, or giving raw materials new properties.9 However, the court stated that “ma[king]” does not extend to testing to determine whether an already synthesized drug substance possesses existing qualities or properties.10

Citing to its previous decision in Housey11, where the court held that a product was not “made by” a process patented in the United States for purposes of § 271(g) where “the patented process [was] not used in the actual synthesis of the drug product,” the court reiterated that the word “made” in 271(g) equates to “manufacture.”

Momenta’s assertions that the FDA’s GMP regulations define “‘[m]anufacture’ and ‘[p]rocessing’ of drug products as including ‘testing[] and quality control of drug products,’” were rejected by the court emphasizing that such definition applies to 21 C.F.R. § 210.3(b)(12)12 and not § 271(g).

Regarding Amphastar’s infringement under § 271(g), based on the holding that the accused products were not “made by” the patented process, the court did “not reach the question of whether that subsection applies if the patented process is practiced domestically rather than abroad.”13

The court’s decision seems to have relied on the claim term “analyzing” which appears in the preamble. A claim preamble typically will not be seen as limiting unless it “breathes life and meaning into the claim.”14 Further, the preamble can be limiting when elements in the preamble serve as an antecedent basis for limitations in the claim body.15 In this instance, the court did not address the issue whether the claim preamble was a limitation.

The fact that the decision, in part, relied on the basis that the claims are directed to “method for analyzing” invites exploring into whether the court would:

a. come to the same conclusion in a situation involving a claim directed to “a method comprising…[with a step of analyzing a product sample as the last step]” instead of “a method for analyzing, comprising …”?
b. determine that “a method comprising…[with a step of analyzing a product sample as the last step],” falls within the meaning of § 271(g) in circumstances similar to the Momenta v. Teva scenario?

Under both scenarios, whether the court would come to the same conclusion would rest on various factors, including whether the claim also includes traditional manufacturing steps. It is thus possible that the scope of such claim will not be limited to “a method for analyzing…” The court may reason that such claim relates to both a method of manufacturing the product and a method of quality control release testing.

Similarly, under scenario (b), because the scope of a claim directed to “a method comprising…” would not be limited to “a method for analyzing…”, the court may more readily find that this claim falls within the meaning of § 271(g).

Focusing solely on claim interpretation, it would be interesting to see what the court would decide when confronted with a claim that is directed to (i) a method for analyzing X, comprising steps that include manufacturing X with the last step as analyzing X, as compared to a claim directed to (ii) a method, comprising steps that include manufacturing X with the last step as analyzing X.

1 Momenta Pharma., Inc. v. Teva Pharma. USA Inc., Nos. 2014-1274, -1277, -1276, and -1278 (Fed. Cir. Nov. 10, 2015).
2 Section 271(g) provides that “[w]hoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—
(1) it is materially changed by subsequent processes; or
(2) it becomes a trivial and nonessential component of another product.”

3 Momenta Pharma., Inc. at 4.
4 Id. at 5.
5 Id. at 4.
6 Id. at 5.
7 Id. at 11.
8 Momenta argued that (i) “made” means “manufactured,” and (ii) its patented method is “a crucial interim step used directly in the manufacture of [Teva’s] product[s],” asserting that its “method is used [by Teva] to select and separate batches of intermediate drug substance that conform to USP requirements for enoxaparin from batches that do not,” and that selected batches are then “further process[ed].”
9 Id. at 9.
10 Id. at 8-9.
11 Bayer AG v. Housey Pharm., Inc., 340 F.3d 1367, 1373 (Fed. Cir. 2003).
12 Momenta Pharma., Inc. at 11. “§ 210.3 explicitly states that its definitions apply when the terms are used in parts 210, 211, 225, and 226 of Chapter 1 of Title 21 (“Food and Drugs”).
13 Id. at 12.
14 In re Wertheim, 541 F.2d 257 (CCPA 1976).
15 Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332 (Fed. Cir. 2003).

shutterstock_405242659The patent eligibility of diagnostic testing methods remains uncertain after the Federal Circuit refused to rehear Ariosa v. Sequenom.1 In Ariosa, the Federal Circuit panel found that Sequenom’s patent on fetal DNA testing was patent ineligible, despite noting the high commercial value of the technology. The panel concluded that the claims failed Mayo’s2 two step analysis for patent eligibility. The claims recited a method for detecting fetal DNA (cffDNA), which can be used for non-invasive genetic testing of the fetus in a variety of applications.

In denying Sequenom’s petition for re hearing en banc, Judge Lourie, with Judge Moore joining, opined that the patent eligibility test in Mayo is too restrictive, but ultimately concluded that the Federal Circuit panel correctly applied the test. Judge Dyk, in a separate concurrence, explained his reasons for reaching the same conclusion. Judge Newman, on the other hand, would have granted rehearing en banc, explaining that “this incorrect decision is [not] required by Supreme Court precedent.”

Judge Lourie’s concurrence expresses concern that a broad range of claims “of this sort” appear in jeopardy because of Mayo, which held that if certain steps merely recite natural laws, the remaining steps must be sufficiently innovative apart from the natural laws. Judge Lourie stated that the claims at issue “contain the nucleus of patent-eligible subject matter” because they “rely on or operate by, but do not recite, a natural phenomenon or law.” Instead, taking maternal serum, separating it, etc. are all physical steps requiring human intervention.3

Judge Dyk’s concurrence takes a different approach, and focuses on claim breadth. Judge Dyk proposes that claims involving laws of nature should be held patent eligible “if the breadth of the claim is sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and reduced to practice . . . .”4 From Judge Dyk’s point of view, the approach would reach the correct balance of allowing the inventor to preclude others from practicing what he/she invented, but not prevent new applications of the natural law by others.5

Judge Newman’s dissent would have granted the petition for en banc rehearing, arguing that the facts of this case diverge significantly from the facts of Mayo and Myriad. In Mayo, argues Judge Newman, the medicinal products and its metabolites were previously known, whereas in the present case, the claims are directed to a new method. Likewise, in Myriad, the claims were directed to the natural phenomenon itself, and the holding was limited to the patent ineligibility of genes and the information they encode.

1 Ariosa Diagnostics, Inc. v. Sequenom, No., slip op. 2014-1139 (Fed. Cir. Dec. 2, 2015).
2 Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012).
3 Id. at 5
4 Id. at 9
5 Id. at 11

shutterstock_232886359In an effort to enhance the quality of patent prosecution in the United States, the PTO launched the Enhanced Patent Quality Initiative (EPQI) in February 2015 with a notice and request for comments in the Federal Register.1 The comment period closed in May 2015. According to PTO Director Michelle K. Lee, “[p]atents of the highest quality can help to stimulate and promote efficient licensing, research and development, and future innovation without resorting to needless high-cost court proceedings. Through correctness and clarity, such patents better enable potential users of patented technologies to make informed decisions on how to avoid infringement, whether to seek a license, and/or when to settle or litigate a patent dispute.”2

The goals of the EPQI are threefold:

  • Build more confidence in the patent system by enhancing patent quality;
  • Make the system understandable and usable by all inventors; and
  • Ensure customers are treated fairly and professionally throughout the patent application process.

The PTO hosted numerous events in 2015 to promote discussion about the EPQI and solicit feedback,3 and on November 6, the PTO Director blogged about the positive response to the Federal Register Notice and the various events. According to the Director, “[p]atent quality is central to fulfilling a core mission of the USPTO, which as stated in the Constitution, is to ‘promote the Progress of Science and useful Arts.’ It is critically important that the USPTO issue patents that are both correct and clear. Historically, our primary focus has been on correctness, but the evolving patent landscape has challenged us to increase our focus on clarity.”4

On the blog, the Director announced two of the initial programs that will take place as a result of numerous comments and extensive feedback the USPTO has received since announcing the EPQI.

First, the PTO will be launching a Clarity of the Record Pilot. Under this pilot program, Examiners will include definitions of key terms, pertinent claim constructions, and more detailed reasons for allowance or rejections of claims as part of the patent prosecution record. Information gleaned from this pilot will lead to the development of best practices for enhancing clarity of the prosecution record.

Second, the PTO is transforming their Review Data Capture Process, which is meant to unify their internal review process by ensuring that any review of a patent examiner’s work product will follow the same process. All reviewers will be systematically recording their review results through an online form, the “master review form,” which will be shared with the public. Data collected from this process and form will allow the PTO to identify reviewing trends across the agency, including at the technology center, art unit, and examiner levels. Additionally, this will allow the PTO to determine “whether the reasons for an examiner’s actions were spelled out in the record clearly and whether there is an omission of a certain type of rejection.”5

The Director stated that the end results of these pilots programs will be the “(1) ability to provide more targeted and relevant training to our examiners with much greater precision, (2) increased consistency in work product across the entire examination corps, and (3) greater transparency in how the USPTO evaluates examiners’ work product.”6

1 Enhanced Patent Quality Initiative, available at: http://www.uspto.gov/patent/initiatives/enhanced-patent-quality-initiative.
2 Enhanced Patent Quality Initiative: Moving Forward, published November 6, 2015, available at: http://www.uspto.gov/blog/.
3 See e.g., Events about the Enhanced Patent Quality Initiative, available at: http://www.uspto.gov/patent/initiatives/enhanced-patent-quality-initiative.
4 Id., emphasis in original.
5 Id.
6 Id.

shutterstock_337013831Here in Washington, D.C., the Trans-Pacific Partnership (TPP) is the latest talk of the town. The TPP is a proposed trade agreement among twelve Asia-Pacific countries concerning a variety of economic policy matters, including intellectual property. TPP’s membership includes several of the U.S.’s largest trading partners, e.g., Canada, Japan, and Mexico. The membership countries reached agreement in early October after years of negotiation. Congress is expected to vote on the agreement in 2016. The full text released on November 15, 2015; the whole of Chapter 18 relates to intellectual property. Overall, it appears that the patent-related provisions in the TPP reflect well-established U.S. patent practice. If ratified, the TPP would likely benefit U.S. companies as it would simplify worldwide patent procurement.

Below is a ten-point summary of the TPP’s patent-related provisions:

New use of a known product is patentable. Article 18.37, paragraph 2 provides that in all states who are parties to the agreement, at least one of the following is patentable: new uses of a known product, new method of a known product, or new processes of using a known product.

Methods of medical treatment may be unpatentable. Based on considerations of public policy and morality, Article 18.37, paragraph 3(a) provides that a party may exclude from patent protection “diagnostic, therapeutic and surgical method for the treatment of human or animals.”

Animals and plants may be unpatentable. Similarly, Article 18.37, paragraphs 3(b) and 4 provide that animals and plants may be excluded from patent protection. However, the language of the text provides a specific caveat: microorganisms apparently do not count as animals. The text also specifically provides that that plant-derived inventions are patentable.

Novelty comes with a one-year grace period. While many non-U.S. jurisdictions’ patent law operates on absolute novelty, Article 18.38 provides a one-year grace period following initial disclosure in all member states. The Article’s language actually resembles AIA 35 U.S.C. § 102(b)(1)(A).

Publication of pending patent applications. Under Article 18.44, all parties are required to publish patent applications 18 months after the filing date or, if priority is claimed, from the earliest priority date.

Public access of patent file history. Article 18.45 provides that the prosecution history of published applications and granted patents are open to the public. The prosecution history contains at a minimum: prior search results, communications from applicants, and art citations from applicants and third parties.

Patent term adjustment. Article 18.46, paragraph 4 contains provisions that are similar in spirit to 35 U.S.C. § 154(b) (Adjustment of Patent Term). The Article guarantees a maximum period of application pendency, which is no more than five years from the filing date, or three years from a request of examination, whichever is longer. Additional delay in examination is compensated by adjusting the patent term.

Patent term extension for pharmaceuticals. Analogously, Article 18.48 provides a bare-minimum equivalent of the Hatch-Waxman Act’s “patent term extension” for pharmaceutical products delayed by marketing approval process. However, the language of the text is rather unspecific, and the availability of such patent term extension is subject to a great number of qualifying conditions.

Presumption of validity for patents. Article 18.72, paragraph 3 gives examined and granted patents a presumption of validity in an enforcement proceeding. In a related footnote, it seems that the burden of proof is placed on the party challenging the validity.

Damages for infringement. As provided by Article 18.74, paragraph 3, TPP parties can order payment of damages from an infringer. However, the Article’s provisions appear to be limited to willful infringement (“an infringer who knowingly, or with reasonable grounds to know, engage in infringing activity”). Paragraph 4 mentions the factors that may be considered in calculating damages, include lost profits, and the market price of the infringe goods or services. Paragraph 10 further provides that the losing party will pay the prevailing party’s court expenses and attorney’s fees.