Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Reported: Aviva Lev-Ari, PhD, RN

Dr. Lev-Ari agrees with Mr. Chris Gladwin:

“Chris thinks that first-to-file and the new Act will better enable new technology businesses and new technology jobs.”

Leahy-Smith America Invents Act Implementation

Beginning on September 16, 2012, the inventor’s oath or declaration provision became effective.  This provision simplifies several of the requirements for filing an inventor’s oath or declaration.  We have summarized the changes relating to the content required to be included in an inventor’s oath or declaration, the situations when an AIA-compliant inventor’s oath or declaration is required, the use of an Application Data Sheet (ADS), delayed submission of an inventor’s oath or declaration, and the process for taking advantage of a combination assignment-statement document.  Stayed tune for more guidance regarding other aspects of the inventor’s oath or declaration provision in the coming weeks concerning the use of various USPTO forms for the inventor’s oath or declaration provision, correction of inventorship, and substitute statements.

Content for an AIA Compliant Inventor’s Oath or Declaration

Section 115 of Title 35, as amended by the AIA, coupled with new USPTO rules, requires an applicant to provide less information in an inventor’s oath or declaration than required by
pre-AIA law.  Specifically, the AIA eliminated the need for identification of the inventor’s country citizenship and a statement that the inventor is the first inventor. The list below identifies the current requirements for an inventor’s oath or declaration based on the AIA:

• Inventor’s name (in the case of joint inventorship, each inventor may sign his/her own oath or declaration provided that an ADS is filed with the application naming the complete inventive entity), residence, and mailing address;
• Identification of the relevant application to which the oath or declaration relates;
• Statement that the application was made or was authorized to be made by the declarant;
• Statement that such individual believes himself/herself to be an original inventor/joint inventor of a claimed invention in the application; and
• An acknowledgement of penalties that any willful false statement made in such oath or declaration is punishable under 18 U.S.C. 1001 by fine or imprisonment of not more than 5 years, or both

When to File an AIA-Compliant Inventor’s Oath or Declaration 

An AIA-compliant inventor’s oath or declaration is required for any application filed on or after September 16, 2012.  This covers non-provisional applications, including continuing applications (i.e., continuation, continuation-in-part, divisional, and “bypass” applications) and reissue applications.  A “bypass” application refers to an international (PCT) application filed as a continuing application under 35 U.S.C. 111(a) and 37 C.F.R. 1.53(b) and thus “bypassing” national stage entry under 35 U.S.C. 371.  For an international (PCT) application filed before September 16, 2012, and entering the national stage on or after September 16, 2012, an
AIA-compliant inventor’s oath or declaration is not required.  But for an international (PCT) application filed after September 16, 2012, and entering the national stage after September 16, 2012, an AIA-compliant inventor’s oath or declaration is required.  The table below summarizes the situations when an AIA-compliant inventor’s oath or declaration is needed.

Use of an Application Data Sheet (ADS)

An ADS is a document containing bibliographic information regarding an application, such as the identity of the named inventors, the identity of the applicant if different from the inventors, and any foreign priority or domestic benefit information.

An ADS must be filed with an application where: (i) submission of the inventor’s oath or declaration is to be postponed; (ii) each inventor’s oath or declaration identifies only the inventor (or person) executing that particular oath or declaration and not all of the inventors; (iii) there is a claim for domestic benefit (37 C.F.R. 1.78), or foreign priority claim (37 C.F.R. 1.55)(except foreign priority for national stage applications); or (iv) there is an identification of applicants other than the inventors under 37 C.F.R. 1.46 (except for national stage applications, where the applicant is the person identified in the international stage).

As to situations (i) and (ii), the Office must know the names of all of the inventors before examination begins in order to apply the correct prior art and to make a proper double patenting determination.

As to situation (iii), the Office has centralized the location of foreign priority and domestic benefit claims to the ADS.  This benefits applicants, the public, and the Office by making it easier to find this information.  Further, the Office will recognize such claims only if they appear in the ADS.

As to situation (iv), the Office needs to know who the applicant is, particularly where a power of attorney is being submitted by other than the inventors.

Finally, even when an ADS is not required, it is a best practice to use an ADS to aid in the correct identification of bibliographic information on the filing receipt.  An ADS must be signed by the applicant or the applicant’s representative.

Postponed Submission of an Inventor’s Oath or Declaration

Where an inventor’s oath or declaration or a signed ADS is not submitted on filing of the application, the Office will mail a notice to file missing parts requiring either an oath or declaration, or an ADS.  Surcharge practice has not changed.  Submission of an inventor’s oath or declaration later than the filing date of the application will cause the Office to mail a notice to file missing parts requiring a surcharge if not already paid, even where an ADS is submitted with the application on filing.  Where an ADS has been submitted, the Office will not mail a missing parts notice requiring submission of the inventor’s oath or declaration.  The Office may, however, mail an informational notice to notify the applicant that an inventor’s oath or declaration has not been submitted for each named inventor or that the submitted oath or declaration is non-compliant.  Where the application is otherwise in condition for allowance, the Office will mail a Notice of Allowability with a 3 month non-extendable period to submit the required inventor’s oath or declaration.

Combination Assignment and Inventor’s Oath or Declaration

An assignment document may contain the statements required to be included in an inventor’s oath or declaration and thereby serve as the inventor’s oath or declaration.  The Office reference to such a dual purpose document as an “assignment-statement.”  If an applicant chooses to file an assignment-statement and reduce the number of documents to be submitted to the USPTO for a particular application, the applicant must record the assignment-statement in the USPTO Assignment Database.

To record an assignment-statement in the Office’s Assignment Database, the assignment recordation cover sheet must set forth the application number.  Additionally, the assignment-statement must identify the application to which it relates, such as by name of the inventors, title of the invention, and the attorney docket number on the specification as filed.  See MPEP 602 VI.

The best practice is to file an assignment-statement electronically per the following steps.  First, the applicant should file the application via EFS-Web and immediately obtain the application number.  Second, on the same day that the applicant files the application, the applicant should submit the assignment-statement for recording via the Electronic Patent Assignment System (EPAS).  In EPAS, the applicant should check the box on the assignment recordation cover sheet to indicate that the document is intended to have a dual purpose (i.e., as both an assignment and the inventor’s oath or declaration).  Checking the box on the assignment recordation cover sheet will trigger the Office to place a copy of the assignment-statement into the application file as well as record it in the assignment database.  If the assignment-statement is recorded on the same day that the application is filed, the applicant can avoid paying the surcharge for the delayed filing of the inventor’s oath or declaration.

SOURCE:

http://www.uspto.gov/aia_implementation/index.jsp

FORBES reported on November 13, 2012

The new patent law put into place by the America Invents Act on September 16, 2011, goes into effect Spring 2013. This marks a fundamental change in US patent protection, moving away from the current first-to-invent rule to the international standard, first-to-file.

Will the new patent law endanger American entrepreneurs? (Photo credit: Wikipedia)

“Effectively, this creates a race to the patent office,” according to Patrick Richards of Richards Patent Law PC. “In a race of established, well-funded businesses with defined intellectual property protection strategies (and patent attorneys in-house or working closely with the business) versus entrepreneurs that may not have any experience with the patent system and the funds to pursue robust patent strategies, the advantage clearly goes to the businesses,” Richards said.

Although some aspects of the change are positive, including a reduced fee structure, the entrepreneur, who above all wants to “gain more certainty about their business plan at an early stage,” is likely to find the changes a net negative, Richards said.

“There are a lot of people that think (first-to-file) might favor large businesses, but no one knows how it’s going to affect” the business climate, according to Chas Rampenthal, general counsel at online legal services provider LegalZoom.com.

A solo entrepreneur who follows the rules carefully in acquiring a patent “has a pretty good leg up,” Rampenthal said, noting the law change actually reduces patent fees and possibly quickens the process.

Although companies with more resources can certainly win the race to getting in line, it “doesn’t get them a leg up on doing the inventing themselves.” He said the solo entrepreneur with a great idea remains ahead of the patent game.

What will be the impact on new business creation?

Anna Prata, an interim and turnaround executive who has worked with both Fortune 500 corporations and startups, sees trouble for entrepreneurs and investors alike. Prata says “this shift favors big companies with broad reach, resources and capabilities. They can quickly file while startups without cash on hand will not be able to protect their idea.” Prata thinks that thus far most early stage entrepreneurs didn’t need to make filing a top priority, especially not prior to fundraising, knowing they invented something and could prove it. But with the new law that’s no longer the case. “Why keep innovating if you do not have the resources to file first and claim ownership? It could really inhibit new company creation,” she said.

Prata thinks the impact of the new patent law on venture funding could also be pronounced: “VCs invest on the future promise of technology that will be patented at some point, knowing that if the start up failed they could retain the patented technology as an asset.” If that promise is threatened, she sees less investment dollars on ideas alone.

The End of Entrepreneurs?

Prata is also concerned about the potential effect on the American dream. Historically an entrepreneur could create and a large corporation would buy the entrepreneur’s company – it was cheaper to buy the little guy’s patent than attempt to re-invent it themselves. But what if corporations became a threat to entrepreneurs instead of their salvation as a rich class of buyers?  Why would a corporation buy the entrepreneur’s company if it could come up with a variation on the theme and quickly file its own patent?

Veteran Entrepreneurs Say Bring it On

Veteran entrepreneur Chris Gladwin, founder and CEO of Cleversafe, knows a thing or two about patents, having authored 300+ issued and pending patents relating to dispersed storage technology. His take is that the patent reform act is a good idea. “In addition to aligning with international patent offices that are all on a first-to-file system, it is materially easier to operate.  First-to-invent is just too hard to measure.  It is practically impossible to know if a prior invention is lurking that hasn’t yet been filed; as a result, a first-to-invent system inhibits investment in new technology areas.” Chris thinks that first-to-file and the new Act will better enable new technology businesses and new technology jobs.

Neil Kane, founder of Advanced Diamond Technologies and now CEO of GlucoSentient, agrees with Gladwin: “I think it’s a net positive. There is a huge misconception about first-to-file. People incorrectly assume that if you give a presentation about an invention or idea, someone in the audience can run to the USPTO with your idea and patent it before you do.” Kane says that’s not the case, that in fact your public disclosure becomes what is known as “prior art” and would invalidate a patent filing.

Sure There’s the Law, But What About Patent Trolls?

Venture capitalist Matt McCall of New World Ventures in Chicago is among those who think the new patent law is a net plus. “Patents are not core in our process. Patents don’t keep players out but can help from being sued.” McCall hopes the new law hinders patent aggregators, often called “patent trolls”, who sue firms they claim infringe on their patents.  “We’ve had too many companies victimized by trolls who have no intent to commercialize, just tax tech firms.”

Nancy Hill, president of the American Association of Advertising Agencies, says the new law “doesn’t solve the problem in our industry.” Ad agencies are a prime example of the creation of new intellectual property, building web-based products and services on top of open source code for clients and believing they are free and clear of patent claims. Hill says agencies believe they are building products “in the public domain” but continue to face legal challenges from patent trolls, making for an impossible situation that won’t be improved by the new law taking effect.

Lev-Ari, A., (2012O). Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers

http://pharmaceuticalintelligence.com/2012/07/30/biosimilars-intellectual-property-creation-and-protection-by-pioneer-and-by-biosimilar-manufacturers/

Lev-Ari, A., (2012P). Biosimilars: Financials 2012 vs. 2008

http://pharmaceuticalintelligence.com/2012/07/30/biosimilars-financials-2012-vs-2008/

Lev-Ari, A., (2012Q). Biosimilars: CMC Issues and Regulatory Requirements

http://pharmaceuticalintelligence.com/2012/07/29/biosimilars-cmc-issues-and-regulatory-requirements/

 

The AIA is the First Universally Equal Patent Law in the World

Written by Ken-Ichi Hattori Partner, Westerman Hattori Daniels & Adrian, LLP Posted: October 14, 2012 @ 9:07 pm

 

All member countries of the Paris Convention and the PCT approve the novelty of an invention claimed in the patent application going back to the priority date in the origin country.  Therefore, as to the novelty of a claimed invention, all member countries treat foreign and domestic patent applications equally.  Still, the member countries’ treatment of the “grace period” poses a serious issue: no patent law in any country recognizes the grace period as starting from the priority date, but only from the domestic filing date.

Thus, if a U.S. inventor publishes his invention, files a U.S. patent application within one year, and files a Japanese patent application within one year from the U.S. filing date claiming priority, he will get a U.S. patent but not a Japanese patent.  This is so because the Japanese Patent Law allows a six-month grace period from the Japanese filing date, not U.S. priority date. This six-month grace period is same in the rest of world except for the United States and Korea.

The AIA broke this barrier by giving both the novelty and the grace period on an effective filing date which goes back to the original filing date, so long as there is priority claim to the original foreign application date.  Thus, under AIA, both U.S. and foreign applications are completely equal with respect to both novelty and grace period.

This is extremely unusual, since no other country provides a grace period commencing from the priority date. In this respect, the AIA is the first and sole universally equal patent law in the world.

 

 

Public Disclosure Before Filing and Its Potential Abuse

There is a new unique prior art exception (grace period) under §102(b)(1)(A), (B) and (b)(2)(B) of the AIA.

If U.S. inventor A publicly discloses his invention and files a U.S. patent application within one year, his disclosure is not a prior art against his own U.S. application (for convenience, I’ll call this grace period as a standard grace period since other countries’ patent offices also have similar (six-month) grace period). Moreover, even if a third party B publicly publishes same subject matter prior to A’s patent application, or even if B files a patent application on same subject matter prior to A’s patent application, B’s subject matter disclosed in his publication or in B’s patent application is not prior art (for convenience, I’ll call this period as an absolute grace period since this is completely different from the standard grace period).  Thus, U.S. inventor A can obtain a patent regardless of B’s prior act is either publication or patent application.

However, if U.S. inventor A files a foreign application within one year from the U.S. application date claiming priority, he cannot obtain a foreign patent since no foreign countries recognize a grace period from the priority date.

In contrast, a foreign inventor has a huge advantage created by the AIA.  If a Japanese inventor publicly publishes an invention, files a patent application in the Japanese Patent Office within six months (the standard grace period under Japanese Patent Law), and files a U.S. application claiming priority within one year, the Japanese inventor can get a patent both in Japan and in the U.S.  This is so because the AIA recognizes a grace period from the earliest effective filing date which is the priority date.

Even if the Japanese inventor publicly publishes the invention one year before his Japanese application and files a U.S. application within one year from the Japanese filing date, the Japanese inventor can still get a U.S. patent although he cannot get a Japanese patent due to his own publication.

Thus, a Japanese inventor or an inventor in any other foreign country can publicly disclose his invention almost two years before the U.S. filing date!  As such, the AIA works better for a foreign applicant than for a U.S applicant.

Moreover, the prior art exception under AIA §102(b)(1)(A), (B) and (b)(2)(B), does not specify languages for the public disclosure.  Suppose an inventor A in a remote foreign country publicly discloses an invention in an unusual foreign language, files a patent application in his county within one year, and files a U.S. application claiming priority within one year, the foreign inventor A can get a U.S. patent by removing as prior art a third party’s disclosure or U.S. patent application concerning the same subject matter disclosed which was filed immediately after the foreign inventor A’s public disclosure.  The foreign inventor A’s U.S. patent application may be filed almost two years from the foreign inventor A’s public disclosure.

And it is quite possible that someone in a remote foreign country might try to abuse this prior art exception.

There is a further unique advantage by foreign inventors. Suppose a foreign inventor files a foreign application but not files a U.S. application for some reasons. The foreign application will be published as a laid-open publication after 18 months of the filing. Then, the foreign inventor all of sudden changed his mind and files a U.S. application within one year from the laid-open publication. Will the laid-open publication be given the absolute grace period by excluding subsequent third party’s disclosure or a U.S. patent application? Since the Federal Court traditionally treats the foreign patent publication as an inventor’s own publication for the purpose of pre-AIA §102 (b), it appears it is quite likely so.

Potential Conflict with Paris Convention

As explained above, under AIA §102(b)(2)(B), once a foreign inventor publishes a subject matter, due to the absolute grace period, he can exclude subsequent U.S. patent application describing same subject matter for almost two years.  It seems that he can extend priority date for almost two years, perhaps conflicting with Paris Convention Article 11 which defines as follows:

(1)  The countries of the Union shall, in conformity with their domestic legislation, grant temporary protection (Authors’ note: grace period) to patentable inventions, utility models, industrial designs, and trademarks, in respect of goods exhibited at official or officially recognized international exhibitions held in the territory of any of them.

(2)  Such temporary protection shall not extend the periods provided by Article A (Authors’ note: one year priority period). If, later, the right of priority is invoked, the authorities of any country may provide that the period shall start from the date of introduction of the goods into the exhibition.

Article 11 (1) allows the Union countries to provide temporary protector, i.e., a grace period, however, (2) also requires that it shall not extend one year priority period as defined in Article 4.

AIA §102 (b)(2)(B)provides not just a standard grace period but the absolute grace period on the foreign filing date since the foreign investor’s public disclosures exclude subsequent U.S. application for almost two years.

Although Paris Convention Article 4 and 11 depict a particular situation in which an inventor disclosed his invention in an exhibition and then files a patent application, it is still covered by AIA §102 (b)(2)(B), and whether or not AIA §102 (b)(2)(B) conflicts with Paris Convention Articles 4 and 11 is a future question for the Federal courts.

 Hybrid Patent Law

AIA is a first-to-file system if an inventor files a patent application without disclosing his invention prior to filing the patent application since a patent is granted to the applicant who has filed the patent application having the earliest effective filing date.

However, due to the absolute grace period, AIA has essentially the nature of a first-to-publish or even first-to-invent aspect since the publication date can often be the invention date.

The USPTO publishes an examination guideline which states that the subject matter the inventor published must be identical to the subject matter disclosed by the third party to mitigate the first-to-publish effect. More precisely, it proposes that if there is “insubstantial change, or only trivial or obvious variation” in the two subject matters, the exception does not apply. Some say that, in order to apply §102(b)(1)(B), not only must the subject matter be identical, but also the disclosures (the way how the subject matter is published) must be identical as well.

I believe this is wrong in view of §102(b)(1)(B).  Section 102(b)(2)(B) concerns the situation where a first inventor publicly published a subject matter and filed a first patent application, it excludes another inventor’s second patent application disclosing the same subject matter which was filed before the first patent application.

The USPTO also proposes in the above examination guideline that if there is “mere insubstantial change or only trivial or obvious variation” in the two subject matters, the exception does not apply. Thus, the USPTO treats §102(b)(1)(B) and (b)(2)(B) same as to the sameness between the two subject matters.

However, under §102(b)(2)(B), the first inventor’s disclosure is always different from the second inventor’s disclosure since the former is either a printed publication, or public use, or on sale while the latter is always a patent specification.

Thus, unless it is the subject matter which must be identical, §102(b)(2)(B) will never be applied. Therefore, same should be true under §102(b)(1)(B).

U.S. Patent With Priority Claim is a Strong Prior Art

Under Pre-AIA §102(e), the reference date of a U.S. patent with priority claim is the U.S. filing date unless the foreign patent application is published in English.

However, under AIA §102(d), the reference date is the earliest effective filing date which should be the foreign application date. Thus, the U.S. patents with priority claim become extremely strong prior art. This is especially so, since strict §112 is not required to the description in the foreign specification.

 AIA is Tough Patent Law for the U.S. Inventors

This means that the AIA is the tough patent law for the U.S. because of the following reasons:

• U.S. applicant cannot get benefit of the standard and absolute grace periods on the earliest effective filing date in a foreign countries whereas foreign applicant can get benefit of their own standard grace period (usually six months) and complete benefit of AIA’s standard and absolute grace periods in the U.S. on the earliest effective filing date.
• U.S. patent claiming foreign priority becomes stronger prior art under AIA §102 (d); and
• Prior art of public use and on sale is now worldwide activity.

Thus, unless foreign countries adapt both standard and absolute grace period at the earliest effective filing date, U.S. applicants will get less benefit.

The big question for the U.S. is whether or not the foreign patent offices will adopt the AIA grace periods. Korea Patent Office has extended its standard grace period from six months to one year  from the Korean filing date but not from the foreign priority date.  No other countries have indicated thus far that it would adapt the AIA grace period.

A Big Mystery of AIA Application

The first-to-file provision of §102 will be applied to a new patent application filed on or after March 16, 2013.

AIA provides as follows:

—Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18-month period beginning on the date of the enactment of this Act, and shall apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—

(A) a claim to a claimed invention that has an effective filing date as defined in section 100 (i) of title 35, United States Code, that is on or after the effective date described in this paragraph; or

(B) (omitted here)

Thus, if a new application filed on or after the effective date has one claim having the effective filing date on or after the effective date, AIA § 102 is applied to the entire application. If so, AIA § 102 is also applied to other claims having the effective filing date BEFORE the effective date and how those claims will be examined?

Suppose a Japanese applicant publicly published subject matter A on June 30, 2012, filed a Japanese application claiming subject matter A on October 30, 2012, and then files a U.S. application having claims A and B respectively on March 16, 2013, claiming priority to the Japanese application.

The U.S. application is considered as AIA application because of new matter claim B. Thus, claim A is also examined under AIA § 102.

If so, will the public publication on June 30, 2012, have effects of § 102 (b)(1)(B) and (b)(2)(B)? Will it exclude third party’s disclosure of same subject matter A or U.S. application disclosing same subject matter A which was filed after June 30, 2012, but before October 30, 2012?

If AIA § 102 takes effect ONLY after the effective date, it is possible to argue that there will be no application of AIA § 102 before the effective date for any claims.

However, how can one argue that, while AIA § 102 is applied to examine the retroactive claims, but, § 102 (b)(1)(B) and (b)(2)(B) are not applied?

USPTO’s examination guideline draft does not address on this issue. This is also a question that the Federal Court should resolve.

About the Author

Ken-Ichi Hattori is a partner in the Washington, DC law firm of Westerman Hattori Daniels & Adrian, LLP.

SOURCE:

http://www.ipwatchdog.com/2012/10/14/the-aia-is-the-first-universally-equal-patent-law-in-the-world/id=28850/