FeSSIF/FaSSIF Dissolution: If you Understand What is Written Above You Should Read this Article

A part of any complete study for a pre-clinical candidate (PCC) pharmaceutical compound is a dissolution study in Fed and Fasted Simulated Stomach and Intestinal Fluids (FeSSIF and FaSSIF) for the active pharmaceutical ingredient (API) and the complete formulation.  These studies are later implemented in the human studies.  Both are conducted to gauge the effect of the drug when the patient’s stomach is empty or full as stomach and gastric pH levels will fluctuate.

Now, what does this have to do with patent law?  The United States Court of Appeals for the Federal Circuit issued an opinion on December 3, 2014 in the case of Par Pharm., Inc. v. TWi Pharms., Inc., 2014 U.S. App. LEXIS 22737 (Fed. Cir. Dec. 3, 2014) further clarifying a long line of cases on inherency in regard to the obviousness of pharmaceutical formulations.  In this opinion the patentee may have avoided invalidation by claiming specific limitations to the C_max difference between fed and fasted states.

In Par Pharm., Inc. v. TWi Pharms, the case involved methods of use of nanosized formulations of the drug megestrol acetate (“megestrol”).  After a bench trial, the U.S. district court for the District of Maryland found the asserted claims of the U.S. Patent No. 7,101,576 (“’576’ patent”) invalid as obvious pursuant to 35 U.S.C. §103(a).  The claim at issue recites:

1. A method of increasing the body mass in a human patient suffering from anorexia, cachexia, or loss of body mass, comprising administering to the human patient a megestrol formulation, wherein:

(a) the megestrol acetate formulation is a dose of about 40 mg to about 800 mg in about a 5 mL dose of an oral suspension;

(b) the megestrol acetate formulation comprises megestrol particles having an effective average particle size of less than about 2000 nm, and at least one surface stabilizer associated with the surface of the megestrol particles; and

(c) the administration is once daily;

wherein after a single administration in a human subject of the formulation there is no substantial difference in the Cmax of megestrol when the formulation is administered to the subject in a fed versus a fasted state,

wherein fasted state is defined as the subject having no food within at least the previous 10 hours, and wherein fed state is defined as the subject having a high-calorie meal within approximately 30 minutes of dosing.

To substantiate the obviousness TWi presented prior art showing: (1) the pharmacokinetic properties of megestrol; and (2) nanoparticle technology in drug formulation decreasing food effects.  Id. at 7.  Par argued that the prior art failed to disclose a known food effect in in megestrol, to which the district court agreed but relied on inherency to supply the missing claim limitation.  Id. at 12.  The district court concluded that “[t]he claimed pharmacokinetic parameters with respect to a food effect . . . are inherent properties of the obvious nanoparticulate formulation.” Par Pharms., Inc. v. Twi Pharms., Inc., No. CCB-11-2466, 2014 U.S. Dist. LEXIS 21704, 2014 WL 694976, at *13.

The Court of Appeals for the Federal Circuit agreed with the district court’s finding that the prior art failed to disclose a known food effect for Megesterol, but concluded that the district court erred in applying the inherency analysis under the Federal Circuit’s current precedent.  Par Pharm., Inc. v. TWi Pharms., Inc., 2014 U.S. App. LEXIS 22737 at 18.  The Federal Circuit reiterated the current law which establishes that:

A party must … meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.  Id. at 21.

The Federal Circuit found that the district court did not require that TWi present evidence sufficient to prove inherency under this standard.  Id. at 21.  Instead, TWi presented evidence only showing that improvement in bioavailability decreases the food effect.  However, the district court’s analysis ignored the claim limitation that specifically recites “no substantial difference in C_max” between the fed and fasted states be within an enumerated percentage difference as recited in Claim 4.  The Federal Circuit held that:

While it may be true that a reduction in particle size naturally results in some improvement in the food effect, the district court failed to conclude that the reduction in particle size naturally results in “no substantial difference” in the food effect.  Id. at 22.

Accordingly, the Federal Circuit held that TWi failed to present evidence sufficient to demonstrate that the claimed food effect limitations are necessarily present in the prior art combinations and vacated the district court’s inherency analysis and remanded the case back to the district court to determine if TWi presented clear and convincing evidence that demonstrates the food effect as claimed is necessarily present in the prior art combination.  Id. at 23.

As we wait for the district courts findings in the remanded hearing, it is important to understand at this point that the “natural result flowing” standard appears to be directed at general properties of the questioned function.  As such, the patentee should take care to incorporate specific limitations that require a certain amount of experimentation to determine beyond what the properties of the component parts can impart.  However, this issue will not be fully understood until the factual findings from the district court are presented and challenged.

Post-Alice Rulings On Subject Matter Eligibility Of Software Patents So Far

The Supreme Court ruled on Alice Corp. v. CLS Bank Int’l, 573 U.S. __, 134 S. Ct. 2347 (2014) on June 19, 2014. Since then, the Court of Appeals for the Federal Circuit has cited to Alice v. CLS Bank in deciding 4[1] cases and district courts have cited to Alice v. CLS Bank in 21[2] cases involving software patents. In all four Federal Circuit cases, the claims at issue were found to recite ineligible subject matter. In three[3] of the district court cases, the claims at issue survived the § 101 challenge and were found to be eligible subject matter. Two[4] of the district court cases involved motions on the pleadings in which the court found that discovery and/or a claim construction was required in order to assess eligibility under § 101, and the motions were dismissed without prejudice.

It has only been a little more than five months since the Supreme Court ruled on Alice v. CLS Bank. The post-Alice jurisprudence will continue to evolve. Still, the numbers do not look good for software patents. The courts in several of these cases made it clear that software is, in general, patentable subject matter.[5] However, the numbers so far suggest that software will always have a hard time proving itself eligible for patents.

It would help to see what we’ve learned so far. What do these cases say about what constitutes an abstract idea, an issue left unclear by Alice v. CLS Bank? What sets claims that survived the § 101 challenge apart from the majority that did not? And, what can practitioners do to improve the odds of surviving a § 101 challenge when drafting claims?

• What is an abstract idea?

Step 1 of the analysis set forth in Alice v. CLS Bank requires that the court determine if the claim at issue is drawn to an abstract idea. One criticism of the Supreme Court’s opinion in Alice v. CLS Bank is the lack of clarity as to when a claim is directed to an “abstract idea.” It was hoped clarification would come as courts interpret Alice v. CLS Bank.

The courts that have addressed subject matter eligibility so far have generally performed Step 1 by looking at the claims at issue as a whole to determine if the claims are directed to an idea or a concept, then whether that idea or concept has a particular tangible or concrete form, or is tied to a specific structure or machine.[6] Courts are finding claims directed to abstract ideas when the claims recite:

1. Organizing information through mathematical correlations or algorithms.[7]
2. Human Activity. Claims directed to processes, activities, or practices that can be, or are known to be performed by humans.[8]
3. Subject matter comparable to the claims at issue in Alice v. CLS Bank and Bilski.[9]

Claims directed to abstract ideas recite processes, activities, or practices, such as, business practices, advertising, marketing, or any other field involving human activity having meaning independent of a structural, physical or technological form. The subject matter recited in claims directed to abstract ideas may not be “abstract” in a real, or non-patent eligibility, sense. It can be argued that a bingo game, or transaction verification information, or charitable giving, or meal-planning are not abstract outside of a subject matter eligibility context. These activities are considered abstract in the context of patent eligibility when presented in a claim with no meaningful structure or physical form.

For those who draft claims, it may help to consider the term “abstract” in a § 101 context to simply mean a lack of recitation of, or lack of any tie to, any meaningful structure or machinery. In some of the claims in the cases so far, no structure or machine is recited and that fact is used to support the conclusion that the claim is directed to an abstract idea.[10] In other cases, the use of a computer is either recited, mentioned in the specification, or implied by the functional language of the claims. If such use merely involved generic computers or conventional computer functionality, claims were deemed drawn to an abstract idea under Step 1 of the analysis.[11]

• What did the subject matter eligible claims have that the ineligible claims didn’t?

Quite simply, more limitations.

In Cal. Inst. Of Tech. v. Hughes Communs., Inc. (“Caltech”), the court found that the claims at issue were drawn to abstract ideas in Step 1 of the Alice v. CLS Bank inquiry. The claims in the Caltech case were found to recite the fundamental concepts of encoding and decoding data, which have existed long before the patents and were well known in the field.[12] In the Court’s Step 2 analysis, the claims were found to recite “meaningful limitations that represent sufficiently inventive concepts.”[13] Examples of such limitations include irregular repetition of bits and the use of linear transform operations. The Court noted that these limitations are mathematical algorithms, but that they were narrowly defined and tied to a specific error correction process. These limitations were deemed to be not necessary or obvious tools for achieving error correction, and were found to ensure that the claims do not preempt the field of error correction.[14] The Court concluded that “Caltech’s patents improve a computer’s functionality by applying concepts unique to computing (like using a linear transform operation to encode data) to solve a problem unique to computing (data corruption due to noise).”[15] The software patent claims in the Caltech case are examples of claims that were found to be directed to an abstract idea, but also to recite “something more” so that the claims recite patent eligible subject matter.

In AutoForm Engineering GmbH v. Engineering Technology Associates, 2-10-cv-14141 (E.D. MI. September 5, 2014), the Court found patents pertaining to computer software that is used to create a tool, which is used to form sheet metal into different objects were drawn to eligible subject matter because they were not drawn to an abstract idea under Step 1.[16] The claims were found to contain “numerous limitations that narrow the scope of the patent.” Examples of the types of limitations found to narrow the scope of the patent include “(1) smoothing an irregular component edge; (2) filling in a fill surface; (3) forming a smooth component edge; (4) where the fill surface runs into the predefined component geometry by a continuous tangent; and (5) arranging sectional profiles along the smooth component edge … .”[17] Despite the fact that these steps were performed using generic computer automation, the Court found the patent at issue covers more than a mere abstract idea.[18] The software patent claims in the Autoform Engineering case are examples of software claims that do not recite an abstract idea under Step 1.

In Ameranth, Inc. v. Genesis Gaming Solutions, Inc., 11-00189 (C.D. Cal. November 12, 2014), the Court found system claims directed to a computer system/computerized method for monitoring a physical casino poker game were not drawn to an abstract idea in Step 1 of the Alice v. CLS Bank test.[19] The Court’s discussion focuses on the defendant’s arguments and provides little actual analysis of the claim language. The claims at issue in Ameranth v. Genesis Gaming Solutions include many computer-related elements and functions, such as “Computer system for monitoring … poker game,” “software enabled to …,” “a database …,” etc. The Court noted that the many different player reward systems could be implemented without infringing the claims, thereby ensuring that the abstract idea is not preempted.[20] The software patent claims in the Ameranth case are examples of software claims that do not recite an abstract idea under Step 1.

A common theme evident in the three cases that survived the § 101 challenge is a narrow claim scope. All three cases involved claims that recite computer-implemented applications that performed data transformations using algorithms, and conventional computer functions such as storing, retrieving and comparing data. However, the courts in these three cases found the claims to be sufficiently narrow to ensure concepts and abstract ideas are not preempted.

These cases in which the patents at issue survived the Alice v. CLS Bank test are district court cases likely headed to the Federal Circuit. It will be interesting to see how they fare on appeal.

• What can practitioners drafting claims do to stay clear of § 101 challenges?

Shortly after the Supreme Court issued its ruling in Alice v. CLS Bank, the USPTO issued preliminary examination instructions to examiners in view of the Alice v. CLS Bank decision. See

Click to access alice_pec_25jun2014.pdf

. These instructions to examiners essentially break down the Supreme Court’s opinion in a manner that would permit examiners to more easily apply the two-step process, which of course, can be helpful to practitioners as well. As far as the case law is concerned, any guidance that can be gleaned so far on surviving subject matter eligibility challenges is rather troublesome.

The post-Alice case law thus far suggests that patent eligible software claims should (1) recite meaningful structural limitations or ties to structure or machinery, and (2)  have a narrow scope so as to preclude preemption of an idea, concept or field. Of course, reciting meaningful structural limitations, or ties to structure, is only possible if the invention includes such features. Many software inventions are implemented using a generic computer and involve no other structure, hardware, or other physical element. Nevertheless, it may help to recite the computer-based elements as structural limitations. The claims at issue in Ameranth v. Genesis Gaming Solutions are examples of claims reciting as much structure as possible for an invention implemented as software.

Drafting claims with a narrow scope seems to be the best strategy for surviving subject matter eligibility challenges. The courts in the three cases in which software claims were deemed eligible subject matter found the narrow scope of the claims to be an important factor in finding subject matter eligibility. The narrow scope appealed to the courts because it helped preclude preemption of any fields, concepts or ideas. However, the cases only noted that the claims had limitations that narrowed the scope of the claims, or allowed for non-infringing implementations[21]. No distinction was made between narrowing the scope to preclude preemption and broadening the scope in the context of novelty or infringement. This is the troubling part.

Drafting narrow claims to ensure software is patent-eligible presents a challenge for patent practitioners. Patent practitioners are trained to draft claims with the broadest possible scope in order to ensnare as many infringers as possible. Claims are narrowed as required by the prior art. Practitioners must now ensure claims are sufficiently narrow to be patent eligible. The problem is claims have a scope regardless of the context. A claim that is narrowed for purposes of subject matter eligibility is also narrowed in the context of an infringement analysis. How narrow must a claim be to be patent eligible and still have a sufficient scope to ensnare as many infringers as possible?

Perhaps this is a question practitioners will have to consider on a case-by-case basis. The case law so far does not suggest any answer and it likely never will. Some guidance may come as post-Alice jurisprudence evolves. However, it would be far better if courts moved away from considering the scope of a claim in determining subject matter eligibility.

[1] Digitech Image Technologies, LLC v. Electronics for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014); Planet Bingo, LLC v.VKGS LLC, 576 Fed. App’x 1005 (Fed. Cir. 2014) (non-precedential); buySafe, Inc. v. Google, Inc., 765 F.3d 1350 (Fed. Cir. 2014); Ultramerical v. Hulu, 10-1544 (Fed. Cir. 2014).

[2] Hemopet v. Hill’s Pet Nutrition Inc., 8-12-cv-01908 (C.D. Cal. November 24, 2014); Ameranth, Inc. v. Genesis Gaming Solutions, Inc., 11-00189 (C.D. Cal. November 12, 2014); Enfish, LLC v. Microsoft Corp, 2-12-cv-07360 (C.D. Cal. Nov. 3, 2014); Cal. Inst. Of Tech. v. Hughes Communs., Inc., 2-13-cv-07245 (C.D. Cal. November 3, 2014); Peter H. Wolf v. Capstone Photography, 2-13-cv-09573 (C.D. Cal. October 28, 2014); Amdocs (Israel) Limited v. Openet Telecom, Inc. et al., 1-10-cv-00910 (E.D. Va. October 24, 2014); DietGoal Innovations LLC v. Chipotle Mexican Grill, Inc., 2-12-cv-00764 (E.D. Tx. October 3, 2014); Cogrent Medicine Inc. v. Elsevier Inc., 5-13-cv-04479 (N.D. Cal. September 30, 2014); Card Verification Solutions, LLC v. Citigroup, Inc., 1-13-cv-06339 (N.D. Ill. September 29, 2014); McRo, Inc. v. Namco Bandai Games America, Inc., 2-12-cv-10322 (C.D. Cal. September 22, 2014); Open Text S.A. v. Alfresco Software LTD et al., 3-13-cv-04843 (N.D. Cal. September 19, 2014); Every Penny Counts, Inc. v. Wells Fargo Bank N.A., 8-11-cv-02826 (M.D. Fla. September 11, 2014); AutoForm Engineering GmbH v. Engineering Technology Associates, 2-10-cv-14141 (E.D. Mi. September 5, 2014); Eclipse IP LLC v. McKinley Equipment Corporation, 8-14-cv-00742 (C.D. Cal. September 4, 2014); Loyalty Conversion Systems Corporation v. American Airlines, Inc.,k 2-13-cv-00655 (E.D. Tx. September 3, 2014); Tuxis Technologies LLC v. Amazon.com Inc., 1-13-cv-01771 (D. Del. September 3, 2014); Walker Digital LLC v. Google Inc., 1-11-cv-00318 (D. Del. September 3, 2014); CMG Financial Services Inc. v. Pacific Trust Bank FSB et al., 2-11-cv-10344 (C.D. Cal. August 29, 2014); Data Distribution Technologies LLC v. BRER Affiliates Inc. et al., 1-12-cv-04878 (D. NJ. August 19, 2014); Comcast IP Holdings I LLC v. Sprint Communications Company LP et al., 1-12-cv-00205 (D. Del. July 16, 2014); DietGoal Innovations LLC v. Bravo Media LLC, 1-13-cv-08391 (S.D. NY July 8, 2014).

[3] Ameranth, Inc. v. Genesis Gaming Solutions, Inc., 11-00189 (C.D. Cal. November 12, 2014); Cal. Inst. Of Tech. v. Hughes Communs., Inc., 2-13-cv-07245 (C.D. Cal. November 3, 2014); AutoForm Engineering GmbH v. Engineering Technology Associates, 2-10-cv-14141 (E.D. Mi. September 5, 2014).

[4] Card Verification Solutions, LLC v. Citigroup, Inc., 1-13-cv-06339 (N.D. Ill. September 29, 2014); Distribution Technologies LLC v. BRER Affiliates Inc. et al., 1-12-cv-04878 (D. NJ August 19, 2014).

[5] See e.g. Cal. Inst. Of Tech. v. Hughes Communs., Inc., 2-13-cv-07245, pg. 12-13 (C.D. Cal. Nov. 3, 2014); Enfish, LLC v. Microsoft Corp, 2-12-cv-07360, pg. 4-5 (C.D. Cal. Nov. 3, 2014).

[6] See Ultramerical v. Hulu, 10-1544, pg. 9-10 (Fed. Cir. 2014), Digitech Image Technologies, LLC v. Electronics for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014).

[7] See e.g. Digitech Image Technologies, LLC v. Electronics for Imaging, Inc. at 11 (organizing information through mathematical correlations); Enfish, LLC v. Microsoft Corp, 2-12-cv-07360, pg. 11-12 (Concept of organizing information using tabular formats); Cogrent Medicine Inc. v. Elsevier Inc., 5-13-cv-04479 (N.D. Cal. September 30, 2014) (Maintaining and searching a library of information); Every Penny Counts, Inc. v. Wells Fargo Bank N.A., 8-11-cv-02826 (M.D. FL. September 11, 2014) (Modifying transaction amounts and depositing designated differences into a recipient account).

[8] See e.g. Planet Bingo, LLC v.VKGS LLC, 576 Fed. App’x 1005 (Fed. Cir. 2014) (non-precedential) (Computer-aided management of a bingo game); buySafe, Inc. v. Google, Inc., 765 F.3d 1350 (Fed. Cir. 2014) (creating a contractual relationship); Card Verification Solutions, LLC v. Citigroup, Inc., 1-13-cv-06339 (N.D. Ill. September 29, 2014) (Verifying transaction information); Every Penny Counts, Inc. v. Wells Fargo Bank N.A., at 9 (concept of routinely modifying transaction amounts and depositing designated, incremental differences into a recipient account is “basic concept” and a “fundamental economic practice long prevalent in our system of commerce.”); CMG Financial Services Inc. v. Pacific Trust Bank FSB et al., 2-11-cv-10344 (C.D. Cal. August 29, 2014) (Mortgagee paying down a mortgage early when funds are available and borrowing funds as needed to reduce the overall interest charged by the mortgage); DietGoal Innovations LLC v. Bravo Media LLC, 1-13-cv-08391 (S.D. NY July 8, 2014) (Computerized meal-planning).

[9] See Planet Bingo, LLC v.VKGS LLC, 576 Fed. App’x 1005; Card Verification Solutions, LLC v. Citigroup, Inc., 1-13-cv-06339.

[10] See Digitech Image Technologies, LLC v. Electronics for Imaging, Inc. at 11 (abstract idea of organizing information through mathematical correlations and not tied to a structure or machine); Ultramerical v. Hulu, 10-1544, pg. 9 (The claim’s “ordered combination of steps recites an abstraction-an idea, having no particular concrete or tangible form”); Card Verification Solutions, LLC v. Citigroup, Inc., 1-13-cv-06339, pg. 6-8 (Claims are drawn to concept of verifying transaction information … and silent regarding machinery.”); CMG Financial Services Inc. v. Pacific Trust Bank FSB et al., 2-11-cv-10344, pg. 27 (Abstract idea … not tied to a specific structure.).

[11] See Planet Bingo, LLC v.VKGS LLC, 576 Fed. App’x 1005, pg. 4 (steps of selecting, storing, and retrieving … can be carried out in existing computers long in use.); Enfish, LLC v. Microsoft Corp, 2-12-cv-07360, pg. 12 (When a claim recites a computer generically, the Court should ignore this element in defining the claim’s purpose); Eclipse IP LLC v. McKinley Equipment Corporation, 8-14-cv-00742, pg. 10-11 (C.D. Cal. September 4, 2014) (using “generic communication devices” is insufficient).

[12] Cal. Inst. Of Tech. v. Hughes Communs., Inc., 2-13-cv-07245, pg. 27.

[13] Id. at 28.

[14] Id.

[15] Id. at 37.

[16] AutoForm Engineering GmbH v. Engineering Technology Associates, 2-10-cv-14141, pg. 6-8 (E.D. MI. September 5, 2014).

[17] Id. at 7.

[18] Id. 8.

[19] Ameranth, Inc. v. Genesis Gaming Solutions, Inc., 11-00189, pg. 7-10 (C.D. Cal. November 12, 2014).

[20] Id. at 10.

[21] Id. at 10.

In re Cuozzo Speed Technologies, LLC: Is BRI the correct standard for IPR claim construction?

On November 3, 2014, the Federal Circuit heard oral arguments in the appeal of the first inter partes review decided under the America Invents Act. In the case, In re Cuozzo Speed Technologies, LLC, Fed. Cir. 14-1301, the Federal Circuit has been asked to review the procedures of the new inter partes review proceedings, especially the standard of claim construction and the availability of appeals for IPR institution decisions.

In re Cuozzo Speed Technologies was the first inter partes review instituted by the PTAB after the AIA went into effect in September 2012. Since that time, the IPR procedure has been highly popular with accused infringers. The USPTO reported that, as of September 25, 2014, a total of 1,821 petitions for IPR had been filed. The PTAB has reached a decision on whether to institute review for 938 of those petitions. In 731 of those decisions, the PTAB instituted an IPR. At this time, the first appeals out of the IPR proceedings are beginning to reach the Federal Circuit, with various challenges to the PTAB’s rules and regulations.

One of the primary concerns raised by patent owners is that the standard relied upon during an instituted IPR, the “broadest reasonable interpretation,” in contrast to the “ordinary and customary meaning” construction standard relied upon during court proceedings.

During the oral arguments, the judges appeared largely supportive of the overall IPR procedure, although they also noted concerns about some of the IPR rules. As asked by Judge Pauline Newman, “So after the patent has issued, why should the result be different in the office than in the court, based on how the claims are construed?” Under the BRI standard, a broader swath of prior art is available to patent challengers and/or accused infringers. The primary justification raised for using the BRI standard is that patentees can amend their claims during the IPR proceeding in response to the PTAB’s construction of the claims. Judge Newman also pushed back on this claim, noting that “It’s not so easy.”

As noted by attorneys for Cuozzo Speed Technologies, in the two years of AIA IPR proceedings, no opposed motion to amend has been granted. Previously, former Federal Circuit Chief Judge Randall Rader even referred to the IPR proceedings as “death squads.”

The other main issue raised by In re Cuozzo Speed Technologies, LLC is whether “non-discretionary” jurisdictional requirements of the IPR proceedings may be appealed. According to briefs filed by Cuozzo, the “non-discretionary” requirements encompass: 1) “the petition must be filed by a person who is not the patent owner (35 U.S.C. § 311(a))”; 2) “the grounds of un-patentability must be limited to 35 U.S.C. § 102 or 103 and only based on patents or printed publications (35 U.S.C. § 311(b))”; 3) “the petitioner or real party in interest cannot have filed a civil action challenging the validity of a claim of the patent (35 U.S.C. § 315(a))”; and 4) “the petitioner, real party in interest or privy of the petitioner cannot have been served with a complaint alleging infringement of the patent more than 1 year before the date on which the petition is filed (35 U.S.C. § 315(b)).” See Reply Brief of Appellant, In re Cuozzo Speed Techs., LLC, No. 2014-1301, 2014 WL 3055159, at *2-3 (Fed. Cir. June 23, 2014). The issues raised by Cuozzo are relevant, because under 35 U.S.C. § 314(d) “The determination by the Director whether to institute an inter partes review under this section shall be final and non-appealable.”

The decision of the Federal Circuit in In re Cuozzo Speed Technologies, LLC will impact the IPR decisions that are just beginning to reach the courts, and potentially alter the course of the IPR proceedings if the Federal Circuit agrees that the BRI standard is inappropriate.

Regardless of the decision, the IPR proceedings remain an attractive option for accused patent infringers, given the substantially lower cost of the IPR proceedings versus litigation, as well as the accelerated timeline of IPRs. But for patent owners, the decision could signal an attempt to balance the IPR proceedings from thus far being heavily in favor of the patent challenger.

By: Matt Remissong