Practical Strategies, Tactics and Tips for the Optimization of IP Assets in a Dynamic Business Environment

International Performance Management Institute (IPMI) is holding the IP Law & Management Institute on November 3rd -5th, 2013 at the Paradise Point Resort & Spa in San Diego, CA.

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  • A Whole New World?  In-House Counsel Perspectives on the America Invents Act and its Implications
  • Proven Strategies for Resolving Patent Lawsuits Efficiently and Cost Effectively
  • Ensuring Effective Alignment of Your Patent Strategy with Corporate Strategy
  • Freedom to Operate: Strategic Considerations in a Post-AIA World
  • Maneuvering in the Cloud: Containing E-Discovery Costs and Avoiding Sanctions in an Evolving Legal Framework
  • Ensuring Freedom of Operation – Strategies for Avoiding Disruptive Assertions by Non Practicing Entities
  • Crafting an Effective Patent Strategy that Optimally Aligns with Regulatory Laws and Provides the Best Market Protection for Medical Products
  • Patent Litigation Forums – Strategies for Choosing Between District Court, International Trade Commission and/or Post-Grant Challenges in the USPTO
  • Honing Your Transactional Acumen: Best Practices in Drafting and Negotiating a Myriad of Agreements
  • A Complaint Shows Up – Voilà, You’re a Defendant.  What Do You Do in the First 24 Hours?
  • Best Practices for Time Sensitive M&A Patent Due Diligence and Analysis
  • Patent Monetization Success: Working with NPEs to Drive Bottom-Line Results
  • Managing Intellectual Property as a Business Strategy
  • Navigating Patent Enforcement Systems and Winning Strategies in Cross-Border Patent Litigation: Spotlight on China, Asia Pacific and Emerging Patent Markets
  • Staying Ahead of the Game – Managing CEO Expectations
  • “We’ve Just Been Sued, What’s our Exposure?”  Using the Litigation Damages Model to Assess Potential Exposure for Your CEO
  • The Innovation Eco-System for Technology-Centric New Business Creation: From Assets to Exit
  • Strategies to Mitigate Your Risk of Trade Secret Theft

Visit their website here for more information.

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Love Stamp

    • Upon consideration en banc, a majority of the court affirms the district court’s holding that the asserted method and computer-readable media claims are not directed to eligible subject matter under 35 U.S.C. § 101.
    • An equally divided court affirms the district court’s holding that the asserted system claims are not directed to eligible subject matter under that statute.

May 10, 2013

717 Madison Place, N.W.
Washington, D.C. 20439

United States Supreme Court
1 1st St NE
Washington, D.C. 20543

RE: CLS BANK INTERNATIONAL v. ALICE CORPORATION PTY. LTD. PER CURIAM

Dear Supreme Court:

When Alice kindly petitions for cert, please grant it – we just can’t figure out how to apply Bilski v. Kappos when it comes to computer system claims (and some of us are also unhappy when it comes to the method claims).

“The court, now rehearing this case en banc, hoped to ameliorate this uncertainty by providing objective standards for section 101 patent-eligibility. Instead we have propounded at least three incompatible standards, devoid of consensus, serving simply to add to the unreliability and cost of the system of patents as an incentive for innovation. Concurring-in-part and dissenting-in-part opinion filed by NEWMAN, Circuit Judge.

Lourie thinks that “[a]t its most basic, a computer is just a calculator capable of performing mental steps faster than a human could. Unless the claims require a computer to perform operations that are not merely accelerated calculations, a computer does not itself confer patent eligibility.” (Concurring opinion filed by LOURIE, Circuit Judge, in which DYK, PROST, REYNA, and WALLACH, Circuit Judges, join.)

But, Rader “[d]isagree[s] with Judge Lourie that a computer must do something other than what a computer does before it may be considered a patent-eligible invention…. Requiring a computer to do something that a human could not would mean that computer implementation could never produce patent eligibility.” (Concurring-in-part and dissenting-in-part opinion filed by RADER, Chief Judge, LINN, MOORE, and O’MALLEY, Circuit Judges, as to all but part VI of that opinion. RADER, Chief Judge, and MOORE, Circuit Judge, as to part VI of that opinion.)

Rader “doubt[s] that innovation is promoted when subjective and empty words like ‘contribution’ or ‘inventiveness’ are offered up by the courts to determine investment, resource allocation, and business decisions.” (Additional Reflections of Chief Judge Rader.)

Plus, Moore pointed out “[l]et’s be clear: if all of these claims, including the system claims, are not patent-eligible, this case is the death of hundreds of thousands of patents, including all business method, financial system, and software patents as well as many computer implemented and telecommunications patents.” (Dissenting-in-part opinion filed by MOORE, Circuit Judge, in which RADER, Chief Judge, and LINN and O’MALLEY, Circuit Judges, join.)

Not to be left out, Linn and O’Malley contest that the method claims should be vilified under 35 USC 101 because “[w]e do not see how Chief Judge Rader and Judge Moore, when analyzing the method claims, can ignore the fact that the specific functionality described in the figures applies just as much to them as to the system claims.” (Dissenting opinion filed by LINN and O’MALLEY, Circuit Judges.)

Newman cut to the heart of the matter:  “I propose that the court make clear that patent eligibility does not depend on the form of the claim, whether computer implemented innovations are claimed as a method or a system or a storage medium, whether implemented in hardware or software. Patent eligibility does not turn on the ingenuity of the draftsman.” (Concurring-in-part and dissenting-in-part opinion filed by NEWMAN, Circuit Judge.)

Besides, if you don’t grant cert, “with today’s judicial deadlock, the only assurance is that any successful innovation is likely to be challenged in opportunistic litigation, whose result will depend on the random selection of the panel.” (Concurring-in-part and dissenting-in-part opinion filed by NEWMAN, Circuit Judge.)

Please help us!

Sincerely yours,

Justices Lourie, Dyk, Prost, Reyna,
Wallach, Radar, Linn, Moore, O’Malley,
Linn and Newman

See the entire 135 page opinion here:  CLS BANK  v. ALICE (11-1301.Opinion.5-8-2013.1)


Today’s post is by Guest Barista Ria Farrell Schalnat* (ria.schalnat@dinsmore.com)  *The views conveyed herein are solely those of the author and do not reflect the views of Dinsmore & Shohl LLP or any of its clients.

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In a unanimous decision, the Supreme Court laid out that patent exhaustion does not permit a farmer to reproduce patented seeds through planting and harvesting without the patent holder’s permission. And….Boom Goes the Dynamite! (Bowman v. Monsanto Co. et al., (Bowman v Monsanto 11-796)

The decision will have an impact on a plethora of businesses besides agriculture including gene therapies, vaccines, cell lines, nano-technologies, software and any invention that can be easily replicated (since soybeans must be planted, cultivated, and harvested — soybeans do not regenerate themselves – they are not exactly “self-replicating”).

soybean seedsMake no mistake, this case is not about the $84,456 in damages awarded to Monsanto. Monsanto has about $13.5 billion in annual sales with half of that coming from seeds and about 10% from the sale of glyphosate.  Monsanto sold over $1.7 billion of soybeans last year so this is not without market desire. The seeds provide such a tremendous benefit that over 90% of corn, cotton, sugar beet, and canola planted in the United States is now Roundup-Ready.

In short, the Court held that:

(a) Under the patent exhaustion doctrine, “the initial authorized sale of a patented article terminates all patent rights to that item,” (Quanta Computer 553 U. S. 625), and confers on the purchaser, or any subsequent owner, “the right to use [or] sell” the thing as he sees fit, United States v. Univis Lens Co., Syllabus 316 U. S. 241, 249–250. However, the doctrine restricts the patentee’s rights only as to the “particular article” sold, id., at 251; it leaves untouched the patentee’s ability to prevent a buyer from making new copies of the patented item. By planting and harvesting Monsanto’s patented seeds, Bowman made additional copies of Monsanto’s patented invention, and his conduct thus falls outside the protections of patent exhaustion. Were this otherwise, Monsanto’s patent would provide scant benefit. After Monsanto sold its first seed, other seed companies could produce the patented seed to compete with Monsanto, and farmers would need to buy seed only once.

(b) Bowman argues that exhaustion should apply here because he is using seeds in the normal way farmers do, and thus allowing Monsanto to interfere with that use would create an impermissible exception to the exhaustion doctrine for patented seeds. But it is really Bowman who is asking for an exception to the well-settled rule that exhaustion does not extend to the right to make new copies of the patented item. If Bowman was granted that exception, patents on seeds would retain little value. Further, applying the normal rule will allow farmers to make effective use of patented seeds. Bowman, who purchased seeds intended for consumption, stands in a peculiarly poor position to argue that he cannot make effective use of his soybeans. Bowman conceded that he knew of no other farmer who planted soybeans bought from a grain elevator. In the more ordinary case, when a farmer purchases Roundup Ready seed from Monsanto or an affiliate, he will be able to plant it in accordance with Monsanto’s license to make one crop.

Justice Kagan delivered the unanimous opinion of the Court.

Under the doctrine of patent exhaustion, the authorized sale of a patented article gives the purchaser, or any subsequent owner, a right to use or resell that article. Such a sale, however, does not allow the purchaser to make new copies of the patented invention.

The question in this case is whether a farmer who buys patented seeds may reproduce them through planting and harvesting without the patent holder’s permission. The Court said “No, way.”

Monsanto markets soybean seed containing this altered genetic material as Roundup Ready seed. Farmers planting that seed can use a glyphosate based herbicide to kill weeds without damaging their crops. Two patents issued to Monsanto cover various aspects of its Roundup Ready technology, including a seed incorporating the genetic alteration (U. S. Patent Nos. 5,352,605 and RE39,247E).

Monsanto sells, and allows other companies to sell, Roundup Ready soybean seeds to growers who assent to a special licensing agreement. That agreement permits a grower to plant the purchased seeds in one(and only one) season. He can then consume the resulting crop or sell it as a commodity, usually to a grain elevator or agricultural processor. But under the agreement, the farmer may not save any of the harvested soybeans for replanting, nor may he supply them to anyone else for that purpose. These restrictions reflect the ease of producing new generations of Roundup Ready seed. Because glyphosate resistance comes from the seed’s genetic material, that trait is passed on from the planted seed to the harvested soybeans: Indeed, single Roundup Ready seed can grow a plant containing dozens of genetically identical beans, each of which, if replanted, can grow another such plant—and so on and so on. The agreement’s terms prevent the farmer from co-opting that process to produce his own Roundup Ready seeds, forcing him instead to buy from Monsanto each season.

Petitioner Vernon Bowman is a farmer in Indiana who purchased Roundup Ready each year, from a company affiliated with Monsanto, for his first crop of the season. In accord with the agreement, he used all of that seed for planting, and sold his entire crop to a grain elevator (which typically would resell it to an agricultural processor for human or animal consumption).

According to the Court:

Bowman, however, devised a less orthodox approach for his second crop of each season. Because he thought such late-season planting “risky,” he did not want to pay the premium price that Monsanto charges for Roundup Ready seed. Id., at 78a; see Brief for Petitioner 6. He therefore went to a grain elevator; purchased “commodity soybeans” intended for human or animal consumption; and planted them in his fields. Those soybeans came from prior harvests of other local farmers. And because most of those farmers also used Roundup Ready seed, Bowman could anticipate that many of the purchased soybeans would contain Monsanto’s patented technology. When he applied glyphosate-based herbicide to his fields, he confirmed that this was so; a significant proportion of the new plants survived the treatment, and produced in their turn a new crop of soybeans with the Roundup Ready trait. Bowman saved seed from that crop to use in his late-season planting the next year—and then the next, and the next, until he had harvested eight crops in that way. Each year, that is, he planted saved seed from the year before (sometimes adding more soybeans bought from the grain elevator),sprayed his fields with glyphosate to kill weeds (and any non-resistant plants), and produced a new crop of glyphosate resistant, i.e., Roundup Ready-soybeans.

After discovering this practice, Monsanto sued Bowman for infringing its patents on Roundup Ready seed. Bowman raised patent exhaustion as a defense, arguing that Monsanto could not control his use of the soybeans be-cause they were the subject of a prior authorized sale(from local farmers to the grain elevator).

The District Court rejected that argument, and awarded damages to Monsanto of $84,456. The Federal Circuit affirmed. It reasoned that patent exhaustion did not protect Bowman because he had created a newly infringing article:

The “right to use” a patented article following an authorized sale, the court explained, “does not include the right to construct an essentially new article on the template of the original, for the right to make the article remains with the patentee.” Ibid. (brackets and internal quotation marks omitted). Accordingly, Bowman could not “‘replicate’ Monsanto’s patented technology by planting it in the ground to create newly infringing genetic material, seeds, and plants.” Ibid.

The doctrine of patent exhaustion limits a patentee’s right to control what others can do with an article embodying or containing an invention.2 Under the doctrine, “the initial authorized sale of a patented item terminates all patent rights to that item.” Quanta Computer, Inc. v. LG Electronics, Inc., 553 U. S. 617, 625 (2008). “The sale confers on the purchaser, or any subsequent owner, “the right to use [or] sell” the thing as he sees fit. United States v. Univis Lens Co., 316 U. S. 241, 249–250 (1942).

[T]he doctrine restricts a patentee’s rights only as to the “particular article” sold, ibid.; it leaves untouched the patentee’s ability to prevent a buyer from making new copies of the patented item. “[T]he purchaser of the [patented] machine . . . does not acquire any right to construct another machine either for his own use or to be vended to another.”

What this means for Farmer Bowman:

Unfortunately for Bowman, that principle decides this case against him. Under the patent exhaustion doctrine, Bowman could resell the patented soybeans he purchased from the grain elevator; so too he could consume the beans himself or feed them to his animals. Monsanto, although the patent holder, would have no business interfering in those uses of Roundup Ready beans. But the exhaustion doctrine does not enable Bowman to make additional patented soybeans without Monsanto’s permission (either express or implied). And that is precisely what Bowman did. He took the soybeans he purchased home; planted them in his fields at the time he thought best; applied glyphosate to kill weeds (as well as any soy plants lacking the Roundup Ready trait); and finally harvested more (many more) beans than he started with. That is how “to ‘make’ a new product,” to use Bowman’s words, when the original product is a seed. Brief for Petitioner 37; see Webster’s Third New International Dictionary 1363 (1961) (“make” means “cause to exist, occur, or appear,” or more specifically, “plant and raise (a crop)”). Because Bowman thus reproduced Monsanto’s patented invention, the exhaustion doctrine does not protect him.

Were the matter otherwise, Monsanto’s patent would provide scant benefit. After inventing the Roundup Ready trait, Monsanto would, to be sure, “receiv[e] [its] reward” for the first seeds it sells. Univis, 316 U. S., at 251. But in short order, other seed companies could reproduce the product and market it to growers, thus depriving Monsanto of its monopoly. And farmers themselves need only buy the seed once, whether from Monsanto, a competitor, or (as here) a grain elevator. The grower could multiply his initial purchase, and then multiply that new creation, ad infinitum—each time profiting from the patented seed without compensating its inventor. Bowman’s late-season plantings offer a prime illustration. After buying beans for a single harvest, Bowman saved enough seed each year to reduce or eliminate the need for additional purchases.

The exhaustion doctrine is limited to the “particular item” sold to avoid just such a mismatch between invention and reward.

Bowman principally argues that exhaustion should apply here because seeds are meant to be planted. The exhaustion doctrine, he reminds us, typically prevents a patentee from controlling the use of a patented product following an authorized sale. And in planting Roundup Ready seeds, Bowman continues, he is merely using them in the normal way farmers do. Bowman thus concludes that allowing Monsanto to interfere with that use would “creat[e] an impermissible exception to the exhaustion doctrine” for patented seeds and other “self-replicating technologies.”

But it is really Bowman who is asking for an unprecedented exception—to what he concedes is the “well settled” rule that “the exhaustion doctrine does not extend to the right to ‘make’ a new product.”

That is because, once again, if simple copying were protected use, a patent would plummet in value after the first sale of the first item containing the invention. The undiluted patent monopoly, it might be said, would extend not for 20 years (as the Patent Act promises), but for only one transaction. And that would result in less incentive for innovation than Congress wanted. Hence our repeated insistence that exhaustion applies only to the particular item sold, and not to reproductions.

Nor do we think that rule will prevent farmers from making appropriate use of the Roundup Ready seed they buy. Bowman himself stands in a peculiarly poor position to assert such a claim. As noted earlier, the commodity soybeans he purchased were intended not for planting, but for consumption.

Still, Bowman has another seeds-are-special argument: that soybeans naturally “self-replicate or ‘sprout’ unless stored in a controlled manner,” and thus “it was the planted soybean, not Bowman” himself, that made replicas of Monsanto’s patented invention.

But we think that blame-the-bean defense tough to credit. Bowman was not a passive observer of his soybeans’ multiplication; or put another way, the seeds he purchased (miraculous though they might be in other respects) did not spontaneously create eight successive soybean crops. As we have explained, supra at 2–3, Bowman devised and executed a novel way to harvest crops from Roundup Ready seeds without paying the usual premium. He purchased beans from a grain elevator anticipating that many would be Roundup Ready; applied a glyphosate-based herbicide in a way that culled any plants without the patented trait; and saved beans from the rest for the next season. He then planted those Roundup Ready beans at a chosen time; tended and treated them, including by exploiting their patented glyphosate-resistance; and harvested many more seeds, which he either marketed or saved to begin the next cycle. In all this, the bean surely figured. But it was Bowman, and not the bean, who controlled the reproduction (unto the eighth generation) of Monsanto’s patented invention.

Note that the Court did try to limit the holding somewhat:

Our holding today is limited—addressing the situation before us, rather than every one involving a self-replicating product. We recognize that such inventions are becoming ever more prevalent, complex, and diverse. In another case, the article’s self-replication might occur outside the purchaser’s control. Or it might be a necessary but incidental step in using the item for another purpose. Cf. 17 U. S. C. §117(a)(1) (“[I]t is not [a copyright] infringement for the owner of a copy of a computer program to make . . . another copy or adaptation of that computer program provide[d] that such a new copy or adaptation is created as an essential step in the utilization of the computer program”). We need not address here whether or how the doctrine of patent exhaustion would apply in such circumstances. In the case at hand, Bowman planted Monsanto’s patented soybeans solely to make and market replicas of them, thus depriving the company of the reward patent law provides for the sale of each article. Patent exhaustion provides no haven for that conduct. We accordingly affirm the judgment of the Court of Appeals for the Federal Circuit.

*Side Note: Monsanto seeds do not contain a “terminator gene” that kills seeds. While Monsanto has rights to the patented processes – which could be used to prevent farmers from saving seeds – the company has vowed not to use it due to global food security and developing-country agriculture concerns over sterile seed sales.

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TOM+CRUISE+TOP+GUN+1980S1Today is “Talk Like Top Gun Day.”  It’s a day to celebrate the 80’s classic  film that highlights both the US Navy Strike Fighter Tactics Instructor program (SFTI program) and beach volleyball.

From the Top Gun Day website:

Top Gun Day is May 13th.   What is Top Gun Day?  Well it’s like talk like a pirate day, only way cooler because it allows you to quote Top Gun all day long, wear aviator sunglasses (no matter how cheap), pretend you’re a fighter pilot (“it’s time to buzz the fridge”), play volleyball in jeans, and drink Hemlock–wait, wait–I mean ICE water. 

It looks like a planned sequel to Top Gun has fallen apart.  So, put on some aviator sunglasses and Call the Ball.

Cue the Kenny Loggins soundtrack.

 

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Today’s post is by Guest Barista Jay Pattumudi, a Patent Attorney with Bruzga and Associates.

Under the new U.S. patent reform act, America Invents Act (AIA), the scope of prior art for making novelty and obviousness determinations has been broadened in some aspects but, in some cases, has been narrowed. With regard to making such determinations, the act’s provisions took effect March 16, 2013. This article makes a comparison of the provisions of AIA with those of European (i.e., EPO) and Japanese (i.e., JPO) patent law in the following two tables, which will be discussed below.

The following table entitled “Five main categories of prior art by others under AIA and a Comparison” (hereinafter, the “first table”) highlights the five categories of prior art by others than the inventor and compares their applicability with treatment under corresponding European and Japanese jurisdictions (referred in the table as EPO and JPO respectively). As shown in the first table, an inventor, subject to important exceptions for his or her own actions[1], is barred from obtaining a patent if his or claimed invention was (1) patented by others; (2) described in a printed publication by others; (3) in public use by others; (4) on sale by others; or (5) otherwise available to the public before the effective filing date of his or her claimed invention.

The effective filing date is the actual filing date of a patent or a patent application, or an earlier date where the patent or patent application claims priority to an earlier application (such as right of priority under (1) section 119 (e.g., Paris Convention priority), (2) section 365(a),[2] or (3) section 365(b)[3] or the benefit of an earlier filing date under (1) section 120 (e.g., continuation application or continuation-in-part application), (2) section 121 (i.e., divisional application) or (3) section 365[c]).[4] With respect to claiming priority to an earlier application, the earlier application must provide “continuity of disclosure” in that the earlier application must comply with 35 U.S.C. § 112; the earlier application must describe the claimed invention as well as enable a person to make and use the claimed invention. The “otherwise available to the public” is a new category under American patent law but analogous counterparts were already recognized in EPO and JPO. 

Five main categories of prior art by others under AIA and a Comparison

 

Patents

Publications

Public use

 Sale   Catch-all provision

U.S.

Patents prior to effective filing date of claimed invention are a bar.[5] §102(a)(1)  Printed publications that disclose the claimed invention and prior to effective filing date of claimed invention are a bar. §102(a)(1); see following second table for discussion of published patent applications. Public use of the claimed invention prior to effective filing date of claimed invention is a bar. §102(a)(1) Sale of the claimed invention prior to effective filing date of claimed invention is a bar. §102(a)(1) If the claimed invention is otherwise available to the public prior to effective filing date of claimed invention, such occurrence is a novelty bar. §102(a)(1)

EPO

Yes.[6] Yes.[7] Yes.[8] Yes, under general catch-all provision.[9] Yes.[10]

JPO

Yes.[11] Yes.[12] Yes.[13] Generally yes.[14] Yes.[15]

The following table “Earlier-filed later-published patent applications of others” (hereinafter the “second table”) focuses on a separate sub-category of prior art printed publications. The second table focuses on the prior art applicability of earlier-filed applications by others which become prior art when they become published.  The earlier-filed later-published application of others, unlike other prior art, could not be discovered by an inventor because it was not published at the time an inventor had filed his or her own patent application. The second table compares the applicability of such earlier-filed application as prior art with those of corresponding European and Japanese jurisdictions. Thus, under U.S. patent law, an inventor, subject to important exceptions for his or her own actions, is barred from obtaining a patent if the claimed invention was described in another inventor’s published patent application which was filed before the effective filing date of the claimed invention.

Earlier-Filed Later-Published Patent Applications of Others As Prior Art Bars

 

Novelty

Obviousness

U.S.

Yes. An earlier-filed application of another, from any country is prior art from earliest effective filing date of claimed invention, provided that the application is subsequently published. 35 U.S.C. §102(a)(2) Yes. Same standard as for novelty.

EPO

Yes, provided that the EPO application is published on or after the filing date of the later-filed application.[16]Article 54 No.

JPO

Yes.[17] No.

However, AIA recognizes an exception for this separate sub-category of prior art. For example, earlier-filed later-published applications having a common inventor or common assignee are not considered to be prior art. However, double patenting issues may arise. JPO has a similar exception regarding prior art applicability of earlier applications having a common assignee. EPO, unlike JPO and the U.S., does not have such an exception.[18]

Summary of Main Points

We will now discuss several key points that can be gathered from the foregoing tables. Although many of AIA’s provisions are conforming to aspects of EPO and JPO patent law, AIA has some importance differences.

Point #1: Earliest effective filing date of a patent application is an important criterion for determining prior scope.

The effective filing date of a patent application by another inventor is now a key criterion for determining the scope of prior art. The effective filing date is the actual filing date of a patent or a patent application, or an earlier date where the patent or patent application claims priority to an earlier application, as further detailed previously.

Thus, only the effective filing date determines the applicability of a prior art reference. Accordingly, under U.S. patent law, a Rule 131 affidavit, which was used in order to provide evidence that than applicant had an earlier invention date, can no longer be used. However, one should nevertheless retain evidence such as lab notebooks for use in derivation proceedings which concern whether an individual derives the claimed invention from the true inventor.

Point #2: Public use and sale of the claimed invention are now novelty-destroying prior art regardless of where they occurred.

As shown in the first table, public use and public sale, under the AIA, anywhere in the world, acts as a novelty bar. Thus, another inventor who sells, offers to a sell an invention or uses the invention anywhere in the world can create novelty-destroying prior art. Previously under older U.S. patent law, acts of public use and public sale by another inventor were novelty-destroying only if such activities occurred in the United States.[19] Inventors, however, could use their own activities, such as sale or use of the invention outside the U.S., such as in countries bound by NAFTA and WTO regulations, in order to establish an earlier date of invention. Id. Accordingly, AIA now treats such acts of public use and sale as novelty-destroying in the same way as European and Japanese patent law.

Point #3: Patent application of another inventor creates novelty and obviousness bars from the earliest effective filing date, regardless of whether the language of filing is in English.

As shown in the second table, a prior application by another inventor (i.e., earlier-filed later-published applications) can be used for novelty and obviousness bars against later-filed applications.

Concerning this category of earlier-filed later-published applications, AIA makes no distinction between a U.S. patent application claiming priority to an earlier foreign patent application and a U.S. patent application claiming priority to an earlier domestic patent application, where both of them become published patent applications for purposes of being applicable prior art. Under section 102(e) of the old U.S. patent law, a published U.S. application that claimed priority to a non-English language application, such as a Japanese application, was prior art as of its U.S. filing date because the earlier application was not filed in an English language.

Now, under AIA, any earlier-filed U.S. patent application of another inventor, is prior art as of its earliest effective filing date, regardless of whether the earliest application was filed in the English language. Thus, such a U.S. patent application, irrespective of whether the priority application was filed in a non-English language,[20] can now be used for both novelty and obviousness determinations against patent applications of other inventors. Comparisons with Europe and Japan are further discussed below.

Point #4: Earlier-filed applications under AIA can be used for both novelty and obviousness determinations unlike Europe and Japan.

As shown in the second table, an earlier-filed application by another inventor, provided that the application was subsequently published, can be used as prior art for both novelty and obviousness applications.

An earlier-filed application under European patent law, can be used as prior art for novelty purposes only and under certain conditions. First, under EPC Article 54(3), the earlier application must be a European national application that is a novelty-destroying prior art from earliest effective filing date provided that the application by the other inventor was published on or after the filing date of the later application of the inventor.[21] However, non-European patent applications cannot be used for novelty purposes; a European national phase of a PCT application is considered prior art under EPC Article 54(3) provided that the international application, accompanied by a national fee, is filed in an official language of the EPO.[22] Yet even the scope of the European national application is limited; the European patent application under EPC Article 56 cannot be used as prior art for obviousness purposes. Under AIA, WIPO publication of a PCT international application, by virtue of designating the U.S., is prior art from earliest effective filing date.[23]

A Japanese patent application by another inventor is prior art from the earliest effective date (regardless of country of origin) but, can only be applicable prior art for novelty but not for obviousness.[24]  In addition, Japanese patent law, like the AIA, recognizes the inapplicability of earlier-filed applications having a common inventor or a common assignee).[25] Thus, Japanese patent law, unlike AIA or European patent law, will only consider prior art applicability to an earlier-filed later-published application by another inventor if it is within the category of all prior art publicly available to an inventor at the time of filing his or her patent application.

Accordingly, under AIA, the scope of prior art with respect to the applicability of earlier-filed, later-published application by others is greater than those of Europe or Japan because they can be used for both novelty and obviousness rejections. Thus, a European or a Japanese patent application that did not encounter such rejections could still face them in the United States.

Point #5: Inventors still have protections for their own actions under AIA.

The United States Patent and Trademark Office recently published new rules regarding inventor’s exceptions for their own actions and related matters. Some generalizations can be made. For example, actions by an inventor, if such actions were done a year or less before the effective filing date of the claimed invention, are not prior art against the inventor.[26] A journal article, which was published less than a year before the filing of a patent application, is one such example. Important exceptions for prior art also include earlier-filed later-published applications having a common inventor or common assignee and filed before the effective filing date of the second patent application.[27]

However, inventors should be wary of what disclosures that they publish before they file a patent application as well as should be concerned about intervening third-party disclosures. For example, an inventor’s second, intervening grace period disclosure of a new feature or a more specific description of subject matter previously disclosed (e.g., a later disclosure of a species vs. an initial disclosure of a genus) is applicable prior art against the patent application filed within one year from the inventor’s first disclosure.[28] Intervening third-party disclosures published during the one year grace period generally are applicable prior art and thus do not count towards the grace period; such third-party disclosures are disqualified only if the inventor’s earlier public disclosure disclosed as much of the subject matter as was disclosed in the third party disclosure.[29] Nevertheless, because most of the world utilizes a first to file system, prudent inventors would still be advised to file a patent application before publishing a journal article, for example.

Conclusion

Inventors and corporate executives alike should consider the following points: (1) five categories of prior art are to be considered for prior art analysis; (2) the earliest effective filing date of a patent or a patent application by others is the key criterion for prior art applicability but keeping evidence is still important in certain situations such as derivation disputes; (3) public use and sale are potential novelty-bars, irrespective of geographic location; (4) a published U.S. patent application claiming priority to an earliest effective filing date, can be used for novelty and obviousness bars, regardless of whether the earlier priority application was filed in an English language; and (5) inventors still have a one-year grace period for filing a patent application, but keep in mind that such a grace period is only applicable to filings in the United States, and that even certain types of inventors’ disclosures can be applicable prior art.

Note: This commentary does not represent legal advice and is merely a summary of general points about the scope of prior art in various jurisdictions. Comments on this article are appreciated. Should you have any questions, please contact the author at jpattumudi@aboutiplaw.com.


[1] We will briefly discuss exceptions for an inventor’s own prior art later.

[2] For example, a national application is entitled to right of priority based on an international application      designating at least one country other than the United States.

[3] For example, an international application designating the U.S. is entitled to a right of priority based on a prior foreign application, or a prior international application designating at least one country other than the U.S.

[4] For example, an international application designating the U.S. is entitled to benefit of filing date of a prior national application or an international application designating the United States, and a national application shall be entitled to the benefit of the filing date of a prior international application designating the United States.

[5] The effective filing date is the actual filing date of a patent or a patent application, or an earlier date when the patent or patent application claims priority to an earlier application.

[6] Covered generally; everything made available to the public by means of a written or oral description before the date of filing of the European patent application constitutes a novelty bar. EPC Article 54(2).

[7] Covered under the category previously described for patents; see also second table.

[8] Everything made available to the public by use and before the date of the filing of the European patent application constitutes a novelty bar. EPC Article 54(2); see endnote 9 for further info.

[9] Not specific; sale is covered by the catch-all provision under EPC Article 54(2); our European patent counsel, Manuel Schockmel of Dennemeyer and Associates, has kindly provided us with the following information: a mere sale or use of the invention can be a novelty-destroying event provided that it is available to the public without any bar of confidentiality restricting use or dissemination of the invention; this holds true even where the features of the invention are not readily ascertained from external examination (e.g., visual examination of the invention) but would require further analysis.

[10] Everything made available to the public in any other way and before the date of the filing of the European patent application constitutes a novelty bar. See EPC Article 54(2).

[11] Covered generally; inventions that were described in a distributed publication in Japan or a foreign country, prior to the filing of a patent application, constitute a novelty bar. See Article 29(iii) of the Patent Act of Japan.

[12] Covered under the category previously described for patents; see also specific table for discussion of published patent applications.

[13] Inventions that were publicly worked in Japan or a foreign country, prior to the filing of a patent application, constitute a novelty bar. See Article 29(ii) of the Patent Act of Japan; see also endnote 14 for further detail and information.

[14] Inventions that were publicly worked in Japan or a foreign country, prior to the filing of a patent application, constitute a novelty bar. See Article 29(ii) of the Patent Act of Japan. The mere public use and the mere sale of an invention are novelty-destroying events against others. However, this presumption is rebuttable. For example, Japanese civil procedure allows a person to challenge the general presumption that the prior use and sale are novelty bars if the features of the invention are not readily ascertainable to others through external examination or further analysis of the sold invention. Rieko Yamazaki, a colleague at the firm provided the foregoing advice.

[15] Inventions that were publicly known in Japan or a foreign country, prior to the filing of a patent application, constitute a novelty bar. See Article 29(i) of the Patent Act of Japan.

[16] General standard for prior art criteria applies; an earlier-filed EPO application of another, is prior art against a later-filed application provided that the EPO application was published prior to the filing date of a later application. See EPC Articles 54 and 56.

[17] Articles 29(1) and 29(2) of the Patent Act of Japan.

[18] EPC Article 54(3); contrast with Article 29bis of Patent Act of Japan

[20] An earlier-filed U.S. patent application of another is applicable prior art from earliest effective filing date provided that the application is subsequently published.

[21] For purposes of this article, we use the term “earliest effective filing date,” to be consistent with US AIA language. For example, EPC Article 87 allows a “right of priority” for a later-filed application within twelve months from the date of filing of the first application.

[22] EPC Article 158(2); AIA appears to be broader than EPC patent law because a published PCT application is that designated the U.S. is considered prior art from earliest effective filing date, even if the PCT application has not entered the U.S. national phase.

[23]  78 Fed. Register 11059, 11063 (February 14, 2013).

[24] Articles 29(1), 29(2) and 39 of Patent Act of Japan

[25] Article 29bis of Patent Act of Japan

[26] See 35 U.S.C. § 102(b)(1)(A)-(B); in addition to actions by an inventor, actions by a joint inventor, or by another who obtained the subject matter disclosed directly or indirectly from the inventor or joint inventor, are also to be considered for prior art exceptions.

[27] See 35 U.S.C. § 102(2)(C); under certain circumstances, applications having a common inventor or a common assignee, are not prior art.

[28] 78 Fed. Register 11059, 11077 (February 14, 2013).

[29] Id., citing 78 Fed. Register 11067.

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{8db1ecb3-604b-4ace-9b9d-b20683e69874}_Topblog_100x100Pharma IQ put out it’s list of the Top Pharma Bloggers for 2013. These lists tend to be subjective and always leave off many great sites. But, these can be a good way to discover a blog you haven’t been following.  The only downside is that when you follow great blog’s like those by Kurt Karst or Ed Silverman, they can make you feel like a real slacker in comparison to all they do.

Here are Pharma IQ’s picks:

Pharmalot:  Pharmalot is edited by Ed Silverman, a prize-winning journalist who has covered the industry for 16 years, and comes from the publishers of the PharmaLive website.  Recent posts have included an interview with Tom Abrams, head of the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion.

PharmaGossip: This blog claims to look “beyond the spin of big pharma PR” and has recently reported on stories including a suggestion in a research paper published in the European Journal of Clinical Investigation that drugs companies have too much influence over medical research. PharmaGossip is a popular source of news and opinion, with nearly 9,400 followers on Twitter.

PJ Online: The PJ Online blog is linked to the website of the Pharmaceutical Journal, which itself is affiliated with the Royal Pharmaceutical Society, although all publications are editorially independent of the society. A range of figures keep the blog updated with regular posts, ranging from students and trainees to practising pharmacists and consultants.

Drug Channels: Written by Adam J Fein, chief executive of Drug Channels Institute and president of Pembroke Consulting, Drug Channels focuses on pharmaceutical economics and the distribution system. It aims to offer “timely analysis and provocative opinions” on topics such as the fast-growing specialty drugs market, industry trends and legal aspects of the supply chain.

European Journal of Hospital Pharmacy blog: The European Journal of Hospital Pharmacy blog from the British Medical Journal is a good source of news and information about the pharma industry in the UK and on the continent. Recent posts have looked at the growing problem of drug-resistant tuberculosis and the impact of benzodiazepines on pneumonia.

FDA Law Blog: This is the official blog of Hyman, Phelps & McNamara, the largest dedicated food and drug law firm in the US. Overseen by Kurt Karst, a director at the firm, and Jeffrey Wasserstein, whose areas of expertise include pharmaceutical marketing and compliance, the blog explores topics ranging from drug development to fraud and abuse.

IN VIVO: IN VIVO provides regular commentary on biopharmaceutical business development, research and development, financing, marketing and policy. The blog’s latest post looked at the growth of Isis Pharmaceuticals, which recently confirmed a new tie-up with Roche and also counts AstraZeneca, GlaxoSmithKline and Bristol-Myers Squibb among its biopharma partners.

Patent Baristas: This lighthearted, coffee-themed blog is run by Stephen Jenei, who is also the owner of a business and intellectual property law firm specialising in the biotechnology, pharmaceutical and chemical fields.It focuses on patent issues facing drug manufacturers, as do the Patent Docs and IPWatchdog blogs.

Pharma Marketing Blog: The Pharma Marketing Blog has been called a “must read” for industry insiders by the Wall Street Journal and described as “often entertaining and always informative” by MedAdNews editor-in-chief Christiane Truelove. Posts are provided by John Mack, the publisher and editor of independent monthly newsletter Pharma Marketing News.

In the Pipeline: Derek Lowe, the author of In the Pipeline, has worked with a number of major pharmaceutical companies since the late 1980s, contributing to projects targeting schizophrenia, Alzheimer’s, diabetes and other diseases.His blog focuses on the drug discovery process and also looks at issues of interest to the pharma industry in general.

Pharma IQ is an online portal where experts and industry professionals share their knowledge and insight on a huge range of topics across the pharma and biotech industries.

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The question of to what extent genes are patentable will be argued before the Supreme Court on April 15. The Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics may finally settle a long-standing controversy.

This whole brouhaha has to do with U.S. Patent Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 6,033,857.  The composition claims cover two “isolated” human genes, BRCA1 and BRCA2 and certain mutations in these genes associated with a predisposition to breast and ovarian cancers. Representative composition claims include claims 1, 2, and 5 of the ’282 patent:

1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2.  The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5.  An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

Patentable Subject Matter

Under the Patent Act, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101.

The Supreme Court has consistently construed § 101 broadly, explaining that “[i]n choosing such expansive terms . . . modified by the comprehensive ‘any,’ Congress plainly contemplated that the patent laws would be given wide scope.” Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (quoting Chakrabarty, 447 U.S. at 308).

Supreme Court  precedents provide three judicially created exceptions to § 101’s broad patent-eligibility principles: “laws of nature, physical phenomena, and abstract ideas.”

Here, the Plaintiffs challenge Myriad’s composition claims directed to “isolated” DNA molecules and method claims directed to “analyzing” or “comparing” DNA sequences under § 101.

Composition Claims: Isolated DNA Molecules

Myriad argues that an isolated DNA molecule is patent eligible because it is, as claimed, “a nonnaturally occurring composition of matter” with “a distinctive name, character, and use.”

The Plaintiffs argue that claims to isolated DNA molecules fail to satisfy § 101 because such claims cover natural phenomena and products of nature. The Plaintiffs assert that to be patent eligible a composition of matter must also have a distinctive name, character, and use, making it “markedly different” from the natural product.

Petition for Certiorari

The petition for certiorari requesting that the Supreme Court review the constitutionality of the matter posed the following questions:

Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent-eligible simply by removing (“isolating”) the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case therefore presents the following questions:

1. Are human genes patentable?

2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court’s ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?

3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision inMedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its  patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?

The Supreme Court has granted certiorari only on question 1.

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What:

Southern Methodist University Dedman School of Law’s “10th Annual Symposium on Emerging Intellectual Property Issues: The Federal Circuit and Patent Law.” The Symposium will focus on the U.S. Court of Appeals for the Federal Circuit and its unique role in the development of the nation’s patent law.

Presented by SMU Dedman School of Law, this Symposium will address the latest theories and practices important to the development of intellectual property law and explore emerging issues of intellectual property law through discussions with distinguished academics, jurists and leaders in the industry.

When:

Friday, March 22, 2013.

Where:

The Hillcrest Classroom in the SMU Dedman School
of Law Underwood Law Library at 6550 Hillcrest Road,
Dallas, TX, 75205

Registration

For more information, inlcuding CLE approval information, or to register for the event, please click here.

$125. Seating is limited; registration is first-come, first-serve. This fee covers the symposium session, continental breakfast, lunch, and a copy of the speaker materials.

Register online at www.law.smu.edu and click under “Upcoming Events.”

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