Tag: patent

DNA Sequencing Patents: Simultaneous Invention As Secondary Evidence Of Obviousness

I do not usually write about non-precedential Federal Circuit decisions, but I could not let the discussion of “simultaneous invention” in Columbia University v. Illumina, Inc., go without comment. As if protecting patents from a hindsight-based determination of obviousness is not challenging enough, this theory holds that subsequent invention by another relatively soon after the invention at issue can support a finding of obviousness.

The Columbia University DNA Sequencing Patents

The patents at issue were three DNA sequencing patents: U.S. Patent No. 7,713,698; U.S. Patent No. 8,088,575; and U.S. Patent No. 7,790,869. Illumina challenged selected claims of the patents in Inter Partes Review (IPR) proceedings, and the USPTO Patent Trial and Appeal Board (PTAB) found all challenged claims anticipated or obvious over the asserted prior art references.

The Obviousness Issue

The Federal Circuit opinion was authored by Judge Wallach and joined by Chief Judge Prost and Judge Schall.

As summarized in the Federal Circuit opinion, the claims at issue “involve modified nucleotides that contain: (1) a labeled base; (2) a removable 3’-OH cap; and (3) a deazasubstituted base.” Columbia argued that “‘it would not have been obvious … to use ‘a reversible chain-terminating nucleotide with a label attached to the base, rather than to the cap on the 3’-OH group of the sugar.’”

After reviewing the prior art, the court found substantial evidence to support the PTAB’s findings regarding the disclosures of the asserted prior art references and reasonable expectation of success. It is in its discussion of secondary considerations of non-obviousness that the court discusses “simultaneous invention”:

“Independently made, simultaneous inventions, made within a comparatively short space of time, are persuasive evidence that the claimed apparatus was the product only of ordinary mechanical or engineering skill.” George M. Martin Co. v. Alliance Mach. Sys. Int’l LLC, 618 F.3d 1294, 1305 (Fed. Cir. 2010) ….

*****

As a secondary consideration … simultaneous invention is relevant when it occurs within a short space of time from the date of invention, and “is strong evidence of what constitutes the level of ordinary skill in the art.” Ecolochem v. S. Cal. Edison Co., 227 F.3d 1361, 1379 (Fed. Cir. 2000). Unlike the ultimate determination of obviousness, which requires courts to answer the hypothetical question of whether an invention “would have been obvious,” 35 U.S.C. § 103, simultaneous invention demonstrates what others in the field actually accomplished.

On the facts before it, the court noted that “Illumina did not present its simultaneous invention argument to the PTAB,” and because “the record is not fully developed, the evidence of simultaneous invention as a whole weighs only modestly in favor of obviousness.”

Why cite it as a factor at all if it wasn’t raised in the PTAB proceedings on appeal?

Simultaneous Invention

I traced the theory of “simultaneous invention” through the cases cited in the Federal Circuit decision.

In George M. Martin Co., the Federal Circuit already had determined that the district court had “correctly concluded as a matter of law that the differences between the prior art and the claimed improvement were minimal,” before it discussed “simultaneous invention.” Even then, it discussed it with this caveat:

Independently made, simultaneous inventions, made “within a comparatively short space of time,” are persuasive evidence that the claimed apparatus “was the product only of ordinary mechanical or engineering skill.” Concrete Appliances Co. v. Gomery, 269 U.S. 177, 184, 46 S.Ct. 42, 70 L.Ed. 222 (1925). But see Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1460 (Fed. Cir. 1984) (“Because the statute, 35 U.S.C. § 135, (establishing and governing interference practice) recognizes the possibility of near simultaneous invention by two or more equally talented inventors working independently, that occurrence may or may not be an indication of obviousness when considered in light of all the circumstances.”).

In Ecolochem, the Federal Circuit discussed “simultaneous invention” in the context of reflecting the level of ordinary skill in the art, not obviousness per se:

The fact of near-simultaneous invention, though not determinative of statutory obviousness, is strong evidence of what constitutes the level of ordinary skill in the art.” The Int’l Glass Co. v. United States, 187 Ct.Cl. 376, 408 F.2d 395, 405 (1969). “[T]he possibility of near simultaneous invention by two or more equally talented inventors working independently, … may or may not be an indication of obviousness when considered in light of all the circumstances.” Lindemann, 730 F.2d at 1460, 221 USPQ at 487.

In the pre-Patent Act 1925 decision in Concrete Appliances Co., the Supreme Court noted that “[t]he several elements in the petitioners’ claims which we have enumerated embrace familiar devices long in common use, separately or in smaller groups, both in this and in kindred mechanical arts. It is not argued that there is any novelty in such units or groups; and the only serious question presented is whether, in combination in the apparatus described, they constitute an invention.” The Court then discussed numerous examples of similar devices made around the same time as the invention at issue before it explained:

The adaptation independently made by engineers and builders of these familiar appliances to the movement and distribution of wet concrete in building operations and the independent patent applications, within a comparatively short space of time, for devices for that purpose are in themselves persuasive evidence that this use in combination of well known mechanical elements was the product only of ordinary mechanical or engineering skill and not of inventive genius.

This appears to be the genesis of “simultaneous invention.”

Now that U.S. patent applicants are becoming accustomed to the importance of being the “first inventor to file” under the America Invents Act, do they also have to worry about how many file after them?

ARTICLE BY Courtenay C. Brinckerhoff of Foley & Lardner LLP
© 2015 Foley & Lardner LLP

Mixing Things Up: Let’s Talk Recipes, Part Two of a Four-Part Series (Patent)

Discussions about protecting intellectual property often focus on cutting-edge technologies, corporate branding campaigns, and widely distributed artistic works like movies and music.  But let’s mix things up a bit.  Follow us through this four-part series as we answer a question that is sure to hit home for anyone with taste buds—can you protect a food recipe?  In Part 1, here, we examined whether food recipes are eligible for copyright protection.

CupcakeWe concluded that, although a recipe itself is not eligible, you can claim copyrights in certain commentary, illustrations, or other expressive elements used to present the recipe.  Here, in Part 2, we investigate whether patent protection offers a viable solution for chefs, bakers, restaurateurs, and others hoping to safeguard their culinary creations.  Later, in Parts 3 and 4, we will break down whether recipes are eligible for trade secret protection (Part 3) or trademark/trade dress protection (Part 4).

PART 2: Can you Patent a Recipe?

To qualify for patent protection, an invention must be useful, new, and nonobvious. See 35 U.S.C. §§ 101-103. It must also fall into one of the Patent Act’s defined categories of “patent-eligible subject matter” (some things are outright barred from receiving patent protection, such as a mathematical algorithm). See 35 U.S.C. § 101. To warrant patent protection, a recipe must satisfy all four requirements.

On the “patent-eligible subject matter” front, a recipe would need to qualify as either a “process,” a “machine,” a “manufacture,” or a “composition of matter.”  See 35 U.S.C. § 101.  Of those categories, we can safely eliminate “machine” as a potential candidate and focus on the remaining possibilities.

A “process” is “a mode of treatment of certain materials to produce a given result.  It is an act, or series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing.”Gottschalk v. Benson, 409 U.S. 63, 70 (1972). Most recipes are essentially a set of step-by-step instructions for combining specified ingredients to produce a dish or food product. Thus, as a “series of acts” that transforms ingredients into a different end product, a recipe could constitute a patent-eligible “process.”

A “manufacture,” more commonly called “an article of manufacture,” is “an article produced from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by handlabor or by machinery.” Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980). A recipe itself does not qualify as an article of manufacture, but many consumer food products created according to a recipe likely qualify (think Hot Pockets® sandwiches, for example).

A “composition of matter” is “all compositions of two or more substances and all articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids, for example.” Chakrabarty, 447 U.S. at 308.  Most recipes—a basic cake batter recipe, for instance—call for the mechanical or chemical mixture of “fluids” and “powders or solids” (e.g., water and flour).  Accordingly, although a recipe is not a “composition of matter,” the end product could be.

Thus, a recipe can be a patent-eligible process, while a resulting dish or food product can be a patent-eligible article of manufacture or composition of matter. But whether or not a recipe is patent-eligible subject matter is only one of four hurdles along the road to patent protection. The recipe must also be useful, new, and nonobvious.  The bar for what counts as “useful” under the Patent Act is low and, as a result, virtually every recipe will satisfy the usefulness requirement.

When it comes to demonstrating that a recipe is “new” and “nonobvious,” however, the road gets much tougher.  Every recipe seeking patent protection must distinguish itself from the millions of recipes that preceded it (eating is, after all, one of our most basic needs). Not only are multitudes of recipes already known, but in many cases the properties and effects of the underlying ingredients are also well-known. Adding a roux to a soup, for example, will predictably thicken the soup. Adding chocolate chips to a cake recipe will predictably increase the likelihood that the resulting cake will taste like, well, chocolate. When examining patent applications, the U.S. Patent and Trademark Office often views the results obtained from combining well-understood ingredients as having been predictable or obvious to people of ordinary skill in the culinary arts.

But take heart, innovative foodies, because the Patent Office does occasionally grant patents for recipes, dishes, and food products.  Many of them involve an unconventional step, ingredient, or end product.  Check out, for instance, U.S. patent number 5,894,027 titled Milk and protein powder-coated cereal products; U.S. patent number 8,147,893 titled Refrigerator stable pressurized baking batter; U.S. patent number 5,510,137 titled Sweet ice stuffs and jellied foods; or U.S. patent number 8,236,366 titled Flavorful Waterless Coffee. As the Patent Office recently put it, “[i]f you look at most of these patents, you’ll find that the recipe was more likely to have been created in a laboratory than on a kitchen counter.”  Larry Tarazano. Can Recipes Be Patented?  United States Patent and Trademark Office. InventorsEye 4:3 (June 2013). With the popularity of modernist techniques like “molecular gastronomy” on the rise (molecular gastronomy focuses on transforming physical and chemical properties to produce new tastes and textures), we could see a slight uptick in recipe patents in the coming years.

In short, returning to our original question—can you patent a food recipe?—the answer is “yes, if you can overcome the difficult nonobviousness hurdle.” Stay tuned for the next part of our series as we investigate the benefits of safeguarding a recipe under the banner of trade secret protection.

ARTICLE BY Kyle N. Siegal of Lewis Roca Rothgerber LLP

©2015 All Rights Reserved. Lewis Roca Rothgerber LLP

In Light of Supreme Court’s Spider-Man Case, Which Antitrust Precedents are Ripe for Overturning?

On June 22, 2015, the US Supreme Court in Kimble v. Marvel Entertainment LLC declined on stare decisis grounds to overturn a criticized intellectual property precedent on royalty payments. In both the majority and dissenting opinions, the justices said that their respect for precedent would have been less had it been one interpreting the Sherman Antitrust Act. These comments prompt the question: Which old and criticized antitrust precedent might be subject to reversal?

Kimble had a patent on a device that allowed a user to shoot webs—really, just pressurized foam string—from the palm of his hand. Kimble and Spider-Man’s owner, Marvel, reached an agreement that allowed Marvel to sell such toys in exchange for a lump sum payment to Kimble plus a 3% annual royalty that had no end date. After years of payments, Marvel discovered Brulotte v. Thys Co., a 1964 Supreme Court case that had read the patent laws to prevent a patent owner from receiving royalties for sales made after the patent’s expiration. The Court considered such arrangements illegal per se because they were attempts to extend the patent’s monopoly beyond the patent’s life. Relying on that precedent, Marvel convinced lower courts that its payments to Kimble should stop with the 2010 expiration of the patent.

Kimble asked the Court to overturn Brulotte and replace it with a rule of reason analysis. Six justices declined that invitation, saying the long-standing precedent was based on an interpretation of patent statutes that Congress could, but had declined to, amend and that contracting parties might have relied on. The dissent would have overturnedBrulotte because its rationale was based on now-discredited antitrust policy, not statutory interpretation.

Perhaps more interesting to antitrust practitioners, the two opinions discussed the lower level of respect for the Court’s antitrust precedents. As the majority opinion pointed out, Congress “intended [the Sherman Act’s] reference to ‘restraint of trade’ to have ‘changing content,’ and authorized courts to oversee the term’s ‘dynamic potential.’” As a result, the Court has “felt relatively free to revise our legal analysis as economic understanding evolves.” The dissent agreed, saying “we have been more willing to reexamine antitrust precedents because they have attributes of common-law decisions.”

Given that seeming-unanimity on the weakness of antitrust precedents, the next obvious question for antitrust lawyers is which antitrust precedents might be overturned. One candidate is the so-called baseball exemption. In 1922’s Federal Baseball Club v. National League, the Court found that the “business [of] giving exhibitions of base ball” did not constitute interstate commerce and so was not reached by the Sherman Act. Commentators and even subsequent Court opinions have termed the decision an “anomaly” (though refusing to overturn it).  Even retired Justice Stevens criticized the breadth of the exemption in a recent speech. In reaching this conclusion, Stevens relied on his experience on the Court, his early representation of the former A’s owner, and his work for Congress in the 1950s as it studied the exemption. Yet, while lower court decisions and The Curt Flood Act of 1998 have narrowed its scope, the exemption is still very much alive and has been used recently to cut short actions involving both the Cubs and the A’s. The Court could revisit the exemption yet again if it accepts the cert petition from the City of San Jose in the case involving the latest possible relocation of the A’s franchise.

Another candidate is the per se rule against tying, the only remaining vertical restraint to which the per se rule applies. In a tying arrangement, a seller agrees to sell one product (“tying product”) but only on the condition that the buyer also purchase a different product (“tied product”). Early Court cases applied the per se rule and described the arrangements harshly, saying they “serve hardly any purpose beyond the suppression of competition.” More recently, the Court has recognized that tying might be pro-competitive in certain circumstances. It has retained a rule that it calls per se; however, unlike per se rules against horizontal price fixing and the like, the tying per se rule requires proof of the seller’s power in the market for the tying product. If an appropriate case reaches the Court, it might complete the evolution of vertical restraints analysis and make all tying arrangements subject only to the rule of reason.

Finally, the Court’s 1963 Philadelphia National Bank opinion has faced severe criticism. In that case, the Court found that a merger that “produces a firm controlling an undue percentage share of the relevant market, and results in a significant increase in the concentration of firms” is presumptively anticompetitive. While that presumption has been significantly weakened in the various iterations of the DOJ/FTC Horizontal Merger Guidelines, it still plays a role at least when the agencies challenge a merger in court. FTC Commissioner Wright has called it bad law based on outdated economics and has criticized its continued use by the agencies. DOJ Assistant Attorney General Bill Baer, on the other hand, has called the presumption a useful tool for the agencies when challenging mergers in court. Because so few merger cases go beyond the preliminary injunction standard, let alone all the way to the Supreme Court, this precedent might remain safe.

ARTICLE BY Steven J. Cernak, Gregory L. Curtner & William M. Hannay

© 2015 Schiff Hardin LLP

New Amendments to USPTO Post-Grant Regulations

OUS-PatentTrademarkOffice-Sealn May 19, 2015, the United States Patent and Trademark Office (USPTO) issued a final rule amending its regulations that apply to post-grant proceedings. These new rules deal with ministerial changes such as increasing page limits and making the regulations reflect the current practices used by the Patent Trial and Appeal Board (PTAB).

A second set of rule changes—to be issued later this year—will be more substantive and issued in proposed form first with an opportunity for public comment. We will issue an On the Subject when the second set of rules is issued, and we will be happy to assist with the submission of any comments. Below is a brief overview of the major provisions of this first amendment to the regulations.

  • Motions to Amend. The page limit for motions to amend, and oppositions to motions to amend, is increased from 15 pages to 25 pages. The required claim listing may now be made in an appendix accompanying the motion to amend, and the appendix is not counted toward the 25-page limit.

  • Petitioner’s Reply Brief. The page limit for the petitioner’s reply to patent owner’s response after institution is increased from 15 pages to 25 pages.

  • Font Style. All filings must be in 14-point, Times New Roman proportional font.

  • Back-Up Counsel. The rules are modified to make it clear that there can be more than one back-up counsel. There may be only one lead counsel.

  • Fees. The rules clarify that you must include in the number of claims in the petition when calculating the required fees each challenged claim as well as any claim from which a challenged claim depends, unless that claim is separately challenged. The USPTO explains that the claims from which the dependent claim depends must be construed along with the dependent claim.

  • Right to Depose. The rules make clear that routine or automatic discovery only includes affidavit testimony prepared for the post-grant proceeding. Consequently, if an affidavit is submitted from a district court proceeding, a motion must be filed to depose that affiant.

  • Objections to Evidence. The rule makes it clear that objections to evidence must be filed with the PTAB and served on opposing counsel.

  • Covered Business Method Proceedings. The rule explicitly provides that a covered business method proceeding may not be instituted where the petitioner filed a civil action challenging the validity of a claim of the patent before filing the petition. The change was made to track the statute.

ARTICLE BY Bernard Knight & Carey C. Jordan of McDermott Will & Emery
© 2015 McDermott Will & Emery

Ariosa Diagnostics, Inc. v. Sequenom, Inc. – Another Diagnostic Patent Meets its End

On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015) finding that the claims of U.S. Patent No. 6,258,540 (the ‘540 patent) did not meet the patent-eligibility requirements of 35 U.S.C. §101.

The ‘540 patent

The ‘540 patent claims certain methods of using cell-free fetal DNA (cffDNA). In 1996, the inventors, Doctors Dennis Lo and James Wainscoat, discovered cffDNA in material plasma and serum. Traditionally, this portion of maternal blood samples was discarded by researchers as medical waste. As a result, the inventors developed a method for detecting a small fraction of paternally inherited cffDNA in maternal plasma or serum to determine certain fetal characteristics, such as gender. The method was commercialized by Sequenom as the MaterniT21 test. An advantage provided by the test is that it created an alternative for prenatal diagnosis of fetal DNA that avoided the risks of widely-used techniques that took samples from the fetus or placenta.

In addition to claiming methods of using cffDNA, the ‘540 patent also provides for making a diagnosis of certain fetal characteristics based on the detection of paternally inherited cffDNA. According to the specification, a pregnant woman carrying a fetus with certain genetic defects has more cffDNA in her blood than a woman with a normal fetus.

Claims 1, 24 and 25 of the ‘540 patent recite:

1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:

amplifying a paternally inherited nucleic acid from the serum or plasma sample, and

detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

24. A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises:

removing all or substantially all nucleated and a nucleated cell populationS from the blood sample,

amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the paternally inherited fetal nucleic acid.

25. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises:

obtaining a non-cellular fraction of the blood sample,

amplifying a paternally inherited nucleic acid from the non-cellular fraction,

and performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid.

The remaining claims describe how the method of detection occurs or how it can be used. For example, claim 2, which depends from claim 1, recites amplification by polymerase chain reaction (PCR). Claim 4, which also depends from claim 1, recites detection by a sequence specific probe.

District Court Proceedings

Ariosa Diagnostics, Inc. (Ariosa) and Natera, Inc. (Natera) make and sell alternative non-invasive tests that compete with Sequenom’s MaterniT21 test. Specifically, Ariosa sells the Harmony Test, a non-invasive test used for prenatal diagnosis of certain fetal characteristics, and Natera sells the Non-Invasive Paternity Test, which is used to confirm the paternity or non-paternity of a gestating fetus from genetic information in fetal DNA available in the blood of a pregnant female.

In response to letters threatening claims of infringement, from December 2011 through early 2012, Ariosa and Natera each filed separate declaratory judgment actions against Sequenom alleging non-infringement of the ‘540 patent. Sequenom counterclaimed alleging infringement. Sequenom filed a motion seeking an preliminary injunction to enjoin Ariosa from selling the Harmony Prenatal test. In July 2012, the district court denied the motion finding that there was a substantial question over whether the subject matter of the asserted claims was directed to eligible subject matter. Sequenom appealed to the Federal Circuit.

In August 2013, the Federal Circuit vacated and remanded the case, holding that the district court erred in certain respects not relevant to this appeal. Additionally, the Court did not offer any opinion regarding the subject matter eligibility of the asserted claims.

After remand, the parties filed cross motions for summary judgment regarding invalidity under 35 U.S.C. §101. The district court found that the ‘540 patent was directed to the natural phenomenon of paternally inherited cffDNA and that the claims did not add enough to the natural phenomenon to make the claims patent eligible under §101. According to the district court, at the time of the filing of the ‘540 patent in 1997, the steps of amplifying and detecting were well-understood, routine, or conventional. Thus, the district court concluded that the ‘540 patent was not directed to patentable subject matter finding that the only “inventive concept of the processes of the ‘540 patent is to apply those well-understood, routine processes to paternally inherited cffDNA, a natural phenomenon”. Additionally, the district court also found that the claimed processes posed a risk of preempting a natural phenomenon. Sequenom appealed.

Federal Circuit Decision

The Federal Circuit began its decision by setting forth the two-prong patent-eligibility test (citing Mayo Collaborative Services v. Prometheus Laboratories, Inc. (March 2012)). The first prong is to determine whether the claims at issue are directed to a patent-ineligible concept. If answered in the affirmative, the second prong is to determine whether the elements of each claim, both individually and as an ordered combination, recite additional elements that transform the nature of the claim into a patent-eligible invention that amounts to significantly more than the ineligible concept itself.

Regarding the first prong, the Federal Circuit noted that the claims of the ‘540 patent were method claims, which generally constitute eligible subject matter. However, upon further inspection, the Court further noted that the claims were directed to a multistep method that began with cffDNA taken from a maternal plasma or serum sample. cffDNA was naturally occurring and circulated freely in the blood stream of a pregnant woman. As a result, the existence of cffDNA in maternal blood was a natural phenomena. The Court further noted that the method ended with paternally inherited cffDNA, which was also a natural phenomena. Therefore, because the method began and ended with a natural phenomenon, the Federal Circuit held that the claims were directed to naturally occurring matter. The Court stated that the specification supported its conclusion. For example, column 1, lines 50-51 states: “[i]t has now been discovered that foetal DNA is detectable in maternal serum or plasma samples”, column 13, line 11-13 states: “[t]hese observations indicate that maternal plasma/serum DNA may be a useful source of material for the non-invasive prenatal diagnosis of certain genetic disorders,” and column 16, lines 12-14 states: “[t]he most important observation in this study is the very high concentration of foetal DNA in maternal plasma and serum”.

Regarding the second prong, the Federal Circuit concluded that the practice of the method claims did not result in an inventive concept that transformed the natural phenomena of cffDNA into a patentable invention. Specifically, the Court stated that for process claims that encompass natural phenomenon, the process steps must recite additional features that are new and useful. According to the Court:

“The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.”

With respect to the preparation and amplification steps, the Court noted that the specification confirmed that in 1997 that these steps were well-understood, routine, conventional activities performed by doctors. Additionally, Sequenom’s expert testified that PCR and other methodologies for amplifying DNA were well known in 1997. The Court further found that the detecting steps were also similarly well-understood, routine and conventional.

Regarding the dependent claims, the Court found that these claims were broad examples of how to detect cffDNA in maternal plasma. The Court noted that these claims were focused on the use of the natural phenomenon in combination with well-understood, routine and conventional activity.

The Court concluded stating

“Thus in this case, appending routine conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept. Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.”

Regarding preemption, Sequenom argued that there were numerous other uses of cffDNA aside from those claimed in the ‘540 patent and as a result, the ‘540 patent did not preempt all uses of cffDNA. The Federal Circuit disagreed. The Court noted that while preemption might signal patent ineligible subject matter, the absence of complete preemption did not demonstrate patent eligibility. Specifically, in this case, the Court noted that Sequenom’s attempts to limit the breadth of the breadth of the claims by showing alternative uses of cffDNA outside the scope of the claims did not change the conclusion that the claims were directed to patent ineligible subject matter.

At the end of the opinion, the Court addressed Sequenom’s arguments that before the ‘540 patent that “no one” was using plasma or serum of pregnant mothers to amplify and detect paternally-inherited cffDNA. Moreover, Sequenom noted that the 1997 Lancet publication of the inventors had been cited over a thousand times and that the claimed method utilized the man-made tools of biotechnology in a new way that revolutionized prenatal care. The Court agreed but noted, citing to Ass’n for Molecular Pathology v. Myriad Genetics, Inc. (June 2013), that just because a discovery is groundbreaking, innovative or brilliant does not by itself satisfy §101. The Court stated:

“While Drs. Lo and Wainscoat’s discovery regarding cffDNA may have been a significant contribution to the medical field, that alone does not make it patentable. We do not disagree that detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science. But even such valuable and contributions can fall short of statutory patentable subject matter, as it does here”.

ARTICLE BY Lisa L. Mueller of Michael Best & Friedrich LLP

© MICHAEL BEST & FRIEDRICH LLP

Allvoice Decision Provides Roadmap For Software-based Inventions

In a refreshing break from Alice/Mayo abstract idea based 35 U.S.C. § 101 rejections, the Federal Circuit released a decision invalidating certain claims of U.S. Patent No. 5,799,273 as not being directed to one of the four statutory categories of inventions (see Allvoice Developments US, LLC, v. Microsoft Corp., CAFC 2014-1258, decided May 22, 2015) The matter was on appeal, by Allvoice, from a district court decision invalidating claims 60-68 as non-statutory subject matter. The decision also affirms a non-infringement decision by the district court, while interesting that that portion of the decision is not the focus of this post.

The claims of the ‘273 Patent at issue were directed towards a speech-recognition “interface,” see claim 60 reproduced below. Both the CAFC and the district court interpreted, probably correctly, the claimed interface as software without any tangible form (e.g., not interpreted as instructions on a computer-readable medium or as part of a tangible system).

60.  A universal speech-recognition interface that enables operative coupling of a speech-recognition engine to at least any one of a plurality of different computer-related applications, the universal speech-recognition interface comprising:

input means for receiving speech-recognition data including recognised words;

output means for outputting the recognised words into at least any one of the plurality of different computer-related applications to allow processing of the recognised words as input text; and

audio playback means for playing audio data associated with the recognised words. ’273 Patent, col. 29 ll. 22–34.

Allvoice essentially reinforces the Court’s interpretation by asserting that the claimed speech-recognition interfaces are described in the specification as “interface applications,” and thus the claims are limited to software. Allvoice attempts to clarify their position by further asserting that the claims should be interpreted as reciting “software instructions,” and further asserting that the instructions must necessarily be in a machine readable, physical state, in order to exist. It is interesting to consider whether the decision in this case might have been different if Allvoice had been able to argue an interpretation of the “means” elements as including hardware components of a system. Unfortunately, such an interpretation was either not supported by the specification, or not pursued for other reasons by the litigation team.

The Court dismisses Allvoice’s assertions regarding the implied physical form, stating “this Court has recognized, instructions, data, or information alone, absent a tangible medium, is not a manufacture.” (Citing Digitech Image Techs.,758 F.3d at 1349–50 (rejecting a patentee’s attempt to argue that the disputed claims

were subject matter eligible because the claim language did not describe “any tangible embodiment of this information (i.e., in physical memory or other medium) or claim any tangible part of the digital processing system”).) Earlier in the decision, the Court had already determined that the claims were clearly not directed to a process. Thus, because the claims were not directed to a tangible article and were not process claims, the district court’s invalidity holding was upheld.

The good news from this case is that the Court provides a fairly clear roadmap for claiming software-based inventions – software must be claimed as a process (method) or as instructions on a machine-readable medium (tangible manufacture), at least outside of a system claim. While this case does not seem to cover any “new” ground per se, it does clearly reinforce that claims directed to pure software, such as the recited speech-recognition interfaces, and not fashioned as a process or machine-readable medium are not likely to find favor in the courts.

ARTICLE BY Gregory M. Stark of Schwegman, Lundberg & Woessner, P.A.
© 2015 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

Patent Safe Harbor Applies To Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for patent infringement when the activities generated information that was submitted to the FDA to support a supplemental New Drug Application andCitizen’s Petition. However, the Federal Circuit remanded the case to the district court to determine whether other allegedly infringing activities, such as using the information to file a patent application, also were shielded by the statute.

The Claims At Issue

The patent at issue was Classen’s U.S. 6,584,472, directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and then commercializing the new use. Claim 36 (which depends from claim 33, which was canceled during reexamination) is representative of the asserted method claims, and claim 59 is representative of the asserted kit claims:

33. A method for creating and using data associated with a commercially available product, wherein the method comprises the steps of:
accessing at least one data source, comprising together or separately, adverse event data associated with exposure to or use of the product and commercial data regarding marketing, sales, profitability or related information pertaining to the product;
analyzing the accessed data to identify (i) at least one new adverse event associated with exposure to or use of the product, (ii) at leastone new use for the product responsive to identification of the at least one new adverse event, and (iii) the potential commercial value of the at least one new use for the product; and
commercializing the newly identified product information based upon the analyzed data.

36.  The method of claim 33, wherein the commercializing step comprises formatting the data relating to at least one new adverse event associated with exposure to, or use of the product, or documenting same, such that a manufacturer or distributor of the product must inform consumers, users or individuals responsible for the user, physicians or prescribers about at least one new adverse event associated with exposure to or use of the product.

59.  A proprietary kit comprising (i) product and (ii) documentation notifying a user of the product of at least one new adverse event relating to the product, wherein determination of the new adverse event is based upon the data provided by the method of claim 36.

Footnote 1 of the Federal Circuit decision states, “Because issues of validity are not before us in this appeal, we express no opinion as to whether the asserted claims cover patent ineligible subject matter in light of the Supreme Court’s decision in Alice Corp. v. CLS Bank International, 573 U.S. __, 134 S. Ct. 2347 (2014).”

Procedural Background

Classen asserted U.S. Patent No. 6,584,472 against Elan, alleging that Elan infringed the patent by (i) studying the effect of food on the bioavailability of the FDA-approved muscle relaxant Skelaxin, (ii) using the clinical data to identify a new use for the drug, and (iii) commercializing the new use. In particular, after Skelaxin was approved, Elan conducted clinical studies on the effect of the drug when administered with or without food, and then submitted the results to the FDA when seeking approval of a supplemental New Drug Application (“sNDA”) to revise the labeling for Skelaxin and in a Citizen’s Petition proposing changes to the approval requirements for generic versions of Skelaxin. Additionally, Elan filed patent applications based on the new clinical data and sold kits with the revised label containing information derived from the data.

The U.S. District Court for the District of Maryland granted Elan’s motion for summary judgment of non-infringement, finding that Elan’s activities were “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act (FDCA), and were therefore protected by the safe harbor provision of 35 U.S.C. § 271(e)(1). Classen appealed to the Federal Circuit.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Lourie and joined by Chief Judge Prost and District Judge Gilstrap (of the Eastern District of Texas) sitting by designation.

On appeal, Classen argued that Elan’s activities are not exempt under the safe harbor because they involved merely “routine” post-approval reporting to the FDA, which the Federal Circuit held in its 2011 decision in Classen Immunotherapies, Inc. v. Biogen IDEC lies outside the scope of the § 271(e)(1) safe harbor.

This statute provides in relevant part:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .

In Classen v. Biogen, the court indicated that the safe harbor applies only to pre-marketing activities, and held that the safe harbor “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” However, a year later in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the Federal Circuit held that the safe harbor can shield post-approval activities from giving rise to liability for patent infringement where the information submitted to the FDA “is necessary both to the continued approval of the ANDA and to the ability to market the … drug.” Thus, it is not surprising that in this case the Federal Circuit noted that the statutory language does not “categorically exclude post-approval activities from the ambit of the safe harbor.”

Turning to the activities at issue, the Federal Circuit found that post-approval studies conducted to support an sNDA “serve similar purposes as pre-approval studies in ensuring the safety and efficacy of approved drugs.” Thus, the court reasoned, “As an integral part of the regulatory approval process, those activities are ‘reasonably related to the development and submission of information’ under the FDCA, 35 U.S.C. § 271(e)(1), and are therefore exempt from infringement liability.” The court  therefore concluded that the post-approval clinical trials, sNDA and Citizen’s Petition “clearly fall within the scope of the safe harbor.”

Although the Federal Circuit remanded to the district court to determine whether Elan’s activities related to “reanalyzing the clinical data to identify patentable information and filing patent applications are commercial activities outside the scope of the safe harbor,” and whether “selling Skelaxin with the revised label that contained the information derived from the clinical study” infringed the Classen kit claims, the court took it upon itself to “assist the district court in its analysis of infringement . . . [by] mak[ing] the following observations of the record:”

  • Filing a patent application is generally not an infringement of a patent

  • Filing a patent application is not commercialization of an invention, and so a method claim requiring commercialization is likely not infringed by Elan’s actions

  • Placing information submitted to the FDA on a product label generally cannot be an act of infringement.

Given these “observations,” it seems unlikely that the district court will find that Elan infringed the claims at issue.

The Wide Mouth of the Safe Harbor

This decision is one of many Federal Circuit decisions that broadly construe the safe harbor of § 271(e)(1). Indeed, less than one year after the court seemed to draw a bright line around the scope of the safe harbor that excluded post-approval activities, the court blurred that line in Momenta and now it has erased it further in this case.

The Commercial Value of Patent Applications

Although the Federal Circuit’s “observation” that filing a patent application generally is not an act of infringement may be correct, we question its suggestion that filing a patent application is not a commercial activity. To the contrary, filing a patent application can be an essential step of a commercialization plan, and can increase the commercial value of the invention. On the other hand, we would agree that it is unusual that a patent could be infringed by “commercializing … information,” as recited in the Classen patent.

Apple-Samsung Trade Dress Case Demonstrates Potential Value of Design Patents

A jury awarded Apple more than $1 billion in damages after finding that smartphones sold by Samsung diluted Apple’s trade dress and infringed Apple’s design and utility patents. After a partial retrial limited to determining the appropriate amount of damages, Apple still arose victorious with a $930 million award. Samsung moved for judgment as a matter of law and for a new trial. The district court denied those motions, and Samsung appealed. On May 18, 2015, the Federal Circuit upheld the jury’s verdict of design and utility patent infringement, but reversed the finding of trade dress dilution.

Trade Dress Claims

At issue on appeal was whether Apple’s purported registered and unregistered trade dress associated with its iPhone 3G and 3GS products is functional. Because trademark law gives the trademark owner a “perpetual monopoly,” a design that is functional cannot serve as protectable trade dress. Apple Inc. v. Samsung Elecs. Co., Ltd., No. 14-1335, slip op. at 7 (Fed. Cir. May 18, 2015). The standard is even higher when the owner claims trade dress protection over the configuration of a product, as opposed to product packaging or other forms of trade dress. Slip op. at 8. In fact, the court noted that Apple had not cited a single Ninth Circuit case finding trade dress of a product configuration to be non-functional. Id.

Apple claimed the following elements as its unregistered trade dress:

  • a rectangular product with four evenly rounded corners;
  • a flat, clear surface covering the front of the product;
  • a display screen under the clear surface;
  • substantial black borders above and below the display screen and narrower black borders on either side of the screen; and
  • when the device is on, a row of small dots on the display screen, a matrix of colorful square icons with evenly rounded corners within the display screen, and an unchanging bottom dock of colorful square icons with evenly rounded corners set off from the display’s other icons.

Slip op. at 9. “In general terms, a product feature is functional if it is essential to the use or purpose of the article or if it affects the cost or quality of the article.” Id. (quoting Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 850 n.10 (1982)). Because this case came to the Federal Circuit on appeal from a district court sitting in the Ninth Circuit, the Federal Circuit applied the Ninth Circuit’s Disc Golf test for determining whether a design is functional. Under that test, courts consider whether: (1) the design yields a utilitarian advantage; (2) alternative designs are available; (3) advertising touts the utilitarian advantages of the design; and (4) the particular design results from a comparatively simple or inexpensive method of manufacture. Slip op. at 10. Because this purported trade dress was not registered, Apple had the burden to prove its validity, which required Apple to show that the product features at issue “serve[] no purpose other than identification.” Id. (citing Disc Golf Assoc., Inc. v. Champion Discs, 158 F.3d 1002, 1007 (9th Cir. 1998)). The court of appeals applied those factors and found extensive evidence supporting Samsung’s claim that the alleged trade dress was functional. Slip op. at 12–14.

In addition to the unregistered product configuration discussed above, Apple also asserted a claim based on US Registration 3,470,983, which covered the design details in each of the 16 icons on the iPhone’s home screen framed by the iPhone’s rounded-rectangular shape with silver edges and a black background. Slip op. at 15. Although Apple enjoyed an evidentiary presumption of validity for its registered trade dress, the court again looked to the Disc Golffactors and found that Samsung met its burden of overcoming that presumption and proving the trade dress was functional and the registration invalid. Slip op. at 16. Because the court held Apple’s purported trade dress was functional, it vacated the jury’s verdict on Apple’s claims for trade dress dilution and remanded that portion of the case for further proceedings. Slip op. at 17.

Design Patent Claims

Apple fared better on its design patent claims. Here, Apple asserted three design patents directed to the “front face” (D’677 patent), “beveled front edge” (D’087 patent) and “graphical user interface (GUI)” (D’305 patent) of its iPhone products.

design patent claims - apple samsung

Samsung challenged the court’s claim construction and jury instructions for failing to “ignore[]” functional elements of the designs from the claim scope, such as rectangular form and rounded corners. Slip op. at 20. The court disagreed, finding that Samsung’s proposed rule to eliminate entire elements from the scope of design claims was unsupported by precedent. Id. Rather, the court found that both the claim construction and jury instructions properly focused the infringement analysis on the overall appearance of the claimed design. Id. at 21.

This victory was financially significant for Apple, as the court found they were entitled to Samsung’s entire profits on its infringing smartphones as damages. Like the district court, the court of appeals found that 35 U.S.C. § 289 explicitly authorizes the award of total profit from the article of manufacture bearing the patented design, rather than an apportionment of damages based only on the infringing aspects of the device (i.e., external features and not internal hardware/software). The court of appeals interpreted Samsung’s argument as imposing an “apportionment” requirement on Apple—a requirement the Federal Circuit previously rejected in Nike, Inc. v. Wal-Mart Stores, Inc., 138 F.3d 1437, 1441 (Fed. Cir. 1998). Thus, Apple maintains a claim to at least a significant portion of the $930 million damages award in the case.

Summary and Takeaways

Ultimately, after holding that Apple’s purported trade dress covering elements of the iPhone’s overall shape, black-bordered display screen, and matrix of colorful square icons was invalid, the district court upheld the jury’s verdict that Samsung’s devices infringed Apple’s design patents relating to the iPhone’s overall shape, display screen, and matrix of colorful square icons. The image depicted in Apple’s now-invalid trade dress registration is below on the left. Figures from two of its still-valid design patents are on the right. Although the overlap in what was claimed in these different forms of intellectual property is readily apparent, Apple lost on one set of claims and prevailed on the other.

design patent apple samsung iphone

It remains to be seen how damages associated with the design patent claims differ from damages associated with the now-invalid trade dress claims. But this much is clear: the Federal Circuit has given a reason for companies to reevaluate the role of design patents in their intellectual property portfolios. The time and expense associated with obtaining design patents will not suit all products, but for the right product, they can provide a valuable method of recovery in litigation involving similar product designs.

ARTICLE BY Kristin J. Achterhof, Karen Artz Ash, Richard P. Bauer & Floyd A. Mandell of Katten Muchin Rosenman LLP
©2015 Katten Muchin Rosenman LLP

Amicus Briefs On Biosimilar Patent Litigation

Foley and Lardner LLP

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal Circuit, and three amicus briefs have been filed. All of the amicus briefs argue for reversal of at least some of the district court’s decision regarding the biosimilar patent litigation framework of the BPCIA.

The Biotechnology Industry Organization

The Biotechnology Industry Organization filed an amicus brief arguing that the BPCIA should be interpreted as requiring “notice to the reference product sponsor of the initial submission of the biosimilar application” and “notice of potential commercial marketing upon approval.” BIO argues that these procedures must be mandatory in order for the patent dispute resolution provisions of the law to achieve their purpose of “provid[ing] a significant and real opportunity to resolve patent issues prior to the launch of the biosimilar.”

Abbvie Inc.

AbbVie Inc. filed an amicus brief arguing that “the notice-and-exchange provisions are mandatory” and that a biosimilar applicant’s “failure to comply with the statute is unlawful.” According to AbbVie, if the district court decision is upheld “the entire biosimilar litigation process would become a free-for-all, where biosimilar companies would utilize the data and work of innovator companies but refuse to provide basic information about their products … leaving innovators to blindly guess as to which patents they should sue on and when.”

AbbVie also argues that the BPCIA does not preempt Amgen’s state law claims of unfair competition.

Janssen Biotech, Inc.

Janssen Biotech, Inc. filed an amicus brief asking the Federal Circuit to “clarify that the statutory patent dispute resolution procedures are intended to be followed as written, and are not merely optional choices or empty formalities.” Janssen criticizes the district court decision for “transforming [the BPCIA’s patent provisions] from a carefully orchestrated dispute resolution process into a series of strategic options existing for the sole benefit of the biosimilar applicant.”

Janssen also urges the Federal Circuit to decide that the notice of commercial marketing required by the BPCIA may not be provided before a biosimilar product is licensed by the FDA. One argument Janssen makes on this point is that the notice of commercial marketing gives the reference product sponsor the right to seek a preliminary injunction based on alleged patent infringement, but a preliminary injunction cannot be granted unless commercial launch is imminent, and commercial launch is not possible until the biosimilar has been licensed by the FDA.

The Expedited Appeal Schedule 

Amgen filed its opening brief on April 3. Sandoz filed its brief on April 21. Oral arguments are scheduled for June 3.

ARTICLE BY

Courtenay C. Brinckerhoff
Foley & Lardner LLP

Target Corp. v. Destination Maternity Corp., Final Written Decision IPR2013-00532

Drinker Biddle & Reath LLP a leading law firm with a national footprint

Takeaway: Where neither party provides an interpretation of a term that provides additional clarity, the Board will give the term its plain and ordinary meaning.

In its Final Written Decision, the Board found that Petitioner had shown by a preponderance of the evidence that all challenged claims (claims 1, 2, 5, 6, 10, 11, and 15-17) of the ’531 patent are unpatentable. The ’531 patent “relates to a garment worn during different stages of pregnancy and different stages of postpartum body changes.”

The Board addressed claim construction, stating that claims in an unexpired patent are given their broadest reasonable construction in light of the specification of the patent. The Board first analyzed the term “just beneath the wearer’s breast area.” Patent Owner argued that the term means “beneath the location of the breasts by a very small margin.” However, the term “very small margin” does not provide any further clarity. The Board determined that because neither party offered a construction that provides additional clarity, the plain and ordinary meaning will be given. Also, the Board determined that the term is a term of approximation and that a garment may satisfy claim 1 for one wearer but not another because of differences in the wearers’ body types.

The Board then analyzed the term “different body types” used in claims 2 and 17. Although Patent Owner did not propose constructions for this limitation, its patentability arguments advance an implicit construction of “different body types” that requires an unspecified amount of difference between said body types. The Board determined that the broadest reasonable construction of “different body types” means “two or more body types that are not identical.”

The Board then analyzed the term “an elastic fabric that is contractible elastically to cover an abdomen during different stages of postpartum body changes” from claim 5. Although Patent Owner did not propose constructions for this limitation, the Board determined that its patentability arguments advanced an implicit construction that claim 5 requires a specific, yet unspecified, minimum amount of contractability. However, the specification does not specify any minimum amount of contractability and does not describe or identify any stages of postpartum body changes. Accordingly, the Board determined that the broadest reasonable construction of “during different stages of postpartum body changes” means “during any postpartum body change of any wearer,” which means that the fabric does not have to contract to cover postpartum body changes of every potential wearer or to cover all postpartum body changes of any wearer.

The Board next addressed the asserted grounds of unpatentability. Addressing anticipation based on a JC Penney catalog for fold-over panel jeans, the Board disagreed with Patent Owner’s assertion that the product shown in the catalog did not disclose a panel extending “high enough on the wearer’s body.” The Board found that the JC Penney catalog disclosed a panel substantially covering the belly region and noted that it was the belly region, and not the panel, that the claims require to extend to just beneath the wearer’s breast area. Thus, the Board was persuaded that claim 1 was anticipated by the JC Penney reference. Also, the Board disagreed with Patent Owner’s assertion that Petitioner has failed to prove that the panel of the JCP fold-over panel jeans stretches or expands enough to conform to different body types, because the claims do not require any quantified amount of stretching or expansion and the term “different body types” includes any two or more body types that are not identical. The Board was also not persuaded by Patent Owner’s argument that the panel of the JCP fold-over panel jeans is not described as being contractible as allegedly recited in claim 5. The Board indicated that contraction is always present where there is contraction, and the claims did not require any specific amount of contraction.

With respect to dependent claims 6, 11, 15, and 16, Petitioner asserted obviousness based on the JC Penney catalog applied to claim 1 in view of JC Penney Bootcut jeans. Patent Owner alleged nonobviousness based on the secondary consideration of commercial success. However, Patent Owner failed to link the alleged commercial success of the products to the inventions of claims 6, 11, 15, and 16. Specifically, Patent Owner’s witness conceded that the commercial success of Patent Owner’s products had nothing to do with the unique characteristics of claims 6 and 11, which add limitations directed exclusively to features of the garment lower portion.

Target Corp. v. Destination Maternity Corp., IPR2013-00532
Paper 76: Final Written Decision
Dated: February 12, 2015
Patent: RE43,531 E
Before: Jennifer S. Bisk, Michael J. Fitzpatrick, and Mitchell G. Weatherly
Written by: Fitzpatrick
Related Proceedings: Destination Maternity Corp. v. Target Corp., Case No. 2:12-cv-05680-AB (E.D. Pa.); IPR2013-00531; IPR2014-00508; IPR2013-00530; IPR2013-00533; IPR2014-00509

ARTICLE BY

Carrie A. Beyer
OF
Drinker Biddle & Reath LLP